protocolSection
dict | hasResults
bool 2
classes | documentSection
dict |
|---|---|---|
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Dexmedetomidine 0.5 mic/kg"
},
{
"name": "Tramadol 1mg/kg"
},
{
"name": "Paracetamol 10mg/kg"
}
]
},
"conditionsModule": {
"conditions": [
"Percutaneous Nephrolithotripsy (PCNL)"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cairo",
"contacts": [
{
"email": "[email protected]",
"name": "Neveen Kohaf, Ph.D",
"phone": "+201069482380",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Hany Bauiomy, M.D",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Ahmed M. Abosakaya, M.D",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Egypt",
"facility": "Neveen Kohaf",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": null,
"status": "RECRUITING",
"zip": "11865"
}
]
},
"descriptionModule": {
"briefSummary": "The insertion of a urinary catheter in a patient undergoing a surgical procedure, especially urinary interventions, may lead to catheter-related bladder discomfort (CRBD) with varying degrees of severity during the postoperative period. Paracetamol is a drug with proven efficacy for the management of mild and moderate postoperative pain. Tramadol is a centrally acting, synthetic opioid analgesic with weak opioid agonist properties. It inhibits the detrusor activity by inhibition of type-1 muscarinic (M1) and type-3 muscarinic (M3) receptors. Dexmedetomidine, a highly selective α2-adrenergic receptor agonist, with analgesic, sedative, anxiolysis, sympatholytic, and sedative properties, is a very useful associated agent for general anesthesia."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "20 Years",
"sex": "MALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Adding Dexmedetomidine or Tramadol to Paracetamol- An Effort to Attenuate Catheter Related Bladder Discomfort",
"nctId": "NCT06274333",
"orgStudyIdInfo": {
"id": "RC.18.1.2024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The incidence of catheter-related bladder discomfort (CRBD)"
}
],
"secondaryOutcomes": [
{
"measure": "Postoperative pain"
},
{
"measure": "Meperidine requirement"
},
{
"measure": "Patient satisfaction"
},
{
"measure": "Surgeon satisfaction"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Benha University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Al-Azhar University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-28"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Group A: holistic approach"
},
{
"name": "Group B: Tolak® Standard of use"
}
]
},
"conditionsModule": {
"conditions": [
"Actinic Keratoses"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Wuppertal",
"contacts": null,
"country": "Germany",
"facility": "CentroDerm GmbH",
"geoPoint": {
"lat": 51.27027,
"lon": 7.16755
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This study is conducted in one center in Germany, in adult subjects having actinic keratoses (grade I or II) lesions on the scalp and meeting specific inclusion/exclusion criteria. The purpose of the study is to evaluate a holistic management (efficacy, tolerability and lesion cosmetic outcomes) of Tolak® treatment."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Lipikar Urea 30% Before Actinic Keratoses Treatment",
"nctId": "NCT06274320",
"orgStudyIdInfo": {
"id": "LRP22002 LIPIKAR UREA 30%",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in lesion response rate"
}
],
"secondaryOutcomes": [
{
"measure": "Percentage change"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Cosmetique Active International"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Transversus abdominis plane block"
}
]
},
"conditionsModule": {
"conditions": [
"Anesthesia, Local"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Detroit",
"contacts": [
{
"email": "[email protected]",
"name": "George M McKelvey, PhD",
"phone": "313-598-6036",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Justin Hruska, M.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Detroit Medical Center Detroit Receiving Hospital",
"geoPoint": {
"lat": 42.33143,
"lon": -83.04575
},
"state": "Michigan",
"status": "RECRUITING",
"zip": "48201"
},
{
"city": "Detroit",
"contacts": [
{
"email": "[email protected]",
"name": "George M McKelvey, PhD",
"phone": "313-598-6036",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Justin Hruska, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Detroit Medical Center, Harper University Hospital",
"geoPoint": {
"lat": 42.33143,
"lon": -83.04575
},
"state": "Michigan",
"status": "RECRUITING",
"zip": "48201"
}
]
},
"descriptionModule": {
"briefSummary": "This study aims to assess the efficacy of Transversus Abdominus Plane (TAP) blocks, a well-established anesthetic technique, to decrease the amount of post-operative pain in patients who undergo minimally invasive gynecologic surgeries. During minimally invasive gynecologic surgeries, the abdomen is inflated with pressurized air for visualization purposes and released at the end of the surgery. Traditionally, TAP blocks are performed by injecting long-acting local anesthetic agents under ultrasound guidance into the abdominal wall after abdominal surgery after the air has been emptied from the abdomen for additional anesthetic coverage post-operatively. This study proposes a novel approach: that performing TAP blocks while the abdomen is still insufflated will result in better post-operative pain outcomes as compared to the traditional method."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The treatment group (Group 1) will have a transversus abdominis plane (TAP) block performed with an insufflated abdomen in the operating room. The control group (Group 2) will receive the traditionally performed standard of care TAP block performed in the post-anesthesia care unit",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "The patient will be unaware of their grouping allotment. The outcomes assessor will be unaware of the patient grouping allotment.",
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 120,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficacy of Transversus Abdominis Plane Block",
"nctId": "NCT06274307",
"orgStudyIdInfo": {
"id": "IRB-21-10-4045",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Time to perform TAP Block"
},
{
"measure": "TAP block attempts"
},
{
"measure": "Pain Score Visual Analog Scale (VAS) 0 Hours Post Surgery"
},
{
"measure": "Pain Score Visual Analog Scale (VAS) 1 Hours Post Surgery"
},
{
"measure": "Pain Score Visual Analog Scale (VAS) 2 Hours Post Surgery"
},
{
"measure": "Pain Score Visual Analog Scale (VAS) 4 Hours Post Surgery"
},
{
"measure": "Pain Score Visual Analog Scale (VAS) 24 Hours Post Surgery"
},
{
"measure": "Postoperative Opioid Consumption"
},
{
"measure": "Ease of performing TAP Block-anatomical plane visualization"
},
{
"measure": "Ease of performing TAP Block-performance efficacy"
},
{
"measure": "Patient satisfaction"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Justin Hruska"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-06-22"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "CT-P13"
}
]
},
"conditionsModule": {
"conditions": [
"Inflammatory Bowel Diseases"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to compare induction treatment with CT-P13 SC to induction treatment with CT-P13 IV in terms of pharmacokinetics in adult patients with inflammatory bowel disease (IBD) who have been diagnosed for at least 3 months and for whom the physician has decided to initiate treatment with infliximab CT-P13 as part of the standard of care.The main aim of this study is to demonstrate that induction treatment with CT-P13 SC is non-inferior to CT-P13 IV in terms of pharmacokinetics at Week 6."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The full sample size comprises 130 patients, with 65 patients allocated to each arm. The arms are defined as follows:* Experimental Arm: Patients receive CT-P13 SC at weeks 0, 1, 2, 3, 4, and 6, followed by subcutaneous administration every two weeks until week 24.* Control Arm: Patients receive CT-P13 IV at weeks 0 and 2, followed by subcutaneous administration every two weeks until week 24.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 130,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PASSPORT",
"briefTitle": "Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous as Induction Therapy in Patients With Active CD or UC",
"nctId": "NCT06274294",
"orgStudyIdInfo": {
"id": "2023/12",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Ratio SC/IV"
}
],
"secondaryOutcomes": [
{
"measure": "Ctrough at week 24 (non-inferiority)"
},
{
"measure": "AUC at week 24"
},
{
"measure": "Clinical response at week 6 and week 24"
},
{
"measure": "IBD disability index at week 6"
},
{
"measure": "Fecal calprotectin at week 24"
},
{
"measure": "Clinical remission at week 6 and week 24"
},
{
"measure": "Presence of antibodies to infliximab at Week 6 and Week 24"
},
{
"measure": "Concentration of C-reactive protein up to week 6 (the samples are collected at weeks 0, 6 and 24)"
},
{
"measure": "Adverse events, including injection site reactions and hypersensitivity reactions"
},
{
"measure": "TSQM collected at Week 6 and Week 24"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Paris IBD Center"
},
{
"name": "Celltrion HealthCare France"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "CMC Ambroise Paré"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Digital Telerehabilitation"
},
{
"name": "Usual care"
}
]
},
"conditionsModule": {
"conditions": [
"Functional Movement Disorder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Verona",
"contacts": null,
"country": "Italy",
"facility": "Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona",
"geoPoint": {
"lat": 45.4299,
"lon": 10.98444
},
"state": null,
"status": null,
"zip": "37131"
},
{
"city": "Verona",
"contacts": null,
"country": "Italy",
"facility": "USD Parkinson's Disease and Movement Disorders Unit",
"geoPoint": {
"lat": 45.4299,
"lon": 10.98444
},
"state": null,
"status": null,
"zip": "37134"
}
]
},
"descriptionModule": {
"briefSummary": "Functional motor disorders (FMDs) are a broad spectrum of functional neurological disorders, including abnormal gait/balance disorders. Patients experience high degrees of disability and distress, equivalent to those suffering from degenerative neurological diseases. Rehabilitation is essential in their management. However, the current systems of rehabilitation delivery face two main challenges. Patients are not receiving the amount and kind of evidence-based rehabilitation they need due to the lack of rehabilitation professionals and experts in the field. The rehabilitation setting is not adequate for the long-term management and monitoring of these patients. Digital medicine is a new field that means \"using digital tools to upgrade the practice of medicine to one that is high-definition and far more individualized.\" It can upgrade rehabilitation practice, addressing the existing critical components towards marked efficiency and productivity. Digital telerehabilitation will increase the accessibility to personalized rehabilitation by expert professionals placing tools to monitor the patient's health by themselves.The increasing development and availability of portable and wearable technologies are rapidly expanding the field of technology-based objective measures (TOMs) in neurological disorders. However, substantial challenges remain in (1) recognizing TOMs relevant to patients and clinicians to provide accurate, objective, and real-time assessment of gait and activity in a real-world setting and (2) their integration into telerehabilitation systems towards a digital rehabilitation transition.This feasibility study provides preliminary data on the integration of a real-time gait and activity analysis by wearable devices in the real world with a digital platform to improve the diagnosis, monitoring, and rehabilitation of patients with FMDs."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "This is an experimental single-blind randomized-controlled trial (RCT) with 2-parallel arms comparing the effects between the experimental group (EG) and control group (CG). After screening, a simple randomization list will be generated by a physician using an automated randomization system (alloca-tion ratio 1:1) to assign eligible patients to either the EG or the CG. Group allocation will be kept concealed.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "The outcome assessor will be blinded to the type of intervention performed by the patient.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Digital Telerehabilitation in Functional Motor Disorders",
"nctId": "NCT06274281",
"orgStudyIdInfo": {
"id": "TOMs_FMD",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "number of patients who accept/refuse the treatment, physiotherapy compliance and falls or event near falling occurred during rehabilitation"
},
{
"measure": "Budget issues related to TOMs"
},
{
"measure": "Time spent to train patients"
}
],
"secondaryOutcomes": [
{
"measure": "Change in the Simplified Functional Movement Disorders Rating Scale (S-FMDRS) score"
},
{
"measure": "Multidimensional Fatigue Inventory Scale (MFI-20) score"
},
{
"measure": "Change in the Brief Pain Inventory (BPI) score"
},
{
"measure": "Change in the Beck Depression Inventory (BDI-II) score"
},
{
"measure": "Change in the Beck Anxiety Inventory (BAI) score"
},
{
"measure": "Change in the 12-item Short-Form Health Survey (SF-12) score"
},
{
"measure": "The EuroQol-5D (EQ-5D)"
},
{
"measure": "iMTA Productivity Cost Questionnaire"
},
{
"measure": "Change in the Clinical Global Impression (CGI) score"
},
{
"measure": "Gait outcome: Gait speed"
},
{
"measure": "Gait outcome: Stride length"
},
{
"measure": "Gait outcome: Cadence"
},
{
"measure": "Balance outcome: CoP trajectory"
},
{
"measure": "Balance outcomes: Sway area"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Universita di Verona"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-02-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Sarcopenia diagnostic test"
}
]
},
"conditionsModule": {
"conditions": [
"Sarcopenia",
"Oncology",
"Physical Inactivity",
"Toxicity Due to Chemotherapy"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to learn about the effect of sarcopenic status on the occurrence of treatment-related toxicity during the first course of anti-cancer treatment in several types of cancers.The main question it aims to answer is :Is sarcopenia a predictive marker for the occurrence of toxicity in the initial phase of cancer treatment?The evaluation will focus on the body composition of the participants, assessed by impedancemetry, and on their muscular performance by standardized physical tests."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Prospective cohort study",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 700,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "SARC-ONCO",
"briefTitle": "Effect of Sarcopenia on the Occurrence of Toxicity Related to Anti-cancer Treatments",
"nctId": "NCT06274268",
"orgStudyIdInfo": {
"id": "CHMS23006",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Event-free survival according to sarcopenic statut"
}
],
"secondaryOutcomes": [
{
"measure": "Event-free survival according to the link between: 1/ the dose/lean mass ratio and 2/ body composition and the occurrence of adverse events linked to treatment."
},
{
"measure": "Progression free-survival"
},
{
"measure": "Overall survival"
},
{
"measure": "Objective response rate at 6 and 12 months"
},
{
"measure": "Number of patients classified as sarcopenic by BIA method and CT method."
},
{
"measure": "Exploratory: Event-free survival during PACLITAXEL protocol"
},
{
"measure": "Exploratory: Level of spontaneous activity measurement by accelerometry (m.s-2)."
},
{
"measure": "Exploratory: RCB-based objective response rate at 6 and 12 months"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Université Savoie Mont Blanc"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Centre Hospitalier Metropole Savoie"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Migraine, Magnesium, Pediatric"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Balıkesir",
"contacts": [
{
"email": "[email protected]",
"name": "Hilal Aydın, assoc. Dr.",
"phone": "+902666121461",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Hilal Aydın, assoc. Dr.",
"phone": "+905072607541",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Hilal Aydın",
"geoPoint": {
"lat": 39.64917,
"lon": 27.88611
},
"state": "Türkiye",
"status": null,
"zip": "33343"
},
{
"city": "Mersin",
"contacts": null,
"country": "Turkey",
"facility": "Aysen Orman",
"geoPoint": {
"lat": 36.79526,
"lon": 34.61792
},
"state": "Türkiye",
"status": null,
"zip": "33343"
},
{
"city": "Mersin",
"contacts": [
{
"email": "[email protected]",
"name": "Aysen Orman",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Aysen Orman",
"phone": "3242410000",
"phoneExt": "2646",
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "MersinU",
"geoPoint": {
"lat": 36.79526,
"lon": 34.61792
},
"state": "Türkiye",
"status": null,
"zip": "33343"
},
{
"city": "Mersin",
"contacts": [
{
"email": "[email protected]",
"name": "Aysen Orman, assoc. Dr.",
"phone": "+903242410000",
"phoneExt": "+903242410000",
"role": "CONTACT"
},
{
"email": null,
"name": "Aysen Orman, assoc. Dr.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Turkey",
"facility": "Aysen Orman",
"geoPoint": {
"lat": 36.79526,
"lon": 34.61792
},
"state": "Türkiye",
"status": null,
"zip": "38000"
}
]
},
"descriptionModule": {
"briefSummary": "Aim: The purpose of this study is to compare serum magnesium levels between patients with migraine and a control group and to examine the relationship between the frequency and duration of attacks in patients with migraine and mean serum magnesium levels.Material-Method: Patients diagnosed presenting to the Balıkesir University Medical Faculty pediatric neurology clinic between 01.09.2019 and 01.04.2023 and diagnosed with migraine were enrolled retrospectively. Patients diagnosed with migraine were included as the study group and healthy children presenting to the pediatric neurology clinic in the same period as the control group. The demographic characteristics (age, sex, and body mass index) of the patient group and their clinical (attack durations and frequencies, symptoms during attacks, and treatments) and laboratory (hemoglobin, hematocrit, platelet, glucose, calcium, magnesium, vitamin D, folate and ferritin levels) characteristics were recorded."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "72 Months",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": "Migraine",
"briefTitle": "Serum Magnesium Level and Pediatric Migraine",
"nctId": "NCT06274255",
"orgStudyIdInfo": {
"id": "BalikesirU",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Serum Magnesium Level and Pediatric Migraine"
}
],
"secondaryOutcomes": [
{
"measure": "Serum Magnesium Level and Pediatric Migraine"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mersin University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Haruna"
},
{
"name": "Placebo Powder"
}
]
},
"conditionsModule": {
"conditions": [
"Constipation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nakhon Pathom",
"contacts": null,
"country": "Thailand",
"facility": "Mahidol University",
"geoPoint": {
"lat": 13.8196,
"lon": 100.04427
},
"state": null,
"status": null,
"zip": "73170"
}
]
},
"descriptionModule": {
"briefSummary": "Mixed Natural Prebiotic-Fibers Impact on Stool Frequency and Fecal Microbiota in Constipated Thai Adults: A Randomized Clinical Trial."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 98,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Mixed Natural Prebiotic-Fibers Impact on Stool Frequency and Fecal Microbiota in Constipated Thai Adults",
"nctId": "NCT06274242",
"orgStudyIdInfo": {
"id": "MU-CIRB 2022/300.0711",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in Stool Frequency"
},
{
"measure": "Change in Fecal Microbiota"
}
],
"secondaryOutcomes": [
{
"measure": "Change in Stool consistency"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mahidol University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-19"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2023-07-22"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-10"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Air pollution and noise reducing installations"
}
]
},
"conditionsModule": {
"conditions": [
"Psychological Stress",
"Psychological Well-Being",
"Pollution; Exposure"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Berlin",
"contacts": [
{
"email": "[email protected]",
"name": "Farid I Kandil, PhD",
"phone": "+491605631744",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "Charité -- Universitaetsmedizin Berlin",
"geoPoint": {
"lat": 52.52437,
"lon": 13.41053
},
"state": null,
"status": "RECRUITING",
"zip": "14109"
}
]
},
"descriptionModule": {
"briefSummary": "To reduce stress among urban residents, the consortium members of the European Council Horizon 2020 research program DivAirCity install different stress reducing, noise reducing and air quality improving means in the five cities of the consortium. This study measures physiological and psychological stress and health factors before and after the implementation of the project (at intervention sites) and compares the change (improvement) to the change in comparable places where no means were installed (control site)."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "ECOLOGIC_OR_COMMUNITY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 1000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "DivAirCitySH",
"briefTitle": "DivAirCity Social Health Survey",
"nctId": "NCT06274229",
"orgStudyIdInfo": {
"id": "EA4/252/23",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Questionnaire for General Physiological Health"
},
{
"measure": "Questionnaire about feelings of safety and security at the site"
}
],
"primaryOutcomes": [
{
"measure": "WHO-5 Well-being Scale"
}
],
"secondaryOutcomes": [
{
"measure": "Kessler K6 psychological distress"
},
{
"measure": "ASKU questionnaire"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Universitat Politècnica de València"
},
{
"name": "Universitatea din Bucuresti"
},
{
"name": "University of Aarhus"
},
{
"name": "Fondazione C.N.R./Regione Toscana \"G. Monasterio\", Pisa, Italy"
},
{
"name": "European Commission"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Charite University, Berlin, Germany"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-20"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Vitamin D3"
},
{
"name": "Vitamin E 400"
}
]
},
"conditionsModule": {
"conditions": [
"Osseointegration Failure of Dental Implant"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Karachi",
"contacts": null,
"country": "Pakistan",
"facility": "Afifa Razi",
"geoPoint": {
"lat": 24.8608,
"lon": 67.0104
},
"state": "Sindh",
"status": null,
"zip": "74700"
}
]
},
"descriptionModule": {
"briefSummary": "Dental implantation is a new technique for the single or more missing tooth replacement. Dental professionals might utilize the findings of this investigation to generate local data and learn more about how vitamin D affects bone metabolism and implant osseo-integration. The long-term success of dental implants would also be enhanced and preserved with the right medical use of vitamin D"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The research commences through a self-administered questionnaire such as age, gender, weight, height, BMI, smoking habits, sun exposure, and employment status.Prior to implant surgery, each participant undergoes a blood test to assess their vitamin D levels.Detailed records are maintained concerning the anatomical position (molar, pre-molar, canine, and incisor) and implant site (maxilla and mandible) for every participant.Group Formation: The participant pool is stratified into two distinct groups - Group A and Group B. This categorization is essential for implementing and comparing different interventions within the study. Group A undergoes a specific intervention wherein they receive a daily oral dose of 5000 IU of vitamin D3 for a duration of 12 weeks. In contrast, Group B receives a placebo.Following the intervention period, the implants are allowed to cure adequately",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Groups A and B were created out of all patients who had signed up. Patients in group A received 5000 IU of vitamin D3 orally every day for 12 weeks , whereas patients in group B received a placebo. Patients were blinded to the study medication. The implants were then allowed to cure adequately and submerged for a further three months. Patients were summoned back three months later to un-cover the implant.The both groups were compared for the difference of osseo-integration at 3 months, as well as difference of osseo-integration were compared with respect to implant site (maxilla and mandible).Additionally, change in vitamin D levels were also assessed pre-operatively and post-operatively at 3 months.",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 100,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Vitamin D Supplementation on Dental Implant Osseointegration: A Randomized Controlled Trial",
"nctId": "NCT06274216",
"orgStudyIdInfo": {
"id": "4381021ABOS",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Osseo-integration is measured by evaluating the ISQ value (Implant Stability Quotient, ranging from 1-100)"
}
],
"secondaryOutcomes": [
{
"measure": "Evaluation of Mean Change in Serum Vitamin D Levels in Dental Implant Patients with and without Vitamin D Supplementation at a Tertiary Care Hospital"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ziauddin University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-03-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-09-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Vitamin D3"
}
]
},
"conditionsModule": {
"conditions": [
"Sickle Cell Disease",
"Vitamin D Deficiency",
"Health Related Quality of Life",
"Hand Grip Strength",
"Bone Mineral Density"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Zagazig",
"contacts": null,
"country": "Egypt",
"facility": "Zagazig university",
"geoPoint": {
"lat": 30.58768,
"lon": 31.502
},
"state": "Sharkia",
"status": null,
"zip": "44519"
}
]
},
"descriptionModule": {
"briefSummary": "Suboptimal vitamin D status is well reported in sickle cell disease (SCD) patients and associated with a negative impact on health-related quality of life (HRQL). The investigators enrolled 42 SCD patients and 42 healthy controls, subjects within each group received monthly oral vitamin D3 dose according to the baseline status of vitamin D as follows: sufficient: 100,000 IU, insufficient: 150,000 IU, and deficient: 200,000 IU. The investigators assessed safety and efficacy on normalization of vitamin D level, bone mineral density (BMD), hand grip strength (HGS), and HRQL."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 75,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "High Dose Vitamin D Supplementation in Children With Sickle Cell Disease",
"nctId": "NCT06274203",
"orgStudyIdInfo": {
"id": "10584-2/5-2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Serum 25(OH)D level"
}
],
"secondaryOutcomes": [
{
"measure": "Bone mineral density (BMD)"
},
{
"measure": "Maximum handgrip strength (HGS)"
},
{
"measure": "Health related quality of life (HRQL)"
},
{
"measure": "Serum concentrations of C reactive protein (CRP)"
},
{
"measure": "Serum concentrations of Erythrocyte sedimentation rate (ESR)"
},
{
"measure": "Safety reporting of any adverse events"
},
{
"measure": "Safety measurements of serum Ca"
},
{
"measure": "childhood health assessment"
},
{
"measure": "Safety measurements of serum 25(OH)D levels"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Zagazig University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-02-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-01-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-05-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "bowel e-diary"
}
]
},
"conditionsModule": {
"conditions": [
"Rectal Cancer",
"LARS - Low Anterior Resection Syndrome"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Colorectal cancer is the 2nd and 3rd most common cancer in respectively women and men, of which about 40% is located in the rectum. The gold standard treatment for rectal cancer (RC) is a low anterior resection, combined with chemoradiotherapy. However, this treatment will negatively impact different aspects of bowel function and the patients' quality of life. These bowel symptoms often remain prevalent, even at 12 months after RC treatment. Most assessment tools are however not capable of capturing the full range or therapeutic-related evolution of these bowel symptoms. Consequently, the aim is to develop a validated bowel diary for diagnosing and evaluation of all bowel symptoms."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 118,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "Treatable",
"briefTitle": "Personalized Care Pathways for Bowel Symptoms in Rectal Cancer patients_development of E-diary",
"nctId": "NCT06274190",
"orgStudyIdInfo": {
"id": "S68746",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Selection of items for the newly developed bowel diary"
},
{
"measure": "Assessment of content validity of the newly developed bowel diary in a post-Delphi patient focus group consisting of 8-12 participants"
},
{
"measure": "The usability of the newly developed e-diary, assessed with the System Usability Scale (SUS) in patients after rectal surgery for rectal cancer"
},
{
"measure": "The usability of the newly developed e-diary will be evaluated through conversations with patients who have undergone rectal surgery for rectal cancer, after these patients have used the e-diary for seven consecutive days"
},
{
"measure": "Construct validity of the newly developed bowel e-diary"
},
{
"measure": "Criterion validity of the newly developed bowel e-diary"
},
{
"measure": "Test-retest reliability of the newly developed bowel e-diary"
},
{
"measure": "Responsiveness of the newly developed bowel e-diary in patients after rectal surgery for rectal cancer. The newly validated e-diary is the primary outcome."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Universitaire Ziekenhuizen KU Leuven"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "KU Leuven"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-29"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "BTL-785-7"
}
]
},
"conditionsModule": {
"conditions": [
"Fat Burn"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Davie",
"contacts": null,
"country": "United States",
"facility": "Precision Skin LLC",
"geoPoint": {
"lat": 26.06287,
"lon": -80.2331
},
"state": "Florida",
"status": null,
"zip": "33328"
},
{
"city": "Chicago",
"contacts": null,
"country": "United States",
"facility": "Chicago Cosmetic and Dermatologic Research",
"geoPoint": {
"lat": 41.85003,
"lon": -87.65005
},
"state": "Illinois",
"status": null,
"zip": "60654"
},
{
"city": "Montclair",
"contacts": null,
"country": "United States",
"facility": "New Jersey Plastic Surgery (NJPS)",
"geoPoint": {
"lat": 40.82593,
"lon": -74.20903
},
"state": "New Jersey",
"status": null,
"zip": "07042"
},
{
"city": "Youngstown",
"contacts": null,
"country": "United States",
"facility": "Gentile Facial Plastic and Aesthetic Laser Center",
"geoPoint": {
"lat": 41.09978,
"lon": -80.64952
},
"state": "Ohio",
"status": null,
"zip": "44512"
}
]
},
"descriptionModule": {
"briefSummary": "This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive reduction of submental fat and skin laxity treatment."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 37,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "21 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of the BTL-785F Device for Submental Fat Reduction and Neck Rejuvenation",
"nctId": "NCT06274177",
"orgStudyIdInfo": {
"id": "BTL-785_CTUS1400",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Submental fat thickness reduction"
}
],
"secondaryOutcomes": [
{
"measure": "Incidence of Treatment-related Adverse Events"
},
{
"measure": "Change on the Clinician Reported - Submental Fat Rating Scale score"
},
{
"measure": "Satisfaction Assessed by the Satisfaction Questionnaire"
},
{
"measure": "Change in the submental-cervical angle"
},
{
"measure": "Comfort Assessed by Therapy Comfort Questionnaire"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "BTL Industries Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-07-26"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Electroencephalography/Polysomnography (EEG/PSG)"
},
{
"name": "Skin Biopsy"
},
{
"name": "Blood draw"
}
]
},
"conditionsModule": {
"conditions": [
"RAI1 Gene 17P11.2 Deletion+Duplication"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Houston",
"contacts": [
{
"email": "[email protected]",
"name": "Davut Pehlivan, MD",
"phone": "713-798-6970",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Texas Children's Hospital",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas",
"status": "RECRUITING",
"zip": "77030"
}
]
},
"descriptionModule": {
"briefSummary": "Currently, there is no clinically available genetic-based treatment for RAI1 (Retinoic Acid-Induced 1) -related disorders other than symptomatic management and there are no established clinical or molecular biomarkers that could be used as measures for the efficacy of therapy in future treatment studies. Biomarkers are measures of what is happening inside the body, shown by the results of laboratory, imaging or other tests.Biomarkers can help doctors and scientists diagnose diseases and health conditions, monitor responses to treatment and see how a person's disease or health condition changes over time.The goal of this observational and laboratory study is to develop clinical, neurophysiology and molecular biomarkers in RAI1-related disorders. The main question\\[s\\] it aims to answer are:* to characterize the disease features more precisely and analyze the differentiating and overlapping features of RAI1-related disorders (Smith-Magenis syndrome and Potocki-Lupski Syndrome)* to identify clinical, neurophysiology, and laboratory biomarkers that differentiate RAI1-related disorders one from another.Participants will have to complete:* a clinical examination* a blood draw* a skin biopsy (optional)* a sleep studyResearchers will compare patients' blood to control group's blood for biomarker studies."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 90,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "1 Month",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Clinical and Molecular Biomarker Studies in RAI1 (Retinoic Acid-Induced 1) -Related Disorders",
"nctId": "NCT06274164",
"orgStudyIdInfo": {
"id": "H-54820 / RAI1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Rate of neurological clinical finding"
},
{
"measure": "Rate of electroencephalogram (EEG) and/or sleep abnormalities"
},
{
"measure": "Concentration of downstream molecular pathway interactors of RAI1"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Doris Duke Charitable Foundation"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Baylor College of Medicine"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-01"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-13"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Naproxen 500 Mg"
},
{
"name": "Rehabilitation"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Muscle Strain, Multiple Sites",
"Inflammation"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Acute muscle strain injuries occur both during sports, in leisure time activities and during manual occupation and represent a major clinical challenge and has societal economic costs. The recovery time is long and a substantial injury recurrence is observed. Despite current best evidence rehabilitation with early mechanical loading, a significant loss of muscle mass, fatty infiltration and formation of scar tissue is reported.Animal models and human in vitro experiments suggest that inflammation is vital in the early period after an injury, however an inhibition of inflammatory processes is beneficial for healing.We investigate here whether a pharmacological inhibition of inflammatory pathways in the 2nd week following a muscle strain injury will provide a better clinical outcome and an advantageous cellular profile than rehabilitative training alone would."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Optimal Treatment of Acute Skeletal Muscle Injury",
"nctId": "NCT06274151",
"orgStudyIdInfo": {
"id": "H-22038917",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Effect of anti-inflammatory medicine on cellular profile in skeletal muscle"
}
],
"secondaryOutcomes": [
{
"measure": "Functional outcome performance"
},
{
"measure": "Functional outcome re-injury rate"
},
{
"measure": "Functional outcome Patient Related Outcome Measures (PROM)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Bispebjerg Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-07-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "haptonomy"
}
]
},
"conditionsModule": {
"conditions": [
"Infertility"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": null,
"country": "Turkey",
"facility": "Başkent University",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Pregnancies resulting from infertility treatment are considered normal and 'low-risk' in some countries, they often entail significant stress. Prenatal attachment may be experienced differently by parents conceiving through fertility interventions. The rising prevalence of fertility treatments is associated with increased risks such as preterm birth, low birth weight, and perinatal mortality for pregnancies achieved through infertility treatments. Beyond medical implications, post-infertility treatment pregnancies can induce high levels of anxiety and a perception of pregnancy as risky, affecting individuals psychologically. The transition to parenthood after infertility treatment can be psychologically challenging.Healthy prenatal attachment in expectant mothers fosters the development of a healthy role as both mother and father. Maternal bonding is closely tied to a woman's mental health during the prenatal period and her commitment to her baby. Similarly, prenatal bonding with the father sheds light on the emotional connection developing between the father and the unborn child. Active participation in prenatal experiences, such as attending ultrasound appointments or discussing parenting plans, contributes to a stronger sense of attachment for fathers and establishes a positive foundation for future bonding. Supportive partner relationships during pregnancy enhance paternal bonding and emphasize the importance of a collaborative approach to prenatal care for both parents. The prenatal period is critical for fathers to establish an early emotional connection with their unborn children, laying a positive groundwork for postnatal bonding.Various interventions aim to enhance communication between parents and augment prenatal attachment. One such practice is haptonomy-haptotherapy. Haptotherapy focuses on restoring emotional connections, especially with one's own body. It helps individuals recognize their emotional capacities and allows them to experience these capacities through insightful conversations, therapeutic touch, and skill exercises. In the context of pregnancy, haptonomy involves physical contact between the pregnant woman, her partner, and the unborn baby. Advocates of haptonomy believe that this touch-based communication can strengthen the bond between parents and the baby, promote a sense of security, and positively influence the pregnancy experience.Haptonomy is thought to contribute positively to the psychological well-being of women during pregnancy, birth, and the postpartum period, potentially preventing mental health issues and enhancing the health of both mother and baby. It is emphasized that haptonomy is a distinct practice focused on enhancing communication between parents and the baby. Existing literature suggests that haptonomy can increase emotional bonding during the prenatal period and may be effective for parents showing low attachment. Studies indicate that touch communication develops from the second month, involving vibrations for communicating with the fetus, ultimately increasing bonding through haptonomy. Furthermore, haptonomy is reported to enhance both spousal and parental attachment, as demonstrated in a study emphasizing increased attachment for fathers with their partners and children.Despite documented benefits of haptonomy in various patient groups, from cancer patients undergoing chemotherapy to pregnant women and those with chronic pain, limited research exists on haptotherapy for pregnant women. This study aims to investigate the impact of partner-administered haptonomy on prenatal attachment and marital adjustment in pregnant women. Conducted through a randomized controlled experimental design, the study seeks to provide evidence by enhancing prenatal attachments in both mothers and fathers.Research Hypotheses:H0-1: The application of haptonomy by partners has an effect on maternal attachment in pregnant women.H1-1: The application of haptonomy by partners does not have an effect on maternal attachment in pregnant women.H0-2: The application of haptonomy by partners has no effect on paternal attachment in pregnant women.H1-2: The application of haptonomy by partners has an effect on paternal attachment in pregnant women.H0-3: The application of haptonomy by partners has no effect on marital adjustment in pregnant women.H1-3: The application of haptonomy by partners has an effect on marital adjustment in pregnant women."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 76,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Enchanting Symphony of Haptonomy's Impact on Attachment and Spousal Harmony for Women Conceiving Through Infertility Treatment",
"nctId": "NCT06274138",
"orgStudyIdInfo": {
"id": "HAPTONOMY",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Marital adjustment score"
},
{
"measure": "Prenatal attachment score"
},
{
"measure": "Father attachment score"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Baskent University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-03-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-05"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-03-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Robotic-Assisted Laparoscopic Radical Prostatectomy"
}
]
},
"conditionsModule": {
"conditions": [
"Prostatectomy",
"Neutrophil Gelatinase-Associated Lipocalin",
"Kidney Function Tests"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": null,
"country": "Turkey",
"facility": "Ankara Bilkent City Hospital",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": "Çankaya",
"status": "RECRUITING",
"zip": "06530"
}
]
},
"descriptionModule": {
"briefSummary": "The main objective of this study is to evaluate whether blood NGAL measurement provides superiority over sCr and BUN tests in early diagnosis for assessing renal function in patients undergoing robotic urological surgery."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 55,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of Kidney Damage Using NGAL Measurements",
"nctId": "NCT06274125",
"orgStudyIdInfo": {
"id": "AslıDemircioglu1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The main objective of this study is to evaluate whether blood NGAL measurement has superiority over sCr and BUN tests in terms of early diagnosis for assessing kidney function in patients undergoing robotic urologic surgery."
}
],
"secondaryOutcomes": [
{
"measure": "The relationship between demographic parameters such as age, BMI, comorbidities, and ASA classification will be evaluated in relation to the development of AKI."
},
{
"measure": "The evaluation of the relationship between intraabdominal pressure and the development of AKI."
},
{
"measure": "The relationship between intraoperative mean arterial pressure (MAP) and NGAL (Neutrophil Gelatinase-Associated Lipocalin) values."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ankara City Hospital Bilkent"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "TMS"
}
]
},
"conditionsModule": {
"conditions": [
"Social Avoidant Behavior",
"Major Depressive Disorder",
"Social Anxiety Disorder"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "The purpose of this study is to use transcranial magnetic stimulation (TMS) to better understand the neural circuits associated with social motivation.Participant includes four study visits each that range from 1.5 - 3.0 hours in duration over approximately a one month period. The first study visit involves answering survey questions, a clinical interview, and computer tasks. The second study visit involves a magnetic resonance imaging (MRI) scan, computer tasks, and a brief TMS protocol. The second and third study visits involve a full session of TMS followed by an MRI scan and computer tasks.Adults in the Auburn/Apelika area who avoid social situations, experience symptoms of depression or social anxiety, and are between 25 years old and 50 years old are eligible to participate."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "All participants will receive each dose of TMS in a counterbalanced order (AB or BA)",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "25 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Using TMS to Understand Neural Processes of Social Motivation",
"nctId": "NCT06274112",
"orgStudyIdInfo": {
"id": "1K23MH135222",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Social motivation"
},
{
"measure": "Neural circuit function"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Auburn University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2029-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-09"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "nursing care"
}
]
},
"conditionsModule": {
"conditions": [
"Hemodialysis Complication",
"Nurse's Role"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Erzurum",
"contacts": [
{
"email": "[email protected]",
"name": "REVA BALCI AKPINAR, PROF. DR",
"phone": "+904422312214",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "RUKIYE DEMİR DIKMEN",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Turkey",
"facility": "Ataturk University",
"geoPoint": {
"lat": 39.90861,
"lon": 41.27694
},
"state": "Diğerleri",
"status": null,
"zip": "25200"
},
{
"city": "Erzurum",
"contacts": [
{
"email": "[email protected]",
"name": "REVA BALCI AKPINAR, PROF. DR",
"phone": "+904422312214",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Ataturk University",
"geoPoint": {
"lat": 39.90861,
"lon": 41.27694
},
"state": "Diğerleri",
"status": null,
"zip": "25200"
}
]
},
"descriptionModule": {
"briefSummary": "Kolcaba's comfort theory is a theory used by nurses to increase the comfort of patients. There are limited studies determining that nursing care provided according to this theory contributes to the increase in patients' comfort levels in various patient groups. This study will be carried out in the hemodialysis center of a public hospital located in the city center of Bingöl. Patients in the intervention group receiving hemodialysis treatment will be given nursing care by the researcher for 12 sessions during the sessions in which the patient receives hemodialysis treatment. In order to provide nursing care, nursing diagnoses suitable for the patient group will be determined in advance and the care the patient needs will be given according to these diagnoses.. If necessary, the researcher will add additional diagnoses to the preliminary diagnosis form and provide care.In this research, the individual nursing care needs of the researcher patient will be determined. Individualized caregiving is unique to this study. Individually provided care is expected to increase patient comfort and satisfaction. Increased comfort will help the patient cope more easily with the disease and hemodialysis treatment symptoms. In addition, the results of individual care provided can guide nurses in their care behaviors. By adding this research to the literature, the groundwork will be laid for studies that will provide individual care to patients. It is expected that the results of this research will guide the planning of the research and the provision of individualized care in all patient groups, especially patients receiving hemodialysis treatment."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "pretest posttest randomized controlled trial",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR",
"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": "The Effect of the Care Given to Hemodialysis Patients on Comfort Level and Complaints",
"nctId": "NCT06274099",
"orgStudyIdInfo": {
"id": "TDK-2023-12649",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "General Comfort Scale"
},
{
"measure": "Dialysis Symptom Index"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Atatürk University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Reva Balci Akpinar"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Two-session catheter-directed sclerotherapy"
}
]
},
"conditionsModule": {
"conditions": [
"Sclerotherapy",
"Endometrioma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Seoul",
"contacts": null,
"country": "Korea, Republic of",
"facility": "Asan Medical Center",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null,
"status": null,
"zip": "05505"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to evaluate the safety and clinical outcomes of two-session catheter-directed sclerotherapy (CDS) with 96% ethanol in patients with endometrioma. The main question it aims to answer is:• Is two-session CDS with 96% ethanol safe and effective for treating endometrioma?Participants will:* Receive the first session CDS for endometrioma* Carry the catheter overnight and be monitored in the patient ward* Receive the second session CDS the next day"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 22,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Two-session Catheter-directed Sclerotherapy Using Ethanol for Endometrioma",
"nctId": "NCT06274086",
"orgStudyIdInfo": {
"id": "S2022-2027-0001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Recurrence"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Asan Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2020-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Dorsal digital block"
},
{
"name": "Palmar digital block"
}
]
},
"conditionsModule": {
"conditions": [
"Laceration of Skin",
"Anesthesia, Local",
"Pain",
"Nerve Block"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": null,
"country": "Turkey",
"facility": "Ankara City Hospital Emergency Medicine Department",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to compare the traditional dorsal double injection digital block with the palmar single injection technique in the suturing of acute traumatic hand finger lacerations in terms of injection pain score (NRS), anesthesia onset time, and success of anesthesia.It is understood that single injection digital block and double injection digital block techniques do not have significant advantages over each other in terms of pain levels and procedure times.However, the need for rescue anesthesia was evaluated to be lower in the single injection digital block technique. This difference is especially due to measurements in the volar region incisions.According to the results of this study, we think that choosing the single injection digital block technique for volar region incisions is a more rational approach, especially in terms of the data of the need for rescue anesthesia."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Two parallel groups (two digital block techniques)",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 160,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Double-dorsal Versus Single-volar Digital Block",
"nctId": "NCT06274073",
"orgStudyIdInfo": {
"id": "E2-22-2566",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Anesthesia pain score"
}
],
"secondaryOutcomes": [
{
"measure": "Anesthesia onset time"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ankara City Hospital Bilkent"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-09-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-07-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-10-12"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Case management"
},
{
"name": "Food vouchers"
},
{
"name": "PrEP support buddy"
},
{
"name": "Community-based PrEP pickup points"
}
]
},
"conditionsModule": {
"conditions": [
"Pre-exposure Prophylaxis",
"HIV Infections"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Pietermaritzburg",
"contacts": [
{
"email": "[email protected]",
"name": "Chitra Singh, MSocSci",
"phone": "+27721516828",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Joel Steingo, MBChB, MPH",
"phone": "+27833009377",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Harry Hausler, MD, PhD, MPH",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Mfezi Mcingana, BA",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Jenny Mcloughlin, RN",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Joel Steingo, MBChB, MPH",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "South Africa",
"facility": "TB HIV Care",
"geoPoint": {
"lat": -29.61679,
"lon": 30.39278
},
"state": "KwaZulu Natal",
"status": "RECRUITING",
"zip": "3200"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this trial is to understand which strategies work best to support pre-exposure prophylaxis (PrEP) use among female sex workers (FSW) and adolescent girls and youth women (AGYW) in uMgungundlovu, KwaZulu-Natal, South Africa. Participants will be randomly assigned to receive a combination of up to four support strategies encourage the participants in continuing to use PrEP. The four strategies being tested are: case management, food vouchers, peer support buddies, and community-based PrEP pick-up points. The intention of this trial is to determine which PrEP support strategy or bundle(s) of strategies best promote(s) long-term PrEP use, so that these services can be scaled up to other districts in South Africa."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "FACTORIAL",
"interventionModelDescription": "This fractional factorial design includes four strategies resulting in 16 trial arms/conditions. The design compares results in arms with and without each of the strategies, but is not fully powered to test every combination of strategies.Thus, each strategy will be received by half of the participants, though the combinations of strategies will vary.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 304,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "16 Years",
"sex": "FEMALE",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Project Phakama: Testing Support Strategies to Empower Young Women on PrEP in South Africa",
"nctId": "NCT06274060",
"orgStudyIdInfo": {
"id": "135399",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "R01MH121161",
"link": "https://reporter.nih.gov/quickSearch/R01MH121161",
"type": "NIH"
},
{
"domain": "JHSPH IRB",
"id": "IRB00012628",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "PrEP persistence at 7 months after PrEP initiation"
},
{
"measure": "PrEP adherence at 7 months after PrEP initiation among all trial participants"
}
],
"secondaryOutcomes": [
{
"measure": "PrEP persistence at 1 month after PrEP initiation"
},
{
"measure": "PrEP persistence at 4 months after PrEP initiation"
},
{
"measure": "PrEP persistence at 13 months after PrEP initiation"
},
{
"measure": "PrEP adherence at 7 months after PrEP initiation among trial participants who provided dried blood spot samples"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "TB/HIV Care"
},
{
"name": "Unity Health Toronto"
},
{
"name": "National Institute of Mental Health (NIMH)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Johns Hopkins Bloomberg School of Public Health"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-19"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-16"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Apalutamide"
},
{
"name": "Androgen Deprivation Therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Androgen Axis Suppression",
"Prostatectomy",
"Prostate Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Houston",
"contacts": [
{
"email": "[email protected]",
"name": "Karen Hoffman, MD",
"phone": "713-563-2339",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Karen Hoffman, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "MD Anderson Cancer Center",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas",
"status": null,
"zip": "77030"
}
]
},
"descriptionModule": {
"briefSummary": "1. Personalize treatment for prostate cancer based on how aggressive the disease is and2. Learn if apalutamide-based treatment can help to reduce fatigue and other side effects of treatment in participants who are being treated with radiation therapy for prostate cancer, as compared to standard therapy."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 120,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "PROSTATE-IQ: Parallel RandOmized STudy of Personalized Apalutamide Treatment and Evaluation to Improve Quality of Life in Post-Operative Radiation With Androgen Axis Suppression. A Phase III Multi-center Study for Men With Detectable PSA After Prostatectomy for Prostate Cancer.",
"nctId": "NCT06274047",
"orgStudyIdInfo": {
"id": "2023-0409",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "NCI-CTRP Clinical Registry",
"id": "NCI-2024-01553",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Janssen Scientific Affairs, LLC"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "M.D. Anderson Cancer Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-28"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-08-31"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Electronic Health Record Review"
},
{
"name": "Medical Device Usage and Evaluation"
},
{
"name": "Meditation Therapy"
},
{
"name": "Survey Administration"
}
]
},
"conditionsModule": {
"conditions": [
"Breast 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": "Stacy D. D'Andre, 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 early phase I trial evaluates the feasibility and impact of a meditation headband system (MUSE-S) for breast cancer survivors. Anxiety and insomnia are among the most common distresses in breast cancer survivors during and after chemotherapy, in part due to the side effects of chemotherapy, fear of cancer coming back, progression of the cancer, and uncertainty of the future. These distresses impair patients' well-being and quality of life (QOL) in general, and their cancer treatment adherence and effectiveness in particular. Meditation has been demonstrated to be an effective management tool of stress and anxiety and is given the highest level of evidence (grade A) in the systematic review-based guidelines by the Society of Integrative Medicine. The portable, interactive, electroencephalographic (EEG) Muse headband guided meditation has been shown to improve fatigue, QOL, and stress in newly diagnosed breast cancer patients. The MUSE-S Headband System may decrease anxiety and insomnia among breast cancer survivors."
},
"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": 40,
"type": "ESTIMATED"
},
"phases": [
"EARLY_PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "MUSE-S Headband System for Improving Anxiety and Insomnia Among Breast Cancer Survivors",
"nctId": "NCT06274034",
"orgStudyIdInfo": {
"id": "23-006870",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "CTRP (Clinical Trial Reporting Program)",
"id": "NCI-2024-01019",
"link": null,
"type": "REGISTRY"
},
{
"domain": "Mayo Clinic Institutional Review Board",
"id": "23-006870",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Frequency of use of meditation"
},
{
"measure": "Feasibility of a wearable electroencephalographic (EEG) headband (Muse™ S Headband)"
},
{
"measure": "Impact of interactive meditation and sleep support through the Muse-S™ system"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mayo Clinic"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-08"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Transcutaneous spinal stimulation at 100 Hz"
},
{
"name": "Transcutaneous spinal stimulation at 50 Hz"
},
{
"name": "Transcutaneous spinal stimulation at 50 Hz and single dose of baclofen"
},
{
"name": "Transcutaneous spinal stimulation at 50 Hz and single dose of tizanidine"
},
{
"name": "Sham transcutaneous spinal stimulation"
}
]
},
"conditionsModule": {
"conditions": [
"Spinal Cord Injuries",
"Spinal Cord Injury",
"Spinal Cord Injury Cervical",
"Spinal Cord Injury Thoracic"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Jackson",
"contacts": [
{
"email": "[email protected]",
"name": "Dobrivoje S Stokic, MD, DSc",
"phone": "601-364-3314",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Methodist Rehabilitation Center",
"geoPoint": {
"lat": 32.29876,
"lon": -90.18481
},
"state": "Mississippi",
"status": null,
"zip": "39216"
},
{
"city": "Jackson",
"contacts": [
{
"email": "[email protected]",
"name": "Matthias J Krenn, PhD",
"phone": "601-364-3413",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of Mississippi Medical Center",
"geoPoint": {
"lat": 32.29876,
"lon": -90.18481
},
"state": "Mississippi",
"status": null,
"zip": "39216"
}
]
},
"descriptionModule": {
"briefSummary": "People with spinal cord injuries may experience muscle tightness or uncontrollable spasms. This study is being conducted to investigate whether transcutaneous spinal stimulation can improve these symptoms. Transcutaneous spinal stimulation is a non-surgical intervention by applying electrical currents using skin electrodes over the lower back and belly.The investigators want to see how well the intervention of transcutaneous spinal stimulation performs by testing different levels of stimulation pulse rates. Also, transcutaneous spinal stimulation is compared to muscle relaxants such as baclofen and tizanidine, commonly given to people with spinal cord injuries, to reduce muscle stiffness and spasms. By doing this, the investigators hope to discover if transcutaneous spinal stimulation similarly reduces muscle spasms and stiffness or if combining both methods works best. This could help improve treatment options for people with spinal cord injuries in the future."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "This study employs a crossover design, wherein each participant is systematically administered a sequence of five distinct interventions randomly. This approach ensures that every participant receives each intervention in a unique sequence. The design facilitates within-subject comparisons by minimizing inter-individual variability, as each participant effectively serves as their own control across the study phases. The random assignment of intervention sequences aims to balance potential carryover effects and period effects.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "The participants and assessors are kept unaware of which intervention is being administered. For this, the study drugs are designed to be visually identical for all participants, and the intervention and sham stimulation configuration is set without the assessor being present in the room.",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 16,
"type": "ESTIMATED"
},
"phases": [
"EARLY_PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Neuromodulation to Reduce Muscle Stiffness Following Spinal Cord Injury",
"nctId": "NCT06274021",
"orgStudyIdInfo": {
"id": "UMMC-IRB-2023-125",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change from baseline of posterior root reflexes (PRRs) recruitment curves."
},
{
"measure": "Change from baseline of flexion withdrawal reflex (FWR) response amplitude."
},
{
"measure": "Change from baseline of stretch reflex (SR) response amplitude."
},
{
"measure": "Change from baseline in muscle stiffness as measured by the Modified Ashworth Scale (MAS),"
},
{
"measure": "Change from baseline in spasms as measured by the Spinal Cord Assessment Tool for Spastic Reflexes (SCATS)."
}
],
"secondaryOutcomes": [
{
"measure": "Change from baseline of posterior root reflexes (PRRs) recruitment curves."
},
{
"measure": "Change from baseline of flexion withdrawal reflex (FWR) response amplitude."
},
{
"measure": "Change from baseline of stretch reflex (SR) response amplitude."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Methodist Rehabilitation Center"
},
{
"name": "The Craig H. Neilsen Foundation"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Mississippi Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Exparel"
}
]
},
"conditionsModule": {
"conditions": [
"ACL Tear",
"Opioid Misuse",
"Pain",
"Anxiety"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Orange",
"contacts": [
{
"email": "[email protected]",
"name": "Haydee Cortes",
"phone": "714-456-2837",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Kiran Athreya",
"phone": "9493064857",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "John Schlechter, DO",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Zeev N. Kain, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "United States",
"facility": "CHOC Children's Hospital",
"geoPoint": {
"lat": 33.78779,
"lon": -117.85311
},
"state": "California",
"status": "RECRUITING",
"zip": "92868"
}
]
},
"descriptionModule": {
"briefSummary": "Opioid misuse and addiction among children and adolescents is an increasingly concerning problem. Post-surgical opioid prescriptions for commonly performed surgeries such as anterior cruciate ligament reconstruction (ACLR) increase opioid exposure in young athletes. The purpose of the current study is to determine if extended-release Bupivacaine Liposome Injectable Suspension (Exparel) is effective in decreasing at home narcotic consumption compared to standard Bupivacaine Adductor Canal Block for Anterior Cruciate Ligament (ACL) reconstruction/reconstruction for the surgical treatment of adolescents with ACL tears and concomitant pathology i.e. meniscus / cartilage injury/tear."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 96,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "17 Years",
"minimumAge": "7 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Exparel vs. ACB With Bupivacaine for ACL Reconstruction",
"nctId": "NCT06274008",
"orgStudyIdInfo": {
"id": "230110",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "At-home narcotic consumption by the patients as measured by the medication form completed by parents post discharge"
}
],
"secondaryOutcomes": [
{
"measure": "Postoperative pain level of child"
},
{
"measure": "Functional disability of child"
},
{
"measure": "Parent and child anxiety"
},
{
"measure": "Child pain"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Children's Hospital of Orange County"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-12"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Behavioral Activation"
}
]
},
"conditionsModule": {
"conditions": [
"Depression",
"Suicide and Self-harm",
"Depression in Adolescence",
"Depression Mild",
"Depression Moderate",
"Depression Severe"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Houston",
"contacts": [
{
"email": "[email protected]",
"name": "Eric Storch, Ph.D.",
"phone": "713-798-3080",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Baylor College of Medicine",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas",
"status": "RECRUITING",
"zip": "77030"
}
]
},
"descriptionModule": {
"briefSummary": "Behavioral activation is one such empirically supported intervention. Derived from cognitive-behavioral therapy, a well-established treatment for depression, behavioral activation uses psychoeducation and skill-building to increase an individual's engagement in valued and enjoyable activities (e.g., socializing with family and friends, exercising, participating in a hobby) in order to improve depressive symptoms. Research has shown that behavioral activation is an effective intervention for depressed youth. Additionally, it has been shown as a promising intervention that can be conducted in a brief, virtual format and can be effectively implemented by both trained clinicians and trained, non-licensed interventionists. This project will provide Behavioral Activation for youth (12-17) experiencing depression or suicidal ideation who are currently enrolled in the Youth Depression Suicide Network study in Texas."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Single group, open-label behavioral activation",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 250,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "12 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Telehealth Behavioral Activation for Teens",
"nctId": "NCT06273995",
"orgStudyIdInfo": {
"id": "H-54233",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Patient Health Questionnaire 9-modified for adolescents (PHQ-A)"
},
{
"measure": "Behavioral Activation for Depression-Short Form (BAD-SF)"
},
{
"measure": "Dimensional Anhedonia Rating Scale (DARS)"
}
],
"secondaryOutcomes": [
{
"measure": "Strengths and Difficulties Questionnaire (SDQ)"
},
{
"measure": "Duke Social Support Index (DSSI)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Texas"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Baylor College of Medicine"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2029-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "STEP-UP (transdiagnostic behavioral therapy for pediatric anxiety and depression)"
},
{
"name": "ARC (assisted referral to community care)"
}
]
},
"conditionsModule": {
"conditions": [
"Depression, Anxiety"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to test a brief, behavioral telehealth treatment program (STEP-UP) for depression and anxiety in youths (age 8-16 years old). Youths and families will be recruited through participating community health centers and will be randomly assigned to either: (a) receive STEP-UP care from providers at their health center or (b) be referred to care from local community mental health clinicians. Youth and families will be interviewed before treatment starts, 16 weeks later, and 24 weeks later to assess how youth are feeling. The main question the study aims to answer is whether STEP-UP improves youths functioning in daily life, anxiety symptoms, and depression symptoms. Researchers will compare STEP-UP to referral to community treatment-as-usual mental health services to see if STEP-UP is more effective."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 220,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "16 Years",
"minimumAge": "8 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "STEP-UP",
"briefTitle": "Behavioral Telehealth in Low-resource Primary Care Settings for Anxiety and Depression in Youth",
"nctId": "NCT06273982",
"orgStudyIdInfo": {
"id": "1R01MH131698",
"link": "https://reporter.nih.gov/quickSearch/1R01MH131698",
"type": "NIH"
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Children's Global Assessment Scale (CGAS)"
},
{
"measure": "Pediatric Anxiety Rating Scale (PARS)"
},
{
"measure": "Children's Depression Rating Scale -- Revised (CDRS-R)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Kaiser Permanente"
},
{
"name": "OCHIN, Inc."
}
],
"leadSponsor": {
"class": "OTHER",
"name": "San Diego State University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-05-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-05-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Osteopathic Manipulative Treatment (OMT)"
}
]
},
"conditionsModule": {
"conditions": [
"Thoracic Outlet Syndrome"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The purpose of the study is to develop a protocol to assess blood flow in the upper limb vasculature before and after osteopathic manipulative treatment (OMT) using Pulsed-wave Doppler ultrasonography (US). We will assess the subclavian artery and vein at two locations (above and below the clavicle) and the brachial artery and vein (within the axilla) to determine the reproducibility of the blood flow findings at each location and the impact of OMT on the blood flow. Additionally we will qualitatively assess morphological changes of the brachial plexus before and after OMT with US."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Twelve consented male and/or female volunteers between the ages of 18 and 65 with intermittent tingling and/or numbness in one or both hands that has occurred with two weeks of the start date of the study will be evaluated using pulsed-wave doppler ultrasonography (US) and then treated with osteopathic manipulative treatment (OMT).US examination of the thoracic outlet will be performed using a Mindray-6 ultrasound machine and will include 4 views/positions with the subject in a seated position.The following intervention will consist of four osteopathic manipulation techniques (OMT) being performed that target the somatic dysfunctions associated with TOS. These techniques include: 1) Direct Thoracic Inlet Myofascial Release (TIMFR); 2) Direct Muscle Energy for the Scalene Muscles; 3) Direct Muscle Energy for the Pectoralis Muscles; and 4) Supraclavicular Fascial Release.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 12,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "TOS",
"briefTitle": "Ultrasonographic Evaluation of Osteopathic Manipulation for Thoracic Outlet Syndrome",
"nctId": "NCT06273969",
"orgStudyIdInfo": {
"id": "PK20240105- 001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Blood flow changes in the upper extremity."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "A.T. Still University of Health Sciences"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04-24"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-24"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"ITP - Immune Thrombocytopenia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Assiut",
"contacts": [
{
"email": "[email protected]",
"name": "Rania Mohammed Mahmoud Hafez, professor",
"phone": "+201000019198",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Yousreyia Abdel Rahman Ahmed, professor",
"phone": "+201223971307",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Aml Sayed Hamed",
"geoPoint": {
"lat": 27.18096,
"lon": 31.18368
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Assessment of bleeding scores in immune thrombocytopenia purpuria to explore the relationship between platelet count and bleeding score in immune thrombocytopenia purpura (ITP) and compare the clinical practicability of bleeding grading systems with adult patients with ITP."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 100,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Explore the Relationship Between Platelet Count and Bleeding Score in ITP",
"nctId": "NCT06273956",
"orgStudyIdInfo": {
"id": "bleeding scores in ItP",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "explore the relationship between platelet count and bleeding assessment systems (ITP Bleeding Assessment Tool (ITP -BAT) and ITP Bleeding Scale (IBLS) in Patients with ITP to measure severity of bleeding"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assiut University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-10-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-04-10"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Cabotegravir Tablets, for oral use."
},
{
"name": "Cabotegravir Extended-Release Injectable Suspension, for intramuscular use."
},
{
"name": "Tenofovir disoproxil/Emtricitabine 300mg/200mg fixed-dose combination tablets, for oral use"
},
{
"name": "Rectal Biopsies"
}
]
},
"conditionsModule": {
"conditions": [
"Prevention"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Paris",
"contacts": null,
"country": "France",
"facility": "Hôpital Hôtel Dieu",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": "Ile De France",
"status": null,
"zip": "75004"
},
{
"city": "Paris",
"contacts": null,
"country": "France",
"facility": "Hôpital Lariboisière",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": "Ile De France",
"status": null,
"zip": "75010"
},
{
"city": "Paris",
"contacts": null,
"country": "France",
"facility": "Hôpital Saint Louis",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": "Ile De France",
"status": null,
"zip": "75010"
},
{
"city": "Paris",
"contacts": null,
"country": "France",
"facility": "Hôpital Saint Antoine",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": "Ile De France",
"status": null,
"zip": "75012"
},
{
"city": "Paris",
"contacts": null,
"country": "France",
"facility": "Hôpital La Pitié Salpêtrière",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": "Ile De France",
"status": null,
"zip": "75013"
},
{
"city": "Paris",
"contacts": null,
"country": "France",
"facility": "Hôpital Necker",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": "Ile De France",
"status": null,
"zip": "75015"
},
{
"city": "Paris",
"contacts": null,
"country": "France",
"facility": "Hôpital Bichat",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": "Ile De France",
"status": null,
"zip": "75018"
},
{
"city": "Paris",
"contacts": null,
"country": "France",
"facility": "Hôpital Tenon",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": "Ile De France",
"status": null,
"zip": "75020"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to evaluate if offering long-acting injectable cabotegravir (CAB-LA) as an additional HIV prevention choice among oral PrEP-experienced men who have sex with men (MSM) in France can significantly increase the sustained PrEP use over time and the PrEP coverage of at-risk sexual risk behaviors."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Participants will be randomly assigned in a 1:1 ratio to remain on their current oral PrEP regimen with daily and/or on-demand TDF/FTC (Control arm) or to switch to a CAB-LA based PrEP (Intervention arm).",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 322,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CABOPrEP",
"briefTitle": "Impact of Long-acting Injectable Cabotegravir for HIV PrEP in MSM in France.",
"nctId": "NCT06273943",
"orgStudyIdInfo": {
"id": "ANRS 0410s CABOPrEP",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "2024-510678-25",
"link": null,
"type": "EUDRACT_NUMBER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of protocol visits completed with a documented PrEP prescription aligned with the randomization arm."
}
],
"secondaryOutcomes": [
{
"measure": "Number of protocol visits completed with a documented PrEP prescription aligned with the randomization arm."
},
{
"measure": "Number of participants with missing follow-up visits, temporary PrEP discontinuation, permanent PrEP discontinuation, switching to another PrEP regimen, study discontinuation, lost to follow-up."
},
{
"measure": "Number of participants whose last condomless anal sexual intercourse was not covered by PrEP."
},
{
"measure": "Number of condomless anal sexual intercourse in the month prior to each study visit."
},
{
"measure": "Number of sexual partners in the last 3 months."
},
{
"measure": "Mean PrEP satisfaction score based on study arm."
},
{
"measure": "Number of participants with syphilis, chlamydiae, and/or gonorrhea infection."
},
{
"measure": "Number of participants with Grade 2 or higher clinical or laboratory drug-related adverse events at any time during the study."
},
{
"measure": "Change from baseline in body weight (kg)."
},
{
"measure": "Change from baseline in lipids"
},
{
"measure": "Change from baseline in the insulin resistance index (HOMA-IR)."
},
{
"measure": "Number and severity of injection site reaction."
},
{
"measure": "Cabotegravir concentration in plasma and tenofovir diphosphate and emtricitabine triphosphate concentration in dried blood spots."
},
{
"measure": "Number of participants with new HIV infection."
},
{
"measure": "Number of participants who used psychoactive drugs in the last 3 months"
},
{
"measure": "Score of quality of life measured by the EuroQol-5D questionnaire"
},
{
"measure": "Depression score assessed with the Center for Epidemiologic Studies Depression Scale (CES-D)."
},
{
"measure": "Self-esteem score assessed with the Rosenberg scale."
},
{
"measure": "Number and nature of uses of community peer support and therapeutic patient education."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "ANRS, Emerging Infectious Diseases"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-10-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-10-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "5% CALCIUM SODIUM PHOSPHOSILICATE"
},
{
"name": "8% Arginine"
}
]
},
"conditionsModule": {
"conditions": [
"Sensitivity, Tooth"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rawalpindi",
"contacts": [
{
"email": null,
"name": "Muhammad J Iqbal",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Pakistan",
"facility": "AFID",
"geoPoint": {
"lat": 33.6007,
"lon": 73.0679
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "To assess the impact of the use of 5% Calcium Sodium Phosphosilicate or 8% Arginine dentifrices on dentinal hypersensitivity following non-surgical periodontal therapy in patients with periodontitis."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 87,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "30 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "Dentrifices",
"briefTitle": "Reduction of Dentine Hypersensitivity After Use of Different Dentifrices",
"nctId": "NCT06273930",
"orgStudyIdInfo": {
"id": "AFID",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To assess the impact on Dentinal hypersensitivity following the use of 5% CSPS or 8% Arginine following non-surgical periodontal therapy in patients with Periodontitis by VAS."
},
{
"measure": "To assess the impact on Dentinal hypersensitivity following the use of 5% CSPS or 8% Arginine following non-surgical periodontal therapy in patients with Periodontitis by Schiff scale."
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Armed Forces Institute of Dentistry, Pakistan"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "PRIDE"
}
]
},
"conditionsModule": {
"conditions": [
"Dementia"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chicago",
"contacts": [
{
"email": "[email protected]",
"name": "Scott Dresden, Dr.",
"phone": "312-926-6494",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Anuva Fellner",
"phone": "312-926-8816",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Northwestern Memorial Hospital",
"geoPoint": {
"lat": 41.85003,
"lon": -87.65005
},
"state": "Illinois",
"status": null,
"zip": "60611"
},
{
"city": "Lake Forest",
"contacts": [
{
"email": "[email protected]",
"name": "Timothy Loftus",
"phone": "312-926-6612",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Northwestern Medicine Lake Forest Hospital",
"geoPoint": {
"lat": 42.25863,
"lon": -87.84063
},
"state": "Illinois",
"status": null,
"zip": "60045"
},
{
"city": "Palos Heights",
"contacts": [
{
"email": "[email protected]",
"name": "JiHun Lee, DO",
"phone": "708-923-5811",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Northwestern Medicine Palos Hospital",
"geoPoint": {
"lat": 41.66809,
"lon": -87.79644
},
"state": "Illinois",
"status": null,
"zip": "60463"
}
]
},
"descriptionModule": {
"briefSummary": "Aim 1: To demonstrate the feasibility by determining proportion of completed medication reconciliation, Central Nervous System active Potentially Inappropriate Medication (CNS PIM) use among patients with Alzheimer's Disease and Related Dementias (ADRD) and Mild Cognitive Impairment (MCI) in the emergency department (ED), and communication between ED clinical pharmacists and outpatient prescribers.Aim 2: To demonstrate the feasibility of collecting the primary and secondary outcomes for a subsequent study. The future primary outcome will be reduction in CNS PIMs 90 days after an ED visit. Secondary outcomes will include outpatient follow-up, repeat ED visits, and hospitalizations during the 90 days following an ED visit.Aim 3: To demonstrate the acceptability of the PRIDE intervention to outpatient clinicians using the Acceptability of Intervention Measure and qualitative analysis of responses."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 290,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "120 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "IMPACT",
"briefTitle": "Deprescribing Potentially Inappropriate Medications in the Emergency Department for Persons Living With Dementia",
"nctId": "NCT06273917",
"orgStudyIdInfo": {
"id": "FY23_Pilot2_Dresden",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pharmacist communication of deprescribing recommendation"
}
],
"secondaryOutcomes": [
{
"measure": "Medication reconciliation"
},
{
"measure": "Medication supply of CNS PIMs"
},
{
"measure": "Outpatient follow up"
},
{
"measure": "Repeat Emergency Department visits"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Brown University"
}
],
"leadSponsor": {
"class": "NIH",
"name": "National Institute on Aging (NIA)"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Active transcranial focused ultrasound (tFUS)"
},
{
"name": "Sham transcranial focused ultrasound (tFUS)"
}
]
},
"conditionsModule": {
"conditions": [
"Anxiety Disorders"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Charleston",
"contacts": null,
"country": "United States",
"facility": "Medical University of South Carolina",
"geoPoint": {
"lat": 32.77657,
"lon": -79.93092
},
"state": "South Carolina",
"status": null,
"zip": "29425"
}
]
},
"descriptionModule": {
"briefSummary": "This is a study to find out if a cutting-edge technology called transcranial focused ultrasound (tFUS) can be used to treat how people with anxiety or related concerns cope with emotional situations. tFUS is a brain stimulation technology that causes temporary changes in the activity of deep brain areas without a need for any surgery or other permanent or invasive procedures.This study is recruiting participants who recently started treatment for anxiety or a related concern to come in for 3 visits at the Medical University of South Carolina. At the first visit, participants will do interviews and surveys asking about anxiety and related concerns, and they do tasks where they respond to emotional pictures while brain activity is measured using magnetic resonance imaging (MRI). At the next two visits, participants again do a task where they see and react to emotional images, and this time the task is done once before and again once after receiving tFUS that either actively causes temporary changes (lasting for about an hour) in a targeted brain area or is not active (no changes elicited). At each tFUS visit, responses are measured with sensors worn on the hand, arms, face, and head (these visits do not involve MRI).Each visit in this study is expected to last between 2 - 3 hours. This study is not a treatment study, but it could help improve treatment in the future. Participants in this study are paid for their time."
},
"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": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Modulating Escape Using Focused Ultrasound",
"nctId": "NCT06273904",
"orgStudyIdInfo": {
"id": "Pro00132631",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Task-Related Regional Brain Activation"
}
],
"primaryOutcomes": [
{
"measure": "Change in Fear-Potentiated Startle Reflex"
}
],
"secondaryOutcomes": [
{
"measure": "Change in speed to initiate avoidance behavior"
},
{
"measure": "Change in Electroencephalography (EEG)-Assessed Contingent Negative Variation During Escape/ Avoidance Preparation"
},
{
"measure": "Change in Electroencephalography (EEG)-Assessed N200 During Implicit Approach/ Avoid Bias Assessment"
},
{
"measure": "Change in Electroencephalography (EEG)-Assessed Theta-Band Power During Behavioral Tasks"
},
{
"measure": "Change in High-Frequency Heart Rate Variability/ Respiratory Sinus Arrhythmia"
},
{
"measure": "Change in Task-Based Heart Rate (Beats per Minute) Changes"
},
{
"measure": "Change in Task-Based Galvanic Skin Conductance"
},
{
"measure": "Change in State Anxiety During Session"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Medical University of South Carolina"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-09"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Erythromycin"
},
{
"name": "Azithromycin"
}
]
},
"conditionsModule": {
"conditions": [
"Premature Rupture of Membrane"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Falls Church",
"contacts": [
{
"email": "[email protected]",
"name": "Ellen M Murrin, DO",
"phone": "703-776-6040",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Antonio Saad, MD, MBA",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Ellen M Murrin, DO",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Inova Fairfax Medical Campus",
"geoPoint": {
"lat": 38.88233,
"lon": -77.17109
},
"state": "Virginia",
"status": "RECRUITING",
"zip": "22042"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this study is to help identify the best antibiotic treatment for pregnant people when their water breaks prematurely (a condition abbreviated as PPROM). Current practice is to attempt to maintain the pregnancy until at least 34 weeks gestational age, when the risks of prematurity to the baby are lessened. Research shows that antibiotics help the pregnancy last longer, but there have been limited studies about which combination works best. Currently, both azithromycin and erythromycin are accepted antibiotic treatments, in addition to ampicillin and amoxicillin. Participants diagnosed with PPROM will be randomized to receive ampicillin and amoxicillin plus either azithromycin or erythromycin, in addition to the care they would normally receive. Studying these two drugs will help decide the best care for future patients with PPROM."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 140,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "PRACET",
"briefTitle": "Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes",
"nctId": "NCT06273891",
"orgStudyIdInfo": {
"id": "INOVA-2023-58",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Latency period"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Inova Fairfax Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-10-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-08-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-08"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Endometrial Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Rome",
"contacts": [
{
"email": "[email protected]",
"name": "Benito Chiofalo, Doctor",
"phone": "ND",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Valentina Bruno, Doctor",
"phone": "ND",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "National Cancer Institute - IFO -",
"geoPoint": {
"lat": 41.89193,
"lon": 12.51133
},
"state": "RM",
"status": "RECRUITING",
"zip": "00144"
},
{
"city": "Rome",
"contacts": [
{
"email": "[email protected]",
"name": "Benito Chiofalo, Doctor",
"phone": "ND",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Valentina Bruno, Doctor",
"phone": "ND",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "\"Regina Elena\" National Cancer Institute",
"geoPoint": {
"lat": 41.89193,
"lon": 12.51133
},
"state": null,
"status": "RECRUITING",
"zip": "00144"
}
]
},
"descriptionModule": {
"briefSummary": "Non-interventional retro-prospective study on Endometrial tissue samples taken from surgically treated patients."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "From Fetal-maternal Interface Immune Tolerance to Endometrial Cancer Immune Escape: Potential Targets for Immunotherapy",
"nctId": "NCT06273878",
"orgStudyIdInfo": {
"id": "RS1439/20",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Validate the differential expression of LOX-1 and NALP3 receptors."
}
],
"secondaryOutcomes": [
{
"measure": "Characterize phenotypic alterations."
},
{
"measure": "Evaluate the predictive and/or prognostic value."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Università degli Studi dell'Insubria"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Regina Elena Cancer Institute"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-01-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Several assays"
}
]
},
"conditionsModule": {
"conditions": [
"Hemophilia A"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nijmegen",
"contacts": null,
"country": "Netherlands",
"facility": "Radboud university medical center",
"geoPoint": {
"lat": 51.8425,
"lon": 5.85278
},
"state": null,
"status": null,
"zip": "6525 GA"
}
]
},
"descriptionModule": {
"briefSummary": "Background of the study:To measure blood clotting, blood is taken from a vein. This blood is processed in the laboratory and then tested. A new device has been developed that requires only a very small volume of blood (5-10 drops of blood) to perform the laboratory tests. The long-term goal is that this device can be used by a doctor or at home to quickly measure blood clotting. In this research we want to compare this new system with the standard methods - measurement in the laboratory - and evaluate whether the correct value is determined.Objective of the study:The primary objective of this study is to demonstrate that the EnzySystem HemA version A can record thrombin generation TG and quantify FVIII activity levels within a time frame of 60 min in fresh whole blood samples of healthy volunteers and patients with hemophilia A in the Enzyre laboratory (for healthy volunteers) and the Radboudumc (for patients with hemophilia A).Study design:This is a cross-sectional observational study. All participants are asked to fill a questionnaire prior to blood collection. The blood of healthy volunteers will be collected in an office of Enzyre BV, the blood of patients will be collected in the Radboudumc. Blood collection, by venepuncture, will be conducted by a Radboudumc research nurse or physician of the research team in both locations. In total, four blood tubes with citrate as anticoagulant will be drawn (a total of around 11 mL).Study population:The study population consists of 20 healthy volunteers: evenly distributed between male and female; ages spread over the range from 20 to 70 years old; recruited by Enzyre via advertisement. 20 Patients: 5 severe hemophilia A; 5 moderate hemophilia A; 10 mild hemophilia A; recruited from the Hemophilia Treatment Center (HTC) Nijmegen-Eindhoven-Maastricht (NEM) (location Radboudumc).Primary study parameters/outcome of the study:Demonstrate that the EnzySystem HemA version A can record TG and quantitative FVIII activity levels within a time frame of 60 min in fresh blood samples of healthy volunteers and patients with hemophilia A.Secondary study parameters/outcome of the study (if applicable):Secondary study parameters are composed whether the measured values comply with the desired assay specificity and accuracy.Outcomes are analysed for equivalence compared to one-stage FVIII assay, FVIII chromogenic assay, thrombin generation via the Nijmegen Hemostasis Assay, and possibly via the Technoclone assay.Is it possible to measure FVIII activity with the EnzySystem HemA version A in fresh blood samples of healthy volunteers and patients with hemophilia A, compared to the gold standard with;* Precision in the normal range (60-140%): min. 30%* Precision in the low range (3-10%): min. 50%* Limit of Detection range min. 100 % FVIII activity* Limit of Detection low range min. 3 % FVIII activity Is it possible to measure TG with the EnzySystem HemA version A in fresh blood samples of healthy volunteers and patients with hemophilia A, compared to the gold standard with;* Precision in the normal range (60-140%) of control samples: min. 30%* Precision in patient with hemophilia A: min. 50%* Limit of Detection, high range \\> 400 nM thrombin activity* Limit of Detection measured with Plasma, low range \\< 50 nM thrombinOther study parameters All samples will also be tested for other hemostasis specific parameters as these parameters may affect a proper measurement of both FVIII activity and Thrombin Generation. The following parameters will be measured in plasma obtained from the whole blood vacutainers. Moreover, left over samples (plasma) will eventually be used to develop other coagulation related parameters.* von Willebrand Factor antigen levels* von Willebrand Factor ristocetin activity levels* Prothrombin Fragment 1+2 levels* ADAMTS13 activity* FVIII antigen levels* blood group"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Version Testing of EnzySystem Version A for Hemophilia A",
"nctId": "NCT06273865",
"orgStudyIdInfo": {
"id": "HEMSTOL77",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Time between venipuncture and EnzySystem assay results"
}
],
"secondaryOutcomes": [
{
"measure": "Validity of EnzySystem FVIII activity results"
},
{
"measure": "Validity of EnzySystem thrombin generation results"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Enzyre B.V."
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Radboud University Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "PBA-0405"
}
]
},
"conditionsModule": {
"conditions": [
"Head and Neck Squamous Cell Carcinoma",
"Soft Tissue Sarcoma Adult",
"Triple Negative Breast Cancer"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "This is a multi-center, single arm, open-label, localized pharmacodynamic biomarker Phase 0 trial designed to study the biological effects within the tumor microenvironment of PBA-0405 when administered intratumorally in microdose quantities via the CIVO device."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "This is an exploratory clinical trial to evaluate intratumoral mechanistic effects of novel and approved agents on intact human tumors. This substudy is not blinded.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
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"sex": "ALL",
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"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study of the Intratumoral Microdose Administration of PBA-0405 in Patients With Solid Tumors",
"nctId": "NCT06273852",
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"id": "PBL-0405-01",
"link": null,
"type": null
},
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},
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{
"measure": "Quantification of Cell Death and Immune Cell Biomarkers by immuno-histochemistry (IHC) and In-Situ Hybridization (ISH)"
}
],
"secondaryOutcomes": [
{
"measure": "Number of Patients with Adverse Events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Presage Biosciences"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Pure Biologics S.A."
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},
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"date": "2025-03"
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"date": "2024-02-29"
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"date": "2025-03"
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"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
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"interventions": [
{
"name": "Tafamidis 61 mg free acid tablet (Test 1)"
},
{
"name": "Tafamidis 70 mg free acid tablet (Test 1)"
},
{
"name": "Tafamidis 61 mg free acid capsule (Reference)"
}
]
},
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]
},
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{
"city": "Brussels",
"contacts": null,
"country": "Belgium",
"facility": "Pfizer Clinical Research Unit - Brussels",
"geoPoint": {
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"lon": 4.34878
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"state": "Bruxelles-capitale, Région DE",
"status": null,
"zip": "B-1070"
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]
},
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},
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},
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},
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"sex": "ALL",
"stdAges": [
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"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study to Learn How Different Forms of Study Medicine Tafamidis Are Taken Up Into The Blood in Healthy Adults",
"nctId": "NCT06273839",
"orgStudyIdInfo": {
"id": "B3461114",
"link": null,
"type": null
},
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},
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"measure": "Area under the concentration-time curve (AUCinf)"
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{
"measure": "Maximum observed plasma concentration (Cmax)"
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],
"secondaryOutcomes": null
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"name": "Pfizer"
}
},
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"date": "2024-05-27"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-02"
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"overallStatus": "ACTIVE_NOT_RECRUITING",
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"date": "2024-05-27"
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"date": "2024-02-27"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
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"name": "\"Colorectal Leakage App\""
}
]
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"conditions": [
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"Anastomotic Leak Rectum"
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},
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"contacts": [
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"email": "[email protected]",
"name": "Saule Khamzina, MD",
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},
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"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
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"OLDER_ADULT"
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},
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"nctId": "NCT06273826",
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"id": "01",
"link": null,
"type": null
},
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},
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"measure": "Diagnostic effectiveness of \"Colorectal Leakage App\"."
},
{
"measure": "Frequency of anastomotic leakage after colorectal surgeries."
}
],
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{
"measure": "Mortality within 30 days"
},
{
"measure": "Delay in the diagnosis of anastomotic leakage"
},
{
"measure": "Duration of hospital stay."
},
{
"measure": "Number of days in the ICU."
},
{
"measure": "Number of days between surgery and detection of AL."
}
]
},
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"class": "OTHER",
"name": "National Research Oncology and Transplantology Center, Kazakhstan"
}
},
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"date": "2025-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
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"overallStatus": "RECRUITING",
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"date": "2025-01"
},
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"startDateStruct": {
"date": "2024-01-19"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
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"name": "Ketorolac Tromethamine 15 MG/ML"
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{
"name": "Ketorolac Tromethamine"
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]
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"conditions": [
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"Acute Pain",
"Gout Flare"
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},
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{
"city": "Blacktown",
"contacts": [
{
"email": "[email protected]",
"name": "Rahul Rahul",
"phone": "+61 1300 742 326",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Rahul Rahul",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Australia",
"facility": "Paratus Clinical,",
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"lon": 150.91667
},
"state": null,
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"zip": "2148"
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{
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"name": "Jasmine Williams",
"phone": "+61 8 6382 5100",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Australia",
"facility": "Linear Clinical Research Ltd",
"geoPoint": {
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"lon": 115.8073
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"state": null,
"status": null,
"zip": "6009"
}
]
},
"descriptionModule": {
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},
"designModule": {
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"interventionModelDescription": "All cohost 1 subjects receive single ketorolac tromethamine injection, followed by escalating doses of ketorolac tromethamine gel Cohort 2 and 3 subjects receive doses of ketorolac tromethamine gel for 5 days",
"maskingInfo": {
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},
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"studyType": "INTERVENTIONAL"
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"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
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"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Treatment of Topical Ketorolac Gel in Acute Gouty Flare",
"nctId": "NCT06273813",
"orgStudyIdInfo": {
"id": "NOV-1776-CL-101",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0"
},
{
"measure": "Area Under the Plasma Concentration Versus Time Curve (AUC) of topical ketorolac tromethamine"
}
],
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},
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"name": "Novilla Pharmaceuticals"
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},
"statusModule": {
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"date": "2024-12"
},
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"date": "2024-02-23"
},
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"date": "2024-12"
},
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"startDateStruct": {
"date": "2024-02"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
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"name": "Blood sample"
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]
},
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{
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},
{
"email": null,
"name": "Veerle Geurts, PhD",
"phone": null,
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"role": "CONTACT"
},
{
"email": null,
"name": "Marleen Kok, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
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],
"country": "Netherlands",
"facility": "Antoni van Leeuwenhoek",
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"status": null,
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]
},
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},
"designModule": {
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"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "collection of serum sample blood at first day of neo adjuvant treatment",
"maskingInfo": {
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},
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"phases": [
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"eligibilityModule": {
"maximumAge": "59 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
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]
},
"identificationModule": {
"acronym": "Chemosense",
"briefTitle": "Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients",
"nctId": "NCT06273800",
"orgStudyIdInfo": {
"id": "M23CMC",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
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"measure": "pCR rate"
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],
"secondaryOutcomes": [
{
"measure": "Radiological reduction on tumor size"
},
{
"measure": "Pathological reduction on tumor size"
},
{
"measure": "Residual cancer burden (RCB)"
},
{
"measure": "Distant recurrence free interval (DRFI)"
},
{
"measure": "Recurrence-free interval (RFI)"
},
{
"measure": "Overall survival (OS)"
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]
},
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},
"statusModule": {
"completionDateStruct": {
"date": "2036-07-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2035-07-15"
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"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
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}
} | false | null |
{
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"interventions": [
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"name": "diaphragmatic release"
}
]
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"SLEEP APNEA PREGNANCY"
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},
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{
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"contacts": null,
"country": "Egypt",
"facility": "MTI",
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"lon": 31.24967
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"zip": null
}
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},
"descriptionModule": {
"briefSummary": "Sleep disordered breathing (SDB) is very common during pregnancy, and is most likely explained by hormonal, physiological and physical changes. Maternal obesity, one of the major risk factors for SDB, together with physiological changes in pregnancy may predispose women to develop SDB. SDB has been associated with poor maternal and fetal outcomes. Thus, early identification, diagnosis and treatment of SDB are important in pregnancy."
},
"designModule": {
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"interventionModel": "PARALLEL",
"interventionModelDescription": "Parallel Assignment group a : Diaphragmatic Release in addition to positioning instruction group b: positioning instruction",
"maskingInfo": {
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"phases": [
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"sex": "FEMALE",
"stdAges": [
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},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Diaphragmatic Release in Sleep Quality During Pregnancy",
"nctId": "NCT06273787",
"orgStudyIdInfo": {
"id": "Mitu",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
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"measure": "pittshurgh sleep quality index"
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"measure": "diaphragmatic excursion assessment"
}
]
},
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},
"statusModule": {
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"date": "2024-03-17"
},
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},
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"date": "2024-02-29"
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"startDateStruct": {
"date": "2023-11-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
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"name": "MK-8189"
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{
"name": "Placebo"
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]
},
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},
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},
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"orgStudyIdInfo": {
"id": "8189-020",
"link": null,
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},
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{
"domain": "Merck",
"id": "MK-8189-020",
"link": null,
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]
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{
"measure": "Number of Participants Who Discontinue Study Treatment Due to an AE"
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"date": "2024-04-08"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
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}
} | false | null |
{
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"interventions": [
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"name": "Medication Management Service (MMS)"
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},
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"conditions": [
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"Diabetes Mellitus, Type 2",
"Hypertension",
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"city": "Hong Kong",
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"email": "[email protected]",
"name": "Kam Kit Mak",
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{
"city": "Hong Kong",
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"email": "[email protected]",
"name": "Ka Shing Mak",
"phone": "3612 9515",
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{
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"email": "[email protected]",
"name": "Sze Yin Lee",
"phone": "2116 0382",
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],
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},
{
"city": "Hong Kong",
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"email": "[email protected]",
"name": "Mei Lun Bruce Tsui",
"phone": "2156 2280",
"phoneExt": null,
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}
],
"country": "Hong Kong",
"facility": "PHARM+ Haven of Hope Community Pharmacy",
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"zip": null
},
{
"city": "Hong Kong",
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{
"email": "[email protected]",
"name": "Kwok leung Li",
"phone": "59506880",
"phoneExt": null,
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},
{
"email": "[email protected]",
"name": "Anson Tsz Kin Leung",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Hong Kong",
"facility": "PHARM+ Pok Oi Hospital Community Pharmacy",
"geoPoint": {
"lat": 22.27832,
"lon": 114.17469
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Hong Kong",
"contacts": [
{
"email": "[email protected]",
"name": "Kit Sze Chan",
"phone": "2835 4320",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Hong Kong",
"facility": "PHARM+ St. James' Settlement Community Pharmacy",
"geoPoint": {
"lat": 22.27832,
"lon": 114.17469
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Hong Kong",
"contacts": [
{
"email": "[email protected]",
"name": "William Ho Ching Yuen",
"phone": "21872780",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Hong Kong",
"facility": "PHARM+ The Lok Sin Tong Community Pharmacy",
"geoPoint": {
"lat": 22.27832,
"lon": 114.17469
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Hong Kong",
"contacts": [
{
"email": "[email protected]",
"name": "Sui Hong Ho",
"phone": "2511 6020",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Hong Kong",
"facility": "PHARM+ YWCA Community Pharmacy",
"geoPoint": {
"lat": 22.27832,
"lon": 114.17469
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Medication management services (MMS) is a pharmacist-led service of optimizing the medication use and health outcomes, by promoting medication safety and enhancing the ability in self-management of health and diseases of patients and their caregivers. Yet, only limited evidence on the implementation of MMS service in Hong Kong is available. The goal of this clinical trial is to evaluate the cost effectiveness and effects of implementing MMS in community pharmacies owned by 8 non-government organizations (NGOs) in Hong Kong on humanistic and clinical outcomes in patients with hypertension and/or type II diabetes mellitus. The clinical trial aims to look into the following aspects:* To evaluate the perception and satisfaction of patients on MMS service* To investigate whether MMS could improve patients' adherence to their medication regimen, health-related quality of life, health outcomes and health service utilization, as well as their ability to understand and cope with their illness and drug-related problems* To identify and categorize the types of drug-related problems identified during MMS* To evaluate the cost-effectiveness of implementing MMS in community pharmaciesMMS services will be rolled out in a total of 8 NGO community pharmacies progressively (2 pharmacies per phase) in 4 successive phases. Participants will complete the questionnaires at the following time points throughout the trial, namely 1) during recruitment, 2) baseline (1 month before MMS), 3) 3 months after MMS begins, 4) 12 months after MMS begins, and 5) 24 months after MMS begins. Researchers will compare the results of questionnaires conducted at different time points to identify the potential changes in the effects of MMS. Furthermore, researchers will link up the electronic health records of the participants and identify the potential changes in the health outcomes and health service utilizations after receiving MMS."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 640,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of Medication Management Service",
"nctId": "NCT06273761",
"orgStudyIdInfo": {
"id": "UW 23-550",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Medication adherence"
}
],
"secondaryOutcomes": [
{
"measure": "Additional health service utilization"
},
{
"measure": "Patient perception and satisfaction"
},
{
"measure": "Patient perceived sensitivity to medicines"
},
{
"measure": "Social impact"
},
{
"measure": "Health-related quality of life"
},
{
"measure": "Drug-related problems"
},
{
"measure": "Change in costs"
},
{
"measure": "Change in effectiveness"
},
{
"measure": "Incremental cost effectiveness ratio (ICER)"
},
{
"measure": "Beliefs in medicines"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Hong Kong Jockey Club Charities Trust"
},
{
"name": "Hong Kong Sheng Kung Hui Welfare Council"
},
{
"name": "Hong Kong Young Women's Christian Association"
},
{
"name": "Haven of Hope Hospital"
},
{
"name": "Pok Oi Hospital"
},
{
"name": "St. James Settlement"
},
{
"name": "Aberdeen Kai-fong Welfare Association"
},
{
"name": "Health In Action"
},
{
"name": "Lok Sin Tong Benevolent Society, Kowloon"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "The University of Hong Kong"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-23"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-08-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-06"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Uveitis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cincinnati",
"contacts": [
{
"email": null,
"name": "Sheila Angels-Han",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Cincinnati Children's Hospital Medical Center",
"geoPoint": {
"lat": 39.12713,
"lon": -84.51435
},
"state": "Ohio",
"status": "RECRUITING",
"zip": "45207"
},
{
"city": "Athens",
"contacts": [
{
"email": null,
"name": "Lampros Fotis",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Greece",
"facility": "- ATTIKON General Hospital",
"geoPoint": {
"lat": 37.97945,
"lon": 23.71622
},
"state": null,
"status": "RECRUITING",
"zip": "12462"
},
{
"city": "Florence",
"contacts": [
{
"email": "[email protected]",
"name": "Gabriele Simonini",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Meyer Children's Hospital IRCCS",
"geoPoint": {
"lat": 43.77925,
"lon": 11.24626
},
"state": "Firenze",
"status": "RECRUITING",
"zip": null
},
{
"city": "Brescia",
"contacts": [
{
"email": null,
"name": "Marco Cattalini",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "Ospedale Spedali Civili di Brescia",
"geoPoint": {
"lat": 45.53558,
"lon": 10.21472
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Trieste",
"contacts": [
{
"email": null,
"name": "Serena Pastore",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "IRCCS materno infantile Burlo Garofolo",
"geoPoint": {
"lat": 45.64953,
"lon": 13.77679
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Uveitis is an inflammatory disease of the uvea, one of the highly vascularized fundamental structures of the eye. It is a rare condition in children, with an incidence in the pediatric population ranging from 2% to 14% of all uveitis cases. The diagnosis and management of patients with uveitis rely on a multidisciplinary approach involving an ophthalmologist, a rheumatologist, and an infectious disease specialist to establish the correct diagnosis and assess the involvement of other organs. In Italy, there is no national or regional registry for non-infectious chronic uveitis as per the Prime Ministerial Decree (DPCM) of March 3, 2017 (Identification of surveillance systems and registries for mortality, tumors, and other diseases). However, many clinical centers adopt data recording systems to evaluate the quality of care and to study diseases and outcomes. The Universitary Hospital Meyer Institute Research Hospital (IRCCS) is a national referral center for managing these pediatric cases of non-infectious chronic uveitis, estimated to constitute 95% of all pediatric uveitis cases"
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 290,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "16 Years",
"minimumAge": "1 Year",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "RChildUV:Study on Non-infectious Chronic Uveitis in Pediatric Age",
"nctId": "NCT06273748",
"orgStudyIdInfo": {
"id": "RChildUV",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Describe a population of paediatric patients with chronic non-infectious uveitis"
},
{
"measure": "Describe a population of paediatric patients with chronic non-infectious uveitis"
},
{
"measure": "Identify any differences between the different forms of uveitis in terms of characteristics and outcomes"
},
{
"measure": "Identify risk factors for a more severe course"
},
{
"measure": "Frequency achievement of response for each drug according to the definition of response"
},
{
"measure": "Time to archieve the response after drug initiation"
},
{
"measure": "Achievement of inactive disease on therapy according to the definition of MIWGUC"
},
{
"measure": "Time to achieve inactive disease on therapy according to the definition of MIWGUC"
},
{
"measure": "Presence and percentages of flares on therapy after achievement of remission on therapy"
},
{
"measure": "Time to the first flare on therapy"
},
{
"measure": "Time to flare after drug withdrawal"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Meyer Children's Hospital IRCCS"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2032-05-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-08"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2032-02-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-02-10"
},
"studyFirstPostDateStruct": {
"date": "2024-02-23"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Pre- and postoperative determination of troponin as part of the study and 24-month FU survey"
}
]
},
"conditionsModule": {
"conditions": [
"Myocardial Injury"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hamburg",
"contacts": [
{
"email": "[email protected]",
"name": "Markus Graefen, Professor",
"phone": "+4904741051300",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Anke Renter",
"phone": "+49407410533115",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "Martini-Klinik am UKE GmbH",
"geoPoint": {
"lat": 53.57532,
"lon": 10.01534
},
"state": null,
"status": "RECRUITING",
"zip": "20246"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to prospectively analyse the rate of MINS in the standardised radical prostatectomy patient clientele at the Martini-Clinic and to identify risk factors. Pre- and postoperative troponin levels are determined (1st and 2nd postoperative day). The patient's height, weight, age and cardiovascular risk factors (including determination of the Revised Cardiac Risk Index) are recorded in the medical history as well as previous medical and interventional cardiological therapy. Furthermore, the prostate carcinoma-associated tumour and surgical parameters are determined. Clinically significant cardiovascular events during the inpatient stay are also described. Finally, a description of the rate of events, a check for correlation with the Revised Cardiac Risk Index and an identification of risk factors are carried out."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 1000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Prospective Trial: Myocardial Injury After Noncardiac Surgery (MINS) Following Radical Prostatectomy",
"nctId": "NCT06273735",
"orgStudyIdInfo": {
"id": "2019-PS-33b",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Martini-Klinik",
"id": "PV7350",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "rate of MINS in standardised open and robot-assisted radical prostatectomy"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Universitätsklinikum Hamburg-Eppendorf"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Martini-Klinik am UKE GmbH"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-03"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-08-14"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner"
}
]
},
"conditionsModule": {
"conditions": [
"Basal Cell Carcinoma",
"Optical Coherence Tomography"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The current gold standard for diagnosing basal cell carcinoma (BCC) is the histopathological examination of biopsy specimen. However, non-invasive imaging modalities such as optical coherence tomography (OCT) may replace biopsy if BCC presence and its subtype can be established with high confidence. Subtype differentiation is crucial; while superficial BCCs (sBCC) can be treated topically, nodular (nBCC) and infiltrative BCCs (iBCC) require excision. Dynamic OCT (D-OCT) is a functionality integrated within the OCT device, enabling the visualization of vascular structures through speckle variance.Descriptive studies have unveiled vascular shapes and patterns associated with BCC and its respective subtypes. These findings suggest that D-OCT could contribute to the accuracy of BCC detection and subtyping. Yet comparative clinical studies between OCT and D-OCT are lacking. In the proposed diagnostic cohort study, we aim to assess whether D-OCT assessment is superior to OCT in terms of accuracy for BCC detection and subtyping."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 424,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "D-OCT for Detection and Subtyping of BCC: a Diagnostic Cohort Study",
"nctId": "NCT06273722",
"orgStudyIdInfo": {
"id": "2024-0059",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Diagnostic accuracy for BCC detection on D-OCT assessment"
}
],
"secondaryOutcomes": [
{
"measure": "Diagnostic accuracy for BCC subtyping on D-OCT assessment"
},
{
"measure": "Diagnostic value of vascular structures and patterns"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Maastricht University Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner"
}
]
},
"conditionsModule": {
"conditions": [
"Basal Cell Carcinoma"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Basal cell carcinoma (BCC) is the most common form of cancer and entails approximately 80% of all cutaneous malignancies. This locally destructive neoplasm is commonly diagnosed by punch biopsy which is considered painful, causes procedural scarring and carries a small risk of infection and re-bleeding associated with invasive procedures. Moreover, awaiting the results of the subsequent histopathological examination causes treatment delay and can be stressful for the patient. The drawbacks of biopsy could be overcome by optical coherence tomography (OCT), a non-invasive diagnostic modality that may replace biopsy in up to 66% of patients. However, OCT assessors are scarce which hinders the implementation of OCT. This problem may be addressed by teledermatology in which remote OCT assessment by an assessor facilitates simultaneous assessment for multiple clinics. Remote OCT assessment withholds the OCT assessor from visually inspecting the lesion. But the effect of visual inspection on the diagnostic accuracy remains unknown and the question arises whether visual inspection is necessary for accurate OCT assessment. In this diagnostic case-control study we will determine whether distant OCT assessment without visual information on the lesion is non-inferior to distant OCT assessment with clinical and dermoscopic photographs (CDP-OCT)."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 120,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Remote Assessment of OCT Scans for BCC Detection",
"nctId": "NCT06273709",
"orgStudyIdInfo": {
"id": "2023-3698",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Diagnostic accuracy of high-confidence BCC diagnosis with and without clinical/dermoscopic photographs"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Maastricht University Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "ShangRing"
}
]
},
"conditionsModule": {
"conditions": [
"Penile Infection",
"Penile Haematoma",
"Penile Bleeding",
"Deformity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shinyanga",
"contacts": null,
"country": "Tanzania",
"facility": "Kahama District Hospital",
"geoPoint": {
"lat": -3.66393,
"lon": 33.42118
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Shinyanga",
"contacts": null,
"country": "Tanzania",
"facility": "Ushetu Health Centre",
"geoPoint": {
"lat": -3.66393,
"lon": 33.42118
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this observational study was to evaluate the safety and acceptability of the ShangRing device for male circumcision among men in Shinyanga, Tanzania. The main question aims to answer both provider acceptability (practicality of device use and placement and removal times) and client acceptability (comfort during placement and removal, experience while wearing the ring, and penile appearance after healing). Participants voluntarily underwent male circumcision using the ShangRing device and before being discharged, were interviewed about their experience. Participants were also interviewed at device removal day (day 7), during a follow-up phone call (day 10), a sample were selected to participate in in-depth interviews (day28), and finally all men were asked to return for a follow-up visit (day 49)."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 575,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "13 Years",
"sex": "MALE",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania",
"nctId": "NCT06273696",
"orgStudyIdInfo": {
"id": "2019-519",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Centers for Disease Control and Prevention",
"id": "NU2GGH001927",
"link": null,
"type": "OTHER_GRANT"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of Adverse Events"
},
{
"measure": "Number of Clients with Adverse Events"
},
{
"measure": "Descriptions of Adverse Events"
}
],
"secondaryOutcomes": [
{
"measure": "Provider Training"
},
{
"measure": "Client Follow-up Visit Rate"
},
{
"measure": "Client Preference for ShangRing Over Surgical Circumcision"
},
{
"measure": "Client Recommendation Rate"
},
{
"measure": "Cosmetic Result Acceptability"
},
{
"measure": "Client Experience While Performing Routine Activities"
},
{
"measure": "Client Discomfort"
},
{
"measure": "Provider Ease of Application"
},
{
"measure": "Provider Preference"
},
{
"measure": "Provider Recommendation"
},
{
"measure": "Description of Procedures"
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{
"measure": "Healing rate"
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"name": "Ministry of Health, Tanzania"
},
{
"name": "President Office Regional Administration and Local Government, Tanzania"
},
{
"name": "Centers for Disease Control and Prevention"
},
{
"name": "Jhpiego"
},
{
"name": "World Health Organization"
}
],
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"name": "IntraHealth International"
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},
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"date": "2019-07-30"
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"date": "2019-06-11"
},
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"date": "2019-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
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{
"date": "2018-10-22",
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{
"name": "Traditional suture ligation"
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]
},
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"Pregnancy Related"
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},
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},
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"measure": "Total procedure estimated blood loss"
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"measure": "Pain score"
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"measure": "Surgical site infection"
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"measure": "Cost"
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} | false | null |
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"name": "mahmoud abdelaleem, Doctorate",
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],
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},
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},
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"link": null,
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]
},
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"facility": "Apotek 1 Andslimoen",
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{
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},
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{
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},
{
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},
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{
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"facility": "Boots apotek Linnea",
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]
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"briefSummary": "Medisinstart is a counseling service in pharmacies where patients who start taking a new medicine receive two follow-up appointments with a pharmacist. The aim of the service is to promote correct medication use and increase patient adherence. The effect of Medisinstart has previously been studied among patients starting a new cardiovascular drug. The aim of the project is to map the effects of Medisinstart among patients starting a new medication for type 2 diabetes. Knowledge about the effects of Medisinstart is important in order to maximize the benefits of the service for patients and society. The project is being conducted as a randomized controlled trial among adult patients starting a new medication for type 2 diabetes. The intervention group receives Medisinstart, while the control group only receives prescription dispensing as normal. Data collection includes HbA1c analysis in blood samples and responses to questionnaires. HbA1c is an established measure of glycemic control."
},
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},
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},
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},
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"measure": "HbA1c"
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],
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{
"measure": "Self-reported adherence"
},
{
"measure": "Frequency of medication-related problems"
},
{
"measure": "Patients' beliefs about their medicines"
},
{
"measure": "Diabetes Self-Management"
},
{
"measure": "Diabetes Treatment Satisfaction"
}
]
},
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"name": "Norwegian Pharmacy Association"
}
],
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},
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},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
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"name": "Carbohydrates"
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]
},
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},
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"name": "Elin Storjord, MD PhD",
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},
{
"email": "[email protected]",
"name": "Hilde Thunhaug, IC nurse",
"phone": "+47 95057864",
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},
{
"email": null,
"name": "Elin Storjord, MD PhD",
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},
{
"email": null,
"name": "Amy Dickey, MD",
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},
{
"email": null,
"name": "Bjørn Steen Skålhegg, PhD, Prof.",
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},
{
"email": null,
"name": "Bård O. Karlsen, PhD",
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},
{
"email": null,
"name": "Elin Røst, Master",
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},
{
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{
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{
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{
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},
{
"email": null,
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},
{
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},
{
"email": null,
"name": "Nina Lorentsen, Master",
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},
{
"email": null,
"name": "Ole-Lars Brekke, MD,PhD,Prof",
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"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Randolf Hardersen, MD, PhD",
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"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Rita Laastad, Bachelor",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Steinar Daae Johansen, PhD, Dean",
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"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Tor Erik Jørgensen, PhD",
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},
{
"email": null,
"name": "Vegar Rangul, PhD",
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"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Åse Emblem, PhD",
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"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Fredrik Ellefsrud, MD",
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},
{
"email": null,
"name": "Tor Claudi, MD",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Norway",
"facility": "Nordland Hospital Trust",
"geoPoint": {
"lat": 67.28,
"lon": 14.40501
},
"state": "Nordland",
"status": "RECRUITING",
"zip": "8092"
}
]
},
"descriptionModule": {
"briefSummary": "The main aim of this clinical trial is to learn about the effect of carbohydrate-rich diet as a treatment for AIP (acute intermittent porphyria).Aim: Investigate the diet's impact on tissue and serum glucose, plasma insulin, cytokine levels, amino acids, and gut microbiota in AIP, and their correlation with PBG (Porphobilinogen).Aim: Assess the diet's effect on AIP symptoms and health status in AIP. Aim: Measure the effect of a high-carbohydrate diet on mitochondrial activity in AIP Aim: Map and detect potential mutations in mitochondrial genomic DNA in AIP Aim: Discover new markers in AIP through RNA sequencing and machine learning.Participants will follow two diet plans, a 4-week intervention with 60-65 E% carbohydrates and a 4 week intervention with 40-45 E% carbohydrates."
},
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"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "The study is a crossover study involving 50 individuals with AIP. The study design was chosen to determine whether the treatment has an effect compared to baseline analyses and whether the sequence of treatment has an effect, as well as whether one of the interventions is more effective than the other.",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Blinding is attempted by labeling the provided diet plans as A and B. The physician recording outcome variables and the researcher performing statistical analysis are blinded to the given diet.",
"whoMasked": [
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"OUTCOMES_ASSESSOR"
]
},
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"primaryPurpose": "TREATMENT",
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},
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"type": "ESTIMATED"
},
"phases": [
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"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Clinical Research on Acute Intermittent Porphyria and the Use of Carbohydrate-Rich Diet as a Treatment",
"nctId": "NCT06273644",
"orgStudyIdInfo": {
"id": "HNF1719-24",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in Urine Porphobilinogen/creatinine"
},
{
"measure": "Urine Porphobilinogen/creatinine concentration, percentage change of repeated measurements"
}
],
"secondaryOutcomes": [
{
"measure": "Number of Hospitalizations,sick leaves, and doctor visits due to AIP"
},
{
"measure": "Health status"
},
{
"measure": "Plasma Glucose level"
},
{
"measure": "Interstitial fluid glucose level"
},
{
"measure": "Number of hypoglycemic events"
},
{
"measure": "Amino acid profile"
},
{
"measure": "Plasma insulin, glucose, c-peptide"
},
{
"measure": "HOMA score"
},
{
"measure": "HbA1c"
},
{
"measure": "Cytokines in plasma"
},
{
"measure": "Intestinal microbiota composition"
},
{
"measure": "Physical activity"
},
{
"measure": "Blood pressure"
},
{
"measure": "Body composition, metabolic age"
},
{
"measure": "Mitochondrial oxygen consumption rate"
},
{
"measure": "ALAS1mRNA"
},
{
"measure": "Urine-ALA/creatinine & urine-porphyrins"
},
{
"measure": "Mitochondrial function-related genes"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Oslo"
},
{
"name": "Nord University"
},
{
"name": "UiT The Arctic University of Norway"
},
{
"name": "Norwegian University of Science and Technology"
},
{
"name": "The University of Texas Medical Branch, Galveston"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Nordlandssykehuset HF"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2037-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-10-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-27"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "multiple-diverse carbohydrate diet"
},
{
"name": "middle carbohydrate diet"
}
]
},
"conditionsModule": {
"conditions": [
"Type 1 Diabetes",
"Diet Intervention",
"Glucose Control"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The blood glucose fluctuates greatly in T1DM patients, especially in the middle and late stages of the disease, and carbohydrate (CHO) is the main determinant of postprandial glucose response (PGR). Based on the previous investigation to understand how nutritional habits affect blood glucose control, we will conduct dietary intervention studies in T1DM patients to explore whether the adjustment of dietary pattern is beneficial to blood glucose control, and further explore the relevant mechanism through the detection of related metabolic indicators."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 78,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Changes in Carbohydrate Intake on Glucose Control in Patients With Type 1 Diabetes",
"nctId": "NCT06273631",
"orgStudyIdInfo": {
"id": "2022-SR-481",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change of time in range (TIR)"
}
],
"secondaryOutcomes": [
{
"measure": "Change of coefficient of variation of blood glucose（CV）"
},
{
"measure": "Change of mean amplitude of glycemic excursions（MAGE）"
},
{
"measure": "Change in large amplitude of glycemic excursions (LAGE) from baseline"
},
{
"measure": "Change in GA（glycosylated albumin）from baseline"
},
{
"measure": "Change in HbA1c from baseline"
},
{
"measure": "Change in 1,5-anhydroglucitol (1,5-AG) from baseline"
},
{
"measure": "Change in time above range(TAR) from baseline"
},
{
"measure": "Change in time below range(TBR) from baseline"
},
{
"measure": "Change in total insulin dose from baseline"
},
{
"measure": "Change in blood lipids from baseline"
},
{
"measure": "Change in body weight from baseline"
},
{
"measure": "Change in Incidence of hypoglycemic events from baseline"
},
{
"measure": "Change in gut microbiota from baseline"
},
{
"measure": "Change in metabolomics from baseline"
},
{
"measure": "Change in autoimmunity from baseline"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Yang Tao"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Micro-Learning"
}
]
},
"conditionsModule": {
"conditions": [
"Knowledge",
"Attitudes",
"Practice"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Hershey",
"contacts": null,
"country": "United States",
"facility": "Penn State College of Medicine",
"geoPoint": {
"lat": 40.28592,
"lon": -76.65025
},
"state": "Pennsylvania",
"status": null,
"zip": "17033"
}
]
},
"descriptionModule": {
"briefSummary": "This project investigates whether a multi-faceted strategy involving iLookOut's evidence-based Core Training plus an innovative follow-up Micro-Learning can promote knowledge retention and change behavior among early childhood professionals (ECPs) with regard to child abuse and its reporting. Additionally, this study will evaluate if non-ECPs experience similar improvements and retention of knowledge and changes in behavior as do ECPs."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Early Childhood Professionals (ECPs) will be randomized to 1 of 4 groups, which will differ in terms of when they receive access to Micro-Learning. Non-ECPs will constitute a separate group, which will receive access to Micro-Learning immediately upon completing the Core Training.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 12000,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "iLookOut Micro-learning to Improve Knowledge Retention",
"nctId": "NCT06273618",
"orgStudyIdInfo": {
"id": "iLO-ML-23396",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in knowledge about child maltreatment and its reporting as assessed by validated iLookOut knowledge test"
},
{
"measure": "Change in behavior regarding child maltreatment and its reporting as measured by self-report questionnaire"
}
],
"secondaryOutcomes": [
{
"measure": "Comparison of early childhood professionals vs. non-early childhood professionals"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Milton S. Hershey Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-25"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Egg Ladder"
}
]
},
"conditionsModule": {
"conditions": [
"Food Allergy",
"Food Allergy in Infants"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Melbourne",
"contacts": [
{
"email": "[email protected]",
"name": "Vicki McWilliam, PhD",
"phone": "0418588953",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Kirsten Perrett, MD, PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Australia",
"facility": "Murdoch Children's Research Institute (MCRI)",
"geoPoint": {
"lat": -37.814,
"lon": 144.96332
},
"state": "Victoria",
"status": "RECRUITING",
"zip": "3052"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this study is to test the safety and feasibility of a change in management approach for infants with newly diagnosed egg allergy. Infants with newly diagnosed egg allergy will have egg introduced via a gradual and graded home based approach known as an \"egg ladder\" supervised by a dietitian. The main questions this study aims to answer are how safe and feasible are home-based dietitian-led \"egg ladders\" as a treatment pathway to achieve tolerance of egg for newly diagnosed infants with egg allergy."
},
"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": "12 Months",
"minimumAge": "4 Months",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Egg Up Trial - Testing a New Treatment Pathway for Infants With Newly Diagnosed Egg Allergy",
"nctId": "NCT06273605",
"orgStudyIdInfo": {
"id": "102828",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number and severity of adverse events related to baked egg ingestion (step 1) while following the home-based egg ladder protocol as collected via parent questionnaire and medical history."
},
{
"measure": "Number and severity of adverse events related to ingestion of well cooked egg as an ingredient (step 2) while following the home-based egg ladder protocol as collected via parent questionnaire and medical history."
},
{
"measure": "Number and severity of adverse events related ingestion of well cooked whole egg (step 3) while following the home-based egg ladder protocol as collected via parent questionnaire and medical history."
},
{
"measure": "Number and severity of adverse events related to ingestion of lightly cooked whole egg (step 4) while following the home-based egg ladder protocol as collected via parent questionnaire and medical history."
},
{
"measure": "Number and severity of adverse events related to raw egg ingestion (step 5) while following the home-based egg ladder protocol as collected via parent questionnaire and medical history."
},
{
"measure": "Feasibility of the home-based, egg ladder protocol to achieve egg allergy resolution 12 months from egg allergy diagnosis"
}
],
"secondaryOutcomes": [
{
"measure": "Change from baseline (diagnosis) in parent reported Quality of Life scores using the Food Allergy Quality of Life Questionnaire (FAQLQ-PF) to study completion (12 months from diagnosis)"
},
{
"measure": "Change from baseline (diagnosis) in parental anxiety scores measured using the Impairment Measure for Parental Food Allergy - Associated Anxiety and Coping Tool (IMPAACT) to study completion (12 months from diagnosis)"
},
{
"measure": "Heath care costs"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Murdoch Childrens Research Institute"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-17"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-08-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-09"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Animal-based meal"
},
{
"name": "Plant-based meat meal"
}
]
},
"conditionsModule": {
"conditions": [
"Erectile Dysfunction"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this study is to determine whether erectile function is differentially impacted by a single plant-based meat meal versus a single animal meat meal in healthy men with normal erectile function."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Randomized crossover design",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Outcomes assessor will be blinded to randomization group and order of testing.",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 24,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "32 Years",
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "Erection 2",
"briefTitle": "The Impact of a Plant-based Meat Meal Versus an Animal Meat Meal on Erectile Function in Healthy Men.",
"nctId": "NCT06273592",
"orgStudyIdInfo": {
"id": "2023-15558",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Heart rate"
},
{
"measure": "Blood pressure"
}
],
"primaryOutcomes": [
{
"measure": "Percent of time with ≥70% erection during overnight sleep after 1 meal"
}
],
"secondaryOutcomes": [
{
"measure": "Erection events per hour during overnight sleep after 1 meal"
},
{
"measure": "Tumescence events per hour during overnight sleep after 1 meal."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Beyond Meat"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Montefiore Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Experimental Group - Verbal expert instructor feedback in AI's words"
},
{
"name": "Experimental Group - Verbal expert instructor feedback in expert's own words"
}
]
},
"conditionsModule": {
"conditions": [
"Surgical Education"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Montréal",
"contacts": [
{
"email": "[email protected]",
"name": "Rolando F Del Maestro, MD, PhD",
"phone": "(519) 708-0346",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Bianca Giglio, BSc",
"phone": "(514) 802-1608",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Canada",
"facility": "Neurosurgical Simulation and Artificial Intelligence Learning Centre",
"geoPoint": {
"lat": 45.50884,
"lon": -73.58781
},
"state": "Quebec",
"status": null,
"zip": "H2X 4B3"
}
]
},
"descriptionModule": {
"briefSummary": "At the Neurosurgical Simulation and Artificial Intelligence Learning Centre, we seek to provide surgical trainees with innovative technologies that allow them to improve their surgical technical skills in risk-free environments, potentially improving patient operative outcomes. The Intelligent Continuous Expertise Monitoring System (ICEMS), a deep learning application that assesses and trains neurosurgical technical skill and provides continuous intraoperative feedback, is one such technology that may improve surgical education.In this randomized controlled trial, medical students from four Quebec universities will be blinded and randomized to one of three groups (one control and two experimental). Group 1 (control) will be provided with verbal AI tutor feedback based on the ICEMS error detection. Group 2 will be tutored by a human instructor who will receive ICEMS error data and deliver verbal instruction identical to that which the AI tutor delivers. Group 3 will be tutored by a human instructor who will be provided with ICEMS data but may deliver feedback as they feel is appropriate to correct the error.The aim of this study is to determine how the method of delivery of verbal surgical error instruction influences trainee response to instruction and overall surgical performance. Evaluating trainee responses to AI instructor verbal feedback as compared to feedback from human instructors will allow for further development, testing, and optimization of the ICEMS and other AI tutoring systems."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomized Controlled Trial",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Double (Participant, Expert Instructor)Both study participants and expert instructors are unaware of the intervention (varying the method of delivery of verbal error instruction). Moreover, when rating performance in the realistic scenario using the OSATS, experts are unaware of which group any given trainee is part of.",
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 78,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Efficiency of Verbal Intelligent Tutor Instruction in Neurosurgical Simulation",
"nctId": "NCT06273579",
"orgStudyIdInfo": {
"id": "2010-270, NEU-09-042-Trial 5",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Response to instruction"
},
{
"measure": "Average Intelligent Continuous Expertise Monitoring System (ICEMS) expertise score"
},
{
"measure": "Objective Structured Assessment of Technical Skills (OSATS) global rating"
}
],
"secondaryOutcomes": [
{
"measure": "Difference in the strength of emotions elicited"
},
{
"measure": "Difference in cognitive load"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "McGill University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-05"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Questionnaire"
}
]
},
"conditionsModule": {
"conditions": [
"Cystic Fibrosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Caen",
"contacts": null,
"country": "France",
"facility": "PSLA GDD",
"geoPoint": {
"lat": 49.18585,
"lon": -0.35912
},
"state": null,
"status": null,
"zip": "14000"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this observational study is to translate and validate the Adt-Physio scale in French, and to validate on a large number of patients the French translation of the Adt-Physio scale as a tool for evaluating adherence and perception of the intervention of a physiotherapist in patients with cystic fibrosis.participants will have to answer the French trans-AdT scale, the Brief Cope and GSES questionnaire."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 121,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "100 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "Trans-AdT",
"briefTitle": "French Validation of the AdT-Physio Scale",
"nctId": "NCT06273566",
"orgStudyIdInfo": {
"id": "20230202",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "AdT-Physio scale (Adherence to Treatment of Physiotherapy scale)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Pole Sante Grace de Dieu"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-07-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-19"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "RG002 injection"
}
]
},
"conditionsModule": {
"conditions": [
"Human Papillomavirus Associated Intraepithelial Neoplasia",
"Cervical Intraepithelial Neoplasia Grade 2/3",
"Human Papillomavirus Type 16 Infection",
"Human Papillomavirus Type 18 Infection"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "The purpose of this study is to to evaluate the safety, tolerability, immunogenicity, and efficacy of RG002 Injection in subjects with HPV16/18 associated Cervical Intraepithelial Neoplasia Grade 2 or 3(CIN2/3)."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 39,
"type": "ESTIMATED"
},
"phases": [
"PHASE1",
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study in Subjects With Human Papillomavirus 16 or 18 Associated Cervical Intraepithelial Neoplasia Grade 2 or 3",
"nctId": "NCT06273553",
"orgStudyIdInfo": {
"id": "RG002-A1201",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Part A: Safety and Tolerability of RG002 Injection, measured by the incidence of adverse events"
},
{
"measure": "Part A: Maximum tolerated dose (MTD) and/or RP2D of RG002 Injection"
},
{
"measure": "Part B: Primary efficacy of RG002 Injection, measured by the proportion of subjects with histopathological regression"
}
],
"secondaryOutcomes": [
{
"measure": "Part A: Preliminary efficacy of RG002 Injection,measured by proportion of subjects with histopathological regression"
},
{
"measure": "Part A: Preliminary efficacy of RG002 Injection,measured by proportion of subjects with clearance of HPV16/18"
},
{
"measure": "Part A: Preliminary efficacy of RG002 Injection,measured by proportion of subjects with histopathological regression and clearance of HPV16/18"
},
{
"measure": "Part A and B: Immunogenicity of RG002 Injection,measured by the level of cellular immune response"
},
{
"measure": "Part A and B: Immunogenicity of RG002 Injection,measured by the proportion of T lymphocytes"
},
{
"measure": "Part A and B: Immunogenicity of RG002 Injection,measured by the expression of cytokines in serum"
},
{
"measure": "Part A and B: Immunogenicity of RG002 Injection,measured by the serum levels of anti-HPV16 and anti-HPV18 IgG antibodies."
},
{
"measure": "Part A and B: Exposure level of RG002 Injection, measured by mRNA"
},
{
"measure": "Part A and B: Exposure level of RG002 Injection, measured by cationic lipids"
},
{
"measure": "Part A and B: Anti-drug antibody (ADA) to polyethylene glycol (PEG) of RG002 injection, measured by the serum titer of anti-PEG IgG and anti-PEG IgM"
},
{
"measure": "Part B: Secondary efficacy, measured by proportion of subjects with histopathological regression"
},
{
"measure": "Part B: Secondary efficacy, measured by proportion of subjects with clearance of HPV16/18"
},
{
"measure": "Part B: Secondary efficacy, measured by proportion of subjects with histopathological regression and clearance of HPV16/18"
},
{
"measure": "Part B: Safety and tolerability of RG002 Injection, measured by the incidence of adverse events"
},
{
"measure": "Part B: Optionally assess the biomarker of RG002 Injection, measured by the level of potential biomarkers and the level of infiltrating T cells and myeloid cells in the lesions."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "RinuaGene Biotechnology Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-10"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "STP7 (mavoglurant) or Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Cocaine Use Disorder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Overland Park",
"contacts": [
{
"email": null,
"name": "Debra Kelsh, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Altasciences Clinical Kansas",
"geoPoint": {
"lat": 38.98223,
"lon": -94.67079
},
"state": "Kansas",
"status": "RECRUITING",
"zip": "66212"
}
]
},
"descriptionModule": {
"briefSummary": "This is a double-blind, placebo-controlled, parallel group study to compare the effects of STP7 (mavoglurant) vs placebo control on i.v. cocaine's physiological and subjective effects in non-treatment seeking, cocaine-experienced males or females participants between 18 and 59 years of age.The primary objective of this study is to determine if there are clinically meaningful interactions between oral STP7 (mavoglurant) treatment concurrent with 20 and 40 mg i.v. cocaine infusions by measuring adverse events and cardiovascular responses including heart rate, blood pressure, and electrocardiogram (including corrected QT interval).The secondary objectives are:* To evaluate whether administration of STP7 (mavoglurant) alters the pharmacokinetics of cocaine and/or its major metabolite, benzoylecgonine.* To determine the pharmacokinetic of STP7 (mavoglurant) administered at a dose of 200 mg twice a day.* To evaluate whether STP7 (mavoglurant) treatment alters the subjective effects of cocaine measured by Visual Analog Scales (VAS) and Brief Substance Craving Scale (BSCS)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "59 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Phase1, STP7 Cocaine Drug-Drug Interaction Study",
"nctId": "NCT06273540",
"orgStudyIdInfo": {
"id": "STA-P7-C001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Incidence of Treatment-Emergent Adverse Events."
},
{
"measure": "Heart Rate response following the STP7 treatment with the cocaine infusion."
},
{
"measure": "Heart Rate response following the STP7 treatment with the cocaine infusion."
},
{
"measure": "Blood Pressure (diastolic) response following the STP7 treatment with the cocaine infusion ."
},
{
"measure": "Blood Pressure (diastolic) response following the STP7 treatment with the cocaine infusion."
},
{
"measure": "Blood Pressure (systolic) response following the STP7 treatment with the cocaine infusion."
},
{
"measure": "Blood Pressure (systolic) response following the STP7 treatment with the cocaine infusion."
},
{
"measure": "ECG changes (HR) following the STP7 treatment with the cocaine infusion."
},
{
"measure": "ECG changes (RR) following the STP7 treatment with the cocaine infusion."
},
{
"measure": "ECG changes (PR) following the STP7 treatment with the cocaine infusion."
},
{
"measure": "ECG changes (QRS) following the STP7 treatment with the cocaine infusion."
},
{
"measure": "ECG changes (QT) following the STP7 treatment with the cocaine infusion."
},
{
"measure": "ECG changes (HR) following the STP7 treatment with the cocaine infusion."
},
{
"measure": "ECG changes (RR) following the STP7 treatment with the cocaine infusion."
},
{
"measure": "ECG changes (PR) following the STP7 treatment with the cocaine infusion."
},
{
"measure": "ECG changes (QRS) following the STP7 treatment with the cocaine infusion."
},
{
"measure": "ECG changes (QT) following the STP7 treatment with the cocaine infusion."
}
],
"secondaryOutcomes": [
{
"measure": "Pharmacokinetics: Maximum Plasma Concentration [Cmax] of cocaine."
},
{
"measure": "Pharmacokinetics: Maximum Plasma Concentration [Cmax] of benzoylecgonine."
},
{
"measure": "Pharmacokinetics: Maximum Plasma Concentration [Cmax] of STP7."
},
{
"measure": "Pharmacokinetics: Maximum Plasma Concentration [Cmax] of STP7."
},
{
"measure": "Pharmacokinetics: time to maximum plasma concentration [Tmax] of cocaine."
},
{
"measure": "Pharmacokinetics: time to maximum plasma concentration [Tmax] of benzoylecgonine."
},
{
"measure": "Pharmacokinetics: time to maximum plasma concentration [Tmax] of STP7."
},
{
"measure": "Pharmacokinetics: time to maximum plasma concentration [Tmax] of STP7."
},
{
"measure": "Pharmacokinetics: area under the concentration-time curve from time 0 to time t of cocaine."
},
{
"measure": "Pharmacokinetics: area under the concentration-time curve from time 0 to time t of benzoylecgonine."
},
{
"measure": "Pharmacokinetics: area under the concentration-time curve from time 0 to time of STP7."
},
{
"measure": "Pharmacokinetics: area under the concentration-time curve from time 0 to time of STP7."
},
{
"measure": "Pharmacokinetics: area under the concentration-time curve from time 0 to 12 hours post-dose of cocaine."
},
{
"measure": "Pharmacokinetics: area under the concentration-time curve from time 0 to 12 hours post-dose of benzoylecgonine."
},
{
"measure": "Pharmacokinetics: area under the concentration-time curve from time 0 to 12 hours post-dose of STP7."
},
{
"measure": "Pharmacokinetics: area under the concentration-time curve from time 0 to 12 hours post-dose of STP7."
},
{
"measure": "Pharmacokinetics: area under the concentration-time curve from time 0 to time infinity post-dose of cocaine."
},
{
"measure": "Pharmacokinetics: area under the concentration-time curve from time 0 to time infinity post-dose of benzoylecgonine."
},
{
"measure": "Pharmacokinetics: area under the concentration-time curve from time 0 to time infinity post-dose of STP7."
},
{
"measure": "Pharmacokinetics: area under the concentration-time curve from time 0 to time infinity post-dose of STP7."
},
{
"measure": "Pharmacokinetics: trough plasma concentration (Ctrough) of cocaine."
},
{
"measure": "Pharmacokinetics: trough plasma concentration (Ctrough) of benzoylecgonine."
},
{
"measure": "Pharmacokinetics: trough plasma concentration (Ctrough) of STP7."
},
{
"measure": "Pharmacokinetics: trough plasma concentration (Ctrough) of STP7."
},
{
"measure": "Pharmacokinetics: terminal rate constant of cocaine."
},
{
"measure": "Pharmacokinetics: terminal rate constant of benzoylecgonine."
},
{
"measure": "Pharmacokinetics: terminal rate constant of STP7."
},
{
"measure": "Pharmacokinetics: terminal rate constant of STP7."
},
{
"measure": "Pharmacokinetics: half-life of cocaine."
},
{
"measure": "Pharmacokinetics: half-life of benzoylecgonine."
},
{
"measure": "Pharmacokinetics: half-life of STP7."
},
{
"measure": "Pharmacokinetics: half-life of STP7."
},
{
"measure": "Pharmacokinetics: clearance of cocaine."
},
{
"measure": "Pharmacokinetics: clearance of benzoylecgonine."
},
{
"measure": "Pharmacokinetics: clearance of STP7."
},
{
"measure": "Pharmacokinetics: clearance of STP7."
},
{
"measure": "Pharmacokinetics: Clearance from plasma after oral administration of cocaine."
},
{
"measure": "Pharmacokinetics: Clearance of benzoylecgonine from plasma after oral administration (CL/F) of cocaine."
},
{
"measure": "Pharmacokinetics: Clearance from plasma after oral administration (CL/F) of STP7."
},
{
"measure": "Pharmacokinetics: Clearance from plasma after oral administration (CL/F) of STP7."
},
{
"measure": "Visual evaluation of the STP7 on the subjective effects of cocaine at screening"
},
{
"measure": "Visual evaluation of the STP7 on the subjective effects of cocaine at baseline and during treatment"
},
{
"measure": "Craving evaluation of the STP7 on the subjective effects of cocaine."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institute on Drug Abuse (NIDA)"
}
],
"leadSponsor": {
"class": "INDUSTRY",
"name": "Stalicla SA"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-19"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "COGENT"
},
{
"name": "Sham Program"
}
]
},
"conditionsModule": {
"conditions": [
"Anxiety Disorders",
"Depression",
"Post Traumatic Stress Disorder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "San Diego",
"contacts": [
{
"email": "[email protected]",
"name": "Edith Jimenez",
"phone": "858-822-1470",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Nathalie Dugas",
"phone": "858-534-2148",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "UC San Diego",
"geoPoint": {
"lat": 32.71533,
"lon": -117.15726
},
"state": "California",
"status": null,
"zip": "92037"
}
]
},
"descriptionModule": {
"briefSummary": "The proposed project aims to test the cognitive and neural effects of a cognitive training in a sample of individuals seeking treatment for anxiety, depression, or traumatic stress symptoms. Participants will be randomly assigned to one of two groups. Group 1 will receive a computer-based program that is designed as a cognitive training intervention and Group 2 will receive a similar computer-based exercise that researchers think will be less effective in training thinking skills (also known as a control or sham condition). Participants will be compared on cognitive performance and brain response during cognitive tasks from baseline to post-treatment."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 128,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "21 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol (R33)",
"nctId": "NCT06273527",
"orgStudyIdInfo": {
"id": "808681",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Disability"
},
{
"measure": "Suicide Cognitions"
},
{
"measure": "Mood and Emotions"
},
{
"measure": "Self-reported attention"
},
{
"measure": "Anxiety Symptoms"
},
{
"measure": "Symptoms of Depression"
},
{
"measure": "PTSD Symptoms"
}
],
"primaryOutcomes": [
{
"measure": "Change in cognitive performance"
}
],
"secondaryOutcomes": [
{
"measure": "Reading Span Blood Oxygen Level Dependent (BOLD) Response"
},
{
"measure": "Neuropsychological Performance"
},
{
"measure": "Repetitive Negative Thinking (RNT)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of California, San Diego"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-11"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "TECAR"
},
{
"name": "Dry needling"
}
]
},
"conditionsModule": {
"conditions": [
"Myofascial Pain Syndrome of Neck",
"Myofascial Trigger Point Syndrome",
"Myofascial Trigger Point Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ruda Śląska",
"contacts": null,
"country": "Poland",
"facility": "Medical fit",
"geoPoint": {
"lat": 50.2584,
"lon": 18.85632
},
"state": "Śląsk",
"status": null,
"zip": "41-717"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of the study is to assess the effectiveness of dry needling (DN) and capacitive and resistive transfer of energy (TECAR) therapy in the treatment of myofascial trigger points (MTrPs) as well comparison of their efficacy.Research hypothesis:Capacitive and resistive energy transfer therapy is comparable to dry needling therapy for the treatment of myofascial trigger points.It is estimated that the presence of trigger points is the main cause of pain in 30-85% of patients visiting primary health care facilities and pain management clinics. The presence of trigger points may significantly affect the patient's functional status and daily functioning. Recently, diagnostic criteria and methods of treating trigger points have evolved significantly. However, the usefulness of different imaging methods in the diagnosis of trigger points has not yet been established. Despite numerous studies, the long-term effectiveness of the dry needling method is still unknown. Furthermore, there is no available research on the short- and long-term effectiveness of capacitive and resistive energy transfer therapy in the treatment of trigger points.Therefore, the objectives of the work were:Determination and comparison of the short- and long-term effects of capacitive and resistive energy transfer therapy and the dry needling technique of myofascial trigger points located in the upper trapezius muscle (UT) on the strength, neck range of motion and pain intensity within this muscle.The study is planned to include a group of 26 men aged 25 to 45 who suffer from pain caused by the presence of myofascial trigger points in the upper trapezius muscle. The subjects will be divided into two groups of equal number of people. The first group will undergo therapy using the dry needling technique, while the second group will undergo capacitive and resistive energy transfer therapy.In order to determine the immediate effects of capacitive and resistive energy transfer therapy and dry needling techniques, measurements of muscle strength, the intensity of pain in the upper trapezius muscle and neck range of motion will be performed before and after each therapeutic session (2 session in 2 weeks are planed). In turn, to determine the long-term effects of capacitive and resistive energy transfer therapy and dry needling, the next above-mentioned measurements will be performed four weeks after the end of first therapy."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 22,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "25 Years",
"sex": "MALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparison the Effects of TECAR With Dry Needling in the Treatment of Myofascial Trigger Points",
"nctId": "NCT06273514",
"orgStudyIdInfo": {
"id": "TECAR and DN intervention",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pain - Pressure pain threshold (PPT)"
},
{
"measure": "Pain - numerical rating scale (NRS)"
}
],
"secondaryOutcomes": [
{
"measure": "Muscle strength"
},
{
"measure": "Cervical spine range of motion (ROM)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Medical University of Silesia"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2022-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2020-12-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Magtrace"
}
]
},
"conditionsModule": {
"conditions": [
"Vulvar Cancer",
"Lymph Node Metastasis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Gothenburg",
"contacts": null,
"country": "Sweden",
"facility": "Department of Obstetrics and gynecology",
"geoPoint": {
"lat": 57.70716,
"lon": 11.96679
},
"state": null,
"status": null,
"zip": "41345"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of the feasibility study is to evaluate whether SPIO-MRI and a magnetometer could be a potential substitute to the routine dual technique in pre-and intraoperative SLN localization. Secondary, to explore if SPIO-MRI could predict lymph node status in comparison to histopathological analysis."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "POSVUC",
"briefTitle": "MRI and Magnetometer-guided Sentinel Lymph Node Detection in Vulvar Cancer",
"nctId": "NCT06273501",
"orgStudyIdInfo": {
"id": "D-NR 2022-02876-01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Sentinel lymph node identification"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Sahlgrenska University Hospital, Sweden"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-12-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-03-24"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Auriculotherapy"
}
]
},
"conditionsModule": {
"conditions": [
"Auriculotherapy",
"Arthroplasty, Replacement, Knee",
"Enhanced Recovery After Surgery"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": [
{
"email": "[email protected]",
"name": "qindong Mi",
"phone": "8615871784551",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Peking Union Medical College Hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": "RECRUITING",
"zip": "100000"
}
]
},
"descriptionModule": {
"briefSummary": "To further improve the surgical outcomes of patients undergoing total knee arthroplasty (TKA). This study aims to use ear acupoint therapy to address the following clinical issues: 1 The degree of postoperative inflammation and edema in the patient; 2. Patient pain; 3. Patient functional recovery. 4. Surgical scar repair for patients; 5. Patient perioperative anxiety and postoperative satisfaction. Exploring the safety and effectiveness of ear acupoint therapy in the postoperative application of TKA, leveraging the advantages of suitable traditional Chinese medicine techniques in simplicity, convenience, effectiveness, and cost-effectiveness, and further improving the ERAS Chinese and Western medicine collaborative plan for TKA."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 86,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Role of Auricular Point Diagnosis and Treatment in ERAS During TKA",
"nctId": "NCT06273488",
"orgStudyIdInfo": {
"id": "EXZL20240002",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Range of motion(ROM)"
}
],
"secondaryOutcomes": [
{
"measure": "Visual Analogue Pain Scale (VAS)"
},
{
"measure": "Self-Assessment Survey for Anxiety（SAS）"
},
{
"measure": "Acupoint electrical measurement value(AE)"
},
{
"measure": "Vancouver Scar Assessment Scale（VSS）"
},
{
"measure": "Dosage of painkillers"
},
{
"measure": "Hospital stay"
},
{
"measure": "HSS knee joint scoring"
},
{
"measure": "Thigh circumference(knee joint circumference)"
},
{
"measure": "Kine siphobia (TSK) score"
},
{
"measure": "C-reactive protein (CRP)"
},
{
"measure": "Erythrocyte Sedimentation Rate(ESR)"
},
{
"measure": "Postoperative satisfaction"
},
{
"measure": "Expenses during hospitalization"
},
{
"measure": "Demand rate and satisfaction rate of auricular point diagnosis and treatment"
},
{
"measure": "Adverse events related to auricular acupuncture diagnosis and treatment"
},
{
"measure": "Affected limb drainage volume"
},
{
"measure": "Preoperative Anxiety Scale (PAS-7) score"
},
{
"measure": "Total number of pain pump uses (presses)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Peking Union Medical College"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-08"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-23"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Robot-assisted Training"
},
{
"name": "Standard Training"
}
]
},
"conditionsModule": {
"conditions": [
"Stroke",
"Ischemic Stroke"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Copenhagen",
"contacts": [
{
"email": "[email protected]",
"name": "Jon Skovgaard Jensen, Ph.d.-student",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Christina Rostrup Kruuse, Professor, MD, PhD, DMSc",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Denmark",
"facility": "Rigshospitalet and Herlev Gentofte Hospital",
"geoPoint": {
"lat": 55.67594,
"lon": 12.56553
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Odense",
"contacts": [
{
"email": "[email protected]",
"name": "Jon Skovgaard Jensen, Ph.d.-student",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Anders Holsgaard-Larsen, Professor",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Denmark",
"facility": "Odense University Hospital",
"geoPoint": {
"lat": 55.39594,
"lon": 10.38831
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this randomised controlled trial (RCT) nested in a prospective cohort, is to investigate the superior effect of late-phase robot-assisted versus standard training on motor function, physical function, fatigue, and quality of life in a moderately-to-severely impaired chronic stroke population following subacute rehabilitation.The main hypothesis of the study is:Robot-assisted training has a superior effect on motor function (Fugl-Meyer Lower Extremity Assessment; primary outcome), physical function, fatigue, and quality of life in moderately-to-severely impaired chronic stroke-affected individuals in comparison to standard training."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Multicentre randomised (1:1) parallel-group intervention study with assessor-blinding.",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "Data will be analysed by the PhD student blinded towards group allocation. The test leader responsible for RCT outcome assessment will be blinded towards group allocation.",
"whoMasked": [
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Robot-Assisted Training Versus Standard Training in Ischemic Stroke",
"nctId": "NCT06273475",
"orgStudyIdInfo": {
"id": "OUH RoboRehab",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Contractile Muscle Power (between-group change)"
},
{
"measure": "Modified Sit-to-Stand Test (between-group change)"
},
{
"measure": "Blood Biomarkers (between-group change)"
},
{
"measure": "Modified Ashworth Scale (between-group change)."
},
{
"measure": "Oxford Cognitive Screen (between-group change)"
},
{
"measure": "Montreal Cognitive Assessment (between-group change)"
},
{
"measure": "Major Depression Inventory (between-group change)"
}
],
"primaryOutcomes": [
{
"measure": "Fugl-Meyer Lower Extremity Assessment of Motor Function"
}
],
"secondaryOutcomes": [
{
"measure": "Modified Rankin Scale Score (between-group change)"
},
{
"measure": "Functional Ambulation Category (between-group change)"
},
{
"measure": "Berg Balance Scale (between-group change)"
},
{
"measure": "Barthel-100 Index (between-group change)"
},
{
"measure": "Global Rating of Change (between-group change)"
},
{
"measure": "International Physical Activity Questionnaire - Short Form (between-group change)"
},
{
"measure": "Fatigue Severity Scale 7 (between-group change)"
},
{
"measure": "EQ-5D-5L Quality of Life (between-group change)"
},
{
"measure": "Hand-grip strength (between-group change)"
},
{
"measure": "Gait speed (between-group change)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Southern Denmark"
},
{
"name": "Rigshospitalet, Denmark"
},
{
"name": "Herlev and Gentofte Hospital"
},
{
"name": "Stanford University"
},
{
"name": "Sygehus Lillebaelt"
},
{
"name": "Danish Association of the Physically Disabled"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Odense University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-02-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-18"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Palmitoylethanolamide 600mg twice a day"
},
{
"name": "placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Chronic Pain"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "San Diego",
"contacts": [
{
"email": "[email protected]",
"name": "Naval Medical Center Institutional Review Board",
"phone": "619-532-9927",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Brian McLean COL, USA MC, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Naval Medical Center San Diego",
"geoPoint": {
"lat": 32.71533,
"lon": -117.15726
},
"state": "California",
"status": null,
"zip": "92118"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to evaluate if a supplement called palmitoylethanolamide (PEA) is effective in reducing the pain in patients with chronic inflammatory pain conditions. The main question the trial aims to answer is if PEA works better at treating a patients pain and improving their function better than a placebo.Participants will be divided into two equal groups and asked to take either PEA or a placebo for 8 weeks."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Prospective Randomize Double Blind Placebo Controlled study comparing the supplement palmitoylethanolamide (PEA) to a visually identical placebo",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": "Double Blinded, patients will receive visually identical capsules from research pharmacist with study label indicating PEA vs Placebo",
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Palmitoylethanolamide for Chronic Inflammatory Pain Conditions",
"nctId": "NCT06273462",
"orgStudyIdInfo": {
"id": "NMCSD.2024.0006",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pain Level"
}
],
"secondaryOutcomes": [
{
"measure": "Pain interference and function"
},
{
"measure": "Pain Catastrophizing Scale (PCS)"
},
{
"measure": "Patient Reported Outcome Measurement Information System (PROMIS) (Pain interference, Social satisfaction; Physical function)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "FED",
"name": "Navy Medical Center San Diego"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-05-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Group 3 - 3D Printed Removable Partial Denture"
},
{
"name": "Group 2 - 3D Printed Removable Partial Denture"
}
]
},
"conditionsModule": {
"conditions": [
"Partial-edentulism"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Singapore",
"contacts": [
{
"email": "[email protected]",
"name": "Hazel Goh Si Ying",
"phone": "63248754",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Zi Ying Phang",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Khim Hean Teoh",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
},
{
"email": null,
"name": "Janice Tan Zhi Hui",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Singapore",
"facility": "National Dental Centre Singapore",
"geoPoint": {
"lat": 1.28967,
"lon": 103.85007
},
"state": null,
"status": "RECRUITING",
"zip": "168938"
}
]
},
"descriptionModule": {
"briefSummary": "Tooth loss is a major chronic problem in dentistry and edentulous elderly endures poorer quality of life worldwide. Removable partial dentures (RPDs) are the most widely accepted and cost-effective treatment for patients to restore oral functions. RPDs contain three components including the metal framework, denture base and acrylic teeth. Conventionally, RPD fabrication involves tedious clinical and dental laboratory procedures and is time consuming, labour-intensive, and often imprecise, therefore incapable of meeting the growing demands of RPD by an ageing population. The challenges to achieve a high quality and high-throughput RPD service lie in three aspects: 1) accuracy in capturing oral profile; 2) immediate oral information analysis and device design, and 3) automation in production."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "1. Conventional: The Standard of Care (SOC) workflow, which will act as a baseline compared to the other 2 groups.2. Partial digital workflow: Adopts the same teeth profile capture method, where a physical impression of teeth profile is taken from the subject. However, instead of using physical wax pattern on the stone model for design, the stone model is scanned and, on the scan, the design is performed digitally. For fabrication of RPD, instead of using lost wax casting, the digital design is used for additive manufacturing.3. SmartRPD digital workflow Adopts a different teeth profile capture method by using the intraoral scanner to digitally scan and save the subject's teeth profile. From the intraoral scan, a digital model of the subject's teeth profile is created but on the digital model instead, the design of RPD is digitally performed. The digital design is used for additive manufacturing.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 141,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "21 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Smart Digital Workflow Towards High Precision and Through-Put Production for Removable Partial Dentures",
"nctId": "NCT06273449",
"orgStudyIdInfo": {
"id": "385/2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Evaluation of Precision in Fabricated Metal Frameworks Across Three Workflows"
},
{
"measure": "Comparison of Patient Satisfaction with RPD Prostheses Fabricated Using Three Workflows"
},
{
"measure": "Comparison of Fabrication Cost and Time Across Three Workflows"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Medical Research Council (NMRC), Singapore"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "National Dental Centre, Singapore"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-12-29"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "H.E.A.R. for Mamas"
}
]
},
"conditionsModule": {
"conditions": [
"Postpartum Complication"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of the proposed research is to test the comparative effectiveness of AIM safety bundles for post-partum women delivered in-person vs. via text/phone to improve early detection of and timely care for complications during the first six weeks postpartum for women experiencing significant health disparities."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 2894,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "HEAR4Mamas",
"briefTitle": "Healing, Equity, Advocacy and Respect for Mamas",
"nctId": "NCT06273436",
"orgStudyIdInfo": {
"id": "Pro00130902",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Social Determinants of Health (SDoH), Patient Activation, Shared Decision Making"
},
{
"measure": "Patient Activation"
},
{
"measure": "Shared Decision Making"
}
],
"primaryOutcomes": [
{
"measure": "Emergency Department (ED) visits within six weeks postpartum"
}
],
"secondaryOutcomes": [
{
"measure": "Patient Reported Outcomes (PROs)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Patient-Centered Outcomes Research Institute"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Medical University of South Carolina"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-11-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-11-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-29"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "OULA, Mind-body Physical Activity"
}
]
},
"conditionsModule": {
"conditions": [
"Postpartum Depression"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The objective of this pilot project is to assess the feasibility, acceptability, and mental health impact of OULA for women with postpartum depression (PPD)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "39 Years",
"minimumAge": "20 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Feasibility Evaluation of a Dance Fitness Program",
"nctId": "NCT06273423",
"orgStudyIdInfo": {
"id": "OULA for Postpartum Depression",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Feasibility and acceptability"
}
],
"secondaryOutcomes": [
{
"measure": "Changes in postpartum depression"
},
{
"measure": "Changes in postpartum anxiety"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Montana State University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-10"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Cention N"
},
{
"name": "Cention N + Adhesive"
},
{
"name": "Bulk Fill Composite"
}
]
},
"conditionsModule": {
"conditions": [
"Dental Restoration Failure"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Alexandria",
"contacts": null,
"country": "Egypt",
"facility": "Alexandria Faculty of Dentistry",
"geoPoint": {
"lat": 31.21564,
"lon": 29.95527
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Despite significant advances in composite materials, they are still perceived as technique-sensitive and exhibit failure related to excessive wear and polymerization shrinkage. Cention N is a recently introduced alkasite restorative that contains special reactive fillers. Its application in restorative dentistry may be significant, promoting remineralization of carious lesions \\& reduction of polymerization shrinkage. The study will aim to compare the clinical performance of Cention N (with and without adhesive) and composite resin (Filtek Bulk Fill) in class I restorations using FDI criteria. Thirty-six class I cavities will be selected and equally allocated into 3 groups: Group I (n=12): (Cention N with adhesive), Group II (n=12): (Cention N without adhesive) \\& Group III (n=12): composite resin (Filtek Bulk Fill) in class I cavities. Patients will be followed up at 1 week 3, 6, and 12 months and evaluated using the FDI criteria. Postoperative sensitivity, staining, and recurrent caries will be evaluated in this clinical trial."
},
"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": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Clinical Performance of An Alkasite Based Restorative Material With And Without Adhesive",
"nctId": "NCT06273410",
"orgStudyIdInfo": {
"id": "0453-6/2022",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change in pain sensitivity"
},
{
"measure": "Change in occurrence of recurrent caries"
},
{
"measure": "Change in occurrence of marginal stains"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hams Hamed Abdelrahman"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-11-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-11-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-10-13"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Acetazolamide 250 MG"
},
{
"name": "Metolazone 2.5 MG"
},
{
"name": "Furosemide Injection"
}
]
},
"conditionsModule": {
"conditions": [
"Heart Failure Acute",
"Decompensated Heart Failure"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Impact of Acute Heart Failure:According to the World Health Organization (WHO), approximately 26 million people suffer from Heart Failure (HF), with a mortality rate of up to 50% within five years of diagnosis. Acute Heart Failure (AHF) exacerbations, leading to hospitalization, are common and represent the primary cause of hospital admissions in those over 65. Effective decongestion during hospitalization is crucial, as failure to achieve it doubles the risk of rehospitalization and mortality, incurring significant healthcare costs.Use of Diuretics in Acute Heart Failure:Diuretics, particularly loop diuretics like furosemide, are a cornerstone in managing AHF by inducing natriuresis and achieving decongestion. Clinical experience supports their use, though limited clinical trials exist. Pharmacological concepts guide their administration, emphasizing intravenous delivery in high doses and adjusting subsequent doses based on decongestive efficacy. Additionally, sequential tubular blockade with other diuretics like metolazone and acetazolamide is explored to enhance decongestion.Use of Metolazone and Acetazolamide:Sequential tubular blockade, using metolazone and acetazolamide in conjunction with furosemide, aims to achieve rapid and effective decongestion. While metolazone targets the distal tubule, inhibiting sodium-chloride channels, acetazolamide affects proximal tubular function. Studies like ADVOR (acetazolamide) and CLOROTIC (thiazide-like diuretic) demonstrate the potential benefits of combining these diuretics for quicker decongestion but with potential risks (in the case of Hydrochlorothiazide).Outcomes Measured by Major Studies:Recent studies assessing decongestion in AHF reveal a lack of uniformity in outcome selection. The primary focus should be on reducing rehospitalizations and post-discharge mortality by achieving effective decongestion. The ADVOR study, using a simple congestion score based on clinical and imaging criteria, underscores the importance of reaching a congestion score of 0 or 1 promptly.Congestion Monitoring:Monitoring diuretic treatment solely based on clinical aspects may not capture subclinical congestion, necessitating biochemical and imaging parameters. The ACME-AHF trial proposes a diagnostic score integrating clinical and imaging aspects to evaluate congestion status. Secondary outcomes include cumulative diuresis, weight loss, diuretic efficiency, and natriuresis, with a focus on natriuresis as a reliable physiological parameter for decongestion.Aim of the study:The ACME-AHF trial is designed to compare the efficacy and safety of two diuretic combination strategies: acetazolamide with furosemide and metolazone with furosemide. The primary objective is to relieve congestion, assessed using a congestion score, within the first three days of treatment during an hospitalization for acute heart failure."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "This is an Open, Multicenter, Prospective, and Randomized study with three treatment arms. The outcomes to be assessed in the initial phase will be at 4 days post-randomization, followed by evaluation at 90 days after hospital discharge.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1050,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ACME-AHF",
"briefTitle": "Acetazolamide or Metolazone in Acute Heart Failure",
"nctId": "NCT06273397",
"orgStudyIdInfo": {
"id": "ACME-AHF",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Any adverse event"
},
{
"measure": "Changes in pH value"
},
{
"measure": "Change in plasma electrolyte values"
}
],
"primaryOutcomes": [
{
"measure": "Treatment success"
}
],
"secondaryOutcomes": [
{
"measure": "Mortality"
},
{
"measure": "Worsening Heart Failure"
},
{
"measure": "Cumulative 24-hour Natriuresis"
},
{
"measure": "Cumulative weight loss"
},
{
"measure": "Subclinical congestion"
},
{
"measure": "Change in Hematocrit value"
},
{
"measure": "Change in NT-proBNP concentration"
},
{
"measure": "Change in CA125 value"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Clinica Alemana de Santiago"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-05-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-18"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Helicobacter Pylori Infection",
"Peptic Ulcer Hemorrhage"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bangkok Noi",
"contacts": null,
"country": "Thailand",
"facility": "Faculty of Medicine Siriraj Hospital, Mahidol University",
"geoPoint": {
"lat": 13.76266,
"lon": 100.47798
},
"state": "Bangkok",
"status": null,
"zip": "10700"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this cross-sectional study is to evaluate the efficacy of current infection marker (CIM) method for H. pylori detection. The main questions it aims to answer are:* To evaluate the efficacy of CIM method for H. pylori detection compared to rapid urease test(RUT), histopathology, polymerase chain reaction (PCR), and urea breath test (UBT) in patients who presented with upper gastrointestinal hemorrhage from peptic ulcer, and their sensitivity, specificity, accuracy, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio, and negative likelihood ratio.* To evaluate the advantages of CIM method for H. pylori detection comparing to RUT, histopathology, PCR, and UBT in patients who presented with upper gastrointestinal hemorrhage from peptic ulcer as net reclassification index (NRI).* To study the associated factors in false negative value of H. pylori detection methods with CIM, RUT, histopathology, PCR, and UBT."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 135,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "CIM",
"briefTitle": "Diagnostic Performance of CIM for Helicobacter Pylori Infection in Patients With Peptic Ulcer Bleeding",
"nctId": "NCT06273384",
"orgStudyIdInfo": {
"id": "Si 062/2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The efficacy of CIM method for H. pylori detection"
}
],
"secondaryOutcomes": [
{
"measure": "The advantages of CIM method for H. pylori detection"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mahidol University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Damira 2000 Infant formula"
}
]
},
"conditionsModule": {
"conditions": [
"Cow's Milk Protein Allergy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Córdoba",
"contacts": null,
"country": "Spain",
"facility": "Hospital Quirónsalud de Córdoba",
"geoPoint": {
"lat": 37.89155,
"lon": -4.77275
},
"state": "Andalucia",
"status": null,
"zip": null
},
{
"city": "Sevilla",
"contacts": null,
"country": "Spain",
"facility": "H. Virgen del Rocío",
"geoPoint": {
"lat": 37.38283,
"lon": -5.97317
},
"state": "Andalucia",
"status": null,
"zip": null
},
{
"city": "Sevilla",
"contacts": null,
"country": "Spain",
"facility": "H. Virgen Macarena",
"geoPoint": {
"lat": 37.38283,
"lon": -5.97317
},
"state": "Andalucia",
"status": null,
"zip": null
},
{
"city": "Sevilla",
"contacts": null,
"country": "Spain",
"facility": "Instituto Hispalense de pediatría",
"geoPoint": {
"lat": 37.38283,
"lon": -5.97317
},
"state": "Andalucia",
"status": null,
"zip": null
},
{
"city": "Orense",
"contacts": null,
"country": "Spain",
"facility": "Hospital Materno infantil de Ourense",
"geoPoint": {
"lat": 42.33669,
"lon": -7.86407
},
"state": "Galicia",
"status": null,
"zip": null
},
{
"city": "Santiago De Compostela",
"contacts": null,
"country": "Spain",
"facility": "H. Clínico de Santiago",
"geoPoint": {
"lat": 42.88052,
"lon": -8.54569
},
"state": "Galicia",
"status": null,
"zip": null
},
{
"city": "Madrid",
"contacts": null,
"country": "Spain",
"facility": "Clínica privada Dr. Romera",
"geoPoint": {
"lat": 40.4165,
"lon": -3.70256
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Madrid",
"contacts": null,
"country": "Spain",
"facility": "Fundación Jiménez Día",
"geoPoint": {
"lat": 40.4165,
"lon": -3.70256
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Damira 2000© is a 100% extensive casein hydrolysate (eHCF). It is formulated to help reverse growth retardation as a result of cow's milk proteins allergy (CMPA), to be well tolerated and to help improve symptoms.Damira 2000 is indicated for allergy/intolerance to cow's milk proteins, atopic dermatitis secondary to CMPA, intestinal malabsorption processes and prevention of allergy/intolerance to cow's milk proteins.The study aimed at evaluating the tolerance of Damira 2000 in a cohort of children with CMPA."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 61,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "12 Months",
"minimumAge": "0 Months",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "DELISA",
"briefTitle": "Tolerance and Growth Outcomes in Children Diagnosed With Cow's Milk Protein Allergy and Prescribed an Extensively Hydrolyzed Casein Formula (Damira 2000©) in Spain",
"nctId": "NCT06273371",
"orgStudyIdInfo": {
"id": "DELISA2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Tolerance"
}
],
"secondaryOutcomes": [
{
"measure": "Weight"
},
{
"measure": "Height"
},
{
"measure": "Weight for height and BMI"
},
{
"measure": "Head circumference"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Lactalis"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-12-21"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-12-21"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-12"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"PREOPERATIVE SLEEP QUALITY ON POSTOPERATIVE DELIRIUM"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Konya",
"contacts": null,
"country": "Turkey",
"facility": "Yasin Tire",
"geoPoint": {
"lat": 37.87135,
"lon": 32.48464
},
"state": "Meram",
"status": null,
"zip": "42140"
}
]
},
"descriptionModule": {
"briefSummary": "Background: Delirium is a neurocognitive illness that has lately been connected to sleep difficulties. It is a stressful condition. is still not fully understood. A poor sleep burden and its progress were investigated in this study to determine their correlations with the risk of delirium following surgical procedures.Methods: Between August 1st and December 5th, 2023, 124 patients undergoing non-cardiac general anesthesia (mean age 63.68 ± 8.81 years \\[SD\\]; range 46-82 years) reported on their sleep characteristics. PSQI, 1- sleep duration, 2- sleep disturbance, 3- sleep latency, 4- daytime dysfunction resulting from sleepiness, 5- sleep efficiency, 6- overall sleep quality, and 7- usage of sleep medications were among these sleep characteristics. Seven component scores, ranging from 0 (no difficulty) to 3 (extreme difficulty), are obtained while assessing the PSQI. The global score ranges from 0 to 21 and is calculated by adding the component scores. Higher scores indicate poorer sleep quality. A three-day median follow-up time was used to analyze hospitalization records to gather data on new-onset delirium (n = 26). Approximately 124 people on average, with a mean."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 150,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "45 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Preoperative Sleep Quality and Postoperative Delirium",
"nctId": "NCT06273358",
"orgStudyIdInfo": {
"id": "Study Sleep Quality",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Sleep quality and QR 15 score"
}
],
"primaryOutcomes": [
{
"measure": "Sleep quality and delirium index"
}
],
"secondaryOutcomes": [
{
"measure": "Preop. and postop. sleep quality index"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Konya City Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-01-27"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-12-18"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-08-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Oligometastatic Prostate Carcinoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bressanone",
"contacts": [
{
"email": "[email protected]",
"name": "Michael Aigner, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Michael Aigner, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Ospedale di Bressanone",
"geoPoint": {
"lat": 46.71503,
"lon": 11.65598
},
"state": "Bolzano",
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Abano Terme",
"contacts": [
{
"email": "[email protected]",
"name": "Daniele Romagnoli, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Daniele Romagnoli, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Casa di Cura Abano Terme",
"geoPoint": {
"lat": 45.35753,
"lon": 11.78725
},
"state": "Padova",
"status": "RECRUITING",
"zip": null
},
{
"city": "Dolo",
"contacts": [
{
"email": "[email protected]",
"name": "Gianna Pace, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Gianna Pace, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Ospedale di Dolo",
"geoPoint": {
"lat": 45.42528,
"lon": 12.08429
},
"state": "Venezia",
"status": "RECRUITING",
"zip": null
},
{
"city": "Bassano Del Grappa",
"contacts": [
{
"email": "[email protected]",
"name": "Antonio Celia, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Antonio Celia, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Ospedale di Bassano Del Grappa",
"geoPoint": {
"lat": 45.76656,
"lon": 11.72739
},
"state": "Vicenza",
"status": "RECRUITING",
"zip": null
},
{
"city": "Mestre",
"contacts": [
{
"email": "[email protected]",
"name": "Francesco Gerardo Mandato, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Francesco Gerardo Mandato, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Ospedale dell'Angelo - Mestre",
"geoPoint": {
"lat": 45.49167,
"lon": 12.24538
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Padova",
"contacts": [
{
"email": "[email protected]",
"name": "Angelo Porreca, MD",
"phone": "0423 421321",
"phoneExt": "+39",
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Gian Luca De Salvo, MD",
"phone": "049 8215710",
"phoneExt": "+39",
"role": "CONTACT"
},
{
"email": null,
"name": "Angelo Porreca, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Istituto Oncologico Veneto IRCCS",
"geoPoint": {
"lat": 45.40797,
"lon": 11.88586
},
"state": null,
"status": "RECRUITING",
"zip": "35128"
},
{
"city": "Padova",
"contacts": [
{
"email": "[email protected]",
"name": "Fabio Zattoni, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Fabio Zattoni, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Azienda Ospedale Università Padova",
"geoPoint": {
"lat": 45.40797,
"lon": 11.88586
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Padova",
"contacts": [
{
"email": "[email protected]",
"name": "Pierpaolo Curti, MD",
"phone": "0442 622387",
"phoneExt": "+39",
"role": "CONTACT"
},
{
"email": null,
"name": "Pierpaolo Curti, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Ospedale MAter Salutis - Legnago",
"geoPoint": {
"lat": 45.40797,
"lon": 11.88586
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Padova",
"contacts": [
{
"email": "[email protected]",
"name": "Nicola Zanovello, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Nicola Zanovello, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Ospedali Riuniti Padova Sud",
"geoPoint": {
"lat": 45.40797,
"lon": 11.88586
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Trieste",
"contacts": [
{
"email": "[email protected]",
"name": "Carlo Trombetta, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Carlo Trombetta, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)",
"geoPoint": {
"lat": 45.64953,
"lon": 13.77679
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Udine",
"contacts": [
{
"email": "[email protected]",
"name": "Gianluca Giannarini, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Gianluca Giannarini, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Presidio Ospedaliero Universitario Santa Maria della Misericorida (ASU FC)",
"geoPoint": {
"lat": 46.0693,
"lon": 13.23715
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Verona",
"contacts": [
{
"email": "[email protected]",
"name": "Alessandro Antonelli, MD",
"phone": "0458127702/03",
"phoneExt": "+39",
"role": "CONTACT"
},
{
"email": null,
"name": "Alessandro Antonelli, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Italy",
"facility": "Azienda Ospedaliera Universitaria Integrata - Verona",
"geoPoint": {
"lat": 45.4299,
"lon": 10.98444
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The proposed study consists of a multicentre prospective observational study involving patients with oligometastatic prostatic neoplasia defined according to CHAARTED criteria.The aim of the study is the creation of a registry including patients with newly diagnosed OMPCa, belonging to the main urological centres in the Triveneto region, in order to evaluate the oncological outcomes and the impact on the quality of life of local treatment of the primary neoplasm (surgical or radiotherapy) in addition to systemic hormonal treatment (ADT as monotherapy or in combination with Docetaxel/androgen receptor signal inhibitors (ARTA)).The above criteria define 'high metastatic volume' disease with the following parameters* ≥ 4 bone metastases, including at least one outside the spine and pelvis* Presence of visceral metastases Consequently, patients included in the study should not have the above-mentioned characteristics."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "OLIGOS",
"briefTitle": "OLIGOS: Impact of Treatment on Primary Tumour in Patients With Newly Diagnosed Oligometastatic Neoplasia of the Prostate",
"nctId": "NCT06273345",
"orgStudyIdInfo": {
"id": "IOV-PR-1-2022-OLIGOS",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Overall survival (OS)"
}
],
"secondaryOutcomes": [
{
"measure": "Cancer-specific survival"
},
{
"measure": "CRPCa development"
},
{
"measure": "Radiological progression-free survival"
},
{
"measure": "Quality of life assessment"
},
{
"measure": "Quality of life assessment"
},
{
"measure": "Complications"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istituto Oncologico Veneto IRCCS"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-01-23"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "AI-assisted registration"
},
{
"name": "Point-based registration"
}
]
},
"conditionsModule": {
"conditions": [
"Registration Accuracy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Cairo",
"contacts": null,
"country": "Egypt",
"facility": "Private maxillofacial digital lab",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Our study investigates the accuracy and duration needed for 3D model registration using artifical intelligence (AI) assistance compared to conventional point-based registration. Manual segmentation of all cone beam computed tomography (CBCT) scans will be performed before the registration procedure."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 16,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "15 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Assessment of the Artifical Intelligence Assisted Registration Versus Conventional Point Based Registration on Cone Beam-computed Tomography (CBCT) With Heavy Metal Artifacts",
"nctId": "NCT06273332",
"orgStudyIdInfo": {
"id": "AI surgery protocol",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Registration accuracy"
}
],
"secondaryOutcomes": [
{
"measure": "Duration for registration"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ain Shams University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-02-25"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-01-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-12-20"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "OXYGEN THERAPY"
}
]
},
"conditionsModule": {
"conditions": [
"Gastric Disease",
"Gastric Distress"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Malatya",
"contacts": null,
"country": "Turkey",
"facility": "Inonu universitesi",
"geoPoint": {
"lat": 38.35018,
"lon": 38.31667
},
"state": null,
"status": null,
"zip": "44050"
}
]
},
"descriptionModule": {
"briefSummary": "To compare desaturation and respiratory complications by applying oxygen therapy with double nasal cannula to patients who are planned to undergo gastrointestinal endoscopy."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "2",
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Oxygen Application With Double Nasal Cannula on Respiratory Complications",
"nctId": "NCT06273319",
"orgStudyIdInfo": {
"id": "010656",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Determination of the amount of oxygen to prevent the peripheral oxygen saturation of the patients from falling below 95%"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Inonu University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "IMIDOC"
}
]
},
"conditionsModule": {
"conditions": [
"Telemedicine",
"Telehealth",
"eHealth",
"Rheumatic Diseases",
"Arthritis, Rheumatoid",
"Spondylarthritis"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The main objective is to evaluate the implementation of a hybrid care model called the mixed attention model (MAM) in clinical practice and to evaluate whether its implementation improves clinical outcomes compared to conventional follow-up.This is a multicenter prospective observational study involving 360 patients with rheumatoid arthritis (RA) and Spondylarthritis (SpA) from five Spanish Hospitals. Patients will be followed-up by the MAM protocol, which is a care model that incorporates the use of digital tool consisting of a mobile application (App) that patients can use at home and that professionals can review asynchronously to detect incidents and to follow their patients; clinical evolution between face-to-face visits. Another group of patients, whose follow-up will be conducted in accordance with a traditional face-to-face care model, will be assessed as the control group. Sociodemographic characteristics, treatments, laboratory parameters, assessment of tender and swollen joints, visual analogue scale for pain and electronic patient reported outcome reports (ePROs) will be collected for all subjects. In the MAM group, these items will be self-assessed both by the mobile App and during face-to-face visits with rheumatologist, who will do the same for patients included in the traditional care model. Patients will be able to report any incidence related to their disease or treatment through the mobile App."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 360,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "IMIDOC",
"briefTitle": "Towards Telemonitoring in Immune-Mediated Inflammatory Diseases: Implementation of a Mixed Attention Model (IMIDOC)",
"nctId": "NCT06273306",
"orgStudyIdInfo": {
"id": "HULP.PI-4519",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Fondo de investigaciones sanitarias.Instituto de Salud Carlos III",
"id": "PI22/00777",
"link": null,
"type": "OTHER_GRANT"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To assess the primary objective, composite endpoints that consider the viability, adherence and degree of satisfaction of the MAM are included"
}
],
"secondaryOutcomes": [
{
"measure": "To identify features associated with adherence to follow-up through the MAM."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Instituto de Investigación Hospital Universitario La Paz"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Fractional Flow Reserve"
}
]
},
"conditionsModule": {
"conditions": [
"Coronary Disease"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "the use of pressure wires is the standar of care to evaluate angiographically intermediate coronary lesions, however, limitations in the management of these type of lesions continue to be a challenge for the interventional cardiologist. The use of FFR has some limitations such as the use of adenosine due to its cost, adverse effects (e.g. transient atrioventricular block, angina, headache, etc.), time consuming and some relative contraindications for its use. In this sense, in recent years new rest indices (iFR, RFR, dPR) and hyperemic indices without adenosine (cFFR-NTG, Pd/Pa-NTG or cFFR) have been developed, demonstrating an improvement in terms of outcomes with its use, so they can also be used as a tool to guide us to plan our strategy. These new indices, particularly the cFFR-NTG, are simpler, at least as safe and have an excellent correlation with the FFR with adenosine in the assessment of intermediate coronary lesions.In recent years, functional assessment after intervention has also been increasingly implemented, which, like intracoronary imaging, can make us change our attitude and correlate with the prognosis. The lower implementation of this practice, especially in multivessel patients, may result from having to lose the position of the wire to check equalization, difficulty in crossing the wire, wear/breakage of the material after diagnosis (2-3 vessels), use more time and contrast, etc. These problems could be reduced, at least partially, with the use of the workhorse coronary guidewire pressure microcatheter to measure post-PCI functional assessment. Although the usefulness of post-PCI FFR has been demonstrated, there is no clearly established cut-off value (0.84-0.96) and it seems that in reality the values are a continuum of risk so that the higher the value, the better the prognosis . Furthermore, other simpler indices such as rest or hyperemic indices without adenosine have not been correlated with FFR in post-PCI.The purpose of this study is to evaluate the correlation between cFFR-NTG and other indices taking FFR as a reference in multivessel patients after undergoing intervention. Establish cut-off points and correlate it with adverse cardiovascular events (MACE) in a 1-year clinical follow-up."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "DIAGNOSTIC",
"timePerspective": null
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Postprocedural Contrast Mediated FFR Plus Intracoronary Infusion of Nitroglycerin in Multivessel Patients (PROMETEUS TRIAL)",
"nctId": "NCT06273293",
"orgStudyIdInfo": {
"id": "EPIC35-PROMETEUS",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Agreement between cFFR+NTG and FFR"
},
{
"measure": "SAFETY: MACE"
}
],
"secondaryOutcomes": [
{
"measure": "Agreement between Pd/Pa or dPR and FFR"
},
{
"measure": "Cut-off point for cFFR+NTG post-ICP"
},
{
"measure": "Evaluate the change in strategy that the measurement of FFR values ≤0.90 post-PCI"
},
{
"measure": "Cardiac death"
},
{
"measure": "Cardiovascular death"
},
{
"measure": "Acute myocardial infarction of the lesion treated/functionally evaluated"
},
{
"measure": "Acute myocardial infarction from any lesion"
},
{
"measure": "Need for revascularization of the lesion treated/functionally evaluated"
},
{
"measure": "Need for revascularization of any lesion"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fundación EPIC"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-01-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-13"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-01-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-20"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "SOC"
},
{
"name": "Protocolized up-titration"
}
]
},
"conditionsModule": {
"conditions": [
"Heart Failure",
"Heart Failure With Reduced Ejection Fraction"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Genk",
"contacts": null,
"country": "Belgium",
"facility": "Ziekenhuis Oost-Limburg AV",
"geoPoint": {
"lat": 50.965,
"lon": 5.50082
},
"state": "Limburg",
"status": null,
"zip": "3600"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to evaluate guideline-directed medical therapy (GDMT) up-titration in patients with heart failure with reduced ejection fraction.The main question it aims to answer is the improvement in prescription rate and dose uptitration of quadruple GDMT in patients with HFrEF, assessed by a weighed composite score.Participants will be randomized towards control (standard of care, SOC) or intervention group.Researchers will compare SOC with protocol-based up-titration to see if the protocolized optimization improves prescription rate of GDMT."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "This is a prospective, randomized-controlled trial. Due to the design, the study is open-label, but the endpoint assessment is blinded.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Due to the study design, the study is open-label. In order to reduce bias, a study nurse (blinded for allocation arm) will see or call the patient to register the heart failure medication and dose of loop diuretics at three months and optionally 12months (open-label, endpoint-blinded).",
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 345,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ReQUAD-HF",
"briefTitle": "Renal-based Optimization of QUADruple Therapy in Patients With Heart Failure With Reduced Ejection Fraction.",
"nctId": "NCT06273280",
"orgStudyIdInfo": {
"id": "Z-2023025",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "All-cause mortality"
},
{
"measure": "Number of patients with heart failure hospitalizations"
},
{
"measure": "Change in prescription rate per GDMT class"
},
{
"measure": "Incidence of predefined safety endpoints"
}
],
"primaryOutcomes": [
{
"measure": "Weighed composite score of maximal guideline-directed medical therapy"
}
],
"secondaryOutcomes": [
{
"measure": "All-cause mortality and heart failure hospitalizations"
},
{
"measure": "Change in NTproBNP"
},
{
"measure": "Change in renal function"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "King Baudouin Foundation"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Ziekenhuis Oost-Limburg"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-14"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Collection of data from the patient's medical file"
}
]
},
"conditionsModule": {
"conditions": [
"Encephalopathy",
"Cerebral Palsy",
"Cerebral Malformation",
"Traumatic Head Injury"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Paris",
"contacts": [
{
"email": "[email protected]",
"name": "Ashley RIDLEY, M.D.",
"phone": "1 42 19 27 28",
"phoneExt": "+33",
"role": "CONTACT"
}
],
"country": "France",
"facility": "Hôpital Necker-Enfants Malades",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": null,
"status": null,
"zip": "75015"
}
]
},
"descriptionModule": {
"briefSummary": "Due to the wide range of diagnoses encountered in pediatric palliative care, the Association for Children's Palliative Care (ACT) and the Royal College of Paediatrics and Child Health (RCPCH) have developed a classification of life-limiting illnesses, based on support models.This classification includes four groups. ACT 4 category is made up of children with a serious incurable non-progressive neurological disease (for example: anoxic ischemia, cerebral palsy, traumatic or infectious brain injuries).Although data relating to specific ACT groups are scarce, experience from clinical practice suggests that the needs and use of Pediatric palliative care resources are different across the four categories.The specific history of ACT-4 patients suggests that pediatric palliative care may be required early on in the history of the disease but effective intervention varies greatly from one patient to another. Tthis study aims to better understand the optimal timing for introducing a PPC team into the care pathway for these children. The study also aims to describe the care trajectory over the first year of PPC intervention."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 150,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "25 Years",
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": "StartSPP",
"briefTitle": "Initiating Pediatric Palliative Care in ACT Group 4",
"nctId": "NCT06273267",
"orgStudyIdInfo": {
"id": "APHP231232",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Description of first pediatric palliative care intervention"
}
],
"secondaryOutcomes": [
{
"measure": "Description of the patient situation"
},
{
"measure": "Timing of pediatric palliative care intervention"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Assistance Publique - Hôpitaux de Paris"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Sacubitril and Valsartan Tablets 49mg/51mg"
},
{
"name": "Entresto® (Sacubitril and Valsartan Tablets 49mg/51mg)"
}
]
},
"conditionsModule": {
"conditions": [
"Bioequivalence Study"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bangkok",
"contacts": [
{
"email": "[email protected]",
"name": "Ariya Khunvichai, Ph.D",
"phone": "666 2428 7178",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Suvimol Niyomnaitham, Assist. Prof., M.D., Ph.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Thailand",
"facility": "Medica Innova Co Ltd",
"geoPoint": {
"lat": 13.75398,
"lon": 100.50144
},
"state": null,
"status": null,
"zip": "10310"
}
]
},
"descriptionModule": {
"briefSummary": "Primary objective is to is to evaluate the bioequivalence of two formulations"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 48,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Bioequivalence Study of Sacubitril/Valsartan Film-coated Tablets Under Fasting Conditions",
"nctId": "NCT06273254",
"orgStudyIdInfo": {
"id": "SCVL-TFZ-1009",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Cmax"
},
{
"measure": "AUC"
}
],
"secondaryOutcomes": [
{
"measure": "tmax"
},
{
"measure": "t1/2"
},
{
"measure": "λz"
},
{
"measure": "AUC0-t/AUC0-∞"
},
{
"measure": "residual area"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Viatris Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "food intake"
}
]
},
"conditionsModule": {
"conditions": [
"Pharmacokinetic Study in Healthy Volunteers"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Greifswald",
"contacts": [
{
"email": "[email protected]",
"name": "Stefan Engeli, Prof.",
"phone": "+49 3834865633",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Christin Jeschke",
"phone": "+491746471584",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Stefan Engeli, Prof.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Germany",
"facility": "University Medicine Greifswald, Institute of Pharmacology",
"geoPoint": {
"lat": 54.09311,
"lon": 13.38786
},
"state": "Mecklenburg-Vorpommern",
"status": null,
"zip": "17487"
}
]
},
"descriptionModule": {
"briefSummary": "The influence of genetic variants of the CYP2D6 enzyme and the Organic Cation Transporter 1 on the kinetics of berberine (BERKI-1) has recently been studied. A significant sex difference was observed. These results lead to the BERKI-2 study, investigating the influence of the female hormonal cycle on berberine kinetics. In this study, women took a single berberine dose once in the first and once in the second half of their menstrual cycle, men served as a control group ingesting a single berberine dose. Contrary to our expectations, the previously observed sex difference could not be confirmed.In both BERKI-1 and 2 studies, the plasma concentration curve exhibited two peaks. The first after about 2-3 h, and the second after approximately 5 h of berberine intake. All participants took a single dose of Berberine under fasting conditions in the morning and 4 h after berberine intake, they ate a meal. Shortly after meal intake, the plasma concentration curve peaked again BERKI-3 will investigate the impact of food intake on berberine bioavailability and the kinetic properties. Given the suspected influence of berberine on glycemic control, we will also measure insulin and glucose after the meal at noon.As in BERKI-1 and 2, time dependent blood and urine samples will be collected after a single berberine dose. One By measuring berberine metabolites by Liquid Chromatography and Mass-spec One dose will be taken in the fasted condition and the other two after a light or high caloric meal, respectively.24 heathy volunteers with an equal ratio of man and women will be enrolled."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "This is an unblinded, randomized, prospective study comparing berberine intake in fasted condition and after a high or low caloric meal in a cross-over design.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "This study will be an open label study. Participants will be selected from an existing database of our Institute.",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 24,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "BERKI-3",
"briefTitle": "Impact of Food Intake on Berberine Kinetics",
"nctId": "NCT06273241",
"orgStudyIdInfo": {
"id": "IPHA-2024-009",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Blood glucose concentrations"
},
{
"measure": "Blood insulin concentrations"
}
],
"primaryOutcomes": [
{
"measure": "Berberine plasma concentration fasted vs fed"
}
],
"secondaryOutcomes": [
{
"measure": "Berberine plasma concentrations light vs heavy meal"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Medicine Greifswald"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-04"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Family Check-Up Online"
}
]
},
"conditionsModule": {
"conditions": [
"Parenting",
"Parent-Child Relations",
"Substance Use Disorders",
"Stress",
"Depression",
"Anxiety",
"Parenting Self-efficacy",
"Pediatrics"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Eugene",
"contacts": [
{
"email": "[email protected]",
"name": "Katherine Hails, PhD",
"phone": "610-457-8627",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Elizabeth Stormshak, PhD",
"phone": "541-912-3792",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Katherine Hails, PhD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Prevention Science Institute, University of Oregon",
"geoPoint": {
"lat": 44.05207,
"lon": -123.08675
},
"state": "Oregon",
"status": "RECRUITING",
"zip": "97403"
}
]
},
"descriptionModule": {
"briefSummary": "Research suggests that one in eight children in the U.S. currently lives with a parent with a substance use disorder. Parents who misuse substances are at increased risk of using harsh and other negative parenting practices with their young children, who are more likely to face challenges with emotional and behavioral regulation and subsequently misuse substances themselves. There is thus an urgent need for evidence-based interventions to promote positive parenting skills in parents who misuse substances. Interventions must be convenient, non-stigmatizing, and accessible to parents with problematic substance use, who frequently face barriers to engaging with healthcare systems. Pediatric primary care is an ideal setting to offer a brief intervention for maladaptive parenting behaviors associated with parental substance use, as the vast majority of children under 5 access pediatric primary care at least annually and parents generally report high levels of trust in their child's pediatrician.The Family Check-Up (FCU) Online app, which was created specifically to promote positive parenting skills in parents with past or current substance misuse, is ideal for delivery to parents with pre-school age children in a pediatric primary care setting as it is brief, convenient, and delivered in a self-directed format that parents favor. The main objective of this pilot study is to test the feasibility and acceptability of the FCU-Online, a brief, app-based parenting intervention, for parents reporting lifetime problematic substance use in a pediatric primary care setting.In this study, investigators will partner with pediatric primary care providers to recruit parent participants, then evaluate feasibility and acceptability by systematically assessing parents' engagement with the FCU Online app. Engagement data from the app includes time spent in app overall and in each module, activities completed, and which modules were accessed. Investigators will also administer a consumer satisfaction survey, which will ask parents to report on their perceptions of the app (e.g., helpfulness, useability, and effects on parenting). To assess engagement in telehealth coaching sessions, investigators will use the following variables: number of telehealth sessions completed, length of session, content of sessions, and coaches' ratings of participant engagement in the session and barriers to using the app. Coaches will also rate participant engagement on a 3-point scale from \"low\" to \"high.\" Lastly, investigators will conduct qualitative interviews with a sub-sample of participants to solicit additional feedback on the acceptability of the FCU Online, focusing particularly on the perception of acceptability within an integrated primary care context and stigma associated with endorsing substance use in this setting.A second aim of this study is to assess pediatric healthcare providers' perceptions and attitudes regarding the fit of the FCU Online with their practice settings as well as potential barriers to implementation. Through semi-structured focus groups and qualitative interviews with pediatric healthcare providers, investigators will assess provider- and practice-level factors that may facilitate or impede the implementation of the FCU Online in pediatric primary care settings."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Parents will be recruited in pediatric primary care settings and will be assessed at baseline and at a 3-month follow-up. Parents will receive the intervention between baseline and follow-up. Nine parents will be randomly selected for an additional follow-up interview.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 36,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Parenting Young Children in Pediatrics",
"nctId": "NCT06273228",
"orgStudyIdInfo": {
"id": "STUDY00000788",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "change from baseline in parenting skills"
},
{
"measure": "change from baseline in parenting efficacy"
},
{
"measure": "change from baseline in parent executive functioning"
},
{
"measure": "change from baseline in child social-emotional behavior"
},
{
"measure": "change from baseline in family conflict"
},
{
"measure": "change from baseline in parental substance use"
},
{
"measure": "change from baseline in parental depression"
},
{
"measure": "change from baseline in parental anxiety"
},
{
"measure": "change from baseline in parental stress"
},
{
"measure": "change from baseline in parental impact of negative life events"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institute on Drug Abuse (NIDA)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Oregon"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-10-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-27"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "The combinations of 10 µg midazolam, 375 µg dabigatran etexilate, 10 µg pitavastatin, 50 µg rosuvastatin, and 100 µg atorvastatin were administered to diabetic patients on an empty stomach."
}
]
},
"conditionsModule": {
"conditions": [
"Diabetes"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": [
{
"email": "[email protected]",
"name": "Yafen Li",
"phone": "18222566785",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Dongyang Liu",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"email": null,
"name": "Tianpei Hong",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "Peking University Third Hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": "RECRUITING",
"zip": "100191"
}
]
},
"descriptionModule": {
"briefSummary": "1.To explore the functional changes of P-gp, CYP3A4, OATP1B and BCRP in Diabetic patients (including the non-obese T2DM, obese T2DM, elderly T2DM, and T1DM)."
},
"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": 48,
"type": "ESTIMATED"
},
"phases": [
"PHASE4"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of the Pharmacokinetics of Microdose Midazolam, Dabigatran, Pitavastatin, Atorvastatin and Rosuvastatin in Diabetic Patients",
"nctId": "NCT06273215",
"orgStudyIdInfo": {
"id": "DCTC-IIR202217",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pharmacokinetics of study drug"
}
],
"secondaryOutcomes": [
{
"measure": "Concentration of endogenous markers of CYP3A and OATP"
},
{
"measure": "Genotype of OATP and BCRP"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Peking University Third Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-05"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Infant Massage"
}
]
},
"conditionsModule": {
"conditions": [
"Prematurity"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this interventional study is to investigate through musculoskeletal ultrasonography how the thickness and muscle trophism in infants aged 28 to 35 weeks undergoing infant massage compared with a group of infants with similar characteristics not subjected to treatment.The main questions it aims to answer are:* To assess by musculoskeletal ultrasound the impact of infant massage on muscle thickness muscle. Specifically, changes in muscle thickness and trophism of the quadriceps femoris.* Potential effects on spontaneous motility and stature-ponderal growth of infants. In addition, the discomfort and behavioral status of the infant before and after massage will be investigated infant.Patients included in the study will be randomized according to a random sequence with a 1:1 ratio into theexperimental group (GS) or the control group (GC). Patients in the GS will perform therapy with infant massage in addition to the usual rehabilitation therapies as specified by the program individual habilitative, to which patients in the control group will be subjected exclusively control.Infant massage will be performed three times a day (10 minutes per session) until they reach the 35th week of post-conceptional age (35+6) by the two departmental physical therapists (ADP and ADV).Ultrasound will be performed at the time of randomization (T0) and then 1 time per week until the 35th week by two operators (SN and VA); at the same time, the circumference of the thigh subjected to ultrasound examination. A 12Hz linear ultrasound probe will be used, applied perpendicular to the skin. The infant will be placed supine, with the thigh extended, in a neutral position; excessive compression will be avoided by applying a generous amount of gel. At the midpoint of the thigh, the thickness of the quadriceps muscle will be calculated by measuring the distance between the cortex of the femur and the most superficial muscle fascia. The average of at least 2 measurements will be then calculated. The Heckmatt scale will be used to assess the echogenicity of muscle and bone. In addition, at time T0 and at week 35 the following data will be collected: weeks gestational age, weight at birth and at the end of treatment, rectal temperature, blood gas parameters if present."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 24,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Weeks",
"minimumAge": "28 Weeks",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "NeoMassage",
"briefTitle": "Ultrasound Monitoring of Muscle Thickness in Premature Patients",
"nctId": "NCT06273202",
"orgStudyIdInfo": {
"id": "6257",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Quadriceps femuri thickness"
},
{
"measure": "Quadriceps femuri trophism"
}
],
"secondaryOutcomes": [
{
"measure": "To valuate the discomfort/behavioral status of the infant."
},
{
"measure": "To valuate the potential effects on spontaneous motility."
},
{
"measure": "To evaluate differences in ponderal growth."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Fondazione Policlinico Universitario Agostino Gemelli IRCCS"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Conventional"
},
{
"name": "Bone Scalpel"
}
]
},
"conditionsModule": {
"conditions": [
"Maxillofacial Abnormalities"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kayseri",
"contacts": null,
"country": "Turkey",
"facility": "Selin Çelebi",
"geoPoint": {
"lat": 38.73222,
"lon": 35.48528
},
"state": "Melikgazi",
"status": null,
"zip": "38039"
}
]
},
"descriptionModule": {
"briefSummary": "The conventional saw compared with the piezo surgery in BSSO to evaluate cutting time, surgery duration, amount of bleeding. The purpose of this study was to answers following clinical questions: Is ultrasonic bonescalpel effective osteotomy like conventional bur in BSSO? and 2) Does it reduce operative parameter like bleeding, duration, lingual split pattern? 3) Does it reduce postoperative morbidity after BSSO."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "double blind",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Ultrasonic Bone Scalpel in BSSO",
"nctId": "NCT06273189",
"orgStudyIdInfo": {
"id": "2017/558",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Cutting Time"
},
{
"measure": "neurosensory disturbance"
}
],
"secondaryOutcomes": [
{
"measure": "The length of the procedure"
},
{
"measure": "The splitting time"
},
{
"measure": "The pattern of the split"
},
{
"measure": "postoperative edema"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "TC Erciyes University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2021-12-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2020-12-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2018-12-15"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Awake mapping under local anesthesia"
},
{
"name": "Asleep mapping under general anesthesia"
},
{
"name": "Resection under general anesthesia without mapping"
}
]
},
"conditionsModule": {
"conditions": [
"Glioblastoma, IDH-wildtype",
"Glioblastoma",
"Glioblastoma Multiforme of Brain",
"Astrocytoma, Malignant",
"Brain Neoplasms",
"Brain Neoplasms, Adult, Malignant",
"Brain Neoplasms, Adult",
"Recurrent Adult Brain Tumor",
"Recurrent Glioblastoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "San Francisco",
"contacts": [
{
"email": null,
"name": "Mitchel Berger, MD PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of California, San Francisco",
"geoPoint": {
"lat": 37.77493,
"lon": -122.41942
},
"state": "California",
"status": "RECRUITING",
"zip": "94143"
},
{
"city": "Boston",
"contacts": [
{
"email": null,
"name": "Brian Nahed, MD PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Massachusetts General Hospital",
"geoPoint": {
"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts",
"status": "RECRUITING",
"zip": "02114"
},
{
"city": "Leuven",
"contacts": [
{
"email": null,
"name": "Steven De Vleeschouwer, MD PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Belgium",
"facility": "University Hospital Leuven",
"geoPoint": {
"lat": 50.87959,
"lon": 4.70093
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Heidelberg",
"contacts": [
{
"email": null,
"name": "Christine Jungk, MD PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Sandro Krieg, MD PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "Universitätsklinikum Heidelberg",
"geoPoint": {
"lat": 49.40768,
"lon": 8.69079
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Munich",
"contacts": [
{
"email": null,
"name": "Arthur Wagner, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Germany",
"facility": "Technical University Munich",
"geoPoint": {
"lat": 48.13743,
"lon": 11.57549
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
},
{
"city": "Rotterdam",
"contacts": [
{
"email": null,
"name": "Jasper Gerritsen, MD PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Netherlands",
"facility": "Erasmus Medical Center",
"geoPoint": {
"lat": 51.9225,
"lon": 4.47917
},
"state": "Zuid-Holland",
"status": "RECRUITING",
"zip": "3015 GD"
},
{
"city": "The Hague",
"contacts": [
{
"email": null,
"name": "Marike Broekman, MD PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Netherlands",
"facility": "Haaglanden Medical Center",
"geoPoint": {
"lat": 52.07667,
"lon": 4.29861
},
"state": null,
"status": "RECRUITING",
"zip": null
},
{
"city": "Bern",
"contacts": [
{
"email": null,
"name": "Philippe Schucht, MD PhD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Switzerland",
"facility": "Inselspital Universitätsspital Bern",
"geoPoint": {
"lat": 46.94809,
"lon": 7.44744
},
"state": null,
"status": "NOT_YET_RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Resection of glioblastoma in or near functional brain tissue is challenging because of the proximity of important structures to the tumor site. To pursue maximal resection in a safe manner, mapping methods have been developed to test for motor and language function during the operation. Previous evidence suggests that these techniques are beneficial for maximum safe resection in newly diagnosed grade 2-4 astrocytoma, grade 2-3 oligodendroglioma, and recently, glioblastoma. However, their effects in recurrent glioblastoma are still poorly understood. The aim of this study, therefore, is to compare the effects of awake mapping and asleep mapping with no mapping in resections for recurrent glioblastoma.This study is an international, multicenter, prospective 3-arm cohort study of observational nature. Recurrent glioblastoma patients will be operated with mapping or no mapping techniques with a 1:1 ratio. Primary endpoints are: 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months, and 6 months after surgery and 2) residual tumor volume of the contrast-enhancing and non-contrast-enhancing part as assessed by a neuroradiologist on postoperative contrast MRI scans. Secondary endpoints are: 1) overall survival (OS), 2) progression-free survival (PFS), 4) health-related quality of life (HRQoL) at 6 weeks, 3 months, and 6 months after surgery, and 4) frequency and severity of Serious Adverse Events (SAEs) in each arm. Estimated total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.The study will be carried out by the centers affiliated with the European and North American Consortium and Registry for Intraoperative Mapping (ENCRAM)."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 225,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "90 Years",
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "RECMAP",
"briefTitle": "The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma",
"nctId": "NCT06273176",
"orgStudyIdInfo": {
"id": "MEC-2020-0812",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Residual volume"
},
{
"measure": "Neurological morbidity at 6 weeks"
}
],
"secondaryOutcomes": [
{
"measure": "Overall survival"
},
{
"measure": "Progression-free survival"
},
{
"measure": "Onco-functional outcome (OFO)"
},
{
"measure": "Serious Adverse Events"
},
{
"measure": "Neurological morbidity at 3 months"
},
{
"measure": "Neurological morbidity at 6 months"
},
{
"measure": "Overall functioning at 6 weeks"
},
{
"measure": "Overall functioning at 3 months"
},
{
"measure": "Overall functioning at 6 months"
},
{
"measure": "Quality of life at 6 weeks (EORTC QLQ C30)"
},
{
"measure": "Quality of life at 3 months (EORTC QLQ C30)"
},
{
"measure": "Quality of life at 6 months (EORTC QLQ C30)"
},
{
"measure": "Quality of life at 6 weeks (EORTC QLQ BN20)"
},
{
"measure": "Quality of life at 3 months (EORTC QLQ BN20)"
},
{
"measure": "Quality of life at 6 months (EORTC QLQ BN20)"
},
{
"measure": "Quality of life at 6 weeks (EQ-5D)"
},
{
"measure": "Quality of life at 3 months (EQ-5D)"
},
{
"measure": "Quality of life at 6 months (EQ-5D)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Haaglanden Medical Centre"
},
{
"name": "Universitaire Ziekenhuizen KU Leuven"
},
{
"name": "University Hospital Heidelberg"
},
{
"name": "Technical University of Munich"
},
{
"name": "Insel Gruppe AG, University Hospital Bern"
},
{
"name": "Massachusetts General Hospital"
},
{
"name": "University of California, San Francisco"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Erasmus Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-01-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-01-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Medically tailored meals"
},
{
"name": "Noom®"
},
{
"name": "Usual care"
}
]
},
"conditionsModule": {
"conditions": [
"Obesity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Dallas",
"contacts": [
{
"email": "[email protected]",
"name": "Carolyn Haskins, MS",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Jessica Turcios, BS",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Kelseanna Hollis-Hansen, PhD, MPH",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "UT Southwestern Medical Center",
"geoPoint": {
"lat": 32.78306,
"lon": -96.80667
},
"state": "Texas",
"status": "RECRUITING",
"zip": "75390"
}
]
},
"descriptionModule": {
"briefSummary": "Longitudinal studies show there is a steep increase in weight regain in the first 3-4 months after stopping GLP-1 receptor agonist medications (GLP-1s) and most patients regain most of their weight within a year. Insurers now question the utility of GLP-1s for weight loss as they are hesitant to cover these costs long-term (\\~$833 per person per month). Some patients would also prefer not to take these medications in perpetuity and are likely to struggle with lifelong adherence. These challenges present an opportunity to test alternative interventions, such as meal replacements and behavioral treatments, to support weight maintenance after successful weight loss with GLP-1s. This regimen would allow patients to benefit from significant weight loss in the first year of taking GLP-1s and use more cost effective and sustainable strategies for long-term maintenance."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomized repeated measures between-subjects design",
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "Complete masking is not feasible given the nature of the interventions - the program coordinator and participants will know if the participant receives home delivered medically tailored meals, a smart device application subscription, or usual care. The care provider will not be told the participants group assignment, but the participant may reveal it themselves in discussions with the provider.",
"whoMasked": [
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Identifying Strategies to Curtail Weight Regain After GLP-1 Receptor Agonist Treatment Cessation",
"nctId": "NCT06273163",
"orgStudyIdInfo": {
"id": "STU-2023-1168",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Incremental cost effective ratio (ICER)"
}
],
"primaryOutcomes": [
{
"measure": "Intervention Adherence"
},
{
"measure": "Intervention Satisfaction"
}
],
"secondaryOutcomes": [
{
"measure": "Percent weight loss maintained"
},
{
"measure": "Diet quality"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "UT Southwestern Nutrition Obesity Research Center"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Texas Southwestern Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-08"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-05"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Positive genetic test for pathological expansion in ATN1"
}
]
},
"conditionsModule": {
"conditions": [
"Dentatorubral-Pallidoluysian Atrophy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "New York",
"contacts": [
{
"email": "[email protected]",
"name": "Claire Miller",
"phone": "212-263-4838",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "NYU Grossman School of Medicine",
"geoPoint": {
"lat": 40.71427,
"lon": -74.00597
},
"state": "New York",
"status": "RECRUITING",
"zip": "10017"
},
{
"city": "Chapel Hill",
"contacts": [
{
"email": "[email protected]",
"name": "Yael Shiloh-Malawsky",
"phone": "919-966-2528",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of North Carolina at Chapel Hill",
"geoPoint": {
"lat": 35.9132,
"lon": -79.05584
},
"state": "North Carolina",
"status": "RECRUITING",
"zip": "27599-7025"
},
{
"city": "London",
"contacts": [
{
"email": "[email protected]",
"name": "Paola Giunti",
"phone": "+44 7899974923",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United Kingdom",
"facility": "University College London",
"geoPoint": {
"lat": 51.50853,
"lon": -0.12574
},
"state": null,
"status": "RECRUITING",
"zip": "WC1N 3BG"
}
]
},
"descriptionModule": {
"briefSummary": "DRPLA Natural History and Biomarkers Study (DRPLA NHBS) is a prospective observational study that will lay the foundation for clinical trials in DRPLA. The aims of this project are:* To characterize the natural history of DRPLA in both juvenile- and adult-onset patients and study different modalities of biomarkers in this condition.* To identify genetic factors and biomarkers that could predict disease progression.* To provide a platform to support the design and conduct of clinical trials.This study has three arms:1. Adult Participants: this arm of the study will require participants to be 16 years old or over to participate.2. Pediatric Participants: this arm of the study will require participants to be under 16 years old to participate.3. Remote Participants: patients that cannot or do not wish to travel to one of the study sites can participate in this arm of the study, irrespective of their age.Participants will have an annual visit for three years (baseline visit and two follow-up visits, three visits in total). Subjects who complete the whole protocol will be assessed on two consecutive days to reduce patient burden.This project will allow for a better understanding of DRPLA and its course, and therefore allow for future clinical trials on this condition to be more precisely and effectively conducted."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 225,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "DRPLA NHBS",
"briefTitle": "Dentatorubral-pallidoluysian Atrophy Natural History and Biomarkers Study",
"nctId": "NCT06273150",
"orgStudyIdInfo": {
"id": "142048",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Scale for the assessment and rating of ataxia (SARA)"
},
{
"measure": "Brain atrophy"
},
{
"measure": "Neurofilament plasma concentration (NfL)"
}
],
"secondaryOutcomes": [
{
"measure": "Inventory of non-ataxia signs (INAS)"
},
{
"measure": "Upper limb function test AIM-S"
},
{
"measure": "Redenlab DRPLA specific speech battery"
},
{
"measure": "Clinical Assessment of Dysphagia in Neurodegeneration (CADN)"
},
{
"measure": "Tau plasma concentration"
},
{
"measure": "Glial fibrillary acidic protein (GFAP) concentration"
},
{
"measure": "Ubiquitin carboxyterminal hydrolase L1 (UCH-L1) concentration"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of North Carolina, Chapel Hill"
},
{
"name": "NYU Grossman School of Medicine"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University College, London"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Positive affect treatment"
}
]
},
"conditionsModule": {
"conditions": [
"Depression"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Irvine",
"contacts": [
{
"email": "[email protected]",
"name": "Kate R Kuhlman",
"phone": "949-824-5574",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "University of California Irvine",
"geoPoint": {
"lat": 33.66946,
"lon": -117.82311
},
"state": "California",
"status": "RECRUITING",
"zip": "92617"
}
]
},
"descriptionModule": {
"briefSummary": "Youth exposed to early life adversity (ELA) are known to be at greater risk for depression and suicidality and account for almost half of the youth suffering from psychiatric diseases today. Youth exposed to ELA consistently report symptoms of anhedonia as well as dysregulated positive affect. The present project will test the efficacy of PAT in a sample of ELA-exposed adolescents in order to determine whether PAT increases positive affect, and subsequently symptoms of depression. For this pilot, the investigators will recruit 22 adolescents exposed to two or more childhood adversities (ACEs) who do not currently have major depressive disorder, and randomize them (1:1) to either participate in PAT or a waitlist control condition. At study enrollment, then 4-, 8, and 12-months thereafter the investigators will measure positive affect and depressive symptoms (including anhedonia). The results of this study will be used to inform whether PAT has the potential to prevent major depressive episodes among adversity-exposed youth."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "Participants will be randomized 1:1 to either receive PAT upon enrollment or after a waitlist period.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 22,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "16 Years",
"minimumAge": "12 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "PAT4ELA",
"briefTitle": "Positive Affect Treatment for Adolescents With Early Life Adversity",
"nctId": "NCT06273137",
"orgStudyIdInfo": {
"id": "2963",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Positive affect"
}
],
"secondaryOutcomes": [
{
"measure": "depressive symptoms - total"
},
{
"measure": "depressive symptoms - anhedonia subscale"
},
{
"measure": "Systemic inflammation - C-reactive protein (CRP)"
},
{
"measure": "Inflammatory gene expression"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of California, Irvine"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-10-16"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-28"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-02-16"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-03"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "SteadiSet Extended Wear Infusion Set"
}
]
},
"conditionsModule": {
"conditions": [
"Type1diabetes"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Newport Beach",
"contacts": [
{
"email": "[email protected]",
"name": "Brittany Dennis",
"phone": "949-764-6896",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "David Ahn, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Hoag Memorial Hospital Presbyterian",
"geoPoint": {
"lat": 33.61891,
"lon": -117.92895
},
"state": "California",
"status": "RECRUITING",
"zip": "92663"
},
{
"city": "Stanford",
"contacts": [
{
"email": "[email protected]",
"name": "Rayhan Lal",
"phone": "925-727-1317",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Rayhan Lal, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Stanford University",
"geoPoint": {
"lat": 37.42411,
"lon": -122.16608
},
"state": "California",
"status": "NOT_YET_RECRUITING",
"zip": "94305"
},
{
"city": "Aurora",
"contacts": [
{
"email": "[email protected]",
"name": "Samantha Lange",
"phone": "303-724-7514",
"phoneExt": null,
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}
],
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"name": "Jessica Tapia",
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],
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{
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"name": "Wyatt Larson",
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{
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"name": "Grazia Aleppo",
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"email": null,
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],
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},
{
"city": "Boston",
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{
"email": "[email protected]",
"name": "Amy Sabean",
"phone": "617-726-1729",
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},
{
"email": null,
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}
],
"country": "United States",
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},
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},
{
"city": "Detroit",
"contacts": [
{
"email": "[email protected]",
"name": "Davida Kruger",
"phone": "313-916-3906",
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},
{
"email": null,
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}
],
"country": "United States",
"facility": "Henry Ford Health System",
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},
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},
{
"city": "Minneapolis",
"contacts": [
{
"email": "[email protected]",
"name": "Kathryn Leet, RD,LD, CDCES",
"phone": "952-993-9793",
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"role": "CONTACT"
},
{
"email": null,
"name": "Richard Bergenstal, MD",
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}
],
"country": "United States",
"facility": "International Diabetes Center - HealthPartners Institute",
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},
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{
"city": "Rochester",
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{
"email": "[email protected]",
"name": "Corey Kurek",
"phone": "507-255-0316",
"phoneExt": null,
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},
{
"email": null,
"name": "Yogish Kudva, MD",
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],
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},
{
"city": "New York",
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"email": "[email protected]",
"name": "Denisa Tamarez",
"phone": "212-241-9089",
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},
{
"email": null,
"name": "Camilla Levister, MS, ANCP-C",
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}
],
"country": "United States",
"facility": "Icahn School of Medicine at Mt. Sinai",
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},
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},
{
"city": "Syracuse",
"contacts": [
{
"email": "[email protected]",
"name": "Suzan Bzdick, RN, CDCES",
"phone": "315-464-9006",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Ruth Weinstock, MD",
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"role": "PRINCIPAL_INVESTIGATOR"
}
],
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"facility": "SUNY Upstate Medical University",
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},
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"status": "RECRUITING",
"zip": "13210"
},
{
"city": "Austin",
"contacts": [
{
"email": "[email protected]",
"name": "Emmanuel Lopez",
"phone": "512-334-3505",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Jean Chen, MD",
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}
],
"country": "United States",
"facility": "Texas Diabetes and Endocrinology",
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},
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"zip": "78731"
},
{
"city": "Renton",
"contacts": [
{
"email": "[email protected]",
"name": "Tina Mitchell",
"phone": "425-251-1720",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Frances Broyles, MD",
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"role": "PRINCIPAL_INVESTIGATOR"
}
],
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"facility": "Rainier Clinical Research Center",
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},
"state": "Washington",
"status": "NOT_YET_RECRUITING",
"zip": "98057"
},
{
"city": "Seattle",
"contacts": [
{
"email": "[email protected]",
"name": "Dori Khakpour",
"phone": "206-945-4965",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Irl Hirsch, MD",
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}
],
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}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to collect clinical data to support a 7-day wear of the Extended Wear Infusion Set (EWIS).Participants will be asked to:1. Wear the EWIS for up to 7 consecutive days for 12 consecutive wear periods2. Perform blood glucose and ketone measurements if continuous glucose meter is ≥250mg/dL for one hour"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Device Extended Wear Infusion Set Each participant will wear each extended wear infusion set for up to 168 hours for 12 sequential wear periods.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 260,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Investigational Extended Wear Insulin Infusion Set in People With Type 1 Diabetes",
"nctId": "NCT06273124",
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"id": "150-1261-00",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "Primary Outcome Measure"
},
{
"measure": "Primary Outcome"
}
],
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},
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"collaborators": [
{
"name": "Jaeb Center for Health Research"
}
],
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"class": "INDUSTRY",
"name": "Tandem Diabetes Care, Inc."
}
},
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"completionDateStruct": {
"date": "2025-01-15"
},
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"date": "2024-04-25"
},
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"date": "2025-01-15"
},
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"startDateStruct": {
"date": "2024-03-07"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "5% simvastatin ointment"
}
]
},
"conditionsModule": {
"conditions": [
"Hemangioma Skin"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Palo Alto",
"contacts": [
{
"email": "[email protected]",
"name": "Ramrada Lekwuttikarn, MD",
"phone": "650-313-8207",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "[email protected]",
"name": "Thomas Buschbacher",
"phone": "352-278-7603",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Stanford University",
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"lon": -122.14302
},
"state": "California",
"status": null,
"zip": "94304"
}
]
},
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"briefSummary": "This is a 24-week, open-label pilot study to evaluate the safety and preliminary efficacy of 5% simvastatin ointment in treating 12 children with superficial IH.The primary objective:To evaluate the safety and tolerability of topical treatment with 5% simvastatin ointment for superficial IH over 24 weeks.The secondary objective:1.1 To evaluate the efficacy of 5% simvastatin ointment when topical treatment is administered twice daily for 24 weeks. Evaluation is performed at each clinic visit via investigator global assessment (IGA) based on standardized 3D digital photography and hemangioma activity score (HAS).1.2 To evaluate the impact of 5% simvastatin ointment on quality of life using the IH-QoL questionnaire."
},
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"interventionModel": "SINGLE_GROUP",
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},
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},
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"type": "ESTIMATED"
},
"phases": [
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],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "5 Years",
"minimumAge": "3 Months",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "TSTIH",
"briefTitle": "Topical Simvastatin for Treating Infantile Hemangioma",
"nctId": "NCT06273111",
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"id": "73840",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "Number of Participants with Treatment-Related Adverse Events"
}
],
"secondaryOutcomes": [
{
"measure": "Percentage of participants achieved a 50% HAS reduction at week 12 compared to baseline"
},
{
"measure": "Percentage of participants achieved a 75% HAS reduction from baseline by the end of the study (week 24) compared to baseline."
},
{
"measure": "Percentage of targeted hemangiomas with complete or nearly complete resolution (IGA 0 or 1), defined as a minimal degree of telangiectasia, skin thickening, and no definitive palpable cutaneous texture changes."
},
{
"measure": "Percentage of targeted hemangiomas that are stabilized (no noticeable change to baseline) or continue to progress."
},
{
"measure": "Percentage of participants with a significant improvement in quality-of-life, defined as > 50% reduction in the IH-QoL questionnaire score from baseline to week 24."
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Stanford University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Joyce Teng"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-07-31"
},
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"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Bladder Health Education"
}
]
},
"conditionsModule": {
"conditions": [
"Urinary Dysfunction",
"Lower Urinary Tract Symptoms",
"Urinary Tract Infections",
"Urinary Tract Infections in Children"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Palo Alto",
"contacts": null,
"country": "United States",
"facility": "Stanford Hospital and Clinics",
"geoPoint": {
"lat": 37.44188,
"lon": -122.14302
},
"state": "California",
"status": null,
"zip": "94304"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this study is to promote healthy bladder behaviors among school children. We hypothesize that a combination of bladder health education and awareness events, additional resources such as a water station to support healthy bladder behaviors, and tailored changes to classroom bathroom policies can promote healthy bladder behaviors among school children."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 0,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "10 Years",
"minimumAge": "5 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "School-Based Bladder Health Intervention",
"nctId": "NCT06273098",
"orgStudyIdInfo": {
"id": "73162",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Bathroom use"
},
{
"measure": "Symptom score"
},
{
"measure": "Urine volume"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Stanford University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2033-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-24"
},
"overallStatus": "WITHDRAWN",
"primaryCompletionDateStruct": {
"date": "2033-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2028-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Patient education"
}
]
},
"conditionsModule": {
"conditions": [
"Heart Failure",
"Patient Acceptance of Health Care"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Baltimore",
"contacts": [
{
"email": "[email protected]",
"name": "Ahmad Amin, MD",
"phone": "401-533-0696",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Medstar Union Memorial Hospital",
"geoPoint": {
"lat": 39.29038,
"lon": -76.61219
},
"state": "Maryland",
"status": "RECRUITING",
"zip": "21218"
},
{
"city": "Baltimore",
"contacts": [
{
"email": "[email protected]",
"name": "Sumanth Bandaru, MBBS",
"phone": "646-240-5289",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Medstar Harbor Hospital",
"geoPoint": {
"lat": 39.29038,
"lon": -76.61219
},
"state": "Maryland",
"status": "RECRUITING",
"zip": "21225"
},
{
"city": "Baltimore",
"contacts": [
{
"email": "[email protected]",
"name": "Anup Agarwal, MD",
"phone": "505-620-7815",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Medstar Franklin Medical Center",
"geoPoint": {
"lat": 39.29038,
"lon": -76.61219
},
"state": "Maryland",
"status": "RECRUITING",
"zip": "21237"
},
{
"city": "Baltimore",
"contacts": [
{
"email": "[email protected]",
"name": "Sumanth Bandaru, MBBS",
"phone": "646-240-5289",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "Medstar Good Samaritan Hospital",
"geoPoint": {
"lat": 39.29038,
"lon": -76.61219
},
"state": "Maryland",
"status": "RECRUITING",
"zip": "21239"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this randomized clinical trial is to test the effect of patient education on extent of use of guideline directed medical treatment (GDMT) of heart failure with reduced ejection fraction. The main question that our study aims to answer is if patient education can improve the adherence to GDMT in heart failure with reduced ejection fraction. Participants will receive educations about GDMT benefits in 1,3 and 5 months after discharge from hospital."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
"whoMasked": [
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"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 500,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Intensive Education Versus Usual Education of Patients for Improving Guideline Directed Medical Therapy (GDMT) Prescription in Heart Failure With Reduced Ejection Fraction",
"nctId": "NCT06273085",
"orgStudyIdInfo": {
"id": "MOD00016877",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
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"primaryOutcomes": [
{
"measure": "Change in GDMT score"
}
],
"secondaryOutcomes": [
{
"measure": "Heart Failure hospitalization"
},
{
"measure": "cardiovascular death/Left Ventricular Assist Device implantation/Cardiac Transplant"
},
{
"measure": "Number of GDMT classes of medications in use"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Medstar Health Baltimore"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-02"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-26"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Metformin hydrochloride extended-release tablets"
},
{
"name": "Visually identical placebo Metformin hydrochloride extended-release tablets"
}
]
},
"conditionsModule": {
"conditions": [
"Asthma",
"Asthma Chronic",
"Overweight and Obesity"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "This is a randomized clinical trial of metformin among overweight or obese adults with not well-controlled asthma despite maintenance inhaler therapy."
},
"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": 100,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Metformin IN Asthma for Overweight and Obese Individuals (MINA)",
"nctId": "NCT06273072",
"orgStudyIdInfo": {
"id": "IRB00409080",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "R34HL166438-01A1",
"link": "https://reporter.nih.gov/quickSearch/R34HL166438-01A1",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of completed telemedicine visits"
},
{
"measure": "Adherence to study drug"
},
{
"measure": "Retention rate"
}
],
"secondaryOutcomes": [
{
"measure": "Asthma control as assessed by the Asthma Control Test (ACT) score"
},
{
"measure": "Change in Asthma exacerbations rate"
},
{
"measure": "Pre-bronchodilator lung function"
},
{
"measure": "Fractional exhaled nitric oxide (FeNO)"
},
{
"measure": "Airways hyperresponsiveness"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Baylor College of Medicine"
},
{
"name": "National Heart, Lung, and Blood Institute (NHLBI)"
},
{
"name": "Temple University"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Johns Hopkins University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-03-15"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Genomic",
"Diabetes Mellitus",
"MODY"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Jakarta Pusat",
"contacts": [
{
"email": null,
"name": null,
"phone": "1 500 135",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Indonesia",
"facility": "Cipto Mangunkusumo Hospital",
"geoPoint": {
"lat": -6.1818,
"lon": 106.8223
},
"state": "DKI Jakarta",
"status": "RECRUITING",
"zip": "10430"
}
]
},
"descriptionModule": {
"briefSummary": "Diabetes Mellitus (DM) has been a major contributor to health burden in Indonesia and currently its burden still continues to rise. This is a result of increasing DM prevalence in the country as well as high rates of chronic complications from DM. Findings in Indonesia show that there is a high proportion of young people with diabetes, and also a high risk of therapeutic failure and complications from DM occurring in the younger population.Young-onset DM has a wide clinical spectrum, including autoimmune DM, polygenic DM, and monogenic DM such as Mature Onset Diabetes of the Young (MODY). Identification and proper diagnosis of young-onset DM spectrum is crucial to treatment outcomes, as certain spectrums, such as some subtypes of MODY, may benefit from cost-efficient alternatives with better outcomes.However, proper diagnosis of young-onset DM in Indonesia is still a great challenge, as currently some examinations, including genetic testing, has not yet been feasibly done in the country. With current advances in genomics, genetic testing may prove to be fundamental in providing optimal and personalized treatment and care for DM patients.This study is a pilot project aimed to initiate genomic research in young-onset DM patients in Indonesia. In the short term, this study aims to identify genetic variants that may be able to increase diagnostic accuracy of the young-onset DM spectrum. In the long term, this study aims to identify new genetic variants of young-onset DM. The study also aims to identify genetic variants associated with risks of chronic complications."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 1000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "8 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Genomic Study of Young-Onset Diabetes Mellitus",
"nctId": "NCT06273059",
"orgStudyIdInfo": {
"id": "22-07-0717",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The overall objective of this study is to identify and describe genetic variation of young-onset DM in Indonesia."
}
],
"secondaryOutcomes": [
{
"measure": "To describe the proportion of MODY in young-onset DM"
},
{
"measure": "To describe genetic variation of MODY in Indonesia."
},
{
"measure": "To describe genetic variation in young-onset DM with diabetic complications in various systems:"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Indonesia University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-02-22"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-09-12"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
{
"armsInterventionsModule": {
"interventions": [
{
"name": "Biofeedback"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Fecal Incontinence",
"Outlet Dysfunction Constipation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Barcelona",
"contacts": [
{
"email": null,
"name": "Jordi Serra, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Hospital Vall d'Hebron",
"geoPoint": {
"lat": 41.38879,
"lon": 2.15899
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Background. Rehabilitation and re-education using instrumental anorectal biofeedback are the main treatment of anorectal functional disorders producing incontinence and outlet obstructed defecation. These treatments imply intubation of patient and several sessions of treatment leading to high consumption of resources and costs.Hypothesis. A cognitive intervention based on original audiovisual programs developed specifically for the management of anorectal functional disorders is effective in correcting anorectal function disorders that cause fecal incontinence and evacuation disorders.Aim. To prove in two different protocols (fecal incontinence and dyssinergic defecation) the efficacy of specifically developed non-instrumental biofeedback techniques.Selection criteria. Patients with fecal incontinence and altered sphincter function and patients with outlet obstructed evacuation referred for biofeedback treatment.Intervention. In separate studies (incontinence and dyssynergic defecation) patients will be randomized into biofeedback and placebo groups. One session of either biofeedback or placebo intervention will be performed at the beginning of the intervention period and patients will be instructed to performed the assigned daily treatment at home. A visit for outcome assessment will be performed at 3 months in incontinence study and at 4 weeks in the dyssinergic defecation study. In addition, in the incontinence study a phone call will be performed after 6 months of the beginning of the study to evaluate treatment outcome.Biofeedback: patients will be taught to control anal and abdominal muscular activity by providing instructions using original video supports. Patients will be instructed to perform the same exercises daily at home in scheduled times.Placebo: a pill of placebo containing 0.3 g glucose will be administered every day at home."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 96,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Treatment of Fecal Incontinence and Functional Defecation Disorders Using Non-instrumental Biofeedback",
"nctId": "NCT06273046",
"orgStudyIdInfo": {
"id": "PR(AG)614/2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Fecal incontinence study: Number of anal leaks"
},
{
"measure": "Dyssinergic defecation study: Number of bowel movements"
}
],
"secondaryOutcomes": [
{
"measure": "Incontinence study: Wexner scale"
},
{
"measure": "Incontinence study: Quality of life"
},
{
"measure": "Incontinence study: anxiety and depression"
},
{
"measure": "Incontinence study: Anal sphincter function"
},
{
"measure": "Dyssinergic defecation study: sensation of outlet obstructed evacuation"
},
{
"measure": "Dyssinergic defecation study: Wexner scale"
},
{
"measure": "Dyssinergic defecation study: Quality of life"
},
{
"measure": "Dyssinergic defecation study: anxiety and depression"
},
{
"measure": "Dyssinergic defecation study: defecatory maneuvers"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hospital Universitari Vall d'Hebron Research Institute"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-25"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-04-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-19"
},
"studyFirstPostDateStruct": {
"date": "2024-02-22"
}
}
} | false | null |
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