documentSection
dict | hasResults
bool 2
classes | protocolSection
dict |
---|---|---|
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Self-Hypnosis"
},
{
"name": "Ankle Education"
}
]
},
"conditionsModule": {
"conditions": [
"Ankle Sprains",
"Motor Coordination or Function; Developmental Disorder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Athens",
"contacts": null,
"country": "United States",
"facility": "Ohio University",
"geoPoint": {
"lat": 39.32924,
"lon": -82.10126
},
"state": "Ohio",
"status": null,
"zip": "45701"
}
]
},
"descriptionModule": {
"briefSummary": "This study will determine the relationship of one's self-reported awareness of their body and their ankle motor control for people with chronic ankle instability. This study will further identify the correlates between certain psychological characteristics (i.e., fear and anxiety) and autonomic nervous system arousal (i.e., heart rate variability). Furthermore, this study will elucidate the potential impact of a brief hypnosis practice on balance performance."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "This basic experimental pilot study involved a randomized cross-over design of two brief interventions with a 1:1 allocation ratio",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 24,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Project Hypnos: The Impact of a Brief Hypnosis Intervention on Single-limb Dynamic Balance in People With Chronic Ankle Instability",
"nctId": "NCT06390072",
"orgStudyIdInfo": {
"id": "23-X-71",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Balance test 1"
},
{
"measure": "Balance test 2"
},
{
"measure": "Heart rate variability"
}
],
"secondaryOutcomes": [
{
"measure": "Ankle disability measure 1"
},
{
"measure": "Ankle disability measure 2"
},
{
"measure": "Interoceptive awareness measure 1"
},
{
"measure": "Interoceptive awareness measure 2"
},
{
"measure": "Emotional Distress-Anxiety"
},
{
"measure": "Kinesiophobia"
},
{
"measure": "Pain self-efficacy"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Ohio University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-11-27"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-11-27"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-09-25"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Tumor Treating Fields"
},
{
"name": "Atezolizumab"
},
{
"name": "Gemcitabine"
},
{
"name": "nab-paclitaxel"
}
]
},
"conditionsModule": {
"conditions": [
"Metastatic Pancreatic Ductal Adenocarcinoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Barcelona",
"contacts": [
{
"email": "tmacarulla@vhebron.net",
"name": "Teresa Macarulla Mercade",
"phone": "34 (93) 274 6085",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "University Hospital Vall d'Hebron",
"geoPoint": {
"lat": 41.38879,
"lon": 2.15899
},
"state": null,
"status": "RECRUITING",
"zip": "08035"
},
{
"city": "Madrid",
"contacts": [
{
"email": "angela.lamarca@quironsalud.es",
"name": "Angela Lamarca Lete",
"phone": "34 951 504800",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "1",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "University Hospital Foundation Jimenez Diaz",
"geoPoint": {
"lat": 40.4165,
"lon": -3.70256
},
"state": null,
"status": "RECRUITING",
"zip": "28040"
},
{
"city": "Madrid",
"contacts": [
{
"email": "acubillo@hmhospitales.com",
"name": "Antonio Cubillo Gracian",
"phone": "34 91 756 7800",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Clara Campal Comprehensive Cancer Center (CIOCC)",
"geoPoint": {
"lat": 40.4165,
"lon": -3.70256
},
"state": null,
"status": "RECRUITING",
"zip": "28050"
},
{
"city": "Málaga",
"contacts": [
{
"email": "inales@hotmail.com",
"name": "Inmaculada Ales",
"phone": "34 951308129",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Regional University Hospital of Malaga",
"geoPoint": {
"lat": 36.72016,
"lon": -4.42034
},
"state": null,
"status": "RECRUITING",
"zip": "29010"
},
{
"city": "Pamplona",
"contacts": [
{
"email": "mponz@unav.es",
"name": "Mariano Ponz-Sarvise",
"phone": "34 948 255 400",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "University Clinic of Navarra - Pamplona",
"geoPoint": {
"lat": 42.81687,
"lon": -1.64323
},
"state": null,
"status": "RECRUITING",
"zip": "31008"
}
]
},
"descriptionModule": {
"briefSummary": "The PANOVA-4 study is designed to evaluate the safety and efficacy of Tumor Treating Fields (TTFields) therapy together with atezolizumab, gemcitabine and nab-paclitaxel, for the treatment of metastatic pancreatic cancer. The study is intended for patients who have been diagnosed with metastatic pancreatic cancer and have not received prior systemic therapy."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Prospective, open-label, single arm, multi-center, historical control pilot study.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 76,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "EF-39 PANOVA-4: Study of Tumor Treating Fields Concomitant With Atezolizumab, Gemcitabine and Nab-Paclitaxel as First-LineTreatment for Metastatic Pancreatic Ductal Adenocarcinoma",
"nctId": "NCT06390059",
"orgStudyIdInfo": {
"id": "EF-39",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Sponsor",
"id": "EF-39",
"link": null,
"type": "OTHER"
},
{
"domain": null,
"id": "2022-003157-55",
"link": null,
"type": "EUDRACT_NUMBER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Disease control rate (DCR)"
}
],
"secondaryOutcomes": [
{
"measure": "Overall survival (OS)"
},
{
"measure": "Progression-free survival (PFS)"
},
{
"measure": "1-Year survival rate"
},
{
"measure": "Objective response rate (ORR)"
},
{
"measure": "Progression free survival at 6 months (PFS6)"
},
{
"measure": "Duration of response (DOR)"
},
{
"measure": "Rate of of patients with treatment emergent adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "NovoCure GmbH"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-08-28"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Intubation"
},
{
"name": "TIVA versus Inhalation"
}
]
},
"conditionsModule": {
"conditions": [
"Analgesics, Opioid",
"Anesthesia; Adverse Effect"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kraków",
"contacts": [
{
"email": "t.skladzien@interia.pl",
"name": "Tomasz Skladzien, phd md",
"phone": "506602250",
"phoneExt": "48",
"role": "CONTACT"
}
],
"country": "Poland",
"facility": "Jagiellonian University",
"geoPoint": {
"lat": 50.06143,
"lon": 19.93658
},
"state": "Malopolskie",
"status": "RECRUITING",
"zip": "31501"
}
]
},
"descriptionModule": {
"briefSummary": "Total intravenous general anesthesia and combined general anesthesia are recognized methods used during anesthesia. They allow you to effectively control pain and reduce the number of complications associated with taking large doses of opioid drugs. It should be emphasized that both methods of anesthesia are currently approved for use in routine anesthetic practice, and only the experience, knowledge and preferences of the anesthesiologist determine which technique will be used in a given patient. Both techniques are used in everyday anesthetic practice, but there is no conclusive scientific data confirming the superiority of either method in patients undergoing bariatric surgery, therefore currently only the individual experience, knowledge and preferences of the anesthesiologist determines which technique will be used in a given patient."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "The study group will be male and female patients, ASA II or III, over 18 years of age and under 75 years of age. Each patient will undergo abdominal (bariatric) surgery.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Opioid-free Anesthesia, Optimization of Anesthesia After Bariatric Surgery",
"nctId": "NCT06390046",
"orgStudyIdInfo": {
"id": "1072.6120.135.2023",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "compare the effectiveness of analgesia"
},
{
"measure": "determine whether modern technologies such as videolaryngoscopy shorten intubation time."
}
],
"secondaryOutcomes": [
{
"measure": "incidence of postoperative nausea and vomiting"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Jagiellonian University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-14"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Prosthetic foot"
}
]
},
"conditionsModule": {
"conditions": [
"Amputation",
"Prosthesis User"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Kowloon",
"contacts": null,
"country": "Hong Kong",
"facility": "The Hong Kong Polytechnic University",
"geoPoint": {
"lat": 22.31667,
"lon": 114.18333
},
"state": null,
"status": null,
"zip": "999077"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this observational study is to evaluate and compare the performance of two prosthetic feet for unilateral transtibial amputees during both indoor and outdoor activities. The main research questions aim to answer are:\n\n1. Can a low-cost prosthetic foot enhance gait mechanics and physical performance in individuals who have undergone traumatic unilateral transtibial amputation, as compared to the traditional K2 - K3 prosthetic feet currently available on the market, during both indoor and outdoor activities?\n2. Can the low-cost prosthetic foot meet user satisfaction levels after traumatic unilateral transtibial amputation, when compared to the traditional K2 - K3 prosthetic foot on the market?\n\nParticipants will be asked to do\n\n1. Prior to the commencement of the experiment, a professional prosthetist and orthotist will conduct all fitting and alignment procedures for the transtibial amputees. Participants will then be given a two to three-week period to train and acclimate to the individual socket alignment and prosthetic foot.\n2. Participants are asked to refrain from consuming caffeine or any stimulants for 24 hours before the tests.\n3. Participants will be required to perform the Berg Balance Test.\n4. Participants will undergo a series of clinical tests, including: 1) Time to Go Up (measured in seconds), 2) Four Square Step Test (measured in seconds), 3) 10-Meter Walk Test (measured in seconds), 4) Eye Close Standing, 5) Tandem Test, and 6) Functional Reach Test. Each test will be conducted three times. The test items of 4) and 5) will be performed on a force plate (Bertect, Ohio, USA) with dimensions of 400 x 600 mm and a capturing frequency of 1,000 Hz.\n5. Participants will be asked to walk on a force plate (AMTI, Advanced Mechanical Technology, Inc., Watertown, USA) at a fixed walking speed of 1.11 ± 0.11m/s, allowing the foot to land naturally on the force plate. Five trials of the gait cycle with a clean foot will be used for analysis.\n6. Participants will perform the Counter Movement Jump Test three times with maximum effort on the force plate (Bertect, Ohio, USA), which will be performed without a hand swing.\n7. Participants will be asked to perform a 2-minute walking test on flat concrete ground, stairs, and a ramp, respectively.\n8. Finally, participants will be asked to complete the Locomotion Capabilities Index questionnaire."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 6,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "64 Years",
"minimumAge": "36 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Biomechanical Study of Different Prostheses for Unilateral Transtibial Amputees During Indoor and Outdoor Activities",
"nctId": "NCT06390033",
"orgStudyIdInfo": {
"id": "ITS/133/21",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Basic mobility function with two prostheses by Berg Balance Test"
},
{
"measure": "Basic mobility function with two prostheses by Time to Go Up"
},
{
"measure": "Basic mobility function with two prostheses by Four Square Step Test"
},
{
"measure": "Basic mobility function with two prostheses by 10-meter Walk Test"
},
{
"measure": "Stability index with two prostheses by Eye Close Standing"
},
{
"measure": "Stability index with two prostheses by Tandem Test"
},
{
"measure": "Functional Reach Test"
},
{
"measure": "Gait symmetry analysis of lower limb joint angle"
},
{
"measure": "Gait symmetry analysis of lower limb joint power"
},
{
"measure": "Gait symmetry analysis of lower limb joint moment"
},
{
"measure": "Walking feasibility with two prostheses"
},
{
"measure": "Jump feasibility with two prostheses"
},
{
"measure": "Subjective evaluation by Locomotion Capabilities Index questionnaire"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The Hong Kong Polytechnic University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-06-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "MBSR"
}
]
},
"conditionsModule": {
"conditions": [
"Sensory Processing Sensitivity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nijmegen",
"contacts": [
{
"email": "mindfulness@radboudumc.nl",
"name": "Anne Speckens, prof. dr.",
"phone": "(024) 36 68 456",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Netherlands",
"facility": "The Radboudumc Center for Mindfulness",
"geoPoint": {
"lat": 51.8425,
"lon": 5.85278
},
"state": "Gelderland",
"status": "RECRUITING",
"zip": "6525 GC"
}
]
},
"descriptionModule": {
"briefSummary": "This study investigates the efficacy of MBSR training in alleviating stress-related symptoms among individuals with high sensory processing sensitivity. Participants will be randomly allocated to either the MBSR group or the control group.\n\nThe primary hypothesis is that participants in the MBSR group, relative to control group, will have lower depression-anxiety-stress scores post-intervention, after controlling for baseline scores. The secondary hypothesis is that in the MBSR group, relative to control group, other mental health, physical health and well-being outcomes, as well as potential mindfulness mechanisms will also improve, after controlling for baseline scores."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 52,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "MindSens",
"briefTitle": "Mindfulness-Based Stress Reduction (MBSR) for People High on the Personality Trait Sensory Processing Sensitivity: A Mixed Methods Study",
"nctId": "NCT06390020",
"orgStudyIdInfo": {
"id": "NL84880.091.23",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Change from Baseline to Post-intervention in self-reported depression, anxiety, and stress"
}
],
"secondaryOutcomes": [
{
"measure": "Change from Baseline to Post-intervention in self-reported well-being"
},
{
"measure": "Change from Baseline to Post-intervention in self-reported burnout symptoms"
},
{
"measure": "Change from Baseline to Post-intervention in self-reported physical symptoms"
},
{
"measure": "Change from Baseline to Post-intervention in self-reported overstimulation"
},
{
"measure": "Change from Baseline to Post-intervention in self-reported mindfulness"
},
{
"measure": "Change from Baseline to Post-intervention in self-reported attention regulation"
},
{
"measure": "Change from Baseline to Post-intervention in self-reported strategies for cognitive emotion regulation"
},
{
"measure": "Change from Baseline to Post-intervention in self-reported body awareness"
},
{
"measure": "Change from Baseline to Post-intervention in self-reported self-compassion"
},
{
"measure": "Change from Baseline to Post-intervention in self-reported sensory processing sensitivity"
},
{
"measure": "Perceived facilitators, barriers, effects, and mechanisms of participating in the MBSR training"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Radboud University Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Sham press needle"
},
{
"name": "Press needle acupuncture"
}
]
},
"conditionsModule": {
"conditions": [
"Pain, Postoperative",
"Pediatric Disorder"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Jakarta Pusat",
"contacts": [
{
"email": "irene.tambunan@yahoo.co.id",
"name": "Irene Yuniar",
"phone": "+6281380327808",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Indonesia",
"facility": "RSUPN Dr. Cipto Mangunkusumo",
"geoPoint": {
"lat": -6.1818,
"lon": 106.8223
},
"state": "DKI Jakarta",
"status": null,
"zip": "10430"
}
]
},
"descriptionModule": {
"briefSummary": "Pain is an unpleasant sensory and emotional experience resulting from tissue damage. Pain management is typically conducted according to the World Health Organization (WHO) pain management ladder. Analgesics administered to pediatric patients vary in dosage and type, but these analgesics often have significant side effects. The acupuncture technique using press needles is a non-pharmacological pain therapy modality that has been studied for its ability to reduce the use of analgesic drugs, thereby potentially decreasing side effects associated with analgesic use.\n\nThe study was conducted using a randomized controlled trial (RCT) design involving 70 pediatric postoperative patients aged 1-18 years who were admitted to the Pediatric Intensive Care Unit at Cipto Mangunkusumo Hospital. Subjects were divided into two groups: a control group and an experimental group. The control group received standard analgesic therapy and sham press needle application (a patch resembling a press needle without a needle), while the experimental group received standard analgesic therapy and press needle application at acupuncture points after the patient had been in the Pediatric Intensive Care Unit for 24 hours. Pain scale monitoring was conducted at 1, 6, 24, 48, and 72 hours using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale for children aged 1-8 years, and the Numeric Rating Scale (NRS) for children over 8 years old.\n\nThis study hypothesizes that the acupuncture technique using press needles can reduce the pain scale in pediatric postoperative patients, leading to a decrease in the use of analgesics and a reduction in side effects associated with analgesic use."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 70,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "18 Years",
"minimumAge": "1 Year",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Efficacy of Acupuncture in the Management of Postoperative Pain in the Pediatric Intensive Care Unit at Cipto Mangunkusumo Hospital",
"nctId": "NCT06390007",
"orgStudyIdInfo": {
"id": "24916",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Face, Legs, Activity, Cry, and Consolability (FLACC) pain scale"
},
{
"measure": "Numeric Rating Scale (NRS) pain scale"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Indonesia University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Esophageal String Test"
}
]
},
"conditionsModule": {
"conditions": [
"Eosinophilic Esophagitis (EoE)"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Philadelphia",
"contacts": [
{
"email": "carbonara@chop.edu",
"name": "Sharon A Carbonara, MS, BSN, RN",
"phone": "267-426-8603",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "The Children's Hospital of Philadelphia",
"geoPoint": {
"lat": 39.95233,
"lon": -75.16379
},
"state": "Pennsylvania",
"status": "RECRUITING",
"zip": "19104"
}
]
},
"descriptionModule": {
"briefSummary": "Patients with IgE mediated food Allergy have elevated risk of eosinophilic esophagitis, and new therapies like oral immunotherapy (OIT) carry additional risk of Eosinophilic Esophagitis (EoE). The goal of this study is to investigate the Esophageal String Test (EST) as a screening tool for Eosinophilic Esophagitis (EoE) during OIT therapy. Investigators will compare the efficacy of the Esophageal String Test to symptom assessment using a validated patient reported symptom questionnaire, the Pediatric Eosinophilic Esophagitis Symptom Score (PEESS) v2.0. Investigators will utilize these tools to screen patients at their baseline visit prior to the start of OIT, then at the 3- and 6-month OIT follow-up visits."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 75,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "17 Years",
"minimumAge": "7 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Esophageal String Test Monitoring to Monitor Eosinophilic Esophagitis During Oral Immunotherapy",
"nctId": "NCT06389994",
"orgStudyIdInfo": {
"id": "23-021041",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Esophageal String Test"
}
],
"secondaryOutcomes": [
{
"measure": "Prevalence of Eosinophilic Esophagitis"
},
{
"measure": "Eosinophilic Esophagitis Symptoms"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Children's Hospital of Philadelphia"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-10-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-04-02"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Veterans peer connect Program"
}
]
},
"conditionsModule": {
"conditions": [
"Lung Cancer"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Co-design will be implemented to develop an innovative, Veteran-centered intervention (Vet Peer Connects program) that meets the needs of Black Veterans.\n\nNext, a feasibility pilot test of the Vet Peer Connects program will be conducted. The Peer will lead up to 4 group lung cancer screening orientations in community partner sites to reach around 40 lung cancer screening eligible Black Veterans. The Peer will provide one-to-one tailored support to up to 15 Veterans (coaching, goal-setting, navigation to access Veterans Affairs lung cancer screening). Then, the study team will evaluate program delivery through ethnographic observation and field notes, Peer activity logs, and weekly check-ins between the study team and Peer. Investigators will interview Veteran participants, community partners, and lung cancer screening clinical staff to explore feasibility and acceptability of the Vet Peer Connects program and solicit suggestions for improvement. Preliminary data on the outcomes of the Vet Peer Connects program will be collected by study team through administering surveys to assess change in Social Cognitive Theory constructs, and extracting lung cancer screening uptake and tobacco treatment 3 months post enrollment from VA's Corporate Data Warehouse. This work will inform a subsequent multi-site stepped-wedge trial to assess effectiveness, implementation, and cost of the Vet Peer Connects program in VA lung cancer screening sites and neighboring branches of the National Association for Black Veterans"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SCREENING",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "50 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "VPC",
"briefTitle": "Co-Design and Pilot Testing of Peer-led Community Outreach to Improve Equity, Veteran-Centeredness and Uptake of Lung Cancer Screening",
"nctId": "NCT06389981",
"orgStudyIdInfo": {
"id": "1692052",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Lung Cancer Screening Uptake"
}
],
"secondaryOutcomes": [
{
"measure": "Tobacco cessation Treatment"
},
{
"measure": "Stigma Related to Smoking"
},
{
"measure": "Perceived support from peer"
},
{
"measure": "Lung Cancer Screening Knowledge"
},
{
"measure": "Lung Cancer Screening Fatalism"
},
{
"measure": "Trust in VA"
},
{
"measure": "Lung Cancer Self-efficacy"
},
{
"measure": "General Cancer Self-efficacy"
},
{
"measure": "Intention to engage in shared decision making"
},
{
"measure": "Motivation to quit smoking"
},
{
"measure": "Intention to undergo lung cancer screening"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "FED",
"name": "VA Boston Healthcare System"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-02-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Light stimulation"
},
{
"name": "Sham light stimulation"
}
]
},
"conditionsModule": {
"conditions": [
"Multiple Sclerosis, Relapsing-Remitting",
"Optic Neuritis"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "The aim of this monocentric randomized controlled intervention study is to improve visual function in persons with multiple sclerosis (pwMS) following optic neuritis (neuritis nervi optici, NNO) by means of a light stimulation.\n\nIn the treatment arm, two 80-second light stimulations are to be administered daily for 12 days in 25 pwMS following recent NNO (1-3 months). For the standardized application of light stimulation in the sense of standardized training, the light stimulation is to be carried out by watching a generated flicker video on a mobile phone. In a sham-intervened control group (n=25), the spontaneous course after NNO will be recorded in parallel. Intensive neuronal stimulation of the visual pathway will be used to stimulate regenerative processes, which will be recorded by means of changes in high-contrast visual acuity (primary endpoint). Secondary endpoints are changes in a colored-contrast test, in 2.5% low contrast visual acuity (LCVA), the P100 conduction latency of visual evoked potentials, and retinal layer thicknesses and vessel densities measured in optical coherence tomography (OCT) and OCT angiography (OCTA). These physiological parameters should help to understand the underlying processes of a potentially altered visual performance."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "sham-controlled",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "ONSTIM",
"briefTitle": "Light Stimulation to Improve Visual Function After Optic Neuritis in Persons With Multiple Sclerosis",
"nctId": "NCT06389968",
"orgStudyIdInfo": {
"id": "2023-491-S-KH",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "High contrast visual sensitivity"
}
],
"secondaryOutcomes": [
{
"measure": "Low contrast visual sensitivity"
},
{
"measure": "VEP"
},
{
"measure": "OCT"
},
{
"measure": "OCT Angiography"
},
{
"measure": "Color contrast"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Technical University of Munich"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-02"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "TP 3654"
}
]
},
"conditionsModule": {
"conditions": [
"Effect of Drug"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Secaucus",
"contacts": null,
"country": "United States",
"facility": "Frontage Investigative Site",
"geoPoint": {
"lat": 40.78955,
"lon": -74.05653
},
"state": "New Jersey",
"status": null,
"zip": "07094"
}
]
},
"descriptionModule": {
"briefSummary": "This study comprised of 2 parts, Part A and Part B. Part B will only be conducted if the relative bioavailability of the tablet formulation was at least 70% of the capsule formulation."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 12,
"type": "ACTUAL"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Assessment of Relative Bioavailability and Effect of Food on Capsule and Tablet Formulations of TP-3654",
"nctId": "NCT06389955",
"orgStudyIdInfo": {
"id": "TP-3654-103",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Part A - The maximum concentration (Cmax) of TP-3654 in a capsule formulation"
},
{
"measure": "Part A - The area under the curve (AUC) of TP-3654 in a capsule formulation"
},
{
"measure": "Part A - Ratio of Peak Plasma Concentration (Cmax) of TP-3654 tablet versus TP-3654 capsule under fasted conditions"
},
{
"measure": "Part B - The maximum concentration (Cmax) of TP-3654 in a tablet formulation"
}
],
"secondaryOutcomes": [
{
"measure": "Number of participants with Treatment Emergent Adverse Events (TEAE)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Sumitomo Pharma America, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-08-24"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-08-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-05-22"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "9MW3011"
},
{
"name": "9MW3011 placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Healthy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Zibo",
"contacts": null,
"country": "China",
"facility": "PKUcare Luzhong Hospital",
"geoPoint": {
"lat": 36.79056,
"lon": 118.06333
},
"state": "Shandong",
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The objectives of the study are to evaluate the safety , tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single ascending intravenous (IV) doses of 9MW3011 in Chinese healthy volunteers."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 48,
"type": "ACTUAL"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Single Ascending Dose Study of 9MW3011 in Chinese Healthy Subject",
"nctId": "NCT06389942",
"orgStudyIdInfo": {
"id": "9MW3011-2022-CP101",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Adverse Event(including serious adverse event)"
}
],
"secondaryOutcomes": [
{
"measure": "Number of subjects with abnormal vital signs"
},
{
"measure": "Number of subjects with abnormal clinically significant results from physical examination"
},
{
"measure": "Number of subjects with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters"
},
{
"measure": "Number of subjects with abnormal clinically significant clinical laboratory results"
},
{
"measure": "Cmax"
},
{
"measure": "AUC0-t"
},
{
"measure": "AUC0-∞"
},
{
"measure": "Tmax"
},
{
"measure": "λz"
},
{
"measure": "t1/2z"
},
{
"measure": "Vz"
},
{
"measure": "CL"
},
{
"measure": "MRT"
},
{
"measure": "Pharmacodynamic(PD)parameters-hepcidin"
},
{
"measure": "PD parameters-serum iron"
},
{
"measure": "PD parameters-TSAT"
},
{
"measure": "Anti-drug antibodies(ADA)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Mabwell (Shanghai) Bioscience Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-04"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-10"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Education"
}
]
},
"conditionsModule": {
"conditions": [
"Nursing Caries"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Bartin",
"contacts": null,
"country": "Turkey",
"facility": "Simge OZTURK",
"geoPoint": {
"lat": 41.63583,
"lon": 32.3375
},
"state": "None Selected",
"status": null,
"zip": "74100"
}
]
},
"descriptionModule": {
"briefSummary": "Purpose: This study aimed to examine the effect of health education material developed by nursing students in gynecological health and disease nursing on students' teaching material motivation and material design self-efficacy belief.\n\nMethod: The study was conducted as a prospective randomized controlled study. n=86 (43=control, 43=intervention) students who took the Women's Health and Diseases Nursing course at Bartın University Faculty of Health Sciences Nursing Department between 30.10.2023-20.01.2024 and volunteered to participate in the study were randomized. It was conducted in two groups: intervention and control.In the research, data will be collected with the Data Collection Form prepared by reviewing the literature, Instructional Material Motivation Scale and Material Design Self-Efficacy Belief Scale. Descriptive statistics, Student t-test, Mann-Whitney U Test, Wilcoxon Signed Rank Test and Pearson correlation tests will be used to evaluate the data."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Prospective randomized controlled n = 86 (43 = control, 43 = intervention) students who took the Women's Health and Diseases Nursing course at Bartın University, Faculty of Health Sciences, Department of Nursing and volunteered to participate in the study were randomly assigned to two groups: intervention and control.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
},
"enrollmentInfo": {
"count": 92,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Do the Health Education Materials Developed in the Gynecology and Diseases Nursing Course Affect Students' Teaching Material Motivation and Material Design Self-Efficacy Beliefs?",
"nctId": "NCT06389929",
"orgStudyIdInfo": {
"id": "IU-HB-RK-02",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Instructional Material Motivation Scale"
}
],
"secondaryOutcomes": [
{
"measure": "Material Design Self-Efficacy Belief Scale"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Inonu University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-01-28"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-01-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Euclid orthokeratology MAX (current design)"
},
{
"name": "Euclid orthokeratology MAX Phoenix (new design)"
}
]
},
"conditionsModule": {
"conditions": [
"Myopia",
"Cornea"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Costa Mesa",
"contacts": null,
"country": "United States",
"facility": "Insight Vision Center Optometry",
"geoPoint": {
"lat": 33.64113,
"lon": -117.91867
},
"state": "California",
"status": null,
"zip": "92626"
},
{
"city": "Saint Johns",
"contacts": null,
"country": "United States",
"facility": "Dau Family Eye Care",
"geoPoint": {
"lat": 30.0815,
"lon": -81.54774
},
"state": "Florida",
"status": null,
"zip": "32259"
},
{
"city": "Edina",
"contacts": null,
"country": "United States",
"facility": "Cornea and Contact Lens Institute of Minnesota",
"geoPoint": {
"lat": 44.88969,
"lon": -93.34995
},
"state": "Minnesota",
"status": null,
"zip": "55436"
},
{
"city": "North Brunswick",
"contacts": null,
"country": "United States",
"facility": "Somerset Eye Care",
"geoPoint": {
"lat": 40.454,
"lon": -74.482
},
"state": "New Jersey",
"status": null,
"zip": "08902"
},
{
"city": "Tysons Corner",
"contacts": null,
"country": "United States",
"facility": "Treehouse Eyes",
"geoPoint": {
"lat": 38.91872,
"lon": -77.23109
},
"state": "Virginia",
"status": null,
"zip": "22182"
}
]
},
"descriptionModule": {
"briefSummary": "The \"first fit\" success rate of the current Euclid orthokeratology \"MAX\" lens design will be compared to that of the new Euclid orthokeratology MAX \"Phoenix\" lens design in 30 children."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "QUADRUPLE",
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]
},
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},
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},
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"measure": "First fit success rate"
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},
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}
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"name": "assessment"
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"conditions": [
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]
},
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{
"city": "Sotteville Les Rouen",
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},
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}
]
},
"descriptionModule": {
"briefSummary": "This is a pilot, prospective, monocentric study concerning 15 Parkinson's disease patients requiring deep brain stimulation implantation.\n\nThe primary objective is to evaluate the psychiatric lesion effects of deep brain stimulation in patients with Parkinson's disease, using the Young Mania Rating Scale (YMRS), Big Five Inventory and the Hamilton Depression Rating Scale (HAMD 21)."
},
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},
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},
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"measure": "Assessment of change of mania symptoms"
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],
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"measure": "Assessment of change of depressive symptoms"
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"measure": "Assessment of change of Behavior"
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"measure": "Assessment of change of Impulsivity"
},
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"measure": "Assessment of change of Apathy"
},
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"measure": "Assessment of personality"
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{
"measure": "Assessment of executive functions"
},
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"measure": "Assessment of confusion"
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}
} |
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"name": "Pancreatic resection procedure"
}
]
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]
},
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"locations": null
},
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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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"measure": "In-hospital mortality"
}
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"name": "Medizinische Hochschule Brandenburg Theodor Fontane"
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}
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"date": "2019-12-31"
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}
} |
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"name": "BEAM-302"
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]
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]
},
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{
"city": "London",
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}
]
},
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},
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"measure": "Phase 2 Dose Expansion: Absolute blood levels of total AAT"
}
],
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}
} |
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"measure": "The resting motor threshold (RMT)"
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"measure": "Arabic version Conners' Parent Rating Scale - Revised Long form"
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"measure": "Clinical Global Impression CGI"
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} |
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"name": "Experimental: Case group - Diet enriched with tomatoes"
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},
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"city": "Castellana Grotte",
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]
},
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},
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},
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},
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},
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},
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},
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"measure": "The effect of intervention on CAP value (Controlled Attenuation Parameter)"
},
{
"measure": "The effect of intervention on FLI value (fatty liver index)"
},
{
"measure": "The effect of intervention on routine blood chemistry parameters, relating to NAFLD and fibrosis"
},
{
"measure": "The effect of the intervention on the integrity of the intestinal barrier"
},
{
"measure": "The effect of the intervention on the microbiota"
}
],
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},
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"name": "Dr. Di Stasi Vincenza"
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{
"name": "Dr. Donvito Rosanna"
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{
"name": "Dr. Cozzolongo Raffaele"
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{
"name": "Dr. Giannuzzi Vito"
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{
"name": "Dr. Zappimbulso Marianna"
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{
"name": "Dr. Shahini Endrit"
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{
"name": "Dr. Notarnicola Maria"
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{
"name": "Dr. Russo Francesco"
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{
"name": "Dr. Riezzo Giuseppe"
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{
"name": "Dr. Donghia Rossella"
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{
"name": "Dr. Cesternino Anna Maria"
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{
"name": "Dr. Cici Rosalisa"
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{
"name": "Dr. Cerabino Nicole"
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{
"name": "Dr. Martina Di Chito"
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{
"name": "Dr. Pesole Pasqua Letizia"
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{
"name": "Dr. Coletta Sergio"
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{
"name": "Dr. Stabile Dolores"
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{
"name": "Dr. Ancona Anna"
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{
"name": "Dr. D'Attoma Benedetta"
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{
"name": "Dr. Ignazzi Antonia"
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{
"name": "Dr. De Nunzio Valentina"
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{
"name": "Dr. Tatoli Rossella"
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{
"name": "Dr. Pinto Giuliano"
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],
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},
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}
}
} |
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}
],
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},
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},
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},
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},
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}
]
},
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"measure": "Incontinence episodes"
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],
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"measure": "ICIQ-SF"
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"measure": "I-QoL"
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{
"measure": "PAM-13"
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{
"measure": "PGI-I"
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{
"measure": "Cured patients"
},
{
"measure": "Urinary frequency day"
},
{
"measure": "Urinary frequency night"
},
{
"measure": "Pad use"
},
{
"measure": "Urge incontinence"
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{
"measure": "Functional bladder capacity"
},
{
"measure": "Body weight"
},
{
"measure": "Treatment Failure"
}
]
},
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"collaborators": [
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"name": "Johannes Gutenberg University Mainz"
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}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
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"name": "Healthy diet"
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]
},
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"Nutrition, Healthy",
"Cholesterol, Elevated"
]
},
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"locations": [
{
"city": "Québec",
"contacts": [
{
"email": "valerie.guay@fsaa.ulaval.ca",
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"role": "CONTACT"
}
],
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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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"id": "FH-Diet-RX",
"link": null,
"type": null
},
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},
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"primaryOutcomes": [
{
"measure": "Post-diet differences in LDL-C levels."
}
],
"secondaryOutcomes": [
{
"measure": "Post-diet differences in plasma metabolomics profiles"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
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"class": "OTHER",
"name": "Laval University"
}
},
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"date": "2024-06-30"
},
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"date": "2024-04-29"
},
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"date": "2024-06-30"
},
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"date": "2024-04-01"
},
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"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Dual-task exercise traning"
}
]
},
"conditionsModule": {
"conditions": [
"Dementia",
"Mild Cognitive Impairment",
"Older Adults"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Loughborough",
"contacts": null,
"country": "United Kingdom",
"facility": "Loughborough University",
"geoPoint": {
"lat": 52.76667,
"lon": -1.2
},
"state": "Leicestershire",
"status": null,
"zip": "LE11 3TU"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to explore how performing two exercise-based tasks simultaneously (dual-task exercise) affects the neurovascular and cognitive responses of people with cognitive impairment, which is a growing concern globally. Specifically, the study will examine how motor-cognitive dual-task exercises, such as using elastic resistance bands combined with visual perception training, including eye movement exercises, can immediately improve outcomes such as Brain-derived neurotrophic factor (BDNF) levels, cerebral blood flow, cognitive function, and mobility. BDNF is a special chemical in our brain that helps with the connections between brain cells. Participants will be asked to complete a single 30-minute exercise session and undergo assessments before and after the intervention. Participants with cognitive impairment will be initially assessed using Mini-Mental State Examination (MMSE) which is a 30-point questionnaire used extensively in clinical and research settings to measure cognitive impairment. Any score of 24 or more (out of 30) indicates normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points), or mild (19-23 points) cognitive impairment. Participants with lower MMSE scores (\\<10) will be removed from the study."
},
"designModule": {
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"interventionModel": "PARALLEL",
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]
},
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},
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"type": "ESTIMATED"
},
"phases": [
"NA"
],
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},
"eligibilityModule": {
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"minimumAge": "65 Years",
"sex": "ALL",
"stdAges": [
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Dual-task Exercise in People With Cognitive Impairment",
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"id": "LoughboroughUni",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
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"primaryOutcomes": [
{
"measure": "BDNF serum level"
}
],
"secondaryOutcomes": [
{
"measure": "Visual screening"
}
]
},
"sponsorCollaboratorsModule": {
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"class": "OTHER",
"name": "Loughborough University"
}
},
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"completionDateStruct": {
"date": "2024-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
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"date": "2024-04-30"
},
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"startDateStruct": {
"date": "2023-08-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Pemigatinib"
},
{
"name": "Retifanlimab"
}
]
},
"conditionsModule": {
"conditions": [
"Dedifferentiated Liposarcoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Oslo",
"contacts": [
{
"email": "kjetil.boye@rr-research.no",
"name": "Kjetil Boye, MD",
"phone": "4722934000",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Norway",
"facility": "Oslo University Hospital HF",
"geoPoint": {
"lat": 59.91273,
"lon": 10.74609
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Göteborg",
"contacts": [
{
"email": "lina.hansson@vgregion.se",
"name": "Lina Hansson, MD",
"phone": "46313427950",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Sweden",
"facility": "Sahlgrenska University Hospital",
"geoPoint": {
"lat": 57.70716,
"lon": 11.96679
},
"state": null,
"status": null,
"zip": null
},
{
"city": "Lund",
"contacts": [
{
"email": null,
"name": "Helena Nyström, MD",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "helena.nystrom@skane.se",
"name": null,
"phone": "+4646177520",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Sweden",
"facility": "Lund University Hospital",
"geoPoint": {
"lat": 55.70584,
"lon": 13.19321
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Dedifferentiated liposarcomas (DDLPS) are aggressive soft tissue sarcomas with no effective medical treatment options.\n\nImmunotherapy with checkpoint inhibitors, so-called PD-1 inhibitors, have shown some effect in DDLPS in previous studies. Effect of immunotherapy can be improved by combining it with other types of tumor drugs. Medicines that inhibit signaling via the FGF receptor, so-called FGFR inhibitors, have shown a tumor-slowing effect in DDLPS in early studies. FGFR inhibitors can also induce changes that make the tumor more available to treatment with immunotherapy.\n\nThe study aims to investigate whether the combination of an FGFR inhibitor, pemigatinib, with a PD-1 inhibitor, retifanlimab can provide a tumor-slowing effect in patients with advanced DDLPS who have progressed on first-line treatment."
},
"designModule": {
"designInfo": {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
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"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
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},
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"count": 33,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "100 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PERELI",
"briefTitle": "A Phase 2, Open Label Study of PEmigatinib and REtifanlimab in Advanced Dedifferentiated LIposarcoma (PERELI)",
"nctId": "NCT06389799",
"orgStudyIdInfo": {
"id": "PERELI",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "2022-501993-21-00",
"link": null,
"type": "CTIS"
}
]
},
"outcomesModule": {
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"primaryOutcomes": [
{
"measure": "To evaluate clinical benefit of retifanlimab and pemigatinib in patients with advanced DDLPS"
}
],
"secondaryOutcomes": [
{
"measure": "To further evaluate clinical efficacy of retifanlimab and pemigatinib in DDLPS"
},
{
"measure": "To evaluate the safety and tolerability of pemigatinib and retifanlimab"
},
{
"measure": "To evaluate impact of treatment and disease status on quality of life"
},
{
"measure": "To evaluate the relationship between baseline and on-treatment biomarkers and clinical activity"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Lund University Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-07"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Bilateral Pelvic Lymph Node Dissection"
},
{
"name": "Biospecimen Collection"
},
{
"name": "Bone Scan"
},
{
"name": "Computed Tomography"
},
{
"name": "Electronic Health Record Review"
},
{
"name": "Flotufolastat F-18 Gallium"
},
{
"name": "Laparoscopic Radical Prostatectomy with Robotics"
},
{
"name": "Magnetic Resonance Imaging"
},
{
"name": "Positron Emission Tomography"
}
]
},
"conditionsModule": {
"conditions": [
"Localized Prostate Carcinoma",
"Oligometastatic Prostate Carcinoma",
"Stage I Prostate Cancer AJCC v8",
"Stage II Prostate Cancer AJCC v8",
"Stage III Prostate Cancer AJCC v8",
"Stage IVA Prostate Cancer AJCC v8"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Jacksonville",
"contacts": [
{
"email": "mayocliniccancerstudies@mayo.edu",
"name": "Clinical Trials Referral Office",
"phone": "855-776-0015",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Ram A. Pathak, M.D.",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Mayo Clinic in Florida",
"geoPoint": {
"lat": 30.33218,
"lon": -81.65565
},
"state": "Florida",
"status": null,
"zip": "32224-9980"
}
]
},
"descriptionModule": {
"briefSummary": "This clinical trial evaluates the use of an imaging scan (18F-rhPSMA-7.3 positron emission tomography \\[PET\\]/magnetic resonance imaging \\[MRI\\]) for identifying patients who are at risk of having their disease spread to the lymph nodes in those undergoing radical prostatectomy for prostate cancer that has not spread to other parts of the body (localized). Prostate specific membrane antigen (PSMA) PET/computed tomography (CT) has emerged as an option to stage newly diagnosed high risk prostate cancer patients. PSMA PET/CT has demonstrated improved diagnostic accuracy for identifying metastasis. PET is procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is used. Because cancer cells often use more glucose than normal cells, the pictures can be used to find cancer cells in the body. MRI is procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. These pictures can show the difference between normal and diseased tissue. This study may help researchers learn whether 18F-rhPSMA-7.3 PET/ MRI may improve predicting which patients are at risk of lymph node metastases and who are suitable candidates for pelvic lymph node dissection in patients with localized high-risk prostate cancer undergoing radical prostatectomy."
},
"designModule": {
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},
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},
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},
"phases": [
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],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "30 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Accuracy of 18F-rhPSMA-7.3 PET/ MRI for Prediction of Lymph Node Metastasis in Localized High-Risk Prostate Cancer",
"nctId": "NCT06389786",
"orgStudyIdInfo": {
"id": "MC230504",
"link": null,
"type": null
},
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{
"domain": "CTRP (Clinical Trial Reporting Program)",
"id": "NCI-2024-03306",
"link": null,
"type": "REGISTRY"
},
{
"domain": "Mayo Clinic Institutional Review Board",
"id": "23-009377",
"link": null,
"type": "OTHER"
},
{
"domain": "Mayo Clinic",
"id": "MC230504",
"link": null,
"type": "OTHER"
}
]
},
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"primaryOutcomes": [
{
"measure": "Sensitivity of flotufolastat F-18 gallium (18F-rhPSMA-7.3) positron emission tomography (PET)/magnetic resonance (MRI) for the detection of lymph node metastasis"
}
],
"secondaryOutcomes": [
{
"measure": "Specificity"
},
{
"measure": "Positive/negative predictive value"
},
{
"measure": "Prostate specific antigen (PSA): < 5, 5-10, 10-20, > 20"
},
{
"measure": "Gleason score"
},
{
"measure": "Digital rectal examination"
},
{
"measure": "Number of patients where management has changed"
},
{
"measure": "Rates of biochemical recurrent disease (BCR)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mayo Clinic"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-31"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Teamwork"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this ethnographic study is to observe how healthcare professionals work together in an intensive care unit (ICU). The main questions it aims to answer are\n\n* How do healthcare staff work together in everyday ICU settings?\n* What helps people work together in ICUs?\n* What challenges do staff face in working together in ICUs?\n* How have teamwork practices changed since the COVID-19 pandemic?\n\nResearchers will shadow staff during their day-to-day work. Key staff members will also be interviewed about their perceptions and experiences of teamwork."
},
"designModule": {
"designInfo": {
"allocation": null,
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},
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},
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},
"eligibilityModule": {
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"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "FEARLESS_ICU",
"briefTitle": "Teamwork for Resilient Staff and Safe Care in ICU",
"nctId": "NCT06389773",
"orgStudyIdInfo": {
"id": "302958",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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{
"measure": "Examine the changing nature of teamwork in ICUs in the post-pandemic context"
}
],
"secondaryOutcomes": null
},
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}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09-30"
},
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"date": "2024-04-29"
},
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"date": "2025-09-30"
},
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"startDateStruct": {
"date": "2024-09-02"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Nimotuzumab"
},
{
"name": "mFOLFIRINOX"
}
]
},
"conditionsModule": {
"conditions": [
"Pancreatic Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nanjing",
"contacts": [
{
"email": "dujunglyy@163.com",
"name": "Juan Du, M.D. Ph.D",
"phone": "+86-025-83106666",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Juan Du, M.D. Ph.D",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School",
"geoPoint": {
"lat": 32.06167,
"lon": 118.77778
},
"state": "Jiangsu",
"status": "RECRUITING",
"zip": "210008"
}
]
},
"descriptionModule": {
"briefSummary": "This is a prospective, multicenter, single-arm, phase II trial. The main purpose of the study is to evaluate the efficacy and safety of Nimotuzumab combined with mFOLFIRINOX for postoperative adjuvant treatment of pancreatic cancer."
},
"designModule": {
"designInfo": {
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"whoMasked": null
},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
},
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"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Single-arm Study of Nimotuzumab Combined With mFOLFIRNIOX as Postoperative Adjuvant Therapy in Pancreatic Cancer",
"nctId": "NCT06389760",
"orgStudyIdInfo": {
"id": "IST-Nim-PC-16",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "disease-free survival (DFS)"
}
],
"secondaryOutcomes": [
{
"measure": "distant metastasis-free survival (DMFS)"
},
{
"measure": "overall survival (OS)"
},
{
"measure": "European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)"
},
{
"measure": "European Organization for Research and Treatment of Cancer Quality of Life Questionnaire pancreatic cancer 29 (EORTC-QLQ-PAN26)"
},
{
"measure": "tumor-related markers"
},
{
"measure": "adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-10-18"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "BFR technique"
}
]
},
"conditionsModule": {
"conditions": [
"Pain Intensity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Istanbul",
"contacts": [
{
"email": "gmzetsn@gmail.com",
"name": "Gamze Aydın",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Gamze Aydın",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": null,
"status": "RECRUITING",
"zip": "34940"
},
{
"city": "Istanbul",
"contacts": [
{
"email": "gmzetsn@gmail.com",
"name": "Gamze Aydın, PhD",
"phone": "+905377600256",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Istanbul Okan University",
"geoPoint": {
"lat": 41.01384,
"lon": 28.94966
},
"state": null,
"status": "RECRUITING",
"zip": "34944"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of our study is to determine and evaluate the effects of blood flow restriction technique on pain, biomechanical properties and strength of the muscle in delayed onset muscle pain in healthy individuals. A Double Blind, Randomized Controlled, prospective study was planned."
},
"designModule": {
"designInfo": {
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"interventionModelDescription": null,
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"whoMasked": [
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"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
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},
"enrollmentInfo": {
"count": 15,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Blood Flow Restriction Technique on Delayed Onset Muscle Soreness",
"nctId": "NCT06389747",
"orgStudyIdInfo": {
"id": "OU",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Visual analog scale"
},
{
"measure": "myoton"
},
{
"measure": "dynamometer"
},
{
"measure": "dolorimeter"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istanbul University - Cerrahpasa (IUC)"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-05-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-24"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Manual soft tissue release"
},
{
"name": "Myofascial release"
},
{
"name": "Exercise training"
}
]
},
"conditionsModule": {
"conditions": [
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"Manual Soft Tissue Release",
"Exercise Training",
"Lung Function",
"Exercise Capacity",
"Cardiac Autonomic Function"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tainan",
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"facility": "National Cheng Kung University",
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"lat": 22.99083,
"lon": 120.21333
},
"state": null,
"status": null,
"zip": "701"
}
]
},
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"briefSummary": "The potential effects of combining manual soft tissue release and physical exercise training on lung function, exercise capacity, and cardiac autonomic function in patients with moderate and severe chronic obstructive pulmonary disease were investigated."
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},
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},
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"id": "B-ER-111-470",
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},
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},
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"measure": "Forced expiratory volume in 1 s (FEV1)"
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{
"measure": "forced vital capacity (FVC)"
},
{
"measure": "FEV1/FVC ratio"
},
{
"measure": "expiratory reserve volume (ERV)"
},
{
"measure": "functional residual capacity (FRC)"
},
{
"measure": "inspiratory capacity (IC)"
},
{
"measure": "inspiratory reserve volume (IRV),"
},
{
"measure": "residual volume (RV)"
},
{
"measure": "total lung capacity (TLC)"
},
{
"measure": "tidal volume (TV)"
},
{
"measure": "vital capacity (VC)"
}
],
"secondaryOutcomes": [
{
"measure": "Rate of perceived exertion (RPE)"
},
{
"measure": "Oxygen consumption (VO2)"
},
{
"measure": "oxygen saturation"
},
{
"measure": "heart rate (HR)"
},
{
"measure": "blood pressure (BP)"
},
{
"measure": "Diaphragmatic mobility"
},
{
"measure": "Cardiac Autonomic Function"
},
{
"measure": "six minute walk test (6-MWT)"
},
{
"measure": "maximal expiratory pressure (MEP)"
},
{
"measure": "maximal inspiratory pressure (MIP)"
},
{
"measure": "St. George's Respiratory Questionnaire (SGRQ)"
},
{
"measure": "fatigue severity scale (FSS)"
},
{
"measure": "Modified Medical Research Council (mMRC)"
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{
"measure": "36-Item Short Form Health Survey (SF-36)"
}
]
},
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"class": "OTHER",
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},
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}
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"name": "Electroencephalogram (EEG)"
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]
},
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]
},
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{
"city": "Houston",
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{
"email": "sprinsloo@mdanderson.org",
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"phone": "713-563-9627",
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},
{
"email": null,
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}
],
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"lon": -95.36327
},
"state": "Texas",
"status": null,
"zip": "77030"
}
]
},
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"briefSummary": "Cohort 1: To track the onset and progression of a condition called chemotherapy-induced peripheral neuropathy (CIPN).\n\nCohort 2: To track the onset and progression of a condition called chemotherapy-induced peripheral neuropathy (CIPN) and to test a certain type of experimental neuromodulation (stimulation of the brain) with a device called a closed-loop brain-computer interface (clBCI) to see if can help to prevent pain due to CIPN."
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},
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"domain": "NCI-CTRP Clinical Registry",
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}
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]
},
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},
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"briefSummary": "Heart failure is a syndrome that progresses with symptoms and signs caused by cardiac dysfunction and results in a shortened life expectancy (1). Acute heart failure resulting in hospitalization is a significant cause of morbidity and mortality. With the increase in the severity of the disease and rapid advances in the treatment of heart failure, these patients are frequently hospitalized and monitored in intensive care. (2) Five years after diagnosis, mortality can be up to 67%. Additionally, it is known that patients with heart failure are hospitalized on average once a year after diagnosis. (3) In a multicenter study, it constituted 14% of 3000 cardiac patients admitted to intensive care units. Additionally, due to longer ICU stays, these patients accounted for 33% of total inpatient days. An increasing number of heart failure patients require intensive care due to respiratory failure, regardless of left ventricular ejection fraction. Heart failure accounts for approximately one-third of patient days in intensive care units, and this burden is increasing. This shows that attention should be paid to the quality of care for patients requiring critical care. (2) Multidisciplinary programs have been implemented to deal with the high prevalence. However, the optimal follow-up frequency is unknown. Therefore, some tools are needed to improve patient prognosis (3). Neutrophil gelatinase-associated lipocalin (NGAL) is a biomarker whose values in both urine and plasma have been associated with acute kidney injury (AKI). Although NGAL is an early specific biomarker for AKI, it has not yet come into routine use, but is frequently used in clinical and experimental studies (4). Venous load ultrasonography score (VExUS) is a new systemic congestion scoring method based on inferior vena cava dilation and pulsed wave Doppler (PW-Doppler) morphology of the hepatic, portal and renal veins. It has been proposed as a score to assess systemic congestion."
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},
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},
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"measure": "VEXUS"
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{
"measure": "MORTALİTY"
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{
"measure": "AKI"
}
],
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},
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}
} |
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"interventions": [
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"name": "68Ga-NYM032 injection"
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]
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]
},
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"locations": [
{
"city": "Wuxi",
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{
"email": "ycj_wxd1978@163.com",
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}
]
},
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"briefSummary": "68Ga-NYM032 is a PSMA-targeting small-molecular radiotracer for PET/CT imaging of prostate cancer, which is needed for clinical trial to be conducted"
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},
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},
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}
} |
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{
"name": "68Ga-NYM005 injection"
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]
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"conditions": [
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]
},
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"locations": [
{
"city": "Wuxi",
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"email": "ycj_wxd1978@163.com",
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}
],
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]
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"briefSummary": "68Ga-NYM005 is a CAIX-targeting small-molecular radiotracer for PET/CT imaging of clear cell renal cell carcinoma"
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]
},
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},
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},
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},
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"date": "2024-04-29"
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}
} |
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"armsInterventionsModule": null,
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"conditions": [
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]
},
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"locations": [
{
"city": "Malatya",
"contacts": null,
"country": "Turkey",
"facility": "Inonu Univercity",
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"lat": 38.35018,
"lon": 38.31667
},
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}
]
},
"descriptionModule": {
"briefSummary": "Although low-flow anaesthesia (LFA) has been described for many years and its benefits are known, its clinical use has been limited. Concerns about the risk of hypoxia contributed to this situation. Although the risk of hypoxia is almost prevented with advanced anaesthesia machines, the use of LFA has not reached the desired levels. However, in recent years, as adverse developments related to climate change have started to affect us all, LFA has started to be on the agenda of anaesthetists again. In this study, our aim is to examine the feasibility of its clinical use in order to popularise the use of LFA."
},
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"OLDER_ADULT"
]
},
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"acronym": null,
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"id": "Inonu LTI",
"link": null,
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},
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},
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"measure": "Feasibility of Low Flow Anaesthesia"
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],
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"measure": "Factors affecting oxygen consumption"
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"date": "2024-04-29"
}
}
} |
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"name": "Behavioral Weight Management"
},
{
"name": "Weight Bias Internalization"
}
]
},
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"Body Weight",
"Weight Bias",
"Weight Stigma",
"Weight"
]
},
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"locations": [
{
"city": "Providence",
"contacts": [
{
"email": "katherine_darling@brown.edu",
"name": "Katherine Darling, PhD",
"phone": "401-793-8688",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "agrenga@lifespan.org",
"name": "Andrea M Grenga, BA",
"phone": "401-793-8997",
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"role": "CONTACT"
}
],
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},
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}
]
},
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"briefSummary": "Weight stigma and weight bias internalization (WBI) are common among adolescents at higher weight statuses. WBI is associated with negative physical and mental health outcomes. The current study aims to test intervention for weight stigma and WBI in conjunction with an evidence-based adolescent weight management program. Adolescents (ages 13-17) will participate in a 20-week program tailored to improve WBI and weight-related health behaviors in tandem. Primary outcomes are feasibility and acceptability of the developed intervention, assessed following the 20-week intervention."
},
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},
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},
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"link": "https://reporter.nih.gov/quickSearch/1K23DK135791-01",
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},
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"measure": "Total score on an adapted version of the Acceptability of Intervention Measure (AIM)"
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{
"measure": "In depth qualitative feedback from teens regarding intervention acceptability and feasibility"
},
{
"measure": "Attendance rates at intervention sessions"
},
{
"measure": "Retention rate for intervention sessions"
}
],
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{
"measure": "Total score on the Modified Weight Bias Internalization Scale (WBIS-M)"
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{
"measure": "Total score on the Weight Self-Stigma Questionnaire (WSSQ)"
},
{
"measure": "Total score on the weight-related teasing sub-scale of the Perception of Teasing Scale (POTS)"
},
{
"measure": "Total score on the competency-related teasing subscale of the Perception of Teasing Scale (POTS)"
},
{
"measure": "Anthropometrics"
}
]
},
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},
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}
}
} |
null | false | {
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"interventions": [
{
"name": "Four-point scleral fixation of Akreos AO60 IOL"
},
{
"name": "Sutureless scleral fixation of AcrySof MA60AC IOL with Yamane technique"
}
]
},
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"conditions": [
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]
},
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{
"city": "Warsaw",
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]
},
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"allocation": "RANDOMIZED",
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"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Comparison of Safety and Efficacy of Four-Point Scleral Intraocular Lens Fixation and Yamane Techniques",
"nctId": "NCT06389643",
"orgStudyIdInfo": {
"id": "11/WIM/2021",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "BCVA"
},
{
"measure": "RE"
},
{
"measure": "ECC"
}
],
"secondaryOutcomes": [
{
"measure": "Number of complications"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Military Institute od Medicine National Research Institute"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-09-19"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2022-09-14"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-03-19"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "video-assisted training group"
},
{
"name": "low fidelity simulation model group"
}
]
},
"conditionsModule": {
"conditions": [
"Complication of Injection"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Subject: Subcutaneous (SC) insulin injection is frequently used in the treatment of Type 2 Diabetes patients. Complications such as pain, ecchymosis, hematoma, lipoatrophy and lipohypertrophy are frequently observed after SC injections. These complications that develop due to incorrect injection application negatively affect the use of injection application areas, change body image and negatively affect drug absorption. In order to reduce and prevent complications related to SC insulin injection, it is very important to gain the skill of safe SC insulin injection. It is stated that there are a limited number of studies on which of the teaching methods used in sick individuals are effective. In the national and international literature, no study has been found evaluating the effect of SC injection skill teaching based on video-supported training and low-fidelity simulation model applications on disease management in individuals diagnosed with Type 2 Diabetes Mellitus. In this regard, the research was planned as an experimental design in order to examine the effectiveness of video-supported training and low-fidelity simulation model-based teaching in gaining safe insulin injection skills via SC. For this purpose; It is aimed to evaluate the effect of two different skill teaching methods on the patient's SC injection ability, complication management and blood glucose level.\n\nPurpose: This research was planned as an experimental design to examine the effectiveness of two different teaching methods (video-supported training and low-fidelity simulation model) in gaining safe insulin injection skills via the Subcutaneous (SC) route.\n\nDesign: A pretest-posttest two-group, quasi-experimental design will be used in the study."
},
"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": 82,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "EETDTMSSİS",
"briefTitle": "Evaluation of the Efficiency of Two Different Teaching Methods in Safe Subcutaneous Injection Skills",
"nctId": "NCT06389630",
"orgStudyIdInfo": {
"id": "0012",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "subcutaneous injection skills"
},
{
"measure": "ecchymosis"
},
{
"measure": "hematoma"
},
{
"measure": "lipoarthrrophy"
},
{
"measure": "lipohypertrophy"
},
{
"measure": "pain"
},
{
"measure": "blood glucose level"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Kocaeli Sağlık ve Teknoloji Üniversitesi"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-01-20"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-29"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "supraclavicular block with 20mls of Ropivacaine 0.5% and Intravenous administered dexamethasone"
}
]
},
"conditionsModule": {
"conditions": [
"End Stage Renal Failure"
]
},
"contactsLocationsModule": null,
"descriptionModule": {
"briefSummary": "To compare the analgesic properties of ultrasound guided supraclavicular block using ropivacaine 0.5% in arteriovenous fistula creation when used in combination with intravenous administered dexamethasone at 4mg and 8 mg as an adjuvant"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Different Doses of Intravenous Administered Dexamethasone Effecting Brachial Plexus Supraclavicular Block",
"nctId": "NCT06389617",
"orgStudyIdInfo": {
"id": "USM/JEPeM/KK/24010061",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "To compare the difference of onset time between sensory and motor block of supraclavicular block between ropivacaine with IV dexamethasone 4mg and ropivacaine with IV dexamethasone 8mg"
},
{
"measure": "To compare the difference in duration of analgesia between supraclavicular block with ropivacaine and IV dexamethasone 4mg with ropivacaine and IV dexamethasone 8mg"
}
],
"secondaryOutcomes": [
{
"measure": "To compare the duration difference of the return of motor block between supraclavicular block using ropivacaine with IV dexamethasone 4mg and ropivacaine with IV dexamethasone 8mg"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Hospital Universiti Sains Malaysia"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Heat acclimation"
}
]
},
"conditionsModule": {
"conditions": [
"Body Temperature Changes",
"Heat Exposure",
"Heat Stress",
"Hyperthermia"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "As the ongoing progression of climate change exposes individuals to elevated temperatures and an escalating frequency of extreme heat events, the risk of more intense and prolonged heat waves raises significant concerns for public health, particularly among vulnerable populations. The physiological response to acute heat stress involves involuntary thermolytic reactions that may strain the cardiovascular system, especially in individuals with pre-existing vulnerabilities. Heat acclimation has been identified as a potential strategy to enhance thermoregulation and mitigate the adverse effects of heat stress. While existing research primarily focuses on athletes and military, this study aims to investigate the impact of a practical heat acclimation strategy, combining passive and active heat exposure, on thermophysiological, cardiovascular and metabolic parameters in healthy overweight adults. The study targets a population at increased risk for heat-related complications, seeking to provide realistic guidelines for broader application when a heat wave appears on the weather forecast."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Non-randomized, within subject experiemental trial",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "No blinding due to nature of intervention",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 12,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "60 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "Prep4heat",
"briefTitle": "Preparing for Heat Waves - Enhancing Human Thermophysiological Resilience",
"nctId": "NCT06389604",
"orgStudyIdInfo": {
"id": "NL86367.068.24",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Core temperature"
}
],
"secondaryOutcomes": [
{
"measure": "Skin temperature"
},
{
"measure": "Sweat rate"
},
{
"measure": "Heart rate"
},
{
"measure": "Blood pressure"
},
{
"measure": "Skin blood flow"
},
{
"measure": "Energy expenditure"
},
{
"measure": "Substrate oxidation"
},
{
"measure": "Plasma metabolites"
},
{
"measure": "Brain blood flow"
},
{
"measure": "Flow-mediated dilation"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Maastricht University Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "pp65 RNA loaded lipid particles, pp65 RNA-LPs (Drug Product 1 or DP1)"
},
{
"name": "RNA loaded lipid particles, RNA-LPs (Drug Product 2 or DP2)"
}
]
},
"conditionsModule": {
"conditions": [
"Recurrent Glioblastoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Gainesville",
"contacts": [
{
"email": "marcia.hodik@neurosurgery.ufl.edu",
"name": "Marcia Hodik",
"phone": "352-273-9000",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Ashley Ghiaseddin, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "UF Health",
"geoPoint": {
"lat": 29.65163,
"lon": -82.32483
},
"state": "Florida",
"status": null,
"zip": "32608"
}
]
},
"descriptionModule": {
"briefSummary": "This is a Phase I study to demonstrate the manufacturing feasibility and safety, and to determine the maximum tolerated dose (MTD) of RNA-LP vaccines in adult patients with recurrent glioblastoma."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 24,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "80 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "RNA-Lipid Particle (RNA-LP) Vaccines for Recurrent Adult Glioblastoma (GBM)",
"nctId": "NCT06389591",
"orgStudyIdInfo": {
"id": "OCR44973",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Percentage of vaccines meeting release criteria in the DLT window during the first three vaccines"
},
{
"measure": "Incidence of investigational treatment related toxicities"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Florida"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-12"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Teprotumumab"
}
]
},
"conditionsModule": {
"conditions": [
"Thyroid Eye Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Miami",
"contacts": null,
"country": "United States",
"facility": "Bascom Palmer Eye Institute - University of Miami",
"geoPoint": {
"lat": 25.77427,
"lon": -80.19366
},
"state": "Florida",
"status": null,
"zip": "33136"
},
{
"city": "Saint Louis",
"contacts": null,
"country": "United States",
"facility": "Barnes Jewish Hospital Washington University",
"geoPoint": {
"lat": 38.62727,
"lon": -90.19789
},
"state": "Missouri",
"status": null,
"zip": "63108"
},
{
"city": "Bellaire",
"contacts": null,
"country": "United States",
"facility": "Neuro-Eye Clinical Trials",
"geoPoint": {
"lat": 29.70579,
"lon": -95.45883
},
"state": "Texas",
"status": null,
"zip": "77401"
}
]
},
"descriptionModule": {
"briefSummary": "The main goal of this study is to learn how teprotumumab will be processed in the body (Pharmacokinetics) subcutaneously and whether it is safe and tolerable after administration into adult patients with thyroid eye disease."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 16,
"type": "ACTUAL"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Study of TEPEZZA® Treatment in Participants With Thyroid Eye Disease",
"nctId": "NCT06389578",
"orgStudyIdInfo": {
"id": "HZNP-TEP-103",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Pharmacokinetics (PK): Area Under the Curve (AUC) of Teprotumumab"
},
{
"measure": "PK: Maximum Serum Concentration (Cmax) of Teprotumumab"
},
{
"measure": "Number of Participants With Adverse Events (AE)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Horizon Therapeutics USA, Inc."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-09-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-02-28"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-07-14"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Problem Solving Therapy"
},
{
"name": "Change My Story"
}
]
},
"conditionsModule": {
"conditions": [
"Hiv",
"Depression",
"Psychological Distress"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Psychological distress and depression are common among young people living with HIV (Y-PLWH) and negatively impact medication adherence and disease control. In low- and middle-income countries, this problem is compounded by the lack of trained mental health professionals on the provider side and the requirement of frequent clinic-based visits imposing greater cost, inconvenience, and stigma for patients. Change My Story, is a theory-grounded, interactive narrative game designed to address the key drivers of depression and psychological distress among Y-PLWH in Nigeria. This pilot hybrid implementation-effectiveness randomized controlled trial (RCT) will compare Change My Story combined with PST to PST alone among 80 Y-PLWH with depression or psychological distress."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "24 Years",
"minimumAge": "16 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Pilot Randomized Clinical Trial of Change My Story",
"nctId": "NCT06389565",
"orgStudyIdInfo": {
"id": "2024p000857",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Engagement"
},
{
"measure": "Satisfaction"
},
{
"measure": "Feasibility 1"
},
{
"measure": "Feasibility 2"
},
{
"measure": "Feasibility 3"
},
{
"measure": "Feasibility 4"
},
{
"measure": "Feasibility 5"
},
{
"measure": "Feasibility 6"
},
{
"measure": "Feasibility 7"
},
{
"measure": "Acceptability 1"
},
{
"measure": "Acceptability 2"
},
{
"measure": "Acceptability 3"
},
{
"measure": "Acceptability 4"
},
{
"measure": "Acceptability 5"
}
],
"secondaryOutcomes": [
{
"measure": "Remission of depression."
},
{
"measure": "Remission of psychological distress."
},
{
"measure": "ART adherence"
},
{
"measure": "Viral suppression"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University of Ibadan"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Massachusetts General Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2025-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Adjuvant Chemotherapy"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Seoul",
"contacts": [
{
"email": null,
"name": "Myung-Ah Lee",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Myung-Ah Lee",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Korea, Republic of",
"facility": "Seoul ST. Mary's Hospital",
"geoPoint": {
"lat": 37.566,
"lon": 126.9784
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This study is designed to evaluate the safety and efficacy of adjuvant FOLFIRINOX regimen in pancreatic cancer patients after curative surgery."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 36,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "19 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Long-term Observational Study to Evaluate the DFS and OS of Adjuvant FOLFIRINOX Regimen in Pancreatic Cancer Patients",
"nctId": "NCT06389552",
"orgStudyIdInfo": {
"id": "IN_CTP_N01",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Disease-free survival"
}
],
"secondaryOutcomes": [
{
"measure": "Overall survival"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
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},
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"briefSummary": "Rationale for conducting the study:\n\nThe study aims to systematically evaluate the clinical and economic impacts of Robotic-Assisted Total Knee Replacement (RTKR) compared to conventional Total Knee Replacement (TKR). It focuses on the potential benefits of RTKR, including improved precision in surgery, potentially leading to better patient outcomes and reduced healthcare costs. Our primary endpoint is the Forgotten Joint Score (FJS), aimed at measuring patients awareness of their knee joint in everyday life, indicating the success of the knee replacement surgery in restoring natural joint function. Secondary endpoints include patient-reported outcome measures (PROMs), patient activity levels, the accuracy of implant positioning on x-ray, and the incidence of adverse events.\n\nStudy design:\n\nMulticentre,, preference-tolerant, randomized, controlled, superiority trial with two treatment arms that compares the outcomes of RTKR with traditional TKR techniques.\n\nStudy population:\n\nAdult patients aged 18 years and older who are eligible for TKR as per local guidelines and who have given informed consent to participate in the study.\n\nNumber of patients:\n\n400\n\nInclusion criteria:\n\nPatients must be adults aged 18 years and older, eligible for TKR according to local guidelines, and willing to participate in the study.\n\nExclusion criteria:\n\nPatients with extreme malalignment requiring special implants or techniques, patients unfit for surgery due to medical reasons, and those deemed unsuitable to participate in the study for other reasons.\n\nPrimary outcome variables:\n\nThe Forgotten Joint Score (FJS) at 2 years after surgery"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 250,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "ROCKETS",
"briefTitle": "RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques",
"nctId": "NCT06389435",
"orgStudyIdInfo": {
"id": "2024DS",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Danderyds sjukhus",
"id": "Knee",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The Forgotten Joint Score (FJS)"
}
],
"secondaryOutcomes": [
{
"measure": "KOOS"
},
{
"measure": "ADLS knee instability"
},
{
"measure": "The Forgotten Joint Score (FJS)"
},
{
"measure": "EQ-5D"
},
{
"measure": "Knee alignment"
},
{
"measure": "Adverse events"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Karolinska Institutet"
},
{
"name": "Stockholm South General Hospital"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Danderyd Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Moderate-dose Hypofractionated Intensity-modulated Radiotherapy"
},
{
"name": "Pembrolizumab"
}
]
},
"conditionsModule": {
"conditions": [
"Hepatocellular Carcinoma",
"Radiotherapy",
"Pembrolizumab",
"Tumor Thrombosis"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Beijing",
"contacts": [
{
"email": "chenboo@outlook.com",
"name": "Bo Chen, MD",
"phone": "0086-13240000876",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciecnces and Peking Union Medical College",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "This is a single-center, single-arm, open-label study that includes patients meeting the inclusion criteria (liver-GTV volume \\< 700ml or estimated liver-GTV V5 \\< 300ml) with hepatocellular carcinoma with diffuse tumor thrombosis involving both left and right lobes. All lesions receive moderate-dose hypofractionated intensity-modulated radiotherapy, with a gross tumor dose of 25Gy/5f, and a maximum dose of 35Gy/5f at the tumor center. One week before or during the radiotherapy, patients receive concurrent Pembrolizumab at a dose of 200mg. Subsequently, Pembrolizumab is administered intravenously every 3 weeks. Follow-up examinations are conducted 1-3 months post-radiotherapy. Lenvatinib 4mg may be used for maintenance therapy with Pembrolizumab if there are no contraindications. Maintenance therapy is continued until disease progression or intolerance. The primary endpoint is median overall survival (mOS), and secondary endpoints include objective response rate (ORR), progression-free survival (PFS), and toxicity."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 30,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "90 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Phase II Study of Moderate-dose Hypofractionated RT Combined With Pembrolizumab for HCC With Diffuse Tumor Thrombosis",
"nctId": "NCT06389422",
"orgStudyIdInfo": {
"id": "NCC4620",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Median Overall Survival"
}
],
"secondaryOutcomes": [
{
"measure": "Objective Response Rate"
},
{
"measure": "Progression-free Survival"
},
{
"measure": "Toxicity"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Cancer Institute and Hospital, Chinese Academy of Medical Sciences"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-04-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-04-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Observation of testicular cancer patients"
}
]
},
"conditionsModule": {
"conditions": [
"Testicular Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Milan",
"contacts": [
{
"email": "darma.alessia@hsr.it",
"name": "Alessia d'Arma, PhD",
"phone": "02 2643 5506",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Italy",
"facility": "IRCCS Ospedale San Raffaele",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": "Lombardy",
"status": "RECRUITING",
"zip": "20132"
}
]
},
"descriptionModule": {
"briefSummary": "The research aims to collect data in order to report the main problems related to the testicular cancer; To reach this aim, this study proposes to create a database of the testicular cancer condition.\n\nFrom this perspective, the aim of this project is the improving of scientific knowledge of the disease and develop appropriate and effective procedures for the diagnosis and treatment of the patient."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 3000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "MALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Study on the Quality of Life and Functional/Oncological Outcome of Testicular Cancer Patients",
"nctId": "NCT06389409",
"orgStudyIdInfo": {
"id": "Protocollo N.2009 Testicolo",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Clinical data"
},
{
"measure": "Adjuvant therapy"
},
{
"measure": "lactate dehydrogenase"
},
{
"measure": "Testicular objective examination"
},
{
"measure": "Testicular objective examination - cysts"
},
{
"measure": "Testicular objective examination - nodules"
},
{
"measure": "Testicular objective examination - varicocele"
},
{
"measure": "Testicular objective examination - hydrocele"
},
{
"measure": "α-feto protein"
},
{
"measure": "β human Chorionic Gonadotropin"
},
{
"measure": "carcinoembryonic antigen"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "IRCCS San Raffaele"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2040-08-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2030-09-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2010-08-24"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "CP362 Test Catheter"
}
]
},
"conditionsModule": {
"conditions": [
"Bowel Management"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Århus",
"contacts": [
{
"email": null,
"name": "Peter Christensen",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Denmark",
"facility": "Århus Universitetshospital",
"geoPoint": {
"lat": 56.15674,
"lon": 10.21076
},
"state": "Jutland",
"status": "RECRUITING",
"zip": "8200"
},
{
"city": "Hvidovre",
"contacts": [
{
"email": null,
"name": "Michael Sørensen",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Denmark",
"facility": "Amager Hvidovre Hospital",
"geoPoint": {
"lat": 55.65719,
"lon": 12.47364
},
"state": "Zealand",
"status": "RECRUITING",
"zip": "2650"
}
]
},
"descriptionModule": {
"briefSummary": "The clinical investigation is an exploratory, randomised controlled, open-labelled, crossover investigation.\n\nThe clinical investigation will be conducted as a multi-centre clinical investigation in two different clinical investigation sites in Denmark."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"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": "Investigation of a New Rectal Catheter for Users of Transanal Irrigation",
"nctId": "NCT06389396",
"orgStudyIdInfo": {
"id": "CP362",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The primary endpoint is: Was it possible to perform transanal irrigation (assessed after irrigation at V1 and V2)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Coloplast A/S"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-08"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Nasal Swab"
}
]
},
"conditionsModule": {
"conditions": [
"Newborn; Infection"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Caen",
"contacts": null,
"country": "France",
"facility": "CAEN University Hospital",
"geoPoint": {
"lat": 49.18585,
"lon": -0.35912
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The objective of our study is therefore to study the evolution of the respiratory microbiome of hospitalized newborns, its interaction with viral infections and their impacts on the evolution of newborns."
},
"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": 38,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "NEONATMICROBIO",
"briefTitle": "Pilot Study - Monitoring the Nasal Microbiome and Viral Respiratory Infections in Newborn Hospitalized in Neonatalogy.",
"nctId": "NCT06389383",
"orgStudyIdInfo": {
"id": "22-0182",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "rate of viral infections"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University Hospital, Caen"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2023-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2022-12-21"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "HU-DBI questionnaire"
}
]
},
"conditionsModule": {
"conditions": [
"Oral Health Knowledge, Attitude and Behaviour of Dental Students"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The knowledge, behaviour and attitude of oral health professionals reflects their awareness and understanding of oral preventive measures, which will have significant impact on their delivery of public oral health promotion in the future. They are expected to set an example for positive oral health behaviour among other college students, family members and their patients. Various external factors like sociodemographic factors like age, gender, marital state, occupation, and number of family members play a major role in oral hygiene. The relationships between various modifiable factors needs to be assesses in a vast manner.\n\nThere were some researches about oral health knowledge, behaviour and attitude in correlation to socio-demographic data, of dental students in other countries, but little was known in Egypt. Dental students are expected to play a critical role in instructing public oral health for improving their patient's, families, and friends. In addition, it may pave the way to develop new programs to encourage needful oral health practices."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 535,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "27 Years",
"minimumAge": "17 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "ASSESSMENT OF ORAL HEALTH KNOWLEDGE, ATTITUDE AND BEHAVIOUR AND ITS ASSOCIATION WITH SOCIODEMOGRAPHIC FACTORS OF PRECLINICAL AND CLINICAL DENTAL STUDENTS IN CAIRO UNIVERSITY: A CROSS-SECTIONAL STUDY",
"nctId": "NCT06389370",
"orgStudyIdInfo": {
"id": "knowledge, Attitude, Behaviour",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Increase of dental students KAB by preceding through higher academic levels"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Cairo University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-03"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-18"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-11-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "training and counselling"
}
]
},
"conditionsModule": {
"conditions": [
"Childhood Cancer",
"ALL, Childhood",
"AML, Childhood",
"Lymphoma",
"Solid Tumor, Childhood"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": [
{
"email": "cakirgzem@gmail.com",
"name": "Gizem Cakir, PhD(c)",
"phone": "+905300858879",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Gizem Cakir",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": "Cankaya",
"status": null,
"zip": "06490"
}
]
},
"descriptionModule": {
"briefSummary": "This study is planned to evaluate the effect of back-to-school adaptation programme on social anxiety score, coping score and back-to-school readiness score in children aged 8-17 years who are followed up with a diagnosis of cancer.\n\nH1: Is there a significant difference in children's social anxiety scores before and after the back-to-school adaptation programme? H2: Is there a significant difference in children's coping scores before and after the back-to-school adaptation programme? H3: Is there a significant difference in children's readiness to return to school scores before and after the back-to-school adaptation programme?"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "The research is a technical/scientific/collaborative action research design.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 35,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "17 Years",
"minimumAge": "8 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": "web-based",
"briefTitle": "Return to School Adaptation Programme for Children With Cancer",
"nctId": "NCT06389357",
"orgStudyIdInfo": {
"id": "1305G2024",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "social anxiety"
},
{
"measure": "coping"
},
{
"measure": "back to school readiness"
}
],
"secondaryOutcomes": [
{
"measure": "process evaluation"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Gazi University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-11-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-06"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-07-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Esketamine"
},
{
"name": "normal saline"
}
]
},
"conditionsModule": {
"conditions": [
"Esketamine",
"Consciousness Disorders"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to learn about the effect of intraoperative infusion of subanesthetic dose of esketamine on conscious status in patients with prolonged disorders of consciousness under sevoflurane anesthesia.\n\nParticipants will be patients with prolonged disorders of consciousness undergoing surgery with general anesthesia at Beijing Tiantan Hospital. 0.3mg/kg esketamine or saline will be infused will be infused intravenously at a constant speed within 30 min after tracheal intubation/pneumatectomy fixation. Coma recovery scale-revised, Glasgow coma scale, Full Outline of UnResponsiveness scores, SedLine multi-channel electroencephalogram and perioperative adverse events after surgery will be investigated."
},
"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": 116,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
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"maximumAge": "65 Years",
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],
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},
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},
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},
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},
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"measure": "Resting-state functional connectivity"
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{
"measure": "Cue-induced craving"
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{
"measure": "Tiffany Brief Questionnaire of Smoking Urges (QSU)"
},
{
"measure": "Self-reported craving"
}
],
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"measure": "Wisconsin Smoking Withdrawal Scale (WSWS)"
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"measure": "Fagerstrom Test for Nicotine Dependence (FTND)"
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},
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}
} |
null | false | {
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],
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"facility": "Università Vita-Salute San Raffaele",
"geoPoint": {
"lat": 45.46427,
"lon": 9.18951
},
"state": null,
"status": null,
"zip": "20132"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of the study is to investigate the effect of subtalar extra-articular calcaneo-stop screw on the proprioceptive and nociceptive pathways of the ankle before and after implantation. The hypothesis of the study is that an increased number of receptors related to proprioception will be detected in the sinus tarsi."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
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"timePerspective": "CROSS_SECTIONAL"
},
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"count": 40,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "10 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Subtalar Extra-articular Screw Arthroereisis",
"nctId": "NCT06389253",
"orgStudyIdInfo": {
"id": "HTSW1",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Primary Endpoint (%)"
}
],
"secondaryOutcomes": [
{
"measure": "Secondary Endpoint"
}
]
},
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"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Università Vita-Salute San Raffaele"
}
},
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"completionDateStruct": {
"date": "2025-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
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"primaryCompletionDateStruct": {
"date": "2025-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "6 weeks post-operatively early weight bearing"
},
{
"name": "10 weeks post-operatively weight bearing (standard of care)"
}
]
},
"conditionsModule": {
"conditions": [
"Early Mobilization"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Salt Lake City",
"contacts": null,
"country": "United States",
"facility": "University of Utah Orthopedics",
"geoPoint": {
"lat": 40.76078,
"lon": -111.89105
},
"state": "Utah",
"status": null,
"zip": "84108"
}
]
},
"descriptionModule": {
"briefSummary": "The investigators aim of the study is to assess the effects of early mobilization after surgically treated unicondylar tibia plateau fractures (6 weeks without weight bearing) on gait, patient satisfaction, return to work/sports and complication rate. The data will be compared to a 10-12 week non-weight bearing group (standard of care).\n\nIt is assumed that earlier mobilization does not lead to an increase in the complications - in particular osteosynthesis failure and infections -, but leads to improved patient satisfaction, reduced return to work/sports times, and has a positive impact on the overall outcome"
},
"designModule": {
"designInfo": {
"allocation": null,
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"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 60,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "65 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Early Weight Bearing in Unicondylar Tibial Plateau Fractures",
"nctId": "NCT06389240",
"orgStudyIdInfo": {
"id": "160848",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Average peak load (Newtons (N))"
},
{
"measure": "Average peak load (Newtons (N))"
},
{
"measure": "Average peak load (Newtons (N))"
},
{
"measure": "Average peak load (Newtons (N))"
},
{
"measure": "Average peak load (Newtons (N))"
},
{
"measure": "Average peak load (Newtons (N))"
},
{
"measure": "Average peak load (Newtons (N))"
}
],
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},
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"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Utah"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12"
},
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"date": "2024-04-29"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
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"date": "2025-12"
},
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"startDateStruct": {
"date": "2022-12-21"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "dynamic ecological approach (DEA)"
},
{
"name": "traditional training group"
}
]
},
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"conditions": [
"Verify the Effects of a Soccer Training Program Based on the Dynamic-ecological Approach on U13 Sub-elité Players' Physical Efficiency"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Turin",
"contacts": null,
"country": "Italy",
"facility": "Cit Turin LDE",
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"lat": 45.07049,
"lon": 7.68682
},
"state": null,
"status": null,
"zip": "10100"
}
]
},
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"briefSummary": "Therefore, this study aims to verify the effects of a soccer training program based on the dynamic-ecological approach on U13 sub-elité players' physical efficiency by analysing explosive strength, speed, resistance to speed and muscle flexibility. This study hypothe-sises that the dynamic-ecological approach can consistently help players develop adequate physical efficiency and motor coordination."
},
"designModule": {
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"allocation": "RANDOMIZED",
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"whoMasked": null
},
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},
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"count": 35,
"type": "ACTUAL"
},
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"NA"
],
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},
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"maximumAge": "13 Years",
"minimumAge": "12 Years",
"sex": "MALE",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Developing the Physical Performance in Youth Soccer: Short-term Effect of Dynamic-Ecological Versus Traditional Training Approach for Sub-élite U13 Players: An Ecological Exploratory Cluster Randomised Trial",
"nctId": "NCT06389227",
"orgStudyIdInfo": {
"id": "0433611",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
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{
"measure": "Number of participants evaluated on physical efficiency"
}
],
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},
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"collaborators": null,
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"class": "OTHER",
"name": "University of Turin, Italy"
}
},
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"completionDateStruct": {
"date": "2024-02-15"
},
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"date": "2024-04-29"
},
"overallStatus": "COMPLETED",
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"date": "2023-10-30"
},
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"startDateStruct": {
"date": "2023-10-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Reproxalap Ophthalmic Solution (0.25%)"
},
{
"name": "Vehicle Ophthalmic Solution"
}
]
},
"conditionsModule": {
"conditions": [
"Dry Eye Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Mississauga",
"contacts": [
{
"email": "pcouroux@cliantha.com",
"name": "Patricia Couroux, MD",
"phone": "(888) 989-1808",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Canada",
"facility": "Cliantha Research",
"geoPoint": {
"lat": 43.5789,
"lon": -79.6583
},
"state": "Ontario",
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "A Randomized, Double-Masked, Vehicle-Controlled Parallel Group Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease"
},
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"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
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},
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"type": "ESTIMATED"
},
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"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "70 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Phase 3 Clinical Trial to Assess the Efficacy and Safety of Subjects With Dry Eye Disease",
"nctId": "NCT06389214",
"orgStudyIdInfo": {
"id": "ADX-102-DED-030",
"link": null,
"type": null
},
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},
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{
"measure": "Ocular discomfort symptom score over 100 minutes in the dry eye chamber at Visit 2 and Visit 4"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Aldeyra Therapeutics, Inc."
}
},
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"completionDateStruct": {
"date": "2024-12-31"
},
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"date": "2024-04-29"
},
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"date": "2024-12-31"
},
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"startDateStruct": {
"date": "2024-04-09"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "HCQ"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Nasopharyngeal Carcinoma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Nantong",
"contacts": null,
"country": "China",
"facility": "Bo You",
"geoPoint": {
"lat": 32.03028,
"lon": 120.87472
},
"state": "Jiangsu",
"status": null,
"zip": "226000"
}
]
},
"descriptionModule": {
"briefSummary": "Dormant cancer cells that survive anti-cancer therapy can lead to cancer recurrence and disseminated metastases that prove fatal in most cases. Recently, specific dormant polyploid giant cancer cells (PGCC) have drawn our attention because of their association with the clinical risk of nasopharyngeal carcinoma (NPC) recurrence, as demonstrated by previous clinical data. In study, we report the biological properties of PGCC, and reveal that autophagy is a critical mechanism of PGCC induction. Moreover, pharmacological inhibition of autophagy greatly impaired PGCC formation, significantly suppressing metastasis and improving survival in a mouse model. Mechanistically, chemotherapeutic drugs partly damaged mitochondria, and activated autophagy to promote PGCC formation. High numbers of PGCCs correlated with shorter recurrence time and worse survival outcomes in NPC patients. Collectively, these findings suggest a therapeutic approach of targeting dormant PGCCs in cancer.\n\nPretreatment with an autophagy inhibitor (HCQ) before chemotherapy and radiotherapy could prevent formation of therapy-induced dormant polyploid giant cancer cells, thereby reducing recurrence and metastasis of nasopharyngeal carcinoma."
},
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]
},
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},
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},
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"NA"
],
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},
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"maximumAge": "70 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Pretreatment With HCQ Before Radiotherapy and Chemotherapy in Advanced NPC Patients",
"nctId": "NCT06389201",
"orgStudyIdInfo": {
"id": "2024HCQ",
"link": null,
"type": null
},
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},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Recurrence and metastasis"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Affiliated Hospital of Nantong University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2024-12-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "RHB Group"
}
]
},
"conditionsModule": {
"conditions": [
"Whiplash"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Terrassa",
"contacts": [
{
"email": "joanparera@osteopatiaterrassa.com",
"name": "Joan Parera-Turull, PhD",
"phone": "937310007",
"phoneExt": "0007",
"role": "CONTACT"
}
],
"country": "Spain",
"facility": "Consorci Sanitari de Terrassa.",
"geoPoint": {
"lat": 41.56667,
"lon": 2.01667
},
"state": "Barcelona",
"status": null,
"zip": "08227"
}
]
},
"descriptionModule": {
"briefSummary": "To determine the mid- and long-term efficiency (15, 30 and 120 days after starting sessions) of the SAT technique in patients with grade II acute WL, comparing it with a conventional rehabilitation program."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
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"interventionModelDescription": null,
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"maskingDescription": null,
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"OUTCOMES_ASSESSOR"
]
},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
},
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"count": 100,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "60 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effectiveness of Cervical Osteopathic Manipulation in Patients With Whiplash",
"nctId": "NCT06389188",
"orgStudyIdInfo": {
"id": "JVT003",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Subjective pain intensity"
},
{
"measure": "Neck specific disability"
}
],
"secondaryOutcomes": [
{
"measure": "Cervical range of motion (CROM)"
},
{
"measure": "Cervical lordosis Cobb angle"
},
{
"measure": "Hospital anxiety and depression scale"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "Consorci Sanitari de Terrassa"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Universidad Miguel Hernandez de Elche"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
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"date": "2024-09-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Transcutaneous non-invasive vagus nerve stimulation (tVNS)"
},
{
"name": "Sham stimulation"
}
]
},
"conditionsModule": {
"conditions": [
"Depressive Disorder, Major"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The overarching goal of the project is to determine whether differences in stomach-brain coupling contribute to key symptoms of major depressive disorder (MDD) and whether transcutaneous non-invasive vagus nerve stimulation (tVNS) may serve as a non-invasive intervention to improve aberrant interoceptive signaling in participants suffering from MDD."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "55 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Non-invasive Vagus Nerve Stimulation as a Tool to Modulate Stomach-Brain Coupling in Depression",
"nctId": "NCT06389175",
"orgStudyIdInfo": {
"id": "BON001",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "Deutsche Forschungsgemeinschaft (DFG)",
"id": "KR 4555/10-1",
"link": null,
"type": "OTHER_GRANT"
}
]
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Stimulation-induced mid-term changes in discounting-related decision-making"
},
{
"measure": "Stimulation-induced mid-term changes in reward learning"
},
{
"measure": "Stimulation-induced mid-term changes in loneliness"
}
],
"primaryOutcomes": [
{
"measure": "Stimulation-induced acute changes in stomach-brain coupling"
},
{
"measure": "Stimulation-induced acute changes in gastric motility"
},
{
"measure": "Stimulation-induced mid-term changes in gastric motility"
},
{
"measure": "Stimulation-induced mid-term changes in self-reported interoception"
},
{
"measure": "Stimulation-induced mid-term changes in somatic symptoms"
},
{
"measure": "Stimulation-induced mid-term changes in depressive symptoms"
},
{
"measure": "Stimulation-induced acute neural changes in food cue reactivity"
},
{
"measure": "Stimulation-induced acute behavioral changes in invigoration"
},
{
"measure": "Stimulation-induced acute neural changes during foraging"
},
{
"measure": "Stimulation-induced acute behavioral changes in foraging decisions"
}
],
"secondaryOutcomes": [
{
"measure": "Stimulation-induced mid-term changes in positive and negative affect"
},
{
"measure": "Stimulation-induced mid-term changes in self-reported interoception"
},
{
"measure": "Stimulation-induced mid-term changes in motivation"
},
{
"measure": "Stimulation-induced mid-term changes in physical activity"
},
{
"measure": "Stimulation-induced mid-term changes in heart rate"
},
{
"measure": "Stimulation-induced acute changes in blood parameters"
},
{
"measure": "Stimulation-induced mid-term changes in blood parameters"
},
{
"measure": "Stimulation-induced mid-term changes in composition of microbiome"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "University Hospital Tuebingen"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of Bonn"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-12"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "transcranial direct current stimulation"
}
]
},
"conditionsModule": {
"conditions": [
"Fatigue"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Las Vegas",
"contacts": null,
"country": "United States",
"facility": "University of Nevada Las Vegas",
"geoPoint": {
"lat": 36.17497,
"lon": -115.13722
},
"state": "Nevada",
"status": null,
"zip": "89154"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial is to learn if transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC) can impact muscle fatigue. The main questions it aims to answer are:\n\n1. Does tDCS of the left DLPFC increase the time that a fatiguing contraction can be maintained?\n2. Does tDCS of the left DLPFC decrease the rate of increase of muscle activity, force error, and standard deviation of force during a fatiguing contraction.\n\nResearchers will compare tDCS of the left DLPFC to a SHAM stimulation (a type of stimulation that feels like real tDCS but does not elicit physiological effects) to see if tDCS of the left DLPFC works to reduce the progression of muscle fatigue.\n\nParticipants will:\n\nPerforming two experimental sessions held 3-10 days apart (usually 7 days) Perform a 9 hole pegboard test, maximum voluntary contractions, and a fatiguing contraction."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": "Double-blind",
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 20,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Dorsolateral Prefrontal Cortex Transcranial Direct Current and Muscle Fatigue Stimulation on Muscle Fatigue",
"nctId": "NCT06389162",
"orgStudyIdInfo": {
"id": "UNLV-2024-115",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Time to Task Failure"
},
{
"measure": "Fatigue Index"
}
],
"secondaryOutcomes": [
{
"measure": "Average EMG activity"
},
{
"measure": "Force error"
},
{
"measure": "Standard deviation of force"
},
{
"measure": "9 Hole Pegboard Test"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Nevada, Las Vegas"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2024-08-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "LEAP therapy"
},
{
"name": "no LEAP therapy"
}
]
},
"conditionsModule": {
"conditions": [
"Peripheral Arterial Disease",
"Peripheral Vascular Disease",
"Peripheral Artery Occlusive Disease",
"Peripheral Artery Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Omaha",
"contacts": null,
"country": "United States",
"facility": "University of Nebraska - Omaha",
"geoPoint": {
"lat": 41.25626,
"lon": -95.94043
},
"state": "Nebraska",
"status": null,
"zip": "68182"
}
]
},
"descriptionModule": {
"briefSummary": "1) The purpose of this study is to test the effects of leg exercise assistive paddling (LEAP) therapy during prolonged sitting (PS) on vascular and functional performance in those with peripheral artery disease (PAD) and age-matched controls. LEAP therapy is a novel application of passive limb movement to enhance blood flow through the legs without muscular contractions. Specifically, LEAP therapy is the rotational passive movement of the lower leg about the knee from 90 to 180 degrees of rotation at a cadence of 1Hz. Previous literature has indicated that this movement pattern can produce robust increases in blood flow in the passively moved limb in healthy individuals, and passive limb movement may protect vascular function during PS. However, the impact of LEAP therapy to improve blood flow in the legs of those with PAD during PS is unknown. 2) To be eligible for this study, those with PAD must be between the ages of 50-85 years, women must be postmenopausal, must have a history of exercise-limiting claudication, have an ankle brachial index (ABI) 0.9. 3) Subjects will participate in a randomized cross-over design study with 2 visits (LEAP therapy and no LEAP therapy). For the first visit, subjects will be randomly allocated to receive LEAP therapy during 2.5 hours of PS or not. For the second visit, subjects will sit for 2.5 hours and will receive the condition that they did not previously receive. Before and after PS, the following measurements will be made: flow-mediated dilation of the popliteal and brachial arteries, arterial stiffness with tonometry techniques, microvascular vasodilatory capacity and skeletal muscle metabolic rate with near-infrared spectroscopy, autonomic nervous system function, and there will be blood drawn from the antecubital vein. After PS, subjects will participate in a graded exercise test to assess functional walking capacity. Finally, during PS, near-infrared spectroscopy on the calf muscles and electrocardiogram will be collected continuously to monitor muscle oxygen availability and autonomic activity, respectively. 4) There will be no follow-up."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "There will be a peripheral artery disease (PAD) group and an age-matched healthy control group. Within each of these groups will be a 1:1 randomized, crossover study design.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 24,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "55 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Leg Exercise Assistive Paddling (LEAP) Therapy for Peripheral Artery Disease",
"nctId": "NCT06389149",
"orgStudyIdInfo": {
"id": "0165-24-FB",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Macrovascular Endothelial Function"
},
{
"measure": "Microvascular Vasodilatory Capacity"
},
{
"measure": "Femoral and Popliteal Artery Blood Flow"
},
{
"measure": "Walking capacity"
},
{
"measure": "Autonomic Function"
},
{
"measure": "Autonomic Activity"
},
{
"measure": "Arterial Stiffness"
},
{
"measure": "Muscle Oxygenation"
},
{
"measure": "Peripheral blood mononuclear cell mitochondrial function"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "University of Nebraska"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-08"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-08"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Upadacitinib Dose A"
},
{
"name": "Dupilumab Dose A"
},
{
"name": "Upadacitinib Dose B"
}
]
},
"conditionsModule": {
"conditions": [
"Atopic Dermatitis"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study aims to provide data on the efficacy and safety of upadacitinib at different doses in adult participants with moderate to severe AD.\n\nUpadacitinib is an approved drug for the treatment of moderate to severe atopic dermatitis (AD). This study is conducted in 2 periods. During Period 1, participants are randomly assigned into 1 of 2 groups called treatment arms to receive upadacitinib Dose A or dupilumab Dose A. Based on the participants response to upadacitinib Dose A, they may have their dose increased to upadacitinib Dose B after 2 weeks. In Period 2, participants that completed Period 1 will either remain on their assigned dose or be reassigned to a different dose based on their Eczema Area and Severity Index (EASI) response. Approximately 300 adult participants ages 18 to 64 with moderate to severe AD who are current users of dupilumab and had a history of inadequate response to dupilumab will be enrolled at up to 94 sites worldwide.\n\nThe study is comprised of a 35-day Screening Period, an 8-week Open-Label Period 1 and a 24-week Open-Label Period 2 for participants that completed Period 1. Participants will receive upadacitinib oral tablets once daily or dupilumab subcutaneous (SC) injection every other week for 32 weeks and followed for 30 days.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SEQUENTIAL",
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"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 300,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "63 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": "Switch-Up",
"briefTitle": "A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab",
"nctId": "NCT06389136",
"orgStudyIdInfo": {
"id": "M24-601",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Participants who achieve a composite endpoint of both a 90% reduction in Eczema Area and Severity Index from Baseline (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1)"
}
],
"secondaryOutcomes": [
{
"measure": "Percentage of participants who achieve EASI 90"
},
{
"measure": "Percentage of participants achieving worst pruritus numerical rating scale (WP-NRS) 0/1"
},
{
"measure": "Percentage of participants achieving worst pruritus numerical rating scale (WP-NRS) 0/1"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "AbbVie"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-03-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-08-22"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-24"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "[68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G."
}
]
},
"conditionsModule": {
"conditions": [
"Metastatic Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Sacramento",
"contacts": [
{
"email": "jlsutcliffe@ucdavis.edu",
"name": "Julie L Sutcliffe, PhD",
"phone": "916-734-5536",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "United States",
"facility": "The University of California Davis Comprehensive Cancer Center",
"geoPoint": {
"lat": 38.58157,
"lon": -121.4944
},
"state": "California",
"status": "RECRUITING",
"zip": "95817"
}
]
},
"descriptionModule": {
"briefSummary": "This is a Phase I study to evaluate the safety and efficacy of the \\[68Ga\\]Ga DOTA-5G and \\[177Lu\\]Lu DOTA-ABM-5G theranostics pair in patients with metastatic cancer."
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Single treatment",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 40,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Molecularly Targeted Theranostic Approach for the Detection and Treatment of Metastatic Carcinomas",
"nctId": "NCT06389123",
"orgStudyIdInfo": {
"id": "1788760",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "[68Ga]Ga DOTA-5G PET/CT imaging"
}
],
"secondaryOutcomes": [
{
"measure": "[177Lu]Lu DOTA-ABM-5G treatment"
},
{
"measure": "[177Lu]Lu DOTA-ABM-5G treatment efficacy"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institutes of Health (NIH)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "University of California, Davis"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-03-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Alleance®"
},
{
"name": "Placebo"
}
]
},
"conditionsModule": {
"conditions": [
"Myopia",
"Myopia, Progressive"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "Phase III clinical study to evaluate the efficacy of Alleance® (atropine sulfate 0.01%) ophthalmic solution through the incidence of unexpected adverse events, changes in Best Corrected Visual Acuity (BCVA), changes in intraocular pressure, changes in the amplitude of accommodation, compared to placebo, as a treatment to delay the progression of myopia and axial ocular elongation in children."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "This is a study to demonstrate superiority, double-blind, randomized, controlled, comparative, and multicenter phase III clinical trial.",
"maskingInfo": {
"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
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"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 123,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "12 Years",
"minimumAge": "3 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Study to Evaluate the Efficacy of Alleance® (Atropine Sulfate 0.01%) as a Treatment to Delay Myopia and Axial Ocular Elongation in Children.",
"nctId": "NCT06389110",
"orgStudyIdInfo": {
"id": "SOPH201-1023/III",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Changes in the spherical equivalent"
},
{
"measure": "Changes in axial eye length"
}
],
"secondaryOutcomes": [
{
"measure": "Incidence of unexpected adverse events related to the interventions"
},
{
"measure": "Incidence of photophobia between interventions"
},
{
"measure": "Changes in pupillary diameter between the interventions"
},
{
"measure": "Changes in Best Corrected Visual Acuity (BCVA)"
},
{
"measure": "Changes in near best-corrected visual acuity"
},
{
"measure": "Changes in the amplitude of accommodation (AA) between interventions"
},
{
"measure": "Changes in intraocular pressure (IOP)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Laboratorios Sophia S.A de C.V."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-06-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-12-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Radium-223"
},
{
"name": "177Lu-DOTATATE"
},
{
"name": "177Lu-PSMA-617"
}
]
},
"conditionsModule": {
"conditions": [
"Prostate Cancer",
"Advanced Cancer"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The investigators will study SPECT imaging of radiopharmaceutical therapies given as standard of care or as part of other compatible research protocols. The goal is to validate the quantitative SPECT image reconstruction methods developed in this proposal, and to investigate the relation between dosimetry calculated from SPECT images and the outcomes. Patients will be recruited for SPECT/CT imaging during treatment. This is an observational study no additional new drugs or activities will be administrated. The investigators will perform SPECT imaging on a total of 80 patients (\\~20 each from year 2 to year 5). Each participant will be imaged 3 times after the first and last cycles of planned radiopharmaceutical therapy."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 80,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "100 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "(SEEtoTREAT)",
"briefTitle": "SPECT Imaging for Pharmacokinetics and dosimEtry Towards TREATment Optimization",
"nctId": "NCT06389097",
"orgStudyIdInfo": {
"id": "J23152",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "JHM IRB",
"id": "IRB00411454",
"link": null,
"type": "OTHER"
},
{
"domain": null,
"id": "P01CA272222",
"link": "https://reporter.nih.gov/quickSearch/P01CA272222",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Mean absorbed dose to normal organs compared using different quantitative methods"
}
],
"secondaryOutcomes": [
{
"measure": "Variability of intra-patient and inter-patient mean absorbed dose to normal organs compared using SPECT images"
},
{
"measure": "Mean absorbed dose to normal organs correlated with toxicity"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Cancer Institute (NCI)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2029-05"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-05"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Parents Together parenting course"
}
]
},
"conditionsModule": {
"conditions": [
"Child Eating Behaviours",
"Child Nutrition",
"Early Child Development",
"Parenting"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Toronto",
"contacts": null,
"country": "Canada",
"facility": "The Hospital for Sick Children",
"geoPoint": {
"lat": 43.70011,
"lon": -79.4163
},
"state": "Ontario",
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The Parents Together trial aims to determine if the Parents Together program consisting of virtual parent group sessions and coaching calls, will result in better health outcomes for children. The program which is facilitated by a Public Health Nurse seeks to encourage healthy lifestyle behaviours, help build strong family relationships, and promote child development and mental health."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Randomized control trial",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 128,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "5 Years",
"minimumAge": "2 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Parents Together: Supporting Parents to Promote Healthy Behaviours in Children",
"nctId": "NCT06389084",
"orgStudyIdInfo": {
"id": "179939",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Child eating behaviours"
}
],
"secondaryOutcomes": [
{
"measure": "Dietary intake and food environment"
},
{
"measure": "Nutritional risk"
},
{
"measure": "Physical Activity, Sedentary Time, Sleep Duration"
},
{
"measure": "Physical activity"
},
{
"measure": "Social and emotional development"
},
{
"measure": "Child development"
},
{
"measure": "Family psychosocial health"
},
{
"measure": "Parenting"
},
{
"measure": "Parenting sense of competence"
},
{
"measure": "sociodemographic, maternal and child characteristics"
},
{
"measure": "zBMI"
},
{
"measure": "Waist circumference"
},
{
"measure": "Blood pressure"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "The Hospital for Sick Children"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-03-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Fractional 2940 nm Laser"
}
]
},
"conditionsModule": {
"conditions": [
"Lichen Sclerosus Lesion"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Val-d'Or",
"contacts": [
{
"email": null,
"name": "Josee Parent, MD",
"phone": "819-825-3800",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Canada",
"facility": "Clinique Medicale Uro-Gyneco de l'Abitibi",
"geoPoint": {
"lat": 48.0974,
"lon": -77.79737
},
"state": "Quebec",
"status": "RECRUITING",
"zip": "J9P1W1"
}
]
},
"descriptionModule": {
"briefSummary": "Fractional ablative laser treatment for Lichen Sclerosus lesion"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Laser Treatment for Lichen Sclerosus",
"nctId": "NCT06389071",
"orgStudyIdInfo": {
"id": "PLS001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Histological clearance"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Sciton"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-12-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-12-20"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-03-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Recommendation for the diagnoses and treatment of Severe Athma"
}
]
},
"conditionsModule": {
"conditions": [
"Severe Asthma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "San Diego",
"contacts": null,
"country": "United States",
"facility": "San Diego State University",
"geoPoint": {
"lat": 32.71533,
"lon": -117.15726
},
"state": "California",
"status": null,
"zip": "92182-1309"
}
]
},
"descriptionModule": {
"briefSummary": "The study aims to to use new technologies (ML, AI, NLP), to autonomously identify moderate to severe asthma populations within an EHR system, describe differences in treatment patterns across different populations, and determine trial eligibility.\n\nPrimary Objectives Please ensure you detail primary objectives Aim 1. Determine and validate a diagnosis of severe asthma (SA) using predictive features obtained from the Scripps Health EHR.\n\n* Aim 1a: Use ML applied to structured EHR data to predict SA. Use the opinion of 2 specialty-trained physicians and ATS guidelines to determine model accuracy.\n* Aim 1b: Use NLP applied to unstructured text to predict SA. Determine model accuracy as above in Aim 1a.\n* Aim 1c: Use a combination of ML applied to structured data to predict SA. Determine model accuracy as above in Aim 1a."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 31795,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "85 Years",
"minimumAge": "6 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Using NLP and Neural Networks to Autonomously Identify Severe Asthma and Determine Study Eligibility in a Large Healthcare System",
"nctId": "NCT06389058",
"orgStudyIdInfo": {
"id": "G00014538",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Identification of Patients with Severe Asthma"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "GlaxoSmithKline"
},
{
"name": "Scripps Health"
},
{
"name": "Modena Allergy + Asthma, La Jolla, CA"
},
{
"name": "University of California, San Diego"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "San Diego State University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-11"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "ACTIVE_NOT_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-07-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Procedural Sedation"
}
]
},
"conditionsModule": {
"conditions": [
"Sedation Complication",
"Endoscopic Ultrasonography",
"Procedural Sedation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Samsun",
"contacts": [
{
"email": "dr.canergenc@gmail.com",
"name": "Caner Genc, M.D.",
"phone": "5444846865",
"phoneExt": "+90",
"role": "CONTACT"
}
],
"country": "Turkey",
"facility": "Samsun University Faculty of Medicine",
"geoPoint": {
"lat": 41.27976,
"lon": 36.3361
},
"state": null,
"status": "RECRUITING",
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Endoscopic ultrasonography (EUS) is an endoscopic procedure performed to investigate conditions affecting the stomach, liver, and bile ducts, as well as for therapeutic interventions. The complexity of EUS can vary significantly, with increased complexity affecting procedure duration, technical success, and the occurrence of adverse events. For the comfort of patients and the success of the procedure, these interventions are typically performed under anesthesia with procedural sedation. To enhance the success rate of the procedure, reduce the risk of side effects, and maximize patient comfort, EUS is generally performed under sedation according to the recommendations of the American Society of Anesthesiologists (ASA). During sedation, the aim is for the patient to be more relaxed and comfortable while maintaining spontaneous respiratory function. Preserving spontaneous respiratory parameters is crucial for procedural safety."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 70,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Profopol and Remifentanil Sedation in Endoscopic Ultrasonography",
"nctId": "NCT06389045",
"orgStudyIdInfo": {
"id": "EUS",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Anesthesia related major complications"
}
],
"secondaryOutcomes": [
{
"measure": "The prevalence of symptoms of inadequate sedation"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Samsun University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-07-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-24"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-24"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Peer Mentor Support and Caregiver Education"
},
{
"name": "Caregiver Education"
}
]
},
"conditionsModule": {
"conditions": [
"Lewy Body Dementia",
"Parkinson Disease Dementia",
"Dementia With Lewy Bodies",
"Lewy Body Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chicago",
"contacts": [
{
"email": "persevere@rush.edu",
"name": "Persevere Study Team",
"phone": "312-563-3300",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Dr. Jori Fleisher, MD MSCE",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Rush University Medical Center",
"geoPoint": {
"lat": 41.85003,
"lon": -87.65005
},
"state": "Illinois",
"status": null,
"zip": "60612"
}
]
},
"descriptionModule": {
"briefSummary": "Lewy Body Dementia (LBD) is the second most common form of degenerative dementia, affecting at least 2.4 million US adults, and the overwhelming majority of persons living with LBD (PLBD) are cared for by family caregivers. LBD caregiver strain: 1) exceeds that of non-LBD dementia caregivers; 2) worsens caregiver physical and mental health; and 3) increases the risk of PLBD hospitalization and institutionalization. LBD progression is complicated by combined motor, cognitive, and neuropsychiatric decline, and is punctuated by falls, infections, dehydration, and neuropsychiatric symptoms leading to acute healthcare utilization. Although family caregivers are uniquely positioned to identify and manage these challenges, which may avert emergency department visits and reduce morbidity, many caregivers lack the knowledge, skills, confidence, resources, and support to do so.\n\nWe aim to 1) quantify the impact of PERSEVERE on caregiver knowledge, attitudes, mastery, and strain; 2) identify the intervention and mentor factors determining implementation fidelity; and 3) test the effects of PERSEVERE on PLBD quality of life and healthcare utilization. This will be accomplished in an NIH Behavioral Model Stage II national, randomized, attention-controlled, 12-week trial of PERSEVERE in 502 LBD caregivers in partnership with the Lewy Body Dementia Association, Parkinson's Foundation, and LBD Caregiver Advisors. We will match intervention arm caregivers with a trained peer mentor who will coach them through a modular, theory-based curriculum on LBD knowledge and social support. Attention-control participants will receive weekly, curated links to educational materials. We will identify immediate and delayed intervention effects, including mediators of strain at 12 weeks, and caregiver strain and PLBD outcomes at nine months. Implementation fidelity and PLBD healthcare utilization will be tracked biweekly. Qualitative methods will explore the intervention- and mentor-specific factors predicting fidelity, mentee outcomes, and retention. Remote recruitment, mentoring, and community engagement strategies will maximize accessibility and inclusion of underrepresented caregiver groups. Results will illuminate the extent to which leveraging prior LBD caregivers as expert interventionists can improve current caregiver outcomes, and in turn, PLBD outcomes. These results will inform future adaptation and dissemination of this model for other conditions."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
},
"enrollmentInfo": {
"count": 622,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "PERSEVERE in Lewy Body Dementia: A Randomized, Controlled Trial of Peer Mentor Support and Caregiver Education",
"nctId": "NCT06389032",
"orgStudyIdInfo": {
"id": "21041503",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": null,
"id": "1R01AG079128-01A1",
"link": "https://reporter.nih.gov/quickSearch/1R01AG079128-01A1",
"type": "NIH"
}
]
},
"outcomesModule": {
"otherOutcomes": [
{
"measure": "Frequency and Duration of Mentoring Calls"
},
{
"measure": "Study adherence of Mentors and Mentees"
},
{
"measure": "Coverage of target topics; additional topics discussed"
}
],
"primaryOutcomes": [
{
"measure": "Multidimensional Caregiver Strain Index (MCSI)"
},
{
"measure": "Quality of Life in Alzheimer's Disease ( QoL-AD)"
},
{
"measure": "Dementia Attitudes Scale (DAS)"
},
{
"measure": "LBD Knowledge Test ( LBDK)"
},
{
"measure": "Baseline PLBD Fall Frequency and Healthcare Utilization Questionnaire"
}
],
"secondaryOutcomes": [
{
"measure": "Fortinsky Caregiver Self-Efficacy Score"
},
{
"measure": "Multidimensional Scale of Perceived Social Support (MSPSS)"
},
{
"measure": "Pearlin Mastery Scale"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "National Institute on Aging (NIA)"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Rush University Medical Center"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-06-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-10-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Deep learning system for prognostication prediction in bladder cancer"
}
]
},
"conditionsModule": {
"conditions": [
"Bladder Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Chongqing",
"contacts": [
{
"email": "2020120460@stu.cqmu.edu.cn",
"name": "QuanHao He, PHD",
"phone": "800-555-5555",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "2023140134@stu.cqmu.edu.cn",
"name": "Mingzhao Xiao, PHD",
"phone": "023-89012557",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Department of Urology, The First Affiliated Hospital of Chongqing Medical University",
"geoPoint": {
"lat": 29.56278,
"lon": 106.55278
},
"state": "Chongqing",
"status": "RECRUITING",
"zip": "400016"
}
]
},
"descriptionModule": {
"briefSummary": "Bladder cancer (BLCA), with its diverse histopathological features and varying patient outcomes, poses significant challenges in diagnosis and prognosis. Postoperative survival stratification based on radiomics feature and whole slide image feature may be useful for treatment decisions to improve prognosis. In this research, we aim to develop a deep learning-based prognostic-stratification system for automatic prediction of overall and cancer-specific survival in patients with BLCA."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "RETROSPECTIVE"
},
"enrollmentInfo": {
"count": 1000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Whole-slide Image and CT Radiomics Based Deep Learning System for Prognostication Prediction in Bladder Cancer",
"nctId": "NCT06389019",
"orgStudyIdInfo": {
"id": "BLCA_CMUFH",
"link": null,
"type": null
},
"secondaryIdInfos": [
{
"domain": "The First Affiliated Hospital of Chongqing Medical University",
"id": "K2024-187-01",
"link": null,
"type": "OTHER"
}
]
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Overall survival"
}
],
"secondaryOutcomes": [
{
"measure": "Recurrence free survival"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Mingzhao Xiao"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-01-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Disitamab Vedotin for Injection"
},
{
"name": "Toripalimab"
},
{
"name": "Epirubicin"
},
{
"name": "Cyclophosphamide"
}
]
},
"conditionsModule": {
"conditions": [
"HR-positive, HER2-low Breast Cancer"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": [
{
"email": null,
"name": "Jiong Wu, Ph.D",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Jiong Wu",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": "Fudan University Shanghai Cancer Center",
"status": null,
"zip": "200032"
}
]
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Toripalimab sequential chemotherapy as in patients with HR-positive, HER2-low breast cancer"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 79,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "To Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer",
"nctId": "NCT06389006",
"orgStudyIdInfo": {
"id": "RC48-C025",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Total pathological complete response (tpCR) rate"
}
],
"secondaryOutcomes": [
{
"measure": "Breast pathological complete response(bpCR)"
},
{
"measure": "Event free survival (EFS)"
},
{
"measure": "Disease-free survival (DFS)"
},
{
"measure": "Objective Response Rate (ORR)"
},
{
"measure": "Adverse events (AEs)"
},
{
"measure": "Change in cluster of differentiation 8 (CD8)"
},
{
"measure": "Health-related quality of life - EORTC-QLQ-C30"
},
{
"measure": "Residual cancer burden score"
},
{
"measure": "Change in tumor-infiltrating lymphocytes (TILs)"
},
{
"measure": "Change in programmed cell death protein L1 (PD-L1)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "RemeGen Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-12-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2025-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Bone Marrow Collection"
}
]
},
"conditionsModule": {
"conditions": [
"Hip Arthropathy",
"Avascular Necrosis of Bone",
"Subchondral Cysts"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Columbus",
"contacts": [
{
"email": "michael.keller@osumc.edu",
"name": "Michael Keller",
"phone": "614-293-2410",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "andrea.persons@osumc.edu",
"name": "Karen Persons",
"phone": null,
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "William K Vasileff, MD",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "United States",
"facility": "Jameson Crane Sports Medicine Institute",
"geoPoint": {
"lat": 39.96118,
"lon": -82.99879
},
"state": "Ohio",
"status": "RECRUITING",
"zip": "43202"
}
]
},
"descriptionModule": {
"briefSummary": "Six patients with diagnosed bone loss of the hip who have consented to minimally invasive repair will be approached to participate in the study. Participants will have the liquid portion of bone marrow collected using the Zimmer Biomet Biocue system, which is the standard system used by physicians at The Ohio State University, and the novel Marrow Cellutions system™. Bone marrow liquid will be collected from the surgical hip using the Zimmer Biomet Biocue system, and the Marrow Cellutions system™ will be used to collect bone marrow liquid from the non-surgical hip. Following collection, the bone marrow liquid will be processed using the respective systems to concentrate the cells and molecules found in the bone marrow liquid. As part of the standard of care for this arthroscopic procedure, concentrated bone marrow liquid processed using the Zimmer Biomet Biocue system will be delivered to the surgical site as an adjunct to promote healing. Concentrated bone marrow liquid prepared with the Zimmer Biomet Biocue system is given as part of the standard of care for patients undergoing minimally invasive treatment for bone loss of the hip; therefore, the target population for this study are individuals between the ages of 18-50 years with confirmed bone loss of the hip who have consented to minimally invasive repair. In addition to the concentrated bone marrow liquid prepared using the Zimmer Biomet Biocue system, patients will also have bone marrow liquid collected from the non-surgical hip using the Marrow Cellutions™ system. Only concentrated bone marrow liquid produced with the Zimmer Biomet Biocue system will be given to the patient. All concentrated bone marrow liquid produced with the Marrow Cellutions™ system will be sent to the laboratory for analysis. Additionally, white blood cells will be concentrated into an autologous protein solution (APS) using the Zimmer Biomet Plasmax system from blood collected using a routine blood draw. All protein solution produced will be sent to the laboratory for analysis. No protein solution will be given to the patient. As the bone marrow liquid collection using the Marrow Cellutions™ system and the blood draw to produce protein solution using the Zimmer Biomet Plasmax system are being performed for research,"
},
"designModule": {
"designInfo": {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 6,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "50 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Marrow Cellution™ vs. Traditional BMA Harvest Project",
"nctId": "NCT06388993",
"orgStudyIdInfo": {
"id": "2023H0351",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Assess overall number of stem cells collected from each aspiration method"
}
],
"secondaryOutcomes": [
{
"measure": "Assess overall number of cytokines collected from each aspiration method"
},
{
"measure": "Assess overall number of growth factors collected from each aspiration method"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
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}
},
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"date": "2025-03-31"
},
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"date": "2024-04-29"
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"date": "2024-12-31"
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"date": "2024-03-25"
},
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"date": "2024-04-29"
}
}
} |
null | false | {
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"name": "Validated questionnaires and ad hoc questions"
}
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},
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"Knowledge, Attitudes, Practice",
"Wound"
]
},
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"locations": [
{
"city": "Sabadell",
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},
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}
]
},
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},
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"OLDER_ADULT"
]
},
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{
"measure": "\"What not to do in chronic wounds?\""
},
{
"measure": "ReAc-PUKT (Renobato-Acosta Pressure Ulcer Knowledge Test)"
}
],
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"measure": "Ad hoc open questions"
}
]
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}
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"date": "2024-06-01"
},
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},
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"date": "2023-06-01"
},
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"date": "2023-05-01"
},
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"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "PANcreatic cancer Exosome Early detectiON (PANXEON)"
}
]
},
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"conditions": [
"Pancreatic Cancer",
"Pancreatic Carcinoma",
"Pancreatic Adenocarcinoma",
"Pancreatic Ductal Adenocarcinoma",
"Pancreatic Neoplasms",
"Pancreatic Cancer Stage I",
"Pancreatic Cancer Stage",
"Pancreatic Cancer Resectable",
"Pancreatic Cancer Stage 0",
"Pancreatic Cancer Stage II",
"Pancreatic Cancer Stage III",
"Pancreatic Cancer, Adult",
"Pancreatic Cancer Non-resectable"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Phoenix",
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{
"email": "dvh@tgen.org",
"name": "Daniel Von Hoff",
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},
{
"email": null,
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},
{
"email": null,
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},
{
"email": null,
"name": "Derek Cridebring",
"phone": null,
"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
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},
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},
{
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{
"email": "erkut.borazanci@honorhealth.com",
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},
{
"email": null,
"name": "Erkut Borazanci",
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}
],
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},
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},
{
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{
"email": "AJGOEL@COH.ORG",
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},
{
"email": null,
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},
{
"email": null,
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},
{
"email": null,
"name": "Vincent Chung",
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},
{
"email": null,
"name": "Caiming Xu",
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},
{
"email": null,
"name": "Alessandro Mannucci",
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}
],
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},
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},
{
"city": "Newport Beach",
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{
"email": "michael.demeure@hoag.org",
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},
{
"email": null,
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}
],
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},
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},
{
"city": "Peoria",
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{
"email": "chandler.d.wilfong@osfhealthcare.org",
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},
{
"email": null,
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}
],
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},
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},
{
"city": "Jefferson",
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"email": "jbolton@ochsner.org",
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},
{
"email": null,
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}
],
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"lat": 29.96604,
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},
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},
{
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{
"email": null,
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},
{
"email": null,
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}
],
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},
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},
{
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{
"email": "Andrew.Page@piedmont.org",
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},
{
"email": null,
"name": "Andrew Page",
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},
{
"email": null,
"name": "Eyal Meiri",
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}
],
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},
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},
{
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{
"email": "devans@mcw.edu",
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},
{
"email": null,
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}
],
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},
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},
{
"city": "Nagoya",
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{
"email": "ykodera@med.nagoya-u.ac.jp",
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},
{
"email": null,
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},
{
"email": null,
"name": "Masamichi Hayashi",
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"phoneExt": null,
"role": "SUB_INVESTIGATOR"
}
],
"country": "Japan",
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"lat": 35.18147,
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},
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},
{
"city": "Seoul",
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{
"email": "drksc@amc.seoul.kr",
"name": "Song Cheol Kim",
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},
{
"email": null,
"name": "Song Cheol Kim",
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}
],
"country": "Korea, Republic of",
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"lat": 37.566,
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},
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}
]
},
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"briefSummary": "This study aims to prospective validate an exosome-based miRNA signature for noninvasive and early detection of pancreatic ductal adenocarcinoma."
},
"designModule": {
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},
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},
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},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PCDC",
"briefTitle": "Pancreatic Cancer Detection Consortium",
"nctId": "NCT06388967",
"orgStudyIdInfo": {
"id": "19288/PCDC",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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{
"measure": "Sensitivity"
}
],
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"measure": "Specificity"
},
{
"measure": "Accuracy"
}
]
},
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"class": "OTHER",
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}
},
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"date": "2025-11-21"
},
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"date": "2024-04-29"
},
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"date": "2025-11-21"
},
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"date": "2023-03-15"
},
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"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "True Transcutaneous auricular Vagus Nerve Stimulation (TaVNS)"
},
{
"name": "Sham Trancutaneous auricular Vagus Nerve Stimulation"
}
]
},
"conditionsModule": {
"conditions": [
"Stroke",
"Motor Disorders"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Giza",
"contacts": [
{
"email": "engybm.saleh@cu.edu.eg",
"name": "Engy BadrEldin S Moustafa, PhD",
"phone": "00201099445112",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": "dr.moshera11@yahoo.com",
"name": "Moshera H. Darwish, PhD",
"phone": "00201015163617",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "Egypt",
"facility": "Faculty of Physical Therapy, Cairo University",
"geoPoint": {
"lat": 30.00808,
"lon": 31.21093
},
"state": "Ad Doqi, Giza District, Giza Governorate",
"status": "RECRUITING",
"zip": "11432"
}
]
},
"descriptionModule": {
"briefSummary": "Forty-eight clinically verified Egyptian patients from both sexes with ischemic stroke that occurred at least 6 months to 2 years before inclusion will be randomly assigned into 2 groups, control group (GA) and the experimental group (GB). Patients will be randomly assigned into two equal groups: the control group (GA) and the experimental group (GB). Patients in the control group (GA) will be treated with sham Vagus nerve stimulation (taVNS) immediately before a selected physical therapy program, while in the experimental group (GB), patients will receive real transcutaneous auricular Vagus nerve stimulation (taVNS) followed by the same selected physical therapy program as (GA). Plasma level of Brain-Derived Neurotrophic Factors (BDNF) and Interleukin-6 (IL-6), Box and Blocks Test (BBT), and modified Ashworth scale (MAS) will be assessed at baseline and immediately post-treatment."
},
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"interventionModel": "PARALLEL",
"interventionModelDescription": "Single-blind, randomized controlled study.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Patients participated will be masked about the type of intervention, where (GA) patients will receive physical therapy program + sham transcutaneous auricular Vagus nerve stimulation, while patients in (GB) will receive true transcutaneous auricular Vagus nerve stimulation in addition to the same physical therapy program as (GA).",
"whoMasked": [
"PARTICIPANT"
]
},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
},
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"count": 50,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
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"maximumAge": "65 Years",
"minimumAge": "55 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Plasticity Biomarkers,Interleukin-6 and Motor Performance in Response to Vagus Nerve Stimulation After Stroke",
"nctId": "NCT06388954",
"orgStudyIdInfo": {
"id": "P.T.REC/012/005107",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Muscle tone of the upper limb"
},
{
"measure": "Gross hand dexterity"
},
{
"measure": "Level of Plasma brain-derived Derived factor (BDNF)"
},
{
"measure": "Level of Serum Interleukin IL-6"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Cairo University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-05-09"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-04-23"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-02-21"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Iptacopan"
},
{
"name": "Placebo"
},
{
"name": "Rituximab"
}
]
},
"conditionsModule": {
"conditions": [
"Anti-Neutrophil Cytoplasm Antibodies (ANCA) Associated Vasculitis"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The purpose of this study is to evaluate the efficacy and safety of iptacopan compared to standard of care (SOC) to induce and maintain remission in study participants with active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), when used in combination with rituximab (RTX) induction. The trial will also assess the impact of iptacopan on disease relapses, evolution of renal function and proteinuria, GC side effects, patients' immune status, and QoL."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
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"masking": "QUADRUPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"INVESTIGATOR",
"OUTCOMES_ASSESSOR"
]
},
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"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 78,
"type": "ESTIMATED"
},
"phases": [
"PHASE2"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Iptacopan in Patients With ANCA Associated Vasculitis",
"nctId": "NCT06388941",
"orgStudyIdInfo": {
"id": "CLNP023R12201",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Sustained remission through Week 48 defined as complete remission at Week 24 without major relapse up to Week 48."
}
],
"secondaryOutcomes": [
{
"measure": "B cell counts"
},
{
"measure": "Total IgG levels"
},
{
"measure": "Complete remission at week 24"
},
{
"measure": "Time to reach BVAS=0"
},
{
"measure": "Time to major relapse"
},
{
"measure": "Estimated glomerular filtration rate (eGFR) using the CKD-EPI formula, urinary protein excretion and hematuria over 48 weeks"
},
{
"measure": "Cumulative dose of glucocorticoid (GC)"
},
{
"measure": "Glucocorticoid toxicity index over 48 weeks"
},
{
"measure": "36-Item short form survey (SF-36)"
},
{
"measure": "Patient's Global Assessment (PtGA)"
},
{
"measure": "Physician's global assessment (PhGA)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Novartis Pharmaceuticals"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-09-22"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-08-27"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-08-28"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": null
},
"conditionsModule": {
"conditions": [
"Menstrual Cycle",
"Manual Dexterity"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Damietta",
"contacts": null,
"country": "Egypt",
"facility": "Horus University",
"geoPoint": {
"lat": 31.41648,
"lon": 31.81332
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "The aim of this observational study was to investigate the effect of the menstrual cycle on the manual dexterity of female dentists.\n\nThis study was conducted to answer the following question:\n\n- Is there any effect of the menstrual cycle on the manual dexterity of female dentists?"
},
"designModule": {
"designInfo": {
"allocation": null,
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"maskingInfo": null,
"observationalModel": "CASE_ONLY",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 45,
"type": "ACTUAL"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": "35 Years",
"minimumAge": "25 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Menstrual Cycle on the Manual Dexterity of Female Dentists",
"nctId": "NCT06388928",
"orgStudyIdInfo": {
"id": "P.T.REC/012/004596",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Manual dexterity assessment"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Cairo University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-12-26"
},
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"date": "2024-04-29"
},
"overallStatus": "COMPLETED",
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"date": "2023-12-26"
},
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"date": "2023-07-09"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": null,
"conditionsModule": {
"conditions": [
"Pelvic Fracture",
"Morel-Lavallee Lesion"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Fuzhou",
"contacts": null,
"country": "China",
"facility": "Fujian Provincial Hospital",
"geoPoint": {
"lat": 26.06139,
"lon": 119.30611
},
"state": "Fujian",
"status": null,
"zip": "350000"
}
]
},
"descriptionModule": {
"briefSummary": "Some related factors of pelvic fracture and Morel-Lavallee injury (MLL) are preliminarily discussed, which provides some preliminary references for early clinical detection and research of such injuries."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_ONLY",
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},
"enrollmentInfo": {
"count": 15,
"type": "ACTUAL"
},
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},
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"minimumAge": null,
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Retrospective Cohort Study of 15 Cases of Pelvic Fractures Complicated by Morel-Lavallee Lesion",
"nctId": "NCT06388915",
"orgStudyIdInfo": {
"id": "K2202403004",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
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"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Site of MLL"
},
{
"measure": "Site of injury and Classification of pelvic fracture"
}
],
"secondaryOutcomes": [
{
"measure": "Time to treatment"
},
{
"measure": "Drainage volume"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
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"class": "OTHER",
"name": "Weikang Chen"
}
},
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"completionDateStruct": {
"date": "2024-03-23"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2024-03-20"
},
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"startDateStruct": {
"date": "2024-03-12"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "BR115 for injection"
}
]
},
"conditionsModule": {
"conditions": [
"Advanced Solid Malignancies"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Guangzhou",
"contacts": [
{
"email": "ruihxu@163.com",
"name": "Rui Xu, MD",
"phone": "86-20-87343468",
"phoneExt": null,
"role": "CONTACT"
}
],
"country": "China",
"facility": "Sun Yat-sen University Cancer Center",
"geoPoint": {
"lat": 23.11667,
"lon": 113.25
},
"state": "Guangdong",
"status": null,
"zip": "510060"
}
]
},
"descriptionModule": {
"briefSummary": "This is a Phase I, multicenter, open-label, single-arm and first-in-human clinical study of BR115 for injection. The study objectives are to evaluate the safety, tolerability, pharmacokinetic profile, anti-tumor activity and immunogenicity of BR115 for injection in patients with advanced solid malignancies.\n\nPatients will receive two doses at the first week of treatment, followed by once per week until intolerable toxicity, disease progression, pregnancy, withdrawal of informed consent, death, study discontinuation, or withdrawal from the study."
},
"designModule": {
"designInfo": {
"allocation": "NA",
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"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
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},
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"count": 120,
"type": "ESTIMATED"
},
"phases": [
"PHASE1"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "A Phase I Study of BR115 for Injection Alone in Subjects With Advanced Solid Malignancies",
"nctId": "NCT06388902",
"orgStudyIdInfo": {
"id": "BR115-101",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Treatment-emergent Adverse Events Following Treatment With BR115"
}
],
"secondaryOutcomes": [
{
"measure": "Objective Response Rate"
},
{
"measure": "Progression-free survival (PFS)"
},
{
"measure": "Overall survival (OS)"
},
{
"measure": "Disease control rate (DCR)"
},
{
"measure": "Duration of response (DOR)."
},
{
"measure": "Pharmacokinetic Parameter Maximum Serum Concentration (Cmax)"
},
{
"measure": "Pharmacokinetic Parameter Area Under the Concentration-time Curve (AUC)"
},
{
"measure": "The anti-drug antibody (ADA)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "BioRay Pharmaceutical Co., Ltd."
}
},
"statusModule": {
"completionDateStruct": {
"date": "2028-12"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2028-08"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-04"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Dexpramipexole Dihydrochloride"
}
]
},
"conditionsModule": {
"conditions": [
"Eosinophilic Asthma"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tampa",
"contacts": null,
"country": "United States",
"facility": "Research Site 20001-004",
"geoPoint": {
"lat": 27.94752,
"lon": -82.45843
},
"state": "Florida",
"status": null,
"zip": "33607"
}
]
},
"descriptionModule": {
"briefSummary": "The goal of this clinical trial\\] is to evaluate the long term safety of dexpramipexole treatment in participants with severe asthma, aged ≥12 years, on Global Initiative for Asthma (GINA) 2021 \\[GINA, 2021\\] Step 4 or 5 therapy and who completed either of the Phase III studies EXHALE-2 or EXHALE-3."
},
"designModule": {
"designInfo": {
"allocation": "NA",
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"maskingInfo": {
"masking": "NONE",
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"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 1600,
"type": "ESTIMATED"
},
"phases": [
"PHASE3"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "99 Years",
"minimumAge": "12 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "EXHALE-5",
"briefTitle": "Phase III Long-Term Extension Study With Dexpramipexole",
"nctId": "NCT06388889",
"orgStudyIdInfo": {
"id": "AR-DEX-22-04",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number and Percentage of Participants with a Treatment Emergent Adverse Event"
},
{
"measure": "Number and Percentage of Participants with Potentially Clinically Significant Postbaseline Changes in Clinical Laboratory Evaluations"
},
{
"measure": "Number and Percentage of Participants with Potentially Clinically Significant Postbaseline Changes in Vital Signs and Body Weight"
},
{
"measure": "Number and Percentage of Participants with Potentially Significant Postbaseline Changes in Electrocardiogram Parameters"
}
],
"secondaryOutcomes": [
{
"measure": "Severe Asthma Exacerbations"
},
{
"measure": "Change in Asthma Control Questionnaire-6 (ACQ-6)"
},
{
"measure": "Change in absolute eosinophil counts (AEC)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Areteia Therapeutics"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-06-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "ENROLLING_BY_INVITATION",
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"date": "2027-06-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-08"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Exercise"
},
{
"name": "lifestyle advice"
}
]
},
"conditionsModule": {
"conditions": [
"Earthquake",
"Stress Disorders, Post-Traumatic"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": null,
"country": "Turkey",
"facility": "Ankara Yildirim Beyazıt University",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Natural disasters can have adverse impacts on both physical and mental health. Post-traumatic stress disorder (PTSD) and sleep disorders are among the most common problems seen after natural disasters. Exercise may represent a safe, cost-effective, accessible, non-pharmacological method for treating PTSD and sleep problems. The aim of this study was to investigate the effect of exercise interventions on PTSD and sleep quality in young individuals affected by the 2023 Kahramanmaraş earthquakes in Türkiye."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "there are 2 groups; exercise and control",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
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"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 38,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "30 Years",
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Exercise on Post-traumatic Stress Disorder and Sleep Quality in Individuals Affected by the 2023 Kahramanmaraş Earthquakes",
"nctId": "NCT06388876",
"orgStudyIdInfo": {
"id": "AnkaraYBUbk",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Post-traumatic Stress Disorder Short Scale"
},
{
"measure": "Pittsburgh Sleep Quality Index"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": [
{
"name": "TÜBİTAK"
}
],
"leadSponsor": {
"class": "OTHER",
"name": "Ankara Yildirim Beyazıt University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-07-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-06-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-04-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Healthy donor-derived FMT capsule"
},
{
"name": "Placebo capsule"
}
]
},
"conditionsModule": {
"conditions": [
"Parkinson Disease"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Shanghai",
"contacts": [
{
"email": "wu.shengdi@zs-hospital.sh.cn",
"name": "Shengdi Wu",
"phone": "(86)13817923359",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Shengdi Wu",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "China",
"facility": "180 Fenglin Road",
"geoPoint": {
"lat": 31.22222,
"lon": 121.45806
},
"state": "Shanghai",
"status": null,
"zip": "200032"
}
]
},
"descriptionModule": {
"briefSummary": "Participants will be allocated to FMT group or placebo group at a 1:1 ratio. For interventional group, patients will be given six FMT capsules twice a week for 24 weeks. Placebo capsules are identical in appearance and smell but contain milk powder. During visitpoints, participants complete specific scales to assess improvement in constipation, emotion and quality of life. Besides, fecal samples are collected for metagenomics and metabolomics sequencing and blood samples are tested peripheral concentration of levodopa."
},
"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": 76,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "75 Years",
"minimumAge": "40 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of the Efficacy and Safety of FMT for Constipation in Parkinson's Disease",
"nctId": "NCT06388863",
"orgStudyIdInfo": {
"id": "B2024-002",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Response rate of constipation in Parkinson's Disease (PD)"
}
],
"secondaryOutcomes": [
{
"measure": "Change from baseline PD symptoms at week 5, week 13 and week 24"
},
{
"measure": "Change from baseline anxiety at week 5, week 13 and week 24"
},
{
"measure": "Change from baseline depression at week 5, week 13 and week 24"
},
{
"measure": "Change from baseline quality of life at week 5, week 13 and week 24"
},
{
"measure": "Change from baseline drug concentration of levodopa in peripheral blood at week 13 and week 24"
},
{
"measure": "Change from baseline fecal microbiota at week 5, week 13 and week 24"
},
{
"measure": "Change from baseline fecal metabolites at week 5, week 13 and week 24"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Shanghai Zhongshan Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2026-05-31"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2026-05-31"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Healthy Relationships Project"
}
]
},
"conditionsModule": {
"conditions": [
"Child Sexual Abuse"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Washington",
"contacts": null,
"country": "United States",
"facility": "Safe Shores",
"geoPoint": {
"lat": 38.89511,
"lon": -77.03637
},
"state": "District of Columbia",
"status": null,
"zip": "20001"
}
]
},
"descriptionModule": {
"briefSummary": "This study is a rigorous experimental evaluation of an existing manualized universal child sexual abuse primary prevention program with a history of 30+ years of implementation across 30 states and robust pilot data."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "A stepped wedge cluster randomized clinical trial design will be used to assess the efficacy of two linked curricula of the Healthy Relationships Project (HRP): Care for Kids (Pre-K through 2nd Grade) and We Care Elementary (3rd through 5th Grade). The HRP includes a 1.5 hour training for school staff prior to implementation, six 30-minute classroom lessons delivered to students once per week for 6 weeks, and 3 caregiver workshops.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 16,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "11 Years",
"minimumAge": "3 Years",
"sex": "ALL",
"stdAges": [
"CHILD"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of HRP Among Pre-K Through 5th Grade",
"nctId": "NCT06388850",
"orgStudyIdInfo": {
"id": "5U01CE003393-03",
"link": "https://reporter.nih.gov/quickSearch/5U01CE003393-03",
"type": "NIH"
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Reports of child sexual abuse"
}
],
"secondaryOutcomes": [
{
"measure": "The Parental Knowledge Scale (PKS)"
},
{
"measure": "The Parental Discussions about Sex Abuse Scale (PDSAS)"
},
{
"measure": "The adapted Parenting Self Agency (PSAM)"
},
{
"measure": "The Parent Knowledge Questionnaire (PKQ)"
},
{
"measure": "HRP evaluation"
},
{
"measure": "The CSA Myths Scale"
},
{
"measure": "The Teachers' Reporting Attitudes Scale for Child Sexual Abuse (TRAS-CSA)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Northeastern University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2025-09-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "ENROLLING_BY_INVITATION",
"primaryCompletionDateStruct": {
"date": "2025-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-03-23"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Injectable Platelet Rich Fibrin"
},
{
"name": "Xenograft"
}
]
},
"conditionsModule": {
"conditions": [
"Symphysis Onlay Bone Graft",
"Platelet Rich Fibrin",
"Xenograft",
"Horizontal Alveolar Ridge Augmentation",
"Esthetic Zone"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Giza",
"contacts": null,
"country": "Egypt",
"facility": "October 6 University",
"geoPoint": {
"lat": 30.00808,
"lon": 31.21093
},
"state": null,
"status": null,
"zip": "12511"
}
]
},
"descriptionModule": {
"briefSummary": "The aim of the study: was to evaluate whether mandibular symphysis Onlay autogenous bone graft mixed with Injectable PRF could offer any advantages for patients undergoing horizontal alveolar ridge widening regarding increase alveolar ridge width compared to mandibular symphysis Onlay autogenous bone graft mixed with Xenograft"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
},
"enrollmentInfo": {
"count": 12,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "40 Years",
"minimumAge": "20 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Effect of Symphysis Onlay Bone Graft, Injectable Platelet Rich Fibrin (I-PRF) and Xenograft on Horizontal Alveolar Ridge Augmentation in Esthetic Zone",
"nctId": "NCT06388837",
"orgStudyIdInfo": {
"id": "RECO6U/20- 2021",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Alveolar ridge width"
}
],
"secondaryOutcomes": [
{
"measure": "Bone density"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "October 6 University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-03-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-03-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2021-02-20"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "normal saline"
},
{
"name": "Esketamine"
}
]
},
"conditionsModule": {
"conditions": [
"Sleep Disturbance"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Tianjin",
"contacts": null,
"country": "China",
"facility": "Tianjin Medical University General Hospital",
"geoPoint": {
"lat": 39.14222,
"lon": 117.17667
},
"state": null,
"status": null,
"zip": "300052"
}
]
},
"descriptionModule": {
"briefSummary": "To explore the efficacy of a single low dose of esketamine during surgical abortion in patients with sleep disturbance"
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
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"maskingDescription": null,
"whoMasked": [
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"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
},
"enrollmentInfo": {
"count": 200,
"type": "ESTIMATED"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "FEMALE",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "The Effect of Esketamine on Sleep Disturbance",
"nctId": "NCT06388824",
"orgStudyIdInfo": {
"id": "GWang028",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "The incidence of sleep disturbance on the first night after surgery"
}
],
"secondaryOutcomes": [
{
"measure": "The incidence of sleep disturbance on the second and third postoperative nights"
},
{
"measure": "The incidence of sleep disturbance on the seventh postoperative nights"
},
{
"measure": "Postoperative anxiety"
},
{
"measure": "Postoperative depression"
},
{
"measure": "Pain intensity"
},
{
"measure": "Adverse event"
},
{
"measure": "preoperative hemoglobin concentration"
},
{
"measure": "Human Chorionic Gonadotropin level"
},
{
"measure": "The incidence of sleep disturbance on the day before surgery"
},
{
"measure": "The incidence of sleep disturbance before surgery"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Tianjin Medical University General Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-10-10"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-09-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-20"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Early Osteoarthritis Questionnaire"
}
]
},
"conditionsModule": {
"conditions": [
"Early Knee Osteoarthritis"
]
},
"contactsLocationsModule": {
"locations": null
},
"descriptionModule": {
"briefSummary": "The symptoms of early osteoarthritis (OA) are quite similar to established knee OA, they differ, particularly in frequency, intensity, and severity. For this reason, in 2023, the International Symposium of intra-articular treatment (ISIAT) technical experts panel (TEP-technical experts panel) published for the first time a questionnaire designed to assess and monitor the follow-up and clinical progression of patients affected by early knee OA. Early management of knee OA is recommended by various guidelines because this approach may alter the course and clinical features of the disease, especially when considering disease-modifying agents that may delay disease progression.\n\nTherefore, the assessment of early knee OA with a questionnaire may facilitate the follow-up of OA in the early stages of the disease when treatment is likely to be more effective. This approach will allow to reduce disability and improve patients' quality of life. While creating the Early Osteoarthritis Questionnaire (EOAQ), it was aimed to have a complete, short and easy-to-understand questionnaire and to ensure that the respondents could complete the questionnaire easily and in a short time. The EOAQ consists of 11 questions. The questions were divided into two different groups. While the first two questions were related with clinical characteristics, the other nine questions aimed to investigate the results reported by the patient. For each question, there are three responses depending on the number of episodes: Never, rarely (between one and three episodes) and frequently (more than three episodes) within a 6-month period. Turkish validity and reliability study of the EOAQ has not been conducted yet.\n\nFor the translation of the questionnaire, the guide recommended by Beaton et al. for the cultural adaptation of questionnaires will be used. According to this guideline the original EOAQ will be translated into Turkish by two experts independently of each other, and then a single Turkish version will be created by two experts working together. This Turkish version will then be translated back into English by an expert who can speak both languages at an advanced level. The experts will then evaluate the translation and adapt the questionnaire accordingly. After the completion of the translated form, 110 patients and 110 control group participants who applied to Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation and met the inclusion criteria will be included. The participants will be informed verbally and in writing about the purpose, duration and method of the study and will be asked to sign an \"Informed Voluntary Consent Form\" after their consent is obtained. Participants will fill in the Turkish version of the questionnaire. Along with the questionnaire, knee pain will be questioned with the Numeric Rating Scale (0=no pain, 10=the most severe pain you experience) and disability will be questioned with the WOMAC Questionnaire, whose Turkish validity and reliability study has been conducted. Test-retest method will be applied for reliability analyses; therefore, at least 30 patients among the patients included in the study will complete the questionnaire twice (the second evaluation will be 2 weeks after the first evaluation)."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
},
"enrollmentInfo": {
"count": 220,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "18 Years",
"sex": "ALL",
"stdAges": [
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Validity and Reliability Study of the Turkish Version of the Early Osteoarthritis Questionnaire",
"nctId": "NCT06388811",
"orgStudyIdInfo": {
"id": "2023/1162",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Numeric Rating Scale"
},
{
"measure": "Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER",
"name": "Istanbul University"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2024-12-15"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2024-11-15"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-05-15"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
{
"largeDocumentModule": {
"largeDocs": [
{
"date": "2023-05-05",
"filename": "Prot_SAP_ICF_000.pdf",
"hasIcf": true,
"hasProtocol": true,
"hasSap": true,
"label": "Study Protocol, Statistical Analysis Plan, and Informed Consent Form",
"size": 163176,
"typeAbbrev": "Prot_SAP_ICF",
"uploadDate": "2024-03-04T06:15"
}
]
}
} | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "Education"
}
]
},
"conditionsModule": {
"conditions": [
"Nursing Education",
"Psychoeducation"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Ankara",
"contacts": null,
"country": "Turkey",
"facility": "Ankara Etlik City Hospital",
"geoPoint": {
"lat": 39.91987,
"lon": 32.85427
},
"state": null,
"status": null,
"zip": null
}
]
},
"descriptionModule": {
"briefSummary": "Summary:\n\nBackground One of the most important roles of psychiatric nurses, who help individuals, families and society in promoting health, preventing diseases and coping with problems, is their educational role. With its educational role, the nurse can help the patient and their family function at the best level in biopsychosocial integrity in preventing and coping with diseases through psychoeducation.\n\nGoals This research was conducted to evaluate the effectiveness of psychoeducational training given to nurses working in a psychiatric clinic.\n\nDesign This research is a randomized controlled experimental study. Participants Participants were determined using simple randomization. The sample of the study consisted of 78 nurses (intervention = 39; control = 39) working in a psychiatric clinic in a city hospital in Turkey.\n\nMethods Groups were determined using the simple randomization method. Psychoeducational training was given to the intervention group, nurses working in the Psychiatry clinic, for a total of 4 sessions, with two sessions of 50 minutes each. The data of the research were collected with the ;Personal Information Form; Form for evaluating the knowledge level of nurses working in the psychiatry clinic regarding psychoeducation and Perception of Adequacy Scale in Psychoeducation Program Development and Implementation. Data were analyzed using independent samples t test and two-way repeated measures analysis of variance (ANOVA)."
},
"designModule": {
"designInfo": {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
},
"enrollmentInfo": {
"count": 78,
"type": "ACTUAL"
},
"phases": [
"NA"
],
"studyType": "INTERVENTIONAL"
},
"eligibilityModule": {
"maximumAge": "45 Years",
"minimumAge": "23 Years",
"sex": "ALL",
"stdAges": [
"ADULT"
]
},
"identificationModule": {
"acronym": null,
"briefTitle": "Evaluation of the Effectiveness of Psychoeducational Training Given to Nurses Working in a Psychiatric Clinic",
"nctId": "NCT06388798",
"orgStudyIdInfo": {
"id": "Ankara Etlik city hospital",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Psychoeducation program development and implementation competence perception scale. Data will be collected before and after the training program in the intervention group, and at parallel times to the intervention group in the control group."
},
{
"measure": "Form for evaluating the knowledge level of nurses working in a psychiatric clinic regarding psychoeducation"
}
],
"secondaryOutcomes": null
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "OTHER_GOV",
"name": "Ankara Etlik City Hospital"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2023-07-30"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "COMPLETED",
"primaryCompletionDateStruct": {
"date": "2023-07-30"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2023-05-30"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |
null | false | {
"armsInterventionsModule": {
"interventions": [
{
"name": "No Intervention"
}
]
},
"conditionsModule": {
"conditions": [
"Dengue Fever"
]
},
"contactsLocationsModule": {
"locations": [
{
"city": "Serdang",
"contacts": [
{
"email": "zamberi@upm.edu.my",
"name": "Study Contact",
"phone": "+603-9769 1000",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Zamberi Sekawi, Dr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Malaysia",
"facility": "Universiti Putra Malaysia",
"geoPoint": null,
"state": "Selangor",
"status": null,
"zip": "43400"
},
{
"city": "Kuala Lumpur",
"contacts": [
{
"email": "sfaridah@ummc.edu.my",
"name": "Study Contact",
"phone": "+60379493641",
"phoneExt": null,
"role": "CONTACT"
},
{
"email": null,
"name": "Sharifah Faridah binti Syed Omar, Dr",
"phone": null,
"phoneExt": null,
"role": "PRINCIPAL_INVESTIGATOR"
}
],
"country": "Malaysia",
"facility": "Universiti Malaya",
"geoPoint": {
"lat": 3.1412,
"lon": 101.68653
},
"state": "Wilayah Persekutuan Kuala Lumpur",
"status": null,
"zip": "50603"
}
]
},
"descriptionModule": {
"briefSummary": "The main aim of this study is to collect the number and type of medical problems (adverse events) after vaccination with QDENGA in Malaysia and to learn more about such medical problems after vaccination. Another aim of this study is to collect the number of persons vaccinated with QDENGA who need to stay in the hospital because of severe dengue fever.\n\nNo vaccination will be given as part of this study. The study will only collect data of persons already vaccinated with QDENGA who agree to participate."
},
"designModule": {
"designInfo": {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
},
"enrollmentInfo": {
"count": 10000,
"type": "ESTIMATED"
},
"phases": null,
"studyType": "OBSERVATIONAL"
},
"eligibilityModule": {
"maximumAge": null,
"minimumAge": "4 Years",
"sex": "ALL",
"stdAges": [
"CHILD",
"ADULT",
"OLDER_ADULT"
]
},
"identificationModule": {
"acronym": "PRIME-Q",
"briefTitle": "A Study to Monitor the Adverse Events of QDENGA Vaccine in Participants in Malaysia",
"nctId": "NCT06388785",
"orgStudyIdInfo": {
"id": "TAK-003-5001",
"link": null,
"type": null
},
"secondaryIdInfos": null
},
"outcomesModule": {
"otherOutcomes": null,
"primaryOutcomes": [
{
"measure": "Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)"
}
],
"secondaryOutcomes": [
{
"measure": "Number of Participants who Require Hospitalization for Severe Dengue Diagnosed by Healthcare Provider (HCP)"
}
]
},
"sponsorCollaboratorsModule": {
"collaborators": null,
"leadSponsor": {
"class": "INDUSTRY",
"name": "Takeda"
}
},
"statusModule": {
"completionDateStruct": {
"date": "2027-09-01"
},
"lastUpdatePostDateStruct": {
"date": "2024-04-29"
},
"overallStatus": "NOT_YET_RECRUITING",
"primaryCompletionDateStruct": {
"date": "2027-09-01"
},
"resultsFirstPostDateStruct": null,
"startDateStruct": {
"date": "2024-06-01"
},
"studyFirstPostDateStruct": {
"date": "2024-04-29"
}
}
} |