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{ "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" } } }

{ "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" } } }

{ "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" } } }

{ "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" } } }

{ "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" } } }

{ "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" } } }

{ "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" } } }

{ "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" } } }

{ "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" } } }

{ "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" } } }

{ "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" } } }

{ "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" } } }

{ "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", "maskingDescription": null, "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 30, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "18 Years", "minimumAge": "6 Years", "sex": "ALL", "stdAges": [ "CHILD", "ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Euclid Phoenix Lens Design Trial", "nctId": "NCT06389916", "orgStudyIdInfo": { "id": "EU-PHX-RCT-001", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "First fit success rate" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "INDUSTRY", "name": "Euclid Systems Corporation" } }, "statusModule": { "completionDateStruct": { "date": "2024-04" }, "lastUpdatePostDateStruct": { "date": "2024-04-29" }, "overallStatus": "ACTIVE_NOT_RECRUITING", "primaryCompletionDateStruct": { "date": "2024-04" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2023-11-01" }, "studyFirstPostDateStruct": { "date": "2024-04-29" } } }

{ "armsInterventionsModule": { "interventions": [ { "name": "assessment" } ] }, "conditionsModule": { "conditions": [ "Parkinson Disease" ] }, "contactsLocationsModule": { "locations": [ { "city": "Sotteville Les Rouen", "contacts": null, "country": "France", "facility": "Marie Desbordes, MD", "geoPoint": { "lat": 49.40972, "lon": 1.09005 }, "state": null, "status": null, "zip": "76300" } ] }, "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)." }, "designModule": { "designInfo": { "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 15, "type": "ACTUAL" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": "PSYLES-STIM", "briefTitle": "Subthalamic Nucleus Stimulation Electrode and Psychiatric Lesion Effects in Parkinson's Disease", "nctId": "NCT06389903", "orgStudyIdInfo": { "id": "2018-A00185-50", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Assessment of change of mania symptoms" } ], "secondaryOutcomes": [ { "measure": "Assessment of change of depressive symptoms" }, { "measure": "Assessment of change of Behavior" }, { "measure": "Assessment of change of Impulsivity" }, { "measure": "Assessment of change of Apathy" }, { "measure": "Assessment of personality" }, { "measure": "Assessment of executive functions" }, { "measure": "Assessment of confusion" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER_GOV", "name": "Centre Hospitalier du Rouvray" } }, "statusModule": { "completionDateStruct": { "date": "2021-10-05" }, "lastUpdatePostDateStruct": { "date": "2024-04-29" }, "overallStatus": "COMPLETED", "primaryCompletionDateStruct": { "date": "2020-07-03" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2019-06-04" }, "studyFirstPostDateStruct": { "date": "2024-04-29" } } }

{ "armsInterventionsModule": { "interventions": [ { "name": "Pancreatic resection procedure" } ] }, "conditionsModule": { "conditions": [ "Volume-Outcome Relationship in Pancreatic Surgery" ] }, "contactsLocationsModule": { "locations": null }, "descriptionModule": { "briefSummary": "The main objective of the study is to identify the optimal annual number of cases in a hospital with regard to minimising hospital mortality in pancreatic surgery. In particular, the prognostic value of such case numbers will be analysed." }, "designModule": { "designInfo": { "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "RETROSPECTIVE" }, "enrollmentInfo": { "count": 80000, "type": "ACTUAL" }, "phases": null, "studyType": "OBSERVATIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": "PaSuT", "briefTitle": "Pancreatic Surgery - Optimal Caseload Thresholds and Predictive Accuracy", "nctId": "NCT06389890", "orgStudyIdInfo": { "id": "PaSuTE", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "In-hospital mortality" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "Medizinische Hochschule Brandenburg Theodor Fontane" } ], "leadSponsor": { "class": "OTHER", "name": "Richard Hunger" } }, "statusModule": { "completionDateStruct": { "date": "2019-12-31" }, "lastUpdatePostDateStruct": { "date": "2024-04-29" }, "overallStatus": "COMPLETED", "primaryCompletionDateStruct": { "date": "2019-12-31" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2010-01-01" }, "studyFirstPostDateStruct": { "date": "2024-04-29" } } }

{ "armsInterventionsModule": { "interventions": [ { "name": "BEAM-302" } ] }, "conditionsModule": { "conditions": [ "Alpha 1-Antitrypsin Deficiency" ] }, "contactsLocationsModule": { "locations": [ { "city": "London", "contacts": null, "country": "United Kingdom", "facility": "Clinical Study Center", "geoPoint": { "lat": 51.50853, "lon": -0.12574 }, "state": null, "status": null, "zip": null } ] }, "descriptionModule": { "briefSummary": "This is a Phase 1/2, multicenter, open-label, dose-exploration (Phase 1) and dose-expansion (Phase 2) study to evaluate the safety, tolerability, PK/PD, and efficacy of BEAM-302 in adult patients with AATD-associated lung disease and/or liver disease and to determine the optimal biological dose (OBD)." }, "designModule": { "designInfo": { "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 106, "type": "ESTIMATED" }, "phases": [ "PHASE1", "PHASE2" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "70 Years", "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "A Study to Evaluate the Safety and Efficacy of BEAM-302 in Adult Patients With Alpha-1 Antitrypsin Deficiency (AATD)", "nctId": "NCT06389877", "orgStudyIdInfo": { "id": "BTX-302-001", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Phase 1 Dose Exploration: Rates of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)" }, { "measure": "Phase 2 Dose Expansion: Absolute blood levels of total AAT" } ], "secondaryOutcomes": [ { "measure": "Phase 1 Dose Exploration: Absolute blood levels of total AAT" }, { "measure": "Phase 2 Dose Expansion: Rates of TEAEs and SAEs" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "INDUSTRY", "name": "Beam Therapeutics Inc." } }, "statusModule": { "completionDateStruct": { "date": "2027-08" }, "lastUpdatePostDateStruct": { "date": "2024-04-29" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2027-06" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-05" }, "studyFirstPostDateStruct": { "date": "2024-04-29" } } }

{ "armsInterventionsModule": { "interventions": [ { "name": "rTMS (repetitive transcranial magnetic stimulation)" } ] }, "conditionsModule": { "conditions": [ "ADHD" ] }, "contactsLocationsModule": { "locations": null }, "descriptionModule": { "briefSummary": "Assess the effect of RTMS on ADHD symptoms and assessment of this effect clinically and objectively." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "TRIPLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 60, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "18 Years", "minimumAge": "6 Years", "sex": "ALL", "stdAges": [ "CHILD", "ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "rTMS in Children and Adolescents With ADHD:", "nctId": "NCT06389864", "orgStudyIdInfo": { "id": "rTMS in ADHD", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "The resting motor threshold (RMT)" }, { "measure": "Arabic version Conners' Parent Rating Scale - Revised Long form" }, { "measure": "Clinical Global Impression CGI" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Assiut University" } }, "statusModule": { "completionDateStruct": { "date": "2026-10" }, "lastUpdatePostDateStruct": { "date": "2024-04-29" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2026-04" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-04" }, "studyFirstPostDateStruct": { "date": "2024-04-29" } } }

{ "armsInterventionsModule": { "interventions": [ { "name": "Experimental: Case Group - Tomato-free diet" }, { "name": "Experimental: Case group - Diet enriched with tomatoes" } ] }, "conditionsModule": { "conditions": [ "NAFLD", "IBS" ] }, "contactsLocationsModule": { "locations": [ { "city": "Castellana Grotte", "contacts": null, "country": "Italy", "facility": "Irccs Saverio de Bellis", "geoPoint": { "lat": 40.88643, "lon": 17.16549 }, "state": "Bari", "status": null, "zip": "70013" } ] }, "descriptionModule": { "briefSummary": "The study in question is an interventional study with nutritional intervention. the aim of the study is to evaluate whether a diet enriched with tomatoes can have favorable effects on:\n\n* specific aspects associated with NAFLD, such as the degree of hepatic steatosis and fibrosis;\n* circulating levels of molecules correlated with the degree of generalized and hepatic inflammation and the blood concentrations of metabolic and cardiovascular risk factors associated with abdominal obesity;\n* intestinal barrier;\n* body composition;\n* intestinal microbiota;\n* symptoms of IBS (irritable bowel syndrome) in patients with NAFLD." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": "The study evaluates the effects on NAFLD, Intestinal Integrity and Microbiota of a diet enriched with tomatoes compared to a diet without tomatoes", "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 60, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "65 Years", "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Effects of Tomato Consumption on Steatosis, Intestinal Function and Glucose and Lipid Metabolism in Subjects With NAFLD", "nctId": "NCT06389851", "orgStudyIdInfo": { "id": "NAFLD-LYCOPENE", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "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" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "Dr. Di Stasi Vincenza" }, { "name": "Dr. Donvito Rosanna" }, { "name": "Dr. Cozzolongo Raffaele" }, { "name": "Dr. Giannuzzi Vito" }, { "name": "Dr. Zappimbulso Marianna" }, { "name": "Dr. Shahini Endrit" }, { "name": "Dr. Notarnicola Maria" }, { "name": "Dr. Russo Francesco" }, { "name": "Dr. Riezzo Giuseppe" }, { "name": "Dr. Donghia Rossella" }, { "name": "Dr. Cesternino Anna Maria" }, { "name": "Dr. Cici Rosalisa" }, { "name": "Dr. Cerabino Nicole" }, { "name": "Dr. Martina Di Chito" }, { "name": "Dr. Pesole Pasqua Letizia" }, { "name": "Dr. Coletta Sergio" }, { "name": "Dr. Stabile Dolores" }, { "name": "Dr. Ancona Anna" }, { "name": "Dr. D'Attoma Benedetta" }, { "name": "Dr. Ignazzi Antonia" }, { "name": "Dr. De Nunzio Valentina" }, { "name": "Dr. Tatoli Rossella" }, { "name": "Dr. Pinto Giuliano" } ], "leadSponsor": { "class": "OTHER", "name": "Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis" } }, "statusModule": { "completionDateStruct": { "date": "2025-05-20" }, "lastUpdatePostDateStruct": { "date": "2024-04-29" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2025-05-20" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-05-20" }, "studyFirstPostDateStruct": { "date": "2024-04-29" } } }

{ "armsInterventionsModule": { "interventions": [ { "name": "Kranus Mictera" } ] }, "conditionsModule": { "conditions": [ "Urinary Incontinence,Stress", "Urinary Incontinence, Urge", "Urinary Incontinence", "Overactive Bladder Syndrome", "Female Urinary Stress Incontinence" ] }, "contactsLocationsModule": { "locations": [ { "city": "München", "contacts": [ { "email": "lwiemer@kranushelath.com", "name": "Laura E Wiemer, MD", "phone": "+4989 124 146 79", "phoneExt": null, "role": "CONTACT" } ], "country": "Germany", "facility": "Kranus Health Gmbh", "geoPoint": { "lat": 48.13743, "lon": 11.57549 }, "state": null, "status": null, "zip": "80331" } ] }, "descriptionModule": { "briefSummary": "This study, titled \"Prospective Randomized Study on Multimodal Self-Treatment for Women with Incontinence Symptoms Using a Digital Health Application,\" abbreviated as DINKS, aims to investigate the efficacy of a digital health application in treating incontinence in women. The study involves a single-center, single blinded, randomized, controlled trial with two arms: one receiving digital therapy intervention and the other serving as a control group with standard of care. The primary objective is to reduce the frequency of incontinence episodes over a 12-week intervention period, with secondary goals including improvements in disease symptoms, quality of life, and patient activation. The study plans to recruit 198 female participants and assess various endpoints related to incontinence severity, quality of life, and treatment outcomes." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": "Prospective, randomized, controlled, single-blinded, 2-arm design", "maskingInfo": { "masking": "SINGLE", "maskingDescription": "Participants know which group they are assigned to, but the investigators are blinded.", "whoMasked": [ "INVESTIGATOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 198, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "FEMALE", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": "DINKS", "briefTitle": "RCT on Multimodal Self-treatment for Women With Incontinence Using a Digital Health Application", "nctId": "NCT06389838", "orgStudyIdInfo": { "id": "DINKS01", "link": null, "type": null }, "secondaryIdInfos": [ { "domain": "DRKS", "id": "DRKS00033704", "link": null, "type": "REGISTRY" }, { "domain": null, "id": "2024-512094-27", "link": null, "type": "EUDRACT_NUMBER" } ] }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Incontinence episodes" } ], "secondaryOutcomes": [ { "measure": "ICIQ-SF" }, { "measure": "I-QoL" }, { "measure": "PAM-13" }, { "measure": "PGI-I" }, { "measure": "Cured patients" }, { "measure": "Urinary frequency day" }, { "measure": "Urinary frequency night" }, { "measure": "Pad use" }, { "measure": "Urge incontinence" }, { "measure": "Functional bladder capacity" }, { "measure": "Body weight" }, { "measure": "Treatment Failure" } ] }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "Johannes Gutenberg University Mainz" } ], "leadSponsor": { "class": "INDUSTRY", "name": "Kranus Health GmbH" } }, "statusModule": { "completionDateStruct": { "date": "2024-12-01" }, "lastUpdatePostDateStruct": { "date": "2024-04-29" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2024-09-30" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-04-29" }, "studyFirstPostDateStruct": { "date": "2024-04-29" } } }

{ "armsInterventionsModule": { "interventions": [ { "name": "Healthy diet" } ] }, "conditionsModule": { "conditions": [ "Familial Hypercholesterolemia", "Nutrition, Healthy", "Cholesterol, Elevated" ] }, "contactsLocationsModule": { "locations": [ { "city": "Québec", "contacts": [ { "email": "valerie.guay@fsaa.ulaval.ca", "name": "Valérie Guay", "phone": "418-656-2131", "phoneExt": null, "role": "CONTACT" } ], "country": "Canada", "facility": "INAF-NUTRISS Université Laval", "geoPoint": { "lat": 46.81228, "lon": -71.21454 }, "state": null, "status": "RECRUITING", "zip": "G1V0a6" } ] }, "descriptionModule": { "briefSummary": "The investigators will conduct a fully controlled dietary randomized crossover trial (RCT) including 10 adults with HeFH using lipid-lowering medication to investigate the impact of a diet low in red and processed meats and high in plant foods, reflecting Canada's Food Guide, in place of a standard North-American diet on LDL-cholesterol (LDL-C) levels and the plasma metabolome." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "CROSSOVER", "interventionModelDescription": null, "maskingInfo": { "masking": "TRIPLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 10, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "60 Years", "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Unravelling the Impact of Diet on Cardiovascular Health in Treated Heterozygous Familial Hypercholesterolemia.", "nctId": "NCT06389825", "orgStudyIdInfo": { "id": "FH-Diet-RX", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Post-diet differences in LDL-C levels." } ], "secondaryOutcomes": [ { "measure": "Post-diet differences in plasma metabolomics profiles" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Laval University" } }, "statusModule": { "completionDateStruct": { "date": "2024-06-30" }, "lastUpdatePostDateStruct": { "date": "2024-04-29" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2024-06-30" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-04-01" }, "studyFirstPostDateStruct": { "date": "2024-04-29" } } }

{ "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": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "SINGLE", "maskingDescription": null, "whoMasked": [ "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 30, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "65 Years", "sex": "ALL", "stdAges": [ "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Dual-task Exercise in People With Cognitive Impairment", "nctId": "NCT06389812", "orgStudyIdInfo": { "id": "LoughboroughUni", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "BDNF serum level" } ], "secondaryOutcomes": [ { "measure": "Visual screening" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Loughborough University" } }, "statusModule": { "completionDateStruct": { "date": "2024-09-30" }, "lastUpdatePostDateStruct": { "date": "2024-04-29" }, "overallStatus": "ACTIVE_NOT_RECRUITING", "primaryCompletionDateStruct": { "date": "2024-04-30" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2023-08-30" }, "studyFirstPostDateStruct": { "date": "2024-04-29" } } }

{ "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", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "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": { "otherOutcomes": null, "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" } } }

{ "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": { "designInfo": { "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "SCREENING", "timePerspective": null }, "enrollmentInfo": { "count": 50, "type": "ESTIMATED" }, "phases": [ "NA" ], "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 }, "secondaryIdInfos": [ { "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" } ] }, "outcomesModule": { "otherOutcomes": null, "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" } } }

{ "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, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "OTHER", "primaryPurpose": null, "timePerspective": "OTHER" }, "enrollmentInfo": { "count": 75, "type": "ESTIMATED" }, "phases": null, "studyType": "OBSERVATIONAL" }, "eligibilityModule": { "maximumAge": null, "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 }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Examine the changing nature of teamwork in ICUs in the post-pandemic context" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "King's College London" } }, "statusModule": { "completionDateStruct": { "date": "2025-09-30" }, "lastUpdatePostDateStruct": { "date": "2024-04-29" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2025-09-30" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-09-02" }, "studyFirstPostDateStruct": { "date": "2024-04-29" } } }

{ "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": { "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 50, "type": "ESTIMATED" }, "phases": [ "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" } } }

{ "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": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "DOUBLE", "maskingDescription": "participants and assessors will be blind to different intensity BFR groups.", "whoMasked": [ "PARTICIPANT", "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "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" } } }

{ "armsInterventionsModule": { "interventions": [ { "name": "Manual soft tissue release" }, { "name": "Myofascial release" }, { "name": "Exercise training" } ] }, "conditionsModule": { "conditions": [ "Chronic Obstructive Pulmonary Disease", "Manual Soft Tissue Release", "Exercise Training", "Lung Function", "Exercise Capacity", "Cardiac Autonomic Function" ] }, "contactsLocationsModule": { "locations": [ { "city": "Tainan", "contacts": null, "country": "Taiwan", "facility": "National Cheng Kung University", "geoPoint": { "lat": 22.99083, "lon": 120.21333 }, "state": null, "status": null, "zip": "701" } ] }, "descriptionModule": { "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." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": "The study population will be randomized and separated in two groups, experimental and control group.", "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "SUPPORTIVE_CARE", "timePerspective": null }, "enrollmentInfo": { "count": 70, "type": "ACTUAL" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "80 Years", "minimumAge": "30 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Combining Manual Soft Tissue Release and Exercise Training in COPD: the Effect on LF, EC, and CAF", "nctId": "NCT06389734", "orgStudyIdInfo": { "id": "B-ER-111-470", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Forced expiratory volume in 1 s (FEV1)" }, { "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)" }, { "measure": "36-Item Short Form Health Survey (SF-36)" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "National Cheng Kung University" } }, "statusModule": { "completionDateStruct": { "date": "2024-02-02" }, "lastUpdatePostDateStruct": { "date": "2024-04-29" }, "overallStatus": "COMPLETED", "primaryCompletionDateStruct": { "date": "2024-02-02" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2023-03-02" }, "studyFirstPostDateStruct": { "date": "2024-04-29" } } }

{ "armsInterventionsModule": { "interventions": [ { "name": "Electroencephalogram (EEG)" } ] }, "conditionsModule": { "conditions": [ "Chemotherapy-induced Peripheral Neuropathy" ] }, "contactsLocationsModule": { "locations": [ { "city": "Houston", "contacts": [ { "email": "sprinsloo@mdanderson.org", "name": "Sarah Prinsloo, PHD", "phone": "713-563-9627", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Sarah Prinsloo, PHD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "United States", "facility": "MD Anderson Cancer Center", "geoPoint": { "lat": 29.76328, "lon": -95.36327 }, "state": "Texas", "status": null, "zip": "77030" } ] }, "descriptionModule": { "briefSummary": "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." }, "designModule": { "designInfo": { "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }, "enrollmentInfo": { "count": 45, "type": "ESTIMATED" }, "phases": null, "studyType": "OBSERVATIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Understanding and Preventing Cortical Mechanisms of Chemotherapy-induced Peripheral Neuropathy", "nctId": "NCT06389721", "orgStudyIdInfo": { "id": "2024-0145", "link": null, "type": null }, "secondaryIdInfos": [ { "domain": "NCI-CTRP Clinical Registry", "id": "NCI-2024-03672", "link": null, "type": "OTHER" } ] }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Safety and adverse events (AEs)" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "M.D. Anderson Cancer Center" } }, "statusModule": { "completionDateStruct": { "date": "2027-01-31" }, "lastUpdatePostDateStruct": { "date": "2024-04-29" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2025-01-31" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-10-31" }, "studyFirstPostDateStruct": { "date": "2024-04-29" } } }

{ "armsInterventionsModule": { "interventions": null }, "conditionsModule": { "conditions": [ "Heart Failure", "Acute Kidney Injury" ] }, "contactsLocationsModule": { "locations": null }, "descriptionModule": { "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." }, "designModule": { "designInfo": { "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }, "enrollmentInfo": { "count": 100, "type": "ESTIMATED" }, "phases": null, "studyType": "OBSERVATIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Evaluation of VEXUS Score of Patients With Heart Failure in the Intensive Care Unit.", "nctId": "NCT06389708", "orgStudyIdInfo": { "id": "VEVUS-HF", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "VEXUS" }, { "measure": "MORTALİTY" }, { "measure": "AKI" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Inonu University" } }, "statusModule": { "completionDateStruct": { "date": "2025-01-15" }, "lastUpdatePostDateStruct": { "date": "2024-04-29" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2024-12-15" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-05-15" }, "studyFirstPostDateStruct": { "date": "2024-04-29" } } }

{ "armsInterventionsModule": { "interventions": [ { "name": "68Ga-NYM032 injection" } ] }, "conditionsModule": { "conditions": [ "Prostate Cancer" ] }, "contactsLocationsModule": { "locations": [ { "city": "Wuxi", "contacts": [ { "email": "ycj_wxd1978@163.com", "name": "Chunjing Yu", "phone": "15312238622", "phoneExt": null, "role": "CONTACT" } ], "country": "China", "facility": "Affliated Hospital of Jiangnan University", "geoPoint": { "lat": 31.56887, "lon": 120.28857 }, "state": "Jiangsu", "status": "RECRUITING", "zip": "214000" } ] }, "descriptionModule": { "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" }, "designModule": { "designInfo": { "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "DIAGNOSTIC", "timePerspective": null }, "enrollmentInfo": { "count": 10, "type": "ESTIMATED" }, "phases": [ "PHASE1" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "75 Years", "minimumAge": "18 Years", "sex": "MALE", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Pharmacokinetics, Biodistribution, Radiation Dose and Safety Study of 68Ga-NYM032 in Patients", "nctId": "NCT06389695", "orgStudyIdInfo": { "id": "CP-2023-03", "link": null, "type": null }, "secondaryIdInfos": [ { "domain": "National Medical Products Administration", "id": "NYM032D01", "link": null, "type": "OTHER" } ] }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Incidence of Adverse Events" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "INDUSTRY", "name": "Norroy Bioscience Co., LTD" } }, "statusModule": { "completionDateStruct": { "date": "2024-12" }, "lastUpdatePostDateStruct": { "date": "2024-04-29" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2024-12" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-05" }, "studyFirstPostDateStruct": { "date": "2024-04-29" } } }

{ "armsInterventionsModule": { "interventions": [ { "name": "68Ga-NYM005 injection" } ] }, "conditionsModule": { "conditions": [ "Clear Cell Renal Cell Carcinoma Metastatic" ] }, "contactsLocationsModule": { "locations": [ { "city": "Wuxi", "contacts": [ { "email": "ycj_wxd1978@163.com", "name": "Chunjing Yu", "phone": "15312238622", "phoneExt": null, "role": "CONTACT" } ], "country": "China", "facility": "Affliated Hospital of Jiangnan University", "geoPoint": { "lat": 31.56887, "lon": 120.28857 }, "state": "Jiangsu", "status": "RECRUITING", "zip": "214000" } ] }, "descriptionModule": { "briefSummary": "68Ga-NYM005 is a CAIX-targeting small-molecular radiotracer for PET/CT imaging of clear cell renal cell carcinoma" }, "designModule": { "designInfo": { "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "DIAGNOSTIC", "timePerspective": null }, "enrollmentInfo": { "count": 12, "type": "ESTIMATED" }, "phases": [ "PHASE1" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "75 Years", "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Pharmacokinetics, Biodistribution, Radiation Dose and Safety Study of 68Ga-NYM005 in Patients", "nctId": "NCT06389682", "orgStudyIdInfo": { "id": "CP-2023-02", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Incidence of Adverse Events" } ], "secondaryOutcomes": null }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "INDUSTRY", "name": "Norroy Bioscience Co., LTD" } }, "statusModule": { "completionDateStruct": { "date": "2024-12" }, "lastUpdatePostDateStruct": { "date": "2024-04-29" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2024-12" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-05" }, "studyFirstPostDateStruct": { "date": "2024-04-29" } } }

{ "armsInterventionsModule": null, "conditionsModule": { "conditions": [ "Feasibility of Low Flow Anaesthesia in Clinical Use", "Factors Affecting Oxygen Consumption" ] }, "contactsLocationsModule": { "locations": [ { "city": "Malatya", "contacts": null, "country": "Turkey", "facility": "Inonu Univercity", "geoPoint": { "lat": 38.35018, "lon": 38.31667 }, "state": null, "status": null, "zip": "44280" } ] }, "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." }, "designModule": { "designInfo": { "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }, "enrollmentInfo": { "count": 600, "type": "ESTIMATED" }, "phases": null, "studyType": "OBSERVATIONAL" }, "eligibilityModule": { "maximumAge": "65 Years", "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Is Low Flow Anaesthesia Feasible?", "nctId": "NCT06389669", "orgStudyIdInfo": { "id": "Inonu LTI", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Feasibility of Low Flow Anaesthesia" } ], "secondaryOutcomes": [ { "measure": "Factors affecting oxygen consumption" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Inonu University" } }, "statusModule": { "completionDateStruct": { "date": "2024-09-15" }, "lastUpdatePostDateStruct": { "date": "2024-04-29" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2024-08-15" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-05-15" }, "studyFirstPostDateStruct": { "date": "2024-04-29" } } }

{ "armsInterventionsModule": { "interventions": [ { "name": "Behavioral Weight Management" }, { "name": "Weight Bias Internalization" } ] }, "conditionsModule": { "conditions": [ "Body Weight", "Weight Bias", "Weight Stigma", "Weight" ] }, "contactsLocationsModule": { "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", "phoneExt": null, "role": "CONTACT" } ], "country": "United States", "facility": "The Miriam Hospital", "geoPoint": { "lat": 41.82399, "lon": -71.41283 }, "state": "Rhode Island", "status": "RECRUITING", "zip": "02903" } ] }, "descriptionModule": { "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." }, "designModule": { "designInfo": { "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": "Open trial", "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 24, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "17 Years", "minimumAge": "13 Years", "sex": "ALL", "stdAges": [ "CHILD" ] }, "identificationModule": { "acronym": "SWIFT", "briefTitle": "Addressing Weight Bias Internalization to Improve Adolescent Weight Management Outcomes", "nctId": "NCT06389656", "orgStudyIdInfo": { "id": "1K23DK135791-01", "link": "https://reporter.nih.gov/quickSearch/1K23DK135791-01", "type": "NIH" }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Total score on an adapted version of the Acceptability of Intervention Measure (AIM)" }, { "measure": "In depth qualitative feedback from teens regarding intervention acceptability and feasibility" }, { "measure": "Attendance rates at intervention sessions" }, { "measure": "Retention rate for intervention sessions" } ], "secondaryOutcomes": [ { "measure": "Total score on the Modified Weight Bias Internalization Scale (WBIS-M)" }, { "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" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "The Miriam Hospital" } }, "statusModule": { "completionDateStruct": { "date": "2025-02" }, "lastUpdatePostDateStruct": { "date": "2024-04-29" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2025-02" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-04-08" }, "studyFirstPostDateStruct": { "date": "2024-04-29" } } }

{ "armsInterventionsModule": { "interventions": [ { "name": "Four-point scleral fixation of Akreos AO60 IOL" }, { "name": "Sutureless scleral fixation of AcrySof MA60AC IOL with Yamane technique" } ] }, "conditionsModule": { "conditions": [ "Aphakia" ] }, "contactsLocationsModule": { "locations": [ { "city": "Warsaw", "contacts": null, "country": "Poland", "facility": "Military Institute of Medicine - National Research Institute", "geoPoint": { "lat": 52.22977, "lon": 21.01178 }, "state": null, "status": null, "zip": "04-141" } ] }, "descriptionModule": { "briefSummary": "Comparison of safety and efficacy of two scleral fixation intraocular lens (IOL) methods of four-point scleral fixation ( Akreos AO60) and the Yamane technique (AcrySof MA60AC)" }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "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" } } }

{ "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" } } }

{ "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" } } }

{ "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" } } }

{ "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" } } }

{ "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" } } }

{ "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" } } }

{ "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": { "class": "INDUSTRY", "name": "HK inno.N Corporation" } }, "statusModule": { "completionDateStruct": { "date": "2027-12" }, "lastUpdatePostDateStruct": { "date": "2024-04-29" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2026-12" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2023-09-25" }, "studyFirstPostDateStruct": { "date": "2024-04-29" } } }

{ "armsInterventionsModule": { "interventions": [ { "name": "SBD111 medical food" }, { "name": "Placebo" } ] }, "conditionsModule": { "conditions": [ "Osteoporosis", "Inflammation", "Aging" ] }, "contactsLocationsModule": { "locations": [ { "city": "Roslindale", "contacts": [ { "email": "KathyTasker@hsl.harvard.edu", "name": "Kathryn Tasker", "phone": "617-971-5351", "phoneExt": null, "role": "CONTACT" } ], "country": "United States", "facility": "Hebrew SeniorLife", "geoPoint": { "lat": 42.29121, "lon": -71.1245 }, "state": "Massachusetts", "status": null, "zip": "02131" } ] }, "descriptionModule": { "briefSummary": "This randomized, double blind, placebo controlled clinical trial will test the efficacy of a probiotic/prebiotic combination (\"synbiotic\") on the skeleton in older women." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": "Participants will be randomized to either SBD111 medical food or placebo capsules for a period of 18 months.", "maskingInfo": { "masking": "QUADRUPLE", "maskingDescription": "Study staff involved in participants' outcome assessments will be masked to the intervention assignment.", "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "OTHER", "timePerspective": null }, "enrollmentInfo": { "count": 220, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "60 Years", "sex": "FEMALE", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": "STARS", "briefTitle": "Synbiotic to Attenuate Resorption of the Skeleton", "nctId": "NCT06389539", "orgStudyIdInfo": { "id": "Pro00070958", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Lumbar spine BMD (g/cm2)" } ], "secondaryOutcomes": [ { "measure": "Vertebral compressive strength (N)" }, { "measure": "volumetric BMD" }, { "measure": "C-terminal cross-linked telopeptide of type I collagen (β-CTX)" }, { "measure": "Procollagen Type I Intact N-terminal Propeptide (P1NP)" } ] }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "Solarea Bio, Inc" }, { "name": "Beth Israel Deaconess Medical Center" }, { "name": "Tufts University" }, { "name": "MaineHealth" } ], "leadSponsor": { "class": "OTHER", "name": "Hebrew SeniorLife" } }, "statusModule": { "completionDateStruct": { "date": "2028-04" }, "lastUpdatePostDateStruct": { "date": "2024-04-29" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2028-04" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-05" }, "studyFirstPostDateStruct": { "date": "2024-04-29" } } }

{ "armsInterventionsModule": { "interventions": [ { "name": "CHS-1000" }, { "name": "Toripalimab" } ] }, "conditionsModule": { "conditions": [ "Advanced or Metastatic Solid Tumors" ] }, "contactsLocationsModule": { "locations": null }, "descriptionModule": { "briefSummary": "The primary purpose of this trial is to assess the tolerability and safety of CHS-1000 alone and in combination with toripalimab-tpzi in participants with advanced solid tumors." }, "designModule": { "designInfo": { "allocation": "NON_RANDOMIZED", "interventionModel": "SEQUENTIAL", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 48, "type": "ESTIMATED" }, "phases": [ "PHASE1" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "A Study of CHS-1000 in Participants With Advanced or Metastatic Solid Tumors", "nctId": "NCT06389526", "orgStudyIdInfo": { "id": "CHS-1000-01", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Number of Participants with Treatment-Emergent Adverse Events (TEAEs)" } ], "secondaryOutcomes": [ { "measure": "Maximum Observed Concentration (Cmax)" }, { "measure": "Area Under the Concentration-time Curve (AUC)" }, { "measure": "Terminal Half-life (t1/2)" }, { "measure": "Number of Participants with Antidrug Antibodies" }, { "measure": "Investigator-assessed Objective Response Rate (ORR)" }, { "measure": "Duration of Response (DoR)" }, { "measure": "Disease Control Rate (DCR)" }, { "measure": "Time to Response (TTP)" }, { "measure": "Progression-free Survival (PFS)" }, { "measure": "Landmark PFS Rate" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "INDUSTRY", "name": "Coherus Biosciences, Inc." } }, "statusModule": { "completionDateStruct": { "date": "2028-01-30" }, "lastUpdatePostDateStruct": { "date": "2024-04-29" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2028-01-30" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-10-01" }, "studyFirstPostDateStruct": { "date": "2024-04-29" } } }

{ "armsInterventionsModule": { "interventions": [ { "name": "MCV4" } ] }, "conditionsModule": { "conditions": [ "Epidemic Meningitis" ] }, "contactsLocationsModule": { "locations": null }, "descriptionModule": { "briefSummary": "This study is an open, multicenter Phase IV clinical study to evaluate the safety of vaccination with Menhycia®. The study plan is to enroll approximately 3,000 infants at 3 months of age who have not been vaccinated with any epidemic encephalitis vaccine, and to administer a total of 3 doses of Menhycia®, with a minimum of 1 month between doses, and a booster dose of 1 dose of immunization is allowed at 12 months of age." }, "designModule": { "designInfo": { "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "PREVENTION", "timePerspective": null }, "enrollmentInfo": { "count": 3000, "type": "ESTIMATED" }, "phases": [ "PHASE4" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "3 Months", "minimumAge": "3 Months", "sex": "ALL", "stdAges": [ "CHILD" ] }, "identificationModule": { "acronym": null, "briefTitle": "Clinical Study of the Safety of Menhycia® in 3-Month-Old Infants", "nctId": "NCT06389513", "orgStudyIdInfo": { "id": "CTP-MCVF-005", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Incidence of localized adverse reactions in subjects" }, { "measure": "Incidence of systemic adverse reactions in subjects" } ], "secondaryOutcomes": [ { "measure": "Incidence of adverse reactions in subjects" }, { "measure": "Incidence of adverse events in subjects" }, { "measure": "Incidence of severe adverse events" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "INDUSTRY", "name": "CanSino Biologics Inc." } }, "statusModule": { "completionDateStruct": { "date": "2025-04" }, "lastUpdatePostDateStruct": { "date": "2024-04-29" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2025-04" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-06" }, "studyFirstPostDateStruct": { "date": "2024-04-29" } } }

{ "armsInterventionsModule": { "interventions": [ { "name": "Adebrelimab" }, { "name": "Lenvatinib" }, { "name": "Hepatic Arterial Infusion Chemotherapy" } ] }, "conditionsModule": { "conditions": [ "Biliary Tract Cancer" ] }, "contactsLocationsModule": { "locations": null }, "descriptionModule": { "briefSummary": "This is a single-arm, exploratory, phase II trial to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy combined with adebrelimab and lenvatinib for borderline resectable, locally advanced biliary tract 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": 30, "type": "ESTIMATED" }, "phases": [ "PHASE2" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "75 Years", "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "HAIC+Adebrelimab+Lenvatinib for Conversion Treatment of Potentially Resectable, Locally Advanced Biliary Tract Cancer", "nctId": "NCT06389500", "orgStudyIdInfo": { "id": "SHR-1316-HLJ-006", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "R0 resection rate" }, { "measure": "Surgery conversion rate" } ], "secondaryOutcomes": [ { "measure": "Objective response rate" }, { "measure": "pathological complete response rate" }, { "measure": "Major pathological response rate" }, { "measure": "Recurrence-free survival" }, { "measure": "Overall survival" }, { "measure": "AEs" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Harbin Medical University" } }, "statusModule": { "completionDateStruct": { "date": "2028-05-01" }, "lastUpdatePostDateStruct": { "date": "2024-04-29" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2027-05-01" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-05-01" }, "studyFirstPostDateStruct": { "date": "2024-04-29" } } }

{ "armsInterventionsModule": { "interventions": [ { "name": "RSVPreF3 OA investigational vaccine" } ] }, "conditionsModule": { "conditions": [ "Respiratory Syncytial Virus Infections" ] }, "contactsLocationsModule": { "locations": [ { "city": "Phoenix", "contacts": [ { "email": "GSKClinicalSupportHD@gsk.com", "name": "US GSK Clinical Trials Call Center", "phone": "877-379-3718", "phoneExt": null, "role": "CONTACT" }, { "email": "GSKClinicalSupportHD@gsk.com", "name": "EU GSK Clinical Trials Call Centre", "phone": "+44 (0) 20 8990 4466", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Abram Burgher", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "United States", "facility": "GSK Investigational Site", "geoPoint": { "lat": 33.44838, "lon": -112.07404 }, "state": "Arizona", "status": null, "zip": "85023" }, { "city": "Tempe", "contacts": [ { "email": "GSKClinicalSupportHD@gsk.com", "name": "US GSK Clinical Trials Call Center", "phone": "877-379-3718", "phoneExt": null, "role": "CONTACT" }, { "email": "GSKClinicalSupportHD@gsk.com", "name": "EU GSK Clinical Trials Call Centre", "phone": "+44 (0) 20 8990 4466", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Joseph Daniel Davis", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "United States", "facility": "GSK Investigational Site", "geoPoint": { "lat": 33.41477, "lon": -111.90931 }, "state": "Arizona", "status": null, "zip": "85284" }, { "city": "North Hollywood", "contacts": [ { "email": "GSKClinicalSupportHD@gsk.com", "name": "US GSK Clinical Trials Call Center", "phone": "877-379-3718", "phoneExt": null, "role": "CONTACT" }, { "email": "GSKClinicalSupportHD@gsk.com", "name": "EU GSK Clinical Trials Call Centre", "phone": "+44 (0) 20 8990 4466", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Aaron Weinberg", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "United States", "facility": "GSK Investigational Site", "geoPoint": { "lat": 34.17223, "lon": -118.37897 }, "state": "California", "status": null, "zip": "91606-3287" }, { "city": "Oakland", "contacts": [ { "email": "GSKClinicalSupportHD@gsk.com", "name": "US GSK Clinical Trials Call Center", "phone": "877-379-3718", "phoneExt": null, "role": "CONTACT" }, { "email": "GSKClinicalSupportHD@gsk.com", "name": "EU GSK Clinical Trials Call Centre", "phone": "+44 (0) 20 8990 4466", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Allison Boyd", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "United States", "facility": "GSK Investigational Site", "geoPoint": { "lat": 37.80437, "lon": -122.2708 }, "state": "California", "status": null, "zip": "94610" }, { "city": "Walnut Creek", "contacts": [ { "email": "GSKClinicalSupportHD@gsk.com", "name": "US GSK Clinical Trials Call Center", "phone": "877-379-3718", "phoneExt": null, "role": "CONTACT" }, { "email": "GSKClinicalSupportHD@gsk.com", "name": "EU GSK Clinical Trials Call Centre", "phone": "+44 (0) 20 8990 4466", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Helen L Stacey", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "United States", "facility": "GSK Investigational Site", "geoPoint": { "lat": 37.90631, "lon": -122.06496 }, "state": "California", "status": null, "zip": "94598" }, { "city": "Hialeah", "contacts": [ { "email": "GSKClinicalSupportHD@gsk.com", "name": "US GSK Clinical Trials Call Center", "phone": "877-379-3718", "phoneExt": null, "role": "CONTACT" }, { "email": "GSKClinicalSupportHD@gsk.com", "name": "EU GSK Clinical Trials Call Centre", "phone": "+44 (0) 20 8990 4466", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Jose Cardona", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "United States", "facility": "GSK Investigational Site", "geoPoint": { "lat": 25.8576, "lon": -80.27811 }, "state": "Florida", "status": null, "zip": "33012" }, { "city": "Miami", "contacts": [ { "email": "GSKClinicalSupportHD@gsk.com", "name": "US GSK Clinical Trials Call Center", "phone": "877-379-3718", "phoneExt": null, "role": "CONTACT" }, { "email": "GSKClinicalSupportHD@gsk.com", "name": "EU GSK Clinical Trials Call Centre", "phone": "+44 (0) 20 8990 4466", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Jorge Caso", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "United States", "facility": "GSK Investigational Site", "geoPoint": { "lat": 25.77427, "lon": -80.19366 }, "state": "Florida", "status": null, "zip": "33173" }, { "city": "Orlando", "contacts": [ { "email": "GSKClinicalSupportHD@gsk.com", "name": "US GSK Clinical Trials Call Center", "phone": "877-379-3718", "phoneExt": null, "role": "CONTACT" }, { "email": "GSKClinicalSupportHD@gsk.com", "name": "EU GSK Clinical Trials Call Centre", "phone": "+44 (0) 20 8990 4466", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Felipe Suplicy", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "United States", "facility": "GSK Investigational Site", "geoPoint": { "lat": 28.53834, "lon": -81.37924 }, "state": "Florida", "status": null, "zip": "32806" }, { "city": "Lexington", "contacts": [ { "email": "GSKClinicalSupportHD@gsk.com", "name": "US GSK Clinical Trials Call Center", "phone": "877-379-3718", "phoneExt": null, "role": "CONTACT" }, { "email": "GSKClinicalSupportHD@gsk.com", "name": "EU GSK Clinical Trials Call Centre", "phone": "+44 (0) 20 8990 4466", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Mark S Adams", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "United States", "facility": "GSK Investigational Site", "geoPoint": { "lat": 37.98869, "lon": -84.47772 }, "state": "Kentucky", "status": null, "zip": "40509" }, { "city": "Silver Spring", "contacts": [ { "email": "GSKClinicalSupportHD@gsk.com", "name": "US GSK Clinical Trials Call Center", "phone": "877-379-3718", "phoneExt": null, "role": "CONTACT" }, { "email": "GSKClinicalSupportHD@gsk.com", "name": "EU GSK Clinical Trials Call Centre", "phone": "+44 (0) 20 8990 4466", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Jonathan Cohen", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "United States", "facility": "GSK Investigational Site", "geoPoint": { "lat": 38.99067, "lon": -77.02609 }, "state": "Maryland", "status": null, "zip": "20904" }, { "city": "Rochester", "contacts": [ { "email": "GSKClinicalSupportHD@gsk.com", "name": "US GSK Clinical Trials Call Center", "phone": "877-379-3718", "phoneExt": null, "role": "CONTACT" }, { "email": "GSKClinicalSupportHD@gsk.com", "name": "EU GSK Clinical Trials Call Centre", "phone": "+44 (0) 20 8990 4466", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Matthew G Davis", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "United States", "facility": "GSK Investigational Site", "geoPoint": { "lat": 43.15478, "lon": -77.61556 }, "state": "New York", "status": null, "zip": "14609" }, { "city": "Oklahoma City", "contacts": [ { "email": "GSKClinicalSupportHD@gsk.com", "name": "US GSK Clinical Trials Call Center", "phone": "877-379-3718", "phoneExt": null, "role": "CONTACT" }, { "email": "GSKClinicalSupportHD@gsk.com", "name": "EU GSK Clinical Trials Call Centre", "phone": "+44 (0) 20 8990 4466", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Charles Lunn", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "United States", "facility": "GSK Investigational Site", "geoPoint": { "lat": 35.46756, "lon": -97.51643 }, "state": "Oklahoma", "status": null, "zip": "73111" }, { "city": "Knoxville", "contacts": [ { "email": "GSKClinicalSupportHD@gsk.com", "name": 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"US GSK Clinical Trials Call Center", "phone": "877-379-3718", "phoneExt": null, "role": "CONTACT" }, { "email": "GSKClinicalSupportHD@gsk.com", "name": "EU GSK Clinical Trials Call Centre", "phone": "+44 (0) 20 8990 4466", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Essack Aziz Mitha", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" } ], "country": "South Africa", "facility": "GSK Investigational Site", "geoPoint": null, "state": null, "status": null, "zip": "2113" } ] }, "descriptionModule": { "briefSummary": "The aim of this study is to demonstrate the immune response and to evaluate safety of the RSVPreF3 OA investigational vaccine in non-immunocompromised adults 18-49 years of age (YOA), who are at increased risk (AIR) for respiratory syncytial virus (RSV) disease, compared to older adults (OA) (\\>=) 60 YOA and above" }, "designModule": { "designInfo": { "allocation": "NON_RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "PREVENTION", "timePerspective": null }, "enrollmentInfo": { "count": 850, "type": "ESTIMATED" }, "phases": [ "PHASE3" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": null, "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults 60 Years of Age and Above", "nctId": "NCT06389487", "orgStudyIdInfo": { "id": "222253", "link": null, "type": null }, "secondaryIdInfos": [ { "domain": "EU CTR Number", "id": "2023-510190-34-00", "link": null, "type": "OTHER" } ] }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "RSV-A neutralizing titers expressed as Geometric Mean Titers (GMTs) ratio (RSV-OA over RSV-A-AIR)" }, { "measure": "Seroresponse rate (SRR) in RSV-A neutralizing titers" }, { "measure": "RSV-B neutralizing titers expressed as GMT ratio (RSV-OA over RSV-A-AIR)" }, { "measure": "SRR in RSV-B neutralizing titers" } ], "secondaryOutcomes": [ { "measure": "Percentage of participants reporting solicited administration site events" }, { "measure": "Percentage of participants reporting solicited systemic events" }, { "measure": "Percentage of participants reporting unsolicited adverse events (AEs)" }, { "measure": "Percentage of participants reporting any serious adverse events (SAEs), related SAEs and fatal SAEs" }, { "measure": "Percentage of participants reporting any adverse events of special interest (AESIs), including potential immune-mediated diseases (pIMDs) and atrial fibrillation (AF)" }, { "measure": "RSV-A neutralizing titers expressed as GMTs" }, { "measure": "RSV-B neutralizing titers expressed as GMTs" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "INDUSTRY", "name": "GlaxoSmithKline" } }, "statusModule": { "completionDateStruct": { "date": "2025-04-28" }, "lastUpdatePostDateStruct": { "date": "2024-04-29" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2024-08-12" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-05-10" }, "studyFirstPostDateStruct": { "date": "2024-04-29" } } }

{ "armsInterventionsModule": { "interventions": [ { "name": "INM004" }, { "name": "Placebo" } ] }, "conditionsModule": { "conditions": [ "Hemolytic-Uremic Syndrome" ] }, "contactsLocationsModule": { "locations": [ { "city": "Florencio Varela", "contacts": null, "country": "Argentina", "facility": "Hospital El Cruce - Néstor Kirchner", "geoPoint": { "lat": -34.82722, "lon": -58.39556 }, "state": "Buenos Aires", "status": null, "zip": null }, { "city": "Mar Del Plata", "contacts": null, "country": "Argentina", "facility": "Hospital Interzonal Especializado Materno Infantil Don Victorio Tetamanti", "geoPoint": { "lat": -38.00228, "lon": -57.55754 }, "state": "Buenos Aires", "status": null, "zip": null }, { "city": "Rosario", "contacts": null, "country": "Argentina", "facility": "Sanatorio de Niños", "geoPoint": { "lat": -32.94682, "lon": -60.63932 }, "state": "Santa Fe", "status": null, "zip": null }, { "city": "Ciudad Autonoma de Buenos Aire", "contacts": null, "country": "Argentina", "facility": "Clínica Zabala", "geoPoint": { "lat": -34.61315, "lon": -58.37723 }, "state": null, "status": null, "zip": null }, { "city": "Ciudad Autonoma de Buenos Aire", "contacts": null, "country": "Argentina", "facility": "Hospital de Niños Dr. Ricardo Gutierrez", "geoPoint": { "lat": -34.61315, "lon": -58.37723 }, "state": null, "status": null, "zip": null }, { "city": "Córdoba", "contacts": null, "country": "Argentina", "facility": "Hospital de Niños de la Santísima Trinidad", "geoPoint": { "lat": -31.4135, "lon": -64.18105 }, "state": null, "status": null, "zip": null }, { "city": "Córdoba", "contacts": null, "country": "Argentina", "facility": "Sanatorio Allende", "geoPoint": { "lat": -31.4135, "lon": -64.18105 }, "state": null, "status": null, "zip": null }, { "city": "Mendoza", "contacts": null, "country": "Argentina", "facility": "Hospital Pediátrico Dr. Humberto Notti", "geoPoint": { "lat": -32.89084, "lon": -68.82717 }, "state": null, "status": null, "zip": null } ] }, "descriptionModule": { "briefSummary": "The objectives of this study are to evaluate the efficacy, safety, and pharmacokinetics of INM004 in pediatric patients with Hemolytic Uremic Syndrome associated to infection by Shiga toxin-producing Escherichia coli (STEC-HUS)." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": "Adaptive design. IA will be done when approximately 50% of the enrollment is reached and the participants have completed 28 days of follow-up. This analysis will not be blinded and will be carried out to declare futility or re-estimate the sample size. The re-estimation of the sample size will allow a maximum of 300 randomized subjects in total, but a reduction in the initial item size of 220 subjects is not expected. In case of re-estimating the sample size, the smallest sample size under 300 will be selected, which allows a power of ≥ 80%. %. If with 300 subjects, a power of 80% is not reached, but it is ≥ 50%, then the sample size is re-estimated to 300 subjects, as long as the conditional power of the IA is ≥ 50% (promising results)", "maskingInfo": { "masking": "QUADRUPLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }, "enrollmentInfo": { "count": 220, "type": "ESTIMATED" }, "phases": [ "PHASE3" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "17 Years", "minimumAge": "9 Months", "sex": "ALL", "stdAges": [ "CHILD" ] }, "identificationModule": { "acronym": null, "briefTitle": "A Phase III Study to Evaluate the Efficacy of INM004 in Children With STEC-HUS", "nctId": "NCT06389474", "orgStudyIdInfo": { "id": "CT-INM004-04", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": [ { "measure": "CKD Risk Assessment According to Kidney Disease Improving Global Outcomes (KDIGO) Categories" }, { "measure": "Evolution of renal function at 7 days (GFR_AUC1-7)" }, { "measure": "Evolution of renal function at 28 days (GFR_AUC1-28)" }, { "measure": "Evolution of renal function at 90 days (GFR_AUC1-90)" }, { "measure": "Incidence of anuria" }, { "measure": "Extrarenal composite endpoint" }, { "measure": "Recovery of the thrombotic microangiopathy (TMA), thrombocytopenia" }, { "measure": "Recovery of the thrombotic microangiopathy (TMA), hemolytic anemia" }, { "measure": "Duration of hospitalization" }, { "measure": "Incidence of adverse events of special interest" }, { "measure": "Incidence of adverse events" }, { "measure": "Pharmacokinetic - AUC0-t" }, { "measure": "Pharmacokinetic - AUC0-inf" }, { "measure": "Pharmacokinetic - Cmax" }, { "measure": "Pharmacokinetic - Tmax" }, { "measure": "Pharmacokinetic - λz" }, { "measure": "Pharmacokinetic - t1/2" }, { "measure": "Pharmacokinetic - Vz" }, { "measure": "Pharmacokinetic - Cl" }, { "measure": "Pharmacokinetic - AUC/dose" }, { "measure": "Pharmacokinetic - Cmax/dose" }, { "measure": "Baseline Shiga toxin serum levels" }, { "measure": "Kinetics of Shiga toxin in serum" } ], "primaryOutcomes": [ { "measure": "Time to recovery of renal function during the acute phase" } ], "secondaryOutcomes": [ { "measure": "Short-term recovery of renal function" }, { "measure": "MAKE 90" }, { "measure": "Dialysis longer than 10 days" }, { "measure": "Dialysis requirement" }, { "measure": "Mortality" } ] }, "sponsorCollaboratorsModule": { "collaborators": [ { "name": "KLIXAR" }, { "name": "Chemo Research" }, { "name": "Linical" }, { "name": "Crovelis" } ], "leadSponsor": { "class": "OTHER", "name": "Inmunova S.A." } }, "statusModule": { "completionDateStruct": { "date": "2025-09-28" }, "lastUpdatePostDateStruct": { "date": "2024-04-29" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2025-07-28" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-05-16" }, "studyFirstPostDateStruct": { "date": "2024-04-29" } } }

{ "armsInterventionsModule": { "interventions": [ { "name": "4th Ventricular Compression Technique" }, { "name": "\"Sham\" Therapy" } ] }, "conditionsModule": { "conditions": [ "Healthy" ] }, "contactsLocationsModule": { "locations": [ { "city": "Porto", "contacts": null, "country": "Portugal", "facility": "Escola Superior da Saúde do Porto", "geoPoint": { "lat": 41.14961, "lon": -8.61099 }, "state": null, "status": null, "zip": "4200-072" } ] }, "descriptionModule": { "briefSummary": "Determinate the effects of the technique of 4th ventricle in college students with anxiety, applying the technique one time per week during three weeks." }, "designModule": { "designInfo": { "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "SINGLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT" ] }, "observationalModel": null, "primaryPurpose": "OTHER", "timePerspective": null }, "enrollmentInfo": { "count": 30, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "25 Years", "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "4th Ventricular Compression Technique on Anxiety", "nctId": "NCT06389461", "orgStudyIdInfo": { "id": "OST1_012", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Change from baseline in anxiety levels through the STAI (The State-Trait Anxiety Inventory) questionnaire score on the 1st and last intervention." } ], "secondaryOutcomes": [ { "measure": "Change from baseline in thoraco-abdominal perimetry on the 1st and last intervention" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Escola Superior de Tecnologia da Saúde do Porto" } }, "statusModule": { "completionDateStruct": { "date": "2024-12-31" }, "lastUpdatePostDateStruct": { "date": "2024-04-29" }, "overallStatus": "NOT_YET_RECRUITING", "primaryCompletionDateStruct": { "date": "2024-12-31" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-09-16" }, "studyFirstPostDateStruct": { "date": "2024-04-29" } } }

{ "armsInterventionsModule": { "interventions": [ { "name": "pCLE-gastr" } ] }, "conditionsModule": { "conditions": [ "Low Grade Intraepithelial Neoplasia", "High Grade Intraepithelial Neoplasia", "Early Gastric Cancer", "Gastric Intraepithelial Neoplasia" ] }, "contactsLocationsModule": { "locations": [ { "city": "Wuhan", "contacts": [ { "email": "bcheng@tjh.tjmu.edu.cn", "name": "Bin Cheng, Professor", "phone": "86-027-8366-3333", "phoneExt": null, "role": "CONTACT" }, { "email": "yilingu2019@163.com", "name": "Yilin Gu", "phone": "86-19884836004", "phoneExt": null, "role": "CONTACT" } ], "country": "China", "facility": "Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology", "geoPoint": { "lat": 30.58333, "lon": 114.26667 }, "state": "Hubei", "status": "RECRUITING", "zip": "430030" } ] }, "descriptionModule": { "briefSummary": "This is a prospective multicenter comparative study, aiming to compare probe-based confocal laser endomicroscopy (pCLE) and endoscopic biopsies in the diagnosis of the whole specific gastric lesion especially for distinguishing low grade intraepithelial neoplasia (LGIN) from high grade intraepithelial neoplasia (HGIN) and create an endoscopic image database for the follow-up research." }, "designModule": { "designInfo": { "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": "Participants undergo pCLE after pre-ESD assessment and before ESD resection.", "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "DIAGNOSTIC", "timePerspective": null }, "enrollmentInfo": { "count": 366, "type": "ESTIMATED" }, "phases": [ "NA" ], "studyType": "INTERVENTIONAL" }, "eligibilityModule": { "maximumAge": "75 Years", "minimumAge": "18 Years", "sex": "ALL", "stdAges": [ "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Comparison of pCLE and EB in Gastric Lesion Diagnosis", "nctId": "NCT06389448", "orgStudyIdInfo": { "id": "pCLE vs EB 2024tj", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Diagnostic accuracy of pCLE and endoscopic biopsy in diagnosing the whole gastric lesion" } ], "secondaryOutcomes": [ { "measure": "The histological upstaging rate of pCLE and endoscopic biopsy in diagnosing the whole gastric lesion" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Huazhong University of Science and Technology" } }, "statusModule": { "completionDateStruct": { "date": "2026-10" }, "lastUpdatePostDateStruct": { "date": "2024-04-29" }, "overallStatus": "RECRUITING", "primaryCompletionDateStruct": { "date": "2026-04" }, "resultsFirstPostDateStruct": null, "startDateStruct": { "date": "2024-04-11" }, "studyFirstPostDateStruct": { "date": "2024-04-29" } } }

{ "armsInterventionsModule": { "interventions": [ { "name": "Patients will be randomized to undergo TKR or RTKR" } ] }, "conditionsModule": { "conditions": [ "Knee Arthroplasty, Total", "Robotic-assisted", "Osteoarthritis of the Knee" ] }, "contactsLocationsModule": { "locations": [ { "city": "Stockholm", "contacts": [ { "email": "olof.skoldenberg@ki.se", "name": "Olof Skoldenberg, Md, PhD", "phone": "800-555-5555", "phoneExt": null, "role": "CONTACT" }, { "email": null, "name": "Olof Skoldenberg, MD, PhD", "phone": null, "phoneExt": null, "role": "PRINCIPAL_INVESTIGATOR" }, { "email": null, "name": "Karl Erikson, MD, PhD", "phone": null, "phoneExt": null, "role": "SUB_INVESTIGATOR" } ], "country": "Sweden", "facility": "Danderyds Sjukhus", "geoPoint": { "lat": 59.33258, "lon": 18.0649 }, "state": null, "status": "RECRUITING", "zip": "18288" } ] }, "descriptionModule": { "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" } } }

{ "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" } } }

{ "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" } } }

{ "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" } } }

{ "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" } } }

{ "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" } } }

{ "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" } } }

{ "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" }, "eligibilityModule": { "maximumAge": "65 Years", "minimumAge": "16 Years", "sex": "ALL", "stdAges": [ "CHILD", "ADULT", "OLDER_ADULT" ] }, "identificationModule": { "acronym": null, "briefTitle": "Effect of Esketamine on Conscious State in Patients With pDoC", "nctId": "NCT06389344", "orgStudyIdInfo": { "id": "lk20240401", "link": null, "type": null }, "secondaryIdInfos": null }, "outcomesModule": { "otherOutcomes": null, "primaryOutcomes": [ { "measure": "Coma recovery scale-revised(CRS-R)" } ], "secondaryOutcomes": [ { "measure": "Coma recovery scale-revised(CRS-R)" }, { "measure": "Full Outline of UnResponsiveness(FOUR)" }, { "measure": "Glasgow coma scale(GCS)" }, { "measure": "Original EEG" }, { "measure": "Patient state index(PSI)" }, { "measure": "Power spectral density" }, { "measure": "Burst-suppression ratio" }, { "measure": "Spectral edge frequency" }, { "measure": "The incidence of perioperative adverse events" } ] }, "sponsorCollaboratorsModule": { "collaborators": null, "leadSponsor": { "class": "OTHER", "name": "Beijing Tiantan 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": "2024-05-01" }, "studyFirstPostDateStruct": { "date": "2024-04-29" } } }