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protocolSection identificationModule nctId: NCT06390072, orgStudyIdInfo id: 23-X-71, briefTitle: Project Hypnos: The Impact of a Brief Hypnosis Intervention on Single-limb Dynamic Balance in People With Chronic Ankle Instability, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-09-25, primaryCompletionDateStruct date: 2023-11-27, completionDateStruct date: 2023-11-27, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Ohio University, class: OTHER, 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., conditionsModule conditions: Ankle Sprains, conditions: Motor Coordination or Function; Developmental Disorder, designModule studyType: INTERVENTIONAL, phases: NA, 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, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ACTUAL, armsInterventionsModule interventions name: Self-Hypnosis, interventions name: Ankle Education, outcomesModule primaryOutcomes measure: Balance test 1, primaryOutcomes measure: Balance test 2, primaryOutcomes measure: Heart rate variability, secondaryOutcomes measure: Ankle disability measure 1, secondaryOutcomes measure: Ankle disability measure 2, secondaryOutcomes measure: Interoceptive awareness measure 1, secondaryOutcomes measure: Interoceptive awareness measure 2, secondaryOutcomes measure: Emotional Distress-Anxiety, secondaryOutcomes measure: Kinesiophobia, secondaryOutcomes measure: Pain self-efficacy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ohio University, city: Athens, state: Ohio, zip: 45701, country: United States, geoPoint lat: 39.32924, lon: -82.10126, hasResults: False

protocolSection identificationModule nctId: NCT06390059, orgStudyIdInfo id: EF-39, secondaryIdInfos id: EF-39, type: OTHER, domain: Sponsor, secondaryIdInfos id: 2022-003157-55, type: EUDRACT_NUMBER, 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, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-28, primaryCompletionDateStruct date: 2026-08, completionDateStruct date: 2026-08, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: NovoCure GmbH, class: INDUSTRY, 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., conditionsModule conditions: Metastatic Pancreatic Ductal Adenocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective, open-label, single arm, multi-center, historical control pilot study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: Tumor Treating Fields, interventions name: Atezolizumab, interventions name: Gemcitabine, interventions name: nab-paclitaxel, outcomesModule primaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: 1-Year survival rate, secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Progression free survival at 6 months (PFS6), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Rate of of patients with treatment emergent adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Vall d'Hebron, status: RECRUITING, city: Barcelona, zip: 08035, country: Spain, contacts name: Teresa Macarulla Mercade, role: CONTACT, phone: 34 (93) 274 6085, email: tmacarulla@vhebron.net, geoPoint lat: 41.38879, lon: 2.15899, locations facility: University Hospital Foundation Jimenez Diaz, status: RECRUITING, city: Madrid, zip: 28040, country: Spain, contacts name: Angela Lamarca Lete, role: CONTACT, phone: 34 951 504800, email: angela.lamarca@quironsalud.es, contacts name: 1, role: CONTACT, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Clara Campal Comprehensive Cancer Center (CIOCC), status: RECRUITING, city: Madrid, zip: 28050, country: Spain, contacts name: Antonio Cubillo Gracian, role: CONTACT, phone: 34 91 756 7800, email: acubillo@hmhospitales.com, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Regional University Hospital of Malaga, status: RECRUITING, city: Málaga, zip: 29010, country: Spain, contacts name: Inmaculada Ales, role: CONTACT, phone: 34 951308129, email: inales@hotmail.com, geoPoint lat: 36.72016, lon: -4.42034, locations facility: University Clinic of Navarra - Pamplona, status: RECRUITING, city: Pamplona, zip: 31008, country: Spain, contacts name: Mariano Ponz-Sarvise, role: CONTACT, phone: 34 948 255 400, email: mponz@unav.es, geoPoint lat: 42.81687, lon: -1.64323, hasResults: False

protocolSection identificationModule nctId: NCT06390046, orgStudyIdInfo id: 1072.6120.135.2023, briefTitle: Opioid-free Anesthesia, Optimization of Anesthesia After Bariatric Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-14, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Jagiellonian University, class: OTHER, 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., conditionsModule conditions: Analgesics, Opioid, conditions: Anesthesia; Adverse Effect, designModule studyType: INTERVENTIONAL, phases: NA, 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., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Intubation, interventions name: TIVA versus Inhalation, outcomesModule primaryOutcomes measure: compare the effectiveness of analgesia, primaryOutcomes measure: determine whether modern technologies such as videolaryngoscopy shorten intubation time., secondaryOutcomes measure: incidence of postoperative nausea and vomiting, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jagiellonian University, status: RECRUITING, city: Kraków, state: Malopolskie, zip: 31501, country: Poland, contacts name: Tomasz Skladzien, phd md, role: CONTACT, phone: 506602250, phoneExt: 48, email: t.skladzien@interia.pl, geoPoint lat: 50.06143, lon: 19.93658, hasResults: False

protocolSection identificationModule nctId: NCT06390033, orgStudyIdInfo id: ITS/133/21, briefTitle: Biomechanical Study of Different Prostheses for Unilateral Transtibial Amputees During Indoor and Outdoor Activities, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-06-30, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: The Hong Kong Polytechnic University, class: OTHER, 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:1. 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?2. 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?Participants will be asked to do1. 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.2. Participants are asked to refrain from consuming caffeine or any stimulants for 24 hours before the tests.3. Participants will be required to perform the Berg Balance Test.4. 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.5. 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.6. 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.7. Participants will be asked to perform a 2-minute walking test on flat concrete ground, stairs, and a ramp, respectively.8. Finally, participants will be asked to complete the Locomotion Capabilities Index questionnaire., conditionsModule conditions: Amputation, conditions: Prosthesis User, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: Prosthetic foot, outcomesModule primaryOutcomes measure: Basic mobility function with two prostheses by Berg Balance Test, primaryOutcomes measure: Basic mobility function with two prostheses by Time to Go Up, primaryOutcomes measure: Basic mobility function with two prostheses by Four Square Step Test, primaryOutcomes measure: Basic mobility function with two prostheses by 10-meter Walk Test, primaryOutcomes measure: Stability index with two prostheses by Eye Close Standing, primaryOutcomes measure: Stability index with two prostheses by Tandem Test, primaryOutcomes measure: Functional Reach Test, primaryOutcomes measure: Gait symmetry analysis of lower limb joint angle, primaryOutcomes measure: Gait symmetry analysis of lower limb joint power, primaryOutcomes measure: Gait symmetry analysis of lower limb joint moment, primaryOutcomes measure: Walking feasibility with two prostheses, primaryOutcomes measure: Jump feasibility with two prostheses, primaryOutcomes measure: Subjective evaluation by Locomotion Capabilities Index questionnaire, eligibilityModule sex: ALL, minimumAge: 36 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: The Hong Kong Polytechnic University, city: Kowloon, zip: 999077, country: Hong Kong, geoPoint lat: 22.31667, lon: 114.18333, hasResults: False

protocolSection identificationModule nctId: NCT06390020, orgStudyIdInfo id: NL84880.091.23, briefTitle: Mindfulness-Based Stress Reduction (MBSR) for People High on the Personality Trait Sensory Processing Sensitivity: A Mixed Methods Study, acronym: MindSens, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Radboud University Medical Center, class: OTHER, 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.The 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., conditionsModule conditions: Sensory Processing Sensitivity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 52, type: ESTIMATED, armsInterventionsModule interventions name: MBSR, outcomesModule 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, secondaryOutcomes measure: Change from Baseline to Post-intervention in self-reported burnout symptoms, secondaryOutcomes measure: Change from Baseline to Post-intervention in self-reported physical symptoms, secondaryOutcomes measure: Change from Baseline to Post-intervention in self-reported overstimulation, secondaryOutcomes measure: Change from Baseline to Post-intervention in self-reported mindfulness, secondaryOutcomes measure: Change from Baseline to Post-intervention in self-reported attention regulation, secondaryOutcomes measure: Change from Baseline to Post-intervention in self-reported strategies for cognitive emotion regulation, secondaryOutcomes measure: Change from Baseline to Post-intervention in self-reported body awareness, secondaryOutcomes measure: Change from Baseline to Post-intervention in self-reported self-compassion, secondaryOutcomes measure: Change from Baseline to Post-intervention in self-reported sensory processing sensitivity, secondaryOutcomes measure: Perceived facilitators, barriers, effects, and mechanisms of participating in the MBSR training, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Radboudumc Center for Mindfulness, status: RECRUITING, city: Nijmegen, state: Gelderland, zip: 6525 GC, country: Netherlands, contacts name: Anne Speckens, prof. dr., role: CONTACT, phone: (024) 36 68 456, email: mindfulness@radboudumc.nl, geoPoint lat: 51.8425, lon: 5.85278, hasResults: False

protocolSection identificationModule nctId: NCT06390007, orgStudyIdInfo id: 24916, briefTitle: The Efficacy of Acupuncture in the Management of Postoperative Pain in the Pediatric Intensive Care Unit at Cipto Mangunkusumo Hospital, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Indonesia University, class: OTHER, 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.The 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.This 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., conditionsModule conditions: Pain, Postoperative, conditions: Pediatric Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Sham press needle, interventions name: Press needle acupuncture, outcomesModule primaryOutcomes measure: Face, Legs, Activity, Cry, and Consolability (FLACC) pain scale, primaryOutcomes measure: Numeric Rating Scale (NRS) pain scale, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: RSUPN Dr. Cipto Mangunkusumo, city: Jakarta Pusat, state: DKI Jakarta, zip: 10430, country: Indonesia, contacts name: Irene Yuniar, role: CONTACT, phone: +6281380327808, email: irene.tambunan@yahoo.co.id, geoPoint lat: -6.1818, lon: 106.8223, hasResults: False

protocolSection identificationModule nctId: NCT06389994, orgStudyIdInfo id: 23-021041, briefTitle: Esophageal String Test Monitoring to Monitor Eosinophilic Esophagitis During Oral Immunotherapy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-02, completionDateStruct date: 2026-10-01, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Children's Hospital of Philadelphia, class: OTHER, 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., conditionsModule conditions: Eosinophilic Esophagitis (EoE), designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: Esophageal String Test, outcomesModule primaryOutcomes measure: Esophageal String Test, secondaryOutcomes measure: Prevalence of Eosinophilic Esophagitis, secondaryOutcomes measure: Eosinophilic Esophagitis Symptoms, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: The Children's Hospital of Philadelphia, status: RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: Sharon A Carbonara, MS, BSN, RN, role: CONTACT, phone: 267-426-8603, email: carbonara@chop.edu, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False

protocolSection identificationModule nctId: NCT06389981, orgStudyIdInfo id: 1692052, briefTitle: Co-Design and Pilot Testing of Peer-led Community Outreach to Improve Equity, Veteran-Centeredness and Uptake of Lung Cancer Screening, acronym: VPC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: VA Boston Healthcare System, class: FED, 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.Next, 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, conditionsModule conditions: Lung Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Veterans peer connect Program, outcomesModule primaryOutcomes measure: Lung Cancer Screening Uptake, secondaryOutcomes measure: Tobacco cessation Treatment, secondaryOutcomes measure: Stigma Related to Smoking, secondaryOutcomes measure: Perceived support from peer, secondaryOutcomes measure: Lung Cancer Screening Knowledge, secondaryOutcomes measure: Lung Cancer Screening Fatalism, secondaryOutcomes measure: Trust in VA, secondaryOutcomes measure: Lung Cancer Self-efficacy, secondaryOutcomes measure: General Cancer Self-efficacy, secondaryOutcomes measure: Intention to engage in shared decision making, secondaryOutcomes measure: Motivation to quit smoking, secondaryOutcomes measure: Intention to undergo lung cancer screening, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06389968, orgStudyIdInfo id: 2023-491-S-KH, briefTitle: Light Stimulation to Improve Visual Function After Optic Neuritis in Persons With Multiple Sclerosis, acronym: ONSTIM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-02, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Technical University of Munich, class: OTHER, 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.In 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., conditionsModule conditions: Multiple Sclerosis, Relapsing-Remitting, conditions: Optic Neuritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: sham-controlled, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Light stimulation, interventions name: Sham light stimulation, outcomesModule primaryOutcomes measure: High contrast visual sensitivity, secondaryOutcomes measure: Low contrast visual sensitivity, secondaryOutcomes measure: VEP, secondaryOutcomes measure: OCT, secondaryOutcomes measure: OCT Angiography, secondaryOutcomes measure: Color contrast, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06389955, orgStudyIdInfo id: TP-3654-103, briefTitle: Assessment of Relative Bioavailability and Effect of Food on Capsule and Tablet Formulations of TP-3654, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-05-22, primaryCompletionDateStruct date: 2023-08-01, completionDateStruct date: 2023-08-24, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Sumitomo Pharma America, Inc., class: INDUSTRY, 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., conditionsModule conditions: Effect of Drug, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ACTUAL, armsInterventionsModule interventions name: TP 3654, outcomesModule primaryOutcomes measure: Part A - The maximum concentration (Cmax) of TP-3654 in a capsule formulation, primaryOutcomes measure: Part A - The area under the curve (AUC) of TP-3654 in a capsule formulation, primaryOutcomes measure: Part A - Ratio of Peak Plasma Concentration (Cmax) of TP-3654 tablet versus TP-3654 capsule under fasted conditions, primaryOutcomes 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), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Frontage Investigative Site, city: Secaucus, state: New Jersey, zip: 07094, country: United States, geoPoint lat: 40.78955, lon: -74.05653, hasResults: False

protocolSection identificationModule nctId: NCT06389942, orgStudyIdInfo id: 9MW3011-2022-CP101, briefTitle: Single Ascending Dose Study of 9MW3011 in Chinese Healthy Subject, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-03-10, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Mabwell (Shanghai) Bioscience Co., Ltd., class: INDUSTRY, 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., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 48, type: ACTUAL, armsInterventionsModule interventions name: 9MW3011, interventions name: 9MW3011 placebo, outcomesModule primaryOutcomes measure: Adverse Event(including serious adverse event), secondaryOutcomes measure: Number of subjects with abnormal vital signs, secondaryOutcomes measure: Number of subjects with abnormal clinically significant results from physical examination, secondaryOutcomes measure: Number of subjects with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters, secondaryOutcomes measure: Number of subjects with abnormal clinically significant clinical laboratory results, secondaryOutcomes measure: Cmax, secondaryOutcomes measure: AUC0-t, secondaryOutcomes measure: AUC0-∞, secondaryOutcomes measure: Tmax, secondaryOutcomes measure: λz, secondaryOutcomes measure: t1/2z, secondaryOutcomes measure: Vz, secondaryOutcomes measure: CL, secondaryOutcomes measure: MRT, secondaryOutcomes measure: Pharmacodynamic(PD)parameters-hepcidin, secondaryOutcomes measure: PD parameters-serum iron, secondaryOutcomes measure: PD parameters-TSAT, secondaryOutcomes measure: Anti-drug antibodies(ADA), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: PKUcare Luzhong Hospital, city: Zibo, state: Shandong, country: China, geoPoint lat: 36.79056, lon: 118.06333, hasResults: False

protocolSection identificationModule nctId: NCT06389929, orgStudyIdInfo id: IU-HB-RK-02, 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?, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-10-30, primaryCompletionDateStruct date: 2024-01-20, completionDateStruct date: 2024-01-28, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Inonu University, class: OTHER, 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.Method: 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., conditionsModule conditions: Nursing Caries, designModule studyType: INTERVENTIONAL, phases: NA, 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., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 92, type: ACTUAL, armsInterventionsModule interventions name: Education, outcomesModule primaryOutcomes measure: Instructional Material Motivation Scale, secondaryOutcomes measure: Material Design Self-Efficacy Belief Scale, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Simge OZTURK, city: Bartin, state: None Selected, zip: 74100, country: Turkey, geoPoint lat: 41.63583, lon: 32.3375, hasResults: False

protocolSection identificationModule nctId: NCT06389916, orgStudyIdInfo id: EU-PHX-RCT-001, briefTitle: Euclid Phoenix Lens Design Trial, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Euclid Systems Corporation, class: INDUSTRY, 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., conditionsModule conditions: Myopia, conditions: Cornea, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Euclid orthokeratology MAX (current design), interventions name: Euclid orthokeratology MAX Phoenix (new design), outcomesModule primaryOutcomes measure: First fit success rate, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Insight Vision Center Optometry, city: Costa Mesa, state: California, zip: 92626, country: United States, geoPoint lat: 33.64113, lon: -117.91867, locations facility: Dau Family Eye Care, city: Saint Johns, state: Florida, zip: 32259, country: United States, geoPoint lat: 30.0815, lon: -81.54774, locations facility: Cornea and Contact Lens Institute of Minnesota, city: Edina, state: Minnesota, zip: 55436, country: United States, geoPoint lat: 44.88969, lon: -93.34995, locations facility: Somerset Eye Care, city: North Brunswick, state: New Jersey, zip: 08902, country: United States, geoPoint lat: 40.454, lon: -74.482, locations facility: Treehouse Eyes, city: Tysons Corner, state: Virginia, zip: 22182, country: United States, geoPoint lat: 38.91872, lon: -77.23109, hasResults: False

protocolSection identificationModule nctId: NCT06389903, orgStudyIdInfo id: 2018-A00185-50, briefTitle: Subthalamic Nucleus Stimulation Electrode and Psychiatric Lesion Effects in Parkinson's Disease, acronym: PSYLES-STIM, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-06-04, primaryCompletionDateStruct date: 2020-07-03, completionDateStruct date: 2021-10-05, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier du Rouvray, class: OTHER_GOV, descriptionModule briefSummary: This is a pilot, prospective, monocentric study concerning 15 Parkinson's disease patients requiring deep brain stimulation implantation.The 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)., conditionsModule conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ACTUAL, armsInterventionsModule interventions name: assessment, outcomesModule primaryOutcomes measure: Assessment of change of mania symptoms, secondaryOutcomes measure: Assessment of change of depressive symptoms, secondaryOutcomes measure: Assessment of change of Behavior, secondaryOutcomes measure: Assessment of change of Impulsivity, secondaryOutcomes measure: Assessment of change of Apathy, secondaryOutcomes measure: Assessment of personality, secondaryOutcomes measure: Assessment of executive functions, secondaryOutcomes measure: Assessment of confusion, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Marie Desbordes, MD, city: Sotteville Les Rouen, zip: 76300, country: France, geoPoint lat: 49.40972, lon: 1.09005, hasResults: False

protocolSection identificationModule nctId: NCT06389890, orgStudyIdInfo id: PaSuTE, briefTitle: Pancreatic Surgery - Optimal Caseload Thresholds and Predictive Accuracy, acronym: PaSuT, statusModule overallStatus: COMPLETED, startDateStruct date: 2010-01-01, primaryCompletionDateStruct date: 2019-12-31, completionDateStruct date: 2019-12-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Richard Hunger, class: OTHER, collaborators name: Medizinische Hochschule Brandenburg Theodor Fontane, 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., conditionsModule conditions: Volume-Outcome Relationship in Pancreatic Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 80000, type: ACTUAL, armsInterventionsModule interventions name: Pancreatic resection procedure, outcomesModule primaryOutcomes measure: In-hospital mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06389877, orgStudyIdInfo id: BTX-302-001, briefTitle: A Study to Evaluate the Safety and Efficacy of BEAM-302 in Adult Patients With Alpha-1 Antitrypsin Deficiency (AATD), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-06, completionDateStruct date: 2027-08, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Beam Therapeutics Inc., class: INDUSTRY, 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)., conditionsModule conditions: Alpha 1-Antitrypsin Deficiency, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 106, type: ESTIMATED, armsInterventionsModule interventions name: BEAM-302, outcomesModule primaryOutcomes measure: Phase 1 Dose Exploration: Rates of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), primaryOutcomes measure: Phase 2 Dose Expansion: Absolute blood levels of total AAT, secondaryOutcomes measure: Phase 1 Dose Exploration: Absolute blood levels of total AAT, secondaryOutcomes measure: Phase 2 Dose Expansion: Rates of TEAEs and SAEs, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinical Study Center, city: London, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False

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

protocolSection identificationModule nctId: NCT06389851, orgStudyIdInfo id: NAFLD-LYCOPENE, briefTitle: Effects of Tomato Consumption on Steatosis, Intestinal Function and Glucose and Lipid Metabolism in Subjects With NAFLD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-20, primaryCompletionDateStruct date: 2025-05-20, completionDateStruct date: 2025-05-20, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis, class: OTHER, collaborators name: Dr. Di Stasi Vincenza, collaborators name: Dr. Donvito Rosanna, collaborators name: Dr. Cozzolongo Raffaele, collaborators name: Dr. Giannuzzi Vito, collaborators name: Dr. Zappimbulso Marianna, collaborators name: Dr. Shahini Endrit, collaborators name: Dr. Notarnicola Maria, collaborators name: Dr. Russo Francesco, collaborators name: Dr. Riezzo Giuseppe, collaborators name: Dr. Donghia Rossella, collaborators name: Dr. Cesternino Anna Maria, collaborators name: Dr. Cici Rosalisa, collaborators name: Dr. Cerabino Nicole, collaborators name: Dr. Martina Di Chito, collaborators name: Dr. Pesole Pasqua Letizia, collaborators name: Dr. Coletta Sergio, collaborators name: Dr. Stabile Dolores, collaborators name: Dr. Ancona Anna, collaborators name: Dr. D'Attoma Benedetta, collaborators name: Dr. Ignazzi Antonia, collaborators name: Dr. De Nunzio Valentina, collaborators name: Dr. Tatoli Rossella, collaborators name: Dr. Pinto Giuliano, 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:* specific aspects associated with NAFLD, such as the degree of hepatic steatosis and fibrosis;* 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;* intestinal barrier;* body composition;* intestinal microbiota;* symptoms of IBS (irritable bowel syndrome) in patients with NAFLD., conditionsModule conditions: NAFLD, conditions: IBS, designModule studyType: INTERVENTIONAL, phases: NA, 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, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Experimental: Case Group - Tomato-free diet, interventions name: Experimental: Case group - Diet enriched with tomatoes, outcomesModule primaryOutcomes measure: The effect of intervention on CAP value (Controlled Attenuation Parameter), primaryOutcomes measure: The effect of intervention on FLI value (fatty liver index), primaryOutcomes measure: The effect of intervention on routine blood chemistry parameters, relating to NAFLD and fibrosis, primaryOutcomes measure: The effect of the intervention on the integrity of the intestinal barrier, primaryOutcomes measure: The effect of the intervention on the microbiota, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Irccs Saverio de Bellis, city: Castellana Grotte, state: Bari, zip: 70013, country: Italy, geoPoint lat: 40.88643, lon: 17.16549, hasResults: False

protocolSection identificationModule nctId: NCT06389838, orgStudyIdInfo id: DINKS01, secondaryIdInfos id: DRKS00033704, type: REGISTRY, domain: DRKS, secondaryIdInfos id: 2024-512094-27, type: EUDRACT_NUMBER, briefTitle: RCT on Multimodal Self-treatment for Women With Incontinence Using a Digital Health Application, acronym: DINKS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-29, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Kranus Health GmbH, class: INDUSTRY, collaborators name: Johannes Gutenberg University Mainz, 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., conditionsModule conditions: Urinary Incontinence,Stress, conditions: Urinary Incontinence, Urge, conditions: Urinary Incontinence, conditions: Overactive Bladder Syndrome, conditions: Female Urinary Stress Incontinence, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective, randomized, controlled, single-blinded, 2-arm design, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Participants know which group they are assigned to, but the investigators are blinded., whoMasked: INVESTIGATOR, enrollmentInfo count: 198, type: ESTIMATED, armsInterventionsModule interventions name: Kranus Mictera, outcomesModule primaryOutcomes measure: Incontinence episodes, secondaryOutcomes measure: ICIQ-SF, secondaryOutcomes measure: I-QoL, secondaryOutcomes measure: PAM-13, secondaryOutcomes measure: PGI-I, secondaryOutcomes measure: Cured patients, secondaryOutcomes measure: Urinary frequency day, secondaryOutcomes measure: Urinary frequency night, secondaryOutcomes measure: Pad use, secondaryOutcomes measure: Urge incontinence, secondaryOutcomes measure: Functional bladder capacity, secondaryOutcomes measure: Body weight, secondaryOutcomes measure: Treatment Failure, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kranus Health Gmbh, city: München, zip: 80331, country: Germany, contacts name: Laura E Wiemer, MD, role: CONTACT, phone: +4989 124 146 79, email: lwiemer@kranushelath.com, geoPoint lat: 48.13743, lon: 11.57549, hasResults: False

protocolSection identificationModule nctId: NCT06389825, orgStudyIdInfo id: FH-Diet-RX, briefTitle: Unravelling the Impact of Diet on Cardiovascular Health in Treated Heterozygous Familial Hypercholesterolemia., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Laval University, class: OTHER, 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., conditionsModule conditions: Familial Hypercholesterolemia, conditions: Nutrition, Healthy, conditions: Cholesterol, Elevated, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Healthy diet, outcomesModule primaryOutcomes measure: Post-diet differences in LDL-C levels., secondaryOutcomes measure: Post-diet differences in plasma metabolomics profiles, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: INAF-NUTRISS Université Laval, status: RECRUITING, city: Québec, zip: G1V0a6, country: Canada, contacts name: Valérie Guay, role: CONTACT, phone: 418-656-2131, email: valerie.guay@fsaa.ulaval.ca, geoPoint lat: 46.81228, lon: -71.21454, hasResults: False

protocolSection identificationModule nctId: NCT06389812, orgStudyIdInfo id: LoughboroughUni, briefTitle: Dual-task Exercise in People With Cognitive Impairment, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-08-30, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Loughborough University, class: OTHER, 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., conditionsModule conditions: Dementia, conditions: Mild Cognitive Impairment, conditions: Older Adults, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Dual-task exercise traning, outcomesModule primaryOutcomes measure: BDNF serum level, secondaryOutcomes measure: Visual screening, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Loughborough University, city: Loughborough, state: Leicestershire, zip: LE11 3TU, country: United Kingdom, geoPoint lat: 52.76667, lon: -1.2, hasResults: False

protocolSection identificationModule nctId: NCT06389799, orgStudyIdInfo id: PERELI, secondaryIdInfos id: 2022-501993-21-00, type: CTIS, briefTitle: A Phase 2, Open Label Study of PEmigatinib and REtifanlimab in Advanced Dedifferentiated LIposarcoma (PERELI), acronym: PERELI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-07, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Lund University Hospital, class: OTHER, descriptionModule briefSummary: Dedifferentiated liposarcomas (DDLPS) are aggressive soft tissue sarcomas with no effective medical treatment options.Immunotherapy 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.The 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., conditionsModule conditions: Dedifferentiated Liposarcoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 33, type: ESTIMATED, armsInterventionsModule interventions name: Pemigatinib, interventions name: Retifanlimab, outcomesModule 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, secondaryOutcomes measure: To evaluate the safety and tolerability of pemigatinib and retifanlimab, secondaryOutcomes measure: To evaluate impact of treatment and disease status on quality of life, secondaryOutcomes measure: To evaluate the relationship between baseline and on-treatment biomarkers and clinical activity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Oslo University Hospital HF, city: Oslo, country: Norway, contacts name: Kjetil Boye, MD, role: CONTACT, phone: 4722934000, email: kjetil.boye@rr-research.no, geoPoint lat: 59.91273, lon: 10.74609, locations facility: Sahlgrenska University Hospital, city: Göteborg, country: Sweden, contacts name: Lina Hansson, MD, role: CONTACT, phone: 46313427950, email: lina.hansson@vgregion.se, geoPoint lat: 57.70716, lon: 11.96679, locations facility: Lund University Hospital, city: Lund, country: Sweden, contacts name: Helena Nyström, MD, role: CONTACT, contacts role: CONTACT, phone: +4646177520, email: helena.nystrom@skane.se, geoPoint lat: 55.70584, lon: 13.19321, hasResults: False

protocolSection identificationModule nctId: NCT06389786, orgStudyIdInfo id: MC230504, secondaryIdInfos id: NCI-2024-03306, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 23-009377, type: OTHER, domain: Mayo Clinic Institutional Review Board, secondaryIdInfos id: MC230504, type: OTHER, domain: Mayo Clinic, briefTitle: Accuracy of 18F-rhPSMA-7.3 PET/ MRI for Prediction of Lymph Node Metastasis in Localized High-Risk Prostate Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-31, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, 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., conditionsModule conditions: Localized Prostate Carcinoma, conditions: Oligometastatic Prostate Carcinoma, conditions: Stage I Prostate Cancer AJCC v8, conditions: Stage II Prostate Cancer AJCC v8, conditions: Stage III Prostate Cancer AJCC v8, conditions: Stage IVA Prostate Cancer AJCC v8, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Bilateral Pelvic Lymph Node Dissection, interventions name: Biospecimen Collection, interventions name: Bone Scan, interventions name: Computed Tomography, interventions name: Electronic Health Record Review, interventions name: Flotufolastat F-18 Gallium, interventions name: Laparoscopic Radical Prostatectomy with Robotics, interventions name: Magnetic Resonance Imaging, interventions name: Positron Emission Tomography, outcomesModule 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, secondaryOutcomes measure: Positive/negative predictive value, secondaryOutcomes measure: Prostate specific antigen (PSA): < 5, 5-10, 10-20, > 20, secondaryOutcomes measure: Gleason score, secondaryOutcomes measure: Digital rectal examination, secondaryOutcomes measure: Number of patients where management has changed, secondaryOutcomes measure: Rates of biochemical recurrent disease (BCR), eligibilityModule sex: MALE, minimumAge: 30 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Florida, city: Jacksonville, state: Florida, zip: 32224-9980, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: mayocliniccancerstudies@mayo.edu, contacts name: Ram A. Pathak, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.33218, lon: -81.65565, hasResults: False

protocolSection identificationModule nctId: NCT06389773, orgStudyIdInfo id: 302958, briefTitle: Teamwork for Resilient Staff and Safe Care in ICU, acronym: FEARLESS_ICU, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-02, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: King's College London, class: OTHER, 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* How do healthcare staff work together in everyday ICU settings?* What helps people work together in ICUs?* What challenges do staff face in working together in ICUs?* How have teamwork practices changed since the COVID-19 pandemic?Researchers will shadow staff during their day-to-day work. Key staff members will also be interviewed about their perceptions and experiences of teamwork., conditionsModule conditions: Teamwork, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 75, type: ESTIMATED, outcomesModule primaryOutcomes measure: Examine the changing nature of teamwork in ICUs in the post-pandemic context, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06389760, orgStudyIdInfo id: IST-Nim-PC-16, briefTitle: Single-arm Study of Nimotuzumab Combined With mFOLFIRNIOX as Postoperative Adjuvant Therapy in Pancreatic Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-18, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2026-09-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, class: OTHER, 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., conditionsModule conditions: Pancreatic Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Nimotuzumab, interventions name: mFOLFIRINOX, outcomesModule primaryOutcomes measure: disease-free survival (DFS), secondaryOutcomes measure: distant metastasis-free survival (DMFS), secondaryOutcomes measure: overall survival (OS), secondaryOutcomes measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30), secondaryOutcomes measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire pancreatic cancer 29 (EORTC-QLQ-PAN26), secondaryOutcomes measure: tumor-related markers, secondaryOutcomes measure: adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210008, country: China, contacts name: Juan Du, M.D. Ph.D, role: CONTACT, phone: +86-025-83106666, email: dujunglyy@163.com, contacts name: Juan Du, M.D. Ph.D, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False

protocolSection identificationModule nctId: NCT06389747, orgStudyIdInfo id: OU, briefTitle: Effect of Blood Flow Restriction Technique on Delayed Onset Muscle Soreness, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-24, primaryCompletionDateStruct date: 2024-05-28, completionDateStruct date: 2024-06-15, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Istanbul University - Cerrahpasa (IUC), class: OTHER, 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., conditionsModule conditions: Pain Intensity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: participants and assessors will be blind to different intensity BFR groups., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: BFR technique, outcomesModule primaryOutcomes measure: Visual analog scale, primaryOutcomes measure: myoton, primaryOutcomes measure: dynamometer, primaryOutcomes measure: dolorimeter, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Gamze Aydın, status: RECRUITING, city: Istanbul, zip: 34940, country: Turkey, contacts name: Gamze Aydın, role: CONTACT, email: gmzetsn@gmail.com, geoPoint lat: 41.01384, lon: 28.94966, locations facility: Istanbul Okan University, status: RECRUITING, city: Istanbul, zip: 34944, country: Turkey, contacts name: Gamze Aydın, PhD, role: CONTACT, phone: +905377600256, email: gmzetsn@gmail.com, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False

protocolSection identificationModule nctId: NCT06389734, orgStudyIdInfo id: B-ER-111-470, briefTitle: Combining Manual Soft Tissue Release and Exercise Training in COPD: the Effect on LF, EC, and CAF, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-02, primaryCompletionDateStruct date: 2024-02-02, completionDateStruct date: 2024-02-02, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: National Cheng Kung University, class: OTHER, 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., conditionsModule conditions: Chronic Obstructive Pulmonary Disease, conditions: Manual Soft Tissue Release, conditions: Exercise Training, conditions: Lung Function, conditions: Exercise Capacity, conditions: Cardiac Autonomic Function, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study population will be randomized and separated in two groups, experimental and control group., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ACTUAL, armsInterventionsModule interventions name: Manual soft tissue release, interventions name: Myofascial release, interventions name: Exercise training, outcomesModule primaryOutcomes measure: Forced expiratory volume in 1 s (FEV1), primaryOutcomes measure: forced vital capacity (FVC), primaryOutcomes measure: FEV1/FVC ratio, primaryOutcomes measure: expiratory reserve volume (ERV), primaryOutcomes measure: functional residual capacity (FRC), primaryOutcomes measure: inspiratory capacity (IC), primaryOutcomes measure: inspiratory reserve volume (IRV),, primaryOutcomes measure: residual volume (RV), primaryOutcomes measure: total lung capacity (TLC), primaryOutcomes measure: tidal volume (TV), primaryOutcomes measure: vital capacity (VC), secondaryOutcomes measure: Rate of perceived exertion (RPE), secondaryOutcomes measure: Oxygen consumption (VO2), secondaryOutcomes measure: oxygen saturation, secondaryOutcomes measure: heart rate (HR), secondaryOutcomes measure: blood pressure (BP), secondaryOutcomes measure: Diaphragmatic mobility, secondaryOutcomes measure: Cardiac Autonomic Function, secondaryOutcomes measure: six minute walk test (6-MWT), secondaryOutcomes measure: maximal expiratory pressure (MEP), secondaryOutcomes measure: maximal inspiratory pressure (MIP), secondaryOutcomes measure: St. George's Respiratory Questionnaire (SGRQ), secondaryOutcomes measure: fatigue severity scale (FSS), secondaryOutcomes measure: Modified Medical Research Council (mMRC), secondaryOutcomes measure: 36-Item Short Form Health Survey (SF-36), eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Cheng Kung University, city: Tainan, zip: 701, country: Taiwan, geoPoint lat: 22.99083, lon: 120.21333, hasResults: False

protocolSection identificationModule nctId: NCT06389721, orgStudyIdInfo id: 2024-0145, secondaryIdInfos id: NCI-2024-03672, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: Understanding and Preventing Cortical Mechanisms of Chemotherapy-induced Peripheral Neuropathy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-31, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2027-01-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, descriptionModule briefSummary: Cohort 1: To track the onset and progression of a condition called chemotherapy-induced peripheral neuropathy (CIPN).Cohort 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., conditionsModule conditions: Chemotherapy-induced Peripheral Neuropathy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Electroencephalogram (EEG), outcomesModule primaryOutcomes measure: Safety and adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Sarah Prinsloo, PHD, role: CONTACT, phone: 713-563-9627, email: sprinsloo@mdanderson.org, contacts name: Sarah Prinsloo, PHD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False

protocolSection identificationModule nctId: NCT06389708, orgStudyIdInfo id: VEVUS-HF, briefTitle: Evaluation of VEXUS Score of Patients With Heart Failure in the Intensive Care Unit., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2024-12-15, completionDateStruct date: 2025-01-15, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Inonu University, class: OTHER, 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., conditionsModule conditions: Heart Failure, conditions: Acute Kidney Injury, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: VEXUS, primaryOutcomes measure: MORTALİTY, primaryOutcomes measure: AKI, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

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

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

protocolSection identificationModule nctId: NCT06389669, orgStudyIdInfo id: Inonu LTI, briefTitle: Is Low Flow Anaesthesia Feasible?, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2024-08-15, completionDateStruct date: 2024-09-15, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Inonu University, class: OTHER, 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., conditionsModule conditions: Feasibility of Low Flow Anaesthesia in Clinical Use, conditions: Factors Affecting Oxygen Consumption, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 600, type: ESTIMATED, outcomesModule primaryOutcomes measure: Feasibility of Low Flow Anaesthesia, secondaryOutcomes measure: Factors affecting oxygen consumption, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Inonu Univercity, city: Malatya, zip: 44280, country: Turkey, geoPoint lat: 38.35018, lon: 38.31667, hasResults: False

protocolSection identificationModule nctId: NCT06389656, orgStudyIdInfo id: 1K23DK135791-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1K23DK135791-01, briefTitle: Addressing Weight Bias Internalization to Improve Adolescent Weight Management Outcomes, acronym: SWIFT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: The Miriam Hospital, class: OTHER, 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., conditionsModule conditions: Body Weight, conditions: Weight Bias, conditions: Weight Stigma, conditions: Weight, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Open trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Behavioral Weight Management, interventions name: Weight Bias Internalization, outcomesModule primaryOutcomes measure: Total score on an adapted version of the Acceptability of Intervention Measure (AIM), primaryOutcomes measure: In depth qualitative feedback from teens regarding intervention acceptability and feasibility, primaryOutcomes measure: Attendance rates at intervention sessions, primaryOutcomes measure: Retention rate for intervention sessions, secondaryOutcomes measure: Total score on the Modified Weight Bias Internalization Scale (WBIS-M), secondaryOutcomes measure: Total score on the Weight Self-Stigma Questionnaire (WSSQ), secondaryOutcomes measure: Total score on the weight-related teasing sub-scale of the Perception of Teasing Scale (POTS), secondaryOutcomes measure: Total score on the competency-related teasing subscale of the Perception of Teasing Scale (POTS), secondaryOutcomes measure: Anthropometrics, eligibilityModule sex: ALL, minimumAge: 13 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: The Miriam Hospital, status: RECRUITING, city: Providence, state: Rhode Island, zip: 02903, country: United States, contacts name: Katherine Darling, PhD, role: CONTACT, phone: 401-793-8688, email: katherine_darling@brown.edu, contacts name: Andrea M Grenga, BA, role: CONTACT, phone: 401-793-8997, email: agrenga@lifespan.org, geoPoint lat: 41.82399, lon: -71.41283, hasResults: False

protocolSection identificationModule nctId: NCT06389643, orgStudyIdInfo id: 11/WIM/2021, briefTitle: Comparison of Safety and Efficacy of Four-Point Scleral Intraocular Lens Fixation and Yamane Techniques, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-03-19, primaryCompletionDateStruct date: 2022-09-14, completionDateStruct date: 2023-09-19, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Military Institute od Medicine National Research Institute, class: OTHER, 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), conditionsModule conditions: Aphakia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 50, type: ACTUAL, armsInterventionsModule interventions name: Four-point scleral fixation of Akreos AO60 IOL, interventions name: Sutureless scleral fixation of AcrySof MA60AC IOL with Yamane technique, outcomesModule primaryOutcomes measure: BCVA, primaryOutcomes measure: RE, primaryOutcomes measure: ECC, secondaryOutcomes measure: Number of complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Military Institute of Medicine - National Research Institute, city: Warsaw, zip: 04-141, country: Poland, geoPoint lat: 52.22977, lon: 21.01178, hasResults: False

protocolSection identificationModule nctId: NCT06389630, orgStudyIdInfo id: 0012, briefTitle: Evaluation of the Efficiency of Two Different Teaching Methods in Safe Subcutaneous Injection Skills, acronym: EETDTMSSİS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-29, primaryCompletionDateStruct date: 2024-11-20, completionDateStruct date: 2025-01-20, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Kocaeli Sağlık ve Teknoloji Üniversitesi, class: OTHER, 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.Purpose: 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.Design: A pretest-posttest two-group, quasi-experimental design will be used in the study., conditionsModule conditions: Complication of Injection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 82, type: ESTIMATED, armsInterventionsModule interventions name: video-assisted training group, interventions name: low fidelity simulation model group, outcomesModule primaryOutcomes measure: subcutaneous injection skills, primaryOutcomes measure: ecchymosis, primaryOutcomes measure: hematoma, primaryOutcomes measure: lipoarthrrophy, primaryOutcomes measure: lipohypertrophy, primaryOutcomes measure: pain, primaryOutcomes measure: blood glucose level, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06389617, orgStudyIdInfo id: USM/JEPeM/KK/24010061, briefTitle: Different Doses of Intravenous Administered Dexamethasone Effecting Brachial Plexus Supraclavicular Block, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Hospital Universiti Sains Malaysia, class: OTHER, 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, conditionsModule conditions: End Stage Renal Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: supraclavicular block with 20mls of Ropivacaine 0.5% and Intravenous administered dexamethasone, outcomesModule 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, primaryOutcomes 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, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06389604, orgStudyIdInfo id: NL86367.068.24, briefTitle: Preparing for Heat Waves - Enhancing Human Thermophysiological Resilience, acronym: Prep4heat, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Maastricht University Medical Center, class: OTHER, 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., conditionsModule conditions: Body Temperature Changes, conditions: Heat Exposure, conditions: Heat Stress, conditions: Hyperthermia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Non-randomized, within subject experiemental trial, primaryPurpose: PREVENTION, maskingInfo masking: NONE, maskingDescription: No blinding due to nature of intervention, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Heat acclimation, outcomesModule primaryOutcomes measure: Core temperature, secondaryOutcomes measure: Skin temperature, secondaryOutcomes measure: Sweat rate, secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Skin blood flow, secondaryOutcomes measure: Energy expenditure, secondaryOutcomes measure: Substrate oxidation, secondaryOutcomes measure: Plasma metabolites, secondaryOutcomes measure: Brain blood flow, secondaryOutcomes measure: Flow-mediated dilation, eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06389591, orgStudyIdInfo id: OCR44973, briefTitle: RNA-Lipid Particle (RNA-LP) Vaccines for Recurrent Adult Glioblastoma (GBM), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-12, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Florida, class: OTHER, 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., conditionsModule conditions: Recurrent Glioblastoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: pp65 RNA loaded lipid particles, pp65 RNA-LPs (Drug Product 1 or DP1), interventions name: RNA loaded lipid particles, RNA-LPs (Drug Product 2 or DP2), outcomesModule primaryOutcomes measure: Percentage of vaccines meeting release criteria in the DLT window during the first three vaccines, primaryOutcomes measure: Incidence of investigational treatment related toxicities, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UF Health, city: Gainesville, state: Florida, zip: 32608, country: United States, contacts name: Marcia Hodik, role: CONTACT, phone: 352-273-9000, email: marcia.hodik@neurosurgery.ufl.edu, contacts name: Ashley Ghiaseddin, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.65163, lon: -82.32483, hasResults: False

protocolSection identificationModule nctId: NCT06389578, orgStudyIdInfo id: HZNP-TEP-103, briefTitle: A Study of TEPEZZA® Treatment in Participants With Thyroid Eye Disease, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-07-14, primaryCompletionDateStruct date: 2023-02-28, completionDateStruct date: 2023-09-12, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Horizon Therapeutics USA, Inc., class: INDUSTRY, 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., conditionsModule conditions: Thyroid Eye Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ACTUAL, armsInterventionsModule interventions name: Teprotumumab, outcomesModule primaryOutcomes measure: Pharmacokinetics (PK): Area Under the Curve (AUC) of Teprotumumab, primaryOutcomes measure: PK: Maximum Serum Concentration (Cmax) of Teprotumumab, primaryOutcomes measure: Number of Participants With Adverse Events (AE), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bascom Palmer Eye Institute - University of Miami, city: Miami, state: Florida, zip: 33136, country: United States, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Barnes Jewish Hospital Washington University, city: Saint Louis, state: Missouri, zip: 63108, country: United States, geoPoint lat: 38.62727, lon: -90.19789, locations facility: Neuro-Eye Clinical Trials, city: Bellaire, state: Texas, zip: 77401, country: United States, geoPoint lat: 29.70579, lon: -95.45883, hasResults: False

protocolSection identificationModule nctId: NCT06389565, orgStudyIdInfo id: 2024p000857, briefTitle: Pilot Randomized Clinical Trial of Change My Story, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-01-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, collaborators name: University of Ibadan, 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., conditionsModule conditions: Hiv, conditions: Depression, conditions: Psychological Distress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Problem Solving Therapy, interventions name: Change My Story, outcomesModule primaryOutcomes measure: Engagement, primaryOutcomes measure: Satisfaction, primaryOutcomes measure: Feasibility 1, primaryOutcomes measure: Feasibility 2, primaryOutcomes measure: Feasibility 3, primaryOutcomes measure: Feasibility 4, primaryOutcomes measure: Feasibility 5, primaryOutcomes measure: Feasibility 6, primaryOutcomes measure: Feasibility 7, primaryOutcomes measure: Acceptability 1, primaryOutcomes measure: Acceptability 2, primaryOutcomes measure: Acceptability 3, primaryOutcomes measure: Acceptability 4, primaryOutcomes measure: Acceptability 5, secondaryOutcomes measure: Remission of depression., secondaryOutcomes measure: Remission of psychological distress., secondaryOutcomes measure: ART adherence, secondaryOutcomes measure: Viral suppression, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 24 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06389552, orgStudyIdInfo id: IN_CTP_N01, briefTitle: Long-term Observational Study to Evaluate the DFS and OS of Adjuvant FOLFIRINOX Regimen in Pancreatic Cancer Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-25, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: HK inno.N Corporation, class: INDUSTRY, descriptionModule briefSummary: This study is designed to evaluate the safety and efficacy of adjuvant FOLFIRINOX regimen in pancreatic cancer patients after curative surgery., conditionsModule conditions: Adjuvant Chemotherapy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 36, type: ESTIMATED, outcomesModule primaryOutcomes measure: Disease-free survival, secondaryOutcomes measure: Overall survival, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Seoul ST. Mary's Hospital, status: RECRUITING, city: Seoul, country: Korea, Republic of, contacts name: Myung-Ah Lee, role: CONTACT, contacts name: Myung-Ah Lee, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.566, lon: 126.9784, hasResults: False

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

protocolSection identificationModule nctId: NCT06389526, orgStudyIdInfo id: CHS-1000-01, briefTitle: A Study of CHS-1000 in Participants With Advanced or Metastatic Solid Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-01, primaryCompletionDateStruct date: 2028-01-30, completionDateStruct date: 2028-01-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Coherus Biosciences, Inc., class: INDUSTRY, 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., conditionsModule conditions: Advanced or Metastatic Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: CHS-1000, interventions name: Toripalimab, outcomesModule primaryOutcomes measure: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), secondaryOutcomes measure: Maximum Observed Concentration (Cmax), secondaryOutcomes measure: Area Under the Concentration-time Curve (AUC), secondaryOutcomes measure: Terminal Half-life (t1/2), secondaryOutcomes measure: Number of Participants with Antidrug Antibodies, secondaryOutcomes measure: Investigator-assessed Objective Response Rate (ORR), secondaryOutcomes measure: Duration of Response (DoR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Time to Response (TTP), secondaryOutcomes measure: Progression-free Survival (PFS), secondaryOutcomes measure: Landmark PFS Rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06389513, orgStudyIdInfo id: CTP-MCVF-005, briefTitle: Clinical Study of the Safety of Menhycia® in 3-Month-Old Infants, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: CanSino Biologics Inc., class: INDUSTRY, 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., conditionsModule conditions: Epidemic Meningitis, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 3000, type: ESTIMATED, armsInterventionsModule interventions name: MCV4, outcomesModule primaryOutcomes measure: Incidence of localized adverse reactions in subjects, primaryOutcomes measure: Incidence of systemic adverse reactions in subjects, secondaryOutcomes measure: Incidence of adverse reactions in subjects, secondaryOutcomes measure: Incidence of adverse events in subjects, secondaryOutcomes measure: Incidence of severe adverse events, eligibilityModule sex: ALL, minimumAge: 3 Months, maximumAge: 3 Months, stdAges: CHILD, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06389500, orgStudyIdInfo id: SHR-1316-HLJ-006, briefTitle: HAIC+Adebrelimab+Lenvatinib for Conversion Treatment of Potentially Resectable, Locally Advanced Biliary Tract Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2028-05-01, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Harbin Medical University, class: OTHER, 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., conditionsModule conditions: Biliary Tract Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Adebrelimab, interventions name: Lenvatinib, interventions name: Hepatic Arterial Infusion Chemotherapy, outcomesModule primaryOutcomes measure: R0 resection rate, primaryOutcomes measure: Surgery conversion rate, secondaryOutcomes measure: Objective response rate, secondaryOutcomes measure: pathological complete response rate, secondaryOutcomes measure: Major pathological response rate, secondaryOutcomes measure: Recurrence-free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: AEs, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06389487, orgStudyIdInfo id: 222253, secondaryIdInfos id: 2023-510190-34-00, type: OTHER, domain: EU CTR Number, 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, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-10, primaryCompletionDateStruct date: 2024-08-12, completionDateStruct date: 2025-04-28, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: GlaxoSmithKline, class: INDUSTRY, 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, conditionsModule conditions: Respiratory Syncytial Virus Infections, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 850, type: ESTIMATED, armsInterventionsModule interventions name: RSVPreF3 OA investigational vaccine, outcomesModule primaryOutcomes measure: RSV-A neutralizing titers expressed as Geometric Mean Titers (GMTs) ratio (RSV-OA over RSV-A-AIR), primaryOutcomes measure: Seroresponse rate (SRR) in RSV-A neutralizing titers, primaryOutcomes measure: RSV-B neutralizing titers expressed as GMT ratio (RSV-OA over RSV-A-AIR), primaryOutcomes measure: SRR in RSV-B neutralizing titers, secondaryOutcomes measure: Percentage of participants reporting solicited administration site events, secondaryOutcomes measure: Percentage of participants reporting solicited systemic events, secondaryOutcomes measure: Percentage of participants reporting unsolicited adverse events (AEs), secondaryOutcomes measure: Percentage of participants reporting any serious adverse events (SAEs), related SAEs and fatal SAEs, secondaryOutcomes measure: Percentage of participants reporting any adverse events of special interest (AESIs), including potential immune-mediated diseases (pIMDs) and atrial fibrillation (AF), secondaryOutcomes measure: RSV-A neutralizing titers expressed as GMTs, secondaryOutcomes measure: RSV-B neutralizing titers expressed as GMTs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: GSK Investigational Site, city: Phoenix, state: Arizona, zip: 85023, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Abram Burgher, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.44838, lon: -112.07404, locations facility: GSK Investigational Site, city: Tempe, state: Arizona, zip: 85284, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Joseph Daniel Davis, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.41477, lon: -111.90931, locations facility: GSK Investigational Site, city: North Hollywood, state: California, zip: 91606-3287, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Aaron Weinberg, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.17223, lon: -118.37897, locations facility: GSK Investigational Site, city: Oakland, state: California, zip: 94610, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Allison Boyd, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.80437, lon: -122.2708, locations facility: GSK Investigational Site, city: Walnut Creek, state: California, zip: 94598, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Helen L Stacey, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.90631, lon: -122.06496, locations facility: GSK Investigational Site, city: Hialeah, state: Florida, zip: 33012, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Jose Cardona, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.8576, lon: -80.27811, locations facility: GSK Investigational Site, city: Miami, state: Florida, zip: 33173, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Jorge Caso, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.77427, lon: -80.19366, locations facility: GSK Investigational Site, city: Orlando, state: Florida, zip: 32806, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Felipe Suplicy, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.53834, lon: -81.37924, locations facility: GSK Investigational Site, city: Lexington, state: Kentucky, zip: 40509, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Mark S Adams, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.98869, lon: -84.47772, locations facility: GSK Investigational Site, city: Silver Spring, state: Maryland, zip: 20904, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Jonathan Cohen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.99067, lon: -77.02609, locations facility: GSK Investigational Site, city: Rochester, state: New York, zip: 14609, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Matthew G Davis, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.15478, lon: -77.61556, locations facility: GSK Investigational Site, city: Oklahoma City, state: Oklahoma, zip: 73111, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Charles Lunn, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.46756, lon: -97.51643, locations facility: GSK Investigational Site, city: Knoxville, state: Tennessee, zip: 37909, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: William Smith, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.96064, lon: -83.92074, locations facility: GSK Investigational Site, city: DeSoto, state: Texas, zip: 75115, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Haresh Boghara, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.58986, lon: -96.85695, locations facility: GSK Investigational Site, city: Charlottesville, state: Virginia, zip: 22911, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: James R Clark, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.02931, lon: -78.47668, locations facility: GSK Investigational Site, city: Wenatchee, state: Washington, zip: 98801, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Anton Grasch, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.42346, lon: -120.31035, locations facility: GSK Investigational Site, city: St Leonards, state: New South Wales, zip: 2065, country: Australia, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Munro Neville, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -33.82344, lon: 151.19836, locations facility: GSK Investigational Site, city: Tarragindi, state: Queensland, zip: 4121, country: Australia, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Ferdinandus de Looze, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -27.53333, lon: 153.03333, locations facility: GSK Investigational Site, city: North Melbourne, state: Victoria, zip: 3051, country: Australia, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Michelle Giles, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -37.80132, lon: 144.95822, locations facility: GSK Investigational Site, city: St Albans, state: Victoria, zip: 3021, country: Australia, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Roy Rasalam, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -37.73901, lon: 144.80024, locations facility: GSK Investigational Site, city: New Westminster, state: British Columbia, zip: V3L 3W4, country: Canada, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: David Shu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.20678, lon: -122.91092, locations facility: GSK Investigational Site, city: Victoria, state: British Columbia, zip: V8V 4A1, country: Canada, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Michael B Jones, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.43294, lon: -123.3693, locations facility: GSK Investigational Site, city: Truro, state: Nova Scotia, zip: B2N 1L2, country: Canada, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Murdo Ferguson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.36685, lon: -63.26538, locations facility: GSK Investigational Site, city: Guelph, state: Ontario, zip: N1G 0B4, country: Canada, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Anthony Bier, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.54594, lon: -80.25599, locations facility: GSK Investigational Site, city: London, state: Ontario, zip: N5W 6A2, country: Canada, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Peter Dzongowski, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.98339, lon: -81.23304, locations facility: GSK Investigational Site, city: Sherbrooke, state: Quebec, zip: J1J 2G2, country: Canada, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Jean-Sebastien Gauthier, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.40008, lon: -71.89908, locations facility: GSK Investigational Site, city: St-Charles-Borromée, state: Quebec, zip: J6E 2B4, country: Canada, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Bonavuth Pek, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.05007, lon: -73.46586, locations facility: GSK Investigational Site, city: Quebec, zip: G1N 4V3, country: Canada, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Jean-Francois Roussy, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.81228, lon: -71.21454, locations facility: GSK Investigational Site, city: Québec, zip: G1V 4G2, country: Canada, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Marie-Louise Vachon, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.81228, lon: -71.21454, locations facility: GSK Investigational Site, city: Weinheim, state: Baden-Wuerttemberg, zip: 69469, country: Germany, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Beate Moeckesch, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.54887, lon: 8.66697, locations facility: GSK Investigational Site, city: Wallerfing, state: Bayern, zip: 94574, country: Germany, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Josef Grosskopf, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.68416, lon: 12.88035, locations facility: GSK Investigational Site, city: Wuerzburg, state: Bayern, zip: 97074, country: Germany, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Tino F Schwarz, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.79391, lon: 9.95121, locations facility: GSK Investigational Site, city: Essen, state: Nordrhein-Westfalen, zip: 45355, country: Germany, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Axel Schaefer, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.45657, lon: 7.01228, locations facility: GSK Investigational Site, city: Witten, state: Nordrhein-Westfalen, zip: 58455, country: Germany, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Thomas Horacek, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.44362, lon: 7.35258, locations facility: GSK Investigational Site, city: Mainz, state: Rheinland-Pfalz, zip: 55116, country: Germany, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Bernhard Schmitt, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.98419, lon: 8.2791, locations facility: GSK Investigational Site, city: Berlin, zip: 10117, country: Germany, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Sameer Kulkarni, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.52437, lon: 13.41053, locations facility: GSK Investigational Site, city: Berlin, zip: 10787, country: Germany, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Keikawus Arasteh, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.52437, lon: 13.41053, locations facility: GSK Investigational Site, city: Berlin, zip: 13347, country: Germany, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Nicole Toursarkissian, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.52437, lon: 13.41053, locations facility: GSK Investigational Site, city: Ibaraki, zip: 300-0062, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Kota Yamada, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.81641, lon: 135.56828, locations facility: GSK Investigational Site, city: Kanagawa, zip: 211-0041, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Masamitsu Takahashi, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.58333, lon: 139.91667, locations facility: GSK Investigational Site, city: Tokyo, zip: 155-0031, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Tomofumi Murakami, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.6895, lon: 139.69171, locations facility: GSK Investigational Site, city: Tokyo, zip: 180-0022, country: Japan, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Minoru Nozaki, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.6895, lon: 139.69171, locations facility: GSK Investigational Site, city: Boksburg, state: Gauteng, zip: 1459, country: South Africa, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Agatha C Wilhase, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -26.21197, lon: 28.25958, locations facility: GSK Investigational Site, city: Bellville, zip: 7530, 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protocolSection identificationModule nctId: NCT06389474, orgStudyIdInfo id: CT-INM004-04, briefTitle: A Phase III Study to Evaluate the Efficacy of INM004 in Children With STEC-HUS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-16, primaryCompletionDateStruct date: 2025-07-28, completionDateStruct date: 2025-09-28, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Inmunova S.A., class: OTHER, collaborators name: KLIXAR, collaborators name: Chemo Research, collaborators name: Linical, collaborators name: Crovelis, 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)., conditionsModule conditions: Hemolytic-Uremic Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE3, 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), primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule interventions name: INM004, interventions name: Placebo, outcomesModule primaryOutcomes measure: Time to recovery of renal function during the acute phase, secondaryOutcomes measure: Short-term recovery of renal function, secondaryOutcomes measure: MAKE 90, secondaryOutcomes measure: Dialysis longer than 10 days, secondaryOutcomes measure: Dialysis requirement, secondaryOutcomes measure: Mortality, otherOutcomes measure: CKD Risk Assessment According to Kidney Disease Improving Global Outcomes (KDIGO) Categories, otherOutcomes measure: Evolution of renal function at 7 days (GFR_AUC1-7), otherOutcomes measure: Evolution of renal function at 28 days (GFR_AUC1-28), otherOutcomes measure: Evolution of renal function at 90 days (GFR_AUC1-90), otherOutcomes measure: Incidence of anuria, otherOutcomes measure: Extrarenal composite endpoint, otherOutcomes measure: Recovery of the thrombotic microangiopathy (TMA), thrombocytopenia, otherOutcomes measure: Recovery of the thrombotic microangiopathy (TMA), hemolytic anemia, otherOutcomes measure: Duration of hospitalization, otherOutcomes measure: Incidence of adverse events of special interest, otherOutcomes measure: Incidence of adverse events, otherOutcomes measure: Pharmacokinetic - AUC0-t, otherOutcomes measure: Pharmacokinetic - AUC0-inf, otherOutcomes measure: Pharmacokinetic - Cmax, otherOutcomes measure: Pharmacokinetic - Tmax, otherOutcomes measure: Pharmacokinetic - λz, otherOutcomes measure: Pharmacokinetic - t1/2, otherOutcomes measure: Pharmacokinetic - Vz, otherOutcomes measure: Pharmacokinetic - Cl, otherOutcomes measure: Pharmacokinetic - AUC/dose, otherOutcomes measure: Pharmacokinetic - Cmax/dose, otherOutcomes measure: Baseline Shiga toxin serum levels, otherOutcomes measure: Kinetics of Shiga toxin in serum, eligibilityModule sex: ALL, minimumAge: 9 Months, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Hospital El Cruce - Néstor Kirchner, city: Florencio Varela, state: Buenos Aires, country: Argentina, geoPoint lat: -34.82722, lon: -58.39556, locations facility: Hospital Interzonal Especializado Materno Infantil Don Victorio Tetamanti, city: Mar Del Plata, state: Buenos Aires, country: Argentina, geoPoint lat: -38.00228, lon: -57.55754, locations facility: Sanatorio de Niños, city: Rosario, state: Santa Fe, country: Argentina, geoPoint lat: -32.94682, lon: -60.63932, locations facility: Clínica Zabala, city: Ciudad Autonoma de Buenos Aire, country: Argentina, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Hospital de Niños Dr. Ricardo Gutierrez, city: Ciudad Autonoma de Buenos Aire, country: Argentina, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Hospital de Niños de la Santísima Trinidad, city: Córdoba, country: Argentina, geoPoint lat: -31.4135, lon: -64.18105, locations facility: Sanatorio Allende, city: Córdoba, country: Argentina, geoPoint lat: -31.4135, lon: -64.18105, locations facility: Hospital Pediátrico Dr. Humberto Notti, city: Mendoza, country: Argentina, geoPoint lat: -32.89084, lon: -68.82717, hasResults: False

protocolSection identificationModule nctId: NCT06389461, orgStudyIdInfo id: OST1_012, briefTitle: 4th Ventricular Compression Technique on Anxiety, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-16, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Escola Superior de Tecnologia da Saúde do Porto, class: OTHER, 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., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: 4th Ventricular Compression Technique, interventions name: "Sham" Therapy, outcomesModule 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, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 25 Years, stdAges: ADULT, contactsLocationsModule locations facility: Escola Superior da Saúde do Porto, city: Porto, zip: 4200-072, country: Portugal, geoPoint lat: 41.14961, lon: -8.61099, hasResults: False

protocolSection identificationModule nctId: NCT06389448, orgStudyIdInfo id: pCLE vs EB 2024tj, briefTitle: Comparison of pCLE and EB in Gastric Lesion Diagnosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-11, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-10, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Huazhong University of Science and Technology, class: OTHER, 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., conditionsModule conditions: Low Grade Intraepithelial Neoplasia, conditions: High Grade Intraepithelial Neoplasia, conditions: Early Gastric Cancer, conditions: Gastric Intraepithelial Neoplasia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Participants undergo pCLE after pre-ESD assessment and before ESD resection., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 366, type: ESTIMATED, armsInterventionsModule interventions name: pCLE-gastr, outcomesModule 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, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430030, country: China, contacts name: Bin Cheng, Professor, role: CONTACT, phone: 86-027-8366-3333, email: bcheng@tjh.tjmu.edu.cn, contacts name: Yilin Gu, role: CONTACT, phone: 86-19884836004, email: yilingu2019@163.com, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False

protocolSection identificationModule nctId: NCT06389435, orgStudyIdInfo id: 2024DS, secondaryIdInfos id: Knee, type: OTHER, domain: Danderyds sjukhus, briefTitle: RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques, acronym: ROCKETS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2027-01, completionDateStruct date: 2028-01, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Danderyd Hospital, class: OTHER, collaborators name: Karolinska Institutet, collaborators name: Stockholm South General Hospital, descriptionModule briefSummary: Rationale for conducting the study:The 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.Study design:Multicentre,, preference-tolerant, randomized, controlled, superiority trial with two treatment arms that compares the outcomes of RTKR with traditional TKR techniques.Study population:Adult 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.Number of patients:400Inclusion criteria:Patients must be adults aged 18 years and older, eligible for TKR according to local guidelines, and willing to participate in the study.Exclusion criteria:Patients 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.Primary outcome variables:The Forgotten Joint Score (FJS) at 2 years after surgery, conditionsModule conditions: Knee Arthroplasty, Total, conditions: Robotic-assisted, conditions: Osteoarthritis of the Knee, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Patients will be randomized to undergo TKR or RTKR, outcomesModule primaryOutcomes measure: The Forgotten Joint Score (FJS), secondaryOutcomes measure: KOOS, secondaryOutcomes measure: ADLS knee instability, secondaryOutcomes measure: The Forgotten Joint Score (FJS), secondaryOutcomes measure: EQ-5D, secondaryOutcomes measure: Knee alignment, secondaryOutcomes measure: Adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Danderyds Sjukhus, status: RECRUITING, city: Stockholm, zip: 18288, country: Sweden, contacts name: Olof Skoldenberg, Md, PhD, role: CONTACT, phone: 800-555-5555, email: olof.skoldenberg@ki.se, contacts name: Olof Skoldenberg, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Karl Erikson, MD, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False

protocolSection identificationModule nctId: NCT06389422, orgStudyIdInfo id: NCC4620, briefTitle: Phase II Study of Moderate-dose Hypofractionated RT Combined With Pembrolizumab for HCC With Diffuse Tumor Thrombosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2027-04-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences, class: OTHER, 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., conditionsModule conditions: Hepatocellular Carcinoma, conditions: Radiotherapy, conditions: Pembrolizumab, conditions: Tumor Thrombosis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Moderate-dose Hypofractionated Intensity-modulated Radiotherapy, interventions name: Pembrolizumab, outcomesModule primaryOutcomes measure: Median Overall Survival, secondaryOutcomes measure: Objective Response Rate, secondaryOutcomes measure: Progression-free Survival, secondaryOutcomes measure: Toxicity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciecnces and Peking Union Medical College, status: RECRUITING, city: Beijing, state: Beijing, country: China, contacts name: Bo Chen, MD, role: CONTACT, phone: 0086-13240000876, email: chenboo@outlook.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False

protocolSection identificationModule nctId: NCT06389409, orgStudyIdInfo id: Protocollo N.2009 Testicolo, briefTitle: Study on the Quality of Life and Functional/Oncological Outcome of Testicular Cancer Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2010-08-24, primaryCompletionDateStruct date: 2030-09-01, completionDateStruct date: 2040-08-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: IRCCS San Raffaele, class: OTHER, 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.From 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., conditionsModule conditions: Testicular Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 3000, type: ESTIMATED, armsInterventionsModule interventions name: Observation of testicular cancer patients, outcomesModule primaryOutcomes measure: Clinical data, primaryOutcomes measure: Adjuvant therapy, primaryOutcomes measure: lactate dehydrogenase, primaryOutcomes measure: Testicular objective examination, primaryOutcomes measure: Testicular objective examination - cysts, primaryOutcomes measure: Testicular objective examination - nodules, primaryOutcomes measure: Testicular objective examination - varicocele, primaryOutcomes measure: Testicular objective examination - hydrocele, primaryOutcomes measure: α-feto protein, primaryOutcomes measure: β human Chorionic Gonadotropin, primaryOutcomes measure: carcinoembryonic antigen, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Ospedale San Raffaele, status: RECRUITING, city: Milan, state: Lombardy, zip: 20132, country: Italy, contacts name: Alessia d'Arma, PhD, role: CONTACT, phone: 02 2643 5506, email: darma.alessia@hsr.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False

protocolSection identificationModule nctId: NCT06389396, orgStudyIdInfo id: CP362, briefTitle: Investigation of a New Rectal Catheter for Users of Transanal Irrigation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Coloplast A/S, class: INDUSTRY, descriptionModule briefSummary: The clinical investigation is an exploratory, randomised controlled, open-labelled, crossover investigation.The clinical investigation will be conducted as a multi-centre clinical investigation in two different clinical investigation sites in Denmark., conditionsModule conditions: Bowel Management, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: CP362 Test Catheter, outcomesModule primaryOutcomes measure: The primary endpoint is: Was it possible to perform transanal irrigation (assessed after irrigation at V1 and V2), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Århus Universitetshospital, status: RECRUITING, city: Århus, state: Jutland, zip: 8200, country: Denmark, contacts name: Peter Christensen, role: CONTACT, geoPoint lat: 56.15674, lon: 10.21076, locations facility: Amager Hvidovre Hospital, status: RECRUITING, city: Hvidovre, state: Zealand, zip: 2650, country: Denmark, contacts name: Michael Sørensen, role: CONTACT, geoPoint lat: 55.65719, lon: 12.47364, hasResults: False

protocolSection identificationModule nctId: NCT06389383, orgStudyIdInfo id: 22-0182, briefTitle: Pilot Study - Monitoring the Nasal Microbiome and Viral Respiratory Infections in Newborn Hospitalized in Neonatalogy., acronym: NEONATMICROBIO, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-12-21, primaryCompletionDateStruct date: 2023-06-30, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University Hospital, Caen, class: OTHER, 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., conditionsModule conditions: Newborn; Infection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 38, type: ACTUAL, armsInterventionsModule interventions name: Nasal Swab, outcomesModule primaryOutcomes measure: rate of viral infections, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CAEN University Hospital, city: Caen, country: France, geoPoint lat: 49.18585, lon: -0.35912, hasResults: False

protocolSection identificationModule nctId: NCT06389370, orgStudyIdInfo id: knowledge, Attitude, Behaviour, 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, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-11-04, primaryCompletionDateStruct date: 2024-11-18, completionDateStruct date: 2024-12-03, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, 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.There 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., conditionsModule conditions: Oral Health Knowledge, Attitude and Behaviour of Dental Students, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 535, type: ESTIMATED, armsInterventionsModule interventions name: HU-DBI questionnaire, outcomesModule primaryOutcomes measure: Increase of dental students KAB by preceding through higher academic levels, eligibilityModule sex: ALL, minimumAge: 17 Years, maximumAge: 27 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06389357, orgStudyIdInfo id: 1305G2024, briefTitle: Return to School Adaptation Programme for Children With Cancer, acronym: web-based, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2024-09-06, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Gazi University, class: OTHER, 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.H1: 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?, conditionsModule conditions: Childhood Cancer, conditions: ALL, Childhood, conditions: AML, Childhood, conditions: Lymphoma, conditions: Solid Tumor, Childhood, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The research is a technical/scientific/collaborative action research design., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: training and counselling, outcomesModule primaryOutcomes measure: social anxiety, primaryOutcomes measure: coping, primaryOutcomes measure: back to school readiness, secondaryOutcomes measure: process evaluation, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Gizem Cakir, city: Ankara, state: Cankaya, zip: 06490, country: Turkey, contacts name: Gizem Cakir, PhD(c), role: CONTACT, phone: +905300858879, email: cakirgzem@gmail.com, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False

protocolSection identificationModule nctId: NCT06389344, orgStudyIdInfo id: lk20240401, briefTitle: Effect of Esketamine on Conscious State in Patients With pDoC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Beijing Tiantan Hospital, class: OTHER, 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.Participants 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., conditionsModule conditions: Esketamine, conditions: Consciousness Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 116, type: ESTIMATED, armsInterventionsModule interventions name: Esketamine, interventions name: normal saline, outcomesModule primaryOutcomes measure: Coma recovery scale-revised(CRS-R), secondaryOutcomes measure: Coma recovery scale-revised(CRS-R), secondaryOutcomes measure: Full Outline of UnResponsiveness(FOUR), secondaryOutcomes measure: Glasgow coma scale(GCS), secondaryOutcomes measure: Original EEG, secondaryOutcomes measure: Patient state index(PSI), secondaryOutcomes measure: Power spectral density, secondaryOutcomes measure: Burst-suppression ratio, secondaryOutcomes measure: Spectral edge frequency, secondaryOutcomes measure: The incidence of perioperative adverse events, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 65 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06389331, orgStudyIdInfo id: IRC/1971/020, briefTitle: Study on Effects of Defect Closure in Laparoscopic Repair of Direct Inguinal Hernia, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-09-01, primaryCompletionDateStruct date: 2021-06-30, completionDateStruct date: 2021-08-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: B.P. Koirala Institute of Health Sciences, class: OTHER, descriptionModule briefSummary: The defect closure was found to have higher pain and less seroma formation at various intervals of time following TEP for moderate-large direct inguinal hernia. Although these findings were statistically insignificant, they may be clinically significant, and further studies with a larger sample size are suggested., conditionsModule conditions: Hernia, conditions: Direct Inguinal Hernia, conditions: Seroma Following Procedure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 88, type: ACTUAL, armsInterventionsModule interventions name: closed the defect with barbed suture, outcomesModule primaryOutcomes measure: seroma, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vijay Pratap Sah, city: Malangwa, state: Madhesh Pradesh, country: Nepal, geoPoint lat: 26.85679, lon: 85.55811, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_ICF, hasProtocol: True, hasSap: False, hasIcf: True, label: Study Protocol and Informed Consent Form, date: 2020-09-01, uploadDate: 2024-04-24T12:06, filename: Prot_ICF_000.pdf, size: 190465, hasResults: False

protocolSection identificationModule nctId: NCT06389318, orgStudyIdInfo id: RC 29-11-2023, briefTitle: Buccal Midazolam Versus Intranasal Dexmedetomidine Plus Oral Chloral Hydrate in Inguinal Hernia Repair, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-26, primaryCompletionDateStruct date: 2024-03-26, completionDateStruct date: 2024-04-24, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Benha University, class: OTHER, descriptionModule briefSummary: Inguinal hernia surgery is one of the most common surgical procedures in early infancy. Preoperative anxiety remains a vexing issue, and it exists in nearly 50% of pediatric patients, conditionsModule conditions: Inguinal Hernia Repair, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Group A (40 patients): Children received oral placebo syrup, Group B (40 patients): Children received oral chloral hydrate (Chloral Hydrate mixture), primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: Both participant and the care-provider in this trial were blinded., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 80, type: ACTUAL, armsInterventionsModule interventions name: buccal midazolam +oral placebo syrup, interventions name: oral chloral hydrate,intranasal dexmedetomidine and buccal normal saline, outcomesModule primaryOutcomes measure: Ramsay sedation score, secondaryOutcomes measure: Parental separation anxiety scale, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 7 Years, stdAges: CHILD, contactsLocationsModule locations facility: Benha University, city: Banha, zip: 13511, country: Egypt, geoPoint lat: 30.45906, lon: 31.17858, hasResults: False

protocolSection identificationModule nctId: NCT06389305, orgStudyIdInfo id: BJGBYY-IIT-LCYJ-2024-012, briefTitle: CIK Cell Therapy for Relapsed or Refractory Acute B-Lymphoblastic Leukemia: Prognostic Impact on Patients With Early CAR-T Cell Dysfunction, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Beijing GoBroad Hospital, class: OTHER, descriptionModule briefSummary: This is a single-center, double-blind, randomized trial. Patients with r/r B-ALL experiencing early functional exhaustion of CAR-T cells will be randomly allocated into three groups: the control cell group, the CIK treatment group, and the mRNA-CIK treatment group. The primary objective of the study is to evaluate the prognostic impact of CIK cell therapy on the early functional exhaustion of CAR-T cells in children and adolescent and young adult (AYA) with r/r B-ALL. The primary endpoint of the study is the event-free survival rate of these patient in the CIK cell therapy group.A total number of 213 subjects will be enrolled., conditionsModule conditions: B-cell Acute Lymphoblastic Leukemia, conditions: Acute Lymphoblastic Leukemia, in Relapse, conditions: Refractory Acute Lymphoid Leukemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: a prospective cohort study, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 213, type: ESTIMATED, armsInterventionsModule interventions name: peripheral blood lymphocytes, interventions name: CIK cell, outcomesModule primaryOutcomes measure: EFS in CIK infusion group, secondaryOutcomes measure: PFS in CIK infusion group, secondaryOutcomes measure: DOR in CIK infusion group, secondaryOutcomes measure: OS in CIK infusion group, secondaryOutcomes measure: EFS in mRNA-CIK infusion group, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 39 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Beijing GoBroad Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 102206, country: China, contacts name: Tengyu Wang, role: CONTACT, phone: 86+18333186020, email: tengyu.wang@gohealtharo.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False

protocolSection identificationModule nctId: NCT06389292, orgStudyIdInfo id: APG2575AG301, briefTitle: A Pivotal Phase 3 Study of APG-2575 (Lisaftoclax) Combined With Azacytidine in the Treatment of Acute Myeloid Leukemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2028-05-25, completionDateStruct date: 2029-03-26, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Ascentage Pharma Group Inc., class: INDUSTRY, descriptionModule briefSummary: An international multicenter, randomized, double-blind, placebo-controlled, phase III pivotal registration study, to evaluate the efficacy of APG-2575 (Lisaftoclax) combined with azacitidine (AZA) versus placebo combined with azacitidine in newly diagnosed acute myeloid leukemia who are not eligible for standard induction chemotherapy., conditionsModule conditions: Acute Myeloid Leukemia, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 486, type: ESTIMATED, armsInterventionsModule interventions name: Lisaftoclax (APG-2575), interventions name: Placebo, interventions name: Azacitidine Injection, outcomesModule primaryOutcomes measure: Overall Survival（OS）, secondaryOutcomes measure: Percentage of Participants with Objective Response Rate (ORR), secondaryOutcomes measure: Safety evaluation based on the adverse event concurrence, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hematology Hospital of the Chinese Academy of Medical Sciences, city: Tianjin, state: Tianjin, zip: 300020, country: China, contacts name: Hui Wei, M.D., role: CONTACT, phone: 022-23909120, email: weihui@ihcams.ac.cn, contacts name: Hui Wei, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.14222, lon: 117.17667, locations facility: The First Affiliated Hospital of Zhejiang University School of Medicine, city: Hangzhou, state: Zhejiang, zip: 310003, country: China, contacts name: Jie Jin, M.D., role: CONTACT, email: jiej0503@163.com, contacts role: CONTACT, phone: 0571-87236896, contacts name: Jie Jin, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False

protocolSection identificationModule nctId: NCT06389279, orgStudyIdInfo id: 2023-18/11, briefTitle: The Effect of Facial Plane Blocks on Postoperative Recovery Quality in Hip Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-24, primaryCompletionDateStruct date: 2024-09-24, completionDateStruct date: 2024-10-24, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Antalya Training and Research Hospital, class: OTHER_GOV, descriptionModule briefSummary: The aim of this study was to evaluate the effect of ultrasound-guided pericapsular nerve block, fascia iliaca compartment block, and femoral block on the quality of recovery as part of multimodal analgesia before hip surgery under spinal anesthesia., conditionsModule conditions: Hip Fracture, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: PENG block group, interventions name: FIC block group, interventions name: Femoral block group, interventions name: Control group, outcomesModule primaryOutcomes measure: recovery quality, secondaryOutcomes measure: postoperative Numeric Rating Scale (NRS) pain score, secondaryOutcomes measure: postoperative opioid consumption, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Health Sciences, Antalya Training and Researh Hospital, city: Antalya, country: Turkey, contacts name: Antalya Training and Research Hospital, role: CONTACT, geoPoint lat: 36.90812, lon: 30.69556, hasResults: False

protocolSection identificationModule nctId: NCT06389266, orgStudyIdInfo id: 221550, briefTitle: Network-Targeted Neuromodulation for Nicotine Dependence in Schizophrenia, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-15, primaryCompletionDateStruct date: 2029-01-10, completionDateStruct date: 2029-01-10, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Vanderbilt University Medical Center, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare two active types of transcranial magnetic stimulation in two nicotine-using populations: nicotine-using people with psychosis and nicotine-using people without a diagnosis of a psychotic disorder. The main questions it aims to answer are:1. Can rTMS change functional connectivity in brain circuits associated with nicotine use?2. Are those rTMS-induced changes in functional connectivity related to craving?Participants will complete tasks assessing their cognitive performance and craving before and after each week of TMS. Researchers will compare the effect of each TMS intervention on participants with and without psychosis to see if one type of TMS has an effect on nicotine craving., conditionsModule conditions: Schizophrenia, conditions: Nicotine Dependence, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: All participants receive five days of DMN-targeted cTBS and five days of L DLPFC-targeted iTBS. The order in which participants receive the two types of TMS is randomized., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, maskingDescription: The study is not sham-controlled, as both arms are active TMS treatments. The type of TMS is not masked from the participant or the investigator. Statistician will be blinded to intervention., enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Repetitive Transcranial Magnetic Stimulation (rTMS), outcomesModule primaryOutcomes measure: Resting-state functional connectivity, primaryOutcomes measure: Cue-induced craving, primaryOutcomes measure: Tiffany Brief Questionnaire of Smoking Urges (QSU), primaryOutcomes measure: Self-reported craving, secondaryOutcomes measure: Wisconsin Smoking Withdrawal Scale (WSWS), secondaryOutcomes measure: Fagerstrom Test for Nicotine Dependence (FTND), secondaryOutcomes measure: Self-reported nicotine use, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vanderbilt University Medical Center, status: RECRUITING, city: Nashville, state: Tennessee, zip: 37232, country: United States, contacts name: Heather B Ward, MD, role: CONTACT, phone: 615-327-7000, email: heather.b.ward@vumc.org, contacts name: Sophia H Blyth, BA, role: CONTACT, phone: 6154345891, email: sophia.h.blyth@vumc.org, contacts name: Stephan Heckers, MD, MSc, role: SUB_INVESTIGATOR, contacts name: Hilary A Tindle, MD, MPH, role: SUB_INVESTIGATOR, geoPoint lat: 36.16589, lon: -86.78444, hasResults: False

protocolSection identificationModule nctId: NCT06389253, orgStudyIdInfo id: HTSW1, briefTitle: Subtalar Extra-articular Screw Arthroereisis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Università Vita-Salute San Raffaele, class: OTHER, descriptionModule briefSummary: The aim of the study is to investigate the effect of subtalar extra-articular calcaneo-stop screw on the proprioceptive and nociceptive pathways of the ankle before and after implantation. The hypothesis of the study is that an increased number of receptors related to proprioception will be detected in the sinus tarsi., conditionsModule conditions: Flatfoot, Flexible, conditions: Ankle Proprioception, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Histological Analysis, outcomesModule primaryOutcomes measure: Primary Endpoint (%), secondaryOutcomes measure: Secondary Endpoint, eligibilityModule sex: ALL, minimumAge: 10 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ircss Ospedale San Raffaele, city: Milan, state: Lombardy, zip: 20149, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Università Vita-Salute San Raffaele, city: Milan, zip: 20132, country: Italy, contacts name: Francesco Pezone, role: CONTACT, contacts role: CONTACT, email: f.pezone@studenti.unisr.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False

protocolSection identificationModule nctId: NCT06389240, orgStudyIdInfo id: 160848, briefTitle: Early Weight Bearing in Unicondylar Tibial Plateau Fractures, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-12-21, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Utah, class: OTHER, descriptionModule briefSummary: The investigators aim of the study is to assess the effects of early mobilization after surgically treated unicondylar tibia plateau fractures (6 weeks without weight bearing) on gait, patient satisfaction, return to work/sports and complication rate. The data will be compared to a 10-12 week non-weight bearing group (standard of care).It is assumed that earlier mobilization does not lead to an increase in the complications - in particular osteosynthesis failure and infections -, but leads to improved patient satisfaction, reduced return to work/sports times, and has a positive impact on the overall outcome, conditionsModule conditions: Early Mobilization, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: 6 weeks post-operatively early weight bearing, interventions name: 10 weeks post-operatively weight bearing (standard of care), outcomesModule primaryOutcomes measure: Average peak load (Newtons (N)), primaryOutcomes measure: Average peak load (Newtons (N)), primaryOutcomes measure: Average peak load (Newtons (N)), primaryOutcomes measure: Average peak load (Newtons (N)), primaryOutcomes measure: Average peak load (Newtons (N)), primaryOutcomes measure: Average peak load (Newtons (N)), primaryOutcomes measure: Average peak load (Newtons (N)), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Utah Orthopedics, city: Salt Lake City, state: Utah, zip: 84108, country: United States, geoPoint lat: 40.76078, lon: -111.89105, hasResults: False

protocolSection identificationModule nctId: NCT06389227, orgStudyIdInfo id: 0433611, briefTitle: Developing the Physical Performance in Youth Soccer: Short-term Effect of Dynamic-Ecological Versus Traditional Training Approach for Sub-élite U13 Players: An Ecological Exploratory Cluster Randomised Trial, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-10-15, primaryCompletionDateStruct date: 2023-10-30, completionDateStruct date: 2024-02-15, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Turin, Italy, class: OTHER, descriptionModule briefSummary: Therefore, this study aims to verify the effects of a soccer training program based on the dynamic-ecological approach on U13 sub-elité players' physical efficiency by analysing explosive strength, speed, resistance to speed and muscle flexibility. This study hypothe-sises that the dynamic-ecological approach can consistently help players develop adequate physical efficiency and motor coordination., conditionsModule conditions: Verify the Effects of a Soccer Training Program Based on the Dynamic-ecological Approach on U13 Sub-elité Players' Physical Efficiency, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ACTUAL, armsInterventionsModule interventions name: dynamic ecological approach (DEA), interventions name: traditional training group, outcomesModule primaryOutcomes measure: Number of participants evaluated on physical efficiency, eligibilityModule sex: MALE, minimumAge: 12 Years, maximumAge: 13 Years, stdAges: CHILD, contactsLocationsModule locations facility: Cit Turin LDE, city: Turin, zip: 10100, country: Italy, geoPoint lat: 45.07049, lon: 7.68682, hasResults: False

protocolSection identificationModule nctId: NCT06389214, orgStudyIdInfo id: ADX-102-DED-030, briefTitle: A Phase 3 Clinical Trial to Assess the Efficacy and Safety of Subjects With Dry Eye Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-09, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Aldeyra Therapeutics, Inc., class: INDUSTRY, descriptionModule briefSummary: A Randomized, Double-Masked, Vehicle-Controlled Parallel Group Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease, conditionsModule conditions: Dry Eye Disease, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Reproxalap Ophthalmic Solution (0.25%), interventions name: Vehicle Ophthalmic Solution, outcomesModule primaryOutcomes measure: Ocular discomfort symptom score over 100 minutes in the dry eye chamber at Visit 2 and Visit 4, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cliantha Research, status: RECRUITING, city: Mississauga, state: Ontario, country: Canada, contacts name: Patricia Couroux, MD, role: CONTACT, phone: (888) 989-1808, email: pcouroux@cliantha.com, geoPoint lat: 43.5789, lon: -79.6583, hasResults: False

protocolSection identificationModule nctId: NCT06389201, orgStudyIdInfo id: 2024HCQ, briefTitle: Pretreatment With HCQ Before Radiotherapy and Chemotherapy in Advanced NPC Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Affiliated Hospital of Nantong University, class: OTHER, descriptionModule briefSummary: Dormant cancer cells that survive anti-cancer therapy can lead to cancer recurrence and disseminated metastases that prove fatal in most cases. Recently, specific dormant polyploid giant cancer cells (PGCC) have drawn our attention because of their association with the clinical risk of nasopharyngeal carcinoma (NPC) recurrence, as demonstrated by previous clinical data. In study, we report the biological properties of PGCC, and reveal that autophagy is a critical mechanism of PGCC induction. Moreover, pharmacological inhibition of autophagy greatly impaired PGCC formation, significantly suppressing metastasis and improving survival in a mouse model. Mechanistically, chemotherapeutic drugs partly damaged mitochondria, and activated autophagy to promote PGCC formation. High numbers of PGCCs correlated with shorter recurrence time and worse survival outcomes in NPC patients. Collectively, these findings suggest a therapeutic approach of targeting dormant PGCCs in cancer.Pretreatment with an autophagy inhibitor (HCQ) before chemotherapy and radiotherapy could prevent formation of therapy-induced dormant polyploid giant cancer cells, thereby reducing recurrence and metastasis of nasopharyngeal carcinoma., conditionsModule conditions: Nasopharyngeal Carcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: HCQ, interventions name: Placebo, outcomesModule primaryOutcomes measure: Recurrence and metastasis, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bo You, city: Nantong, state: Jiangsu, zip: 226000, country: China, geoPoint lat: 32.03028, lon: 120.87472, hasResults: False

protocolSection identificationModule nctId: NCT06389188, orgStudyIdInfo id: JVT003, briefTitle: Effectiveness of Cervical Osteopathic Manipulation in Patients With Whiplash, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Universidad Miguel Hernandez de Elche, class: OTHER, collaborators name: Consorci Sanitari de Terrassa, descriptionModule briefSummary: To determine the mid- and long-term efficiency (15, 30 and 120 days after starting sessions) of the SAT technique in patients with grade II acute WL, comparing it with a conventional rehabilitation program., conditionsModule conditions: Whiplash, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: RHB Group, outcomesModule primaryOutcomes measure: Subjective pain intensity, primaryOutcomes measure: Neck specific disability, secondaryOutcomes measure: Cervical range of motion (CROM), secondaryOutcomes measure: Cervical lordosis Cobb angle, secondaryOutcomes measure: Hospital anxiety and depression scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Consorci Sanitari de Terrassa., city: Terrassa, state: Barcelona, zip: 08227, country: Spain, contacts name: Joan Parera-Turull, PhD, role: CONTACT, phone: 937310007, phoneExt: 0007, email: joanparera@osteopatiaterrassa.com, geoPoint lat: 41.56667, lon: 2.01667, hasResults: False

protocolSection identificationModule nctId: NCT06389175, orgStudyIdInfo id: BON001, secondaryIdInfos id: KR 4555/10-1, type: OTHER_GRANT, domain: Deutsche Forschungsgemeinschaft (DFG), briefTitle: Non-invasive Vagus Nerve Stimulation as a Tool to Modulate Stomach-Brain Coupling in Depression, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Bonn, class: OTHER, collaborators name: University Hospital Tuebingen, descriptionModule briefSummary: The overarching goal of the project is to determine whether differences in stomach-brain coupling contribute to key symptoms of major depressive disorder (MDD) and whether transcutaneous non-invasive vagus nerve stimulation (tVNS) may serve as a non-invasive intervention to improve aberrant interoceptive signaling in participants suffering from MDD., conditionsModule conditions: Depressive Disorder, Major, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Transcutaneous non-invasive vagus nerve stimulation (tVNS), interventions name: Sham stimulation, outcomesModule primaryOutcomes measure: Stimulation-induced acute changes in stomach-brain coupling, primaryOutcomes measure: Stimulation-induced acute changes in gastric motility, primaryOutcomes measure: Stimulation-induced mid-term changes in gastric motility, primaryOutcomes measure: Stimulation-induced mid-term changes in self-reported interoception, primaryOutcomes measure: Stimulation-induced mid-term changes in somatic symptoms, primaryOutcomes measure: Stimulation-induced mid-term changes in depressive symptoms, primaryOutcomes measure: Stimulation-induced acute neural changes in food cue reactivity, primaryOutcomes measure: Stimulation-induced acute behavioral changes in invigoration, primaryOutcomes measure: Stimulation-induced acute neural changes during foraging, primaryOutcomes measure: Stimulation-induced acute behavioral changes in foraging decisions, secondaryOutcomes measure: Stimulation-induced mid-term changes in positive and negative affect, secondaryOutcomes measure: Stimulation-induced mid-term changes in self-reported interoception, secondaryOutcomes measure: Stimulation-induced mid-term changes in motivation, secondaryOutcomes measure: Stimulation-induced mid-term changes in physical activity, secondaryOutcomes measure: Stimulation-induced mid-term changes in heart rate, secondaryOutcomes measure: Stimulation-induced acute changes in blood parameters, secondaryOutcomes measure: Stimulation-induced mid-term changes in blood parameters, secondaryOutcomes measure: Stimulation-induced mid-term changes in composition of microbiome, otherOutcomes measure: Stimulation-induced mid-term changes in discounting-related decision-making, otherOutcomes measure: Stimulation-induced mid-term changes in reward learning, otherOutcomes measure: Stimulation-induced mid-term changes in loneliness, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06389162, orgStudyIdInfo id: UNLV-2024-115, briefTitle: Dorsolateral Prefrontal Cortex Transcranial Direct Current and Muscle Fatigue Stimulation on Muscle Fatigue, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Nevada, Las Vegas, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn if transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC) can impact muscle fatigue. The main questions it aims to answer are:1. Does tDCS of the left DLPFC increase the time that a fatiguing contraction can be maintained?2. Does tDCS of the left DLPFC decrease the rate of increase of muscle activity, force error, and standard deviation of force during a fatiguing contraction.Researchers will compare tDCS of the left DLPFC to a SHAM stimulation (a type of stimulation that feels like real tDCS but does not elicit physiological effects) to see if tDCS of the left DLPFC works to reduce the progression of muscle fatigue.Participants will:Performing two experimental sessions held 3-10 days apart (usually 7 days) Perform a 9 hole pegboard test, maximum voluntary contractions, and a fatiguing contraction., conditionsModule conditions: Fatigue, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Double-blind, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: transcranial direct current stimulation, outcomesModule primaryOutcomes measure: Time to Task Failure, primaryOutcomes measure: Fatigue Index, secondaryOutcomes measure: Average EMG activity, secondaryOutcomes measure: Force error, secondaryOutcomes measure: Standard deviation of force, secondaryOutcomes measure: 9 Hole Pegboard Test, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Nevada Las Vegas, city: Las Vegas, state: Nevada, zip: 89154, country: United States, geoPoint lat: 36.17497, lon: -115.13722, hasResults: False