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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