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protocolSection identificationModule nctId: NCT06380972, orgStudyIdInfo id: HDM6009A-301, briefTitle: A Prospective, Randomized, No-treatment Controlled, Evaluator-blinded Clinical Trial to Evaluate the Efficacy and Safety of Polycaprolactone Microspherical Injectable to Improve Forehead Contour, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: AQTIS Medical B.V., class: OTHER, descriptionModule briefSummary: A Prospective, Multicenter, Randomized, No-treatment-controlled, Evaluator-blinded, Superiority Clinical Trial to Evaluate the Efficacy and Safety of Polycaprolactone Based Facial Injectable to Improve Forehead Contour, conditionsModule conditions: Forehead Contouring, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: the method of endpoint blind evaluation is adopted, that is, it's blinded for the evaluator., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 189, type: ESTIMATED, armsInterventionsModule interventions name: Polycaprolactone (PCL) Based Facial Injectable, outcomesModule primaryOutcomes measure: The response rate for improving the forehead contour is assessed by the blinded investigator using the Asian Sloping Forehead Scale (ASFS), secondaryOutcomes measure: The response rate of forehead contour improvement assessed by blinded investigator using Asian Sloping Forehead Scale (ASFS), secondaryOutcomes measure: The response rate of forehead contour improvement assessed by injection investigator using Asian Sloping Forehead Scale (ASFS), secondaryOutcomes measure: The global aesthetic improvement rate assessed by the injection investigator based on the Global Aesthetic Improvement Scale (GAIS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Guangdong Second Provincial General Hospital, city: Guangzhou, state: Guangdong, zip: 510317, country: China, contacts name: Shengkang Luo, role: CONTACT, phone: 02089168071, email: luoshengkang63@hotmail.com, contacts name: WEIJIN HONG, role: CONTACT, phone: 02089168071, contacts name: shengkang luo, role: PRINCIPAL_INVESTIGATOR, contacts name: weijin hong, role: SUB_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, hasResults: False

protocolSection identificationModule nctId: NCT06380959, orgStudyIdInfo id: 223K879, briefTitle: Art-based Activities in Stroke Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-10-02, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-02-29, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Ege University, class: OTHER, descriptionModule briefSummary: Introduction and Aim: Life after stroke begins a difficult period in which functional capacity is very limited. Disability persists for a long time, and various problems such as hemiparesis, hemiplegia, dysarthria, dysphagia, urinary and bowel incontinence, which are frequently encountered after stroke, can affect the quality of life in the long term. As non-pharmacological approaches, especially non-invasive methods, have gained attention, creative arts-based therapies have often been recommended for stroke survivors because they have an arts-based approach without side effects. It is thought that the study conducted will contribute to the literature as there are not many studies in the literature. The aim of this study is to examine the effects of art-based activities on stroke patients' hope and self-efficacy levels. Its sub-purpose is to reveal the feelings and thoughts that arise with art objects obtained from art-based activities applied to stroke patients.Materials and Methods: The study was conducted as a randomised controlled design. After the groups were determined, art-based activities module was applied to the intervention group for one week, while no additional intervention was made to the control group. Research data were collected using "Individual Introduction Form", "Herth Hope Index", "Generalized Self-Efficacy Scale. Data were analyzed with Statistical Package for the Social Sciences 25.0 package program. Written permission was obtained from the relevant ethics committee, hospital and participants to conduct the study., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomised Controlled, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 72, type: ACTUAL, armsInterventionsModule interventions name: Art Based Activity, outcomesModule primaryOutcomes measure: Herth Hope Index, primaryOutcomes measure: Generalized Self-Efficacy Scale, primaryOutcomes measure: Individual Introduction Form, secondaryOutcomes measure: Art Object Concretization Form, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ege University, city: Bornova, state: İzmir, zip: 35100, country: Turkey, geoPoint lat: 38.47921, lon: 27.2399, hasResults: False

protocolSection identificationModule nctId: NCT06380946, orgStudyIdInfo id: 978/91, briefTitle: Influence of Injectable Platelet Rich Fibrin on Different Orthodontic Tooth Movements During Clear Aligner Therapy, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Al-Azhar University, class: OTHER, descriptionModule briefSummary: The aim of this prospective clinical project will be to assess the effect of platelet rich fibrin on the rate of different orthodontic tooth movements during clear aligner therapy., conditionsModule conditions: Effect of Platelet Rich FibrinDuring Clear Aligner Therapy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 78, type: ESTIMATED, armsInterventionsModule interventions name: iPRF, outcomesModule primaryOutcomes measure: Influence of injectable platelet rich fibrin rate of different orthodontic tooth movements by millimeter, eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 22 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: AlAzhar university, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False

protocolSection identificationModule nctId: NCT06380933, orgStudyIdInfo id: B11103008, briefTitle: The Effects of Receiving Warm Footbath With Lavender Essential Oil on Sleep and Comfort, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-01, primaryCompletionDateStruct date: 2022-09-01, completionDateStruct date: 2024-02-28, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Dalin Tzu Chi General Hospital, class: OTHER, descriptionModule briefSummary: Purposes: Describe the background information and clinical characteristics of respirator-dependent patients, verify the sleep and comfort effects of respirator-dependent patients whether or not they receive a lavender essential oil warm water foot bath, and compare changes of the sleep, comfort, heartbeat, and blood pressure in respirator-dependent patients before and after receiving a lavender essential oil warm water foot bath., conditionsModule conditions: Sleep Quality, conditions: Comfort, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: two-group crossover design trial and block randomly assigns groups after gender stratification. The experimental group first received a foot bath with lavender essential oil at 41-42C warm water for 20 minutes for 3 days, then rested for 3 days, and then received routine care for 3 days; the control group first received routine care for 3 days, then rested for 3 days, and then received lavender essential oil 41-42C warm water foot bath for 20 minutes for 3 days., primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 94, type: ACTUAL, armsInterventionsModule interventions name: experimental group, outcomesModule primaryOutcomes measure: Richards-Campbell Sleep Questionnaire, secondaryOutcomes measure: Numerical Rating of Comfort, eligibilityModule sex: ALL, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hsu Mei-Lian, city: Chiayi City, country: Taiwan, geoPoint lat: 23.47917, lon: 120.44889, hasResults: False

protocolSection identificationModule nctId: NCT06380920, orgStudyIdInfo id: Digital Health App, briefTitle: Function Definition and Clinical Validation of Digital Health App: Using Weight Management as An Example, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: National Cheng-Kung University Hospital, class: OTHER, descriptionModule briefSummary: This project anticipates addressing the obesity epidemics problem which has caused unhealthy lifestyle in billions of obesities and overweight people worldwide. The investigators propose on digital health solution in providing healthcare-on-demand, for personalized health, healthy lifestyle and weight management. This study proposes on using Cognitive Behavior Therapy (CBT) in decreasing individual's food craving, which is administered through AI (Assistive Intelligence) tracking. As with any new medicine, uncertain long-term effects and high costs of these new drugs are also critical factors considered by physicians and policy makers worldwide. Researchers have also reported on 85% of people re-gaining premedication weight after 5 years. There is no easily available self-controlled monitoring strategy/intervention for the unhealthy lifestyle is believed to be one of the main problems. Therefore, the investigators propose on the research and development of self-managing digital health APP (application) for 12 months over two phases, with three months to design APP and nine months to confirm the clinical validation. During the first phase, the investigators propose on design of an "AI Mindful Eating" App, to enhance individual's healthy lifestyle with subsequent weight-loss. Based on "gut-brain-axis", this is anticipated to be achieved by using CBT and AI is used to recognize nutrition and mood within mobile images. This facilitates fulfilling lifestyle and long-term weight-loss. Finally, the study proposes to complete function definition and clinical validation for our AI Humanity APP. By scheduled check-up program by monitoring and analyzing body weight, body fat, anthropometric and metabolic change data between case and control groups. The investigators intend to disclose the effect of the AI assistant APP in weight management and metabolic disease prevention., conditionsModule conditions: Weight Loss, conditions: Body Fat Rate Loss, conditions: Body Composition Change, 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: 100, type: ESTIMATED, armsInterventionsModule interventions name: "AI Mindful Eating" App, interventions name: Outpatient regular follow-up, outcomesModule primaryOutcomes measure: weight change, secondaryOutcomes measure: Parameters of Metabolic syndrome, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06380907, orgStudyIdInfo id: ZL-1102-002, briefTitle: A Phase 2 Study of ZL-1102 in Patients With Chronic Plaque Psoriasis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-02-28, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Zai Lab (Hong Kong), Ltd., class: INDUSTRY, collaborators name: Zai Lab (US) LLC, descriptionModule briefSummary: A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Dose-Ranging, Phase 2 Study to Evaluate the Efficacy and Safety of Different Doses of ZL-1102 Topical gel (A Human VH IL-17A Antibody Fragment) in the Treatment of Chronic Plaque Psoriasis, conditionsModule conditions: Plaque Psoriasis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: ZL-1102 1% w/w gel BID for 16 weeks, interventions name: ZL-1102 3% w/w gel BID for 16 weeks, interventions name: ZL-1102 3% w/w gel QD for 16 weeks, interventions name: Placebo ZL-1102 0% w/w gel BID for 16 weeks, interventions name: Placebo ZL-1102 0% w/w gel QD for 16 weeks, outcomesModule primaryOutcomes measure: Efficacy of different doses of ZL-1102 compared to Vehicle at Week 16., secondaryOutcomes measure: The proportion of patients achieving IGA treatment success., secondaryOutcomes measure: The proportion of patients achieving IGA score of 0 or 1., secondaryOutcomes measure: The percent change from baseline in mPASI score., secondaryOutcomes measure: The proportion of patients achieving mPASI 75 at Week 2, 4, 8, 12, and 20., secondaryOutcomes measure: The proportion of patients achieving mPASI 50/90/100 at Weeks 2, 4, 8, 12, 16, and 20., secondaryOutcomes measure: Time to achieve mPASI 50/75/90., secondaryOutcomes measure: Time to achieve IGA score of 0 or 1., secondaryOutcomes measure: Time to achieve 1- or 2-point improvement in IGA., secondaryOutcomes measure: Incidence of Treatment Related Adverse Events through Week 20., secondaryOutcomes measure: Mean local tolerability scores (LTS), secondaryOutcomes measure: Serum concentration of ZL-1102., secondaryOutcomes measure: Anti-drug antibody (ADA) of ZL-1102., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zai Lab Site 5013, city: Phillip, state: Australian Capital Territory, zip: 2606, country: Australia, geoPoint lat: -31.13333, lon: 150.85, locations facility: Zai Lab Site 5016, city: Kotara, state: New South Wales, zip: 2289, country: Australia, geoPoint lat: -32.95, lon: 151.68333, locations facility: Zai Lab Site 5017, city: Woolloongabba, state: Queensland, zip: 4102, country: Australia, geoPoint lat: -27.48855, lon: 153.03655, locations facility: Zai Lab Site 5014, city: Carlton, state: Victoria, zip: 3053, country: Australia, geoPoint lat: -37.8, lon: 144.96667, locations facility: Zai Lab Site 5002, city: Melbourne E., state: Victoria, country: Australia, geoPoint lat: -37.81667, lon: 144.9879, locations facility: Zai Lab Site 5015, city: Melbourne, state: Victoria, zip: 3124, country: Australia, geoPoint lat: -37.814, lon: 144.96332, hasResults: False

protocolSection identificationModule nctId: NCT06380894, orgStudyIdInfo id: 2020/2239, briefTitle: Virtual Reality Cognitive Training for Mild Cognitive Impairment, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-27, primaryCompletionDateStruct date: 2022-09-30, completionDateStruct date: 2023-01-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Changi General Hospital, class: OTHER, descriptionModule briefSummary: This study aims to assess the feasibility and efficacy of a 10-weekly multi-domain VRCT program on the cognitive function (i.e. attention, memory, and executive functioning) of older adults with MCI., conditionsModule conditions: Mild Cognitive Impairment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: Virtual Reality Cognitive Training, interventions name: Active Control, outcomesModule primaryOutcomes measure: Change from Baseline in Memory Performance on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtests at Week 11, primaryOutcomes measure: Change from Baseline in Attention Performance on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtest at Week 11, primaryOutcomes measure: Change from Baseline in Attention Performance on the Colour Trails Test 1 at Week 11, primaryOutcomes measure: Change from Baseline in Executive Function Performance on the Frontal Assessment Battery (FAB) at Week 11, primaryOutcomes measure: Change from Baseline in Executive Function Performance on the Colour Trails Test 2 at Week 11, eligibilityModule sex: ALL, minimumAge: 65 Years, maximumAge: 85 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Changi General Hospital, city: Singapore, country: Singapore, geoPoint lat: 1.28967, lon: 103.85007, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2021-01-27, uploadDate: 2024-04-15T09:12, filename: Prot_SAP_000.pdf, size: 384298, hasResults: False

protocolSection identificationModule nctId: NCT06380881, orgStudyIdInfo id: SHR-2017-102, briefTitle: PK/PD Study of SHR-2017 Injection in Patients With Bone Metastases, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Suzhou Suncadia Biopharmaceuticals Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: To evaluate the pharmacokinetic characteristics, pharmacodynamic characteristics, safety, tolerability and immunogenicity of SHR-2017 injection in patients with bone metastases, and to evaluate the efficacy of SHR-2017 injection in the treatment of skeletal-related event and cancer pain., conditionsModule conditions: Patients With Bone Metastases, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: SHR-2017, outcomesModule primaryOutcomes measure: The Pharmacokinetic parameters of SHR-2017 after administration, including Cmax, primaryOutcomes measure: The Pharmacokinetic parameters of SHR-2017 after administration, including Tmax, primaryOutcomes measure: The Pharmacokinetic parameters of SHR-2017 after administration, including AUC0-t, primaryOutcomes measure: The Pharmacokinetic parameters of SHR-2017 after administration, including AUC0-∞, primaryOutcomes measure: The Pharmacokinetic parameters of SHR-2017 after administration, including t1/2, primaryOutcomes measure: The Pharmacokinetic parameters of SHR-2017 after administration, including CL/F, primaryOutcomes measure: The pharmacodynamic parameter of SHR-2017 after administration include uNTX/uCr, primaryOutcomes measure: The pharmacodynamic parameter of SHR-2017 after administration include β-CTX, primaryOutcomes measure: The pharmacodynamic parameter of SHR-2017 after administration include BALP [Time, secondaryOutcomes measure: Change from baseline in worst pain/average pain at the designated bone metastasis pain site after dosing, secondaryOutcomes measure: Incidence of skeletal-related event, secondaryOutcomes measure: Average daily total opioids consumption, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Cancer Hospital, city: Beijing, state: Beijing, zip: 100142, country: China, contacts name: Huiping Li, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False

protocolSection identificationModule nctId: NCT06380868, orgStudyIdInfo id: Nanjing-2, briefTitle: IVI-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus, acronym: IVI-DIABETES, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-06-10, primaryCompletionDateStruct date: 2026-06-01, completionDateStruct date: 2027-07-20, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Nanjing First Hospital, Nanjing Medical University, class: OTHER, collaborators name: Shanxi Provincial People's Hospital, descriptionModule briefSummary: Intravascular ultrasound (IVUS) serves as a beneficial instrument during percutaneous coronary intervention (PCI) procedures, affording insight into lesion characteristics and stent implantation. The ULTIMATE trial recently evidenced that IVUS-guided Drug-Eluting Stent (DES) implantation notably ameliorated clinical outcomes in all-comers, especially in patients who underwent an optimal procedure defined by IVUS, as opposed to angiography guidance, resonating with findings from the IVUS-XPL study, OCTOBER trial, and RENOVATE COMPLEX PCI trial, further confirmed by more recent IVUS-ACS trial.Optical coherence tomography (OCT) has a resolution 10 times higher than that of IVUS and can provide valuable information at each step of PCI.Regrettably, a dearth of prospective, randomized, multicenter trials exists that scrutinize the benefits of IVI-guided as opposed to angiography-guided PCI in patients suffering from diabetes mellitus. However, several trials have presented subgroup analyses reporting the reduction of clinical events by IVUS but not OCT guidance in patients with diabetes mellitus, which served as the foundation for the design of this trial., conditionsModule conditions: Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients will undergo 1:1 randomization to either intravascular imaging (including intravascular ultrasound or optical coherence tomography)-guided DES implantation which will be the treatment group or Angio-guided DES implantation which will be the control group, stratified by research sites., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Randomization will be performed in the catheter laboratory by an invasive nurse. Staff in the catheter laboratory will be not blinded to the treatment allocation., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1332, type: ESTIMATED, armsInterventionsModule interventions name: Intravascular imaging-guided PCI, interventions name: Angiography-guided PCI group, outcomesModule primaryOutcomes measure: Rate of target vessel failure (TVF), secondaryOutcomes measure: Rate of target vessel failure without procedure-related MI, secondaryOutcomes measure: Rate of cardiac death, secondaryOutcomes measure: Rate of all-cause death, secondaryOutcomes measure: Rate of procedure-related myocardial infarction (PMI), secondaryOutcomes measure: Rate of spontaneous myocardial infarction (SMI), secondaryOutcomes measure: Rate of clinically-driven revascularization, secondaryOutcomes measure: Rate of stent thrombosis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nanjing First Hospital, city: Nanjing, state: Jiangsu, zip: 210006, country: China, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False

protocolSection identificationModule nctId: NCT06380855, orgStudyIdInfo id: GIHSYSU-34, briefTitle: Flexible Colonoscope Assisted Hybrid Transanal Total Mesorectal Resection (taTME), statusModule overallStatus: RECRUITING, startDateStruct date: 2022-08-24, primaryCompletionDateStruct date: 2025-08-24, completionDateStruct date: 2025-08-24, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: The investigators propose to use flexible endoscopy combined with transanal total mesorectal resection to further reduce anal injury., conditionsModule conditions: Rectal Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 5, type: ESTIMATED, armsInterventionsModule interventions name: Flexible colonoscope assisted hybrid transanal total mesorectal resection, outcomesModule primaryOutcomes measure: Success rate of operation, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510000, country: China, contacts name: Liang Kang, MD, PhD, role: CONTACT, phone: 008613602886833, email: eonkang@163.com, geoPoint lat: 23.11667, lon: 113.25, hasResults: False

protocolSection identificationModule nctId: NCT06380842, orgStudyIdInfo id: 2023HX1970, briefTitle: Organ Dysfunction Change in Acute Necrotizing Pancreatitis Patients With Sepsis After Open Necrosectomy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-12-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Chunling Jiang, class: OTHER, descriptionModule briefSummary: The purpose of this study is to characterize organ dysfunction change in acute necrotizing pancreatitis patients with sepsis after open necrosectomy., conditionsModule conditions: Necrotizing Pancreatitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Necrotizing Pancreatitis patients' organ dysfunction progression, outcomesModule primaryOutcomes measure: Measure organ dysfunction change after open necrosectomy with respect to time, secondaryOutcomes measure: incidence of a composite of major complications, secondaryOutcomes measure: Incidence of ICU mortality, secondaryOutcomes measure: Incidence of hospital mortality, secondaryOutcomes measure: Incidence of 28-day mortality, secondaryOutcomes measure: Incidence of one year mortality, secondaryOutcomes measure: ICU length of hospital stay, secondaryOutcomes measure: Length of hospital stay, secondaryOutcomes measure: The pancreatic symptoms score, secondaryOutcomes measure: The levels of inflammatory factor CRP, secondaryOutcomes measure: The levels of inflammatory cytokines IL-6, secondaryOutcomes measure: The levels of inflammatory procalcitonin, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06380829, orgStudyIdInfo id: Adnan Menderes, briefTitle: Psychometric Properties of the Self-Care Assessment Scale for 3-6 Year Old Children With Cerebral Palsy-Parent Form, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-05, primaryCompletionDateStruct date: 2023-12-05, completionDateStruct date: 2024-02-10, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Aydin Adnan Menderes University, class: OTHER, descriptionModule briefSummary: This study is a methodological study to develop the self-care assessment scale-parent form of children with CP aged 3-6 years and test its validity and reliability.Q1. Is the Self-Care Assessment Scale for 3- to 6-year-old Children with CP a valid scale? Q2. Is the Self-Care Assessment Scale for 3- to 6-year-old Children with CP a reliable scale?, conditionsModule conditions: Cerebral Palsy, conditions: Self Care, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 127, type: ACTUAL, armsInterventionsModule interventions name: Questionnaire, outcomesModule primaryOutcomes measure: To asses Turkish validity and reliability of Self-Care Assessment Scale for Children with CP aged 3-6 years, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: Bircan Kahraman Berberoğlu, city: Aydın, zip: 0900, country: Turkey, geoPoint lat: 37.84501, lon: 27.83963, hasResults: False

protocolSection identificationModule nctId: NCT06380816, orgStudyIdInfo id: CRUKD/24/001, secondaryIdInfos id: ISRCTN26628699, type: REGISTRY, domain: ISRCTN, briefTitle: A Phase I/II Trial of UCB4594 in Participants With Advanced Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2029-11, completionDateStruct date: 2029-11, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Cancer Research UK, class: OTHER, collaborators name: UCB Biopharma SRL, descriptionModule briefSummary: This clinical trial is looking at UCB4594. This is the first time the drug is being tested in humans. UCB4594 is a type of drug called a monoclonal antibody. It has been designed to work by targeting a protein called human leucocyte antigen G (HLA-G) that is found in high levels on some cancer cells. By attaching itself to this protein it may help the immune system to attack and kill the cancer cells.The four main aims of the clinical trial are to find out:1. The best dose of UCB4594 that can be given safely to participants in the trial.2. What the side effects of UCB4594 are and how they can be managed.3. What happens to UCB4594 inside the body and how it affects cancer cells.4. Whether UCB4594 can cause cancer to shrink., conditionsModule conditions: Advanced Solid Tumours, conditions: Squamous Cell Carcinoma of Head and Neck, conditions: Carcinoma, Non-Small-Cell Lung, conditions: Colorectal Neoplasms, conditions: Triple Negative Breast Neoplasms, conditions: Carcinoma, Renal Cell (Clear Cell Only), conditions: Esophageal Neoplasms, conditions: Stomach Neoplasms (Excluding Gastrointestinal Stromal Tumors), conditions: Uterine Cervical Neoplasms, conditions: Ovarian Neoplasms, conditions: Pancreatic Neoplasms, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 167, type: ESTIMATED, armsInterventionsModule interventions name: UCB4594, outcomesModule primaryOutcomes measure: Recommended Phase 2 dose (RP2D) of UCB4594, primaryOutcomes measure: Frequency of adverse events (AEs) considered at least possibly related to UCB4594 (up to 18 cycles)., secondaryOutcomes measure: Number of patients achieving a complete response (CR)/immune CR (iCR) or partial response (PR)/immune PR (iPR) to UCB4594 (all modules)., secondaryOutcomes measure: Maximum concentration of UCB4594 (monotherapy modules; Modules A and B)., secondaryOutcomes measure: Minimum concentration of UCB4594 (monotherapy modules; Modules A and B)., secondaryOutcomes measure: Area under the curve of UCB4594 (monotherapy modules; Modules A and B)., secondaryOutcomes measure: Steady state volume of distribution of UCB4594 (monotherapy modules; Modules A and B)., secondaryOutcomes measure: Clearance of UCB4594 (monotherapy modules; Modules A and B)., secondaryOutcomes measure: Frequency of AEs considered at least possibly related to UCB4594 (up to end of AE reporting period)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Christie NHS Foundation Trust, city: Manchester, country: United Kingdom, contacts name: Fiona Thistlethwaite, Prof, role: CONTACT, phone: +44 (0)161 9187672, email: fiona.thistlethwaite@nhs.net, geoPoint lat: 53.48095, lon: -2.23743, locations facility: University Hospital Southampton NHS Foundation Trust, city: Southampton, country: United Kingdom, contacts name: Ioannis Karydis, Prof, role: CONTACT, email: I.Karydis@soton.ac.uk, geoPoint lat: 50.90395, lon: -1.40428, hasResults: False

protocolSection identificationModule nctId: NCT06380803, orgStudyIdInfo id: 4-2020-1385, briefTitle: Surgical Skill Labs for Robotic Mastectomy and Educational Program Using a Surgical Guide by Artificial Intelligence, acronym: ROMCAPO+AI, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-04-29, primaryCompletionDateStruct date: 2025-01-26, completionDateStruct date: 2025-01-26, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Severance Hospital, class: OTHER, collaborators name: National Research Foundation of Korea, descriptionModule briefSummary: The goal of this prospective study is to investigate the satisfaction, NASA-Task Load Index (TLX), and surgical proficiency of a robotic breast surgery education program using cadaver or porcine models, as well as to develop an AI-based surgical guide for utilization within the educational program in trainees for robotic breast surgery.The main question\[s\]it aims to evaluate :* Satisfaction questionnaire of a educational program* NASA-TLX of a educational program* global evaluative assessment of robotic skills (GEARS) of a robotic breast surgery for surgical proficiencyParticipants will participate the educational program and fill out a satisfaction questionnaire and NASA-TLX.The tutor evaluates GEARS for 15 minutes at the beginning and end of training.After the development of the surgical guide based on AI, researchers will compare a training group with or without surgical guide to see the effect of the surgical guide., conditionsModule conditions: Breast Neoplasms, conditions: Surgery, conditions: Educational Problems, conditions: Surgical Procedure, Unspecified, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: A educational program, outcomesModule primaryOutcomes measure: Satisfaction questionnaire of a educational program, primaryOutcomes measure: NASA-Task Load index of a educational program, primaryOutcomes measure: Global Evaluative Assessment of Robotic Skills of a robotic breast surgery for surgical proficiency, secondaryOutcomes measure: The comparison of satisfaction questionnaire of a educational program between the group with the surgical guide and without the surgical guide, secondaryOutcomes measure: The comparison of NASA-Task Load index of a educational program between the group with the surgical guide and without the surgical guide, secondaryOutcomes measure: The comparison of Global Evaluative Assessment of Robotic Skills of a robotic breast surgery for surgical proficiency between the group with the surgical guide and without the surgical guide, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yonsei University College of Medicine, status: RECRUITING, city: Seoul, zip: 120-752, country: Korea, Republic of, contacts name: Hyung Seok Park, MD, PhD, role: CONTACT, phone: +82-2228-2100, email: imgenius@yuhs.ac, geoPoint lat: 37.566, lon: 126.9784, hasResults: False

protocolSection identificationModule nctId: NCT06380790, orgStudyIdInfo id: 8423, briefTitle: Effect of Laser-aided Csf on the Rate of Leveling and Alignment of Mandibular Anterior Crowding, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-01, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: To test the effect of laser-aided circumferential supracrestal fiberotomy on the rate of leveling and alignment, conditionsModule conditions: Orthodontics, 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: 26, type: ESTIMATED, armsInterventionsModule interventions name: Laser-aided csf, interventions name: placebo laser-aided csf, outcomesModule primaryOutcomes measure: Rate of tooth movement, secondaryOutcomes measure: Pain level, secondaryOutcomes measure: Periodontal health, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 25 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of dentistry cairo university, status: RECRUITING, city: Cairo, country: Egypt, contacts name: Cairo University, role: CONTACT, phone: 0223638755, email: ortho@dentistry.cu.edu.eg, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False

protocolSection identificationModule nctId: NCT06380777, orgStudyIdInfo id: DDT system for sarcopenia, briefTitle: Establishment and Application of Digital Diagnosis and Treatment System for Sarcopenia, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Peking Union Medical College Hospital, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to establish a digital diagnosis and treatment system for sarcopenia, integrating research outcomes into a unified approach encompassing a digital vaccine (early warning screening model), digital drug (intervention model associated with pathogenesis), and digital rehabilitation (preventive system combining early warning and treatment). This aims to create a digital visual tertiary prevention network for sarcopenia.Research aims:Evaluate the effectiveness of the digital vaccine through a cross-sectional epidemiological survey.Establish a specialized cohort for sarcopenia through a longitudinal investigation, implementing the digital drug and digital rehabilitation interventions.Participants will:Engage in screening and assessment based on inclusion and exclusion criteria.Be monitored longitudinally, with tailored interventions for those with muscle atrophy and regular follow-ups for at-risk individuals.Key outcomes will focus on sarcopenia indicators, serum biomarkers, and clinical endpoints such as fracture rates, weakness classification, and quality of life., conditionsModule conditions: Sarcopenia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 10000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Appendicular skeletal muscle mass index, secondaryOutcomes measure: Hand grip strength, secondaryOutcomes measure: Gait speed, otherOutcomes measure: Concentration of insulin, otherOutcomes measure: Concentration of adiponectin, otherOutcomes measure: Concentration of leptin, otherOutcomes measure: Concentration of insulin like growth factor -1(IGF-1), otherOutcomes measure: Concentration of interleukin 18 (IL-18), otherOutcomes measure: Concentration of tumor necrosis factor - α (TNF-α), otherOutcomes measure: Concentration of TNF-like weak inducer of apoptosis (TWEAK), otherOutcomes measure: Concentration of fibroblast growth factor -19 (FGF-19), otherOutcomes measure: Concentration of myostatin, otherOutcomes measure: Concentration of chemoattractant protein-1 (MCP-1), otherOutcomes measure: Concentration of activin, eligibilityModule sex: ALL, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking Union Medical College Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100730, country: China, contacts name: Kang Yu, MD, role: CONTACT, phone: +86 010-69155550, email: yuk1997@sina.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False

protocolSection identificationModule nctId: NCT06380764, orgStudyIdInfo id: RC.11.3.2024, briefTitle: Greater Occipital Nerve Block Value in Management of Postdural Puncture Headache, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-02, primaryCompletionDateStruct date: 2023-07-25, completionDateStruct date: 2023-12-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Benha University, class: OTHER, descriptionModule briefSummary: Neuraxial techniques are well tolerated and effective options for labor analgesia and anesthesia for caesarean section, and may protect high risk women against severe maternal morbidity. However, neuraxial techniques still have drawbacks especially postdural puncture headache (PDPH) and may be associated with chronic headache, back pain and postnatal depression. PDPH is a relatively common acute complication of neuraxial techniques that was traditionally considered benign and self-limiting, but it significantly impacts patients' general health and quality of life.Greater Occipital Nerve (GON) originates from C2-3 segments and through its muscular relations it is divided as proximal and distal parts; the most proximal part lies between obliquus capitis inferior and semispinalis and then passes through the semispinalis to pierce the trapezius muscle. In distal region of trapezius fascia, the GON is crossed by the occipital artery and exits the trapezius fascia into the nuchal line about 5-cm lateral to midline. Functionally, GON provides motor supplies to the muscles while passing through it and its main sensory supply is in the occipital region., conditionsModule conditions: Postdural Puncture Headache, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 152, type: ACTUAL, armsInterventionsModule interventions name: Greater Occipital Nerve Block, interventions name: Bilateral suboccipital intramuscular injection, interventions name: Epidural Blood Patch, interventions name: Normal Saline 10 mL Injection, interventions name: Lidocaine 2% Injectable Solution, outcomesModule primaryOutcomes measure: The extent of reduction of consumed analgesia, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Benha university, city: Banhā, state: El Qalyoubia, zip: 13511, country: Egypt, geoPoint lat: 30.45906, lon: 31.17858, hasResults: False

protocolSection identificationModule nctId: NCT06380751, orgStudyIdInfo id: D9722C00001, briefTitle: Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer, acronym: EvoPAR-BR01, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-18, primaryCompletionDateStruct date: 2029-03-30, completionDateStruct date: 2030-07-18, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+/ ISH non-amplified) advanced breast cancer., conditionsModule conditions: Advanced Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Open label, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Saruparib (AZD5305), interventions name: Camizestrant, interventions name: Abemaciclib, interventions name: Ribociclib, interventions name: Palbociclib, interventions name: Fulvestrant, interventions name: Letrozole, interventions name: Anastrozole, interventions name: Exemestane, outcomesModule primaryOutcomes measure: Progression-Free Survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Progression Free Survival 2, secondaryOutcomes measure: Time to chemotherapy, secondaryOutcomes measure: Objective Response Rate, secondaryOutcomes measure: Duration of Response, secondaryOutcomes measure: Participant-reported tolerability, secondaryOutcomes measure: Time to deterioration in patient-reported global health status/QoL as measured by the global health status/QoL scale within the The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ), secondaryOutcomes measure: Change from baseline in patient-reported global health status/QoL as measured by the global health status/QoL scale within the The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ), secondaryOutcomes measure: Plasma concentrations of saruparib (AZD5305), secondaryOutcomes measure: Plasma concentrations of camizestrant, secondaryOutcomes measure: Samples will be used to develop companion diagnostics by analyzing their performance characteristics and calculate their consistency with clinical trial assays used for enrolment onto the study., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 130 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, city: Toronto, state: Ontario, zip: M5G 2M9, country: Canada, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Research Site, city: Montreal, state: Quebec, zip: H3T 1E2, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, locations facility: Research Site, city: Montréal, state: Quebec, zip: H2X 0A9, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, locations facility: Research Site, city: Saskatoon, state: Saskatchewan, zip: S7N 4H4, country: Canada, geoPoint lat: 52.13238, lon: -106.66892, locations facility: Research Site, city: Toronto, zip: M4N 3M5, country: Canada, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False

protocolSection identificationModule nctId: NCT06380738, orgStudyIdInfo id: D0817R00074, secondaryIdInfos id: D0817R00074, type: OTHER, domain: AstraZeneca, briefTitle: Real-World Clinical Experience of Patients With Metastatic Castration-Resistant Prostate Cancer Treated With Olaparib + Abiraterone (PROceed), acronym: PROceed, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-14, primaryCompletionDateStruct date: 2027-01-31, completionDateStruct date: 2027-01-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, collaborators name: Merck Sharp & Dohme LLC, descriptionModule briefSummary: PROceed is a multisite, prospective, observational study that describes the real-world use and clinical experience of mCRPC patients treated with the combination of olaparib and abiraterone in the mCRPC setting. Clinical outcomes will be assessed in patients who are either NHA-naive or NHA-exposed prior to initiating olaparib + abiraterone treatment, respectively. Patient demographic and clinical characteristics, as well as treatment received prior and subsequent to olaparib + abiraterone, will also be described. The study plans to enroll patients for a maximum of 2 years and follow up patients from initiation of olaparib until 1 year post last patient in., conditionsModule conditions: Metastatic Castration-resistant Prostate Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 250, type: ESTIMATED, outcomesModule primaryOutcomes measure: Time to treatment discontinuation, secondaryOutcomes measure: Time to first subsequent therapy, eligibilityModule sex: MALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, status: RECRUITING, city: Aschaffenburg, country: Germany, geoPoint lat: 49.97704, lon: 9.15214, locations facility: Research Site, status: RECRUITING, city: Berlin, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Berlin, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, locations facility: Research Site, status: RECRUITING, city: Duisburg, country: Germany, geoPoint lat: 51.43247, lon: 6.76516, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Franckfurt, country: Germany, locations facility: Research Site, status: RECRUITING, city: Halle, country: Germany, geoPoint lat: 51.48159, lon: 11.97948, locations facility: Research Site, status: RECRUITING, city: Herzogenaurach, country: Germany, geoPoint lat: 49.56798, lon: 10.88565, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Leipzig, country: Germany, geoPoint lat: 51.33962, lon: 12.37129, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Lueneburg, country: Germany, geoPoint lat: 53.2509, lon: 10.41409, locations facility: Research Site, status: RECRUITING, city: Muhlheim, country: Germany, geoPoint lat: 50.11667, lon: 8.83333, locations facility: Research Site, status: RECRUITING, city: Nurnberg, country: Germany, geoPoint lat: 49.45421, lon: 11.07752, locations facility: Research Site, status: RECRUITING, city: Russelsheim, country: Germany, geoPoint lat: 49.98955, lon: 8.42251, locations facility: Research Site, status: RECRUITING, city: Speyer, country: Germany, geoPoint lat: 49.32083, lon: 8.43111, locations facility: Research Site, status: RECRUITING, city: Wetzlar, country: Germany, geoPoint lat: 50.56109, lon: 8.50495, hasResults: False

protocolSection identificationModule nctId: NCT06380725, orgStudyIdInfo id: jshim8zay6vd, briefTitle: The Treatment of High Intensity Transcranial Current Stimulation for Alzheimer's Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Anhui Provincial Hospital, class: OTHER_GOV, descriptionModule briefSummary: Alzheimer's disease (AD) is a neurodegenerative disorder characterized by progressive cognitive dysfunction and behavioral impairment. It is currently the most common type of dementia in the old age. At present, the clinical treatment of Alzheimer's disease is expensive and has side effects, so it is very important to explore new methods of treatment for AD. Investigators designed a prospective, randomized, double-blinded and placebo-controlled trial to investigate the effect of transcranial alternating current stimulation (tACS) on cognitive function in AD patients and to assess the biological effectiveness of the treatment., conditionsModule conditions: Alzheimer's Disease, conditions: Mild Cognitive Impairment, conditions: Dementia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Investigators designed a randomized double-blinded placebo-controlled trial by randomly dividing subjects into two groups: one is the treatment group and the other is the placebo group., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Investigators designed a double-blinded trial in which neither the investigator nor the subjects know whether they will be received the treatment or a placebo., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Transcranial alternating current stimulation(real stimulation), interventions name: Transcranial alternating current stimulation(sham stimulation), outcomesModule primaryOutcomes measure: Cognitive appraisal, primaryOutcomes measure: Global Cognitive appraisal, primaryOutcomes measure: Psychobehavioral assessment, secondaryOutcomes measure: Near-infrared spectroscopy, secondaryOutcomes measure: Event related potential measurement, secondaryOutcomes measure: Peripheral blood biomarkers, secondaryOutcomes measure: Magnetic Resonance Imaging, secondaryOutcomes measure: Incidence of side effects, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06380712, orgStudyIdInfo id: 6509, briefTitle: HYPERTESSA "HyperTessa User Experience Study (HTUX)", statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-02, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: Background: Hypertension is the primary cause of cardiovascular diseases and premature death in the world. Hypertension management starts with the control of blood pressure, whatever it is the type and severity. The optimum control of blood pressure requires regular and frequent auto-monitoring of blood pressure values, adherence to medication plan, and modification of lifestyle behaviours, including diet, quit smoking, and physical activity. This study is a pilot project to assess acceptance ad usability of a digital health solution to be used by patients diagnosed with hypertension. Materials and methods: Prior to the development of the solution, a literature research was performed, then focus group meetings were conducted with senior experts in the digital field, physicians treating hypertension, and patients. A mobile app and web platform were created to help patients in monitoring and reporting data about health status and lifestyle. In order to execute the study, first the physicians in charge of the study will register in the webApp, creating a personal account. Then, patients who meet the inclusion criteria are proposed to participate to the study and, in case of agreement, will be asked to sign the informed consent (IC) statement and the privacy policy. After the phase of profile setting and onboarding, the patient will start to use the mobile App for hypertension management. Once the patient has used the App for the observation period, the physician will be allowed to analyze the data to understand the level of acceptance and regular usage from each patient. This physician will perform this analysis using a web-based portal which is part of the digital solution. Results: During the study, data about usage patterns will be collected. Specific data about usability and acceptance will be gathered through the use of User Experience Questionnaire (UEQ) and unstructured interviews and tests. After each patient has completed the observation period, all the data will be analysed using mainly descriptive statistics to obtain metrics related to usage patterns, usability and adherence. The study results from this pilot phase will be used to modify the digital solution, leveraging an incremental, iterative logic following a co-design and agile methodology. After incorporating the feedback from this pilot and further enriching the solution, next phases of the study are forseen in order to assess the care benefit of such technology in terms of improved treatment outcomes, due to better adherence, higher motivation in practicing healthy lifestyle, better information, and personalized support from HCP., conditionsModule conditions: Hypertension, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, outcomesModule primaryOutcomes measure: User Experience / User Acceptance Indicators for patients, secondaryOutcomes measure: User Experience / User Acceptance Indicators for Healthcare Professionals, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione Policlinico Universitario A. Gemelli., IRCCS, city: Rome, country: Italy, contacts name: Andrea Flex, MD, PhD, role: CONTACT, phone: + 39 06 3015 4293, email: andrea.flex@policlinicogemelli.it, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False

protocolSection identificationModule nctId: NCT06380699, orgStudyIdInfo id: HJG-CZQH-QHRD106-I, briefTitle: Study to Assess PK, Safety and Tolerability in Healthy Subjects, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-16, primaryCompletionDateStruct date: 2023-11-16, completionDateStruct date: 2023-12-25, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Changzhou Qianhong Bio-pharma Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of QHRD106 in Chinese healthy subjects with single and multiple doses., conditionsModule conditions: Acute Ischemic Stroke, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 56, type: ACTUAL, armsInterventionsModule interventions name: QHRD106 Injection, interventions name: Yurekline, interventions name: placebo, outcomesModule primaryOutcomes measure: Safety as assessed by incidence, severity, and causality of adverse events, primaryOutcomes measure: Plasma measurements of QHRD106, primaryOutcomes measure: Concentration of bradykinin in plasma, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Nanjing Drum Tower Hospital, city: Nanjing, state: Jiangsu, zip: 210008, country: China, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False

protocolSection identificationModule nctId: NCT06380686, orgStudyIdInfo id: AIO-KHT-0322/ass, briefTitle: Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based Biomarkers, Treatment and Outcome, acronym: HEAT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2029-05, completionDateStruct date: 2030-05, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: AIO-Studien-gGmbH, class: OTHER, collaborators name: Merck Sharp & Dohme LLC, descriptionModule briefSummary: Prospective, open, non-interventional, multi-center clinical registry study with the aim to establish a comprehensive research platform reflecting the real-world treatment landscape for recurrent/metastatic head and neck tumor patients., conditionsModule conditions: Squamous Cell Carcinoma of the Oral Cavity, conditions: Squamous Cell Carcinoma of the Oropharynx, conditions: Squamous Cell Carcinoma of the Hypopharynx, conditions: Squamous Cell Carcinoma of the Larynx, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: data collection, outcomesModule primaryOutcomes measure: Sociodemographic factors, primaryOutcomes measure: Treatments, primaryOutcomes measure: Response rates, primaryOutcomes measure: Treatment decision, primaryOutcomes measure: Progression-free survival, primaryOutcomes measure: Time-to-treatment-failure, primaryOutcomes measure: Overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universitätsklinikum Essen, city: Essen, zip: 45147, country: Germany, contacts name: Victor Grünwald, Prof. Dr., role: CONTACT, phone: +49 201 723 85584, email: viktor.gruenwald@uk-essen.de, geoPoint lat: 51.45657, lon: 7.01228, hasResults: False

protocolSection identificationModule nctId: NCT06380673, orgStudyIdInfo id: s68299, briefTitle: Stepwise Heat-Denaturated Protein Introduction for Tolerance Induction in Food Allergy, acronym: TEHITI, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2028-12-30, completionDateStruct date: 2029-12-30, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, descriptionModule briefSummary: This interventional study aims to validate an early heated protein introduction protocol in cow's milk allergic children who already developed tolerance towards extensively heated cow's milk, in order to speed up the development of complete cow's milk tolerance. Natural complete tolerance induction towards cow's milk takes several years of strict cow's milk avoidance with high risk of anaphylaxis by accidental cow's milk intake. By shortening the time towards complete tolerance, not only the quality of life of both children and parents ameliorates drastically, the time frame for potential anaphylactic reactions is also strongly reduced and can be considered as a preventive strategy to reduce allergic reactions too. Moreover, this strategy has proved efficient for hen's egg allergy. The main question this study wants to answer is whether a 12 months stepwise heated cow's milk introduction (either by gradual reduction of the cooking time or by the use of the Flemish Milk Ladder) in 20'-cooked cow's milk tolerant subjects, results in a larger proportion of complete cow's milk tolerant children after 12 months compared to natural tolerance induction (with 20' cooked milk introduction only)., conditionsModule conditions: Food Allergy, conditions: Cow Milk Allergy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Implementation of cow's milk in decreasingly heated forms, interventions name: Implementation of heated cow's milk, interventions name: No intervention, outcomesModule primaryOutcomes measure: Complete cow's milk tolerance after 12 months of stepwise heated cow's milk introduction, secondaryOutcomes measure: Time to complete tolerance in all three arms, secondaryOutcomes measure: Quality of life in all three arms, secondaryOutcomes measure: Clinical reactions, secondaryOutcomes measure: Side effects, secondaryOutcomes measure: IL-10-producing cow's milk specific regulatory T and B cells, secondaryOutcomes measure: BATs to mimic the outcome of cow's milk provocation tests, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Imelda Hospital Bonheiden, status: RECRUITING, city: Bonheiden, country: Belgium, contacts name: Katrien Coppens, MD, role: CONTACT, geoPoint lat: 51.02261, lon: 4.54714, locations facility: AZ Sint-Jan, status: RECRUITING, city: Brugge, country: Belgium, contacts name: Kate Sauer, MD, role: CONTACT, geoPoint lat: 51.20892, lon: 3.22424, locations facility: AZ Maria Middelares, status: RECRUITING, city: Ghent, country: Belgium, contacts name: Jasmine Leus, MD, role: CONTACT, geoPoint lat: 51.05, lon: 3.71667, locations facility: Jessa Hospital, status: RECRUITING, city: Hasselt, country: Belgium, contacts name: Sophie Verelst, MD, role: CONTACT, geoPoint lat: 50.93106, lon: 5.33781, locations facility: UZ Leuven Gasthuisberg, status: RECRUITING, city: Leuven, country: Belgium, contacts name: Dominique MA Bullens, Prof. Dr., role: CONTACT, phone: +32016343801, email: dominique.bullens@kuleuven.be, geoPoint lat: 50.87959, lon: 4.70093, hasResults: False

protocolSection identificationModule nctId: NCT06380660, orgStudyIdInfo id: ACE-106-001, briefTitle: Study of ACE-86225106 to Treat Patients With Advanced Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2028-12-21, completionDateStruct date: 2029-03-21, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Acerand Therapeutics (Shanghai) Limited, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to determine if the experimental treatment with poly-ADP ribose polymerase (PARP) inhibitor, ACE-86225106 is safe, tolerable and has anti-cancer activity in adult patients with advanced solid tumors., conditionsModule conditions: Solid Tumor, Adult, conditions: BRCA1 Mutation, conditions: BRCA2 Mutation, conditions: Ovarian Cancer, conditions: Breast Cancer, conditions: Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 298, type: ESTIMATED, armsInterventionsModule interventions name: ACE-86225106 tablet, outcomesModule primaryOutcomes measure: Number of participants experiencing adverse events (AEs)/serious adverse events (SAEs), primaryOutcomes measure: The number of patients experiencing dose limiting toxicity (DLT), as defined in the protocol, primaryOutcomes measure: Recommended Phase 2 dose (RP2D) and/or maximum tolerated dose (MTD), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Duration of Response (DoR) and Time to Response (TTR), secondaryOutcomes measure: Progression Free Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Pharmacokinetic (PK) parameters and Pharmacodynamic (PD) marker change, secondaryOutcomes measure: Serum tumor marker change: CA125, etc. (OC), prostatic specific antigen (PSA, prostate cancer) decreased, and specific tumor markers for other tumor types may also be included (to be assessed by clinical investigators), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fujian Cancer Hospital, status: RECRUITING, city: Fuzhou, state: Fujian, country: China, geoPoint lat: 26.06139, lon: 119.30611, locations facility: Sun Yat-Sen University Cancer Center, status: NOT_YET_RECRUITING, city: Guangzhou, state: Guangdong, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Hubei Cancer Hospital, status: RECRUITING, city: Wuhan, state: Hubei, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, status: NOT_YET_RECRUITING, city: Wuhan, state: Hubei, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Hunan Cancer Hospital, status: RECRUITING, city: Changsha, state: Hunan, country: China, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Fudan University Shanghai Cancer Center, status: RECRUITING, city: Shanghai, state: Shanghai, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Zhejiang Cancer Hospital, status: RECRUITING, city: Hangzhou, state: Zhejiang, country: China, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False

protocolSection identificationModule nctId: NCT06380647, orgStudyIdInfo id: 0004, briefTitle: Comparison of Prophylactic Acyclovir and Placebo in Prevention of Eczema Herpeticum in Pediatric Burns, acronym: childburn, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-10-01, primaryCompletionDateStruct date: 2020-09-30, completionDateStruct date: 2020-09-30, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: King Edward Medical University, class: OTHER, descriptionModule briefSummary: Introduction: Early detection is important in treating patients with Eczema Herpeticum (EH), which may arise in paediatric burn patients. As soon as a clinical diagnosis is confirmed, antiviral medications should be started to ensure an early resolution of the disease. Several studies have indicated that acyclovir is the best treatment for EH lesions in the majority of individuals.Objective: Compare efficacy of the prophylactic acyclovir and placebo in preventing eczema Herpeticum in paediatric burn patients, conditionsModule conditions: Herpes Virus Infection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Sample size of 64 patients (32 patients in each group) was estimated by using 5% level of significance, 90% power of test with expected percentage of patients given prophylactic acyclovir as 81.3% and patients given placebo as 42.9%., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: parents were blinded to group allocation, whoMasked: PARTICIPANT, enrollmentInfo count: 64, type: ACTUAL, armsInterventionsModule interventions name: Intravenous Acyclovir, outcomesModule primaryOutcomes measure: Number of participants with positive Tzanck smear, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 13 Years, stdAges: CHILD, contactsLocationsModule locations facility: department of pediatric surgery King Edward Medical University, city: Lahore, state: Punjab, zip: 54000, country: Pakistan, geoPoint lat: 31.558, lon: 74.35071, hasResults: False

protocolSection identificationModule nctId: NCT06380634, orgStudyIdInfo id: NYalcinbas, briefTitle: The Effectiveness of Motivational Interviewing in Reducing the Use of Household Chemicals and Personal Care Products During Pregnancy, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-23, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-02-20, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Istanbul University - Cerrahpasa (IUC), class: OTHER, descriptionModule briefSummary: Objective: The aim of the study is to examine the effect of motivational interviewing on reducing the use of household chemicals and personal care products during pregnancy., conditionsModule conditions: Motivational Interview, conditions: Cosmetic Product Causing Toxic Effect, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The research was conducted in a prospective pre-test, post-test based randomized controlled experimental research design., primaryPurpose: SCREENING, maskingInfo masking: NONE, maskingDescription: The groups were randomized into 2 groups using a web-based randomization program (http://www.randomizer.org). The researcher included pregnant women who met the inclusion criteria in the outpatient clinics on certain days of the week, in accordance with the randomization process., enrollmentInfo count: 130, type: ACTUAL, armsInterventionsModule interventions name: Experimental group- Motivational Interview, outcomesModule primaryOutcomes measure: Evaluation Form for Use of Domestic Chemicals and Personal Care Products, primaryOutcomes measure: Self Efficacy Competence Scale, primaryOutcomes measure: Endocrine Disruptors Attitude Scale, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 43 Years, stdAges: ADULT, contactsLocationsModule locations facility: Istanbul University Cerrahpasa, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-02-05, uploadDate: 2024-04-17T16:09, filename: Prot_000.pdf, size: 142041, largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2024-02-05, uploadDate: 2024-04-17T16:13, filename: SAP_001.pdf, size: 234444, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-12-30, uploadDate: 2024-04-17T16:05, filename: ICF_002.pdf, size: 75804, hasResults: False

protocolSection identificationModule nctId: NCT06380621, orgStudyIdInfo id: IRC/1386/018, briefTitle: Bilateral vs Unilateral Totally Extraperitoneal Repair Among Patients With Unilateral Inguinal Hernia, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-03-15, primaryCompletionDateStruct date: 2019-02-15, completionDateStruct date: 2019-03-15, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: B.P. Koirala Institute of Health Sciences, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to investigate the feasibility of bilateral laparoscopic exploration for all unilateral cases followed by laparoscopic bilateral TEP repair in all cases with a contralateral occult hernia and to compare complications, recurrence rates, postoperative pain, and operative duration with prospectively performed unilateral repairs in young to middle-aged patients presenting with unilateral hernias in the surgery outpatient department.The main questions it aims to answer are:* To compare complications, recurrence rates, postoperative pain, and operative duration between both groups.* Incidence of occult contralateral hernia Patients attending the OPD for unilateral inguinal hernia were counseled about the trial and fully encouraged to understand the difference between two procedures for unilateral hernia: bilateral exploration and bilateral TEP repair, upon which if a contralateral occult inguinal hernia was observed, documented, and controls were taken from the patients who denied bilateral exploration and underwent unilateral TEP repair. The allotment of patients was done in two groups of 30 patients each.Researchers will compare Group A( bilateral TEP) with Group B (unilateral TEP) to see if complications, recurrence rates, postoperative pain, and operative duration occur in each group, conditionsModule conditions: Inguinal Hernia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Totally Extra Peritoneal repair (TEP) repair, outcomesModule primaryOutcomes measure: To compare pain in between patients of bilateral totally extra peritoneal repair and unilateral totally extra peritoneal repair., primaryOutcomes measure: To measure incidence of intra- and post-operative complication between patients of unilateral and bilateral TEP repair, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 55 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Bikash Kumar Sah, city: Dharān Bāzār, state: Koshi, zip: 56700, country: Nepal, geoPoint lat: 26.81248, lon: 87.28355, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_ICF, hasProtocol: True, hasSap: False, hasIcf: True, label: Study Protocol and Informed Consent Form, date: 2018-03-15, uploadDate: 2024-04-21T09:41, filename: Prot_ICF_000.pdf, size: 450800, hasResults: False

protocolSection identificationModule nctId: NCT06380608, orgStudyIdInfo id: 0047-23-ASF, briefTitle: Levels of Fear, Anxiety and Wound Healing Among Aental Surgery Patients Under Local Versus General Anesthesia, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Zoya Haitov Ben Zikri, class: OTHER_GOV, descriptionModule briefSummary: Tooth extraction is one of the most common procedures in dentistry. Surgical extraction of damaged wisdom teeth involves bone resection and injury to the soft tissue. Dental care often evokes high levels of anxiety.In addition, stress causes poor regulation of endocrine, autocrine and paracrine systems during the three stages of wound healing of the soft oral tissues. Therefore, special considerations are necessary when performing dental surgery on highly stressed patients. One of the options used in the last decade is to perform this procedure under general anesthesia.A stress response stimulates the secretion of cortisol hormone. Cortisol levels were found to be significantly higher before dental surgery, while after the operation the hormone level dropped significantly.The aim of the study is to assess the level of anxiety/fear and monitor the wound healing process among patients who are about to undergo surgery to remove wisdom teeth or no more than 3 jaw implants under local anesthesia in the dental clinic compared to patients who are about to undergo the same surgery under general anesthesia., conditionsModule conditions: Wisdom Teeth Extraction or Jaw Implant, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: Local anesthesia, interventions name: General anesthesia, outcomesModule primaryOutcomes measure: Fear and anxiety, primaryOutcomes measure: Wound heeling, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shamir (Asaf Harofe) Medical center, status: RECRUITING, city: Be'er Ya'aqov, zip: 60930, country: Israel, contacts name: sara Bar Yehuda, MD, role: CONTACT, phone: 972528981004, email: sarabar1@shamir.gov.il, geoPoint lat: 31.93864, lon: 34.83749, hasResults: False

protocolSection identificationModule nctId: NCT06380595, orgStudyIdInfo id: 23 -1533, briefTitle: Complex EVAR in Inflammatory and Infective Abdominal and Thoracoabdominal Aortic Aneurysms, acronym: CEVARII, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-21, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: CEVARII, class: OTHER, collaborators name: University of Iowa, collaborators name: University of Colorado, Denver, collaborators name: University of Trieste, collaborators name: University of Copenhagen, collaborators name: University of Colorado, Colorado Springs, descriptionModule briefSummary: Complex endovascular aortic repair in inflammatory and infective perivisceral abdominal aortic aneurysms and thoracoabdominal aortic aneurysms (CEVARII) study is a collaborative international effort among vascular surgeons to establish a database on the global experience in the management of INAAs and IAAs. Ethical approval for the study was obtained from the Colorado Multiple Institutional Review Board (COMIRB) under protocol number 23-1533., conditionsModule conditions: Inflammatory Abdominal Aortic Aneurysm, conditions: Aneurysm, Infected, conditions: Aneurysm, Mycotic, conditions: Abdominal Aortic Aneurysm, conditions: Thoracoabdominal Aortic Aneurysm, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule interventions name: Complex endovascular aortic repair (cEVAR), outcomesModule primaryOutcomes measure: Primary Graft Patency, primaryOutcomes measure: Bowel Ischemia, primaryOutcomes measure: Presence of aortic aneurysm endoleak after surgery, primaryOutcomes measure: Aneurysm-related mortality (ARM), primaryOutcomes measure: Conversion to Open Surgical Repair (OSR), primaryOutcomes measure: Aortic rupture, primaryOutcomes measure: Post-operative infection-related complication (IRC), primaryOutcomes measure: The duration of preoperative, perioperative, and postoperative duration of anti-microbial or immunosuppressive pharmacologic therapies., secondaryOutcomes measure: Assessment of Adverse Events (AEs) described in the protocol., secondaryOutcomes measure: All Cause Mortality, secondaryOutcomes measure: Continued Aortic sac growth., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Colorado Healthcare, city: Aurora, state: Colorado, zip: 80045, country: United States, geoPoint lat: 39.72943, lon: -104.83192, hasResults: False

protocolSection identificationModule nctId: NCT06380582, orgStudyIdInfo id: NL85595.068.23, briefTitle: Indoor Air Quality, Temperature and Cognitive Performance, acronym: AEOLUS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2024-12-21, completionDateStruct date: 2024-12-21, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Maastricht University Medical Center, class: OTHER, descriptionModule briefSummary: Study design: A cross-over single-blinded treatment design will be used. Participants will undergo 4 different conditions: (1) low air flow and 23°C, (2) low air flow and 35°C, (3) high air flow and 23°C, and (4) high air flow and 35°C. Participants will be blinded to the air quality level; however, it is not possible to blind them to the temperature condition, as they will be able to perceive it as different.Study population: The population consists of healthy young and middle-aged adults of both sexes between 18 and 40 years.Intervention (if applicable): Each participant undergoes 4 conditions in randomized order. Two conditions consist of poor air quality defined as 3,000 ppm carbon dioxide and 23°C or 35°C temperature, respectively., conditionsModule conditions: Indoor Air Quality, Temperature and Cognitive Performance, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: Temperature and Airflow combination, outcomesModule primaryOutcomes measure: Cognition, primaryOutcomes measure: Cognition, secondaryOutcomes measure: Heart Rate (bpm), secondaryOutcomes measure: Metabolic Rate (ml/kg/min), secondaryOutcomes measure: Blood Pressure (mmHg), secondaryOutcomes measure: Blood samples, secondaryOutcomes measure: Saliva samples, secondaryOutcomes measure: Breathing rate, otherOutcomes measure: Temperature (C), otherOutcomes measure: Humidity %, otherOutcomes measure: Carbon dioxide (CO2) concentration (ppm), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06380569, orgStudyIdInfo id: E-1139-21 Community Setting, briefTitle: A Strength-Based Intervention to Improve Job Interview Skills in Young Adults in a Community Setting, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Kessler Foundation, class: OTHER, descriptionModule briefSummary: We are looking to evaluate how effective a strength-based intervention may be in improving job interview skills in young adults. We are examining the effects of this intervention in young adults who may have difficulty with job interviews, and who may want to improve these skills., conditionsModule conditions: Autism Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: Kessler Foundation Strength Identification and Expression (KF-STRIDE®), primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: KF-STRIDE®, outcomesModule primaryOutcomes measure: Mock Job Interview, primaryOutcomes measure: Employment Status, primaryOutcomes measure: Time-to-reach Employment, primaryOutcomes measure: Strength Knowledge and Strengths Use Scale (SKUS), primaryOutcomes measure: Youth Interview- Self Efficacy and Anxiety, primaryOutcomes measure: Job Search Behavior Scale, primaryOutcomes measure: Work Readiness Scale, primaryOutcomes measure: Global Assessment of Character Strengths (GACS), secondaryOutcomes measure: Rosenberg Self-Esteem Scale (RSES), eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 26 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06380556, orgStudyIdInfo id: 25.05.2022/68, briefTitle: The Effect of Mechanical Vibration and ShotBlocker on Pain Levels During Heel Lance in Healthy Term Neonates, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-10, primaryCompletionDateStruct date: 2023-01-30, completionDateStruct date: 2023-07-13, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Istanbul Medeniyet University, class: OTHER, descriptionModule briefSummary: This study was conducted to determine the effect of mechanical vibration and ShotBlocker methods on pain level, crying time and procedure time during heel prick blood collection in healthy term infants., conditionsModule conditions: Procedural Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In the study, participants were assigned to groups by block randomization. Type of delivery (vaginal and cesarean section), gender (male and female) and birth weight (2500-3000 g, 3001-3500 g, 3501 and above) variables were used for block randomization. Blocks were repeated three times in each group and 36 participants were assigned to each. A randomization list with 2 X 2 X 3 X 3 blocks was developed using an online randomization tool. In the study, the group to which the first participant was assigned was determined by a sealed envelope method., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: Using the block randomization technique, participants were divided into three groups. A web-based randomization list generation tool was used to assign participants to groups. Control and intervention groups were coded as A, B and C using the sealed envelope method. Randomization information was withheld from the researcher involved in data collection until data was collected. The researcher determines which group each baby is in. The researcher found out during the painful procedure. (investigator blinding).Within the scope of the research, parents knew which group the baby was in. However, due to the nature of the sample group, the babies were blind.To avoid statistical bias, study groups were coded as A, B and C; statistical blinding was performed (statistician blinding)., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 108, type: ACTUAL, armsInterventionsModule interventions name: ShotBlocker, interventions name: Mechanical vibration, outcomesModule primaryOutcomes measure: Procedural pain score- Neonatal Infant Pain Scale (NIPS), secondaryOutcomes measure: Crying time, secondaryOutcomes measure: Procedure time, eligibilityModule sex: ALL, minimumAge: 38 Weeks, maximumAge: 42 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: Istanbul Medeniyet University, city: Istanbul, state: Kadıköy, zip: 34720, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False

protocolSection identificationModule nctId: NCT06380543, orgStudyIdInfo id: BILINCE, briefTitle: ERCP Biliary Cannulation Success Using ESGE Algorithm, acronym: BILINCE, statusModule overallStatus: RECRUITING, startDateStruct date: 2019-12-12, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: IRCCS San Raffaele, class: OTHER, collaborators name: Societa Italiana di Endoscopia Digestiva, descriptionModule briefSummary: Papillary cannulation attempts have been shown to be an independent predictor of post-ERCP pancreatitis (PEP) when they are repeated more than 5 times or for 5 minutes or when the pancreatic duct is opacified or cannulated by using guidewire more than 1 time. In order to reduce complications, the 2016 ESGE guideline recommends a precise sequence of alternative cannulation techniques to the primary guidewire approach before exceeding the stated limits. However, there are no published data about the routinary application of this biliary cannulation algorithm.The investigators hypothesised that the ESGE algorithm predicts an increased cannulation success. Nevertheless, it's unclear if this benefit is also associated with a decreased risk of complications, mainly post-procedural pancreatitis., conditionsModule conditions: Biliary Tract Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 800, type: ESTIMATED, outcomesModule primaryOutcomes measure: Success of ERCP biliary cannulation rate, secondaryOutcomes measure: ERCP complication rates, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS OSpedale San Raffaele, status: RECRUITING, city: Milano, zip: 20132, country: Italy, contacts name: Alberto Mariani, MD, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False

protocolSection identificationModule nctId: NCT06380530, orgStudyIdInfo id: SIMULA, briefTitle: Advanced Surgical Simulation Processes in the Correction of Skeletal Defects and Deformities, acronym: SIMULA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2028-05, completionDateStruct date: 2029-05, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Istituto Ortopedico Rizzoli, class: OTHER, collaborators name: Ospedale Pediatrico Bambino Gesù, collaborators name: Istituto Giannina Gaslini, collaborators name: Galeazzi Orthopedic Institute, collaborators name: Istituto Nazionale Tumori Regina Elena, collaborators name: Policlinico San Matteo, collaborators name: Istituto Clinico Humanitas, descriptionModule briefSummary: Virtual Surgical Planning (VSP), Computer-Aided Surgical Simulation (CASS) for bone corrections, and the customization of implants and devices through 3D printing, known as Patient-Specific Instruments (PSI) and Graft-Specific Instruments (GSI), are assuming increasingly central roles in orthopedic clinical and surgical practice.One area witnessing notable advancement is the treatment of musculoskeletal disorders (MMS) in children, adolescents, and young adults. These disorders involve severe and rare abnormalities in skeletal formation and development across three-dimensional planes, often affecting multiple limbs. Managing such deformities is complex, challenging to standardize, and prone to unpredictable clinical, radiographic, and functional outcomes.The application of 3D modeling and printing technologies offers a deeper understanding of deformities and facilitates improved prediction, precision, reproducibility, and safety in surgical interventions.The Musculoskeletal Apparatus Network (RAMS Network) centers are equipped with advanced 3D laboratories for surgical simulation and planning, aligned with the overarching goal of improving surgery quality through "in-silico" medicine (ISM) principles.At present, numerous complex surgeries involving Virtual Surgical Planning (VSP) and sterilizable 3D-printed Patient-Specific Instruments (PSI) and/or Graft-Specific Instruments (GSI) are being simulated and performed at the Rizzoli Institute. Preliminary data from previous protocols indicate a significant reduction in surgical time with the implementation of VSP and the utilization of PSI and GSI.The aim of this study is to enhance the current process of simulating, planning, and designing surgical support tools within 3D Printing Point-of-Care (3D POC) facilities. To achieve this, it is imperative to expand case volumes and systematically organize, categorize, and standardize simulation and planning procedures., conditionsModule conditions: Musculoskeletal Deformity, conditions: Musculoskeletal Abnormalities, conditions: Musculoskeletal Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Deformity correction, outcomesModule primaryOutcomes measure: Achieved skeletal corrections, primaryOutcomes measure: Achieved skeletal corrections, secondaryOutcomes measure: Operating room times, secondaryOutcomes measure: Fluoroscopy times, secondaryOutcomes measure: Blood loss, secondaryOutcomes measure: Intra- and peri-operative complications, secondaryOutcomes measure: Suitability of PSIs, secondaryOutcomes measure: Suitability of GSIs, secondaryOutcomes measure: Suitability of bone graft, secondaryOutcomes measure: Clinical-functional outcome, secondaryOutcomes measure: Clinical-functional outcome, otherOutcomes measure: Cost analysis, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 40 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: IRCCS Istituto Ortopedico Rizzoli, city: Bologna, state: BO, zip: 40136, country: Italy, contacts name: Grazia Chiara Menozzi, role: CONTACT, phone: 0516266, phoneExt: 484, email: graziachiara.menozzi@ior.it, geoPoint lat: 44.49381, lon: 11.33875, locations facility: Istituto Clinico Humanitas, city: Rozzano, state: MI, country: Italy, geoPoint lat: 45.38193, lon: 9.1559, locations facility: Istituto Giannina Gaslini, city: Genova, country: Italy, contacts name: Giorgio Marrè Brunenghi, MD, role: CONTACT, email: giorgiomarre@gaslini.org, geoPoint lat: 44.40478, lon: 8.94438, locations facility: Galeazzi Orthopedic Institute, city: Milano, country: Italy, contacts name: Fabio Verdoni, MD, role: CONTACT, email: fabio.verdoni@grupposandonato.it, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Policlinico San Matteo, city: Pavia, country: Italy, contacts name: Gianluigi Pasta, MD, role: CONTACT, geoPoint lat: 45.19205, lon: 9.15917, locations facility: Istituto Nazionale Tumori Regina Elena, city: Roma, country: Italy, contacts name: Roberto Biagini, MD, role: CONTACT, email: roberto.biagini@ifo.it, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale Pediatrico Bambino Gesù, city: Roma, country: Italy, contacts name: Pier Francesco Costici, MD, role: CONTACT, email: pierfrancesco.costici@opbg.net, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False

protocolSection identificationModule nctId: NCT06380517, orgStudyIdInfo id: ATS23, secondaryIdInfos id: 2UG1EY011751, type: NIH, link: https://reporter.nih.gov/quickSearch/2UG1EY011751, briefTitle: Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age, acronym: ATS23, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-12-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Jaeb Center for Health Research, class: OTHER, collaborators name: National Eye Institute (NEI), collaborators name: Pediatric Eye Disease Investigator Group, descriptionModule briefSummary: In children 4 to 7 years of age, to determine if treatment with 1 hour per day 6 days per week of watching dichoptic movies/shows wearing the Luminopia headset is non-inferior to treatment with 2 hours of patching per day 7 days per week with respect to change in amblyopic eye distance VA from randomization to 26 weeks., conditionsModule conditions: Amblyopia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 238, type: ESTIMATED, armsInterventionsModule interventions name: Luminopia, interventions name: Eye Patch, outcomesModule primaryOutcomes measure: Change in amblyopic eye logMAR distance VA between randomization and 26 weeks, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 7 Years, stdAges: CHILD, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-04-01, uploadDate: 2024-04-18T09:58, filename: Prot_000.pdf, size: 715474, largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2024-04-17, uploadDate: 2024-04-18T15:02, filename: SAP_001.pdf, size: 4154847, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-04-17, uploadDate: 2024-04-18T09:59, filename: ICF_002.pdf, size: 248300, hasResults: False

protocolSection identificationModule nctId: NCT06380504, orgStudyIdInfo id: RSWITCH-Ethiopia, briefTitle: Increasing the Coverage of Severe Acute Malnutrition (SAM) Treatment in Ethiopia, acronym: R-SWITCH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-29, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2027-06-30, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: International Food Policy Research Institute, class: OTHER, collaborators name: Ethiopian Public Health Association, collaborators name: UNICEF, descriptionModule briefSummary: The R-SWITCH intervention aims to address the low coverage of treatment for severe wasting (SAM) by leveraging existing community groups to deliver an integrated package focused on prevention, screening, referral, and treatment of SAM. It includes behavior change communication on child nutrition and health, active screening, improved passive screening at health posts, and follow-up of referred cases and those enrolled in outpatient treatment programs (OTP). The primary objectives of the R-SWITCH studies are to assess the intervention's impact on OTP coverage, identify implementation barriers and facilitators, and evaluate its cost-efficiency and cost-effectiveness., conditionsModule conditions: Acute Malnutrition, Severe, conditions: Malnutrition, Child, conditions: Wasting, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Cluster randomized controlled trial. Unit/cluster of assignment is health post catchment area. Parallel Assignment: baseline-endline design, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, maskingDescription: Evaluator teams will be blinded from intervention allocation, enrollmentInfo count: 1080, type: ESTIMATED, armsInterventionsModule interventions name: R-SWITCH integrated intervention package, outcomesModule primaryOutcomes measure: Period prevalence of SAM OTP treatment coverage in children 6-59 months of age, secondaryOutcomes measure: Point prevalence of SAM OTP treatment coverage in children 6-59 months of age, secondaryOutcomes measure: Period prevalence of SAM OTP treatment coverage in the subgroup of treatment eligible children 6-59 months of age, secondaryOutcomes measure: Screening coverage of SAM, secondaryOutcomes measure: Screening coverage of severe underweight, secondaryOutcomes measure: Platform specific screening coverage of SAM, secondaryOutcomes measure: Growth Monitoring Promotion (GMP) consultation attendance, secondaryOutcomes measure: AFD group meeting attendance, secondaryOutcomes measure: AFD home visit coverage, secondaryOutcomes measure: Prevalence of SAM, secondaryOutcomes measure: Prevalence of wasting, secondaryOutcomes measure: Prevalence of stunting, secondaryOutcomes measure: Prevalence of underweight and severe underweight, secondaryOutcomes measure: Mean height-for-age Z-score (HAZ), secondaryOutcomes measure: Mean weight-for-height Z-score (WHZ), secondaryOutcomes measure: Mean weight-for-age Z-score (WAZ), secondaryOutcomes measure: Mean mid-upper arm circumference (MUAC), secondaryOutcomes measure: Caregiver's knowledge related to breastfeeding, complementary feeding,child health and hygiene, the condition of severe acute malnutrition, outpatient therapeutic programs, screening of wasting, secondaryOutcomes measure: Vaccination coverage, secondaryOutcomes measure: Introduction of (semi) solid and soft complementary foods, secondaryOutcomes measure: Minimum dietary diversity in infants and young children (6-23 mo), secondaryOutcomes measure: Nr of food groups consumed by infants and young children (6-59 mo), secondaryOutcomes measure: Minimum meal frequency in infants and young children, secondaryOutcomes measure: Minimum acceptable diet in infants and young children, secondaryOutcomes measure: Continuous breastfeeding 12-23 months, secondaryOutcomes measure: Egg and/or flesh food consumption, secondaryOutcomes measure: Sweet beverage consumption, secondaryOutcomes measure: Zero vegetable or fruit consumption consumption, secondaryOutcomes measure: Minimum milk feeding frequency for non-breastfed children, secondaryOutcomes measure: Weight-for-length Z-score and MUAC at Severe Acute Malnutrition (SAM) Outpatient Therapeutic Feeding program (OTP), secondaryOutcomes measure: SAM OTP adherence, secondaryOutcomes measure: Weight gain rate during SAM OTP, secondaryOutcomes measure: SAM OTP outcomes (drop-out, death, transfer, non-response rates), secondaryOutcomes measure: SAM OTP duration, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 5 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06380491, orgStudyIdInfo id: REF.2338, secondaryIdInfos id: UNAM-PAPIIT 32-IN216919, type: OTHER, domain: Universidad Nacional Autonoma de Mexico (UNAM), briefTitle: Melatonin's Effect on Nighttime Blood Pressure and Sleep in OSA Patients (MEBP-OSA), acronym: MEBP-OSA, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-22, primaryCompletionDateStruct date: 2024-11-22, completionDateStruct date: 2025-01-22, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, class: OTHER, collaborators name: Universidad Nacional Autonoma de Mexico, collaborators name: Emory University, descriptionModule briefSummary: The goal of this clinical trial is to learn if melatonin works to treat comorbid insomnia in adults with OSA and nocturnal non-dipping blood pressure pattern.The main question it aims to answer is:Does melatonin maintain sleep during night and recover the dipping blood pressure pattern?, conditionsModule conditions: Obstructive Sleep Apnea of Adult, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients with a non-dipper pattern in blood pressure will randomly enter one of two options: 1) usual medical treatment; 2) treatment with melatonin plus usual care., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Melatonin 3 MG Oral Tablet, outcomesModule primaryOutcomes measure: Melatonin at a dose of 3 mg before sleep time, after a period of 30 days changes the time awake after sleep onset (WASO), and recovers the dipper pattern of blood pressure, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: National Institute of Medical Sciences and Nutrition Salvador Zubirán (INCMNSZ), status: RECRUITING, city: Mexico City, country: Mexico, geoPoint lat: 19.42847, lon: -99.12766, hasResults: False

protocolSection identificationModule nctId: NCT06380478, orgStudyIdInfo id: CPRO-000012, briefTitle: Safety and Efficacy of the Bi-Aspheric Monofocal IOL, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2024-12-05, completionDateStruct date: 2024-12-25, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: ICARES Medicus, Inc., class: INDUSTRY, collaborators name: AST Products, Inc., descriptionModule briefSummary: This is an observational, single-center, non-control, open-label post-marketing study. Patients implanted with an aspicio™ Monofocal Intraocular Lens will be scheduled for a follow-up visit at least 3 months after the surgery to undergo a routine basic ophthalmological examination., conditionsModule conditions: Cataract, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: aspicio Monofocal IOL, outcomesModule primaryOutcomes measure: CDVA, primaryOutcomes measure: Defocus curve, secondaryOutcomes measure: UDVA, secondaryOutcomes measure: UIVA, secondaryOutcomes measure: CIVA, secondaryOutcomes measure: IOL glistening, secondaryOutcomes measure: PCO, secondaryOutcomes measure: Satisfaction questionnaire, secondaryOutcomes measure: AE, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chang Gung University Hospital, status: RECRUITING, city: Taoyuan, state: Guishan District, zip: 333, country: Taiwan, contacts name: Lisa Chen, role: CONTACT, email: lisa.phchen@gmail.com, contacts name: Yih-Shiou Hwang, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 24.95233, lon: 121.20193, hasResults: False

protocolSection identificationModule nctId: NCT06380465, orgStudyIdInfo id: 23-11-1838, briefTitle: The Effect of Anthocyanin Intake From Purple Sweet Potato in Cerebral Small Vessel Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Indonesia University, class: OTHER, collaborators name: Fakultas Kedokteran Universitas Indonesia, collaborators name: Universitas Padjadjaran, collaborators name: Institut Pertanian Bogor, collaborators name: School of Science and technology, Kwansei Gakuin University, descriptionModule briefSummary: Cerebral small vessel disease (CSVD) is a major cause of disability, cognitive impairment, and functional loss in the elderly. CSVD occurs due to damage to arterioles, capillaries, and venules in the brain parenchyma, and can cause clinical and neuroimaging symptoms. CSVD also accounts for up to 25% of all ischemic stroke cases, and making it the second leading cause of death in the world after ischemic heart disease.Purple sweet potatoes, scientifically known as Ipomoea batatas (L.) Lam., contains of high anthocyanin specifically peonidin and cyanidin that has antioxidant, anti-inflammatory, and potentially phytoestrogenic activity. These anthocyanins have been linked to a reduced risk of obesity, diabetes, and high cholesterol. They also show potential in improving endothelial function, thereby enhancing blood vessel vasomotor function and potentially reducing the risk of cardiovascular diseases. Anthocyanins and their metabolites can cross the blood-brain barrier and affect signaling pathways, gene expression, and protein function at the molecular level. In addition to their ability to enhance vascular flow, anthocyanins can also help mitigate the risk factors associated with CSVD by counteracting oxidative stress in the body. These findings exploring the potential benefits of anthocyanins for individuals with CSVD by giving purple sweet potatoes extract comparing with placebo.The outcomes that will be assessed are vasomotor reactivity measured by Breath Holding Index in Transcranial Doppler, Nitric Oxide, L-Arginine and Adiponectin levels in blood, Cognitive Test and Gait., conditionsModule conditions: Cerebral Small Vessel Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The participant who meet the inclusion criteria and have signed the consent will be subjected to a baseline assessment followed by randomization into 2 groups/arms consisting of 2 treatments (1 group getting the water extract pf purple sweet potato) and 1 control group that got placebo., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The research was conducted using a single-blind approach, where the participants were unaware of the intervention being implemented, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: The water extract of "Biang" variety purple sweet potato, outcomesModule primaryOutcomes measure: Breath Holding Index, primaryOutcomes measure: Nitric Oxide, primaryOutcomes measure: L-Arginine, primaryOutcomes measure: Adiponectin, primaryOutcomes measure: Cognitive, primaryOutcomes measure: Gait, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-12-02, uploadDate: 2024-04-18T03:49, filename: ICF_000.pdf, size: 332637, hasResults: False

protocolSection identificationModule nctId: NCT06380452, orgStudyIdInfo id: SKABUP, secondaryIdInfos id: 2023-507925-41-00, type: OTHER, domain: EU-Trial-Nr. (EMA), briefTitle: Therapy for Scabies With Two Differently Concentrated Permethrin Creams, acronym: SKABUP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-07, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Infectopharm Arzneimittel GmbH, class: INDUSTRY, collaborators name: Winicker Norimed GmbH, descriptionModule briefSummary: The multi-center, prospective, randomized, double-blind phase III clinical trial will primarily investigate the efficacy and safety of treatment of scabies with Permethrin Cream 5% (approved drug InfectoScab 5% Cream) in direct comparison with Permethrin Cream 10%.The trial participants will be randomly assigned and blinded to either Permethrin Cream 5% or Permethrin Cream 10%., conditionsModule conditions: Scabies, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The SKABUP study is a prospective, randomized, double-blind, 2-arm superiority study in a group sequential design with recruitment stop and interim analysis after 172 patients. If there is no evidence of superiority in the interim analysis, the study will be continued unchanged up to the planned number of 220 patients and will be terminated and analyzed regularly., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: double-blind, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule interventions name: 5% Permethrin Creme, interventions name: 10% Permethrin Creme, outcomesModule primaryOutcomes measure: clinical efficacy (yes/no), secondaryOutcomes measure: effectiveness at Visit 1, secondaryOutcomes measure: frequency of therapy success, secondaryOutcomes measure: itching, secondaryOutcomes measure: patients with evidence of mites, secondaryOutcomes measure: patients with use of antiscabiosa not compliant with the protocol, secondaryOutcomes measure: patients with new scabies efflorescences, secondaryOutcomes measure: patients with "additional confirmed" treatment failure, secondaryOutcomes measure: AEs, SAEs, ADRs, SUAWs, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 85 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06380439, orgStudyIdInfo id: 23-10-1763, briefTitle: The Effect of Wrist Ankle Acupuncture on Post-Total Hip Arthroplasty Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-23, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Indonesia University, class: OTHER, descriptionModule briefSummary: Total hip arthroplasty is one of the most cost-effective orthopedic surgical procedures which can restore hip function and improve the patient's quality of life. However, total hip arthroplasty is significantly associated with postoperative pain. Pain after total hip arthroplasty surgery can adversely affect the patient's early postoperative recovery, postoperative mobility, and hinder rehabilitation.Wrist ankle acupuncture (WAA) is a simpler acupuncture technique, using fewer points, shallow needle insertion and lighter stimulation. Wrist-ankle acupuncture as multimodal analgesia after orthopedic surgery is useful for reducing pain and reduce the incidence of post-surgical side effects. The primary aim of this study is to investigate whether wrist ankle acupuncture therapy gives better and results for post total hip arthroplasty pain than sham wrist ankle acupuncture, conditionsModule conditions: Pain, Postoperative, conditions: Hip Osteoarthritis, conditions: Hip Fractures, conditions: Hip Injuries, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: wrist ankle acupuncture, outcomesModule primaryOutcomes measure: Visual Analog Scale, secondaryOutcomes measure: recovery rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cipto Mangunkusumo Hospital, status: RECRUITING, city: Jakarta Pusat, state: Jakarta, zip: 10430, country: Indonesia, contacts name: Cipto Mangunkusumo Hospital, role: CONTACT, phone: 1 500 135, geoPoint lat: -6.1818, lon: 106.8223, locations facility: Fatmawati Hospital, status: RECRUITING, city: Jakarta, zip: 12430, country: Indonesia, contacts name: Fatmawati Hospital, role: CONTACT, phone: 0217501524, geoPoint lat: -6.21462, lon: 106.84513, locations facility: Persahabatan Hospital, status: RECRUITING, city: Jakarta, zip: 13230, country: Indonesia, contacts name: Persahabatan Hospital, role: CONTACT, phone: (021) 4891708, geoPoint lat: -6.21462, lon: 106.84513, hasResults: False

protocolSection identificationModule nctId: NCT06380426, orgStudyIdInfo id: APHP230441, secondaryIdInfos id: IDRCB : 2023-A02003-42, type: OTHER, domain: ANSM, briefTitle: Real-life Evaluation of WEGOVY (Semaglutide) Treatment in Adults With Monogenic Obesity (ObGeSema), acronym: ObGeSema, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2027-04-30, completionDateStruct date: 2027-11-30, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Rare genetic forms of obesity, so called monogenic obesity are linked to alteration in energy balance involving hypothalamic pathways.More than 60 genes encoding for proteins located in the hypothalamic leptin/melanocortin pathway have been described in the French National Protocol for Diagnostic and Care (PNDS).The natural history of monogenic obesity is characterized by an early onset in childhood, with a major increase in weight in adolescence and young adulthood. The worsening of obesity exposes these patients to severe complications.Severe obesity and eating disorders have a major impact on the quality of life of the person but also of the family and caregivers. Clinical management is complex and requires comprehensive, specialized and multidisciplinary management. But the usual lifestyle approaches have so far shown disappointing results, similarly to bariatric surgery which leads to a more frequent weight regain in the situation of monogenic obesity, justifying new approaches.In this context, evaluating the response to treatment in the particular condition of monogenic obesity is crucial to propose therapeutic options as early as possible to limit weight evolution and its complications.GLP-1 (glucagon-like peptide 1) based innovative therapies have recently emerged as a promising option for treatment of obesity and its complications. This is the case for Semaglutide 2.4mg/week (WEGOVY®), developed by Novo Nordisk. However, there is a lack of data to confirm that semaglutide could be also effective in monogenic obesity.The hypothesis in this study is that treatment with Semaglutide 2.4mg/week (WEGOVY®) could be as effective in monogenic obesities as in common obesity., conditionsModule conditions: Monogenic Obesity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 175, type: ESTIMATED, outcomesModule primaryOutcomes measure: Change in weight and Body Mass Index (BMI), secondaryOutcomes measure: Change in weight and Body Mass Index (BMI), secondaryOutcomes measure: Reduction of body weight equal to or above 5%, secondaryOutcomes measure: Change in Hunger score, secondaryOutcomes measure: Change in eating behaviour measured by Food Craving questionnaire, secondaryOutcomes measure: Change in eating behaviour measured by the Binge Eating Scale (BES), secondaryOutcomes measure: Change in eating behaviour measured by the Dutch Eating Behaviour Questionnaire (DEBQ), secondaryOutcomes measure: Change in eating behaviour measured by the Dykens questionnaire, secondaryOutcomes measure: Change in eating behaviour measured by the Child Eating Behaviour Questionnaire (CEBQ), secondaryOutcomes measure: Change in the International physical activity questionnaire (IPAQ - short form), secondaryOutcomes measure: Change in Digestive disorders (GIQLI ), secondaryOutcomes measure: Change in sleep disorder (MCTQ score), secondaryOutcomes measure: Change in score of quality of life scores (patient and parents), secondaryOutcomes measure: Change in anxiety and depression score, secondaryOutcomes measure: Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre de référence Syndrome de Prader-Willi et autres obésités avec troubles du comportement alimentaire (PRADORT). Service de Nutrition, GH Pitié-Salpêtrière, APHP, city: Paris, zip: 75013, country: France, contacts name: Emilie GUILLON, role: CONTACT, email: emilie.guillon-ext@aphp.fr, contacts name: Sarra POCHON, role: CONTACT, phone: +33(1)42167574, email: sarra.pochon@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False

protocolSection identificationModule nctId: NCT06380413, orgStudyIdInfo id: 78972024.7.0000.5313, briefTitle: Tai Chi Chuan Combined With Walking on Physical and Mental Parameters of Older Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-20, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Federal University of Pelotas, class: OTHER, descriptionModule briefSummary: Background: Tai Chi Chuan, a Chinese martial art style, is a mind-body modality that has shown positive impacts on health markers in various populations, particularly older adults. This study aims to investigate the effects of a 12-week program of Tai Chi Chuan exercises based on the Yang 16-movement form and walking on older adults' physical and mental markers.Methods: This study is a randomized, single-blinded, two-arm, parallel, superiority trial. Forty older adults between 60 and 75 years old who are not engaged in any systematic strength and aerobic training program will be recruited. Candidates with language and cognitive problems, a history of cardiovascular diseases (except controlled hypertension), osteoarticular limitations and fractures, severe injuries, and prosthetic placement in the last six months will be excluded. Participants will be randomly allocated on a 1:1 ratio to a 12-week intervention with Tai Chi Chuan and walking two times per week, or an active-control group with walking two times per week. Physical measures will be muscle strength (i.e., knee extensors maximum strength and lower limbs functional performance -primary outcomes-, dynamic knee extensors endurance, handgrip strength, back-leg-chest strength), functional capacity, static balance, muscle thickness and muscle quality of quadriceps. Mental measures will be quality of life, sleep quality, cognitive function, and depressive and anxiety symptoms. Outcomes will be measured before and after 12 weeks of intervention. The analysis plan will use an intention-to-treat approach and protocol criteria.Discussion: The conceptual hypothesis is that the intervention training program with Tai Chi Chuan and walking will lead to greater improvements in both physical and mental parameters due to its multi-component character compared to the walking active-control group., conditionsModule conditions: Aging, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study is a randomized, single-blinded, two-arm, parallel, superiority trial. Forty healthy and physically inactive subjects, 60 to 75 years of age, are recruited. Participants are randomly allocated on a 1:1 ratio to a 12-week intervention of Tai Chi Chuan plus walking program twice a week, or an active-control group of walking twice a week., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Blinding will be implemented for the outcome assessors. All tests and questionnaires will be supervised by an evaluator blinded to the participant's group. Due to the type of intervention, the investigator conducting exercise sessions and participants will not be blinded., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Tai Chi Chuan Plus Walking, interventions name: Walking, outcomesModule primaryOutcomes measure: Maximal dynamic strength, primaryOutcomes measure: Functional test - 30-s Chair-stand test, secondaryOutcomes measure: Dynamic muscular endurance, secondaryOutcomes measure: Isometric handgrip strength, secondaryOutcomes measure: Isometric back-leg-chest strength, secondaryOutcomes measure: Functional tests - arm curl, secondaryOutcomes measure: Functional tests - 8-ft Up-and-Go, secondaryOutcomes measure: Functional tests - Chair Sit-and-Reach, secondaryOutcomes measure: Functional tests - Back Scratch, secondaryOutcomes measure: Funcional tests - 6-min Walk, secondaryOutcomes measure: Static balance - 30-second single-leg stance test, secondaryOutcomes measure: Quadriceps muscle thickness, secondaryOutcomes measure: Quadriceps muscle quality, secondaryOutcomes measure: Objective cognitive function - Trail Making Test (TMT), secondaryOutcomes measure: Objective cognitive function - Controlled Oral Word Association Test (COWAT), secondaryOutcomes measure: Quality of Life - Abbreviated World Health Organization Quality of Life (WHOQOL-Bref), secondaryOutcomes measure: Sleep quality - Pittsburgh Sleep Quality Index, secondaryOutcomes measure: Depressive and anxiety symptoms is measured using the Hospital Anxiety and Depression Scale (HADS), otherOutcomes measure: Body mass, otherOutcomes measure: Height, otherOutcomes measure: Waist and hip circumferences, otherOutcomes measure: Monitoring the intensity of training sessions - Borg Category-Ratio 10 (CR-10), otherOutcomes measure: Follow-up questionnaire, otherOutcomes measure: Adherence assessments, otherOutcomes measure: Health Questionnaire, otherOutcomes measure: Level of physical activity - International Physical Activity Questionnaire (IPAQ) - extended version, otherOutcomes measure: Cognitive screening - Mini-mental state examination (MMSE), eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Escola Superior de Educação Física e FIsioterapia, city: Pelotas, state: Rio Grande Do Sul, zip: 96055630, country: Brazil, contacts name: Cristine L Alberton, PhD, role: CONTACT, geoPoint lat: -31.77194, lon: -52.3425, hasResults: False

protocolSection identificationModule nctId: NCT06380400, orgStudyIdInfo id: 0000-0001-5786-4385, briefTitle: The Effect of Foot Bath on Birth Pain and Birth Comfort, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-07-30, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Selcuk University, class: OTHER, descriptionModule briefSummary: Although childbirth is seen as a natural, happy, meaningful and universal experience, women are often faced with severe pain, discomfort and a sensory state that can be overwhelming. There are two ways to reduce labour pain: pharmacological (drugs) and non-pharmacological (non-drug methods). Non-pharmacological methods, in particular, attempt to relieve pain by addressing emotional, cognitive, behavioural and socio-cultural dimensions. These methods provide relief and reduce the perception of pain. One of the non-pharmacological methods used to reduce labour pain is footbaths. Footbaths are widely used as a nurse/midwife intervention in many countries. Footbathing is a simple technique used to induce a sense of comfort and relaxation. It involves gently immersing the patient's legs and feet (below the knees) in a basin of warm water. Local heat treatments are generally safe and are considered an effective form of complementary medicine. In its simplest form it means "a tool to be part of supportive care, promoting peace, positive emotions, comfort, satisfaction and enjoyment". The mechanisms responsible for the effects of footbathing are not fully understood, but soaking the feet in warm water and stimulating the sense of touch through massage or washing can reduce sympathetic nerve activity, thereby reducing pain and increasing comfort. In other words, reducing pain during labour means providing support and comfort to the woman. This study was designed to evaluate the effect of a foot bath applied in the first stage of labour on labour pain and comfort in nulliparous women., conditionsModule conditions: Parturition, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 196, type: ESTIMATED, armsInterventionsModule interventions name: Foot bath, outcomesModule primaryOutcomes measure: Visuell analog scale score of the pregnant woman, secondaryOutcomes measure: Birth comfort scale score of the pregnant woman, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Habibe Bay Ozcalik, status: RECRUITING, city: Konya, zip: 42250, country: Turkey, contacts name: Habibe Bay Ozcalik, role: CONTACT, phone: 05424469343, email: habiberk@hotmail.com, geoPoint lat: 37.87135, lon: 32.48464, hasResults: False

protocolSection identificationModule nctId: NCT06380387, orgStudyIdInfo id: H-21046543, briefTitle: Whole Body Metabolism in Children Before and After Treatment of CNS Tumor, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-23, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Rigshospitalet, Denmark, class: OTHER, descriptionModule briefSummary: At the center of pediatric oncology in Copenhagen the investigators experience that the children with brain tumor, more or less have a healthy body with normal skeletal muscle mass and are physical active to the same level as their friends at the same age. The treatment period for brain tumor is approximately two years. After the treatment period, the children are more sedative with less interest in coming out doing physical activities and thus the investigators suspect that they have altered hormonal response, low skeletal muscle mass and perhaps are in risk of developing metabolic syndrome.By comparing children with newly diagnosed CNS tumor with children finished treated for CNS tumor, we wish to describe the metabolic path during the approximately two years treatment period these children go through. These results will also be compared with results from healthy controls.The investigators aim to include 10 children (aged 6-18 years) with newly diagnosed CNS tumor, 10 children (aged 6-18 years) finished treated for CNS tumor and 10 healthy controls (aged 6-18 years). By using stable isotope technique the investigators will investigate systemic fat, glucose and protein metabolism together with liver protein degradation and glucose production. Furthermore, by using DXA scan the investigators will describe the quality and distribution of skeletal muscle. Lastly, the investigators will determine the skeletal muscle signal pathway and metabolism in skeletal muscle via the Bergström biopsy technique in vastus lateralis., conditionsModule conditions: CNS Tumor, Childhood, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Meal, outcomesModule primaryOutcomes measure: Protein breakdown, primaryOutcomes measure: Protein synthesis, primaryOutcomes measure: Phenylalanine concentration, primaryOutcomes measure: Phe oxidation to TYR, primaryOutcomes measure: Whole-body protein synthesis, primaryOutcomes measure: Whole-body protein degradation, primaryOutcomes measure: Netto protein balance, primaryOutcomes measure: Glucose Rate of appearance, primaryOutcomes measure: Total glucose Rate of appearance, primaryOutcomes measure: Total glucose Rate of disappearance, primaryOutcomes measure: Endogenous glucose, primaryOutcomes measure: Oral phenylalanine Rate of appearance, primaryOutcomes measure: Phenylalanine oxidation, primaryOutcomes measure: Rate of Appearance of Palmitate in Plasma, primaryOutcomes measure: Rate of Disappearance of Palmitate, primaryOutcomes measure: Concentration of ketones, secondaryOutcomes measure: Glucose, secondaryOutcomes measure: Quality of Skeletal Muscle, secondaryOutcomes measure: Protein synthesis rate, secondaryOutcomes measure: Pain score, secondaryOutcomes measure: Life quality score, secondaryOutcomes measure: Muscle biopsy, secondaryOutcomes measure: Incretins, secondaryOutcomes measure: Glucagon, secondaryOutcomes measure: Liver parameters ALT, AST, GGT, secondaryOutcomes measure: Bilirubin, secondaryOutcomes measure: International normalized ratio (INR), secondaryOutcomes measure: LDH, secondaryOutcomes measure: Insulin, secondaryOutcomes measure: catecholamines, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Waist- and hip circumference, secondaryOutcomes measure: Lipids, secondaryOutcomes measure: Concentration of Plasma Amino Acids, secondaryOutcomes measure: Concentration of Plasma Glucose, secondaryOutcomes measure: Concentration of Plasma Palmitate, secondaryOutcomes measure: Concentration of Plasma Free Fatty Acids, secondaryOutcomes measure: Level of HbA1c, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Department of Pediatrics and Adolescent Medicine and Copenhagen Neuromuscular Center, Rigshospitalet, status: RECRUITING, city: Copenhagen, state: Copenhagen Ø, zip: 2100, country: Denmark, contacts name: Mette Cathrine Ørngreen, MD, DMSc, role: CONTACT, phone: 35455935, email: mette.cathrine.oerngreen.01@regionh.dk, contacts name: Mette Cathrine Ørngreen, MD, DMSc, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False

protocolSection identificationModule nctId: NCT06380374, orgStudyIdInfo id: 2024\01, briefTitle: Gamification in Disaster Nursing Education, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-07-22, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Selcuk University, class: OTHER, descriptionModule briefSummary: This research will be conducted as a randomized controlled study with a parallel design to evaluate the effectiveness of the disaster nursing training program prepared with a gamification strategy based on multiple intelligence theory for final-year public health nursing students. Research hypothesis "H1a: The disaster nursing knowledge level of the students participating in the program, which is prepared with a Gamification Strategy Based on Multiple Intelligence Theory, differs from the control group. H1b: The perception of volunteering towards disaster nursing differs for the students included in the Program Prepared with Gamification Strategy Based on Multiple Intelligence Theory compared to the control group. H1c: The self-efficacy level of students involved in the Program Prepared with Gamification Strategy Based on Multiple Intelligences Theory regarding disaster nursing differs from the control group.", conditionsModule conditions: Gamification, conditions: Nursing Students, conditions: Multiple Intelligence Theory, conditions: Disaster Nursing, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: Gamification in Disaster Nursing Education, outcomesModule primaryOutcomes measure: Level of knowledge related to disaster nursing services, primaryOutcomes measure: Volunteer intention to become a disaster nurse, primaryOutcomes measure: Perception of self-efficacy related to disaster nursing, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Selcuk University Faculty of Nursing, city: Konya, state: Selcuklu, zip: 42000, country: Turkey, contacts name: Sema Yilmaz Dean, MD, role: CONTACT, phone: +903322230763, email: hemsirelikfakultesi@selcuk.edu.tr, geoPoint lat: 37.87135, lon: 32.48464, hasResults: False

protocolSection identificationModule nctId: NCT06380361, orgStudyIdInfo id: SEN-ONCO-1, briefTitle: InvestigatioN of a Smart Probe for Lung lEsion Characterization Using Impedance Technology, acronym: INSPECT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Sensome, class: INDUSTRY, descriptionModule briefSummary: The objective of the study is to evaluate the feasibility of the BioSpy System sensor to differentiate tissues that are encountered during bronchoscopic biopsy of endobronchial tumors and peripheral lung nodules and masses., conditionsModule conditions: Lung Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Patient with suspected lung cancer coming to the hospital for bronchoscopic biopsy will be selected for this trial., primaryPurpose: OTHER, maskingInfo masking: NONE, maskingDescription: No masking, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: BioSpy System, outcomesModule primaryOutcomes measure: The ability of BioSpy System to acquire electrophysiological measurements in the relevant tissues during bronchoscopic biopsy., secondaryOutcomes measure: The ability of BioSpy Sysem to differentiate the lesion from healthy tissue, secondaryOutcomes measure: The ability of BioSpy Sysem to differentiate various lesion types, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06380348, orgStudyIdInfo id: JMT101-012, briefTitle: JMT101 in Combination With Osimertinib, Versus Cisplatin-pemetrexed in Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Characterized by Epithermal Growth Factor Receptor (EGFR) Exon 20ins Mutations, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-26, primaryCompletionDateStruct date: 2027-03-26, completionDateStruct date: 2028-03-26, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Shanghai JMT-Bio Inc., class: INDUSTRY, descriptionModule briefSummary: This is a multicenter, randomized, open-label, parallel-controlled phase 3 study. This study aims to evaluate the efficacy and safety of JMT101 combined with Osimertinib compared with Cisplatin combined with pemetrexed in participants with local advanced or metastatic non-small-cell lung cancer harboured EGFR 20ins mutation without prior systemic therapy.Primary objective of this study is to assess the efficacy of JMT101 combined with Osimertinib versus Cisplatin combined with pemetrexed using by （Independent Review Center）IRC-assessed Progression Free Survival (PFS) per RECIST 1.1 as primary endpoint. Approximately 398 participants are estimated to be randomized into the study. Participants enrolled will be randomized to JMT101 or Cisplatin chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with/without) and Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (0 versus 1)., conditionsModule conditions: Local Advanced or Metastatic NSCLC, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 398, type: ESTIMATED, armsInterventionsModule interventions name: JMT101 Injection, interventions name: Osimertinib tablet, interventions name: Cisplatin injection, interventions name: Pemetrexed injection, outcomesModule primaryOutcomes measure: Progression Free Survival (PFS) as assessed by Independent Review Center (IRC) per RECIST 1.1, secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Overall Response Rate (ORR) by IRC per RECIST 1.1, secondaryOutcomes measure: Duration of Response (DoR) by IRC per RECIST 1.1, secondaryOutcomes measure: PFS by investigator per RECIST 1.1, secondaryOutcomes measure: ORR by investigator per RECIST 1.1, secondaryOutcomes measure: DoR by investigator per RECIST 1.1, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06380335, orgStudyIdInfo id: RTX001-01S, briefTitle: Study in Patients With Decompensated Liver Cirrhosis, acronym: OPAL, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-10, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2026-11-03, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Resolution Therapeutics Limited, class: NETWORK, descriptionModule briefSummary: OPAL is a multicenter observational study, following the natural disease trajectory of participants who have permanent damage to their liver caused by scarring, sometimes also referred to as liver cirrhosis. These participants will also have recently had an acute worsening of their liver disease, which is also known as a hepatic decompensating event, which has resulted in them being admitted to hospital or required them to seek medical attention as an outpatient., conditionsModule conditions: Liver Cirrhosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 240, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Examine the characteristics of patients admitted to hospital with hepatic decompensation., primaryOutcomes measure: Examine the characteristics of patients admitted to hospital with hepatic decompensation., primaryOutcomes measure: Examine the characteristics of patients admitted to hospital with hepatic decompensation., primaryOutcomes measure: Examine the characteristics of patients admitted to hospital with hepatic decompensation., primaryOutcomes measure: Examine the characteristics of patients admitted to hospital with hepatic decompensation., primaryOutcomes measure: Examine the characteristics of patients admitted to hospital with hepatic decompensation., secondaryOutcomes measure: Follow the natural history of patients admitted to hospital with hepatic decompensation., secondaryOutcomes measure: Follow the natural history of patients admitted to hospital with hepatic decompensation., secondaryOutcomes measure: Follow the natural history of patients admitted to hospital with hepatic decompensation., secondaryOutcomes measure: Follow the natural history of patients admitted to hospital with hepatic decompensation., secondaryOutcomes measure: Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation., secondaryOutcomes measure: Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation., secondaryOutcomes measure: Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation., secondaryOutcomes measure: Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation., secondaryOutcomes measure: Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation., secondaryOutcomes measure: Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation., secondaryOutcomes measure: Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation., otherOutcomes measure: Explore clinical and laboratory parameters., otherOutcomes measure: Evaluate the effect of disease progression on biomarkers of inflammatory activity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bristol Royal Infirmary, status: RECRUITING, city: Bristol, zip: BS2 8HW, country: United Kingdom, geoPoint lat: 51.45523, lon: -2.59665, locations facility: Royal Infirmary Edinburgh, status: RECRUITING, city: Edinburgh, zip: EH16 4SA, country: United Kingdom, geoPoint lat: 55.95206, lon: -3.19648, locations facility: Royal Liverpool Hospital, status: RECRUITING, city: Liverpool, zip: L7 8XP, country: United Kingdom, geoPoint lat: 53.41058, lon: -2.97794, locations facility: Royal Free Hospital, status: RECRUITING, city: London, zip: NW3 2QG, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, locations facility: King's College Hospital, status: RECRUITING, city: London, zip: SE5 9RS, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, locations facility: St George's Hospital, status: RECRUITING, city: London, zip: SW17 0QT, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, locations facility: St Mary's Hospital, status: RECRUITING, city: London, zip: W2 1NY, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Nottingham University Hospital, status: RECRUITING, city: Nottingham, zip: NG5 1PB, country: United Kingdom, geoPoint lat: 52.9536, lon: -1.15047, locations facility: Sunderland Royal Hospital, status: RECRUITING, city: Sunderland, zip: SR4 7TP, country: United Kingdom, geoPoint lat: 54.90465, lon: -1.38222, hasResults: False

protocolSection identificationModule nctId: NCT06380322, orgStudyIdInfo id: PBRC 2023-034, briefTitle: Military Health and Nutrition Examination Study, acronym: MHANES, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-12-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Pennington Biomedical Research Center, class: OTHER, collaborators name: U.S. Army Medical Research and Development Command, descriptionModule briefSummary: The Military Health and Nutrition Examination Study (MHANES) is a Department of Defense funded study conducted by Pennington Biomedical Research Center and the US Army Research Institute of Environmental Medicine. This cross-sectional study will assess, in a large, diverse sample of Army Service Members (n=600), food and supplement intake, cardiovascular health, body composition, biomarkers of nutritional status, measures of health status, injury prevalence, mental wellbeing, gut microbiome composition, and physical performance outcomes. The proposed study is modeled after the National Health and Nutrition Examination Survey (NHANES) and customized for the Army population., conditionsModule conditions: Hypertension, conditions: Type 2 Diabetes, conditions: Dyslipidemias, conditions: Cardiovascular Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Dietary intake, primaryOutcomes measure: Dietary quality, secondaryOutcomes measure: Depression, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Resilience, secondaryOutcomes measure: Posttraumatic stress disorder, secondaryOutcomes measure: Self-efficacy, secondaryOutcomes measure: Mood, secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: Physical performance, secondaryOutcomes measure: Physical injuries, secondaryOutcomes measure: Sleep duration and quality, secondaryOutcomes measure: Sleep duration and quality, secondaryOutcomes measure: Eating behavior (Satiety), secondaryOutcomes measure: Eating behavior (Fast Eating Rate), secondaryOutcomes measure: Eating behavior (Slow Eating Rate), secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Anthropometric and body composition measures, secondaryOutcomes measure: Measures of anemia and iron status, nutrient status, hormone status, stress, cardiometabolic health, and inflammation, secondaryOutcomes measure: Albumin, iodine, and other biomarkers of health, secondaryOutcomes measure: Gut microbiome composition, secondaryOutcomes measure: Prescription and over-the-counter medication and supplement use, secondaryOutcomes measure: Resting metabolic rate (RMR), secondaryOutcomes measure: Heart rate variability (HRV), secondaryOutcomes measure: Genomics, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pennington Biomedical Research Center, city: Baton Rouge, state: Louisiana, zip: 70808, country: United States, contacts name: Claire E Berryman, PhD, RD, role: CONTACT, email: claire.berryman@pbrc.edu, geoPoint lat: 30.45075, lon: -91.15455, hasResults: False

protocolSection identificationModule nctId: NCT06380309, orgStudyIdInfo id: LY001-I001, briefTitle: A Clinical Study on Evaluating Intravenous Administration of IDOV-SAFE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-06, primaryCompletionDateStruct date: 2025-11-30, completionDateStruct date: 2027-10-30, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Peking University, class: OTHER, descriptionModule briefSummary: Subjects were inoperable Chinese patients with histologically or cytologically confirmed advanced malignant solid tumors (mainly focusing on MSS type colorectal cancer) who had failed standard systemic therapy.In the first stage, each subject was given three doses on day 1, day 3 and day 5, and was divided into 4 dose groups, including 1 subject in the first dose group and 3-6 subjects in each of the last three dose groups. The second stage was the dose extension stage, with 2 dose groups, at least 10 subjects were enrolled in the selected group, and the administration method was the same as that of the first stage. There were about 20-60 cases in the two stages., conditionsModule conditions: Advanced Malignant Solid Tumor of Digestive System, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: IDOV-SAFE, outcomesModule primaryOutcomes measure: Occurrence of dose-limiting toxicity (DLT), primaryOutcomes measure: Incidence of adverse events (AE), secondaryOutcomes measure: The level of (non-essential) viral DNA in tumor tissue, secondaryOutcomes measure: Tumor markers, secondaryOutcomes measure: Anti-vaccinia virus neutralizing antibody test(VV-Nab), secondaryOutcomes measure: Levels of viral DNA in blood, secondaryOutcomes measure: Levels of viral DNA in saliva, secondaryOutcomes measure: T cell subsets, secondaryOutcomes measure: Cytokines, secondaryOutcomes measure: ORR, secondaryOutcomes measure: DCR, secondaryOutcomes measure: DOR, secondaryOutcomes measure: PFS, secondaryOutcomes measure: OS, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Cancer Hospital, status: RECRUITING, city: Beijing, country: China, contacts name: Lin Shen, role: CONTACT, phone: +86 10 8819 6561, email: doctorshenlin@sina.cn, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False

protocolSection identificationModule nctId: NCT06380296, orgStudyIdInfo id: 2024-10240, briefTitle: Outcomes of NeoMTA and NeoPUTTY Pulpotomies in Primary Molars, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: McGill University Health Centre/Research Institute of the McGill University Health Centre, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the outcomes of different medications used for pulpotomies (baby root canal) in children. The main question it aims to answer is: • what are the long-term clinical and radiographic success of pulpotomies in baby teeth using two different medications (NeoMTA and NeoPUTTY) over a 24-month follow-up period? Healthy children aged between 3 and 10 years undergoing dental treatment under general anesthesia who have deep caries lesions approximating or reaching the nerve will be invited to participate in this study. Pulpotomies (baby root canal) will be performed by trained dentists following a protocol. Children will receive pulpotomies either with NeoMTA or NeoPUTTY, two medications indicated for the procedure. Participants will be asked to come for an appointment at 1, 6, 12 and 24 months after the procedure. Researcher will compare the clinical and radiographic performance of pulpotomies (baby root canal) done with both medications., conditionsModule conditions: Pulp Disease, Dental, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Primary molars pulpotomies with NeoMTA, interventions name: Primary molar pulpotomies with NeoPUTTY, outcomesModule primaryOutcomes measure: Success rate of a primary molar pulpotomy, primaryOutcomes measure: Radiographic success of a primary molar pulpotomy, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 10 Years, stdAges: CHILD, hasResults: False

protocolSection identificationModule nctId: NCT06380283, orgStudyIdInfo id: 2024-10221, briefTitle: The Feasibility and Clinical Utility of the Use of Virtual Reality for the Management of Pediatric Dental Anxiety, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-21, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: McGill University Health Centre/Research Institute of the McGill University Health Centre, class: OTHER, descriptionModule briefSummary: The use of virtual reality (VR) in pediatric healthcare settings helps to reduce children's pain and anxiety. However, this technology has not been used consistently in pediatric dentistry. Consequently, the goal of this study is to investigate the effectiveness of using a Virtual Reality headset as a distraction technique during dental procedures in children and identify patient and clinician's opinions regarding its use.This study incorporates a single-site, randomized clinical trial design with two paralleled study groups. One group will receive dental treatment following regular standard of care of behavior management while the second group will receive dental treatment using a Virtual Reality distraction headset. Patients in both groups will complete a questionnaire to assess their perception of pain and anxiety before and after the intervention, as well as their satisfaction with the dental treatment. The dentist providing the treatment will also report their observations relating to patient behavior during dental treatment., conditionsModule conditions: Children, Only, conditions: Dental Anxiety, conditions: Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 128, type: ESTIMATED, armsInterventionsModule interventions name: Virtual reality headset, outcomesModule primaryOutcomes measure: Children's pain perception during dental treatment, primaryOutcomes measure: Children's fear during dental treatment, secondaryOutcomes measure: Children's acceptability of virtual reality intervention during dental care, secondaryOutcomes measure: Oral health care provider's acceptability of virtual reality during dental care, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Division of Dentistry, Montreal Children's Hospital, McGill University Health Centre, status: RECRUITING, city: Montreal, state: Quebec, country: Canada, contacts name: Beatriz Ferraz dos Santos, DDS, MSc, role: CONTACT, phone: +1 (514) 412-4400, phoneExt: 23357, email: beatriz.ferrazdossantos@muhc.mcgill.ca, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False

protocolSection identificationModule nctId: NCT06380270, orgStudyIdInfo id: LUMHS/B12/Temp/14.04.2024, briefTitle: Safety and Human Tolerance of Oral Probiotic Streptococcus Salivarius K12, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Liaquat University of Medical & Health Sciences, class: OTHER, descriptionModule briefSummary: Streptococcus salivarius K12, an oral probiotic strain, has emerged as a promising tool in promoting oral health. Found naturally in the mouth, S. salivarius K12 works by establishing itself in the oral cavity and producing antimicrobial compounds, such as bacteriocins, including salivaricin A2 (SalA2) and the 2,740-Da salivaricin B (SboB) lantibiotics, which inhibit the growth of harmful bacteria including Streptococcus pyogenes. By maintaining a healthy balance of oral microbiota, this probiotic may help prevent common oral health issues such as bad breath, throat infections, and tooth decay. While further research is needed to fully elucidate its mechanisms and efficacy, S. salivarius K12 holds potential as a natural and safe adjunct to oral hygiene practices for promoting overall oral health and hygiene., conditionsModule conditions: Strep Throat, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Oral probiotic Streptococcus salivarius K12 sachet, outcomesModule primaryOutcomes measure: Effect on oral health physical condition, primaryOutcomes measure: Effect on other physical features, primaryOutcomes measure: Effect on vital signs, primaryOutcomes measure: Effect on vital signs, primaryOutcomes measure: Effect on vital signs, primaryOutcomes measure: Effect on vital signs, primaryOutcomes measure: Effect on blood biochemistry, primaryOutcomes measure: Effect on blood biochemistry, primaryOutcomes measure: Effect on blood biochemistry, primaryOutcomes measure: Effect on blood biochemistry, primaryOutcomes measure: Effect on blood electrolytes balance, primaryOutcomes measure: Effect on hematology, primaryOutcomes measure: Incidence of inflammation, primaryOutcomes measure: Incidence of gastrointestinal side effects, primaryOutcomes measure: Incidence of Adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Liaquat University of Medical and Health Sciences, city: Jāmshoro, zip: 76090, country: Pakistan, contacts name: Dr. Amjad Khan, DPhil, role: CONTACT, phone: 03000506955, email: amjadkhan@lumhs.edu.pk, geoPoint lat: 25.43773, lon: 68.28522, hasResults: False

protocolSection identificationModule nctId: NCT06380257, orgStudyIdInfo id: ANBA, briefTitle: Anorexia Nervosa and Brain in Adolescence, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2030-08, completionDateStruct date: 2030-12, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Kuopio University Hospital, class: OTHER, descriptionModule briefSummary: Aims of this follow-up study are to investigate effects of anorexia nervosa on brain structure and functions in adolescence., conditionsModule conditions: Anorexia Nervosa, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Observational study methods, outcomesModule primaryOutcomes measure: Neuroimaging, secondaryOutcomes measure: Neuroimaging, otherOutcomes measure: Psychiatric evaluation, otherOutcomes measure: Body composition measurement, otherOutcomes measure: Laboratory tests, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 19 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06380244, orgStudyIdInfo id: 1072.6120.136.2023, briefTitle: Opioid-free Anesthesia as an Alternative to General Anesthesia in Abdominal Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-10, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Jagiellonian University, class: OTHER, descriptionModule briefSummary: Due to the increasing number of reports of cancer progression in people undergoing surgery under general anesthesia using opioids, OFA is believed to have a favorable long-term prognostic effect, especially in cancer patients. The opioid-free protocol is also used in postoperative analgesia. It is estimated that up to 75% of surgical patients experience chronic postoperative pain, which has a particularly negative impact on the quality of life.The investigators would like to compare pain during the first 48 postoperative hours of patients undergoing abdominal surgery who would be anesthetized with opioids and without opioids (patients would be randomly assigned to a group) (1, 2, 6, 12, 24 and 48 h after operations). A secondary objective will be to measure total oxycodone consumption in the postoperative period in both groups. Other secondary objectives: assessment of postoperative nausea and vomiting (PONV)., conditionsModule conditions: Analgesics, Opioid, conditions: Anesthesia, Endotracheal, conditions: Anesthesia, General, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Assignment, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: anesthesia without opioids, outcomesModule primaryOutcomes measure: Pain level, secondaryOutcomes measure: Total long acting opioid consumption in oxycodone equivalents, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 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: NCT06380231, orgStudyIdInfo id: IRU-YAZILE-001, briefTitle: Skin-to-skin Contact Between Premature Infant and Mother, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-11-01, primaryCompletionDateStruct date: 2019-12-01, completionDateStruct date: 2020-12-01, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Istanbul Rumeli University, class: OTHER, descriptionModule briefSummary: Aim: To determine the effect of kangaroo mother care (KMC) on perfusion index, heart rate, and oxygen saturation in premature infants who were discharged early and admitted to the neonatal intensive care in the following days., conditionsModule conditions: Kangaroo-mother Care, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 76, type: ACTUAL, armsInterventionsModule interventions name: kangaroo mother care (KMC), outcomesModule primaryOutcomes measure: power analysis, secondaryOutcomes measure: The effect of kangaroo mother care, eligibilityModule sex: ALL, minimumAge: 24 Weeks, maximumAge: 37 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: TC Istanbul Rumeli University, city: Istanbul, state: Haliç, zip: 34445, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False

protocolSection identificationModule nctId: NCT06380218, orgStudyIdInfo id: 2023-A00249-36, briefTitle: Evaluation of Nutritional Prevention Program for Women's Cardiovascular Health on Quality of Life (SAFE), acronym: SAFE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-11, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-08-01, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Institut Pasteur de Lille, class: OTHER, descriptionModule briefSummary: The objective is to evaluate the effect of a nutritional prevention program associated with the consumption of "Primevère margarine" on the quality of life of women at risk of cardiovascular disease after 10 group coaching sessions in nutrition and physical activity., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Nutrional and physical activity program, outcomesModule primaryOutcomes measure: Change from baseline on quality of life of women with cardiovascular risk at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on life behaviours at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on well-being at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on stress management at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on food behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on food behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on food and physical activity knowledge at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on motivation to change behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on physical behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on recovery capacity at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on static balance at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on flexibility at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on handgrip strengh at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on lower limb strengh at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on endurance at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on lipids metabolism at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on glucose metabolism at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on cardiovascular risk at 3 months after a nutritional prevention program, secondaryOutcomes measure: Change from baseline on BMI at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on waist circumference at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on body composition at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on systolic and diastolic blood pressure at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Satisfaction of Primevere products, eligibilityModule sex: FEMALE, minimumAge: 40 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NutrInvest - Institut Pasteur de Lille, status: RECRUITING, city: Lille, state: Nord, zip: 59019, country: France, contacts name: Coralie Berthier, PhD, role: CONTACT, phone: 0320877333, phoneExt: 0033, email: coralie.berthier@pasteur-lille.fr, contacts name: Bérengère Legendre, role: CONTACT, phone: 0320877346, phoneExt: 0033, email: berengere.legendre@pasteur-lille.fr, contacts name: Jean-Michel Lecerf, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.63297, lon: 3.05858, hasResults: False

protocolSection identificationModule nctId: NCT06380205, orgStudyIdInfo id: INCB54707-111, briefTitle: A Study to Evaluate the Drug Interaction Between Povorcitinib and the Oral Contraceptive Levonorgestrel/Ethinyl Estradiol in Healthy Adult Females, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-07, primaryCompletionDateStruct date: 2024-06-07, completionDateStruct date: 2024-06-07, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Incyte Corporation, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the drug interaction between povorcitinib and the oral contraceptive levonorgestrel/ethinyl estradiol in healthy adult females., conditionsModule conditions: Healthy Participants, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Povorcitinib, interventions name: Levonorgestrel/Ethinyl estradiol, outcomesModule primaryOutcomes measure: Levonorgestrel (LNG) concentration in plasma, primaryOutcomes measure: Ethinyl estradiol (EE) concentration in plasma, secondaryOutcomes measure: Number of participants with Treatment-emergent Adverse Events (TEAEs), secondaryOutcomes measure: Additional LNG/EE PK parameters in plasma, secondaryOutcomes measure: Povorcitinib concentration in plasma, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Celerion Clinical Research Unit, status: RECRUITING, city: Tempe, state: Arizona, zip: 85283, country: United States, geoPoint lat: 33.41477, lon: -111.90931, hasResults: False

protocolSection identificationModule nctId: NCT06380192, orgStudyIdInfo id: HJ22-DEE-RETRO, briefTitle: Developmental and Epileptic Encephalopathy of Genetic Etiology: Natural History Through Reuse of Clinical Data, acronym: DEE-RETRO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Imagine Institute, class: OTHER, descriptionModule briefSummary: Developmental and Epileptic Encephalopathy (DEE) are a heterogeneous group of neurodevelopmental disorders linked to both epilepsy and its underlying etiology, independently of epileptiform activity.The creation of a database with retrospective follow-up of a large number of patients on a national scale will enable better knowledge of specific biomarkers, and thus a better classification and understanding of the natural evolution of DEE according to their etiology. This will enable better, more personalized therapeutic management of patients, depending on etiology and the presence or absence of these biomarkers. The investigators will also be able to draw up management recommendations, which are currently non-existent., conditionsModule conditions: Developmental and Epileptic Encephalopathy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 400, type: ESTIMATED, outcomesModule primaryOutcomes measure: Identification of early diagnostic of a neurodevelopmental trajectory in children with epileptic and developmental encephalopathies, primaryOutcomes measure: Identification of predictive biomarkers of a neurodevelopmental trajectory in children with epileptic and developmental encephalopathies, secondaryOutcomes measure: Identification of patient subgroups presenting the identified biomarkers, secondaryOutcomes measure: Assessment of patients' quality of life, secondaryOutcomes measure: Assessment of age-related adaptive behavior, secondaryOutcomes measure: Assessment of behavioral disorders, secondaryOutcomes measure: Assessment of autism spectrum disorders, eligibilityModule sex: ALL, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06380179, orgStudyIdInfo id: USUHS.2023-126, briefTitle: Photomedicine Project 14: PBMT for Performance Enhancement in SOF, acronym: SOF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Musculoskeletal Injury Rehabilitation Research for Operational Readiness (MIRROR), class: UNKNOWN, collaborators name: Uniformed Services University (USU) of the Health Sciences, collaborators name: 1st Special Forces Group (Airborne), United States Army, collaborators name: United States Army Special Operations Command, collaborators name: The Geneva Foundation, descriptionModule briefSummary: Special Operations Forces (SOF) train continually to maintain peak performance. Thus, they are nearly always in a state of recovery, and in need of noninvasive therapies to address the taxing workload. Photobiomodulation therapy (PBMT) is a noninvasive treatment where a low-level laser is applied to the body to enhance healing, recovery, and performance. Army Tactical Human Optimization Rapid Rehabilitation and Reconditioning (THOR3) provides a consistent avenue for implementation of PBMT as a modality. Studies in athletes have shown performance and recovery benefits with pre-and post-workout focal application of PBMT. While there is less evidence on the potential cognitive/behavioral effects of a systematic application of PBMT, self-reported fatigue has also been found to be significantly lower in groups with focal PBMT application as compared to placebo. Further, PBMT research in healthy military tactical athletes is limited. PBMT may be a promising tool for enhancing physical performance by accelerating musculoskeletal and psychological recovery in the SOF population. The investigators aim to study the physiologic and behavioral effects of PBMT application post-exercise on performance in SOF Operators.The Intent: The investigators propose to conduct a single-blinded randomized-control trial with sham control to investigate the effectiveness of providing PBMT post physical training in a SOF population.The specific aims of this study are to:1. Analyze and describe the physiologic effects, if any, of PBMT application post-exercise in Special Forces Operators undergoing coach-led training.2. Analyze and describe the behavioral effects, if any, of PBMT application post-exercise in Special Forces Operators undergoing coach-led training.3. Evaluate the overall clinical utility of focal PBMT subsequent to physical training in a US Army SOF, tactical athlete population., conditionsModule conditions: Photobiomodulation Therapy, conditions: Photomedicine, conditions: Low-Level Laser Therapy, conditions: Performance Enhancement, conditions: Quadriceps, conditions: Special Operations Readiness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Approach: Special Operators attending THOR3 coach led training will be invited to participate. After consenting and screening for inclusion/exclusion, participants will be randomized into two groups: 1) sham PBMT and 2) PBMT (applied to quadriceps up to 3 times per week, post coach-led training, taking approximately 5-20 minutes each time). Baseline measurements will include body fat percentage, height, weight and military/demographic information. Metrics for counter movement jump and self-reported delayed muscle onset soreness will be taken at baseline and weekly for three weeks. Isokinetic dynamometer measurements for the lower extremities, and self-reported exertion and fatigue will be taken at baseline and at the 3-week follow-up (post three-week intervention). Oura rings will be assigned at baseline and will continuously measure sleep, heart rate, Sp02, and activity. Activity and pain will also be self-reported throughout the duration of the study., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: In order to facilitate participant blinding to their randomized study group, all participants (regardless of their assigned study group) will be asked to wear blackout glasses and headphones during their treatment., whoMasked: PARTICIPANT, enrollmentInfo count: 116, type: ESTIMATED, armsInterventionsModule interventions name: THOR3 training + Photobiomodulation Therapy (PBMT), interventions name: THOR3 training + sham PBMT, outcomesModule primaryOutcomes measure: Countermovement Jump (CMJ) initial baseline: deceleration/concentric impulse, primaryOutcomes measure: Countermovement Jump (CMJ) initial baseline: peak force production, primaryOutcomes measure: Countermovement Jump (CMJ) initial baseline: rate of force production, primaryOutcomes measure: Countermovement Jump (CMJ) initial baseline: unilateral performance comparison, primaryOutcomes measure: Countermovement Jump (CMJ) week 1 follow-up: deceleration/concentric impulse, primaryOutcomes measure: Countermovement Jump (CMJ) week 1 follow-up: peak force production, primaryOutcomes measure: Countermovement Jump (CMJ) week 1 follow-up: rate of force production, primaryOutcomes measure: Countermovement Jump (CMJ) week 1 follow-up: unilateral performance comparison, primaryOutcomes measure: Countermovement Jump (CMJ) week 2 follow-up: deceleration/concentric impulse, primaryOutcomes measure: Countermovement Jump (CMJ) week 2 follow-up: peak force production, primaryOutcomes measure: Countermovement Jump (CMJ) week 2 follow-up: rate of force production, primaryOutcomes measure: Countermovement Jump (CMJ) week 2 follow-up: unilateral performance comparison, primaryOutcomes measure: Countermovement Jump (CMJ) week 3 follow-up: deceleration/concentric impulse, primaryOutcomes measure: Countermovement Jump (CMJ) week 3 follow-up: peak force production, primaryOutcomes measure: Countermovement Jump (CMJ) week 3 follow-up: rate of force production, primaryOutcomes measure: Countermovement Jump (CMJ) week 3 follow-up: unilateral performance comparison, primaryOutcomes measure: Isometric Quadriceps Strength Testing initial baseline, primaryOutcomes measure: Isometric Hamstrings Strength Testing initial baseline, primaryOutcomes measure: Isokinetic Quadriceps Strength Testing initial baseline, primaryOutcomes measure: Isokinetic Hamstrings Strength Testing initial baseline, primaryOutcomes measure: Isometric Quadriceps Strength Testing 3-week follow-up, primaryOutcomes measure: Isometric Hamstrings Strength Testing 3-week follow-up, primaryOutcomes measure: Isokinetic Quadriceps Strength Testing 3-week follow-up, primaryOutcomes measure: Isokinetic Hamstrings Strength Testing 3-week follow-up, primaryOutcomes measure: Defense and Veteran's Pain Rating Scale (DVPRS) initial baseline, primaryOutcomes measure: Defense and Veteran's Pain Rating Scale (DVPRS) daily reports, primaryOutcomes measure: Visual Analog Scale (VAS) initial baseline, primaryOutcomes measure: Visual Analog Scale (VAS) week 1 follow-up, primaryOutcomes measure: Visual Analog Scale (VAS) week 2 follow-up, primaryOutcomes measure: Visual Analog Scale (VAS) week 3 follow-up, primaryOutcomes measure: Borg Modified Rating of Perceived Exertion (RPE) initial baseline, primaryOutcomes measure: Borg Modified Rating of Perceived Exertion (RPE) 3-week follow-up, primaryOutcomes measure: Elloumi fatigue scale initial baseline, primaryOutcomes measure: Elloumi fatigue scale 3-week follow-up, primaryOutcomes measure: Quick Physical Activity Rating scale (QPAR), primaryOutcomes measure: Oura Ring Sleep Data: sleep metrics - sleep duration, primaryOutcomes measure: Oura Ring Sleep Data: sleep metrics - time in bed, primaryOutcomes measure: Oura Ring Sleep Data: sleep metrics - light sleep length, primaryOutcomes measure: Oura Ring Sleep Data: sleep metrics - rapid eye movement (REM) sleep length, primaryOutcomes measure: Oura Ring Sleep Data: sleep metrics - deep sleep length, primaryOutcomes measure: Oura Ring Sleep Data: sleep metrics - sleep latency, primaryOutcomes measure: Oura Ring Sleep Data: sleep metrics - sleep efficiency score, primaryOutcomes measure: Oura Ring Sleep Data: sleep metrics - sleep quality score, primaryOutcomes measure: Oura Ring Sleep Data: Readiness trends - body temperature changes, primaryOutcomes measure: Oura Ring Sleep Data: Readiness trends - heart rate changes, primaryOutcomes measure: Oura Ring Sleep Data: Readiness trends - heart rate variability (HRV), primaryOutcomes measure: Oura Ring Sleep Data: Readiness trends - respiration rate, primaryOutcomes measure: Oura Ring Sleep Data: Readiness trends - blood oxygen saturation, primaryOutcomes measure: Oura Ring Sleep Data: Readiness trends - sleep regularity, primaryOutcomes measure: Oura Ring Sleep Data: Readiness trends - readiness score, otherOutcomes measure: Body Measurements: Height (cm), otherOutcomes measure: Body Measurements: Weight (kg/lbs), otherOutcomes measure: Body Measurements: Body composition (% body fat), otherOutcomes measure: Body Measurements: C1 - proximal thigh circumference (cm), otherOutcomes measure: Body Measurements: C2 - distal thigh circumference (cm), otherOutcomes measure: Body Measurements: L1 - length of thigh (cm), eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-03-20, uploadDate: 2024-03-29T15:19, filename: Prot_SAP_000.pdf, size: 435470, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-03-19, uploadDate: 2024-03-29T15:20, filename: ICF_001.pdf, size: 165533, hasResults: False

protocolSection identificationModule nctId: NCT06380166, orgStudyIdInfo id: A23-356, briefTitle: Hepatitis C Lab Testing Comparison Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: HealthPartners Institute, class: OTHER, descriptionModule briefSummary: Hepatitis C (HCV) HCV antibody assays are the standard of care test used to screen for HCV, but confirmation of acute infection is relegated in the current US guidelines to polymerase chain reaction (PCR) which often takes multiple days and may result in a loss to follow up and treatment, especially in high prevalence populations. HCV core antigen is a new, research use only immunoassay intended for use on the Abbott Alinity i system, an FDA-cleared instrument for clinical chemistry and immunoassay testing. The aim of the study is to evaluate the 48-hour stability of HCV core antigen in fresh serum and plasma specimens collected from individuals with a detectable HCV viral load (HCL VL), as per a recent antibody assay test, under multiple specimen storage conditions mirroring those employed in clinical laboratories., conditionsModule conditions: Hepatitis C, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Hepatitis C core antigen, outcomesModule primaryOutcomes measure: Serum on the clot stability, primaryOutcomes measure: Serum off the clot stability, primaryOutcomes measure: Plasma on the gel stability, primaryOutcomes measure: Plasma off the gel stability, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06380153, orgStudyIdInfo id: HM005PS1S07, briefTitle: To Evaluate the Pharmacokinetics of Hemay005 Tablets in Patients With Renal Impairment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Ganzhou Hemay Pharmaceutical Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: The aim of this study was to evaluate the pharmacokinetics of Hemay005 tablets in subjects with mild to moderate renal impairment and normal renal function, and to provide a basis for the formulation of clinical medication regimens for patients with renal impairment., conditionsModule conditions: Psoriasis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Hemay005, outcomesModule primaryOutcomes measure: Relevant pharmacokinetic parameters，Peak Plasma Concentration（Cmax）, primaryOutcomes measure: Relevant pharmacokinetic parameters，Area under the plasma concentration versus time curve（AUC0-t）, primaryOutcomes measure: Relevant pharmacokinetic parameters，Area under the curve from time 0 extrapolated to infinite time (AUC0-inf), primaryOutcomes measure: Relevant pharmacokinetic parameters，half-life (T1/2), primaryOutcomes measure: Relevant pharmacokinetic parameters，clearance (CL/F), primaryOutcomes measure: Relevant pharmacokinetic parameters，volume of distribution (Vz/F), primaryOutcomes measure: Relevant pharmacokinetic parameters ，Renal clearance rate（CLr）, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06380140, orgStudyIdInfo id: cami3zgmxf3vqyc30ndmdqh6gfjid1, briefTitle: Relationship Between Acute Phase Markers and Post-operative Pain in Open Tension-free Inguinal Hernia Repair: An Observational Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-03, primaryCompletionDateStruct date: 2024-03-03, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: University of Roma La Sapienza, class: OTHER, descriptionModule briefSummary: Many patients undergoing inguinal hernia repair are prone to developing acute and chronic post-operative pain.The aim of the study is to show a possible correlation between pain and acute phase proteins in order to:* predict the severity of pain;* select most suitable pain relief therapy for the patient., conditionsModule conditions: Post Operative Pain, conditions: Inguinal Hernia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 71, type: ESTIMATED, armsInterventionsModule interventions name: Open Tension-free Inguinal Hernia Repair, outcomesModule primaryOutcomes measure: Relationship Between Post-operative Pain and C Reactive Protein (CRP) in Open Tension-free Inguinal Hernia Repair, primaryOutcomes measure: Relationship Between Post-operative Pain and D-dimer in Open Tension-free Inguinal Hernia Repair, primaryOutcomes measure: Relationship Between Post-operative Pain and Fibrinogen in Open Tension-free Inguinal Hernia Repair, primaryOutcomes measure: Relationship Between Post-operative Pain and white blood cell count in Open Tension-free Inguinal Hernia Repair, primaryOutcomes measure: Relationship Between Post-operative Pain and Neutrophil to Lymphocyte Ratio (NLR) in Open Tension-free Inguinal Hernia Repair, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Augusto Lauro, status: RECRUITING, city: Roma, zip: 000186, country: Italy, contacts name: Augusto Lauro, role: CONTACT, phone: +39 388 8663 879, email: augusto.lauro@uniroma1.it, geoPoint lat: 41.89193, lon: 12.51133, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-05-03, uploadDate: 2024-04-18T14:17, filename: Prot_SAP_000.pdf, size: 274127, hasResults: False

protocolSection identificationModule nctId: NCT06380127, orgStudyIdInfo id: CEFADE012021, briefTitle: Feasibility and Effectiveness of Concurrent Exercise Training on Frail Older Adults Living in Nursing Homes, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-10-01, primaryCompletionDateStruct date: 2023-09-30, completionDateStruct date: 2023-12-15, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Universidade do Porto, class: OTHER, descriptionModule briefSummary: The present study is a crossover randomized controlled trial that aims to investigate the effects of concurrent exercise training over usual care on physical performance, muscle strength, and myokines concentrations in frail older adults living in nursing homes.The main questions it aims to answer is: Can a 12-week exercise intervention provide beneficial effects on physical performance, muscle strength and myokines among the most frail participants? Researchers will compare this intervention to usual care. Nursing homes (comprising participants) will be randomly assigned to a sequence of interventions (AB or BA), being A -exercise and B usual care. Participants will be assessed before and after each intervention., conditionsModule conditions: Frailty, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: The trial will follow a 28-week crossover design: 12 weeks for the first intervention period, a 4-week washout, and another 12 weeks for the second intervention period. Nursing homes (clusters) were randomized into sequences (AB or BA), where intervention A involve concurrent exercise training, and B is usual care.Data collection will occurre at four points: baseline, post-first intervention period, post-washout/pre-second intervention period and post-crossover., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 46, type: ACTUAL, armsInterventionsModule interventions name: Exercise training, outcomesModule primaryOutcomes measure: Change from Baseline on Short Physical Performance Battery (SPBB), secondaryOutcomes measure: Change from Baseline on Handgrip test, secondaryOutcomes measure: Change from baseline on isokinetic knee strength, secondaryOutcomes measure: Change from Baseline on circulating levels of myostatin, secondaryOutcomes measure: Change from Baseline on circulating levels of Decorin, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Sports, University of Porto, city: Porto, zip: 4000, country: Portugal, geoPoint lat: 41.14961, lon: -8.61099, hasResults: False

protocolSection identificationModule nctId: NCT06380114, orgStudyIdInfo id: STUDY00009296, briefTitle: Stand Up 2 HPV: Standing Orders to Improve HPV Vaccination, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2027-11, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University of Rochester, class: OTHER, collaborators name: National Institutes of Health (NIH), descriptionModule briefSummary: Each year in the U.S., ≥20,000 women and 14,000 men are affected by HPV-related cancers, including cervical and oropharyngeal cancer. However, in 2020, only 59% of U.S. adolescents aged 13-17 were up-to-date for HPV vaccination, and rates for 11-12 year olds, the primary target age group for HPV vaccination (when the immune reaction is better and before exposure to HPV infection), are even lower. Standing orders (written protocols that authorize designated members of the healthcare team to vaccinate without first obtaining a patient-specific physician order) have been shown to work in inpatient settings and for adults, but have not been evaluated for HPV vaccine, which some parents consider controversial. Also, the ways in which organizational readiness for change (resources, motivation, staff attributes, leadership support and culture) moderate the effect of standing orders has not been studied. A physician's recommendation is correlated with HPV vaccine acceptance, and the investigators have developed a successful online, interactive, communication education program that will be adapted to train nurses and staff in addition to physicians. The investigators propose testing standing orders for HPV vaccine in an Accountable Care Organization (ACO) in Western New York, and assessing which provider and practice factors moderate the effect of standing orders. Advantages of this setting include a diverse group of rural, urban and suburban practices, and the ACO provides data infrastructure and analytics that allow practices to evaluate vaccination rates in real time.Using a 2-arm cluster randomized trial (n=40 practices), the investigators will assess the effectiveness of standing orders (SO) + HPV communication education (intervention arm) relative to HPV communication education alone (control arm) on HPV vaccination for 11-17 year-olds., conditionsModule conditions: Hpv, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 16000, type: ESTIMATED, armsInterventionsModule interventions name: Communication, interventions name: Standing Orders, outcomesModule primaryOutcomes measure: HPV vaccination, eligibilityModule sex: ALL, minimumAge: 11 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06380101, orgStudyIdInfo id: NEAAR-LARC, briefTitle: Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC), acronym: NEAAR-LARC, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-08, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: University of South Florida, class: OTHER, descriptionModule briefSummary: This clinical study aims to assess feasibility, safety, tolerability, and compliance of a Nonessential Amino Acid Restriction (NEAAR) medical food in adult patients with locally advanced rectal cancer during standard of care short course radiotherapy followed by standard of care chemotherapy., conditionsModule conditions: Rectal Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: NEAAR Medical Food, outcomesModule primaryOutcomes measure: Rate of CTCAE v5.0 non-hematological Grade 3 and higher diarrhea, secondaryOutcomes measure: Proportion of clinical complete response 8 weeks post SCRT-TNT with NEAAR medical food defined by the MSK Regression Schema, secondaryOutcomes measure: Absolute and relative change from baseline of circulating non-essential amino acids, secondaryOutcomes measure: Proportion of clinical complete response at Week 4 post SCRT with NEAAR medical food, secondaryOutcomes measure: molecular ctDNA response., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of South Florida, status: RECRUITING, city: Tampa, state: Florida, zip: 33606, country: United States, contacts name: Jennifer Burgess, MS, role: CONTACT, phone: 434-806-6445, email: jburgess@tgh.org, contacts name: Veronique Perry, MSHA, role: CONTACT, phone: 2549873658, email: vperry@tgh.org, contacts name: Richard Tuli, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 27.94752, lon: -82.45843, hasResults: False

protocolSection identificationModule nctId: NCT06380088, orgStudyIdInfo id: VEM-DINOGMI-24, briefTitle: Improving Motor Skills: The Role of Music and Encouragement, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-07-01, primaryCompletionDateStruct date: 2023-08-05, completionDateStruct date: 2024-03-15, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Universita degli Studi di Genova, class: OTHER, descriptionModule briefSummary: This study used a randomised crossover design to analyse the effect of three different experimental interventions - i.e. standard conditions, music and verbal encouragement - on performance in an isometric endurance task, comparing results between untrained and trained individuals. The interval between each intervention was set at seven days. The outcome measures are muscle activity and fatigue, assessed by surface electromyography, and task duration.Isometric endurance task requires participants to keep their arm flexed at a 90° angle while holding a dumbbell with a supine grip loaded to 80% of 1RM on the dominant side of the body. During execution, the back and head should remain in contact with a vertical wall, with the feet shoulder width apart and firmly planted on the floor. The bar is held with the dominant arm while the other arm remains in a neutral position close to the body. It is imperative to avoid any form of rocking or movement that would make it easier to maintain the position. The test officially begins when the bar is handed to the subject, who is already in the correct position, and ends as soon as the angle of the arm varies by more than five degrees from the starting position., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ACTUAL, armsInterventionsModule interventions name: Isometric Task, outcomesModule primaryOutcomes measure: Duration of the task, primaryOutcomes measure: Biceps Brachii muscle fatigue, primaryOutcomes measure: Triceps Brachii muscle fatigue, primaryOutcomes measure: Biceps Brachii activity, primaryOutcomes measure: Triceps Brachii activity, eligibilityModule sex: ALL, minimumAge: 27 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Università degli Studi di Genova, city: Genova, zip: 16122, country: Italy, geoPoint lat: 44.40478, lon: 8.94438, hasResults: False

protocolSection identificationModule nctId: NCT06380075, orgStudyIdInfo id: 2024-0480, secondaryIdInfos id: A536000, type: OTHER, domain: UW Madison, secondaryIdInfos id: SMPH/OPHTHAL&VIS SCI/GEN, type: OTHER, domain: UW Madison, secondaryIdInfos id: Protocol Version 3/22/24, type: OTHER, domain: UW Madison, briefTitle: COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Inherited Retinal Disease, acronym: COCO-IRD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: University of Wisconsin, Madison, class: OTHER, descriptionModule briefSummary: The goal of this research study is to compare two ultrawide field cameras to the gold standard imaging system to evaluate the back of the eye. The main question it aims to answer is the same results and information can be acquired from all of the cameras for evaluating and monitoring inherited retinal diseases (IRDs).Participants will:* undergo pupillary dilation* have photographs taken of the inside of the eyes using three different cameras, conditionsModule conditions: Retinal Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Spectralis FAF imaging, interventions name: Optos imaging, interventions name: Clarus imaging, outcomesModule primaryOutcomes measure: Compare FAF retinal patterns by Clarus and standard Spectralis FAF imaging, primaryOutcomes measure: Compare FAF retinal patterns by Optos and standard Spectralis FAF imaging, primaryOutcomes measure: Compare FAF retinal patterns by Clarus and Optos FAF imaging, primaryOutcomes measure: Compare Spectralis FAF imaging to Spectralis OCT imaging, secondaryOutcomes measure: Prevalence of FAF retinal pattern changes beyond the standard 30 degress in Clarus and Optos ultrawide field images, secondaryOutcomes measure: Prevalence of other autofluorescence abnormalities unique to the IRD across all imaging, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Ophthalmology and Visual Sciences, city: Madison, state: Wisconsin, zip: 53705, country: United States, contacts name: Amy Remm, role: CONTACT, phone: 608-262-3377, email: amy.remm@wisc.edu, contacts name: Kimberly Stepien, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.07305, lon: -89.40123, hasResults: False

protocolSection identificationModule nctId: NCT06380062, orgStudyIdInfo id: Choline Prostate Cancer, briefTitle: Choline Metabolites in People With Prostate Cancer and Those With Benign Hyperplasia, statusModule overallStatus: COMPLETED, startDateStruct date: 2012-01-12, primaryCompletionDateStruct date: 2015-11-30, completionDateStruct date: 2015-11-30, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Universität des Saarlandes, class: OTHER, descriptionModule briefSummary: The aim of this study was to investigate plasma concentrations of one-carbon metabolites and phospholipid classes in participants with primary prostate cancer and those with benign hyperplasia. Moreover, the metabolites were studied in relation to tumor grade and age., conditionsModule conditions: Primary Prostate Urothelial Cancer, conditions: Benign Prostatic Hyperplasia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 350, type: ACTUAL, armsInterventionsModule interventions name: Plasma concentration of choline, outcomesModule primaryOutcomes measure: Plasma choline concentrations, primaryOutcomes measure: Whole blood choline concentrations, secondaryOutcomes measure: Plasma and whole blood folate forms, secondaryOutcomes measure: Plasma phospholipids, secondaryOutcomes measure: Plasma S-adenosylmethionine concentrations, secondaryOutcomes measure: Plasma betaine concentrations, secondaryOutcomes measure: Plasma methylmalonic acid concentrations, secondaryOutcomes measure: Plasma homocysteine concentrations, eligibilityModule sex: MALE, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Saarland, city: Homburg, state: Saarland, zip: 66424, country: Germany, geoPoint lat: 49.32637, lon: 7.33867, hasResults: False

protocolSection identificationModule nctId: NCT06380049, orgStudyIdInfo id: 0720242110, secondaryIdInfos id: 20240012366, type: OTHER, domain: Ministry of Food and Drug Safety, briefTitle: Predicting Fall Risk in Stroke Patients Using a Machine Learning Model and Multi-Sensor Data, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-29, primaryCompletionDateStruct date: 2025-04-28, completionDateStruct date: 2026-04-28, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Seoul National University Hospital, class: OTHER, collaborators name: Ministry of Trade, Industry & Energy, Republic of Korea, descriptionModule briefSummary: The study assesses a machine learning model developed to predict fall risk among stroke patients using multi-sensor signals. This prospective, multicenter, open-label, sponsor-initiated confirmatory trial aims to validate the safety and efficacy of the model which utilizes electromyography (EMG) signals to categorize patients into high-risk or low-risk fall categories. The innovative approach hopes to offer a predictive tool that enhances preventative strategies in clinical settings, potentially reducing fall-related injuries in stroke survivors., conditionsModule conditions: Stroke, conditions: Fall, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: EMG Analysis Software, outcomesModule primaryOutcomes measure: Sensitivity of the Machine Learning Model, secondaryOutcomes measure: Specificity of the Machine Learning Model, otherOutcomes measure: Area Under the Receiver Operating Characteristic Curve, otherOutcomes measure: Matthews Correlation Coefficient, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06380036, orgStudyIdInfo id: 003AEstb/EC/01/2022, briefTitle: Two Approaches to Lower the Chances of Recurrence of Anal Fistula After Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-01, primaryCompletionDateStruct date: 2023-10-31, completionDateStruct date: 2023-10-31, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Sairah Sadaf, class: OTHER_GOV, descriptionModule briefSummary: A total of 80 patients with complex fistula in ano of both genders were included. All patients in Group A underwent a loose seton technique. In group B, video-assisted fistula tract surgery (VAAFTS) was performed.Twice daily Sitz baths, analgesics, and stool bulking agents (bran) were used in follow-up care. Repeated examinations were carried out every four weeks and recurrence was noted at the end of three months, conditionsModule conditions: Fistula in Ano, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ACTUAL, armsInterventionsModule interventions name: video assisted fistula tract surgery, outcomesModule primaryOutcomes measure: recurrence, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sheikh Zayed Medical College, city: Rahim yar khan, state: Punjab, zip: 64200, country: Pakistan, geoPoint lat: 28.41987, lon: 70.30345, hasResults: False

protocolSection identificationModule nctId: NCT06380023, orgStudyIdInfo id: 2022.354, briefTitle: An Investigation Into the Dispersion Pattern During Coughing and Open Nasopharyngeal Suction Using Various Barrier Devices, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-01, primaryCompletionDateStruct date: 2024-03-03, completionDateStruct date: 2024-03-03, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: North District Hospital, class: OTHER, collaborators name: The Hong Kong Polytechnic University, descriptionModule briefSummary: The aim of the study is to examine the air dispersion pattern and the environmental influence of open airway suction in general ward setting. Secondly, the study is aimed at identifying a simple \& practical enclosure device in general ward. Suction will be performed in manikin in supine lying.Nasopharyngeal suction will be performed by physiotherapist with working experience more than 1 years. Besides, surgical mask \& enclosure tent will be adopted as the enclosure barrier device in this study.Research Question1. To assess the extent of the environmental contamination during coughing and simulated airway suction2. To measure the air particle count during coughing and simulated open airway suction.3. To evaluate how effective the enclosure barrier in reducing the air particle dispersion during open airway suction., conditionsModule conditions: Airway Aspiration, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 13, type: ACTUAL, armsInterventionsModule interventions name: Enclosure barrier, outcomesModule primaryOutcomes measure: Air particle count, secondaryOutcomes measure: A fluorescent Dye, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: North District Hospital, city: Hong Kong, zip: 000000, country: Hong Kong, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False

protocolSection identificationModule nctId: NCT06380010, orgStudyIdInfo id: IASO HOSPITAL (ATHENS-GREECE), briefTitle: Mediterranean Diet Intervention in Adolescents With Polycystic Ovary Syndrome, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-12-01, primaryCompletionDateStruct date: 2020-03-31, completionDateStruct date: 2020-06-30, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Iaso Maternity Hospital, Athens, Greece, class: OTHER, collaborators name: Harokopio University, collaborators name: University of Peloponnese, descriptionModule briefSummary: The aim of the present randomized controlled study was to examine wether a clinical decision support stystem would increase the adherence to the Mediterranean diet (MD) of adolescent girls, aged 15-17 years, diagnosed with polycystic ovary syndrome. The intervention lasted for 3 months and in total, 40 girls were randomly assigned to either the MD group (n=20) or a Control group receiving general nutritional advice (n=20). Anthropometry, nutritional intake, psychological well-being, and blood markers were analyzed at the begninning and the end of the trial., conditionsModule conditions: Polycystic Ovary Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Recruitment involved adolescents with polycystic ovary syndrome. Participants, who expressed their willingness to take part, attended personal meetings with the appointed dieticians who provided comprehensive explanations on the objectives, methods, and the potential benefits/risks of the study. A leaflet with related information was provided to all patients. Every eligible volunteer, and their guardian, signed a written informed consent and then kept a hard copy of the signed document. All eligible females were recruited in 12/2019 and were randomly allocated in groups of one to either the Control group (CG) or the Intervention group (IG). The IG received a personalized Mediterranean dietary plan, delivered through a clinical decision support system, while the CG received general dietary advice. Every participant had two individual sessions with the assigned dietician, at the beginning and at the trial endpoint, which involved anthropometry, dietary assessment, and blood withdrawal., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Treatment allocation was not revealed to the appointed statistician until the end of the study and release of the final outcomes., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Mediterranean diet group, outcomesModule primaryOutcomes measure: Adherance to the Mediterranean diet, secondaryOutcomes measure: Improvement of psychological well-being, eligibilityModule sex: FEMALE, minimumAge: 15 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: IASO Hospital, city: Athens, zip: 15123, country: Greece, geoPoint lat: 37.97945, lon: 23.71622, hasResults: False

protocolSection identificationModule nctId: NCT06379997, orgStudyIdInfo id: SANTA LUCIA IRCCS, briefTitle: Oral Supplementation Compared With Hyaluronic Acid Infiltration in Rotator Cuff Tendinopathies, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-02, primaryCompletionDateStruct date: 2025-11-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: I.R.C.C.S. Fondazione Santa Lucia, class: OTHER, descriptionModule briefSummary: The present study aims to investigate the effectiveness of oral supplementation with a nutraceutical containing Collagen, Hyaluronic Acid, Vitamin C, and Manganese in functional outcome and pain reduction in cases of shoulder rotator cuff tendinopathy compared to a cycle of intra-articular hyaluronic acid injections.The project involves the recruitment of 50 adult individuals presenting with shoulder pain and instrumental evidence of rotator cuff tendinopathy. All participants will receive one intra-articular injection of 1 ml of triamcinolone acetonide 40 mg. After the injection, participants will be divided into two groups according to Good Clinical Practice guidelines. One group will begin taking one vial per day for 56 days of an oral supplement containing Hyaluronic Acid, Collagen, Vitamin C, and Manganese (HA-COL) (Tendogenial®, B2Pharma) starting from the day following enrollment (Group 1). The other group will undergo a cycle of 3 intra-articular injections with hyaluronic acid (HA) (Hyalotend®, Fidia) (Group 2).The hypothesis is that oral supplementation with HA-COL may have the same efficacy as intra-articular hyaluronic acid treatment in reducing pain and improving shoulder functionality.Functional assessments will be conducted by a clinician unaware of the participants' group assignment. The following assessment scales will be used:Numeric Rating Scale (NRS) for pain (from 0 to 10), evaluating 3 aspects of pain: 1) pain at rest, 2) nocturnal pain, 3) pain during movement.Shoulder Disability Questionnaire (SDQ) for functionality.Assessments will be conducted at the following time points:T0) Before the administration of corticosteroid intra-articular injection (baseline).T1) Seven days after the start of HA-COL intake for Group 1 and before the first intra-articular HA injection for Group 2 (T1, seven days from T0).T2) At mid-cycle of oral HA-COL supplementation for Group 1 (28 days of intake) and seven days after the last HA injection for Group 2 (T2, 21 days from T1).T3) Follow-up at 28 days from T2, at the end of the 56-day oral treatment cycle for Group 1, and 28 days after the last injection for Group 2 (T3, 56 days from T0)., conditionsModule conditions: Tendinitis of Shoulder, conditions: Hyaluronic Acid, conditions: Dietary Supplements, conditions: Shoulder Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: The enrolling physiatrist, in agreement with the patient and adhering to Good Clinical Practice standards related to safety and clinical-anthropomorphic characteristics, will decide whether to continue the treatment with oral supplements (Group 1 - G1) or with intra-articular hyaluronic acid (Group 2 - G2), primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Both study groups will undergo assessment using pain and functional scales by a clinician who is blinded to the treatment group, whoMasked: INVESTIGATOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Collagen, Hyaluronic Acid, Vitamin C, and Manganese, interventions name: Intra-articular infiltration, outcomesModule primaryOutcomes measure: Numeric rating scale (NRS), secondaryOutcomes measure: Shoulder Disability Questionnaire (SDQ) for shoulder functionality, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06379984, orgStudyIdInfo id: 855013, briefTitle: Rapid Outpatient Low-dose Initiation of Buprenorphine for OUD With Fentanyl Use, acronym: ROLDI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Pennsylvania, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: The goal of this clinical trial is to learn if buprenorphine can be started for opioid use disorder with fentanyl use without requiring or precipitating opioid withdrawal. To be eligible, participants must have moderate or severe opioid use disorder and must have fentanyl detected on a urine drug test.Participants will be admitted to a monitored research unit for the trial. They will be randomized to start buprenorphine with either standard initiation or with a new approach called rapid outpatient low-dose initiation (ROLDI).For standard initiation, participants will be instructed to arrive to the unit with at least 8 hours since last fentanyl use. Once they have at least moderately severe opioid withdrawal (Clinical Opiate Withdrawal Scale \[COWS\] 11 or higher), participants will receive 2 mg, 2 mg, 4 mg, and then 8 mg sublingual buprenorphine, with doses every 2 hours. They will then continue 8-12 mg twice daily. This is the current standard of care.For ROLDI, participants will not be required to have a period abstinence, they will have no or minimal withdrawal (COWS 4 or less) when starting buprenorphine, and participants will take 0.5 mg, 0.5 mg, 1 mg, 1 mg, 1 mg, and then 4 mg sublingual buprenorphine with dosing every two hours. They will then continue 8-12 mg twice daily.The main aim of this clinical trial is to assess whether ROLDI is safe, feasible, acceptable to patients, and worthwhile to study in a larger trial. The secondary aim is to describe fentanyl and norfentanyl pharmacokinetics (that is to say, fentanyl and norfentanyl concentration in blood and urine) during early abstinence to understand why some people using fentanyl develop precipitated withdrawal with standard initiation., conditionsModule conditions: Opioid Use Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Buprenorphine, outcomesModule primaryOutcomes measure: Successful initiation of buprenorphine maintenance, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06379971, orgStudyIdInfo id: 23-2327, briefTitle: Maternal Choline Supplementation and Cannabis Use During Pregnancy: Impact on Early Brain Development, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2029-04, completionDateStruct date: 2029-04, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Denver, class: OTHER, descriptionModule briefSummary: The goal of this study is to determine if providing a nutritional supplement, phosphatidylcholine, to pregnant women who have used cannabis products during the current pregnancy improves the offspring's brain-related development during the first 18 months. Participating pregnant women will receive either phosphatidylcholine or a placebo from approximately 16 weeks gestation through birth. The primary outcomes are the child's brain responses to sound at 4 weeks corrected age, and infant behaviors at 3 months and 18 months corrected age as reported by the primary caregiver. Secondary outcomes include motor, socio-emotional, language and cognitive development., conditionsModule conditions: Child Development, conditions: Cannabis Use, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Phosphatidylcholine or placebo, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Placebo, interventions name: Choline, outcomesModule primaryOutcomes measure: Infant Behavior Questionnaire-Revised (IBQ-R) Orienting/Regulation Index, primaryOutcomes measure: Auditory Sensory Gating (P50), primaryOutcomes measure: Child Behavior Checklist (CBCL) 1 1/2-5, secondaryOutcomes measure: Maternal Plasma Choline Levels, secondaryOutcomes measure: Bayley Scales of Infant and Toddler Development, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: UC Health, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: Sharon Hunter, PhD, role: CONTACT, phone: 303-724-6246, email: sharon.hunter@cuanschutz.edu, geoPoint lat: 39.72943, lon: -104.83192, hasResults: False

protocolSection identificationModule nctId: NCT06379958, orgStudyIdInfo id: IST-05, briefTitle: Drug-Drug Interaction (DDI) Study of Leramistat in Healthy Adult Subjects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-12, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Modern Biosciences Ltd, class: INDUSTRY, descriptionModule briefSummary: A DDI study consisting of 3 parts conducted as an open label, fixed sequence study in healthy adult subjects., conditionsModule conditions: Pharmacokinetics, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: leramistat 40mg, interventions name: Itraconazole 200 mg, interventions name: Phenytoin 100 Mg Oral Capsule, interventions name: Simvastatin 40mg, outcomesModule primaryOutcomes measure: leramistat: Area under the curve - AUC0 t, primaryOutcomes measure: leramistat: Area under the curve - AUC0 24, primaryOutcomes measure: leramistat: Area under the curve - AUC0 inf, primaryOutcomes measure: leramistat: Maximum observed concentration - Cmax, primaryOutcomes measure: leramistat: Time of the maximum observed concentration - Tmax, primaryOutcomes measure: leramistat:Elimination rate constant -Kel, primaryOutcomes measure: leramistat: Half life - t½, primaryOutcomes measure: leramistat: Plasma Clearance -CL/F, primaryOutcomes measure: leramistat: Volume of distribution - Vz/F, secondaryOutcomes measure: Incidence of adverse event., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Celerion, city: Belfast, country: United Kingdom, contacts name: Phase 1 Unit, role: CONTACT, contacts name: Nadine Abdullah, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 54.59682, lon: -5.92541, hasResults: False

protocolSection identificationModule nctId: NCT06379945, orgStudyIdInfo id: PI23/01103, secondaryIdInfos id: PI2024 01 1484, type: REGISTRY, domain: Ethics Committee for Drug Research of the Salamanca Health Area, briefTitle: Unified platforM for a Better integRal Evaluation of MyeLodyspLastic Syndromes in SpAin-Strategy for Unraveling Personalized genoMic Medicine in Public heAlth System (UMBRELLA-SUMMA), acronym: UMBRELLA-SUMMA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Instituto de Investigación Biomédica de Salamanca, class: OTHER, collaborators name: Carlos III Health Institute, descriptionModule briefSummary: Myelodysplastic Syndromes (MDS) are heterogeneous clonal diseases characterized by difficult diagnosis, complex prognostic stratification and unsatisfactory treatment. Based on that, UMBRELLA SUMMA aims to provide better clinical management and personalized medicine to MDS patients in Spain through improving diagnosis (1), prognosis (2 and 3), and treatment (2), and facilitating future investigations (4) of the disease.More concretely, we propose: 1. The application of new technologies such as Optical Genome Mapping (OGM) in the diagnosis of those MDS cases whose cytogenetic alterations cannot be identify by other methods, as well as the implementation of this technology using peripheral blood avoiding more invasive methods for patients. 2. To provide all Spanish Group of MDS (GESMD) members who require it with the newly prognostic stratification of their patients (IPSS-M) by making Next Generation Sequencing (NGS) accessible for all of them. 3. Validate and improve a new prognostic system (AIPSS-MDS) previously developed within the GESMD, thanks to artificial intelligence, one of the tools with the most projection in the field of medicine currently. 4. To build and register ISCIII collections of cells, genetic material and/or plasma from all prospective MDS patients.On the other hand, the dynamics of coexisting mutations in a specific context of chromosomal abnormalities could be defining the clinical fate of each patient. Based on that, the IBSAL team recently proposed three models of MDS evolution based on NGS data from three different cytogenetic subgroups: normal karyotype, trisomy 8 and 5q deletion. The IBSAL proposal aims to deepen into the pathophysiological mechanisms of MDS evolution in these three models through in vitro and in vivo functional studies and single-cell multiomics approaches., conditionsModule conditions: Myelodysplastic Syndromes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, outcomesModule primaryOutcomes measure: Structural variants and complex rearrangements in MDS, primaryOutcomes measure: Mutations in MDS, primaryOutcomes measure: Overall survival and leukemia-free survival in patients with MDS, primaryOutcomes measure: ISCIII collections of viable samples, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fundación Instituto de Investigación Germans Trias i Puyol, status: RECRUITING, city: Badalona, state: Barcelona, zip: 08916, country: Spain, contacts name: Francesc Solé, PhD, role: CONTACT, phone: 935 57 28 06, phoneExt: 4040, email: fsole@carrerasresearch.org, geoPoint lat: 41.45004, lon: 2.24741, locations facility: Hospital Universitario Vall d´Hebron, status: RECRUITING, city: Barcelona, zip: 08035, country: Spain, contacts name: David Valcárcel Ferreiras, PhD, role: CONTACT, phone: 934 89 30 00, email: dvalcarcel@vhio.net, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Clínica Universitaria de Navarra, status: RECRUITING, city: Pamplona, zip: 31008, country: Spain, contacts name: Felipe López Cardoso, PhD, role: CONTACT, phone: 848 42 87 00, email: fprosper@unav.es, geoPoint lat: 42.81687, lon: -1.64323, locations facility: Complejo Asistencial Universitario de Salamanca, status: RECRUITING, city: Salamanca, zip: 37007, country: Spain, contacts name: María Díez Campelo, PhD, role: CONTACT, phone: +34 923 29 11 00, phoneExt: 55418, email: mdiezcampelo@usal.es, contacts name: Sandra Muntión Olave, PhD, role: CONTACT, phone: +34 923 29 11 00, phoneExt: 55015, email: terapiacelular@usal.es, geoPoint lat: 40.96882, lon: -5.66388, hasResults: False

protocolSection identificationModule nctId: NCT06379932, orgStudyIdInfo id: APHP240433, briefTitle: Pain and Muscle Biopsy, acronym: BIODOMU, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Few studies have been conducted on pain assessment during and after open muscle biopsy. Furthermore, no clinical factors likely to influence pain perception during and after open muscle biopsy have been evaluated in previous studies.The proposed observational study aims to study pain perception in subjects over the aged of 18 years old who underwent an open muscle biopsy for a suspected myopathic disorder. Describing the main characteristics of pain during and after open muscle biopsy using a questionnaire will not only clarify this aspect, which is little studied in the literature, but will also provide information for improving analgesic management of the procedure.Studying the prognostic aspects of pain perception will give healthcare professionals an idea of which patients are at risk of suffering greater adverse effects from the procedure, so that they can be offered a personalised service in the future., conditionsModule conditions: Neuromuscular Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Surveys completion, outcomesModule primaryOutcomes measure: To describe the characteristics and intensity of pain during and after open muscle biopsy on the basis of a questionnaire including NRS scale., secondaryOutcomes measure: To identify prognostic factors that may influence pain perception and to gather opinions to improve quality service, secondaryOutcomes measure: Gather patient feedback on procedures, facilities and reception to improve our service to patients., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06379919, orgStudyIdInfo id: C Acnes in TSA, briefTitle: Wound Irrigation Comparative Effectiveness Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2027-05-31, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Orthopaedic Education and Research Institute (dba Hoag Orthopedics), class: OTHER, collaborators name: Irrimax Corporation, descriptionModule briefSummary: The primary objective of this study is to compare the presence of C acnes in bacteriologic cultures taken from participant samples of subcutaneous and deep tissue prior to deep surgical irrigation using either Normal Saline Irrigation (Group 1) or Irrisept Irrigation (Group 2). Secondary objectives are evaluation of patient reported outcome measures and range of motion in relation to C acnes presence among subjects in the two groups., conditionsModule conditions: Cutibacterium Acnes Contamination, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants are assigned at the beginning of the study to treatment arm involving 1 of 2 types of irrigation treatment for their surgery. They continue in that arm through the length of the study and complete the same study procedures, as well as same standard of care., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Participants and Microbiology lab assessing cultures are blinded to the assigned irrigation treatment arm throughout the length of the study., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 126, type: ESTIMATED, armsInterventionsModule interventions name: Irrisept Irrigation, interventions name: Saline Irrigation Solution Delivery, outcomesModule primaryOutcomes measure: C Acnes Presence, secondaryOutcomes measure: American Shoulder and Elbow Surgeons Patient Reported Outcome Measure, secondaryOutcomes measure: Shoulder Range of Motion (ROM), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hoag Orthopedics, status: RECRUITING, city: Orange, state: California, zip: 92868, country: United States, contacts name: Edward Quilligan, BS, role: CONTACT, phone: 949-526-1570, email: Edward.quilligan@hoagorthopedics.org, contacts name: Kalyn Smith, BS, role: CONTACT, phone: (949) 526-1570, email: kalyn.smith@hoagorthopedics.org, geoPoint lat: 33.78779, lon: -117.85311, hasResults: False

protocolSection identificationModule nctId: NCT06379906, orgStudyIdInfo id: DMD, UE and Balance, briefTitle: Upper Extremity Muscle Strength, Balance and Functional Skills in DMD, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-11-10, primaryCompletionDateStruct date: 2023-12-10, completionDateStruct date: 2024-03-10, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Halic University, class: OTHER, collaborators name: Biruni University, collaborators name: Istanbul University, descriptionModule briefSummary: This study aims to examine the relationship between upper extremity muscle strength, balance and functional skills of children with DMD., conditionsModule conditions: Duchenne Muscular Dystrophy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 32, type: ACTUAL, armsInterventionsModule interventions name: Assessment, outcomesModule primaryOutcomes measure: Upper Extremity Muscle Strength Measurements, primaryOutcomes measure: Trunk Control Measurement Scale, primaryOutcomes measure: Functional Reach Test, primaryOutcomes measure: Timed Up & Go Test, secondaryOutcomes measure: Pediatric Evaluation of Disability Inventory, eligibilityModule sex: MALE, minimumAge: 5 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Haliç University, city: Istanbul, state: Eyüpsultan, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False

protocolSection identificationModule nctId: NCT06379893, orgStudyIdInfo id: 300128, secondaryIdInfos id: 2024-510839-22-00, type: CTIS, briefTitle: A Real-World Evidence Study to Evaluate the Effects of Voltaren Use on Mobility and Quality of Life in Participants With Knee Osteoarthritis Pain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-19, primaryCompletionDateStruct date: 2024-11-15, completionDateStruct date: 2024-11-15, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: HALEON, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to investigate how topical diclofenac use can improve functional mobility and physical activity primarily, as well as other quality-of-life (QoL) parameters such as sleep, mood, and engagement in daily activities in participants with knee OA., conditionsModule conditions: Pain, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 195, type: ESTIMATED, armsInterventionsModule interventions name: Voltaren Gel 1% (diclofenac sodium) (US only), interventions name: Voltaren Gel 1.16% (diclofenac diethylammonium) (EU only), interventions name: Voltaren Gel 2.32% (diclofenac diethylammonium) (EU only), outcomesModule primaryOutcomes measure: Change from Baseline in the Average Minutes of Moderate and Vigorous Physical Activity (MVPA) at Week 1, primaryOutcomes measure: Change from Baseline in the Average Minutes of MVPA at Week 2, primaryOutcomes measure: Change from Baseline in the Average Minutes of MVPA at Week 3, secondaryOutcomes measure: Change from Baseline in Daily Average Number of Steps Taken at Days 7, 14 and 21, secondaryOutcomes measure: Change from Baseline in Daily Average Number of Stairs Climbed/Descended at Days 7, 14 and 21, secondaryOutcomes measure: Change from Baseline in Ratio of Sedentary/Non-sedentary Time at Days 7, 14 and 21, secondaryOutcomes measure: Change from Baseline in Gait, Assessed Through Speed and Step Irregularity at Days 7, 14 and 21, secondaryOutcomes measure: Change from Baseline in Indices of Morning Stiffness at Days 7, 14 and 21, secondaryOutcomes measure: Change from Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale Score on Days 7,14, and 21, secondaryOutcomes measure: MVPA on Each Day of the Study, secondaryOutcomes measure: WOMAC Physical Function Subscale Score on Days 7,14, and 21, secondaryOutcomes measure: Change from Baseline in Self-reported Pain Intensity Assessed Through Numeric Rating Scale (NRS), secondaryOutcomes measure: Change from Baseline in the WOMAC Subscale Score on Days 7, 14, and 21: Pain, secondaryOutcomes measure: Change from Baseline in the WOMAC Subscale Score on Days 7, 14, and 21: Stiffness, secondaryOutcomes measure: Change from Baseline in Sleep/Alertness Assessed Using Karolinska Sleepiness Scale on Days 7, 14, and 21, secondaryOutcomes measure: Change from Baseline in Health-related Quality of Life Assessed Using European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire on Days 7, 14, and 21, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06379880, orgStudyIdInfo id: 2023-031, secondaryIdInfos id: 2024-A00120-47, type: OTHER, domain: ID-RCB Number, briefTitle: Impact on Quality of Life and Health of the CONTINUUM+ CONNECT Remote Monitoring Solution, acronym: FEGALA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2024-11-25, completionDateStruct date: 2025-02-25, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Institut de cancérologie Strasbourg Europe, class: OTHER, collaborators name: Continuum Plus Santé, collaborators name: Plateforme nationale qualité de vie et cancer, collaborators name: WeShare, descriptionModule briefSummary: FEGALA is a comparative, multicenter, randomized, prospective, open-label study comparing the results observed at 3 months (± 15 days) on the EORTC QLQ-C30 scale in a group of patients with metastatic cancer followed on an outpatient basis and benefiting from the CONTINUUM+ CONNECT solution (with or without nursing support at home) versus comparable patients benefiting from conventional monitoring., conditionsModule conditions: Prostatic Neoplasms, conditions: Lung Neoplasms, conditions: Breast Neoplasms, conditions: Colorectal Neoplasms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 506, type: ESTIMATED, armsInterventionsModule interventions name: CONTINUUM+ CONNECT remote monitoring, outcomesModule primaryOutcomes measure: Effect of the CONTINUUM+ CONNECT solution on the results in terms of physical health on the EORTC QLQ-C30 questionnaire in patients with metastatic cancer followed in outpatient settings who did not require assistance in self-assessment, secondaryOutcomes measure: Effect of CONTINUUM+ CONNECT solution on the results at 3 months (± 15 days) post-inclusion in terms of physical health on the EORTC QLQ-C30 questionnaire in patients with metastatic cancer followed in outpatient settings, secondaryOutcomes measure: Effect of CONTINUUM+ CONNECT solution on all dimensions of EORTC QLQ-C30 questionnaires (at 3 months), secondaryOutcomes measure: Effect of CONTINUUM+ CONNECT solution on all dimensions of EORTC QLQ-C30 questionnaires (at 6 months), secondaryOutcomes measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - breast cancer group, secondaryOutcomes measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - lung cancer group, secondaryOutcomes measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - prostate cancer group, secondaryOutcomes measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - colorectal cancer group, secondaryOutcomes measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - breast cancer group, secondaryOutcomes measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - lung cancer group, secondaryOutcomes measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - prostate cancer group, secondaryOutcomes measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - colorectal cancer group, secondaryOutcomes measure: Frequency of grade 3 - 4 adverse events present at 3 months post-inclusion, secondaryOutcomes measure: Frequency of grade 3 - 4 adverse events present at 6 months post-inclusion, secondaryOutcomes measure: Percentage of patients with unscheduled hospitalization due to their cancer occurring during the 3 months following inclusion, secondaryOutcomes measure: Percentage of patients with unscheduled hospitalization due to their cancer occurring during the 6 months following inclusion, secondaryOutcomes measure: Satisfaction of professionals regarding CONTINUUM+ CONNECT solution and its functioning, secondaryOutcomes measure: Satisfaction of patients regarding CONTINUUM+ CONNECT solution and its functioning, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sainte-Catherine, Institut du Cancer Avignon-Provence, status: NOT_YET_RECRUITING, city: Avignon, zip: 84918, country: France, contacts name: Julien GRENIER, MD, role: CONTACT, geoPoint lat: 43.94834, lon: 4.80892, locations facility: Polyclinique de Blois, status: NOT_YET_RECRUITING, city: Blois, zip: 41260, country: France, contacts name: Yann MOTTAZ, MD, role: CONTACT, contacts name: Yann MOTTAZ, Md, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.58333, lon: 1.33333, locations facility: Pôle Santé République, status: RECRUITING, city: Clermont-Ferrand, zip: 63000, country: France, contacts name: Pierre DALLOZ, MD, role: CONTACT, contacts name: Pierre DALLOZ, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.77966, lon: 3.08628, locations facility: centre Georges François Leclerc, status: NOT_YET_RECRUITING, city: Dijon, zip: 21079, country: France, contacts name: Leila BENGRINE, MD, role: CONTACT, contacts name: Leila BENGRINE, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.31667, lon: 5.01667, locations facility: Chu Dupuytren, status: NOT_YET_RECRUITING, city: Limoges, zip: 87042, country: France, contacts name: Tiffany DARBAS, MD, role: CONTACT, contacts name: Tiffany DARBAS, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.83153, lon: 1.25781, locations facility: Centre d'oncologie de Gentilly, status: RECRUITING, city: Nancy, zip: 54100, country: France, contacts name: Laurene GAVOILLE, MD, role: CONTACT, contacts name: Laurene GAVOILLE, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.68439, lon: 6.18496, locations facility: Hôpitla privé des Côtes d'Armor - Centre CARIO-HPCA, status: NOT_YET_RECRUITING, city: Plérin, zip: 22190, country: France, contacts name: Jérôme MARTIN-BABAU, MD, role: CONTACT, contacts name: Jérôme MARTIN-BABAU, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.54249, lon: -2.77983, locations facility: Institut Jean Godinot, status: RECRUITING, city: Reims, zip: 51100, country: France, contacts name: Christelle JOUANNAUD, MD, role: CONTACT, contacts name: Christelle JOUANNAUD, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.25, lon: 4.03333, locations facility: CHU de Saint-Etienne, status: NOT_YET_RECRUITING, city: Saint-Priest-en-Jarez, zip: 42270, country: France, contacts name: Pierre CORNILLON, MD, role: CONTACT, contacts name: Pierre CORNILLON, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.47501, lon: 4.37614, locations facility: Institut de cancérologie Strasbourg Europe, status: RECRUITING, city: Strasbourg, zip: 67033, country: France, contacts name: Manon VOEGELIN, role: CONTACT, contacts name: Philippe BARTHELEMY, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.58392, lon: 7.74553, locations facility: Hôpitaux Universitaires de Strasbourg, status: NOT_YET_RECRUITING, city: Strasbourg, zip: 67091, country: France, contacts name: Bertrand MENNECIER, MD, role: CONTACT, contacts name: Bertrand MENNECIER, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.58392, lon: 7.74553, hasResults: False

protocolSection identificationModule nctId: NCT06379867, orgStudyIdInfo id: HSK3486-112, briefTitle: A Study to Evaluate the Effects of HSK3486 Administration on Cardiac Repolarization in Healthy Subjects, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-07, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Haisco Pharmaceutical Group Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: Assess the effects of a single IV bolus of HSK3486 single dose on cardiac repolarization for healthy subjects., conditionsModule conditions: Anesthesia, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: HSK3486, interventions name: Placebo, interventions name: Moxifloxacin, outcomesModule primaryOutcomes measure: ΔQTcI, secondaryOutcomes measure: ΔHR, ΔQTcF, ΔPR, and ΔQRS, secondaryOutcomes measure: Categorical outliers for QTcI, QTcF, HR, PR, and QRS intervals, secondaryOutcomes measure: AE and SAE, secondaryOutcomes measure: Cmax, secondaryOutcomes measure: AUClast, secondaryOutcomes measure: t1/2, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Beijing GoBroad Boren Hospital, status: RECRUITING, city: Beijing, country: China, contacts name: Jie Hou, role: CONTACT, phone: 18611422958, email: jie.hou@gohealtharo.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False

protocolSection identificationModule nctId: NCT06379854, orgStudyIdInfo id: RCRAHS-ISB/REC/MS-PT/01814, briefTitle: Trunk Rotation And Lateral Flexion Exercises In Stroke Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: In this study we want to introduce the beneficiary combine effects of chest mobilization and chest physiotherapy exercises by using cough peak flow meter and chest expansion in stroke patients. by using theses combine exercises physiotherapist can develop target rehabilitation strategies for stroke survivors., conditionsModule conditions: Stroke, Acute, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: chest physiotherapy, interventions name: trunk rotation exercises,deep diaphragmatic also chest physiotherapy, outcomesModule primaryOutcomes measure: Trunk Impairment Scale:, primaryOutcomes measure: Peak Flow Meter, primaryOutcomes measure: Chest Expansion:, eligibilityModule sex: ALL, maximumAge: 50 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Shahida Khaliq Health Centre, status: RECRUITING, city: Islamabad, zip: 44080, country: Pakistan, contacts name: Sara Jahan, MSPT, role: CONTACT, phone: +923415182331, email: saira.jahan@riphah.edu.pk, geoPoint lat: 33.72148, lon: 73.04329, hasResults: False

protocolSection identificationModule nctId: NCT06379841, orgStudyIdInfo id: STUDY00007357, briefTitle: Green Hysteroscopy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Emory University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to determine whether green draping in the operating room prior to a hysteroscopy results in a decreased operating room time.Secondary aims are to determine whether there are any differences in infection rate, complication rate, fluid deficit, operating room turnover time, conditionsModule conditions: Hysteroscopy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Green Draping Procedure, interventions name: Full Draping Procedure, outcomesModule primaryOutcomes measure: Difference in operative times, secondaryOutcomes measure: Infection Rate, secondaryOutcomes measure: Post Operative complication Rate, secondaryOutcomes measure: Peri operative Complication Rate, secondaryOutcomes measure: Number of cases of Fluid deficits, secondaryOutcomes measure: Operative room turnover time in Full Draping, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Emory Hospital, city: Atlanta, state: Georgia, zip: 30322, country: United States, geoPoint lat: 33.749, lon: -84.38798, locations facility: Emory Dunwoody Clinic, city: Atlanta, state: Georgia, zip: 30338, country: United States, geoPoint lat: 33.749, lon: -84.38798, locations facility: Emory Saint Joseph's Hospital, city: Atlanta, state: Georgia, zip: 30342, country: United States, geoPoint lat: 33.749, lon: -84.38798, hasResults: False

protocolSection identificationModule nctId: NCT06379828, orgStudyIdInfo id: 2024-0140, briefTitle: Self-assessment Tool for Implementing the ESCNH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-03, primaryCompletionDateStruct date: 2025-10-01, completionDateStruct date: 2026-09-01, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: European Foundation for the Care of Newborn Infants, class: OTHER, descriptionModule briefSummary: This study aims to develop a tool for hospitals to self-assess the implementation of the European Standards of Care for Newborn Health (ESCNH), standards defining best-practice procedures for neonatal care. The tool shall support healthcare professionals across Europe to measure the level of implementation of the ESCNH, to identify variations in care delivery, and ultimately to improve neonatal care. To achieve this, healthcare professionals from all relevant backgrounds and parent representatives will be invited to take part in an electronic Delphi consensus approach. A subsequent pilot-testing among at least 10 hospitals across Europe will refine the developed tool, indicate potential errors, ensure user-friendliness, and improve the applicability., conditionsModule conditions: Development of a Tool to Assess the Level of Implementing the European Standards of Care for Newborn Health, conditions: Testing of the Developed Self-assessment Tool in European Hospitals, conditions: Self-Assessment, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Please note that this is an observational study; not applicable, outcomesModule primaryOutcomes measure: Online self-assessment tool (including statements and questions), secondaryOutcomes measure: Response rates, secondaryOutcomes measure: Demographics and characteristics, secondaryOutcomes measure: User-friendliness score of the self-assessment tool, secondaryOutcomes measure: Applicability score of the formulation of the questions, secondaryOutcomes measure: Qualitative feedback on illustration of output, secondaryOutcomes measure: Appraisal on the utilisation of the self-assessment tool, secondaryOutcomes measure: Scalability of the self-assessment tool and dissemination, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: European Foundation for the Care of Newborn Infants (EFCNI), city: Munich, state: Bavaria, zip: 81379, country: Germany, contacts name: Isabel Geiger, Dr., role: CONTACT, phone: 0049 89 89 0 83 26-0, email: isabel.geiger@efcni.org, contacts name: Julia Hoffmann, Dr., role: CONTACT, email: julia.hoffmann@efcni.org, contacts name: Luc Zimmermann, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.13743, lon: 11.57549, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-04-17, uploadDate: 2024-04-17T07:49, filename: Prot_SAP_000.pdf, size: 200372, hasResults: False

protocolSection identificationModule nctId: NCT06379815, orgStudyIdInfo id: EMRL-23-03, briefTitle: Effect of Oral Lactate Ingestion on Appetite Regulation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Wilfrid Laurier University, class: OTHER, collaborators name: Natural Sciences and Engineering Research Council, Canada, descriptionModule briefSummary: The goal if this study is to determine how oral lactate ingestion affects markers of appetite regulation. Researchers will compare oral lactate ingestion to a sodium chloride placebo. Participants will consume the lactate or placebo solution and then have blood samples and assessments of appetite over the course of 90 min. Free-living energy intake will be measured for 3 days surrounding each experimental session., conditionsModule conditions: Appetitive Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Participants will consume a sodium lactate and sodium chloride placebo in a double-blind, crossover design., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, maskingDescription: The allocation of lactate and placebo will be completed by a researcher not involved in data collection. Both the participant and the researchers collecting and analyzing the data will be blinded to the treatment allocation. This will be completed in a counter-balanced order., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Sodium Lactate, interventions name: Sodium Chloride, outcomesModule primaryOutcomes measure: Blood Lactate, primaryOutcomes measure: Acylated ghrelin, primaryOutcomes measure: Total ghrelin, secondaryOutcomes measure: Subjective appetite perception, secondaryOutcomes measure: Free-living energy intake, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06379802, orgStudyIdInfo id: 2023-00546-01, briefTitle: Lifestyle Intervention With Physical Activity and Diet, acronym: LI-PAD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Vastra Gotaland Region, class: OTHER_GOV, descriptionModule briefSummary: The aim of this pilot randomized controlled trial LI-PAD is to identify whether a 6-month intervention approach to individually optimize lifestyle behavior, physical activity, and diet, is feasible and leads to larger improvements in body weight, cardiovascular disease risk factors, and health-related quality of life compared to simple written lifestyle advice, in individuals with overweight or obesity.The intervention group will be offered individual support for lifestyle behavioral change (precision health) and the control group will be offered written lifestyle advice, following national recommendations. In total, 60 population-based participants and 60 controls from the Gothenburg area, aged 45-65 years, will be recruited., conditionsModule conditions: Overweight, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Individualized physical activity and diet, outcomesModule primaryOutcomes measure: Change in body weight 1, primaryOutcomes measure: Change in body weight 2, primaryOutcomes measure: Change in body weight 3, primaryOutcomes measure: Change in body weight 4, secondaryOutcomes measure: Length in cm, secondaryOutcomes measure: Weight in kilograms, secondaryOutcomes measure: Cardiovascular disease risk factor change - Body Mass Index (BMI), secondaryOutcomes measure: Cardiovascular disease risk factor change - Waist-to-hip ratio 1, secondaryOutcomes measure: Cardiovascular disease risk factor change - Waist-to-hip ratio 2, secondaryOutcomes measure: Cardiovascular disease risk factor change - Waist-to-hip-ratio 3, secondaryOutcomes measure: Cardiovascular disease risk factor change - Waist-hip-ratio 4, secondaryOutcomes measure: Cardiovascular disease risk factor change - Blood pressure 1, secondaryOutcomes measure: Cardiovascular disease risk factor change - Blood pressure 2, secondaryOutcomes measure: Cardiovascular disease risk factor change - Blood pressure 3, secondaryOutcomes measure: Cardiovascular disease risk factor change - Blood pressure 4, secondaryOutcomes measure: Cardiovascular disease risk factor change - Long-term blood glucose control using glycated haemoglobin (HbA1c), secondaryOutcomes measure: Cardiovascular disease risk factor change - Serum (total) Cholesterol (S-Cholesterol), secondaryOutcomes measure: Cardiovascular disease risk factor change - High density lipoprotein (HDL), secondaryOutcomes measure: Cardiovascular disease risk factor change - Low densitiy lipoprotein (LDL), secondaryOutcomes measure: Cardiovascular disease risk factor change - Triglycerides, secondaryOutcomes measure: Cardiovascular disease risk factor change - Aerobic fitness (predicted V02 max), secondaryOutcomes measure: Cardiovascular disease risk factor change - Physical activity level, secondaryOutcomes measure: Change in functional lower extremity muscle strength, secondaryOutcomes measure: Change in upper extremity muscle strength - Hand grip strength, secondaryOutcomes measure: Change in muscle strength - Shoulder flexion, secondaryOutcomes measure: Change in muscle strength - Ankle Plantar, secondaryOutcomes measure: Cardiovascular disease risk factor change - Healthy food intake, secondaryOutcomes measure: Change in resting energy expenditure 1, secondaryOutcomes measure: Change in resting energy expenditure 2, secondaryOutcomes measure: Change in resting energy expenditure 3, secondaryOutcomes measure: Change in resting energy expenditure 4, secondaryOutcomes measure: Change in respiratory quotient 1, secondaryOutcomes measure: Change in respiratory quotient 2, secondaryOutcomes measure: Change in respiratory quotient 3, secondaryOutcomes measure: Change in respiratory quotient 4, secondaryOutcomes measure: Change in health-related quality of life - Proportions of problems in five dimensions, secondaryOutcomes measure: Change in health-related quality of life - Index score, secondaryOutcomes measure: Change in health-related quality of life - Visual analog score of present health status, secondaryOutcomes measure: Change in health-related quality of life - Health status categories, secondaryOutcomes measure: Change in self-reported physical activity level, secondaryOutcomes measure: Change in exposure pattern to the food environment, secondaryOutcomes measure: Change in exposure pattern to the built environment, secondaryOutcomes measure: Process evaluation measure 1 - Extent to which intervention was implemented as planned, secondaryOutcomes measure: Process evaluation measure 2 - Number of sessions of each intervention component delivered, secondaryOutcomes measure: Process evaluation measure 3 - Number of sessions of each intervention component received, secondaryOutcomes measure: Process evaluation measure 4 - Satisfaction with individual lifestyle counselling, secondaryOutcomes measure: Process evaluation measure 5 - Satisfaction with the lifestyle school, secondaryOutcomes measure: Process evaluation measure 6A - Perceived facilitators, secondaryOutcomes measure: Process evaluation measure 6B - Perceived barriers, secondaryOutcomes measure: Process evaluation measure 7 - Reach, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre for lifestyle intervention, status: RECRUITING, city: Gothenburg, country: Sweden, contacts name: Mats Börjesson, Prof., role: CONTACT, email: mats.borjesson@gu.se, contacts name: Carina Persson, Ass. prof., role: CONTACT, email: carina.perssson@vgregion.se, geoPoint lat: 57.70716, lon: 11.96679, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-04-12, uploadDate: 2024-04-12T10:31, filename: Prot_000.pdf, size: 411005, hasResults: False

protocolSection identificationModule nctId: NCT06379789, orgStudyIdInfo id: R131L1265-HEMB-2318, secondaryIdInfos id: 2023-507260-40-00, type: REGISTRY, domain: EU CTR Number, briefTitle: A Trial to Learn if REGV131-LNP1265 is Safe and Works to Help the Body Make Clotting Factor in Pediatric, Adolescent and Adult Patients With Hemophilia B, acronym: BEYOND-9, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-25, primaryCompletionDateStruct date: 2032-07-03, completionDateStruct date: 2032-07-03, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Regeneron Pharmaceuticals, class: INDUSTRY, collaborators name: Intellia Therapeutics, descriptionModule briefSummary: Participants in this study have a genetic mutation, specifically in the coagulation (blood clotting) Factor 9 gene that causes severe or moderately severe hemophilia B. This study is researching an experimental gene insertion therapy (the adding of a gene into your DNA) called REGV131-LNP1265, also called the "study drug". Gene insertion therapy aims to teach the body how to produce clotting factor long-term, without the need for factor replacement therapy.The main aim of this study is to find a safe and well-tolerated dose of the study drug by checking the side effects that may happen from taking it.The study is looking at several other research questions including:* How much study drug is in the blood at different times* Whether the body makes antibodies against parts of the study drug, which could make the drug less effective or could lead to side effects. Antibodies are proteins produced by the body's immune system in response to a foreign substance* Whether the body makes antibodies against the clotting factor replacement therapy* How quality of life is affected by hemophilia B and if it changes after taking study drug* How joint health is affected by hemophilia B and if it changes after taking study drug* How often visits are required for the emergency room, urgent care center, physician's office, hospital, telephone or online are required as a result of bleeding events, and if the frequency changes after taking study drug* How often factor replacement therapy is needed, both on a regular basis for prevention of bleeding, and as needed to treat bleeding events (and it if changes after taking study drug)* Whether there is a difference in 2 different methods for measuring Factor 9 activity in the blood, conditionsModule conditions: Hemophilia B, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: REGV131, interventions name: LNP1265, outcomesModule primaryOutcomes measure: Incidence of treatment-emergent adverse events (TEAEs), primaryOutcomes measure: Severity of TEAEs, primaryOutcomes measure: Coagulation Factor IX (FIX) functional activity measured using the chromogenic substrate assay, primaryOutcomes measure: Change in FIX functional activity in plasma, measured using the chromogenic substrate assay, primaryOutcomes measure: Annualized bleeding rate (ABR) following sustained FIX functional activity among participants receiving the RDE, secondaryOutcomes measure: Change in FIX functional activity in plasma measured using the chromogenic substrate assay, secondaryOutcomes measure: ABR following sustained FIX functional activity among participants receiving the RDE, secondaryOutcomes measure: FIX functional activity in plasma over time during the study period using the chromogenic substrate assay, secondaryOutcomes measure: Annualized treated bleeding rate (tABR) following sustained FIX functional activity, among participants receiving the RDE, secondaryOutcomes measure: Annualized utilization (IU/kg/year) of FIX replacement therapy following sustained FIX functional activity among participants receiving the RDE, secondaryOutcomes measure: Remaining free of FIX replacement therapy among those receiving the RDE following sustained FIX expression, secondaryOutcomes measure: Remaining zero spontaneous bleeding events among those receiving the RDE over sustained FIX functional activity period, secondaryOutcomes measure: Concentrations of REGV131 components, secondaryOutcomes measure: Concentrations of LNP1265 components, secondaryOutcomes measure: Detection of antibodies to the F9 transgene product FIX protein, secondaryOutcomes measure: Detection of total binding antibodies (TAbs) to the adeno-associated virus 8 (AAV8) capsid proteins, secondaryOutcomes measure: Detection of neutralizing antibodies/transduction inhibitors (NAb/TI) to the adeno-associated virus 8 (AAV8) capsid proteins, secondaryOutcomes measure: Detection of antibodies to LNP1265, secondaryOutcomes measure: Detection of antibodies to CRISPR-associated protein 9 (Cas9) protein, secondaryOutcomes measure: Detection of vector DNA in blood, secondaryOutcomes measure: Detection of vector DNA in saliva, secondaryOutcomes measure: Detection of vector DNA in nasal secretions, secondaryOutcomes measure: Detection of vector DNA in semen, secondaryOutcomes measure: Detection of vector DNA in urine, secondaryOutcomes measure: Detection of vector DNA in feces, secondaryOutcomes measure: Incidence of TEAEs, secondaryOutcomes measure: Severity of TEAEs, secondaryOutcomes measure: Detection of vector DNA in relevant matrices based on data analysis of Part 1 Dose Confirmation Cohort, secondaryOutcomes measure: Detection of vector DNA in relevant matrices over time based on data analysis from adult cohorts over time, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06379776, orgStudyIdInfo id: LabForSIMS-LC1, briefTitle: 3D Model - Classification of Thoracic and Lumbar Spinal Fractures., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-25, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2026-09-30, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Université Paris-Sud, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to evaluate and compare the effectiveness of a 3D interactive model versus traditional teaching methods in enhancing the teaching of thoracic and lumbar spine fractures classification (AO Spine) among orthopedic residents.The main questions this study aims to answer are:Does the use of a 3D interactive model improve residents' knowledge regarding the AO Spine classification of spine fractures compared to traditional teaching methods? To what extent does the utilization of a 3D interactive model enhance understanding of spinal anatomy, injury mechanisms, pathophysiology, and fracture diagnosis among surgical residents?Participants will be randomly assigned to either:Group A: Access to the 3D interactive model depicting thoracic and lumbar spine fractures based on the AO Spine classification. They can explore fractures, access textual information, and anatomical annotations.Group B: Traditional teaching materials including slides, texts, and diagrams illustrating spine fractures according to the AO Spine classification.Researchers will compare the post-training knowledge and confidence levels in managing spine fractures between the two groups to assess the efficacy of the 3D model.Participants will be required to fill out pre- and post-training questionnaires assessing their knowledge, experience with 3D educational tools, confidence levels in managing spine fractures, and satisfaction with the teaching method.The study aims to ascertain if the use of the 3D model significantly enhances residents' comprehension of spine fractures compared to conventional teaching methods within the orthopedic curriculum., conditionsModule conditions: Lumbar Spine Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Education through a 3D model, interventions name: Education through a traditional pedagogical support, outcomesModule primaryOutcomes measure: Specific Questionnaire, secondaryOutcomes measure: Objective Structured Assessment of Technical Skills (OSATS), secondaryOutcomes measure: Subjective questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06379763, orgStudyIdInfo id: 170/2024, briefTitle: Effect of Diaphragmatic Breathing Exercise on Pain and Sleep Quality in Individuals With Non-specific Chronic Neck Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: University of Jordan, class: OTHER, descriptionModule briefSummary: This research focuses on adding diaphragmatic breathing to conventional physiotherapy sessions, particularly for patients suffering from chronic neck pain aged between 20-40 years in Jordan. Chronic neck pain is recognized as one of the most prevalent musculoskeletal pain disorders, significantly impacting physical, social, and psychological aspects of life. This issue leads to a decline in functional performance and work productivity, negatively affecting both individual and societal levels. Several factors, such as poor posture and prolonged use of smartphones, contribute to the exacerbation of non-specific chronic neck pain. These problems also affect respiratory muscles, particularly the diaphragm responsible for primary respiration, resulting in a shift from abdominal to chest breathing. This alteration increases the use of neck muscles, subsequently intensifying neck pain and negatively impacting sleep quality in these individuals. The primary objective of this therapeutic study is to investigate the role of adding diaphragmatic breathing to physiotherapy sessions in alleviating pain and improving sleep quality.RCT study will investigate the effect of adding the diaphragmatic breathing to conventional physiotherapy treatment on pain and sleep quality over one month., conditionsModule conditions: Non-specific Chronic Neck Pain, conditions: Diaphragmatic Breathing Exercise, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized clinical trial (RCT) Participants will be randomly allocated into two groups using the block randomization method. The following groups will be formed: experimental group A (diaphragmatic breathing plus conservative physiotherapy intervention, cervical neck ROM, neck stretching exercises), and group B,, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: the participants will not know which of exercises that will be giving for them more better in experimental or control group, whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: diaphragmatic breathing exercise, interventions name: conventional physiotherapy exercise, outcomesModule primaryOutcomes measure: neck pain, primaryOutcomes measure: neck pain, secondaryOutcomes measure: sleep quality, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: The university of Jordan, status: RECRUITING, city: Amman, zip: 11942, country: Jordan, contacts name: ISLAM ALNAQEEB, master, role: CONTACT, phone: 00962797246713, email: islam.alnaqeeb01@gmail.com, contacts name: Musab Abu beidar, master, role: CONTACT, phone: 00962790319243, email: musababubaider@gmail.com, geoPoint lat: 31.95522, lon: 35.94503, hasResults: False

protocolSection identificationModule nctId: NCT06379750, orgStudyIdInfo id: STOPNCD, briefTitle: Using Healthcare Financing and Digital Technology to Improve Hypertension Prevention and Control in Tanzania, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2027-03-01, completionDateStruct date: 2028-03-01, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Queen's University, class: OTHER, collaborators name: Kilimanjaro Clinical Research Institute, collaborators name: Muhimbili University of Health and Allied Sciences, descriptionModule briefSummary: The aim of our proposed program is to develop and implement a multilevel, multicomponent and health-financing intervention that will facilitate the scale up of evidence-based strategies to improve non-communicable diseases prevention, detection and control in Tanzania. We will accomplish this by: 1) adapting two intervention components that are candidates for inclusion in a highly effective optimized strategy (called STOP-NCDs) and; (b) Assess their individual and combined effectiveness and 2) conducting a robust, mixed-methods evaluation of the implementation process and assess factors that may influence implementation and sustainability for delivering and scaling the optimized STOP-NCDs strategy. We will select and/or adapt intervention components making up the optimized STOP-NCDs strategy. Using a hybrid clinical-effectiveness implementation design, we will conduct a study in 2 sequential phases: 1) A clinical-effectiveness phase in which we evaluate the effect of our combined strategies (task-sharing and WelTel) versus Usual Care, on rates of systolic BP reduction at 12 months; as well as other secondary outcomes including diagnosis and treatment of diabetes and, patient knowledge of CVD risks and prevention, and, other features of health provider NCD prevention activities. 2) A post-implementation phase in which we use the RE-AIM framework to evaluate changes in the adoption and maintenance of our combined strategies in participating iCHF health facilities across Kilimanjaro region. We will use the WelTel communication and Patient Management platform for to deliver culturally and contextually appropriate evidence-based text messaging to patients. It allows for quality improvement and is a unique tool for our program to scaling low-cost interventions that provide capabilities for tracking of health system service uptake, quality-metrics at health facilities, drug stock-out management, and patient-centered behavioral health interventions. Deployment of WelTel will allow for integration of NCD prevention targeted health services to all adult iCHF members across differing life stages and NCD risk and have a significant impact on increasing quality of care and sustainability of health financing and performance-based incentives through improved prescribing, patient engagement, medication adherence and healthy behaviour change., conditionsModule conditions: Hypertension, conditions: Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 1320, type: ESTIMATED, armsInterventionsModule interventions name: Nurse-delivered care using WelTel check-ins and BCC SMS, interventions name: Community-based peer-support model, outcomesModule primaryOutcomes measure: Systolic blood pressure, secondaryOutcomes measure: Blood pressure control, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06379737, orgStudyIdInfo id: 359n/AO/23, secondaryIdInfos id: MASI_CARIVARI21_01, type: OTHER_GRANT, domain: Fondazione Cariparo, briefTitle: Multi-systemic Rehabilitative Interventions in Long COVID-19 Patients in Two Different Settings: a Randomized Controlled Trial, acronym: MULTI-COVID, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2023-12-20, completionDateStruct date: 2023-12-20, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Padua University General Hospital, class: OTHER, descriptionModule briefSummary: Objective: This study aimed to evaluate the effectiveness of a multisystem rehabilitation program for Long Covid patients in two different settings.Design: Randomized controlled trial. Settings: Health resort and home-based. Participants: 72 Long Covid patients. Interventions: Patients were randomly assigned into two groups: Group A (n=36) received health resort intervention, and Group B (n=36) received home-based care. Both groups underwent a 5-week rehabilitation program, involving motor, respiratory, and cognitive exercises, two sessions per week.Outcomes: Assessments were conducted before (T0) and after treatment (T1), at 3 (T2) and 6 months (T3), including respiratory and physical function, handgrip strength, fatigue, pain, quality of life, psychological function, and satisfaction., conditionsModule conditions: Long COVID, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 72, type: ACTUAL, armsInterventionsModule interventions name: Multi-systemic Rehabilitation, outcomesModule primaryOutcomes measure: Numerical Rating Scale (NRS), primaryOutcomes measure: Hand grip strength, primaryOutcomes measure: Barthel Dyspnea Scale, primaryOutcomes measure: Fatigue Assessment Scale, primaryOutcomes measure: Beck's Depression Inventory (BDI, primaryOutcomes measure: Beck Anxiety Inventory (BAI), primaryOutcomes measure: 12-Item Short Form Health Survey (SF-12), secondaryOutcomes measure: Patients satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universityof Padua, city: Padova, zip: 35128, country: Italy, geoPoint lat: 45.40797, lon: 11.88586, hasResults: False

protocolSection identificationModule nctId: NCT06379724, orgStudyIdInfo id: 150349, briefTitle: Burn Study- Tranexamic Acid Versus Thrombin in Split Thickness Skin Graft, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: University of Kansas Medical Center, class: OTHER, descriptionModule briefSummary: Investigators hypothesize that topical tranexamic acid will have better or comparable efficacy to topical thrombin in reducing hematoma formation at the wound base. The purpose of the study is to demonstrate that topical tranexamic acid will be a non-inferior alternative medication to the current standard of care,THROMBIN-JMI®, and at a lower cost to the health system., conditionsModule conditions: Burns, conditions: Skin Graft Complications, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective, randomized, blinded, non-inferiority study, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Subjects will be blinded to their randomization group. Study subject number will be linked to their randomization group. Blinding may be broken if the subject experiences an adverse reaction to the medication utilized for their group so that they are aware that they cannot receive the medication in the future. The research coordinator will have the code to the blind. The surgical team will not be blinded as the overall consistency of the topical agents will differ and may be apparent., whoMasked: PARTICIPANT, enrollmentInfo count: 62, type: ESTIMATED, armsInterventionsModule interventions name: Tranexamic acid, interventions name: Thrombin JMI, interventions name: skin graft, outcomesModule primaryOutcomes measure: The number of participants with hematoma occurrence, primaryOutcomes measure: The rate of percentage of graft take adherence amongst participants, primaryOutcomes measure: Comparison of number of participants that require re-operation, secondaryOutcomes measure: Difference in cost between two hemostatic agents, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06379711, orgStudyIdInfo id: H22-03727, briefTitle: Cardiopulmonary Changes Following Spinal Cord Stimulation in Individuals With Spinal Cord Injury, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2028-08-01, completionDateStruct date: 2028-08-01, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: University of British Columbia, class: OTHER, descriptionModule briefSummary: The aim of this study is to examine the mechanisms of transcutaneous spinal cord stimulation (tSCS) for improving cardiovascular and pulmonary function in individuals with chronic motor-complete spinal cord injury (SCI) by measuring vascular related endothelial biomarkers, plasma catecholamines, and respiratory parameters., conditionsModule conditions: Spinal Cord Injuries, conditions: Cardiovascular Diseases, conditions: Cardiopulmonary Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Pre-Post Study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: Transcutaneous Spinal Cord Stimulation (tSCS), outcomesModule primaryOutcomes measure: Circulating endothelial biomarkers in EMV/µL (Park et al., 2023), secondaryOutcomes measure: Plasma catecholamines in nmol/L (Claydon & Krassioukov, 2008), secondaryOutcomes measure: Spirometric parameters for lung volume in ml/kg (Aung et al., 2019) for FVC, secondaryOutcomes measure: Spirometric parameters for lung volume in ml/kg (Aung et al., 2019) for FEV1, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Blusson Spinal Cord Centre, city: Vancouver, state: British Columbia, zip: V5Z 1M9, country: Canada, geoPoint lat: 49.24966, lon: -123.11934, hasResults: False

protocolSection identificationModule nctId: NCT06379698, orgStudyIdInfo id: CHUBX 2023/78, briefTitle: Rein 3D PRINT PERSONALIZE, acronym: R3DP-P, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2027-06-15, completionDateStruct date: 2027-06-15, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: University Hospital, Bordeaux, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare preoperative information and patient experience using a personalized versus a generic 3D printed models of patients' tumoral kidney before and after nephron-sparing surgery. The main outcome measure will be based on semi-structured interviews with the patient and the carers., conditionsModule conditions: Tumoral Kidney, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: personalized 3D model pré-opérative education, interventions name: generic 3D model pré-opérative education, outcomesModule primaryOutcomes measure: Qualitative assessment of patient experience 1, primaryOutcomes measure: Qualitative assessment of patient experience 2, primaryOutcomes measure: Qualitative assessment of patient experience 3, secondaryOutcomes measure: Description of interactions between carers and patients, secondaryOutcomes measure: Comparison of the evolution and frequency of terms used by patients in the 2 groups during their care., secondaryOutcomes measure: Studying the use of the 3D-printed kidney model introduced during the medical information consultation up to the post-operative visit by describing the life of the model throughout the entire care process, secondaryOutcomes measure: To study the level of understanding of renal anatomy and surgical issues according to the type of tool (personalized vs generic 3D printed model), secondaryOutcomes measure: Comparison of the level of health literacy between the two groups at different times with changes in the average score on the literacy questionnaire (HLSEU-Q16: European Health Literacy Survey Questionnaire), secondaryOutcomes measure: Description of the changes perceived by carers in patients management in both group, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de Bordeaux, city: Bordeaux, country: France, contacts name: Gaëlle MARGUE, Docteur, role: CONTACT, geoPoint lat: 44.84044, lon: -0.5805, hasResults: False

protocolSection identificationModule nctId: NCT06379685, orgStudyIdInfo id: SOPH190-0923/I, briefTitle: Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-30, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Laboratorios Sophia S.A de C.V., class: INDUSTRY, descriptionModule briefSummary: This is a phase I clinical study to evaluate the safety and tolerability of PRO-190 ophthalmic solution through the incidence of unexpected adverse events, changes in Best Corrected Visual Acuity (BCVA), changes in ocular surface integrity, changes in the ocular comfort index (OCI) score, and IOP measurement compared to Systane Ultra®., conditionsModule conditions: Dry Eye, conditions: Dry Eyes Chronic, conditions: Dry Eye Syndromes, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Phase I, controlled, comparative, controlled, comparative., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Single-blind, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: PRO-190, interventions name: Systane Ultra®, outcomesModule primaryOutcomes measure: Incidence Unexpected Related Adverse Reactions, secondaryOutcomes measure: Changes in the ocular comfort index (OCI) score in between interventions, secondaryOutcomes measure: Changes in Best Corrected Visual Acuity (BCVA), secondaryOutcomes measure: Changes in tear film breakup time, secondaryOutcomes measure: Changes in intraocular pressure (IOP), secondaryOutcomes measure: Changes in the integrity of the ocular surface (fluorescein staining), secondaryOutcomes measure: Changes in lissamine green staining, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False