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protocolSection identificationModule nctId: NCT06262633, orgStudyIdInfo id: CRE-2023.079, briefTitle: A Multi-centre Trial on Targeted Microwave Ablation (TMA) for Localized Prostate Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Chinese University of Hong Kong, class: OTHER, descriptionModule briefSummary: This study is to investigate the efficacy of Targeted Microwave Ablation (TMA) under MRI-Ultrasound fusion and organ-based tracking (OBT) navigation in localized prostate cancer (PCa) in a multi-centre trial., conditionsModule conditions: Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 103, type: ESTIMATED, armsInterventionsModule interventions name: Targeted Microwave Ablation (TMA) for localized prostate cancer using organ based tracking (OBT) navigation, outcomesModule primaryOutcomes measure: The oncological control of prostate cancer, secondaryOutcomes measure: Cancer detection on biopsy of each ablated MRI visible lesion, secondaryOutcomes measure: Cancer detection on biopsy of each ablated MRI invisible lesion, secondaryOutcomes measure: Gleason 4 or 5 cancer detected on biopsy of ablated area, secondaryOutcomes measure: Out-of-field recurrence: Any cancer outside treated area on systematic biopsy, secondaryOutcomes measure: Common Terminology Criteria for Adverse Events (CTCAE) v5.0, secondaryOutcomes measure: PSA change, secondaryOutcomes measure: Urinary Symptoms after treatment, secondaryOutcomes measure: Sexual side effects after treatment, secondaryOutcomes measure: Continence side effects after treatment, secondaryOutcomes measure: Common Terminology Criteria for Adverse Events (CTCAE) rectal toxicity, secondaryOutcomes measure: Quality of life measured by ED-5Q-5Lquestionnaire, secondaryOutcomes measure: Quality of life in patients with prostate cancer measured by EPIC-26, secondaryOutcomes measure: Quality of life measured by QLQ-C30,, eligibilityModule sex: MALE, minimumAge: 45 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peter Ka-Fung CHIU, status: RECRUITING, city: Sha Tin, country: Hong Kong, contacts name: Peter Ka-Fung CHIU, PhD,MBChB, role: CONTACT, phone: 35052625, email: peterchiu@surgery.cuhk.edu.hk, geoPoint lat: 22.38333, lon: 114.18333, hasResults: False

protocolSection identificationModule nctId: NCT06262620, orgStudyIdInfo id: 2022-NHLHCRF-LX-01-0201-06, briefTitle: The Comparisonof Mediastinal/Hilar Lymph Node Biopsies by EBUS-TBNA, EBUS-TBCB, and EBUS-TBFB, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-18, primaryCompletionDateStruct date: 2026-02-18, completionDateStruct date: 2026-02-18, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: China-Japan Friendship Hospital, class: OTHER, descriptionModule briefSummary: The goal of this prospective, multi-centre, randomised controlled clinical study is to compare the diagnostic efficacy and safety of the three biopsy techniques (EBUS-TBNA, EBUS-TBCB, and EBUS-TBFB) in mediastinal/hilar lymph node biopsies.Participants will divided into EBUS-TBNA group, EBUS-TBCB group, and EBUS-TBFB group at a 1:1:1 ratio by using central, computerized random sequence, and then undertake EBUS-TBNA, EBUS-TBCB, or EBUS-TBFB according to the group.Researchers will compare the adequacy of sampling by the three biopsy techniques, their sample quality, diagnostic rate, and incidence of each adverse events., conditionsModule conditions: Lymphadenopathy Hilar, conditions: Lymphadenopathy Mediastinal, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 723, type: ESTIMATED, armsInterventionsModule interventions name: EBUS-TBNA, interventions name: EBUS-TBCB, interventions name: EBUS-TBFB, outcomesModule primaryOutcomes measure: Dignostic rate of EBUS-TBNA, EBUS-TBCB, and EBUS-TBFB, primaryOutcomes measure: Incidence rate of adverse events, primaryOutcomes measure: the adequacy of sample acquisition, primaryOutcomes measure: the quality of sample acquisition, eligibilityModule sex: ALL, minimumAge: 15 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06262607, orgStudyIdInfo id: CLE400-NP-201, briefTitle: A Study of CLE-400 (Topical Gel) for the Treatment of Chronic Pruritus in Adult Subjects With Notalgia Paresthetica, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-29, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-01-15, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Clexio Biosciences Ltd., class: INDUSTRY, descriptionModule briefSummary: This is a Phase 2, randomized, double-blind, vehicle-controlled study to assess the efficacy and safety of CLE-400 topical gel for the treatment of chronic pruritus in adult subjects with Notalgia Paresthetica (NP)., conditionsModule conditions: Chronic Pruritus in Adult Subjects With Notalgia Paresthetica (NP), designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 40 subjects, 2 arms, parallel, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: double, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: CLE-400, interventions name: Vehicle, outcomesModule primaryOutcomes measure: Percent change from baseline in weekly mean of the daily 24-hour Worst Itch-Numeric Rating Scale (WI-NRS) score at Week 4., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinical site 11, status: RECRUITING, city: Bryant, state: Arkansas, zip: 72022, country: United States, geoPoint lat: 34.59593, lon: -92.48905, locations facility: Clinical site 01, status: RECRUITING, city: Coral Gables, state: Florida, zip: 33134, country: United States, geoPoint lat: 25.72149, lon: -80.26838, locations facility: Clinical Site 10, status: RECRUITING, city: North Miami Beach, state: Florida, zip: 33116, country: United States, geoPoint lat: 25.93315, lon: -80.16255, locations facility: Clinical Site 02, status: RECRUITING, city: Indianapolis, state: Indiana, zip: 46250, country: United States, geoPoint lat: 39.76838, lon: -86.15804, locations facility: Clinical Site 23, status: RECRUITING, city: Methuen, state: Massachusetts, zip: 01844, country: United States, geoPoint lat: 42.7262, lon: -71.19089, locations facility: Clinical Site 09, status: RECRUITING, city: Dublin, state: Ohio, zip: 43016, country: United States, geoPoint lat: 40.09923, lon: -83.11408, locations facility: Clinical site 16, status: RECRUITING, city: Houston, state: Texas, zip: 77004, country: United States, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Clinical Site 06, status: RECRUITING, city: San Antonio, state: Texas, zip: 78213, country: United States, geoPoint lat: 29.42412, lon: -98.49363, hasResults: False

protocolSection identificationModule nctId: NCT06262594, orgStudyIdInfo id: L'ÉTOILE, briefTitle: Lemborexant Treatment of Insomnia Linked to Epilepsy, acronym: L'ÉTOILE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-08, primaryCompletionDateStruct date: 2025-02-08, completionDateStruct date: 2026-02-08, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: University of Manitoba, class: OTHER, collaborators name: Duke University, descriptionModule briefSummary: The goal of this clinical trial is to assess whether Lemborexant can improve sleep in patients with epilepsy., conditionsModule conditions: Epilepsy, conditions: Sleep, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 26, type: ESTIMATED, armsInterventionsModule interventions name: Lemborexant, outcomesModule primaryOutcomes measure: WASO, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06262581, orgStudyIdInfo id: 2021-FXY-471, briefTitle: Neoadjuvant Tisleizumab(BGB-A317) for dMMR/MSI-H Non-late Stage CRC Patients Before Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-23, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: According to the cancer statistics in 2020, colorectal cancer (CRC) remains a major public health issue worldwide, representing the third common cancer (10%) and second leading cause of death (9.4%) with 5-year survival rate approaching 65%. Meanwhile, 28.8% of the newly diagnosed cases and 30.3% of the CRC-related death occurs in China. Among all the CRC, stage I-III account for 75%. For the standard management for non-late stage(stage I-III) CRC patients, surgery including the primary site and local lymph nodes dissection has been the most important one. But for the high-risk stage II and locally-advanced stage III CRC, neoadjuvant or adjuvant therapy such as chemotherapy and radiotherapy plays a vital role in preventing the residual cancer cells to relapse and spread to distant sites after surgery. For the past decades, immunotherapy like anti-PD-1 and anti-CTLA4 checkpoint inhibitor achieves great process in solid tumor treatment especially for late-stage CRC. And Pembrolizumab and Nivolumab has been proved for dMMR/MSI-H late-stage-CRC by FDA. Combination of Ipilimumab and Nivolumab has achieved great success among the early-stage-CRC in NICHE study. The investigators here to carry out a phase II clinical trial to explore the safety and effect of single anti-PD-1 (Tisleizumab-BGB-A317 ) neoadjuvant treatment for non-late stage CRC patients., conditionsModule conditions: DMMR Colorectal Cancer, conditions: Anti PD-1, conditions: Immunotherapy, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Tisleizumab(BGB-A317), outcomesModule primaryOutcomes measure: pathological complete regression rate, secondaryOutcomes measure: CR rate, secondaryOutcomes measure: Major Pathological Response rate, secondaryOutcomes measure: Disease free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-Sen University Cancer Center, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510060, country: China, contacts name: Gong C Chen, Prof, role: CONTACT, phone: +862087343584, email: chengong@sysucc.org.cn, contacts name: Zhi-zhong Pan, Prof, role: SUB_INVESTIGATOR, contacts name: Xiao-jun Wu, Prof, role: SUB_INVESTIGATOR, contacts name: Zhen-hai Lu, Prof, role: SUB_INVESTIGATOR, contacts name: Pei-rong Ding, Prof, role: SUB_INVESTIGATOR, contacts name: Li-ren Li, Prof, role: SUB_INVESTIGATOR, contacts name: Fu-long Wang, M.D., role: SUB_INVESTIGATOR, contacts name: Rong-xin Zhang, M.D., role: SUB_INVESTIGATOR, contacts name: Jian-hong Peng, M.D., role: SUB_INVESTIGATOR, contacts name: Jun-zhong Lin, M.D., role: SUB_INVESTIGATOR, contacts name: Ling-heng Kong, M.D., role: SUB_INVESTIGATOR, contacts name: Cong Li, M.D., role: SUB_INVESTIGATOR, contacts name: Wu Jiang, M.D., role: SUB_INVESTIGATOR, contacts name: Wen-hua Fan, M.D., role: SUB_INVESTIGATOR, contacts name: Wen-hao Zhou, M.D., role: SUB_INVESTIGATOR, contacts name: Jing-hua Tang, M.D., role: SUB_INVESTIGATOR, contacts name: Yuan Li, M.D., role: SUB_INVESTIGATOR, contacts name: Miaoqing Wu, role: SUB_INVESTIGATOR, contacts name: Di Cao, role: SUB_INVESTIGATOR, contacts name: Yi-fan Liu, role: SUB_INVESTIGATOR, contacts name: Da Kang, role: SUB_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, hasResults: False

protocolSection identificationModule nctId: NCT06262568, orgStudyIdInfo id: Soh-Med-23-03-18MS, briefTitle: Effect of Guidelines on Nurses' Awareness Toward HRP and Maternal Near Miss Cases, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-01, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: The current study will evaluate the impact of awareness of maternity nurses toward instructional guidelines and evaluate the knowledge, practice and attitude of nurses toward high risk pregnancy and maternal near miss cases before and after education., conditionsModule conditions: High Risk Pregnancy and Maternal Near Miss Cases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 71, type: ESTIMATED, armsInterventionsModule interventions name: assess the nurse knowledge and practices., outcomesModule primaryOutcomes measure: Evaluate the outcome of instructional guidelines on maternity nurses' awareness toward high-risk pregnancy and Maternal Near Miss Cases by questionnaire before and after training, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Sohag University hospitals, status: RECRUITING, city: Sohag, country: Egypt, contacts name: ghona Abd EL-Nasser, Professor, role: CONTACT, phone: 01123067894, email: mahmoud.hazem@nursing.sohag.edu.eg, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False

protocolSection identificationModule nctId: NCT06262555, orgStudyIdInfo id: TYGH111061, briefTitle: Novel Light Delivery Method for Performing Transbronchial Photodynamic Therapy for Peripheral Lung Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Taoyuan General Hospital, class: OTHER_GOV, descriptionModule briefSummary: This research aims to develop an innovative photodynamic therapy (PDT) for peripheral lung tumors. Current treatments involve surgery, chemotherapy, and radiation. Photodynamic therapy, using light and photosensitizing drugs, is promising but has limitations. Our team proposes using Lipiodol, a contrast agent, instilled into the trachea via bronchoscopy, surrounding the tumor. Preliminary pig model trials showed safety. Clinical trials, building on a U.S. study (NCT02916745), commenced in October 2021, treating three cases. Initial results suggest safety, but efficacy requires further investigation. Based on ongoing trials, we propose a phase I trial with multiple light treatments from different directions and an additional dose after 48 hours to assess safety and efficacy. This study will guide future clinical trials for optimal PDT dosage., conditionsModule conditions: Lung Cancer, conditions: Lung Cancer Metastatic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 3, type: ESTIMATED, armsInterventionsModule interventions name: Transbronchial PDT peripheral lung tumor ablation, outcomesModule primaryOutcomes measure: Technical Feasibility, primaryOutcomes measure: Technical Safety, secondaryOutcomes measure: Tumor remission rate, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Taoyuan General Hospital, Ministry of Health and Welfare, status: RECRUITING, city: Taoyuan City, zip: 320, country: Taiwan, contacts name: Yei-San Hsieh, MD, role: CONTACT, phone: +886-975061108, email: yeisanh@gmail.com, contacts name: Yei-San Hsieh, Dr., role: PRINCIPAL_INVESTIGATOR, contacts name: Hwi-Lu Chang, Dr., role: SUB_INVESTIGATOR, geoPoint lat: 24.95233, lon: 121.20193, hasResults: False

protocolSection identificationModule nctId: NCT06262542, orgStudyIdInfo id: 111016, briefTitle: Efficacy and Safety of Chinese Herb Medicine-Moxibustion Therapy on Chemotherapy-Induced Leukopenia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Taichung Armed Forces General Hospital, class: OTHER_GOV, descriptionModule briefSummary: Cancer is the second leading cause of death globally, with an estimated 9.6 million deaths in 2018, accounting for one-sixth of total deaths. The economic burden of cancer continues to rise globally, causing significant physiological, psychological, and economic pressures on individuals, families, communities, and healthcare systems. The toxic effects of chemotherapy, such as nausea, vomiting, decreased blood cells, fatigue, etc., can impair patients' function, activities, and quality of life. Chemotherapy-induced leukopenia (CIL), particularly low white blood cell counts (48.9%), is a major concern for cancer patients.Current conventional treatments primarily involve colony-stimulating factors (G-CSF and GM-CSF) to accelerate neutrophil recovery and regulate granulocyte production. However, G-CSF is costly and adds financial burden, and its use is restricted to cases meeting specific criteria. Additionally, rapid changes in patients' symptoms, weakness, and poor appetite may lead to swift deterioration of their condition, making it challenging to predict and prevent. Moreover, G-CSF has frequent side effects, including skin rash, liver function abnormalities, nausea, vomiting, fever, headache, fatigue, palpitations, and increased levels of ALP, LDH, and uric acid, with bone pain being the most common.Traditional Chinese Medicine (TCM) has been a long-standing medical practice in Eastern societies and is a legally recognized healthcare option in Taiwan, covered by national health insurance. TCM includes acupuncture, moxibustion, and Chinese herbal medicine, all of which have been researched for their potential in addressing chemotherapy-induced leukopenia., conditionsModule conditions: Cancer, Chemotherapy-induced Leukopenia, Chinese Herb Medicine-moxibustion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: moxibustion and Chinese herbal medicine group, outcomesModule primaryOutcomes measure: Track the number of white blood cells, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Taichung Armed Force General Hospital, status: RECRUITING, city: Taichung, state: Taiping, zip: 411228, country: Taiwan, contacts name: ming huei cheng, role: CONTACT, phone: 0921059072, email: u9630091@cmu.edu.tw, geoPoint lat: 24.1469, lon: 120.6839, hasResults: False

protocolSection identificationModule nctId: NCT06262529, orgStudyIdInfo id: 22-AOI-06, briefTitle: Neurocognitive Impairment After Ischemic Stroke, acronym: COG-TRA-Y MRI, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-09, primaryCompletionDateStruct date: 2025-02-09, completionDateStruct date: 2027-02-09, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Nice, class: OTHER, descriptionModule briefSummary: Affecting more than 150,000 patients in France, stroke is a major public health issue and a leading cause of disability worldwide. In western countries, 80-85% of strokes are of ischemic subtype. This study will focus on young adults, aged 18-45, with a diagnosis of ischemic stroke.Studies assessing post-stroke cognition in young patients reported an alarming prevalence of cognitive impairment, affecting about 60% of stroke survivors between 4 and 12 months after the acute event. However, longitudinal data on neurocognitive trajectories (i.e., the evolution of cognitive impairment over time) in young patients with ischemic stroke are lacking. Collecting such data requires an exhaustive neuropsychological assessment and several functional evaluations, at different times, for the same patient.Repeated neurocognitive study of young patients with ischemic stroke will enable: a description of the prevalence of impaired global cognitive efficiency, an analysis of the specific neurocognitive domains affected, and the tracing of trajectories of recovery from cognitive impairment over time, in terms of global cognitive efficiency and as a function of specific neurocognitive domains (memory, executive, attentional, social cognition, instrumental functions, fatigability, etc.).Up to date, the clinic-radiological predictors and associated factors of neurocognitive impairment after ischemic stroke in young patients have not been studied. Ischemic stroke causes acute brain lesions of the gray matter (GM) and white matter (WM). Numerous studies suggest that cognitive health may be more closely linked to the integrity of WM than to GM. Magnetic resonance imaging (MRI), and in particular diffusion tensor imaging (DTI) sequences, analyze WM bundles. By using fiber tracking algorithms image analysis enable the WM fiber bundle reconstruction and allow quantifying the volume of lesions (pre-existing and ischemic stroke-induced) in the WM tract.The aim of this study is to study whether the extension of pre-existing and acute white matter lesions is associated with poorer cognitive recovery after ischemic stroke, both in terms of global cognitive performance and impairment in specific neurocognitive domains., conditionsModule conditions: Acute Ischemic Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Cerebral MRI, outcomesModule primaryOutcomes measure: evolution of neurocognitive disorders (trajectories of global cognitive efficiency) over 1 year after stroke, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: cannes Hospital, status: NOT_YET_RECRUITING, city: Cannes, zip: 06600, country: France, contacts name: sylvain LACHAUD, role: CONTACT, email: s.lachaud@ch-cannes.fr, contacts name: Sylvain Lachaud, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.55135, lon: 7.01275, locations facility: Nice University Hospital, status: RECRUITING, city: Nice, zip: 06000, country: France, contacts name: Marina Passalboni, role: CONTACT, phone: 04 92 03 27 90, email: passalboni.m@chu-nice.fr, contacts name: barbara CASOLLA, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70313, lon: 7.26608, hasResults: False

protocolSection identificationModule nctId: NCT06262516, orgStudyIdInfo id: CASE2824, briefTitle: Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2027-01-01, completionDateStruct date: 2029-01-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Case Comprehensive Cancer Center, class: OTHER, descriptionModule briefSummary: The goal of this study is to conduct the first randomized-controlled trial to determine the oncologic efficacy of lymph node dissection in participants with upper tract urothelial cell carcinoma. The main questions it aims to answer are:* To determine oncologic outcomes, specifically 2-year recurrence-free survival* To determine other oncologic outcomes including treatment-free, cancer-specific and overall survival* To determine time to recurrence and recurrence patterns* To determine use of adjuvant therapies* To determine perioperative complicationsParticipants will undergo nephroureterectomy with or without lymph node dissection. Researchers will compare these two groups to determine the oncologic efficacy of performing lymph node dissection., conditionsModule conditions: Urothelial Carcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study is designed as a 1:1 two armed randomized-controlled trial., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 94, type: ESTIMATED, armsInterventionsModule interventions name: Nephroureterectomy, interventions name: Lymph Node Dissection, outcomesModule primaryOutcomes measure: Recurrence-free survival, secondaryOutcomes measure: Treatment-free survival, secondaryOutcomes measure: Cancer-specific survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Time to recurrence, secondaryOutcomes measure: Use of adjuvant therapies, secondaryOutcomes measure: Perioperative complications, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cleveland Clinic Glickman Urological and Kidney Institute, city: Cleveland, state: Ohio, zip: 44195, country: United States, contacts name: Mohamed Eltemamy, MD, role: CONTACT, phone: 216-444-5888, email: Eltemam@ccf.org, geoPoint lat: 41.4995, lon: -81.69541, hasResults: False

protocolSection identificationModule nctId: NCT06262503, orgStudyIdInfo id: P.T.REC/012/004810, briefTitle: the Influence of Virtual Reality Approach on Phantom Pain in Trans Tibial Amputation, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2024-02, completionDateStruct date: 2024-03, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: 1. To investigate the effect of Virtual reality (VR) on phantom limb pain in trans tibial amputation.2. To investigate the effect of Virtual reality (VR) on lower limb Function in trans tibial amputation.A sample size of 60 will be randomly allocated to two groups(30 in each group), by using computer-generated random number list method. Control group will receive conventional physiotherapy(TENS- Phantom exercises and mirroring exercise) for reducing phantom pain in trans -tibial amputation and the experimental group will receive conventional physiotherapy(TENS- Phantom exercises and mirroring exercise) and Virtual Reality for reducing phantom pain in trans -tibial amputation ., conditionsModule conditions: Phantom Pain Following Amputation of Lower Limb, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Group1:conventional physiotherapy for phantom Pain Group2:conventional physiotherapy and Virtual Reality for phantom Pain, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: Virtual Reality, interventions name: Transcutaneous Electrical Nerve Stimulation (TENS), interventions name: Mirroring Therapy, interventions name: Phantom Exercises, outcomesModule primaryOutcomes measure: Pain Intensity Level, primaryOutcomes measure: Lower Extremity Functional, eligibilityModule sex: ALL, minimumAge: 18 Months, maximumAge: 75 Months, stdAges: CHILD, contactsLocationsModule locations facility: Faculty of Physical therapy, Cairo university, city: Giza, zip: 12613, country: Egypt, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False

protocolSection identificationModule nctId: NCT06262490, orgStudyIdInfo id: P.T.REC/012/004765, briefTitle: Impact of Pelvic Floor Rehabilitation Combined With Ultrasound Therapy on Osteomyoarticular Symptoms in Chronic Perineal Pain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: The purpose of the study is to find out the effect of pelvic floor rehab combined with ultrasound have effect in chronic perineal pain subjects associated with osteomyoarticular symptoms ., conditionsModule conditions: Chronic Perineal Pain, conditions: Pelvic Floor Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Traditional ultrasound therapy, interventions name: Pelvic floor rehabilitation, outcomesModule primaryOutcomes measure: Assessment of osteomyoarticular symptoms, primaryOutcomes measure: Assessment of perineal pain intensity, secondaryOutcomes measure: Assessment of pelvic floor muscle strength, secondaryOutcomes measure: Assessment of pelvic floor muscle tightness, secondaryOutcomes measure: Assessment of lumbar spine mobility, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Cairo University, city: Giza, country: Egypt, contacts name: Aya T- Allah M. Nabil, PhD student, role: CONTACT, phone: 01063028038, email: drayanabil1993@gmail.com, contacts name: Salwa M. El Badry, role: CONTACT, contacts name: Amel M. Yousef, Prof., role: PRINCIPAL_INVESTIGATOR, contacts name: Hazem S. Al-Ashmawy, Ass. Prof, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False

protocolSection identificationModule nctId: NCT06262477, orgStudyIdInfo id: NL-TCZ-12280, briefTitle: A Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 Subcutaneously (SC) Compared to Actemra® in Healthy Male Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-02, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Biogen, class: INDUSTRY, descriptionModule briefSummary: The primary objective of the study is to show equivalence in pharmacokinetics (PK) of BIIB800 and Actemra following SC administration of a single dose to healthy male participants. The secondary objective of the study is to evaluate PK over time, clinical safety, pharmacodynamic (PD) profiles and immunogenicity of BIIB800 and Actemra., conditionsModule conditions: Healthy Volunteer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: BIIB800, interventions name: Actemra, outcomesModule primaryOutcomes measure: Maximum Serum Concentration (Cmax) of Tocilizumab, primaryOutcomes measure: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Tocilizumab, primaryOutcomes measure: Area Under the Concentration-Time Curve up to the Last Measurable Concentration (AUC0-t) of Tocilizumab, secondaryOutcomes measure: Time to Reach Cmax (Tmax) of BIIB800 and Tocilizumab, secondaryOutcomes measure: Apparent Total Body Clearance (CL/F) of BIIB800 and Tocilizumab, secondaryOutcomes measure: Apparent Terminal Half-Life (t1/2) of BIIB800 and Tocilizumab, secondaryOutcomes measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), secondaryOutcomes measure: Area Under the Effect-Time Curve (AUE) of Soluble Interleukin-6-Receptor (sIL-6R), secondaryOutcomes measure: Maximum Observed Effect (Emax) of sIL-6R, secondaryOutcomes measure: Time to Emax (tEmax) of sIL-6R, secondaryOutcomes measure: AUE of High Sensitive C-Reactive Protein (hsCRP), secondaryOutcomes measure: Minimum Observed Effect Emin of hsCRP, secondaryOutcomes measure: Time to Emin (tEmin) of hsCRP, secondaryOutcomes measure: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAbs), secondaryOutcomes measure: Number of Participants With ADA Titers, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Fortrea Clinical Research Unit Inc., status: RECRUITING, city: Madison, state: Wisconsin, zip: 53704, country: United States, contacts role: CONTACT, phone: 608-210-5574, email: sarah.russell@fortrea.com, contacts name: Sarah Russell, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.07305, lon: -89.40123, hasResults: False

protocolSection identificationModule nctId: NCT06262464, orgStudyIdInfo id: 17.361/ 07.12.2023, briefTitle: An OCD Prevention Programme for at Risk Adults, acronym: ØCD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-09, primaryCompletionDateStruct date: 2024-03-29, completionDateStruct date: 2024-04-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Babes-Bolyai University, class: OTHER, collaborators name: Romanian National Authority for Scientific Research, descriptionModule briefSummary: The main purpose of this randomised clinical trial is to test the efficacy of a prevention program for adult who are at risk of developing OCD, thus constituting a form of tertiary prevention., conditionsModule conditions: Obsessive-Compulsive Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Prevention, outcomesModule primaryOutcomes measure: Change from baseline in OCD symptoms on the OCI-R after the intervention, primaryOutcomes measure: Change from baseline in depressive symptoms on the PHQ-9 after the intervention, primaryOutcomes measure: Change from baseline in anxiety symptoms on the GAD-7 after the intervention, secondaryOutcomes measure: Change from baseline in experiential avoidance on the EAQ after the intervention, secondaryOutcomes measure: Change from baseline in cognitive distortions on the OBQ-44 after the intervention, secondaryOutcomes measure: Change from baseline in uncertainty intolerance on the IUS after the intervention, secondaryOutcomes measure: Change from baseline in resilience on the RSA after the intervention, otherOutcomes measure: Change from baseline in life quality on the WHOQOL-BREF after the intervention, otherOutcomes measure: Change from baseline in irrationality on the ATQ after the intervention, otherOutcomes measure: Change from baseline in global health on the GHQ-12 after the intervention, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Babes-Bolyai University, Faculty of Psychology and Educational Sciences, Department of Clinical Psychology and Psychotherapy, status: RECRUITING, city: Cluj-Napoca, zip: 400015, country: Romania, contacts name: Roxana AI Cardos, PhD Student, role: CONTACT, phone: 0040751477323, email: roxana.cardos@ubbcluj.ro, geoPoint lat: 46.76667, lon: 23.6, hasResults: False

protocolSection identificationModule nctId: NCT06262451, orgStudyIdInfo id: 20-30182, secondaryIdInfos id: 5R24AI118629, type: NIH, link: https://reporter.nih.gov/quickSearch/5R24AI118629, briefTitle: Fecal Microbiota Transplant National Registry, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-20, primaryCompletionDateStruct date: 2032-10, completionDateStruct date: 2032-10, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: University of California, San Francisco, class: OTHER, collaborators name: National Institute of Allergy and Infectious Diseases (NIAID), descriptionModule briefSummary: A national data registry of patients receiving fecal microbiota transplantation (FMT) or other gut-related-microbiota products designed to prospectively assess short and long-term safety and effectiveness. Neonates will not be enrolled at any site for this study. The study data will derive from patient and donors past and present medical records, research records, and records about phone calls made as part of this research. The patient data will also be used from the records on visits., conditionsModule conditions: Fecal Microbiota Transplant, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 10, type: ESTIMATED, outcomesModule primaryOutcomes measure: To assess short-term and long-term safety of FMT and other gut-related-microbiota products, secondaryOutcomes measure: To characterize effectiveness of FMT and other gut-related-microbiota products., secondaryOutcomes measure: To gather information on FMT practice in North America, secondaryOutcomes measure: To promote scientific investigation., secondaryOutcomes measure: To aid practitioners and sponsors in satisfying regulatory requirements, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of California, San Francisco, status: RECRUITING, city: San Francisco, state: California, zip: 94115, country: United States, contacts name: Rachael Leigh Delacruz, role: CONTACT, phone: 415-514-8087, email: rachaelleigh.delacruz@ucsf.edu, geoPoint lat: 37.77493, lon: -122.41942, hasResults: False

protocolSection identificationModule nctId: NCT06262438, orgStudyIdInfo id: MH22CAQ, secondaryIdInfos id: 2022-002886-14, type: EUDRACT_NUMBER, secondaryIdInfos id: 2023-505000-27, type: OTHER, domain: EU CT Number, briefTitle: CHIP-AML22/Quizartinib: Quizartinib + Chemotherapy in Newly Diagnosed Pediatric FLT3-ITD+ and NPM1wt AML Patients, acronym: CHIP-AML22/Q, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-06, primaryCompletionDateStruct date: 2028-06, completionDateStruct date: 2032-06, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Princess Maxima Center for Pediatric Oncology, class: OTHER, collaborators name: Daiichi Sankyo, descriptionModule briefSummary: The CHIP-AML22 Master protocol has the overall aim of increasing the cure rate in newly diagnosed pediatric de novo AML patients, while avoiding unnecessary toxicity. The linked Quizartinib trial (CHIP-AML22/Quizartinib) is a phase II, single arm, open label, study on the safety, efficacy, pharmacokinetics and pharmacodynamics of quizartinib in combination with chemotherapy and as single-agent after high dose therapy in newly diagnosed pediatric AML patients with a FLT3-ITD mutation and NPM1 wild-type., conditionsModule conditions: Acute Myeloid Leukemia in Children, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Given the rarity of pediatric subjects with newly diagnosed Acute Myeloid Leukemia (AML) with FLT3-ITD mutations and the slow enrollment in historical studies, it is not feasible to enroll a sufficient number of subjects for an adequately powered randomized study. Therefore, a standard oncology Phase 2 response-rate design has been chosen. One of the exploratory objectives planned is to compare the outcome of patients treated in this study to the outcome of patients treated in the NOPHO-DBH AML-2012 study as historical control., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Quizartinib, interventions name: Etoposide, interventions name: Dexrazoxane, interventions name: Mitoxantrone, interventions name: Cytarabine, interventions name: Methotrexate, interventions name: Daunorubicin, interventions name: Fludarabine, interventions name: allo-SCT, outcomesModule primaryOutcomes measure: Primary objective (efficacy), primaryOutcomes measure: Primary objective (safety), secondaryOutcomes measure: Secondary objectives (efficacy_1), secondaryOutcomes measure: Secondary objectives (efficacy_2), secondaryOutcomes measure: Secondary objectives (efficacy_3), secondaryOutcomes measure: Secondary objectives (efficacy_4), secondaryOutcomes measure: Secondary objectives (efficacy_5), secondaryOutcomes measure: Secondary objectives (efficacy_6), secondaryOutcomes measure: Secondary objectives (efficacy_7), secondaryOutcomes measure: Secondary objectives (efficacy_8), secondaryOutcomes measure: Secondary objectives (efficacy_9), secondaryOutcomes measure: Secondary objectives (safety) - Adverse Events, Laboratory Abnormalities and cumulative incidence of non-relapse mortality, secondaryOutcomes measure: Pharmacokinetics (PK_1), secondaryOutcomes measure: Pharmacokinetics (PK_2), secondaryOutcomes measure: Pharmacokinetics (PK_3), secondaryOutcomes measure: Pharmacokinetics (PK_4), secondaryOutcomes measure: Palatability of quizartinib formulations, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Princess Máxima Center for pediatric oncology, status: RECRUITING, city: Utrecht, zip: 3584 CS, country: Netherlands, contacts name: Gertjan Kaspers, Prof. Dr., role: CONTACT, contacts name: Bianca Goemans, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.09083, lon: 5.12222, hasResults: False

protocolSection identificationModule nctId: NCT06262425, orgStudyIdInfo id: ALC001NR004, briefTitle: rTMS Over S1 Enhance Motor Learning in Healthy People, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-20, primaryCompletionDateStruct date: 2025-06-15, completionDateStruct date: 2025-09-15, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Neuron, Spain, class: OTHER, descriptionModule briefSummary: The purpose of this study is to compare the effectiveness of different repetitive Transcranial Magnetic Stimulation protocols for enhancing motor learning in healthy peolple., conditionsModule conditions: Transcranial Magnetic Stimulation, conditions: Motor Learning, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 95, type: ESTIMATED, armsInterventionsModule interventions name: repetitive Transcranial Magnetic Stimulation over primary somatosensory cortex, interventions name: repetitive Transcranial Magnetic Stimulation over primary motor cortex, interventions name: sham repetitive Transcranial Magnetic Stimulation, outcomesModule primaryOutcomes measure: Change in accuracy, secondaryOutcomes measure: Change in reaction time speed, secondaryOutcomes measure: Change in pegs placed in 30 seconds, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Neuron, status: RECRUITING, city: Madrid, zip: 28045, country: Spain, contacts name: Alfredo Lerín Calvo, PhD Student, role: CONTACT, phone: +34620187457, email: alfre_lerin@hotmail.com, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False

protocolSection identificationModule nctId: NCT06262412, orgStudyIdInfo id: 2023-02193-01, briefTitle: Internet-delivered Cognitive-behaviour Therapy for Child and Adolescent Body Dysmorphic Disorder, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-10-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Karolinska Institutet, class: OTHER, collaborators name: Region Stockholm, collaborators name: Vastra Gotaland Region, collaborators name: Region Skane, descriptionModule briefSummary: The purpose of this trial is to evaluate the clinical efficacy, the cost-effectiveness and the 6-month durability of a therapist-guided, Internet-delivered cognitive-behavior therapy programme for children and adolescents with body dysmorphic disorder., conditionsModule conditions: Body Dysmorphic Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multisite parallel-group randomised controlled superiority trial., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: All study personnel who can be blind to study aims/hypotheses and group allocation, will be blind. Assessors conducting post-treatment and follow-up assessments will be external to the research team and blind to study aims/hypotheses and treatment allocation for the full duration of the trial (up to the 6-month follow-up). The assessors will not receive any information about the study design, objectives or treatment conditions in order to maximise the blinding integrity. At each follow-up assessment, participants will be reminded by their assessor to not reveal details about their treatment., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 154, type: ESTIMATED, armsInterventionsModule interventions name: Internet-delivered cognitive-behaviour therapy (ICBT), interventions name: Internet-delivered relaxation treatment (IRT), outcomesModule primaryOutcomes measure: Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder, Adolescent version (BDD-YBOCS-A), secondaryOutcomes measure: Treatment response and full or partial remission, secondaryOutcomes measure: Clinical Global Impression - Severity (CGI-S), secondaryOutcomes measure: Clinical Global Impression - Improvement (CGI-I), secondaryOutcomes measure: Children's Global Assessment Scale (CGAS), secondaryOutcomes measure: Appearance Anxiety Index (AAI), secondaryOutcomes measure: Short Mood and Feeling Questionnaire - child version and parent version (SMFQ) + additional suicide item (only child/adolescent), secondaryOutcomes measure: Generalized Anxiety Disorder - 7 item scale (GAD-7), secondaryOutcomes measure: Deliberate Self-Harm Inventory - Youth version (DSHI-Y-7), secondaryOutcomes measure: CRAFFT (acronym for the key words Car, Relax, Alone, Forget, Friends and Trouble), secondaryOutcomes measure: Work and Social Adjustment Scale - youth (WSAS-Y) and parent version (WSAS-P), secondaryOutcomes measure: Child Health Utility 9D (CHU9D), secondaryOutcomes measure: Trimbos/iMTA Questionnaire for Costs associated with Psychiatric Illness (TiC-P), secondaryOutcomes measure: Working Alliance Inventory - child (WAI-C) and parent version (WAI-P), secondaryOutcomes measure: Client Satisfaction Questionnaire (CSQ-8), secondaryOutcomes measure: Treatment Credibility and Expectancy Scale (TCES), secondaryOutcomes measure: Patient Exposure/Relaxation Adherence Scale (PEAS/PRAS), secondaryOutcomes measure: Treatment preference, otherOutcomes measure: Areas of concern and cosmetic procedures, otherOutcomes measure: School absenteeism, otherOutcomes measure: Concurrent interventions, otherOutcomes measure: BASS platform usage data, otherOutcomes measure: Completed modules, otherOutcomes measure: Adverse events questionnaire, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: BUP OCD och relaterade tillstånd, status: RECRUITING, city: Stockholm, zip: 113 30, country: Sweden, contacts name: Anita Birovecz, MSc, role: CONTACT, phone: +46 70 275 61 25, email: anita.birovecz@ki.se, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False

protocolSection identificationModule nctId: NCT06262399, orgStudyIdInfo id: ITL-2002-CL-999, secondaryIdInfos id: 2022-003778-22, type: EUDRACT_NUMBER, briefTitle: Long-Term Follow-Up (LTFU) of Subjects Treated With NTLA 2002, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2040-04, completionDateStruct date: 2040-04, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Intellia Therapeutics, class: INDUSTRY, descriptionModule briefSummary: This is a follow-up study of subjects who received NTLA-2002 in a previous clinical trial as an observational evaluation of the long-term effects of the investigational therapy., conditionsModule conditions: Hereditary Angioedema, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, outcomesModule primaryOutcomes measure: Incidence of treatment-related Adverse Events (AEs); incidence of treatment-related Serious Adverse Events (SAEs); incidence of treatment-related Adverse Events of Special Interest (AESIs) defined per protocol, secondaryOutcomes measure: To evaluate the long-term efficacy of NTLA-2002 in previously treated subjects, secondaryOutcomes measure: Change from baseline in consumption of on-demand HAE medications for reported HAE attacks, secondaryOutcomes measure: Change from baseline in healthcare utilization for HAE attacks, secondaryOutcomes measure: Change from baseline in QoL parameters as measured by the MOXIE Angioedema-QoL instrument., secondaryOutcomes measure: Change from baseline in QoL parameters as measured by the EQ-5D-5L instrument., secondaryOutcomes measure: Change from baseline in QoL parameters as measured by the WPAI:GH instrument., eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre National de Reference - Grenoble, city: Grenoble, country: France, geoPoint lat: 45.16667, lon: 5.71667, locations facility: Hôpital Claude Huriez, city: Lille, country: France, geoPoint lat: 50.63297, lon: 3.05858, locations facility: New Zealand Clinical Research, city: Auckland, country: New Zealand, geoPoint lat: -36.84853, lon: 174.76349, locations facility: Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, city: Cambridge, country: United Kingdom, geoPoint lat: 52.2, lon: 0.11667, hasResults: False

protocolSection identificationModule nctId: NCT06262386, orgStudyIdInfo id: 202202172B0, briefTitle: Combined Relapse Prediction Model for Resectable Non-Small Cell Patients - a Prospective Clinical Feasibility Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2028-07-31, completionDateStruct date: 2028-07-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Chang Gung Memorial Hospital, class: OTHER, collaborators name: National Science and Technology Council, descriptionModule briefSummary: For patients with lung cancer who have undergone tumor resection, early relapse significantly impacts survival. However, there are currently no reliable screening or imaging tools available to identify patients at risk of early relapse. To address this clinical challenge, many studies have focused on understanding the clinicopathologic characteristics associated with an increased risk of early relapse. Despite these efforts, we can identify patients at risk but cannot pinpoint which individuals will actually experience early relapse. Studies on adjuvant therapy have shown improved survival in cases of more advanced disease but have not demonstrated a reduction in early relapse rates.In our preliminary analysis of previous study data, we observed that patients with a smaller reduction in circulating tumor cells (CTCs) within the first three days after surgery, followed by an increase on the third-day post-operation, are more likely to experience early relapse during regular monitoring. This pattern may be indicative of minimal residual disease. By combining trends in circulating tumor cell variations with pathologic characteristics, we aim to select patients for adjuvant therapy who are at high risk of developing early relapse.The objective of our study is to employ screening based on circulating tumor cell dynamics and pathologic features to identify patients likely to experience early relapse and to assess the effectiveness of adjuvant therapy in these cases., conditionsModule conditions: Lung Cancer, conditions: Relapse/Recurrence, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 358, type: ESTIMATED, armsInterventionsModule interventions name: Cisplatin based chemottherapy, outcomesModule primaryOutcomes measure: Accuracy of proposed relapse prediction model, primaryOutcomes measure: early relapse rate, secondaryOutcomes measure: Overall surveival, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ching-Yang Wu, status: RECRUITING, city: Taoyuan City, zip: 333, country: Taiwan, contacts name: Ching-Yang Wu, role: CONTACT, phone: +886975368204, email: wu.chingyang@gmail.com, contacts name: Jason CH Hsieh, role: CONTACT, phone: +886975366137, email: wisdom5000@gmail.com, contacts name: Jui-Ying Fu, role: SUB_INVESTIGATOR, contacts name: Ching-Feng Wu, role: SUB_INVESTIGATOR, geoPoint lat: 24.95233, lon: 121.20193, hasResults: False

protocolSection identificationModule nctId: NCT06262373, orgStudyIdInfo id: 221321, briefTitle: Angular Pregnancy - Ultrasound Definition and Correlation With Clinical Outcomes, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-10-01, primaryCompletionDateStruct date: 2019-10-01, completionDateStruct date: 2019-10-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: King's College Hospital NHS Trust, class: OTHER, descriptionModule briefSummary: The aim of this study is to establish clinically meaningful ultrasound-based diagnostic criteria for AP. To this end, the investigators will prospectively collect clinical and ultrasound data from early intrauterine pregnancies and correlate this data with pregnancy outcomes (particularly with risk of miscarriage), to establish whether there are any diagnostic criteria that can be used to make the diagnosis, facilitate increased surveillance of at risk pregnancies and reassure those with normally located pregnancies. The collected data will be used to correlate incidence of angular pregnancy and clinical variables such as maternal age, uterine fibroids, assisted conception, multiple pregnancy, ethnicity, previous uterine and adnexal surgery., conditionsModule conditions: Miscarriage in First Trimester, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 236, type: ACTUAL, armsInterventionsModule interventions name: Ultrasound, outcomesModule primaryOutcomes measure: Primary, secondaryOutcomes measure: Secondary, secondaryOutcomes measure: Secondary, eligibilityModule sex: FEMALE, minimumAge: 16 Years, maximumAge: 50 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: King's College Hospital, city: London, zip: SE5 9RS, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False

protocolSection identificationModule nctId: NCT06262360, orgStudyIdInfo id: P2023457, briefTitle: Changes in Pulmonary Ventilation Distribution Assessed by Electrical Impedance Tomography in Healthy Children Under General Anesthesia, acronym: EIT_ped, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-16, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Queen Fabiola Children's University Hospital, class: OTHER, descriptionModule briefSummary: The incidence of atelectasis is high in patients undergoing general anesthesia. This may cause oxygenation impairment and further contribute to post-operative pulmonary complications. As important airway management devices for general anesthesia, few studies have compared the impact of laryngeal mask airway and spontaneous breathing on atelectasis. Through the study, the distribution of the pulmonary ventilation of children undergoing an elective and standard procedure in our center (H.U.D.E.R.F.) will be studied using electric impedance tomography.Children from 1 year-old to 6-year-old, ASA physical status I or II who will undergo elective circumcisions under general anesthesia associated with regional anesthesia (Penile Block10) at the One Day Clinic of H.U.D.E.R.F. (Hôpital des Enfants Reine Fabiola - Brussels - Belgium).Patients will be allocated to three different group in a ration of 1:1:1.* Group 1: spontaneous mask ventilation (20 patients).* Group 2: spontaneous laryngeal mask (LMA) ventilation (20 patients).* Group 3: spontaneous-pressure support LMA ventilation (LMA SV-PS) (20 patients).* Standard monitoring for the inductions of the anesthesia will include non-invasive blood pressure (NIBP), pulse oximetry (SpO2), Electrocardiogram (ECG), End-Tidal CO2 (EtCO2), End Tidal Sevoflurane concentration (EtSev %), inspired fraction of oxygen (FiO2), body temperature (rectal thermometer).Induction is based as well on the local routine protocols using an inhalation induction of the patient with Sevoflurane (Fet of 6-8%) and a recommended FiO2 from 80-90% maximum until the stabilization of the induction. Then the FiO2 will be decreased at least under 40% and Sevoflurane adapted to the need of the deepness of the anesthesia (both at the discretion of the anesthesiologist in charge of the patient).Depending on the randomization, the patient will undergo the surgery either with spontaneous face mask ventilation (group 1), LMA spontaneous ventilation (group 2), or LMA SV-PS (group 3) (during which the pressure support will be adapted at the discretion of the anesthesiologist but with a tidal volume included in the range of 6-10ml/kg).Electrical impedance tomography measurements:The effects of the spontaneous breathing (mask ventilation or LMA) or the pressure support ventilation (LMA SV-PS) on atelectasis formations and the distribution of the ventilation will be assessed using electrical impedance tomography.The device used during the study will be the "PulmoVista 500"; it will be provided by Dräger (Lübeck, Germany) free of charge and without any obligation or results/conclusions requested by Dräger. The device is approved CE (European regulation) and will be used in the conditions for which it has been designed.A reusable belt with 16 evenly spaced electrodes will be placed around the chest of each patient included in the study between the 4th and 6th ribs as recommended by Dräger.The EIT measurements will be taken of 4 different moments:T1: Before induction of the anesthesia in the preoperatory waiting room (and at least 30 min after the premedication).T2: After the induction of anesthesia (GA and penile block), just before the beginning of the surgical procedure.T3: After the end of the surgical procedure, just before discontinuing the general anesthesia.T4: Before the discharge of the PACU., conditionsModule conditions: Anesthesia, Pediatric, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: General anesthesia with mask ventilation, interventions name: General anesthesia and spontaneous laryngeal mask ventilation, interventions name: General anesthesia with spontaneous laryngeal mask ventilation with pressure support, outcomesModule primaryOutcomes measure: Variation of poorly ventilated pulmonary zones, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: H.U.B - Hôpital Universitaire des Enfants Reine Fabiola, status: RECRUITING, city: Brussels, zip: 1020, country: Belgium, contacts name: Denis Schmartz, MD, role: CONTACT, phone: +3225553919, email: denis.schmartz@hubruxelles.be, geoPoint lat: 50.85045, lon: 4.34878, hasResults: False

protocolSection identificationModule nctId: NCT06262347, orgStudyIdInfo id: 2024-0115, secondaryIdInfos id: UG1DA013732, type: NIH, link: https://reporter.nih.gov/quickSearch/UG1DA013732, briefTitle: Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) for Pregnant and Postpartum Persons in MOUD, acronym: TOME, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-12-20, completionDateStruct date: 2025-06-20, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: T. John Winhusen, PhD, class: OTHER, collaborators name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: The primary objective of this study is to evaluate the ability of TOME to increase Medication for Opioid Use Disorder (MOUD) and opioid-overdose knowledge in pregnant and postpartum persons., conditionsModule conditions: Opioid Use Disorder, conditions: Pregnancy Related, conditions: Substance Use, conditions: Drug Abuse, conditions: Drug Abuse in Pregnancy, conditions: Drug Addiction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is an intent-to-treat, two-arm, open-label, randomized controlled trial., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Personally-Tailored Opioid-overdose and Medication for opioid use disorder (MOUD) Education (TOME), interventions name: Control, outcomesModule primaryOutcomes measure: Medication for Opioid Use Disorder (MOUD) knowledge score, primaryOutcomes measure: Opioid Overdose knowledge score, secondaryOutcomes measure: Medication for Opioid Use Disorder (MOUD) Internalized Stigma, secondaryOutcomes measure: Drug Self-efficacy, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06262334, orgStudyIdInfo id: Pro00133917, secondaryIdInfos id: K23MD016123, type: NIH, link: https://reporter.nih.gov/quickSearch/K23MD016123, briefTitle: Evaluating the Fade to Fitness Program: A Barbershop-based Program for Black Men, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-06-15, completionDateStruct date: 2024-06-15, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: University of South Carolina, class: OTHER, collaborators name: National Institute on Minority Health and Health Disparities (NIMHD), descriptionModule briefSummary: The Fade to Fitness Program is a targeted intervention designed to improve the holistic health and quality of life among Black men. This comprehensive initiative focuses on four key health behaviors: Physical Activity, Healthy Eating, Stress Management, and Depression Management.It is grounded in psychological and social theories like Self-Determination Theory, Motivational Interviewing, and Social Cognitive Theory. The program emphasizes the importance of making informed choices, feeling competent and connected, and learning through observation and modeling. Facilitators play a pivotal role, leading group discussions, providing support, and fostering an inclusive atmosphere.The program is structured into weekly sessions that tackle each health behavior, interspersed with off weeks; for community engagement, especially in barbershops, to discuss health topics and promote a healthier lifestyle., conditionsModule conditions: Health Related Quality of Life, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: The Fade to Fitness Program, outcomesModule primaryOutcomes measure: Number of men who are eligible/eligible., primaryOutcomes measure: Length of time needed to enroll 15 men, primaryOutcomes measure: Facilitator-assessed attendance in intervention, primaryOutcomes measure: Number of men who express interest in the study, primaryOutcomes measure: Attrition in intervention, primaryOutcomes measure: Acceptability, appropriateness, demand, implementation, practicality, and integration of the intervention, secondaryOutcomes measure: Change in weight, secondaryOutcomes measure: Change in body mass index, secondaryOutcomes measure: Change in moderate-to-vigorous physical activity, secondaryOutcomes measure: Global Health - Mental 2a, secondaryOutcomes measure: Global Health - Physical 2a, secondaryOutcomes measure: Perceived Stress Scale, secondaryOutcomes measure: Emotional Distress - Depression - Short Form 4a, secondaryOutcomes measure: Healthy Eating Subscale of the Health Promotion Lifestyle Profile II, secondaryOutcomes measure: Instrumental Support- Short Form 4a, secondaryOutcomes measure: Informational Support - Short Form 4a, secondaryOutcomes measure: Emotional Support - Short Form 4a, secondaryOutcomes measure: Companionship - Short Form 4a, secondaryOutcomes measure: Motivation and Attitudes Towards Changing Health (MATCH), secondaryOutcomes measure: NIH Self-Efficacy Measure, secondaryOutcomes measure: Subjective Social Norms of Health Behavior, secondaryOutcomes measure: Valuing Questionnaire, secondaryOutcomes measure: Diet, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of South Carolina, status: RECRUITING, city: Columbia, state: South Carolina, zip: 29208, country: United States, contacts name: Guillermo M Wippold, PhD, role: CONTACT, phone: 803-216-1051, email: wippold@mailbox.sc.edu, contacts name: Guillermo M Wippold, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.00071, lon: -81.03481, hasResults: False

protocolSection identificationModule nctId: NCT06262321, orgStudyIdInfo id: URLUN23099, briefTitle: Thoracic Radiotherapy for Patients With Metastatic (Stage IV) Non-Small Cell Lung Cancer at High Risk of Symptomatic Progression Within the Thorax, acronym: DRO2301, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2029-02-01, completionDateStruct date: 2029-02-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: University of Rochester, class: OTHER, descriptionModule briefSummary: Patients with metastatic non small cell lung cancer with high risk location or size are treated with prophylactic radiation therapy in conjunction with standard of care systemic therapy., conditionsModule conditions: Stage 4 NSCLC, conditions: Radiotherapy, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Prophylactic Palliative Radiotherapy, outcomesModule primaryOutcomes measure: Freedom from symptomatic progression of irradiated thoracic target(s), secondaryOutcomes measure: OS (Kaplan-Meier) (Kaplan-Meier), secondaryOutcomes measure: Freedom from local recurrence of irradiated thoracic target lesion(s), secondaryOutcomes measure: PFS (freedom from local and distant progression; Kaplan-Meier), secondaryOutcomes measure: Duration of time that patient is maintenance, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06262308, orgStudyIdInfo id: 334235, briefTitle: Emotional Support for Women Experiencing PPROM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: King's College London, class: OTHER, descriptionModule briefSummary: Preterm Prelabour Rupture of the Membranes is a pregnancy complication affecting 3% of all pregnancies. Outcomes for both the mother and baby are variable including: preterm delivery, fetal infection, cord prolapse, abruption as well as maternal sepsis and even maternal death. The outcomes are not only variable but the stress and uncertainty can be over a protracted period of time. This is a pilot study that aims to provide personalised psychological intervention at the time of PPROM based on Cognitive Behavioural Principles to see whether this improves psychological outcomes for women., conditionsModule conditions: Fetal Membranes, Premature Rupture, conditions: Preterm Birth Complication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a pilot study where a small cohort of women will give given personalised psychological intervention, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 8, type: ESTIMATED, armsInterventionsModule interventions name: Psychological intervention along Cognitive Behavioural Therapy principles, outcomesModule primaryOutcomes measure: Mood Score 1, primaryOutcomes measure: Mood Score 2, primaryOutcomes measure: Participant Feedback, eligibilityModule sex: FEMALE, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St Thomas' Hospital, King's College London, city: London, state: Greater London, zip: SE1 7EH, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False

protocolSection identificationModule nctId: NCT06262295, orgStudyIdInfo id: 2023-A02475-40, briefTitle: National, Observational Registry for Comprehensive Follow-up of All Implementations of the AVEIR VR LP Device in France (France LEADLESS), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2027-09, completionDateStruct date: 2027-09, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: French Cardiology Society, class: OTHER, collaborators name: Abbott, descriptionModule briefSummary: Although the idea of a leadless pacemaker was first proposed in the 1970s to eliminate the probes, pockets and connectors required by conventional cardiac procedures and the associated complications, the first devices were not developed until the late 2010s. Leadless pacemakers can also improve patient comfort by replacing surgery with a percutaneous procedure, eliminating the mass and scar visible at the implantation site of a conventional pacemaker, and eliminating the need for activity restrictions to prevent dislodgement after implantation of a conventional lead.The AVEIR VR LP leadless pacemaker was CE marked in July 2023 and will be implanted in patients in Europe.The objective of this national registry is to evaluate the safety and performance of the AVEIR VR LP system in a population of patients indicated for implantation of a VVI(R) pacemaker in France. This registry will also allow the collection of patient characteristics and indications under normal conditions of use., conditionsModule conditions: Pacemaker, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: To confirm the safety of the AVEIR VR LP device, primaryOutcomes measure: To confirm the effectiveness of the AVEIR VR LP device, primaryOutcomes measure: To collect patient characteristics and indications in normal conditions of use of the AVEIR VR LP device, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06262282, orgStudyIdInfo id: NTM-OB-17 (PART C), briefTitle: Mycobacteriophage Treatment of Non-tuberculosis Mycobacteria, acronym: POSTSTAMP, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-05, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: National Jewish Health, class: OTHER, collaborators name: Cystic Fibrosis Foundation, descriptionModule briefSummary: About 10 people with cystic fibrosis (CF) and persistent Nontuberculosis mycobacteria (NTM) infection despite treatment will be screened to find out if their NTM infection has at least one mycobacteriophage that is effective in killing the mycobacteria. Individuals who are found to have at least one phage will be offered assistance in pursuing FDA approval for treatment via expanded-access Individual New Drug (IND) for compassionate-use. They will receive phage treatment for 1 year along with their guideline-based antibiotics for NTM. Individuals who are not identified as having a phage match will be followed as they continue to receive guideline based antibiotic therapy for 1 year. All subjects, including those who do not have a phage match will continue to be observed for the duration of the study, or about 1 year., conditionsModule conditions: Cystic Fibrosis, conditions: Nontuberculous Mycobacterial Lung Disease, conditions: Nontuberculous Mycobacterium Infection, conditions: Mycobacterium Infections, conditions: Mycobacterium; Pulmonary, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: mycobacteriophage, outcomesModule primaryOutcomes measure: Adherence to therapy, secondaryOutcomes measure: Phage susceptibility, secondaryOutcomes measure: Culture conversion, secondaryOutcomes measure: Tolerance of treatment, secondaryOutcomes measure: Clinical Response (pulmonary function testing), secondaryOutcomes measure: Microbiologic response to phage, secondaryOutcomes measure: Clinical response (BMI), secondaryOutcomes measure: Clinical response (CFQR), secondaryOutcomes measure: Clinical Response (antibiotic courses for non- NTM exacerbations), eligibilityModule sex: ALL, minimumAge: 6 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Alabama, city: Birmingham, state: Alabama, zip: 35233, country: United States, geoPoint lat: 33.52066, lon: -86.80249, locations facility: Children's Hospital of Los Angeles, city: Los Angeles, state: California, zip: 90027, country: United States, geoPoint lat: 34.05223, lon: -118.24368, locations facility: University of California, city: San Diego, state: California, zip: 92103, country: United States, geoPoint lat: 32.71533, lon: -117.15726, locations facility: Childrens Hospital Colorado, city: Denver, state: Colorado, zip: 80045, country: United States, geoPoint lat: 39.73915, lon: -104.9847, locations facility: National Jewish Health, city: Denver, state: Colorado, zip: 80206, country: United States, geoPoint lat: 39.73915, lon: -104.9847, locations facility: University of Florida, city: Gainesville, state: Florida, zip: 32610, country: United States, geoPoint lat: 29.65163, lon: -82.32483, locations facility: Northwestern University, city: Chicago, state: Illinois, zip: 60611, country: United States, geoPoint lat: 41.85003, lon: -87.65005, locations facility: John Hopkins University, city: Baltimore, state: Maryland, zip: 21218, country: United States, geoPoint lat: 39.29038, lon: -76.61219, locations facility: Boston Childrens Hospital, city: Boston, state: Massachusetts, zip: 02115, country: United States, geoPoint lat: 42.35843, lon: -71.05977, locations facility: University of Michigan, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, geoPoint lat: 42.27756, lon: -83.74088, locations facility: Dartmouth Hitchcock Medical Center, city: Lebanon, state: New Hampshire, zip: 03756, country: United States, geoPoint lat: 43.64229, lon: -72.25176, locations facility: Columbia University, city: New York, state: New York, zip: 10032, country: United States, geoPoint lat: 40.71427, lon: -74.00597, locations facility: University of North Carolina at Chapel Hill, city: Chapel Hill, state: North Carolina, zip: 27599, country: United States, geoPoint lat: 35.9132, lon: -79.05584, locations facility: Nationwide Children's Hospital, city: Columbus, state: Ohio, zip: 43215, country: United States, geoPoint lat: 39.96118, lon: -82.99879, locations facility: University of Pittsburgh Medical Center, city: Pittsburgh, state: Pennsylvania, zip: 15213, country: United States, geoPoint lat: 40.44062, lon: -79.99589, locations facility: Southwestern Medical Center at Dallas, city: Dallas, state: Texas, zip: 75390, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: University of Vermont, city: Burlington, state: Vermont, zip: 05401, country: United States, geoPoint lat: 44.47588, lon: -73.21207, locations facility: University of Washington, city: Seattle, state: Washington, zip: 98195, country: United States, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False

protocolSection identificationModule nctId: NCT06262269, orgStudyIdInfo id: Sportscol, secondaryIdInfos id: 2022-A00021-42, type: OTHER, domain: Number IDRCB, briefTitle: Interest of Adapted Physical Activity by Tele-rehabilitation in Chronic Pathology - Idiopathic Scoliosis in Adolescents, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-09-21, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Association des Paralysees de France (APF), class: OTHER, collaborators name: Fondation de France, descriptionModule briefSummary: This study is a randomised controlled trial designed to compare two adapted physical activity treatments for adolescent idiopathic scoliosis (AIS). The main hypotheses it aims to address are as follows:* Treatment with a HIIT (High-Intensity Interval Training) type training program via tele-rehabilitation, supervised by an adapted physical activity teacher, is effective in AIS.* A 12-week physical activity program maintains this efficacy over the long term. To test this hypothesis, Two groups of adolescents will be evaluated: a first group made up of non-athletic adolescents suffering from Idiopathic Scoliosis who will benefit from a tele-rehabilitation (physical activity sessions at home supervised by a teacher in adapted physical activities by video). A second group, control, also made up of non-athletic adolescents suffering from Idiopathic Scoliosis who will benefit from a self-program at home consisting of exercises specific to their scoliosis., conditionsModule conditions: Adolescent Idiopathic Scoliosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Home-based adapted physical activity program supervised by an APA teacher via individual video conference., interventions name: First period of the home-based adapted physical activity program with an exercise booklet., interventions name: Second period of the home-based adapted physical activity program with an exercise booklet., outcomesModule primaryOutcomes measure: Evaluation to overall physical performance on an ergometer-rowing machine, secondaryOutcomes measure: Evaluation of overall physical performance on an ergometer-rowing machine, secondaryOutcomes measure: Evaluation of perivertebral muscle performance (Plank), secondaryOutcomes measure: Evaluation of perivertebral muscle performance (Rowing), secondaryOutcomes measure: Indirect assessment of VO2 max, secondaryOutcomes measure: The Ratings Perceveid Exertion for Children during exercise (RPE-C), secondaryOutcomes measure: Assessment of motivation to change, secondaryOutcomes measure: Evaluation of attendance at adapted physical activity sessions, secondaryOutcomes measure: Anthropometric evaluation (Height), secondaryOutcomes measure: Anthropometric evaluation (weight), secondaryOutcomes measure: Anthropometric evaluation (BMI), secondaryOutcomes measure: Anthropometric evaluation by bioimpedance measurement, secondaryOutcomes measure: Analysis of the static vertical posture on a force platform SATEL®, secondaryOutcomes measure: Evaluation of the EOS radiograph of the total spine in front (Type), secondaryOutcomes measure: Evaluation of the EOS radiograph of the total spine in front and in profile (Angle), secondaryOutcomes measure: Evaluation of the EOS radiograph of the total spine in front (Frontal deviation), secondaryOutcomes measure: Evaluation of the EOS radiograph of the total spine in front (Risser), secondaryOutcomes measure: Photogrammetric morphostatic evaluation by surface topography, secondaryOutcomes measure: Measurement of the main gibbosity, secondaryOutcomes measure: Assessment of quality of life by the Scoliosis Research Society (SRS) scale : SRS-18, secondaryOutcomes measure: Satisfaction questionnaires, eligibilityModule sex: FEMALE, minimumAge: 13 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: SSR Marc Sautelet, status: RECRUITING, city: Villeneuve-d'Ascq, zip: 59650, country: France, contacts name: Jean-François Catanzariti, Médecin MPR, role: CONTACT, geoPoint lat: 50.61669, lon: 3.16664, hasResults: False

protocolSection identificationModule nctId: NCT06262256, orgStudyIdInfo id: HIIT-GLS-METS, briefTitle: Effects of High-intensity Interval Training on Myocardial Strain in Metabolic Syndrome Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-01, primaryCompletionDateStruct date: 2023-05-30, completionDateStruct date: 2023-12-22, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: University of Castilla-La Mancha, class: OTHER, collaborators name: Complejo Hospitalario de Toledo, descriptionModule briefSummary: the effects of high-intensity interval training on myocardial function will be studied in a group of patients under medical treatment for the components of metabolic syndrome., conditionsModule conditions: High-Intensity Interval Training, conditions: Metabolic Syndrome, conditions: Myocardial Dysfunction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized clinical trial with control group, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Echocardiography evaluators will be masked about participant allocation., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ACTUAL, armsInterventionsModule interventions name: High-intensity interval training, outcomesModule primaryOutcomes measure: Changes in global longitudinal strain, secondaryOutcomes measure: changes in cardiorespiratory fitness, secondaryOutcomes measure: changes in metabolic syndrome z-score, secondaryOutcomes measure: changes in visceral fat, secondaryOutcomes measure: changes in left ventricle passive filling (E wave), secondaryOutcomes measure: changes in early diastolic mitral annulus velocity (e' wave), secondaryOutcomes measure: changes in estimated left ventricle filling pressures (E/e'), eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Castilla-La Mancha, city: Toledo, state: Castilla-La Mancha, zip: 45071, country: Spain, geoPoint lat: 39.8581, lon: -4.02263, hasResults: False

protocolSection identificationModule nctId: NCT06262243, orgStudyIdInfo id: ORDUU-HEM-TÇ-01, briefTitle: The Effect of Heating With Electrical Blanket After Cesarean Section on the Postpartum, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: T.C. ORDU ÜNİVERSİTESİ, class: OTHER, descriptionModule briefSummary: It is known that maintaining and maintaining normal body temperature in women after cesarean section facilitates the mother's adaptation to the postpartum period. One of the important problems after cesarean section is hypothermia. Therefore, various methods are used to maintain normal body temperature. One of these methods is the use of electric blankets. This study will investigate the effect of using electric blankets after cesarean section on postpartum comfort, pain, milk quantity and breastfeeding success., conditionsModule conditions: Cesarean Section, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The research is a randomized controlled experimental design., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, maskingDescription: In this randomized controlled study, 78 mothers, 39 in each group, will be included in the intervention and control groups that meet the criteria for participation in the study. The researcher will give general information about the research to the mothers in the intervention and control groups during hospitalization and nurse admission, and their written informed consent will be obtained., whoMasked: PARTICIPANT, enrollmentInfo count: 78, type: ESTIMATED, armsInterventionsModule interventions name: electric blankets, outcomesModule primaryOutcomes measure: Postpartum comfort scale, primaryOutcomes measure: A Tool to Evaluate the Amount of Breast Milk the Baby Receives, secondaryOutcomes measure: Bristol Breastfeeding Assessment Tool, secondaryOutcomes measure: Insufficient Milk Perception Scale, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Samsun Training and Research Hospital, status: RECRUITING, city: Samsun, state: İ̇lkadim, zip: 55080, country: Turkey, contacts name: TUBA ÇITAK, role: CONTACT, phone: 05349265496, email: tubadlkc@gmail.com, contacts name: Ebru ŞAHİN, role: SUB_INVESTIGATOR, contacts name: Tuba ÇITAK, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.27976, lon: 36.3361, hasResults: False

protocolSection identificationModule nctId: NCT06262230, orgStudyIdInfo id: OPCI on ASD Children, briefTitle: Feasibility and Effectiveness of OPCI on ASD Children, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-20, primaryCompletionDateStruct date: 2023-10-31, completionDateStruct date: 2023-10-31, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Peking University, class: OTHER, descriptionModule briefSummary: The goal of this interventional study was to explore the feasibility and effectiveness of online peer companion intervention (OPCI) on the social abilities and mental health of ASD children. The main questions it aims to answer are:1. What is the acceptability and adherence of OPCI;2. Whether OPCI is effective on the social abilities and mental health of ASD children;3. What impact does OPCI have on ordinary children and parents of both children?, conditionsModule conditions: Autism Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: In this study, ordinary children will be paired with ASD children according to age, hobbies and other conditions, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ACTUAL, armsInterventionsModule interventions name: Online Inclusive Companionship Intervention, outcomesModule primaryOutcomes measure: Social Behavior of ASD Children, primaryOutcomes measure: Mental Health of ASD Children, primaryOutcomes measure: Intervention Process Screen Recording Coding, primaryOutcomes measure: Symptom Severity, secondaryOutcomes measure: Mental Health of Ordinary Children, secondaryOutcomes measure: Social Ability of Ordinary Children, secondaryOutcomes measure: Mental Health of Parents, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule locations facility: Peking University, city: Beijing, state: Beijing, zip: 100871, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False

protocolSection identificationModule nctId: NCT06262217, orgStudyIdInfo id: INGN21ST510, briefTitle: Mobile MRI for Immediate Radiological Acute Cerebral Lesion Evaluation in Stroke, acronym: MIRACLES, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-11, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: NHS Greater Glasgow and Clyde, class: OTHER, collaborators name: University of Glasgow, descriptionModule briefSummary: This prospective observational study will evaluate the potential value of mobile MRI in patients with suspected or proven acute stroke and Transient Ischemic Attack (TIA), undertaking additional imaging in the emergency department, acute stroke unit, or outpatient settings, and comparing diagnostic accuracy, Diffusion-weighted imaging (DWI) lesion volume and detection of complications (brain swelling or haemorrhagic transformation). Information on ease of use, tolerability and image quality will also be gathered., conditionsModule conditions: Stroke, Acute, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Mobile MRI scanner, outcomesModule primaryOutcomes measure: Diagnostic sensitivity and specificity of mobile MRI scanner, secondaryOutcomes measure: Comparison of MRI abnormalities, secondaryOutcomes measure: Final Clinical Diagnosis, secondaryOutcomes measure: Final Clinical Diagnosis, secondaryOutcomes measure: Time from arrival at the Emergency Department to scan, secondaryOutcomes measure: Use of treatments, secondaryOutcomes measure: Patient Outcomes, secondaryOutcomes measure: Level of confidence in final diagnosis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Queen Elizabeth University Hospital, status: RECRUITING, city: Glasgow, country: United Kingdom, contacts name: Stewart Rodney, role: CONTACT, phone: 0141 451 6879, email: stewart.rodney@glasgow.ac.uk, geoPoint lat: 55.86515, lon: -4.25763, hasResults: False

protocolSection identificationModule nctId: NCT06262204, orgStudyIdInfo id: Hallux Shark Screw(R), briefTitle: Hallux Valgus Correction Using the Metal Screw or the Human Allogeneic Cortical Bone Screw (Shark Screw)., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-02-28, completionDateStruct date: 2026-02-28, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Orthopedic Hospital Vienna Speising, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare the treatment of Hallux Valgus using the conventional method (metal screw) with the new method (human allogeneic cortical bone screw (Shark Screw®) in adult patients with confirmed Hallux Valgus.The main questions it aims to answer are:Can the new method obtain comparable results as the conventional method in regard to union rate and time to union? Are the number of complications lower with the new method? Participants will be operated either with the metal screw or with the Shark Screw®. The assignment to the groups is randomized., conditionsModule conditions: Hallux Valgus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: does get the information only after 2 years at the end of teh study, whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Hallux Valgus Treatment with Shark Screw®, interventions name: Hallux Valgus Treatment with metal screw, outcomesModule primaryOutcomes measure: clinical result of Hallux Valgus treatment, secondaryOutcomes measure: radiological (bony union)result of Hallux Valgus treatment, secondaryOutcomes measure: change in forefoot-American Orthopaedic Foot and Ankle Society (AOFAS), secondaryOutcomes measure: Hallux-Valgus angle (HVA) change, secondaryOutcomes measure: gait analysis, secondaryOutcomes measure: Intermetatarsal angle (IMA) change, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Abteilung für Kinderorthopädie und Fußchirurgie Orthopädisches Spital Speising, city: Vienna, zip: 1130, country: Austria, contacts name: Florian Wenzel-Schwarz, MD, role: CONTACT, phone: +43180182, phoneExt: 3081, email: florian.wenzel-schwarz@oss.at, contacts name: Florian Wenzel-Schwarz, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.20849, lon: 16.37208, hasResults: False

protocolSection identificationModule nctId: NCT06262191, orgStudyIdInfo id: 2137249, briefTitle: Testing an Adjustable Ankle Orthosis During Walking in Cerebral Palsy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Northern Arizona University, class: OTHER, descriptionModule briefSummary: This study seeks to determine how an adjustable stiffness ankle braces affects walking performance and biomechanics in cerebral palsy., conditionsModule conditions: Cerebral Palsy, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Differential and adjustable stiffness AFO (DAS-AFO), outcomesModule primaryOutcomes measure: Muscle activity, primaryOutcomes measure: Metabolic cost of transport, secondaryOutcomes measure: Pictorial Children's Effort Rating Table (PCERT), secondaryOutcomes measure: System Usability Score (SUS) questionnaire, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 35 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Northern Arizona University, status: RECRUITING, city: Flagstaff, state: Arizona, zip: 86011, country: United States, contacts name: Zach Lerner, PhD, role: CONTACT, phone: 928-523-1787, email: zachary.lerner@nau.edu, geoPoint lat: 35.19807, lon: -111.65127, hasResults: False

protocolSection identificationModule nctId: NCT06262178, orgStudyIdInfo id: 23-1393, briefTitle: Parenting STAIR: Adapting a Trauma-Focused Parenting Intervention for Military-Connected Mothers and Their Children, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: New York University, class: OTHER, collaborators name: Cohen Veterans Network, collaborators name: University of California, Davis, descriptionModule briefSummary: The purpose of this study, which includes a clinical trial, is to adapt and assess the efficacy of Parenting-STAIR (PSTAIR), an intervention which combines existing evidence-based treatments Skills Training in Affective and Interpersonal Regulation (STAIR) and Parent-Child Care (PC-Care) to reduce symptoms of Post-traumatic Stress Disorder (PTSD) and improve parenting among military-connected mothers. Participants in the clinical trial will receive PSTAIR or trauma-focused treatment as usual (either prolonged exposure or cognitive processing therapy)., conditionsModule conditions: PTSD, conditions: Depression, conditions: Parent-Child Relations, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: PSTAIR combines elements of two existing Evidence-Based Treatments (EBTs): Skills Training in Affective and Interpersonal Regulation (STAIR), targeting maternal trauma and emotion dysregulation, and dyadic Parent-Child Care (PC-CARE), targeting parenting. We will shorten PSTAIR into a 10-15 session modular intervention and individualize treatment using an adaptive decision rule and shared decision making., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Assessors will be blind to treatment arm. Coders blind to treatment arm will also code 10% of dyadic parenting sessions., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Parenting-STAIR, interventions name: Treatment as Usual, outcomesModule primaryOutcomes measure: Post-traumatic stress disorder (PTSD) Checklist 5, primaryOutcomes measure: Patient Health Questionnaire-9 (PHQ-9), primaryOutcomes measure: Parenting Sense of Competence Scale (PSOC), secondaryOutcomes measure: Clinician Administered PTSD Scale Diagnostic and Statistical Manual (DSM) 5 (CAPS 5) Diagnosis, secondaryOutcomes measure: Clinician Administered PTSD Scale Diagnostic and Statistical Manual (DSM) 5 (CAPS 5) Symptom Severity, secondaryOutcomes measure: Structured Clinical Interview for DSM 5 (SCID), secondaryOutcomes measure: Parenting Stress Index 4-Short Form (PSI4-SF), secondaryOutcomes measure: Difficulties in Emotion Regulation Scale (DERS), secondaryOutcomes measure: Brief Cope, secondaryOutcomes measure: Dyadic Parent-Child Interaction Coding System-IV (DPICS), secondaryOutcomes measure: Treatment Acceptability and Expectations (TAE), secondaryOutcomes measure: Strengths and Difficulties Questionnaire (SDQ), secondaryOutcomes measure: Eyberg Child Behavior Inventory (ECBI), eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06262165, orgStudyIdInfo id: RC23_0497, briefTitle: Evaluation of Liver Damage in Patients With Anorexia Nervosa by Blood Biomarker Analysis, acronym: BILAN, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-16, primaryCompletionDateStruct date: 2032-06-15, completionDateStruct date: 2032-12-15, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Nantes University Hospital, class: OTHER, descriptionModule briefSummary: The main goal of the BIocoLlection in Anorexia Nervosa-liver damage evaluation BILAN study the blood biomarkers associated with liver cytolysis., conditionsModule conditions: Anorexia Nervosa, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Patients with Anorexia Nervosa, outcomesModule primaryOutcomes measure: Identification of new blood biomarkers and hepatic cytolysis, eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 99 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nantes University Hospital, status: RECRUITING, city: Nantes, state: Loire-Atlantique, zip: 44093, country: France, contacts name: Sarra SMATI-GRANGEON, MCU-PH, role: CONTACT, phone: 33 2 53 48.27.01, email: sarra.grangeon@chu-nantes.fr, geoPoint lat: 47.21725, lon: -1.55336, hasResults: False

protocolSection identificationModule nctId: NCT06262152, orgStudyIdInfo id: 49187/2023, briefTitle: Sleep Profile of Patients With Septo-optic Dysplasia, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-20, primaryCompletionDateStruct date: 2024-01-20, completionDateStruct date: 2025-05-20, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: IRCCS National Neurological Institute "C. Mondino" Foundation, class: OTHER, descriptionModule briefSummary: The aim of this study is to evaluate sleep of patients with septo-optic dysplasia compared to patients with an isolated disorder of peripheral visual system and patients with corpus callosum agenesis since both visus defict and agenesis of corpus callosum might be present SOD but associated to other features / structural and functional anomalies.Included patients and their caregivers will be asked to compile standardize sleep questionnaires and a sleep screening through an interview will be scheduled. Patients will be asked to wear an actigraph on their non-dominant hand wrist for 7 days., conditionsModule conditions: Septo-Optic Dysplasia, conditions: Agenesis of Corpus Callosum, conditions: Blindness, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Actigraphy, blood and salivary sample, and sleep evaluation, outcomesModule primaryOutcomes measure: Sleep profile ( Sleep quality, sleep efficiency) of patients with SOD, secondaryOutcomes measure: melatonin profile of patients with SOD, secondaryOutcomes measure: Sleep EEG description of patients with SOD, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: IRCCS Casimiro Mondino Foundation, status: RECRUITING, city: Pavia, state: PV, zip: 27100, country: Italy, contacts name: Ludovica Pasca, MD, role: CONTACT, phone: 00393337201551, email: ludovica.pasca@mondino.it, contacts name: Valentina Franco, MD, role: CONTACT, geoPoint lat: 45.19205, lon: 9.15917, hasResults: False

protocolSection identificationModule nctId: NCT06262139, orgStudyIdInfo id: MT218-002, briefTitle: Evaluation of a Targeted Magnetic Resonance Imaging Contrast Agent in Prostate Cancer Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Molecular Theranostics LLC, class: INDUSTRY, collaborators name: Emory University, descriptionModule briefSummary: This phase 1b open label, dose-escalating investigation study is to evaluate the dose dependent initial efficacy of the use of MT218 injection for biomarker targeted MR molecular imaging (MRMI) of prostate cancer in patients scheduled for radical prostatectomy., conditionsModule conditions: MRI Scan, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SEQUENTIAL, interventionModelDescription: prostate cancer patients, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: MT218 injection, outcomesModule primaryOutcomes measure: Detection of aggressive prostate cancer (Gleason score 8 to 10) using peptide based MRI contrast agent (MT218) with comparing the previous clinical mpMRI using the clinical standard MRI contrast agent and PSMA-PET/CT, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Emory University, city: Atlanta, state: Georgia, zip: 30322, country: United States, geoPoint lat: 33.749, lon: -84.38798, hasResults: False

protocolSection identificationModule nctId: NCT06262126, orgStudyIdInfo id: 23-012673, briefTitle: Virtual Reality for Non-cardiac Chest Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-14, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: The purpose of this study is to determine if virtual reality (VR) will improve symptoms in non-cardiac chest pain (NCCP)., conditionsModule conditions: Gastrointestinal Diseases, conditions: Chest Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Virtual Reality, outcomesModule primaryOutcomes measure: Measure changes in GERD symptoms using the GERDQ questionnare, primaryOutcomes measure: Measure changes in GERD quality of life using the GERD-HRQL questionnaire, primaryOutcomes measure: Measure changes in esophageal symptom specific anxiety using the EHAS questionnaire, primaryOutcomes measure: Measure changes in GI symptom severity using the PAGI-SYM questionnaire, primaryOutcomes measure: Measure changes in GI related patient assessment of quality of life using PAGI-QOL, secondaryOutcomes measure: Measure changes in anxiety and depression using the HADs scale, secondaryOutcomes measure: Measure changes in resilience using the brief resilience scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic Florida, status: RECRUITING, city: Jacksonville, state: Florida, zip: 32224, country: United States, contacts name: Wendi Lehman, role: CONTACT, phone: 904-953-8742, email: Lehman.Wendi@mayo.edu, geoPoint lat: 30.33218, lon: -81.65565, hasResults: False

protocolSection identificationModule nctId: NCT06262113, orgStudyIdInfo id: 2024P000392, secondaryIdInfos id: AD-2022C2-24790, type: OTHER_GRANT, domain: PCORI, briefTitle: A Decentralized Clinical Trial to Promote Evidence-Based Care for Underserved Patients With Neurofibromatosis 1, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-11, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-08, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, collaborators name: Patient-Centered Outcomes Research Institute, descriptionModule briefSummary: The goal of this fully decentralized, randomized controlled trial is to compare the efficacy of two educational interventions for individuals with Neurofibromatosis 1 (NF1). The primary objective of the study is to determine which intervention leads to higher rates of evidenced-based health screenings for NF1 patients in primary care settings.Adults with NF1 and parents/guardians of children with NF1 from across the U.S. who do not go to a specialized NF clinic and who have an upcoming annual wellness visits scheduled with a primary care provider (PCP) are eligible to enroll in the study., conditionsModule conditions: Neurofibromatosis 1, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 360, type: ESTIMATED, armsInterventionsModule interventions name: Letters about NF1 Care (Content Type 1), interventions name: Letters about NF1 Care (Content Type 2), outcomesModule primaryOutcomes measure: Receipt of Recommended NF1 Health Screenings, secondaryOutcomes measure: Patient Activation Measure®, secondaryOutcomes measure: Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Clinician and Group Survey Version 4.0 (Beta): Rating of the Visit, secondaryOutcomes measure: Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Clinician and Group Survey Version 4.0 (Beta): How Well Providers Communicate With Patients Subscale, secondaryOutcomes measure: Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Clinician and Group Survey Version 4.0 (Beta): Providers' Use of Information to Coordinate Patient Care Subscale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Massachusetts General Hospital, city: Boston, state: Massachusetts, zip: 02114, country: United States, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False

protocolSection identificationModule nctId: NCT06262100, orgStudyIdInfo id: EYL_23_01, briefTitle: Lubricating Effectiveness of Carragelose Eye Drops in Patients Affected by Mild to Moderate Dry Eye, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2024-07-30, completionDateStruct date: 2024-12-15, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Marinomed Biotech AG, class: INDUSTRY, descriptionModule briefSummary: Patients suffering from dry eye syndrom will treat their eyes with Carragelose® eye drops three times a day for 28 days. Before, in the middle and at the end of the treament period patients will be exposed to adverse conditions to challenge dry eye symptoms. Patient will record their occular symptoms and ophthalmic examinations will be performed by an ophthalmologist. Differences between before and after treatment will be assessed., conditionsModule conditions: Dry Eye Syndromes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Carragelose, outcomesModule primaryOutcomes measure: Change in dry eye symptoms, secondaryOutcomes measure: Responder analysis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IOBA,Ocular Surface Research Group, University of Valladolid, status: RECRUITING, city: Valladolid, zip: 47011, country: Spain, contacts name: Marta Balanco Vázquez, PhD, role: CONTACT, phone: C, email: mblancov@ioba.med.uva.es, contacts name: Margarita Calogne, PhD, role: CONTACT, phone: V, email: calogne@ioba.med.uva.es, geoPoint lat: 41.65518, lon: -4.72372, hasResults: False

protocolSection identificationModule nctId: NCT06262087, orgStudyIdInfo id: MU-CIRB 2023/044.2203, briefTitle: The Combined FIFA 11+ and Change of Direction Training, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Mahidol University, class: OTHER, descriptionModule briefSummary: The study has investigated the effects of adding change of direction (COD) training to the FIFA 11+ on lower extremity performance in soccer players. The investigators are interested in knee valgus angle during cutting which is typically suggested as a critical risk of anterior cruciate ligament injury. Peak knee valgus angle during cutting is expected to reduce immediately after adding COD training to the FIFA 11+., conditionsModule conditions: Rehabilitation, conditions: Physical Therapy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Change of direction training, interventions name: FIFA 11+ program, outcomesModule primaryOutcomes measure: Peak knee valgus angle, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: FFC league in Cambodia, status: RECRUITING, city: Phnom Penh, country: Cambodia, contacts name: Komsak Sinsurin, Ph.D., role: CONTACT, phone: +66 024415450, phoneExt: 20605, email: komsak.sin@mahidol.edu, contacts name: Chanteng Huoth, M.Sc., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 11.56245, lon: 104.91601, hasResults: False

protocolSection identificationModule nctId: NCT06262074, orgStudyIdInfo id: IEC-2418, briefTitle: Effect of Structured Training Program in Diabetic Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-08, primaryCompletionDateStruct date: 2024-02-08, completionDateStruct date: 2024-03-31, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Maharishi Markendeswar University (Deemed to be University), class: OTHER, descriptionModule briefSummary: Diabetic neuropathy, a challenging condition resulting from poorly managed type-1 or type-2 diabetes mellitus, often proves resistant to conventional medications when it comes to alleviating the associated symptoms. In such cases, implementing a well-organized exercise regimen has proven beneficial in mitigating diverse symptoms associated with the condition and enhancing the overall quality of life for affected individuals., conditionsModule conditions: Diabetic Peripheral Neuropathy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Structured Exercise Program, interventions name: Non structured exercise program, outcomesModule primaryOutcomes measure: Michigan neuropathy screening instrument (MNSI), primaryOutcomes measure: Biothesiometer, primaryOutcomes measure: NeuroQoL, secondaryOutcomes measure: NPRS, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MMIPR, status: RECRUITING, city: Ambala, state: Haryana, zip: 133207, country: India, contacts name: Subhashish Chatterjee, MPT(NEURO), role: CONTACT, phone: +918950037407, email: subhasishphysio@gmail.com, contacts name: Subhashish Chatterjee, MPT, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.36099, lon: 76.79782, hasResults: False

protocolSection identificationModule nctId: NCT06262061, orgStudyIdInfo id: PRO-TBI-FS, briefTitle: Propranolol for the Treatment of Traumatic Brain Injury, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: London Health Sciences Centre, class: OTHER, descriptionModule briefSummary: Traumatic brain injury (TBI) is a leading cause of global disease and directly affects over 1.5 million Canadians, with 165 000 TBIs occurring yearly in Canada. Despite the burden of TBIs, there are limited treatment options available and current treatments generally focus on supportive care. The aim of TBI treatment is reduce inflammation and damage occurring after the TBI (secondary injury).Beta- blockers (BBs) are medications commonly used to block the actions of endogenous catecholamines- hormones that are thought to contribute to secondary injury within brain tissue. This reduces metabolic demand in the vulnerable, injured brain. BBs have been studied in several retrospective trials and one single-center, non- blinded randomized controlled study. These results point towards a benefit to the use of BBs in TBI but need to be confirmed in a rigorous manner before they are widely adopted.The current study aims to assess the feasibility of a single centre randomized controlled trial of BBs versus placebo to treat moderate to severe TBI. This feasibility trial will inform the planning of a large multi-center study powered to detect a difference in cognitive outcomes and mortality. It also will allow the investigators to gather biologic samples for measuring serum catecholamines and inflammatory mediators to better understand the basic science mechanisms of BBs in this patient population; and to assess the feasibility of using the Cambridge Battery to assess cognitive outcomes of trial participants., conditionsModule conditions: TBI (Traumatic Brain Injury), designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective, single- center double- blinded randomized control trial comparing placebo to propranolol for the treatment of moderate- severe traumatic brain injury., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Patients will be randomized in a 1:1 allocation to either the propranolol or control group. Our hospital pharmacy will control the randomization procedure. The propranolol group will receive over-encapsulated whole marketed tablets comprised of 20mg oral propranolol \[USP grade\] filled with lactose monohydrate powder \[NF grade\] encapsulated with opaque gelatin capsules twice daily for 14 days (or until hospital discharge or death). The control group will receive an oral placebo comprised of lactose monohydrate powder \[NF grade\] encapsulated with indistinguishable opaque gelatin capsules. The pharmacy will have access to the randomization key. Nursing staff will remove the gelatin capsule casing and dissolve the trial drug \& placebo in sterile water prior to administering it enterally via a feeding tube to the participants. Aside from the nursing staff, the participants, research team, and remainder of the clinical care teams will all remain blinded to treatment allocation., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Propranolol, interventions name: Placebo, outcomesModule primaryOutcomes measure: Hospital Mortality, primaryOutcomes measure: Cognitive function, secondaryOutcomes measure: Catecholamines/Inflammatory markers, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06262048, orgStudyIdInfo id: PrePOURTS, briefTitle: Prevention of Post Operative Urinary Retention After Thoracic Surgery Trial, acronym: PrePOURTS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Lawson Health Research Institute, class: OTHER, descriptionModule briefSummary: The objectives of this study are to determine the efficacy of tamsulosin compared to placebo in reducing post-operative urinary retention and improving other clinical outcomes in people undergoing pulmonary surgery., conditionsModule conditions: Urinary Retention Postoperative, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: single centre, double blind randomized controlled trial, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Tamsulosin Hydrochloride, interventions name: Placebo, outcomesModule primaryOutcomes measure: Rate of post operative urinary retention, secondaryOutcomes measure: Rate of Straight Catheterizations, secondaryOutcomes measure: Rate of Indwelling Catheterizations, secondaryOutcomes measure: Time to first catheterization, secondaryOutcomes measure: Treatment Related Adverse Events, secondaryOutcomes measure: Catheter related complications, secondaryOutcomes measure: Length of stay, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: London Health Sciences Centre, city: London, state: Ontario, zip: N6A 5W9, country: Canada, geoPoint lat: 42.98339, lon: -81.23304, hasResults: False

protocolSection identificationModule nctId: NCT06262035, orgStudyIdInfo id: 2023-02987-01, briefTitle: Transcriptome, Proteome and Microbiome Profile in Periodontal and Peri-implant Diseases, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2030-12-31, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Karolinska Institutet, class: OTHER, descriptionModule briefSummary: 1. To investigate the transcriptomic profile of periodontitis and peri-implantitis. Patients with defined periodontitis, at two non-adjacent teeth and peri-implantitis at ≥ one implant in function of ≥ one year, will be included to investigate the gene expression profile in tissue affected by periodontitis and peri-implantitis. Subjects will undergo a full-mouth examination performed by a calibrated examiner, including assessment of caries, bone abnormalities and infections according to intraoral x-ray, plaque index and pocket probing depth, suppuration, bleeding on probing, alveolar bone loss, and the number of teeth. During surgical intervention, tissue biopsies (two specimens per site) will be collected by a periodontist from site with ongoing periodontitis and site from ongoing peri-implantitis.2. To study the microbiome and biomarker profile associated with periodontitis and peri- implantitis. Patients with defined periodontitis, at two non-adjacent teeth and peri-implantitis at ≥ one implant in function of ≥ one year, will be included in this study to determine the bacteria composition, cytokine profile and inflammatory biomarkers profile. Subjects will undergo a full-mouth examination performed by a calibrated examiner, including assessment of caries, bone abnormalities and infections according to intraoral x-ray, plaque index and pocket probing depth, suppuration, bleeding on probing, alveolar bone loss, and number of teeth. Peri-implant crevicular fluid (PICF), gingival crevicular fluid (GCF), saliva and submucosal/subgingival plaque will be collected.The presence and composition of periodontal and peri-implant plaque samples are investigated., conditionsModule conditions: Peri-implantitis, conditions: Periodontitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Periodontitis and Peri-implantitis, outcomesModule primaryOutcomes measure: Protein levels in peri-implantitis and periodontitis, primaryOutcomes measure: Microbiome composition in peri-implantitis and periodontitis using 16S-rRNA sequencing method., primaryOutcomes measure: Gene expression profile in peri-implantitis and periodontitis., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06262022, orgStudyIdInfo id: KaramanogluMehmetbeyUFGok, briefTitle: The Effect of Cold Application on Pain Level, Edema and Drainage Amount, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Karamanoğlu Mehmetbey University, class: OTHER, collaborators name: Karaman Training and Research Hospital, descriptionModule briefSummary: In this study, we aimed to investigate the effect of cold application applied for 20 minutes every hour for 8 hours on the first day, second and third days after total hip arthroplasty with gel pads, on the pain level, edema and drainage amount of total hip arthroplasty patients. The main question\[s\]it aims to answer are:* Is there a difference between the pain levels of patients in the control and cold application arms?* Is there a difference between the knee edema of patients in the control and cold application arms?* Is there a difference between the amount of drainage of patients in the control and cold application arms? This study was planned as a prospective, parallel, two-arm (1:1) randomized controlled trial (RCT)., conditionsModule conditions: Cold Therapy, conditions: Pain, Postoperative, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study was planned as a prospective, parallel, two-arm (1:1) randomized controlled trial (RCT)., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 78, type: ESTIMATED, armsInterventionsModule interventions name: cold therapy, outcomesModule primaryOutcomes measure: pain level, secondaryOutcomes measure: edema, secondaryOutcomes measure: amount of drainage, otherOutcomes measure: Analgesic consumption, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Karamanoğlu Mehmet bey Üniversitesi, status: RECRUITING, city: Merkez, state: Karaman, zip: 70100, country: Turkey, contacts name: fatma gök, role: CONTACT, phone: 05544906142, email: fatmagok123@gmail.com, hasResults: False

protocolSection identificationModule nctId: NCT06262009, orgStudyIdInfo id: APHP220101, secondaryIdInfos id: 2023-A02282-43, type: OTHER, domain: IDRCB, briefTitle: Dynamics of AMR Spread, Persistence and Evolution Between Humans, Animals and Their Environment, acronym: Dyaspeo, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Humans in contact with animals such as dog owners, may be at risk of antimicrobial resistance (AMR) acquisition. This is the central issue to be investigated in DYASPEO, conditionsModule conditions: Antibiotic Resistant Strain, conditions: Transmission, Close-Contact, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 525, type: ESTIMATED, armsInterventionsModule interventions name: human faecal collection, interventions name: ancillary study, outcomesModule primaryOutcomes measure: generation of a list of priorities for future prevention and control strategies to mitigate antimicrobial resistance (AMR) transmission between companion animals and humans, secondaryOutcomes measure: Rates of AMR acquisitions in one or several housekeepers, secondaryOutcomes measure: A list in nature of changes in dog microbiota, secondaryOutcomes measure: A list in magnitude of changes in dog microbiota, secondaryOutcomes measure: A list in nature of changes in housekeepers microbiota, secondaryOutcomes measure: A list in magnitude of changes in housekeepers microbiota, secondaryOutcomes measure: explore unknown parameters of AMR colonization in dogs under various antibiotic exposures, secondaryOutcomes measure: the generation of a list of sociological factors and potential at-risk practices relevant in the transmission of AMR from dogs to housekeepers, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: the National Veterinary School Alfort, city: Maisons-Alfort, zip: 94700, country: France, contacts name: Jean-Yves Madec, PHD, role: CONTACT, phone: 06 85 08 93 30, phoneExt: +33, email: jean-yves.madec@anses.fr, geoPoint lat: 48.81171, lon: 2.43945, hasResults: False

protocolSection identificationModule nctId: NCT06261996, orgStudyIdInfo id: henanFSH, briefTitle: Safety and Efficacy of Fospropofol vs Propofol During Invasive Mechanical Ventilation., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2025-01-15, completionDateStruct date: 2025-01-15, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Henan Provincial People's Hospital, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare the safety and efficacy of fospropofol and propofol during sedation in invasively mechanically ventilated patients in the Anesthesia Intensive Care Unit (AICU). Specific objectives include the following:* Evaluate the sedative effects of fospropofol and propofol in invasively mechanically ventilated patients. Compare the sedative effects of the two medications using relevant clinical indicators and scoring tools, such as the Richmond Agitation-Sedation Scale (RASS).* Compare the safety of fospropofol and propofol during sedation. Monitor medication-related adverse reactions, such as respiratory depression, hypotension, arrhythmias, headache, injection site pain, and assess the differences in adverse reaction incidence between the two medications.* Compare the characteristics of recovery from sedation between PPD and propofol. Focus on the time from sedation to emergence from sedation and compare the differences in recovery time between the two medications.Participants will be sedated with fospropofol or propofol during invasive mechanical ventilation., conditionsModule conditions: Invasive Mechanical Ventilation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Fospropofol, outcomesModule primaryOutcomes measure: The patient's Richmond Agitation-Sedation Scale (RASS) score and the incidence of adverse reactions, secondaryOutcomes measure: Incidence of adverse reactions during the follow-up period, secondaryOutcomes measure: Extubation time, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06261983, orgStudyIdInfo id: 2019111032, briefTitle: Magnetic Localization of Sentinel Nodes in Squamous Cell Oral Carcinoma., acronym: SentiMag, statusModule overallStatus: RECRUITING, startDateStruct date: 2018-10-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Hospital Donostia, class: OTHER, descriptionModule briefSummary: Sentinel node biopsy has been shown to be a viable alternative to elective neck dissection in the early stages of squamous cell oral carcinoma. The aim of this study was to describe the magnetic localization of sentinel nodes (SN) after peritumoral injection of superparamagnetic iron oxide (SPIO) for treating this type of tumor and to analyze the technique's diagnostic performance in 23 patients. The technique located SNs (with minimal complication) in 95.6 % (22/23) of the patients. Three relapses occurred, one in a patient who had shown negative in magnetic SN location and elective neck dissection. The diagnostic performance of magnetic localization achieved a sensitivity and negative predictive value of 0.80 y 0.94, respectively. Magnetic localization of SNs has been shown to be a reproducible technique that may offer a viable alternative to the conventional technique., conditionsModule conditions: Diagnostic Value of Sentinel Node Biopsy Guided by Magnetic Probe, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Sentinel node biopsy guided by magnetic probe, outcomesModule primaryOutcomes measure: The diagnostic performance of SNB was analyzed in terms of sensitivity (S), specificity (Sp), negative and positive predictive value (NPV and PPV)., eligibilityModule sex: ALL, minimumAge: 29 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Josué Hernando Vázquez, status: RECRUITING, city: Donostia, state: Guipuzkoa, zip: 20011, country: Spain, contacts name: Josué Hernando, PhD, DDS, role: CONTACT, phone: 0034 675825482, email: josue.hernando@gmail.com, geoPoint lat: 43.31283, lon: -1.97499, hasResults: False

protocolSection identificationModule nctId: NCT06261970, orgStudyIdInfo id: 999002684, briefTitle: Increase First-time Mothers' Use of Postpartum Family Planning in Tanzania: The Connect Project, acronym: Connect TZ, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-02-22, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: George Washington University, class: OTHER, collaborators name: Save the Children, collaborators name: Save the Children International Tanzania, collaborators name: Bill and Melinda Gates Foundation, descriptionModule briefSummary: While a growing body of programs have shown promise to increase use of contraception among first time mothers (FTMs), difficulties remain in scaling beyond small pilot areas and institutionalizing within existing systems. Connect's approach aims to strengthen existing government health systems and community-level health efforts, including those supported through local and international non-governmental organizations, by developing and testing light-touch "enhancements" with the goal of increasing postpartum Family Planning (PPFP) adoption among FTMs. The investigators will evaluate Connect's approach through a cluster randomized control trial., conditionsModule conditions: Contraceptive Usage, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 1134, type: ACTUAL, armsInterventionsModule interventions name: Connect, outcomesModule primaryOutcomes measure: Adoption of of Postpartum Family Planning (PPFP):, primaryOutcomes measure: Currently Using PPFP, secondaryOutcomes measure: Adopted or Intention to adopt PPFP, secondaryOutcomes measure: Average Satisfaction with PPFP methods, secondaryOutcomes measure: Contraceptive Preferences, secondaryOutcomes measure: Quality of Family Planning Counseling, secondaryOutcomes measure: Communication and Agency, secondaryOutcomes measure: PPFP Attitudes, secondaryOutcomes measure: PPFP Knowledge, eligibilityModule sex: FEMALE, minimumAge: 14 Years, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: EDI, city: Bahi, state: Dodoma, country: Tanzania, geoPoint lat: -5.98304, lon: 35.3159, locations facility: EDI, city: Kongwa, state: Dodoma, country: Tanzania, geoPoint lat: -6.2, lon: 36.41667, hasResults: False

protocolSection identificationModule nctId: NCT06261957, orgStudyIdInfo id: 220735, secondaryIdInfos id: 2023-509001-76-00, type: OTHER, domain: EU CT Number, briefTitle: A Study to Assess and Compare Safety and Tolerability of 3 Months Treatment With Salbutamol Administered Via MDI Containing Propellant HFA-152a or HFA-134a in Participants 12 Years of Age and Older With Asthma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-19, primaryCompletionDateStruct date: 2025-04-25, completionDateStruct date: 2025-04-25, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: GlaxoSmithKline, class: INDUSTRY, descriptionModule briefSummary: The goal of this study is to assess and compare the safety and tolerability of salbutamol administered via metered dose inhaler (MDI) containing propellant 1,1-difluoroethane (HFA-152a) or 1,1,1,2-tetrafluoroethane (HFA-134a) in participants aged 12 years and above with asthma., conditionsModule conditions: Asthma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 420, type: ESTIMATED, armsInterventionsModule interventions name: Salbutamol HFA-134a, interventions name: Salbutamol HFA-152a, outcomesModule primaryOutcomes measure: Number of participants with Adverse Events (AEs), secondaryOutcomes measure: Number of participants with Serious Adverse Events (SAEs), secondaryOutcomes measure: Absolute Values of Minimum serum potassium (milliequivalents per litre (mEq/L), secondaryOutcomes measure: Absolute values of serum potassium (milligrams per decilitre), secondaryOutcomes measure: Change from baseline in serum potassium (milligrams per decilitre), secondaryOutcomes measure: Absolute value of haematology parameter: Platelet count (cells per microliter), secondaryOutcomes measure: Absolute value of haematology parameter: Red Blood Cell Count (RBC) (million cells per microliter), secondaryOutcomes measure: Absolute value of haematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters), secondaryOutcomes measure: Absolute value of haematology parameter: Mean Corpuscle haemoglobin (MCH) (Picograms), secondaryOutcomes measure: Absolute values of haematology parameters: Reticulocytes (Percentage of reticulocytes), secondaryOutcomes measure: Absolute values of haematology parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre), secondaryOutcomes measure: Absolute values of haematology parameters: haemoglobin (Hgb) (grams per decilitre), secondaryOutcomes measure: Absolute values of haematology parameters: haematocrit (Proportion of red blood cells in blood), secondaryOutcomes measure: Absolute values of Clinical Chemistry parameters: Glucose (non-fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Direct Bilirubin and Total Bilirubin (milligrams per decilitre), secondaryOutcomes measure: Absolute values of Aspartate aminotransferase/serum glutamic-oxaloacetic transaminase,Alanine aminotransferase/serum glutamic-pyruvic transaminase, Alanine aminotransferase,Creatine phosphokinase (International Units per litre), secondaryOutcomes measure: Absolute value of routine urinalysis: potential of hydrogen (pH), secondaryOutcomes measure: Number of participants with abnormal urinalysis dipstick results: glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase, secondaryOutcomes measure: Change from baseline in haematology parameter: Platelet count (cells per microliter), secondaryOutcomes measure: Change from baseline in haematology parameter: Red Blood Cell Count (RBC) (million cells per microliter), secondaryOutcomes measure: Change from baseline in haematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters), secondaryOutcomes measure: Change from baseline in haematology parameter: Mean Corpuscle haemoglobin (MCH) (Picograms), secondaryOutcomes measure: Change from baseline in haematology parameters: Reticulocytes (Percentage of reticulocytes), secondaryOutcomes measure: Change from baseline in haematology parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre), secondaryOutcomes measure: Change from baseline in haematology parameters: haemoglobin (Hgb) (grams per decilitre), secondaryOutcomes measure: Change from baseline in haematology parameters: haematocrit (Proportion of red blood cells in blood), secondaryOutcomes measure: Change from baseline in Clinical Chemistry parameters: Glucose (non-fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Direct Bilirubin and Total Bilirubin (milligrams per decilitre), secondaryOutcomes measure: Change from baseline in Aspartate aminotransferase/ serum glutamic-oxaloacetic transaminase,Alanine aminotransferase/serum glutamic-pyruvic transaminase, Alanine aminotransferase,Creatine phosphokinase (International Units per litre), secondaryOutcomes measure: Change from baseline in routine urinalysis: pH, secondaryOutcomes measure: Absolute values for vital signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [millimeters of mercury (mm Hg), secondaryOutcomes measure: Absolute values for vital signs: pulse rate [beats per min (bpm), secondaryOutcomes measure: Change from baseline in vital signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [millimeters of mercury (mm Hg), secondaryOutcomes measure: Change from baseline in vital signs: pulse rate [beats per min (bpm), secondaryOutcomes measure: Absolute values for 12 Lead ECGs in QTc (milliseconds), secondaryOutcomes measure: Absolute values for heart rate [beats per min (bpm), secondaryOutcomes measure: Change from baseline for 12 Lead ECGs in QTc (milliseconds), secondaryOutcomes measure: Change from baseline for heart rate [beats per min (bpm), eligibilityModule sex: ALL, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: GSK Investigational Site, city: Aventura, state: Florida, zip: 33180, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Jaime Landman, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.95648, lon: -80.13921, locations facility: GSK Investigational Site, city: Clearwater, state: Florida, zip: 33756, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Miguel E Trevino, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 27.96585, lon: -82.8001, locations facility: GSK Investigational Site, city: Edgewater, state: Florida, zip: 32132, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Andrew C Feldman, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.98888, lon: -80.90228, locations facility: GSK Investigational Site, city: Miami, state: Florida, zip: 33155, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Eduardo Martinez, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.77427, lon: -80.19366, locations facility: GSK Investigational Site, city: Winter Park, state: Florida, zip: 32789, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Akinyemi Ajayi, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.6, lon: -81.33924, locations facility: GSK Investigational Site, city: Rincon, state: Georgia, zip: 31326, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Maria Mascolo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.29603, lon: -81.23539, locations facility: GSK Investigational Site, city: Louisville, state: Kentucky, zip: 40217, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: James Wesley Sublett, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.25424, lon: -85.75941, locations facility: GSK Investigational Site, city: Owensboro, state: Kentucky, zip: 42301, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Lee S Clore, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.77422, lon: -87.11333, locations facility: GSK Investigational Site, city: Minneapolis, state: Minnesota, zip: 55402, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Gary D Berman, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.97997, lon: -93.26384, locations facility: GSK Investigational Site, city: Olive Branch, state: Mississippi, zip: 38654, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Randall T. Huling, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.96176, lon: -89.82953, locations facility: GSK Investigational Site, city: Columbia, state: Missouri, zip: 65203, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Mark L Vandewalker, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.95171, lon: -92.33407, locations facility: GSK Investigational Site, city: Jersey City, state: New Jersey, zip: 07306, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Asisat Ope, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.72816, lon: -74.07764, locations facility: GSK Investigational Site, city: Riverdale, state: New Jersey, zip: 07457, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Jeffrey Weiss, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.99399, lon: -74.30348, locations facility: GSK Investigational Site, city: Brooklyn, state: New York, zip: 11220, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Ramsey Joudeh, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.6501, lon: -73.94958, locations facility: GSK Investigational Site, city: Asheville, state: North Carolina, zip: 28803, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: David Cypcar, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.60095, lon: -82.55402, locations facility: GSK Investigational Site, city: Cincinnati, state: Ohio, zip: 45231, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: David I Bernstein, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.12713, lon: -84.51435, locations facility: GSK Investigational Site, city: Dublin, state: Ohio, zip: 43016, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Roy Carl St. John, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.09923, lon: -83.11408, locations facility: GSK Investigational Site, city: Medford, state: Oregon, zip: 97504, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Sarah Smiley, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.32652, lon: -122.87559, locations facility: GSK Investigational Site, city: DuBois, state: Pennsylvania, zip: 15801, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Sandeep Bansal, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.11923, lon: -78.76003, locations facility: GSK Investigational Site, city: Philadelphia, state: Pennsylvania, zip: 19107, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: David A Wheeler, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95233, lon: -75.16379, locations facility: GSK Investigational Site, city: Pittsburgh, state: Pennsylvania, zip: 15241, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Michael J. Palumbo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.44062, lon: -79.99589, locations facility: GSK Investigational Site, city: Greenville, state: South Carolina, zip: 29615, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Luis Ignacio De La Cruz, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.85262, lon: -82.39401, locations facility: GSK Investigational Site, city: Rock Hill, state: South Carolina, zip: 29732, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Michael Denenberg, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.92487, lon: -81.02508, locations facility: GSK Investigational Site, city: Spartanburg, state: South Carolina, zip: 29303, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Charles M. Fogarty, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.94957, lon: -81.93205, locations facility: GSK Investigational Site, city: Union, state: South Carolina, zip: 29379, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Joseph A Boscia III, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.71541, lon: -81.62371, locations facility: GSK Investigational Site, city: Burleson, state: Texas, zip: 76028, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Tiffany Baird, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.54208, lon: -97.32085, locations facility: GSK Investigational Site, city: Tomball, state: Texas, zip: 77375, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Mustafa Naeem, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.09716, lon: -95.61605, locations facility: GSK Investigational Site, city: Waco, state: Texas, zip: 76712, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Niran J. Amar, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.54933, lon: -97.14667, locations facility: GSK Investigational Site, city: Bellingham, state: Washington, zip: 98225, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: David Elkayam, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.75955, lon: -122.48822, locations facility: GSK Investigational Site, city: Caba, state: Buenos Aires, zip: C1425BEN, country: Argentina, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Anahi Yanez, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: GSK Investigational Site, city: Ciudad de Buenos Aires, zip: C1425AZE, country: Argentina, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Nicolas Itcovici, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: GSK Investigational Site, city: Mendoza, zip: M5500CCG, country: Argentina, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Pedro Carlos Elias, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -32.89084, lon: -68.82717, locations facility: GSK Investigational Site, city: Ajax, state: Ontario, zip: L1S 2J5, country: Canada, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: George Philteos, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.85012, lon: -79.03288, locations facility: GSK Investigational Site, city: Brampton, state: Ontario, zip: L6T 0G1, country: Canada, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Naresh K. Aggarwal, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.68341, lon: -79.76633, locations facility: GSK Investigational Site, city: Ottawa, state: Ontario, zip: K1H 1E4, country: Canada, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: William Yang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.41117, lon: -75.69812, locations facility: GSK Investigational Site, city: Toronto, state: Ontario, zip: M9V 4B4, country: Canada, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Anil Gupta, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, locations facility: GSK Investigational Site, city: Windsor, state: Ontario, zip: N8X 2G1, country: Canada, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Joel Liem, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.30008, lon: -83.01654, locations facility: GSK Investigational Site, city: Quebec, zip: G1V 4W2, country: Canada, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Remi Gagnon, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.81228, lon: -71.21454, locations facility: GSK Investigational Site, city: Quebec, zip: G1W 4R4, country: Canada, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Catherine Vaillancourt, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.81228, lon: -71.21454, locations facility: GSK Investigational Site, city: Amiens Cedex 1, zip: 80054, country: France, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Sandrine Soriot-Thomas, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.9, lon: 2.3, locations facility: GSK Investigational Site, city: Argenteuil, zip: 95100, country: France, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Vincent Ioos, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.95, lon: 2.25, locations facility: GSK Investigational Site, city: Brest cedex, zip: 29609, country: France, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Pierrick Cros, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.3903, lon: -4.48628, locations facility: GSK Investigational Site, city: Cannes Cedex, zip: 06614, country: France, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Fabien Rolland, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.55135, lon: 7.01275, locations facility: GSK Investigational Site, city: Créteil Cedex, zip: 94010, country: France, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Ralph Epaud, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.78333, lon: 2.46667, locations facility: GSK Investigational Site, city: Libourne Cedex, zip: 33505, country: France, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Laurent Portel, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.91667, lon: -0.23333, locations facility: GSK Investigational Site, city: Lille, zip: 59000, country: France, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Caroline Thumerelle, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.63297, lon: 3.05858, locations facility: GSK Investigational Site, city: Poitiers cedex, zip: 86021, country: France, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Etienne-Marie Jutant, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.58333, lon: 0.33333, locations facility: GSK Investigational Site, city: Pontoise, zip: 95303, country: France, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Jean-François Boitiaux, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.05, lon: 2.1, locations facility: GSK Investigational Site, city: Strasbourg Cedex, zip: 67091, country: France, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Naji Khayath, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.58392, lon: 7.74553, locations facility: GSK Investigational Site, city: Larissa, state: Thessaly, zip: 41110, country: Greece, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Konstantinos Gourgoulianis, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.63689, lon: 22.41761, locations facility: GSK Investigational Site, city: Alexandroupolis, zip: 68100, country: Greece, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Paschalis Steiropoulos, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.84995, lon: 25.87644, locations facility: GSK Investigational Site, city: Athina, zip: 11527, country: Greece, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Paraskevi Xepapadaki, role: PRINCIPAL_INVESTIGATOR, locations facility: GSK Investigational Site, city: Heraklion, Crete, zip: 71500, country: Greece, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Emmanouil Paraskakis, role: PRINCIPAL_INVESTIGATOR, locations facility: GSK Investigational Site, city: Thessaloniki, zip: 57010, country: Greece, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Konstantinos Porpodis, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.64361, lon: 22.93086, locations facility: GSK Investigational Site, city: Monserrato, state: Cagliari, zip: 09042, country: Italy, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Stefano Del Giacco, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.25642, lon: 9.1444, locations facility: GSK Investigational Site, city: Napoli, state: Campania, zip: 80131, country: Italy, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Giuseppe Spadaro, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.85216, lon: 14.26811, locations facility: GSK Investigational Site, city: Roma, state: Lazio, country: Italy, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Paolo Palange, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.89193, lon: 12.51133, locations facility: GSK Investigational Site, city: Milano, state: Lombardia, zip: 20162, country: Italy, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Paolo Tarsia, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, locations facility: GSK Investigational Site, city: Varese, state: Lombardia, zip: 21100, country: Italy, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Antonio Spanevello, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.82058, lon: 8.82511, locations facility: GSK Investigational Site, city: Foggia, state: Puglia, zip: 71100, country: Italy, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Donato Lacedonia, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.45845, lon: 15.55188, locations facility: GSK Investigational Site, city: Padova, state: Veneto, zip: 35128, country: Italy, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Andrea Vianello, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.40797, lon: 11.88586, locations facility: GSK Investigational Site, city: Verona, state: Veneto, zip: 37134, country: Italy, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Claudio Micheletto, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.4299, lon: 10.98444, locations facility: GSK Investigational Site, city: Firenze, zip: 50134, country: Italy, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Federico Lavorini, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.77925, lon: 11.24626, locations facility: GSK Investigational Site, city: Torino, zip: 10128, country: Italy, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Luisa Brussino, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.07049, lon: 7.68682, locations facility: GSK Investigational Site, city: Ciudad de Panama, zip: 7099, country: Panama, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Reynaldo Chandler, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 8.9936, lon: -79.51973, locations facility: GSK Investigational Site, city: Panama, zip: 1001, country: Panama, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Bruno Hammerschlag, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 8.9936, lon: -79.51973, locations facility: GSK Investigational Site, city: Panama, zip: 7002, country: Panama, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Lorena Noriega, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 8.9936, lon: -79.51973, locations facility: GSK Investigational Site, city: Panama, country: Panama, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Yaricelys Bravo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 8.9936, lon: -79.51973, locations facility: GSK Investigational Site, city: Bialystok, zip: 15-010, country: Poland, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Piotr Siergiejko, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.13333, lon: 23.16433, locations facility: GSK Investigational Site, city: Bielsko-Biala, zip: 43-300, country: Poland, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Marta Frejowska-Reniecka, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.82245, lon: 19.04686, locations facility: GSK Investigational Site, city: Elblag, zip: 82-300, country: Poland, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Marek Mital, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 54.1522, lon: 19.40884, locations facility: GSK Investigational Site, city: Katowice, zip: 40-083, country: Poland, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Szymon Placzek, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.25841, lon: 19.02754, locations facility: GSK Investigational Site, city: Katowice, zip: 40-600, country: Poland, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Jakub Kwiatkowski, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.25841, lon: 19.02754, locations facility: GSK Investigational Site, city: Ostrowiec Swietokrzyski, zip: 27-400, country: Poland, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Anna Olech-Cudzik, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.92936, lon: 21.38525, locations facility: GSK Investigational Site, city: Plock, zip: 09-407, country: Poland, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Maria Wozniak, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.54682, lon: 19.70638, locations facility: GSK Investigational Site, city: Tarnow, zip: 33-100, country: Poland, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Bernadetta Majorek-Olechowska, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.01381, lon: 20.98698, locations facility: GSK Investigational Site, city: Soham, state: Cambridgeshire, zip: CB7 5JD, country: United Kingdom, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Anthony Gunstone, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.33543, lon: 0.33654, locations facility: GSK Investigational Site, city: Rhyl, state: Denbighshire, zip: LL18 4HZ, country: United Kingdom, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Selena Harris, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.31929, lon: -3.49228, locations facility: GSK Investigational Site, city: Ashton-under-Lyne, state: Greater Manchester, zip: OL6 6HD, country: United Kingdom, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Omair Razzaq, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.48876, lon: -2.0989, locations facility: GSK Investigational Site, city: Corby, state: Northamptonshire, zip: NN17 2UR, country: United Kingdom, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Amardeep Heer, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.49637, lon: -0.68939, locations facility: GSK Investigational Site, city: Guisborough, state: South Tees, zip: TS14 7DJ, country: United Kingdom, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Teik Goh, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 54.53478, lon: -1.05606, locations facility: GSK Investigational Site, city: Bebington, zip: CH63 9JP, country: United Kingdom, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Athanasios Simopoulos, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.35, lon: -3.01667, locations facility: GSK Investigational Site, city: Hounslow, zip: TW3 3EL, country: United Kingdom, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Ivor Singh, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.46839, lon: -0.36092, locations facility: GSK Investigational Site, city: Uttoxeter, zip: ST14 5JX, country: United Kingdom, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Satveer Poonian, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.89838, lon: -1.86488, hasResults: False

protocolSection identificationModule nctId: NCT06261944, orgStudyIdInfo id: NIRDM-SXCIP03, briefTitle: A Pivotal Clinical Investigation Confirming the Safety and Accuracy of the Glyconics-DS in Assessment of Glycated Nail Keratin in Individuals With Unknown Diabetes Status and Performance Evaluation of the Glyconics SW Package, acronym: ANODE03, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-08-08, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Glyconics Ltd, class: INDUSTRY, descriptionModule briefSummary: The main clinical study objective is to confirm the accuracy of the Glyconics-DS spectrometer when used in its intended medical purpose population, i.e., in individuals with unknown diabetes risk. Additionally, this investigation will serve as a pivotal performance evaluation for the associated software for correct delivery of the algorithm-based analysis of the individual diabetes risk. The study will be considered positive if the backend delivery of the chemometrics output is performed correctly as per the cloud-based analysis and its delivery represents the essential medical software to be evaluated in this investigation. The 'true' diabetes risk will be contrasted against values of an internal biomarker indicative of glycaemia, HbA1c, as measured based on standardised, certified methodology., conditionsModule conditions: Pre-diabetes, conditions: Undiagnosed Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Mass-screening, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 480, type: ESTIMATED, armsInterventionsModule interventions name: Near-infrared (NIR), outcomesModule primaryOutcomes measure: Dichotomised diabetes risk status, secondaryOutcomes measure: Sensitivity and specificity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sant Pau Hospital, status: RECRUITING, city: Barcelona, country: Spain, contacts name: Didac Mauricio, MD, PhD, role: CONTACT, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False

protocolSection identificationModule nctId: NCT06261931, orgStudyIdInfo id: 6313, briefTitle: Severity Over Time of Early Forms of Spondyloarthritis, acronym: STAR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2026-02-28, completionDateStruct date: 2044-02-28, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: Spondyloarthritis (SpA) is a group of chronic inflammatory pathologies whose progression over time is poorly defined, and in particular the clinical and instrumental elements that can predispose to a condition of disease severity are not completely known. It would be important to have an idea of what the predisposing factors are, possibly already at baseline, and possibly also at follow up, of severe disease, so as to be able to act early with more aggressive and targeted therapies on these patients, so as to achieve remission., conditionsModule conditions: Spondyloarthritis, conditions: Spondyloarthritis, Axial, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 387, type: ESTIMATED, armsInterventionsModule interventions name: Diagnostic assessment, interventions name: Diagnostic assessment, outcomesModule primaryOutcomes measure: spondyloarthritis severity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, city: Roma, zip: 00168, country: Italy, contacts name: Maria Antonietta D'Agostino, role: CONTACT, phone: +390630155701, email: mariaantonietta.dagostino@policlinicogemelli.it, contacts name: Maria Antonietta D'Agostino, role: PRINCIPAL_INVESTIGATOR, contacts name: Augusta Ortolan, role: SUB_INVESTIGATOR, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False

protocolSection identificationModule nctId: NCT06261918, orgStudyIdInfo id: 6269, briefTitle: Transcriptional and Epimetabolic Profile of Breast Carcinoma With Luminal or HER2+ or Locally Advanced Triple-negative Histotype in Patients With/Without Previous Clinical History of Metabolic Syndrome, acronym: PROMETA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2025-02-01, completionDateStruct date: 2026-07-01, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: This prospective pilot study of biological specimens aims to identify new prognostic and predictive biomarkers of response to standard therapy for local advanced BC, as well as to identify new targets for the development of immuno- therapeutic protocols. First aim is therefore to expand our knowledge to increase the response to preoperative treatment, intensify treatment patterns, and select patients based on clinical parameters. In this regard, it appears imperative to investigate yet under-investigated factors that might impair the response to standard therapy for local advanced BC including association to metabolic syndrome and analysis of tumoral and stromal features supporting a tumor microenvironment impenetrable to both drugs and immune system cells., conditionsModule conditions: Breast Cancer, conditions: Metabolic Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Influence of metabolic syndrome on the achievement of pathological complete response, outcomesModule primaryOutcomes measure: Acheivement of pathological complete response, secondaryOutcomes measure: Event-free survival (EFS), eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione Policlinico Universitario A. Gemelli - IRCCS, status: RECRUITING, city: Roma, country: Italy, contacts name: Alessandra Fabi, role: CONTACT, phone: 0630153773, email: alessandra.fabi@policlinicogemelli.it, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False

protocolSection identificationModule nctId: NCT06261905, orgStudyIdInfo id: 2000036908, secondaryIdInfos id: 000, type: OTHER, domain: CTGTY, briefTitle: Vitamin D in OUD: Exploration of Alterations on the Dopamine D2/D3 Receptor System, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Yale University, class: OTHER, collaborators name: University of Pennsylvania, descriptionModule briefSummary: The research team is investigating Opioid Use Disorder (OUD), a disorder characterized by dysregulated dopaminergic tone, to evaluate the mechanisms of adjunctive treatment with calcitriol. The investigators will recruit 12 subjects with OUD and 12 healthy subjects to participate in a double-blind, randomized study design where subjects will complete up to 2 Positron Emission Tomography (PET) scans using \[11C\]-PHNO. The investigators will compare subjects in differences between their own study days and in differences between healthy control subjects and subjects with OUD., conditionsModule conditions: Opioid Use Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: This is primarily a within-subject, two scan, randomized, double-blind, placebo-controlled study design. Healthy control subjects will only complete one scan to serve as a baseline comparison for subjects with OUD., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: [11C]-PHNO, interventions name: Calcitriol, interventions name: Placebo Control, interventions name: PET Scan, outcomesModule primaryOutcomes measure: Non-displaceable Tracer Binding Potentials (BPND), primaryOutcomes measure: Non-displaceable Tracer Binding Potentials (BPND), secondaryOutcomes measure: Spontaneous Blink Rate (SBR), secondaryOutcomes measure: Continuous Performance Task - Identical Pairs (CPT-IP), secondaryOutcomes measure: Probabilistic Reversal Learning Task (PRLT), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Yale School of Medicine, status: RECRUITING, city: New Haven, state: Connecticut, zip: 06510, country: United States, contacts name: Marcella Mignosa, role: CONTACT, phone: 203-903-7795, email: marcella.mignosa@yale.edu, contacts name: Adam Stryjewski, role: CONTACT, phone: 203-535-4424, email: adam.stryjewski@yale.edu, contacts name: Marc Potenza, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Gustavo Angarita, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.30815, lon: -72.92816, hasResults: False

protocolSection identificationModule nctId: NCT06261892, orgStudyIdInfo id: 2023-002, briefTitle: Non-invasive Biomarker Discovery for Pre-cervical or/and Cervical Cancer-HPV DNA and Other Biomarkers in Urine, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-20, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: WomenX Biotech Limited, class: INDUSTRY, collaborators name: Hong Kong Science and Technology Parks Corporation, descriptionModule briefSummary: The goal of this clinical trial is1. To test the sensitivity and specificity of using HPV DNA from urine for the detection of pre-cervical or/and cervical cancer.2. If HPV DNA is not a promising biomarker, other biomarkers will be explored.3. To develop an effective and non-invasive detection method of the pre-cervical or/and cervical cancer. in Women with menstruation.The main question it aims to answer is:To validate whether HPV DNA from urine could be used as a non-invasive means for the detection of pre-cervical or cervical cancerParticipants will1. Join the briefing session of the study2. Sign the consent form and health questionnaire3. Submit the cervical medical report(s) within 3 months or perform sponsored pap smear test4. Collect the urine sampleIf there is a comparison group: Researchers will compare The diseased group and the healthy group according to the medical reports they provided to see if HPV DNA from urine is a promising biomarker for the detection of pre-cervical or cervical cancer, conditionsModule conditions: Cervical Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Collect HPV DNA from urine, outcomesModule primaryOutcomes measure: HPV DNA from urine is a promising biomarkers for the detection of pre-cervical/ cervical cancer, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: WomenX Biotech Limited, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Alan LIU, Master, role: CONTACT, phone: +852 64786939, email: alanliu@womenx.net, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False

protocolSection identificationModule nctId: NCT06261879, orgStudyIdInfo id: 2023-001, briefTitle: Non-invasive Biomarker Discovery for Pre-cervical or/and Cervical Cancer--ACTN4 and Other Biomarkers in Menstrual Blood, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-20, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: WomenX Biotech Limited, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is1. To test the sensitivity and specificity of using ACTN4 from menstrual blood for the detection of pre-cervical or/and cervical cancer.2. If ACTN4 is not a promising biomarker, other biomarkers will be explored.3. To develop an effective and non-invasive detection method for pre-cervical or/and cervical cancer.in Women with menstruation.The main question it aims to answer is:To validate whether menstrual blood could be used as a non-invasive means for the detection of pre-cervical or cervical cancerParticipants will1. Join the briefing session of the study2. Sign the consent form and health questionnaire3. Submit the cervical medical report(s) within 3 months or perform sponsored pap smear test4. Collect the menstrual blood sampleIf there is a comparison group: Researchers will compare The diseased group and the healthy group according to the medical reports they provided to see if ACTN4 from menstrual blood is a promising biomarker for the detection of pre-cervical or cervical cancer, conditionsModule conditions: Cervical Cancer, conditions: CIN, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Special sanitary pad, outcomesModule primaryOutcomes measure: ACTN4 is a promising biomarkers for the detection of pre-cervical/ cervical cancer, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: WomenX Biotech Limited, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Alan LIU, Master, role: CONTACT, phone: +852 64786939, email: alanliu@womenx.net, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False

protocolSection identificationModule nctId: NCT06261866, orgStudyIdInfo id: MultiInter-CCS, briefTitle: Multimodality Imaging and Functional Lesion Assessment in Intermediate Coronary Stenosis in Chronic Coronary Syndrome, acronym: MultiInter-CCS, statusModule overallStatus: RECRUITING, startDateStruct date: 2011-04-07, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Medical University of Warsaw, class: OTHER, descriptionModule briefSummary: The aim of this prospective, investigator-initiated study is to evaluate the diagnostic accuracy and correlations between functional indices (fractional flow reserve, FFR) and morphometric indices: luminal and qualitative parameters assessed by optical coherence tomography (OCT) including minimal lumen area, plaque type, presence of thin cap fibroatheroma among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis., conditionsModule conditions: Chronic Coronary Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Correlation between fractional flow reserve (FFR) and minimal lumen area within the coronary stenosis, primaryOutcomes measure: Correlation between fractional flow reserve (FFR) and mean lumen area within the coronary stenosis, secondaryOutcomes measure: Major adverse cardiovascular events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical University of Warsaw, status: RECRUITING, city: Warsaw, country: Poland, contacts name: Mariusz Tomaniak, MD, PhD, Assoc. Prof., role: CONTACT, email: mariusz.tomaniak@wum.edu.pl, contacts name: Piotr Baruś, MD, role: CONTACT, email: piotr.barus@wum.edu.pl, geoPoint lat: 52.22977, lon: 21.01178, hasResults: False

protocolSection identificationModule nctId: NCT06261853, orgStudyIdInfo id: 2-081-23, briefTitle: The Impact of 3D-CBCT Imaging on Nerve Injuries During Wisdom Tooth Surgery, acronym: IMPACTION, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University of Aberdeen, class: OTHER, collaborators name: Zarqa University, collaborators name: King's College London, descriptionModule briefSummary: The investigators aim to investigate if the additional information available from a 3D scan of the wisdom tooth can reduce the risk of nerve injury during wisdom tooth surgery compared to conventional 2D images.Wisdom tooth surgery is a common surgical procedures that a significant proportion of the population will undergo. As with any other surgical procedure, there are potential complications, of which, injury to the nerve supplying feeling to the lip, chin, and tongue is the most significant. This can lead to persistent pain, tingling, or numbness that may impact a patient's ability to eat and function.The risk of nerve injury during wisdom tooth surgery is assessed using X-ray images, which show the position of the nerve and tooth in the jawbone. 2D and 3D scans are used, which have their own advantages and disadvantages such as reduced cost and radiation dose with 2D or more information from 3D images, but it remains unclear which is better at reducing the risk of nerve injuries., conditionsModule conditions: Inferior Alveolar Nerve Injuries, conditions: Impacted Third Molar Tooth, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Pragmatic, two-arm, single-blinded, randomised controlled trial designed to investigate the differences between 3D cone-beam computerised tomography (CBCT) and 2D orthopantomography (OPG) in reducing inferior alveolar nerve injuries during wisdom tooth surgery., primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: Double (Participant, Outcomes Assessor) A single-blinded methodology will be employed due to the nature of the image-based investigation where the surgeon is required to utilise one imaging modality during the surgery. In order to eliminate any influence or bias on the outcomes and data obtained for the primary objective, both the subject (patient) and the study member who will do the follow-up call will be blinded to the imaging techniques used on the day of surgery., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1292, type: ESTIMATED, armsInterventionsModule interventions name: 3D-CBCT, interventions name: 2D-OPG, outcomesModule primaryOutcomes measure: The number of patients reporting altered sensation in their lip and/or chin on the side of wisdom tooth surgery, secondaryOutcomes measure: Surgical time, secondaryOutcomes measure: Planned surgical approach, secondaryOutcomes measure: Intraoperative complications, secondaryOutcomes measure: Postoperative Complications, secondaryOutcomes measure: Wisdom tooth impaction classification, eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: King'S College Hospital Nhs Foundation Trust, city: London, state: England, zip: SE5 9RS, country: United Kingdom, contacts name: Nadine Khawaja, BDS PhD, role: CONTACT, email: nadine.khawaja@kcl.ac.uk, contacts name: Nadine Khawaja, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Aberdeen Dental Hospital, city: Aberdeen, state: Scotland, zip: AB25 2ZR, country: United Kingdom, contacts name: Anand Lalli, BDS PhD, role: CONTACT, phone: 01224553515, email: anand.lalli@nhs.scot, contacts name: Rahmeh Alhyari, BDS, role: CONTACT, email: r.alhyari.22@abdn.ac.uk, contacts name: Anand Lalli, Consultant in Oral Surgery, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 57.14369, lon: -2.09814, hasResults: False

protocolSection identificationModule nctId: NCT06261840, orgStudyIdInfo id: 2024-101, briefTitle: Refining Treatment Options for Trichomonas Vaginalis Infection: A Comparative Analysis of Metronidazole and Secnidazole, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2029-05-01, completionDateStruct date: 2029-07-31, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Tulane University, class: OTHER, collaborators name: University of Alabama at Birmingham, collaborators name: Louisiana State University Health Sciences Center in New Orleans, descriptionModule briefSummary: This is a multi-centered, randomized, open-label, parallel, phase IV clinical trial comparing the effectiveness and cost-effectiveness of oral multi-dose metronidazole (MTZ) and oral single-dose secnidazole (SEC) for the treatment of Trichomonas vaginalis in both women and men., conditionsModule conditions: Trichomonas Vaginitis, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1200, type: ESTIMATED, armsInterventionsModule interventions name: Metronidazole 500 mg, interventions name: Secnidazole 2000 MG, outcomesModule primaryOutcomes measure: Treatment, as Measured by the Number of Participants that are Cured of Trichomonas Vaginalis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06261827, orgStudyIdInfo id: RECORD, briefTitle: High-dose Inhaled NO Therapy for the pREvenvention of NP After Cardiac Surgery Under CPB, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2025-02-20, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Tomsk National Research Medical Center of the Russian Academy of Sciences, class: OTHER, descriptionModule briefSummary: The primary aim of this single-center, prospective, randomized, controlled, study is to test the hypothesis that inhalation of NO 200 ppm prevents the development of nosocomial pneumonia in patients at risk after cardiac surgery under CPB. The study is interventional. Examination and treatment of patients is carried out in accordance with the approved standards of medical care for the relevant diseases. During the study, no experimental or unregistered (not approved for use) medical or diagnostic procedures in the territory of the Russian Federation will be carried out. The study includes patients admitted to the Cardiac Surgery Department of Cardiology Research Institute of Tomsk National Research Medical Center for elective surgery with CPB., conditionsModule conditions: Nosocomial Pneumonia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Sham treatment, interventions name: 200-ppm NO, outcomesModule primaryOutcomes measure: Incidence of nosocomial pneumonia (percent), secondaryOutcomes measure: Total leukocyte counts (10*9/L), secondaryOutcomes measure: Immature cell counts (percentage), secondaryOutcomes measure: C-reactive protein (CRP) level (mg/L), secondaryOutcomes measure: PCT (procalcitonin) test (ng/mL), secondaryOutcomes measure: Presepsin levels (pg/mL), secondaryOutcomes measure: Ferritin levels (ng/mL), secondaryOutcomes measure: LDH (lactate dehydrogenase) levels (IU/L), secondaryOutcomes measure: Interleukin-6 (IL-6) levels (pg/mL), secondaryOutcomes measure: Interleukin-8 (IL-8) levels (pg/mL), secondaryOutcomes measure: Surfactant protein SP-D plasma levels (ng/mL), secondaryOutcomes measure: sRAGE levels (pg/mL), secondaryOutcomes measure: endothelin-1 levels (pg/mL), secondaryOutcomes measure: Asymmetric dimethylarginine (ADMA) levels (ng/mL), secondaryOutcomes measure: Vascular endothelial growth factor A (VEGF-A) levels (pg/mL), secondaryOutcomes measure: Angiopoietin-1 levels (ng/mL), secondaryOutcomes measure: Angiopoietin-2 levels (ng/mL), secondaryOutcomes measure: S/F index (ratio), secondaryOutcomes measure: Incidence of adverse lung ultrasound findings (percentage), secondaryOutcomes measure: Six-minute walk test (6MWT) distance (meters), secondaryOutcomes measure: Lung vital capacity (L), secondaryOutcomes measure: Forced vital capacity (L), secondaryOutcomes measure: Forced expiratory volume (L/s), secondaryOutcomes measure: Peak expiratory flow (L/s), secondaryOutcomes measure: VE-minute ventilation (L/min), secondaryOutcomes measure: VT-tidal volume (L), secondaryOutcomes measure: VE/VO2 - ventilatory equivalents for oxygen (ratio), secondaryOutcomes measure: VE/VСO2 - ventilatory equivalent for carbon dioxide, secondaryOutcomes measure: PetO2 - partial pressure of oxygen in exhaled air (mm Hg), secondaryOutcomes measure: PetCO2 - partial pressure of carbon dioxide in exhaled air (mmHg), secondaryOutcomes measure: Exhaled NO levels (ppm), secondaryOutcomes measure: Systolic blood pressure (SBP) levels (mmHg), secondaryOutcomes measure: Diastolic blood pressure (DBP) levels (mmHg), secondaryOutcomes measure: Heart rate (HR) (bpm), secondaryOutcomes measure: Respiratory rate (RR) (brpm), secondaryOutcomes measure: Saturation of peripheral oxygen (SpO2) levels (percentage), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cardiology Research Institute Tomsk national Research Medical Center, status: RECRUITING, city: Tomsk, country: Russian Federation, contacts name: Nikolay O. Kamenshchikov, role: CONTACT, phone: +79138183657, email: nikolajkamenof@mail.ru, contacts name: Tatiana P Kalashnikova, role: CONTACT, phone: +79138141664, email: kalashnikova-t@mail.ru, geoPoint lat: 56.49771, lon: 84.97437, hasResults: False

protocolSection identificationModule nctId: NCT06261814, orgStudyIdInfo id: iRISID-2023-2142, briefTitle: Contrast Enhanced Ultrasound to Evaluate Response to Chemoembolization in Patients With Liver Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-31, primaryCompletionDateStruct date: 2027-07-01, completionDateStruct date: 2028-01-01, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: john eisenbrey, class: OTHER, descriptionModule briefSummary: This phase II trial evaluates the diagnostic performance of contrast-enhanced ultrasound (CEUS) for assessing treatment response in patients undergoing transarterial chemoembolization (TACE) for liver tumors. TACE is a hepatic artery embolization technique involving the injection of a blocking agent and a chemotherapy agent to treat liver cancers. Currently, contrast enhanced magnetic resonance imaging or computed tomography are used to assess disease response 1-2 months after TACE treatment, but ultrasound may be a less expensive, earlier alternative. CEUS is an imaging procedure that uses high-frequency sound waves to generate images of the body after administering lumason, an imaging agent used to enhance visualization of blood flow on ultrasounds. CEUS is able to be performed during the TACE procedure, making it possible to evaluate treatment response earlier than standard techniques. CEUS may be an effective method to evaluate treatment response more accurately and much earlier than current standard evaluation methods., conditionsModule conditions: Liver Neoplasms, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: No Data Available, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 266, type: ESTIMATED, armsInterventionsModule interventions name: Sulfur Hexafluoride Lipid Microspheres, interventions name: Contrast-Enhanced Ultrasound, interventions name: Transarterial Chemoembolization, interventions name: Medical Chart Review, outcomesModule primaryOutcomes measure: Recurrence, primaryOutcomes measure: Specificity, primaryOutcomes measure: Positive predictive value, primaryOutcomes measure: Negative predictive value, primaryOutcomes measure: False discovery rate, secondaryOutcomes measure: Residual tumor vacularity, secondaryOutcomes measure: Diagnostic performance for each imaging mode, secondaryOutcomes measure: Ability of the model to predict binary treatment response, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sidney Kimmel Cancer Center at Thomas Jefferson University, city: Philadelphia, state: Pennsylvania, zip: 19107, country: United States, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False

protocolSection identificationModule nctId: NCT06261801, orgStudyIdInfo id: GZY-ZJ-KJ-23088, briefTitle: Efficacy of Electroacupuncture Combined With Pregabalin in the Treatment of Trigeminal Herpetic Neuralgia: a Multicenter Randomized Controlled Trial Study Protocol, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-07, primaryCompletionDateStruct date: 2025-07-20, completionDateStruct date: 2025-12-20, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: The Third People's Hospital of Hangzhou, class: OTHER, collaborators name: The Third Affiliated hospital of Zhejiang Chinese Medical University, descriptionModule briefSummary: Trigeminal herpetic neuralgia is a common type of Zoster-associated Pain (ZAP), which troubles individuals in all ages and burdens society all over the world. Eleactroaupuncture (EA) is increasingly used in the treatment of ZAP due to its advantages such as low price, high safety, no adverse reactions, and high patient acceptance. Therefore, it is necessary to conduct randomized controlled trials to evaluate the effectiveness and safety of EA on ZAP and whether EA can be used as a substitute for pregabalin., conditionsModule conditions: Trigeminal Herpetic Neuralgia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 102, type: ESTIMATED, armsInterventionsModule interventions name: Medication Group, interventions name: EA Group, interventions name: EA+Medication Group, outcomesModule primaryOutcomes measure: Visual Analog Score change, secondaryOutcomes measure: McGill Pain Questionnaire Short Form (SF-MPQ), secondaryOutcomes measure: Brief Pain Inventory Scale (BPI-SF), secondaryOutcomes measure: Medical Outcomes Study Sleep Scale (MOS-SS), secondaryOutcomes measure: Hamilton Depression Rating Scale (HAMD)Hamilton Anxiety Rating Scale (HAMA), secondaryOutcomes measure: Hamilton Depression Rating Scale (HAMD), secondaryOutcomes measure: Short Form 36 Health Survey (SF-36), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Hangzhou Third People's Hospital, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310009, country: China, contacts name: Pin Lin, role: CONTACT, phone: 1358876268686, email: yjlp1@163.com, contacts name: Chengcheng Kong, role: CONTACT, phone: 8613868078286, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False

protocolSection identificationModule nctId: NCT06261788, orgStudyIdInfo id: EASY II Trial, briefTitle: Efficacy and Safety of the Sync-AV II Temporary Cardiac Pacing Catheter, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2023-09-13, completionDateStruct date: 2023-09-26, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Swift Sync, Inc., class: INDUSTRY, collaborators name: Regulatory and Quality Solutions, descriptionModule briefSummary: This is a prospective, single-center, non-randomized open label study. The objective of this study is to evaluate the efficacy and safety of the Sync-AV II Temporary Cardiac Pacing Catheter in subjects whose elective surgical or interventional procedure require temporary pacing support., conditionsModule conditions: Heart Block, conditions: Valve Heart Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Temporary pacing, outcomesModule primaryOutcomes measure: With a commercially available pacing box and/or analyzer, measure the ventricular pacing threshold at 24 hours post implant of the investigational device (index procedure), primaryOutcomes measure: Procedure related complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centro de Intervenciones Endovasculares y Cirugia Cardiovascular, city: Asunción, country: Paraguay, geoPoint lat: -25.30066, lon: -57.63591, hasResults: False

protocolSection identificationModule nctId: NCT06261775, orgStudyIdInfo id: IRB-2401011-EXM, briefTitle: Effect of Minimally Processed Animal Protein on Biomarkers for Cognitive Decline, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-30, primaryCompletionDateStruct date: 2024-02-07, completionDateStruct date: 2026-01-02, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: South Dakota State University, class: OTHER, descriptionModule briefSummary: Minimally processed animal protein is a premier source of essential macro and micronutrients in the diet and is important, especially to older adults who are at increased risk of nutritional deficiency and age-related physiological changes. Our central hypothesis is that adding lean animal protein within a dietary guideline-based diet will enhance nutrient adequacy and attenuate markers of cognitive decline. This is a retrospective study leveraging samples collected from the feeding trial NCT05581953. PI for both studies are the same., conditionsModule conditions: Healthy Lifestyle, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ACTUAL, armsInterventionsModule interventions name: Red meat-based meal, interventions name: Lacto-ovo-vegetarian meal, outcomesModule primaryOutcomes measure: Concentration of phosphatidylcholine in blood, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: South Dakota State University, Wagner Hall 416, city: Brookings, state: South Dakota, zip: 57007, country: United States, geoPoint lat: 44.31136, lon: -96.79839, hasResults: False

protocolSection identificationModule nctId: NCT06261762, orgStudyIdInfo id: SDC-24-1, briefTitle: Hard and Soft Tissue Dimensional Change After Consecutive Extractions and Unassisted Socket Healing in the Esthetic Zone, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to evaluate the post-extraction hard and soft tissue dimension changes in patients requiring consecutive extractions and unassisted socket healing in the anterior maxilla. The main questions it aims to answer are:* Is significant alveolar ridge resorption observed at center sites after consecutive extractions* Is significant alveolar ridge resorption observed at the interalveolar septum after consecutive extractions, are different extraction sites associated with significantly different bone resorption* Is a thick or thin wall phenotype associated with the amount of bone resorption* Is soft tissue thickness change associated with the corresponding location (extraction site or interalveolar septum) and post-extraction thickness of the bone* Is the interdental papilla height significantly affected after extractions.Participants will undergo consecutive (two) extractions and will be evaluated after subsequent unassisted socket healing for 8 weeks., conditionsModule conditions: Wound Heal, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, outcomesModule primaryOutcomes measure: Bone level change from baseline, primaryOutcomes measure: Soft tissue change from baseline, secondaryOutcomes measure: Correlation between baseline facial bone thickness and dimensional soft tissue alterations during healing at the interalveolar septum., eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06261749, orgStudyIdInfo id: EmgSCAPULA, briefTitle: Analysis of Scapular Musculature Activation During Targeted Abdominal Contraction With Scapular Stabilization Exercises, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, descriptionModule briefSummary: Muscle activation of the upper trapezius, lower trapezius and serratus anterior muscles will be measured during prone scapular retraction exercises. Then the same exercises will be performed with abdominal contraction using a stabilizer and muscle activity of the same muscles will be measured. A comparison will be made between the two conditions., conditionsModule conditions: Scapula; Increased, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Voluntary Abdominal Contractions, interventions name: Exercise, outcomesModule primaryOutcomes measure: Electromyography, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hacettepe University, status: RECRUITING, city: Ankara, zip: 06100, country: Turkey, contacts name: İrem Düzgün, Prof, role: CONTACT, phone: +903051577, email: iremduzgun@yahoo.com, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False

protocolSection identificationModule nctId: NCT06261736, orgStudyIdInfo id: 2107044-1, briefTitle: The Effectiveness of Prophylactic Antibiotics for Urethral Bulking, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-24, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Atlantic Health System, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to evaluate if prophylactic antibiotics in urethral bulking are effective in reducing postprocedural urinary tract infections., conditionsModule conditions: Stress Urinary Incontinence, conditions: Postoperative Urinary Tract Infection, conditions: Urethral Bulking, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Prophylactic antibiotics, interventions name: No antibiotics, outcomesModule primaryOutcomes measure: Rate of urinary tract infection (UTI), secondaryOutcomes measure: Rate of postoperative urinary retention, secondaryOutcomes measure: Rates of other postoperative complications, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Atlantic Health, status: RECRUITING, city: Morristown, state: New Jersey, zip: 07960, country: United States, contacts name: Tess Gao, MD, role: CONTACT, phone: 973-971-7267, email: tess.gao@atlantichealth.org, contacts name: Erika Wasenda, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.79677, lon: -74.48154, hasResults: False

protocolSection identificationModule nctId: NCT06261723, orgStudyIdInfo id: PI22/1009, briefTitle: Effect of Non-chirurgical Periodontal Treatment on the Immune System From a Gender Perspective, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Milagros Rocha Barajas, class: OTHER, collaborators name: Instituto de Salud Carlos III, descriptionModule briefSummary: The goal of this observational study is to evaluate non-surgical periodontal treatment in women and men with periodontitis with and without obesity. The main questions it aims to answer are:* If non-surgical periodontal treatment of patients with chronic periodontitis can modulate the innate and adaptive immune response taking into account patient gender and the coexistence of obesity* If there are specific miRNAs that can regulate this immune response and can be considered as suitable biomarkers and therapeutic targets.Obese or non-obese participants with periodontitis will receive non-surgical periodontal treatment, consisting of oral health guidance and mechanical periodontal debridement throughout the mouth using an ultrasonic device and manual curettes. Researchers will compare four groups: obese women, non-obese women, obese men, and non-obese men, to clarify the involment of immune response after treatment, considering the coexistence of obesity and potential gender differences., conditionsModule conditions: Periodontal Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: non-chirurgical periodontal treatment, outcomesModule primaryOutcomes measure: Changes in inflammasome complex activation grade in patients with chronic periodontitis with and without obesity, before and after non-surgical periodontal treatment., primaryOutcomes measure: Changes in endothelial function in the study population., primaryOutcomes measure: Changes in endothelial function at molecular level in the study population., primaryOutcomes measure: Changes in the systemic inflammation status in the study population., primaryOutcomes measure: Changes in the expression of genes related to inflammatory pathways in PBMC in the study population., primaryOutcomes measure: Changes in the expression of genes related to oxidative stress levels in PBMC in the study population., primaryOutcomes measure: Changes in the expression of genes related to cellular respiration in PBMC in the study population., primaryOutcomes measure: Sequence miRNAs in biological fluids in patients with chronic periodontitis with and without obesity, before and after non-surgical periodontal treatment., primaryOutcomes measure: Evaluate the distribution and phenotype of different T lymphocyte and monocyte subpopulations in the study population., secondaryOutcomes measure: Changes in the protein expression of autophagy markers in PBMC in the study population., secondaryOutcomes measure: Evaluate autophagy flux in the study population., secondaryOutcomes measure: Evaluate autophagosome formation in the study population., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 69 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Dr Peset, status: RECRUITING, city: Valencia, zip: 46017, country: Spain, contacts name: Milagros Rocha Barajas, PhD, role: CONTACT, phone: 0034 963 189 132, email: milagros.rocha@fisabio.es, contacts name: Milagros Rocha Barajas, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.46975, lon: -0.37739, locations facility: University Hospital Dr. Peset, status: RECRUITING, city: Valencia, zip: 46017, country: Spain, contacts name: Milagros Rocha Barajas, role: CONTACT, phone: 963188875, email: milagros.rocha@fisabio.es, geoPoint lat: 39.46975, lon: -0.37739, hasResults: False

protocolSection identificationModule nctId: NCT06261710, orgStudyIdInfo id: EA2_253_23, briefTitle: Intrapartum Ultrasound in Labor: Sonography Only, Few Internal Examinations, acronym: SOFIE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-27, primaryCompletionDateStruct date: 2029-02-01, completionDateStruct date: 2030-02-01, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Larry Hinkson, class: OTHER, descriptionModule briefSummary: This is a prospective, randomized trial to determine whether the use of sonographic parameters during labor results in less intrapartum infection compared to traditional invasive examination. Other secondary outcomes include maternal satisfaction and overall birth outcomes., conditionsModule conditions: Labor Complication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 356, type: ESTIMATED, armsInterventionsModule interventions name: Sonography in labour, outcomesModule primaryOutcomes measure: Maternal Fever Incidence, primaryOutcomes measure: Maternal Tachycardia Incidence, primaryOutcomes measure: Maternal Leucocytosis, primaryOutcomes measure: Uterine tenderness, primaryOutcomes measure: Fetal Tachycardia, primaryOutcomes measure: Foul-smelling amniotic fluid, secondaryOutcomes measure: Average age, secondaryOutcomes measure: Maternal weight, secondaryOutcomes measure: Maternal height, secondaryOutcomes measure: Completed weeks of pregnancy, secondaryOutcomes measure: Previous pregnancy, secondaryOutcomes measure: Incidence of Vaginal Examinations, secondaryOutcomes measure: Incidence of Caesarean section, secondaryOutcomes measure: Incidence of Instrumental Delivery, secondaryOutcomes measure: Incidence of estimated blood loss >1000 ml, secondaryOutcomes measure: Incidence of antibiotics usage, secondaryOutcomes measure: Incidence of Neonatal Admission, secondaryOutcomes measure: Neonatal weight, secondaryOutcomes measure: Maternal Satisfaction Scores, otherOutcomes measure: Incidence of Chorioamnionitis on Placenta Histologie, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Charité University Hospital, status: RECRUITING, city: Berlin, country: Germany, contacts name: Larry Hinkson, FRCOG, role: CONTACT, geoPoint lat: 52.52437, lon: 13.41053, hasResults: False

protocolSection identificationModule nctId: NCT06261697, orgStudyIdInfo id: P.T.REC/012/004876, briefTitle: Relationship Between Smartphone Addiction and Temporomandibular Joint Disorders Among Adults in Egypt., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: Cross sectional study to investigate the relation between Smartphone addiction and temporomandibular disorders among youth population in Egypt. An online- based questionnaire study. A 296 participants who are Egyptians with age between18 and 35 years old without prior neck and upper extremity related diseases, orofacial trauma or surgeries, history of rheumatoid arthritis or congenital musculoskeletal problems. An online- based questionnaire will be sent through different social media platforms, it will include three screens, the first includes the consent form, the second includes the demographic data (year of birth, current educational status, gender and geographic information ), and the third page includes questionnaires., conditionsModule conditions: Temporomandibular Disorders, conditions: Smartphone Addiction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: PROSPECTIVE, enrollmentInfo count: 296, type: ESTIMATED, armsInterventionsModule interventions name: A web based survey, outcomesModule primaryOutcomes measure: Fonseca Anamnestic Index (FAI) questionnaire, primaryOutcomes measure: Smartphone Addiction Scale-Short version (SAS-SV) questionnaire, primaryOutcomes measure: Patient Health Questionnaire (PHQ), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06261684, orgStudyIdInfo id: MS-259-2023, briefTitle: Intralesional Acyclovir Versus Cryotherapy in the Treatment of Plantar Warts. A Randomized Controlled Trial., statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: The goal of this prospective randomized controlled study is to study the safety and efficacy of intralesional acyclovir compared to cryotherapy in plantar warts. The main questions needed to be answered are:1. Is Intralesional acyclovir safe for plantar warts?2. Is Intralesional acyclovir more efficient in treating plantar warts compared to cryotherapy?, conditionsModule conditions: Plantar Wart, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 92, type: ESTIMATED, armsInterventionsModule interventions name: Intralesional Acyclovir, interventions name: Cryotherapy, outcomesModule primaryOutcomes measure: Cure rate, primaryOutcomes measure: Recurrence rate, primaryOutcomes measure: Patient satisfaction score, secondaryOutcomes measure: Correlation of treatment with number of ipsilateral warts, secondaryOutcomes measure: Correlation of treatment with age, secondaryOutcomes measure: Correlation of treatment with gender, secondaryOutcomes measure: Correlation of treatment with size of the wart, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cairo University Hospital, status: RECRUITING, city: Cairo, country: Egypt, contacts name: Basant Helal, MRCP, role: CONTACT, contacts name: Shahira Ramadan, Professor, role: PRINCIPAL_INVESTIGATOR, contacts name: Yousra Azzazi, Lecturer, role: SUB_INVESTIGATOR, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False

protocolSection identificationModule nctId: NCT06261671, orgStudyIdInfo id: 2312-ABU-028-VF, briefTitle: Effect of Antioxydant-enriched Media on Blastocyst Euploidy Rates., acronym: GX, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: ART Fertility Clinics LLC, class: OTHER, descriptionModule briefSummary: One of the most sensible factors in IVF culture conditions is the susceptibility of gametes and embryos to an induced increase in reactive oxidative species (ROS) caused by the artificial environment. This study aims to evaluate the impact of using antioxidant-supplemented media during culture to evaluate embryo ploidy rates in a prospective randomized trial using sibling oocytes., conditionsModule conditions: Infertility, conditions: In Vitro Fertilization, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A randomization list (indicating Gx Media Vitrolife or GT Coopersurgical) will be used to verify to which group the first half of oocytes will be allocated to. In case an odd number of oocytes is present, one extra oocyte is allocated to the group as indicated by the randomization list., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: antioxidants-enriched culture medium (Gx), outcomesModule primaryOutcomes measure: Blastocyst ploidy is determined after a biopsy of trophectoderm cells, taken from the blastocyst on day 5, 6 or 7 from development. The following outcomes are possible: • Normal • Abnormal • No result/Inconclusive • Low or high Mosaic, secondaryOutcomes measure: Cycle ploidy rate: the number of euploid embryos in the group Blastocyst quality at the time of biopsy based on modified Gardner's criteria. Usable blastocyst rate per group and per day of biopsy (day 5, 6, 7), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 43 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06261658, orgStudyIdInfo id: TESOVA2022, briefTitle: Improving the Quality of Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma, acronym: TESOVA2022, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-29, completionDateStruct date: 2033-12-29, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: IRCCS Azienda Ospedaliero-Universitaria di Bologna, class: OTHER, descriptionModule briefSummary: The study is aimed to evaluate the effects of intraovarian injection of autologous Platelet-enriched Autologous Plasma on the outcomes of orthotopic transplantation of cryopreserved ovarian tissue., conditionsModule conditions: Cryopreservation, conditions: Ovary Injury, conditions: Infertility, Female, conditions: Menopause Ovarian Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Cryopreserved Ovarian Tissue Reimplantation, outcomesModule primaryOutcomes measure: Safety of Cryopreserved ovarian tissue transplantation Using Platelet-enriched Autologous Plasma, secondaryOutcomes measure: Effectiveness of Cryopreserved ovarian tissue transplantation Using Platelet-enriched Autologous Plasma, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Diego Raimondo, status: RECRUITING, city: Bologna, state: BO, zip: 40138, country: Italy, contacts name: Diego Raimondo, MD, role: CONTACT, phone: 0512144389, phoneExt: 0039, email: die.raimondo@gmail.com, contacts name: Renato Seracchioli, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Diego Raimondo, MD, role: SUB_INVESTIGATOR, contacts name: Rossella Vicenti, PhD, role: SUB_INVESTIGATOR, contacts name: Valentina Magnani, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 44.49381, lon: 11.33875, hasResults: False

protocolSection identificationModule nctId: NCT06261645, orgStudyIdInfo id: ROTOFUNK_2_2023, briefTitle: Rotofunc - Non-traumatic Shoulder Instability and Total Rotator Cuff Function, acronym: ROTOFUNC, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-01, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Sahlgrenska University Hospital, Sweden, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test the effect of a novel assessment and treatment strategy for young adults with severely disabling non-traumatic shoulder instability. The main question it aims to answer is if this treatment will substantially change the patients shoulder function to a more stable and controllable state and thereby give a higher quality of life. Participants failure in active shoulder muscle function will be assessed and exercises will be selected individually. Patients will be asked to perform the exercises twice per day. At clinical visits to a specialized physiotherapist the exercises will be upgraded to restore full dynamic stability throughout shoulder movement range. The active treatment period will be 4 months. Researchers will compare two groups. One group will start directly after a baseline assessment is fulfilled. The other group will receive the treatment with a delay of 4 months to evaluate if the selected exercises can substantially change the shoulder stability compared to no treatment, the natural course of the condition., conditionsModule conditions: Shoulder Dislocation or Subluxation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: A 16 week exercise program with specific exercises to restore total rotator cuff function individually selected during clinical physiotherapy visits and performed 2 - 4 times daily.In addition, the patient will receive education and guidance in the daily use of the arm to adjust to appropriate load on the shoulder., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Investigator: 6 physiotherapists are care providers, responsible for the Intervention . Two independent investigators does not know who is the actual care provider. However, all patients recieve the same intervention.Outcome assessor: each participant is given a research code. The results from the assessments are entered in the data base by a research assistant, not involved in the study on any level.Individuals are not identifiable. The outcome assessor are planning for all statistics used and is not in other ways involved in the study., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Early Physiotherapist selected active exercises, interventions name: Delayed Physiotherapist selected active exercises, outcomesModule primaryOutcomes measure: Neuromuscular control, secondaryOutcomes measure: Clinical assessment - Active and passive range of motion, secondaryOutcomes measure: Pain at rest, secondaryOutcomes measure: Pain during motion, secondaryOutcomes measure: Apprehension of instability during motion, secondaryOutcomes measure: Patient reported quality-of-life in relation to shoulder function, secondaryOutcomes measure: Patient's satisfaction, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 35 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Sahlgrenska University Hospital/Mölndal, Physiotherapy Dpt, status: RECRUITING, city: Gothenburg, state: Mölndal, zip: SE 43180, country: Sweden, contacts name: Ingrid K Hultenheim Klintberg, PhD, role: CONTACT, email: ingrid.hultenheim-klintberg@vgregion.se, geoPoint lat: 57.70716, lon: 11.96679, hasResults: False

protocolSection identificationModule nctId: NCT06261632, orgStudyIdInfo id: Hemo-Blood, briefTitle: Blood Flow Restriction in Improving Muscle Strength of Patients With Hemophilic Knee Arthropathy, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2024-07-28, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Investigación en Hemofilia y Fisioterapia, class: NETWORK, descriptionModule briefSummary: Background. The main physical sequela of patients with hemophilia is the development of a progressive, degenerative intra-articular lesion, known as hemophilic arthropathy). This sequela is manifested by chronic pain, limited range of motion, axial abnormalities, and periarticular muscle atrophy.Objective. To assess the safety and effectiveness of an intervention through blood flow restriction, regarding the frequency of bleeding and the improvement in muscle activation and strength, range of motion, functionality, joint pain, joint status and the perception of quality of life in patients with hemophilic arthropathy. knee and ankle.Study design. Randomized, multicenter, single-blind clinical study. Method. 60 patients with hemophilia A and B will be recruited in this study. Patients will be recruited in 6 regions of Spain. The dependent variables will be: bleeding frequency (self-registration), pain (measured with the visual analog scale and pressure algometer), quality of life (SF-36 scale), joint status (Hemophilia Joint Health Score scale), strength (dynamometer) and muscle activation (surface electromyograph), range of motion (goniometer) and functionality (Timed up and go test). Three evaluations will be carried out: pre-treatment, post-treatment and after a follow-up period of 4 weeks.Expected results. Observe the safety of blood flow restriction in hemophilia patients. To analyze the efficacy of blood flow restriction in improving muscle strength and activation, range of motion, chronic pain, functionality, and the perception of quality of life in patients with hemophilic knee and ankle arthropathy., conditionsModule conditions: Hemophilia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Blood flow restriction, outcomesModule primaryOutcomes measure: Change from baseline hemarthrosis after treatment and at four weeks, secondaryOutcomes measure: Change from baseline pressure pain threshold after treatment and at four weeks, secondaryOutcomes measure: Change from baseline muscle strength after treatment and at four weeks, secondaryOutcomes measure: Change from baseline electrical activity of the muscles after treatment and at four weeks, secondaryOutcomes measure: Change from baseline range of motion after treatment and at four weeks, secondaryOutcomes measure: Change from baseline joint status after treatment and at four weeks, secondaryOutcomes measure: Change from baseline functionality after treatment and at four weeks, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Oviedo, city: Oviedo, state: Asturias, zip: 33006, country: Spain, geoPoint lat: 43.36029, lon: -5.84476, hasResults: False

protocolSection identificationModule nctId: NCT06261619, orgStudyIdInfo id: 2079951, briefTitle: Superiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Ventilation Alone, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Rhode Island Hospital, class: OTHER, descriptionModule briefSummary: Effective respiratory ventilation is achieved by moving the right amount of air to and out of the lungs while keeping the pressures at a safe level. A disposable safety device, Adult Sotair®, was created to improve manual ventilation delivery. In this superiority study, the investigators will perform two-group cross over randomized design to test the superiority of the Adult Sotair® device compared to manual ventilation alone., conditionsModule conditions: Airway Management, conditions: Respiration, Artificial, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Study Design: A superiority trial; a single two-group cross over randomized trial., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: The care provider will not know the recorded lung function recordings., whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Adult Sotair Device, outcomesModule primaryOutcomes measure: Peak airway pressure, secondaryOutcomes measure: Tidal volume, secondaryOutcomes measure: Airflow, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rhode Island Hospital, status: RECRUITING, city: Providence, state: Rhode Island, zip: 02903, country: United States, contacts name: Mark Kendall, MD, role: CONTACT, phone: 401-444-5172, email: mark.kendall@lifespan.org, geoPoint lat: 41.82399, lon: -71.41283, hasResults: False

protocolSection identificationModule nctId: NCT06261606, orgStudyIdInfo id: 4020286, briefTitle: Feasibility of a Multifaceted Program to Reduce Cardiovascular Complications of Air Pollution, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-28, primaryCompletionDateStruct date: 2024-03, completionDateStruct date: 2024-03, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Parham Sadeghipour, class: OTHER, descriptionModule briefSummary: The main goal of this clinical trial is to evaluate the feasibility of conducting a large-scale clinical trial testing a program containing several aspects for reducing the effects of air pollution on cardiovascular health (which is named the hybrid program hereafter) in adult patients (18 years or older) with atherosclerotic cardiovascular disease. Furthermore, we seek to answer how much patients adhere to and are satisfied with implementing the hybrid program, and what problems executing this program will bring for patients., conditionsModule conditions: Atherosclerosis, conditions: Coronary Artery Disease, conditions: Peripheral Arterial Disease, conditions: Ischemic Stroke, conditions: Carotid Artery Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants undergo permuted block randomization with block sizes of four via a web-based system will be used for the study, in a 1:1 ratio between the hybrid strategy or control arms., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Hybrid strategy, outcomesModule primaryOutcomes measure: Feasibility of conducting the trial, secondaryOutcomes measure: Adherence to the individual components of the hybrid strategy, secondaryOutcomes measure: Patient satisfaction with the hybrid strategy, secondaryOutcomes measure: Any potential adverse events in intervention and control groups during the 30-day follow-up, otherOutcomes measure: Change in the health-related quality of life, otherOutcomes measure: Change in the level of anxiety, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rajaie Cardiovascular Medical and Research Center, status: RECRUITING, city: Tehran, zip: 1995614331, country: Iran, Islamic Republic of, contacts name: Parham Sadeghipour, MD, role: CONTACT, phone: +98 21 2392 2092, email: psadeghipour@rhc.ac.ir, geoPoint lat: 35.69439, lon: 51.42151, hasResults: False

protocolSection identificationModule nctId: NCT06261593, orgStudyIdInfo id: Ankle-Blood, briefTitle: Blood Flow Restriction in Improving Muscle Strength of Patients With Hemophilic Ankle Arthropathy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-06, primaryCompletionDateStruct date: 2024-07-03, completionDateStruct date: 2024-09-20, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Investigación en Hemofilia y Fisioterapia, class: NETWORK, descriptionModule briefSummary: Background. The main physical sequela of patients with hemophilia is the development of a progressive, degenerative intra-articular lesion, known as hemophilic arthropathy). This sequela is manifested by chronic pain, limited range of motion, axial abnormalities, and periarticular muscle atrophy.Objective. To assess the safety and effectiveness of an intervention through blood flow restriction, regarding the frequency of bleeding and the improvement in muscle activation and strength, range of motion, stability, joint pain, joint status and the perception of quality of life in patients with hemophilic ankle arthropathy.Study design. Randomized, multicenter, single-blind clinical study. Method. 32 patients with hemophilia A and B will be recruited in this study. Patients will be recruited in 4 regions of Spain. The dependent variables will be: bleeding frequency (self-registration), pain (measured with the visual analog scale and pressure algometer), quality of life (SF-36 scale), joint status (Hemophilia Joint Health Score scale), strength (dynamometer) and muscle activation (surface electromyograph), range of motion (goniometer) and stability (The Single Leg Stance Test). Three evaluations will be carried out: pre-treatment, post-treatment and after a follow-up period of 4 weeks.Expected results. Observe the safety of blood flow restriction in hemophilia patients. To analyze the efficacy of blood flow restriction in improving muscle strength and activation, range of motion, chronic pain, stabilit, and the perception of quality of life in patients with hemophilic ankle arthropathy., conditionsModule conditions: Hemophilia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Blood flow restriction, outcomesModule primaryOutcomes measure: Change from baseline hemarthrosis after treatment and at 4 weeks, secondaryOutcomes measure: Change from baseline pressure pain threshold after treatment and at 4 weeks, secondaryOutcomes measure: Change from baseline muscle strength after treatment and at 4 weeks, secondaryOutcomes measure: Change from baseline electrical activity of the muscles after treatment and at 4 weeks, secondaryOutcomes measure: Change from baseline joint status after treatment and at 4 weeks, secondaryOutcomes measure: Change from baseline range of motion after treatment and at four weeks, secondaryOutcomes measure: Change from baseline balance after treatment and at four weeks, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Oviedo, status: RECRUITING, city: Oviedo, state: Asturias, zip: 33006, country: Spain, contacts name: Rubén Cuesta-Barriuso, PhD, role: CONTACT, geoPoint lat: 43.36029, lon: -5.84476, hasResults: False

protocolSection identificationModule nctId: NCT06261580, orgStudyIdInfo id: TP-CLN-100502, briefTitle: Normal Reference Range Study With the TEG6s Heparin Neutralization Cartridge in Healthy Volunteers, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-07-28, primaryCompletionDateStruct date: 2021-10-25, completionDateStruct date: 2021-10-25, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Haemonetics Corporation, class: INDUSTRY, collaborators name: Machaon Diagnostics, collaborators name: ClinStatDevice, descriptionModule briefSummary: This trial holds minimal risk to the trial volunteers and consists of obtaining whole blood via venipuncture to perform coagulation parameter measurements to define a Normal Reference Range.Written consent to participate in the study will be obtained prior to volunteer screening per site procedures., conditionsModule conditions: Healthy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 181, type: ACTUAL, armsInterventionsModule interventions name: TEG 6s Citrated K, KH, RTH, and FFH Cartridge, interventions name: Clauss Fibrinogen, outcomesModule primaryOutcomes measure: CK-MA TEG Parameter, primaryOutcomes measure: CK-R TEG Parameter, primaryOutcomes measure: CKH-MA TEG Parameter, primaryOutcomes measure: CKH-R TEG Parameter, primaryOutcomes measure: CKH-LY30 TEG Parameter, primaryOutcomes measure: CRTH-MA TEG Parameter, primaryOutcomes measure: CFFH-MA TEG Parameter, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Machaon Diagnostics, city: Oakland, state: California, zip: 94609, country: United States, geoPoint lat: 37.80437, lon: -122.2708, locations facility: Cardiovascular Research Institute - Loyola University Chicago Health Sciences, city: Maywood, state: Illinois, zip: 60153, country: United States, geoPoint lat: 41.8792, lon: -87.84312, locations facility: Louisiana Coagulation / Machaon Division, city: New Orleans, state: Louisiana, zip: 70118, country: United States, geoPoint lat: 29.95465, lon: -90.07507, hasResults: False

protocolSection identificationModule nctId: NCT06261567, orgStudyIdInfo id: D2287R00189, briefTitle: A Retrospective Chart Review to Investigate Clinical Remission in Patients With Severe Asthma Treated With Biologics in the United Kingdom National Health Service, acronym: REMISSION UK, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-27, primaryCompletionDateStruct date: 2024-09-27, completionDateStruct date: 2024-09-27, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: Asthma is a common lung condition that causes occasional breathing difficulties and affects around 5.4 million people in the UK of all ages. Common symptoms can include wheezing when breathing, breathlessness, a tight chest and coughing. However, these symptoms can get worse and lead to an asthma attack which can be fatal.There is currently no cure for asthma but there are treatments that can help keep the symptoms under control. The main types of treatment include reliever inhalers used when needed quickly to reverse asthma symptoms for a short time, and preventer inhalers that are used everyday to prevent symptoms for starting. Unfortunately, not all patients are able to control their asthma on these treatments alone. Biologic treatments, also known as monoclonal antibodies, have been introduced to treat certain types of severe asthma over recent years. These specialist treatments use antibodies produced from cells in a laboratory to help reduce inflammation and might offer the possibility of higher levels of disease control including the reduction or absence of symptoms and normal lung function. This higher level of disease control is called remission.This study aims to understand whether or not remission is possible in patients with severe asthmas treated with biologics in the NHS. This study will take place a 4 specialist asthma centres in the UK and seeks to include retrospective data from approximately 450 adult patients that were treated with biologics as part of routine care between 01 October 2021 and 30 September 2022. Data will be collected directly from medical records and entered into the study database in a pseudonymised format by members of the direct care team ready for analysis., conditionsModule conditions: Asthma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 425, type: ESTIMATED, armsInterventionsModule interventions name: Biologic treatment, outcomesModule primaryOutcomes measure: Proportion of patients in clinical remission, primaryOutcomes measure: Number and proportion achieving specific criteria for clinical remission, primaryOutcomes measure: Number and proportion of super-responders, primaryOutcomes measure: Number and proportion of responders, primaryOutcomes measure: Number and proportion of non-responders, secondaryOutcomes measure: Age at index, secondaryOutcomes measure: Sex, secondaryOutcomes measure: Ethnicity, secondaryOutcomes measure: Smoking status, secondaryOutcomes measure: BMI, secondaryOutcomes measure: IMD quintile, secondaryOutcomes measure: Comorbidities, secondaryOutcomes measure: COVID-19 vaccination status, secondaryOutcomes measure: Fractional Exhaled Nitric Oxide (FeNO), secondaryOutcomes measure: Blood eosinophil count (EOS), secondaryOutcomes measure: IgE, secondaryOutcomes measure: ACQ-6, secondaryOutcomes measure: AQLQ, secondaryOutcomes measure: lung function (FEV1), secondaryOutcomes measure: Rate of exacerbation in prior 12 months, secondaryOutcomes measure: Asthma treatments at 6 months, secondaryOutcomes measure: Asthma treatments at 12 months, secondaryOutcomes measure: Annualised exacerbation rate (AER), secondaryOutcomes measure: mOCS use (proportion with 0 mg/day), secondaryOutcomes measure: ACQ-6 score, secondaryOutcomes measure: AQLQ score, secondaryOutcomes measure: Lung function (FEV-1), secondaryOutcomes measure: Respiratory infections, secondaryOutcomes measure: Annualised exacerbation rate (AER), secondaryOutcomes measure: mOCS use (proportion with 0 mg/day), secondaryOutcomes measure: ACQ-6 score, secondaryOutcomes measure: AQLQ score, secondaryOutcomes measure: Lung function (FEV-1), secondaryOutcomes measure: Respiratory infections, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 130 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, status: NOT_YET_RECRUITING, city: Birmingham, country: United Kingdom, geoPoint lat: 52.48142, lon: -1.89983, locations facility: Research Site, status: RECRUITING, city: London, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Manchester, country: United Kingdom, geoPoint lat: 53.48095, lon: -2.23743, locations facility: Research Site, status: RECRUITING, city: Southampton, country: United Kingdom, geoPoint lat: 50.90395, lon: -1.40428, hasResults: False

protocolSection identificationModule nctId: NCT06261554, orgStudyIdInfo id: Low-dose sesame OIT, briefTitle: Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2027-03-01, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Medical University of Warsaw, class: OTHER, descriptionModule briefSummary: It is a randomized, single-center, controlled trial to evaluate the effectiveness of oral immunotherapy with low-dose sesame protein compared with standard treatment (elimination diet) in patients with sesame allergy., conditionsModule conditions: Food Allergy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 39, type: ESTIMATED, armsInterventionsModule interventions name: Dietary Supplement: Low dose OIT, outcomesModule primaryOutcomes measure: Tolerance of sesame, secondaryOutcomes measure: Adverse event, secondaryOutcomes measure: Laboratory data, secondaryOutcomes measure: Basophil activation test, secondaryOutcomes measure: Skin prick test (SPT), secondaryOutcomes measure: Desensitization dose, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Medical University of Warsaw, status: RECRUITING, city: Warsaw, state: Mazowieckie, zip: 02-091, country: Poland, contacts name: Katarzyna Grzela, PhD, MD, role: CONTACT, phone: +48 22 3179431, email: katarzyna.grzela@wum.edu.pl, geoPoint lat: 52.22977, lon: 21.01178, hasResults: False

protocolSection identificationModule nctId: NCT06261541, orgStudyIdInfo id: ABLEexoMS, briefTitle: Clinical Investigation to Validate the Safety and Performance of the ABLE Exoskeleton Device for Individuals With Multiple Sclerosis in a Clinical Setting, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: ABLE Human Motion S.L., class: INDUSTRY, collaborators name: Fundación Esclerosis Múltiple Madrid (FEMM), descriptionModule briefSummary: The primary objective of the study is to validate the safety and performance of the ABLE Exoskeleton device in people with multiple sclerosis during a 10-session gait training program in a clinical setting. Furthermore, the potential effects of the training on walking, and balance function, general health status, user satisfaction, and quality of life will be assessed., conditionsModule conditions: Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: ABLE Exoskeleton, outcomesModule primaryOutcomes measure: Number and type of device-related Adverse Events, primaryOutcomes measure: Level of Assistance (LoA) to don/doff the device, primaryOutcomes measure: Time taken to don/doff the device, primaryOutcomes measure: Level of Assistance (LoA) to complete therapy activity tasks, primaryOutcomes measure: Time spent upright and time spent walking, primaryOutcomes measure: Number of steps walked, primaryOutcomes measure: Distance walked, secondaryOutcomes measure: Timed 25-Feet Walk test (T25FW), secondaryOutcomes measure: Ambulation Index (AI), secondaryOutcomes measure: 6-Minute Walk Test (6MWT), secondaryOutcomes measure: Timed Up-and-Go test (TUG), secondaryOutcomes measure: Trunk Impairment Scale (TIS), secondaryOutcomes measure: Lower extremity muscle strenght, secondaryOutcomes measure: Modified Ashworth Scale (MAS), secondaryOutcomes measure: Borg Rating of Perceived Exertion, secondaryOutcomes measure: Barthel Index (BI) score, secondaryOutcomes measure: Modified Fatigue Impact Scale (MFIS) score, secondaryOutcomes measure: Multiple Sclerosis Quality of Life-54 (MSQoL-54), secondaryOutcomes measure: Psychosocial Impact of Assistive Devices Scale (PIADS) score, secondaryOutcomes measure: Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0) score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fundación Esclerosis Múltiple Madrid (FEMM), status: RECRUITING, city: Madrid, country: Spain, contacts name: Almudena Chao, role: CONTACT, phone: 913993245, email: achao@femmadrid.org, contacts name: Kenneth Malpartida, role: CONTACT, email: kmalpartida@femmadrid.org, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False

protocolSection identificationModule nctId: NCT06261528, orgStudyIdInfo id: STU-2023-1289, briefTitle: Study of Circadian Focused Light Therapy in Progressive Multiple Sclerosis, acronym: NO-FATIGUE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-18, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Texas Southwestern Medical Center, class: OTHER, collaborators name: National Multiple Sclerosis Society, collaborators name: International Progressive Multiple Sclerosis Alliance, descriptionModule briefSummary: The study is being done to determine if treatment with a novel form of light therapy is tolerated in patients with progressive multiple sclerosis. The goal of this trial to establish the safety profile of this light therapy while generating data on its impact on fatigue, as well as its mechanism of action. Fatigue is often a complex symptom in multiple sclerosis, without any FDA-approved direct therapy. Fatigue is traditionally treated with symptom management through a multidisciplinary team., conditionsModule conditions: Progressive Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This will be an open label, single arm, single center phase 1 research study designed to generate safety data, biomarker data, and preliminary efficacy data to reduce fatigue in patients with progressive MS, to include PPMS and SPMS, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Light therapy, outcomesModule primaryOutcomes measure: Treatment Emergent Adverse Events (TEAEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UT Southwestern Medical Center, status: RECRUITING, city: Dallas, state: Texas, zip: 75247, country: United States, contacts name: Ana Raicu, role: CONTACT, phone: 214-645-0292, email: ana.raicu@utsouthwestern.edu, contacts name: Ana Raicu, role: CONTACT, phone: 214-645-0292, contacts name: Peter Sguigna, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Benjamin Greenberg, MD, role: SUB_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, hasResults: False

protocolSection identificationModule nctId: NCT06261515, orgStudyIdInfo id: Perio-gut PRIN, briefTitle: Multi-omics Analysis of Oral-gut Microbial Profiles, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2026-01-15, completionDateStruct date: 2026-02-15, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: University of Turin, Italy, class: OTHER, descriptionModule briefSummary: Periodontitis is a chronic inflammatory disease of the tooth supporting structures induced by a dysbiosis in the oral and subgingival microenvironment of susceptible patients. The long-term swallowing of high doses of periodontal pathogenic microorganisms could induce a dysbiosis of the intestinal microbiota, favouring the establishment of an 'inflamed' microbiome in terms of composition and/or function. The present project is aimed at a better understanding of the etiopathogenetic correlation between periodontitis and intestinal dysbiosis, and aims to explore the hypothesis that periodontal treatment may influence the multi-omics profile on the oral-gut-systemic axis. 70 patients affected by stage III-IV periodontitis will be recruited, and treated by means of full-mouth scaling and root planing. Salivary, subgingival plaque, plasma and stool samples, together with a complete periodontal charting and a food diary will be collected and compared at baseline and after treatment. Age, gender and BMI-matched healthy individuals will be recruited as controls., conditionsModule conditions: Periodontitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Active periodontal treatment, outcomesModule primaryOutcomes measure: Changes in gut microbial profile measured in stool samples, primaryOutcomes measure: Changes in oral microbial profile measured in saliva samples, primaryOutcomes measure: Changes in oral microbial profile measured in subgingival plaque samples, secondaryOutcomes measure: Changes in oral-gut metabolome measured in stool samples, secondaryOutcomes measure: Changes in oral-gut miRNAome measured in stool samples, secondaryOutcomes measure: Metabolic plasma changes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06261502, orgStudyIdInfo id: 2023-4527, secondaryIdInfos id: 275882, type: OTHER, domain: Health Canada, secondaryIdInfos id: 202010PJT-451514, type: OTHER_GRANT, domain: Canadian Institutes of Health Research, briefTitle: Effect of CANnabidiol on Anxiety and GABAergic Function in Individuals With Fragile-X Syndrome, acronym: CANAX, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2027-08-01, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Université de Sherbrooke, class: OTHER, collaborators name: Canadian Institutes of Health Research (CIHR), collaborators name: Jazz Pharmaceuticals, collaborators name: Centre de recherche du Centre hospitalier universitaire de Sherbrooke, descriptionModule briefSummary: This study focuses on the therapeutic relevance of the endocannabinoid (eCB) system for the treatment of Fragile-X syndrome (FXS), the primary hereditary cause of autism spectrum disorder (ASD). Most individuals with FXS have moderate to severe intellectual disability (ID), and caregivers are mainly concerned about aggressive behavior and anxiety problems. Since FXS individuals have a normal lifespan, the overall lifetime cost for the Canadian society of a single case is estimated at $1.2 to $4.7 millions reaching $18 billions for all FXS cases. There is no cure for FXS, as all clinical trials so far have been unsuccessful.FXS is caused by transcriptional silencing of the Fragile X mental retardation protein (FMR1) gene, making FXS a simple model to study ASD and ID pathophysiological mechanisms. Of those, neuronal hyperexcitability is largely recognized as a core deficit in FXS, and a critical therapeutic target for the disorder. Using transcranial magnetic stimulation (TMS) in FXS patients, our team provided the first direct evidence of Gamma-aminobutyric acid (GABA) receptor a (GABAa) dysfunctions in humans with this disorder and showed that this inhibitory deficit is linked with cortical hyperexcitability (PMID: 31748507). Concurrent lines of evidence suggest that stimulation of the endocannabinoid (eCB) system with the administration of Cannabidiol (CBD) could upregulate GABAergic function and correct inhibitory deficits presumed responsible for the neuropsychiatric phenotype of FXS. CBD has been shown to increase GABA concentration levels in the brains of healthy individuals, an effect that could help correct the hyperexcitability typically found in FXS. Thus, this trial aims to define the therapeutic potential of the eCB system for FXS, by measuring the impacts of oral CBD administration on the principal inhibitory neurotransmitter system of FXS patients, and the severity of the clinical phenotype., conditionsModule conditions: Fragile X Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Randomized, Double-blind, placebo-controlled, single center, cross-over trial, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: The randomization and participant code allocation process will be carried out by the Centre de recherche du Centre hospitalier universitaire de Sherbrooke (CRCHUS) pharmacy. The pharmacy will dispense the medication or placebo based on the randomization. The principal investigators, Drs. Lepage and Corbin and the research, as well as the participants and their caregivers, will never be aware of the randomization. To avoid any suspicions on the part of the investigators, Dr. Artuela Çaku, who is not part of the research team, will have access to the laboratory results. In the event of an adverse drug effect, Dr. Çaku may break the code to make a more informed decision for the patient's well-being, such as discontinuing participation or reducing the dose, etc., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: CBD Oral Solution, interventions name: Placebo, outcomesModule primaryOutcomes measure: Impact of Oral CBD Solution anxiety., primaryOutcomes measure: Impact of Oral CBD Solution on disruptive behavior, primaryOutcomes measure: Impact of Oral CBD Solution on Behavioral Inhibition, secondaryOutcomes measure: Impact of Oral CBD Solution on intracortical inhibition, secondaryOutcomes measure: Impact of Oral CBD Solution on intracortical facilitation, secondaryOutcomes measure: Impact of Oral CBD Solution on, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 40 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06261489, orgStudyIdInfo id: REB23-1128, briefTitle: Cannabis (THC vs. CBD) in Multiple Sclerosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: University of Calgary, class: OTHER, collaborators name: Multiple Sclerosis Society of Canada, descriptionModule briefSummary: The goal of this clinical trial is to examine the effect of Cannabis components, THC and CBD, on cognition and bladder symptoms in people with Multiple Sclerosis (MS).Participants will complete questionnaires and cognitive tests. They will be randomly assigned to receive either CBD or THC oil and will take the study drug for 15 weeks., conditionsModule conditions: Multiple Sclerosis, 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: 30, type: ESTIMATED, armsInterventionsModule interventions name: THC, interventions name: CBD, outcomesModule primaryOutcomes measure: Cognitive outcome: The Differential Effect, if any, of THC and CBD in MS Cognition will be measured by Symbol Digit Modality Test (SDMT)., primaryOutcomes measure: NLUTD outcome: The Differential Effect, if any, of THC and CBD on Neurogenic lower urinary tract dysfunction (NLUTD) symptoms will be measured by Neurogenic Bladder Symptom Score (NBSS)., secondaryOutcomes measure: Blinding feasibility: The ability to blind the administration of THC vs CBD in PwMS will be evaluated based on participants and investigators report., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 59 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06261476, orgStudyIdInfo id: DYP-Pharm-RP-23, briefTitle: Safety of Ashwagandha (Withania Somnifera) Root Extract, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: SF Research Institute, Inc., class: NETWORK, descriptionModule briefSummary: The primary objective is to evaluate the laboratory safety of Ashwagandha standardized root extract 500 mg capsules in healthy adults over 12-week therapy based on Complete Blood Count, Renal Function Test, Liver Function Test, Lipid Profile and Thyroid Function Test, Fasting blood sugar and HbA1c Test. The secondary objectives are to evaluate the clinical safety of Ashwagandha standardized root extract 500 mg capsules in healthy adults over 12-week therapy and to evaluate the effect of the Ashwagandha standardized root extract 500 mg on Quality of Life (QoL) using the SF-36 tool., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Ashwagandha (Withnia somnifera), outcomesModule primaryOutcomes measure: Hemoglobin Test, primaryOutcomes measure: Total Erythrocyte Count, primaryOutcomes measure: Total Leukocyte Count, primaryOutcomes measure: Platelet Count, primaryOutcomes measure: Hematocrit Test, primaryOutcomes measure: Total Cholesterol Test, primaryOutcomes measure: LDL Test, primaryOutcomes measure: HDL Test, primaryOutcomes measure: Triglycerides Test, primaryOutcomes measure: Serum Alkaline Transaminase Test, primaryOutcomes measure: Aspartate Transaminase Test, primaryOutcomes measure: Alkaline Phosphatase Test, primaryOutcomes measure: Bilirubin Test, primaryOutcomes measure: Serum Creatinine Test, primaryOutcomes measure: Blood Urea Nitrogen Test, primaryOutcomes measure: T4, primaryOutcomes measure: T3, primaryOutcomes measure: Serum TSH, primaryOutcomes measure: Fasting Blood Sugar, primaryOutcomes measure: HbA1c, secondaryOutcomes measure: Adverse Events, secondaryOutcomes measure: Quality of Life (SF-36 QoL), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: SF Research Institute, status: RECRUITING, city: San Francisco, state: California, zip: 94127, country: United States, contacts name: John Ademola, PhD, role: CONTACT, phone: 415-549-9362, email: studyrecruitment@sfinstitute.com, geoPoint lat: 37.77493, lon: -122.41942, hasResults: False

protocolSection identificationModule nctId: NCT06261463, orgStudyIdInfo id: 2023-0326, secondaryIdInfos id: K01MH128524-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/K01MH128524-01A1, briefTitle: Pilot Trial of a Peer-led Family and Social Strengthening Group Intervention for Refugee Families, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: University of Illinois at Chicago, class: OTHER, collaborators name: National Institute of Mental Health (NIMH), descriptionModule briefSummary: The proposed study draws on prior research to evaluate the feasibility, acceptability and explore preliminary effectiveness of Coffee and Family Education and Support, Version (CAFES2) using a pilot randomized type 1 hybrid effectiveness-implementation design. CAFES2 is a peer-led family and social strengthening multiple family group intervention that is designed to respond to multi-level needs of refugee families. Results of the trial will contribute to the emerging evidence base on family-based mental health interventions for refugee and newcomer communities. The trial will also generate new insights regarding implementation strategies needed to promote successful delivery of services by peer providers and the unique role of human-centered design practices for adaptation of mental health and psychosocial interventions., conditionsModule conditions: Depression, conditions: Anxiety, conditions: PTSD, conditions: Family Dynamics, conditions: Social Functioning, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The investigators will conduct a randomized controlled trial with Syrian refugee families (n=74). Half of the families will be randomized to receive CAFES2 and half will be randomized to the enhanced control condition where they will receive ongoing access to services through partner organizations and healthy lifestyle materials., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: The Research Assistants (RAs) who will collect both qualitative and quantitative data will be blind to the condition in which study participants are randomized., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 74, type: ESTIMATED, armsInterventionsModule interventions name: CAFES2, outcomesModule primaryOutcomes measure: Changes in PTSD symptoms via the PTSD Checklist (adult, exploratory), primaryOutcomes measure: Changes in adult depression and anxiety via the Hopkins Symptom Checklist (HSCL, adult, exploratory), primaryOutcomes measure: Changes in youth depression and anxiety via the Hospital Anxiety and Depression Scale (HADS, youth, exploratory), primaryOutcomes measure: Changes in PTSD in children and youth via the Child Revised Impacted of Events Scale (CRIES, youth, exploratory), secondaryOutcomes measure: Changes in social support via the Medical Outcomes Study Social Support Survey, secondaryOutcomes measure: Changes in social interaction via the Duke Social Support Index, social interaction subscale, secondaryOutcomes measure: Changes in parenting via the Alabama Parenting Questionnaire (adult and youth), secondaryOutcomes measure: Changes in family communication via the Family Problem Solving Communication Scale, otherOutcomes measure: Changes in acceptability of the intervention via the Johns Hopkins University Dissemination and Implementation Science Measure, otherOutcomes measure: Changes in feasibility of the intervention via the Johns Hopkins University Dissemination and Implementation Science Measure, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 45 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06261450, orgStudyIdInfo id: 2020-3424, secondaryIdInfos id: 236114, type: OTHER, domain: Health Canada, secondaryIdInfos id: 202010PJT-451514, type: OTHER_GRANT, domain: Canadian Institutes of Health Research, briefTitle: Effect of CBD on the Brain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-08-15, completionDateStruct date: 2027-08-15, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Université de Sherbrooke, class: OTHER, collaborators name: Canadian Institutes of Health Research (CIHR), collaborators name: Jazz Pharmaceuticals, collaborators name: Centre de recherche du Centre hospitalier universitaire de Sherbrooke, descriptionModule briefSummary: This proposal focuses on the therapeutic relevance of the endocannabinoid (eCB) system for the treatment of Fragile-X syndrome (FXS), the primary hereditary cause of autism spectrum disorder (ASD). Although most individuals with FXS have moderate to severe intellectual disability (ID), caregivers are mainly concerned about aggressive behavior and anxiety problems, hallmark features of the condition. Concurrent lines of evidence suggest that targeting the endocannabinoid (eCB) system by administration of cannabidiol (CBD) could upregulate GABAergic functions and correct inhibitory deficits presumed responsible for the neuropsychiatric phenotype of FXS. However, the eCB system and its effect on the brain remains unexplored in FXS patients. This clinical trial aims to define the therapeutic relevance of the eCB system for FXS using a multimodal neuroimaging approach to finely characterize the acute effects of oral CBD on the principal inhibitory neurotransmitter system (GABA) in a large cohort of FXS patients., conditionsModule conditions: Fragile X Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: This study is a double-blind-crossover placebo control comparing the acute effect of oral CBD in patients with FXS to controls., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, maskingDescription: Randomization and dispensing of active and control will be conducted by the research center pharmacy., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: CBD Oral Solution (eCBD system Target), interventions name: Placebo, outcomesModule primaryOutcomes measure: Short Intracortical Inhibition, secondaryOutcomes measure: Intracortical Facilitation, secondaryOutcomes measure: Gaba concentration levels, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 55 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06261437, orgStudyIdInfo id: M-11053, secondaryIdInfos id: MO230060, type: OTHER_GRANT, domain: Military Operational Medicine Research Program (MOMRP), briefTitle: Effect of Ration Formulations on Warfighter Energy Balance and Physical Performance During a Field Training Exercise, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-22, primaryCompletionDateStruct date: 2024-03-04, completionDateStruct date: 2024-03-04, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: United States Army Research Institute of Environmental Medicine, class: FED, descriptionModule briefSummary: The goal of this randomized clinical trial is to determine the effects of consuming the Close Combat Assault Ration (CCAR) compared to the First Strike Ration (FSR) during a 7-day strenuous military training on energy intake and energy balance in healthy, Active Duty Warfighters.The main questions it aims to answer are:* Will consuming the CCAR result in lower energy intake or energy balance compared to consumption of the FSR?* Will consuming the CCAR result in lower lower body strength or anaerobic power compared to consuming the FSR?* Will those consuming the CCAR report lower ration acceptability or greater gastrointestinal side effects compared to those consuming the FSR?Participants will be asked to consume either the CCAR or FSR as the sole nutrition source during a 7-day field training exercise (FTX). The vertical jump test, running-based anaerobic sprint test, and lower-body strength pull will be conducted pre and post the 7-day FTX to assess physical performance. Energy expenditure and intake will be measured by the doubly-labelled water method and dietary logs, respectively. Surveys will be completed to assess ration acceptability and gastrointestinal symptoms.Researchers will compare the CCAR and FSR groups to see if their consumption impacted energy intake, energy balance, physical performance, ration acceptance, or gastrointestinal side effects., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: CCAR, interventions name: FSR, outcomesModule primaryOutcomes measure: Energy intake, primaryOutcomes measure: Energy expenditure, primaryOutcomes measure: Energy balance, secondaryOutcomes measure: Physical performance (vertical jump), secondaryOutcomes measure: Physical performance (peak power), secondaryOutcomes measure: Physical performance (Anaerobic capacity), secondaryOutcomes measure: Physical performance (lower-body strength), secondaryOutcomes measure: Food acceptance scale, secondaryOutcomes measure: Gastrointestinal Quality of Life Index, secondaryOutcomes measure: Hunger and Satiety Visual Analog Scales, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: U.S. Army Research Institute of Environmental Medicine, city: Natick, state: Massachusetts, zip: 01760, country: United States, contacts name: USARIEM, role: CONTACT, phone: 508-206-2200, email: usarmy.natick.medcom-usariem.mbx.usariem-webmaster@health.mil, contacts name: Michael A Dawson, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.28343, lon: -71.3495, hasResults: False

protocolSection identificationModule nctId: NCT06261424, orgStudyIdInfo id: 2024-1426, briefTitle: Effects of a Supervised Rehabilitation Program on Disease Severity in Spastic Ataxias, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Université du Québec à Chicoutimi, class: OTHER, collaborators name: McGill University, collaborators name: Université de Sherbrooke, collaborators name: Université du Québec a Montréal, collaborators name: Laval University, collaborators name: University of Calgary, collaborators name: Corporation de recherche et d'action sur les maladies héréditaires (CORAMH), collaborators name: Cégep de Jonquière, collaborators name: Centre intégré universitaire de santé et de services sociaux du Saguenay-Lac-St-Jean, collaborators name: Muscular Dystrophy Canada, collaborators name: University of Alberta, collaborators name: Integrated University Health and Social Services Center of the Capitale-Nationale, descriptionModule briefSummary: Spastic ataxias are a group of diseases causing symptoms such as walking difficulties and balance impairments that lead to a high risk of falls. No pharmacological treatments exist to treat these diseases. Unfortunately, little effort is made to develop non-pharmacological treatments specific to spastic ataxias despite the detrimental impact of the disease on several aspects of an individual's life and the high cost of falls for society each year. The three objectives of this project are: 1) to determine the effect of a 12-week rehabilitation program on disease severity as compared with usual care for individuals with spastic ataxias; 2) to identify which factors can help (or not) the implementation of the program in the clinical settings ("reel world"); and 3) to explore the cost-benefits of IMPACT \[rehabIlitation prograM for sPAstiC aTaxias\]. The team has developed the program to specifically target symptoms present in these patients and was previously pilot-tested. Based on the results obtained in this pilot project, positive effects are expected concerning the disease severity of participants. The investigators want, with this project, provide to health care professionals an option to offer better-suited services to people living with spastic ataxia worldwide., conditionsModule conditions: ARSACS, conditions: SPG7, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A multicentre and controlled trial design., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: All participants will be assessed at their respective neuromuscular clinic (Saguenay, Quebec, Montreal or Calgary) by physiotherapists trained according to standard operating procedures (SOP). These physiotherapists will not be involved in the supervision of the program and will be blinded., whoMasked: CARE_PROVIDER, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: IMPACT - rehabIlitation prograM for sPAstiC aTaxias, outcomesModule primaryOutcomes measure: Severity of ataxia, secondaryOutcomes measure: Medication change, secondaryOutcomes measure: Weight, secondaryOutcomes measure: height, secondaryOutcomes measure: Physical activities, secondaryOutcomes measure: Walking speed., secondaryOutcomes measure: Standing balance, secondaryOutcomes measure: Balance confidence, secondaryOutcomes measure: Sitting balance, secondaryOutcomes measure: Activities of Daily Living, secondaryOutcomes measure: Muscle tone, secondaryOutcomes measure: Life habits, secondaryOutcomes measure: Community mobility, secondaryOutcomes measure: Plasma, secondaryOutcomes measure: DNA, secondaryOutcomes measure: Serum, secondaryOutcomes measure: RNA, secondaryOutcomes measure: Urine, secondaryOutcomes measure: Saliva, secondaryOutcomes measure: Mobility Life-space, secondaryOutcomes measure: Ataxia impact scale, secondaryOutcomes measure: Lower limb coordination, secondaryOutcomes measure: Peak respiratory flow and cough, secondaryOutcomes measure: Fatigue, secondaryOutcomes measure: Falls., secondaryOutcomes measure: Patient-reported impression of change., secondaryOutcomes measure: Anxiety and Depression, secondaryOutcomes measure: Pain characteristics, secondaryOutcomes measure: Functional lower extremity strength, secondaryOutcomes measure: Focus group with intervention group participants, secondaryOutcomes measure: Focus groups with stakeholders, secondaryOutcomes measure: Lower limb muscle activation, secondaryOutcomes measure: Quality of life, secondaryOutcomes measure: CBA analyses and Willingness to pay, secondaryOutcomes measure: Gait's temporal parameters, secondaryOutcomes measure: Stance balance, secondaryOutcomes measure: Postural balance, eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CIUSSS de la Capitale-Nationale, Hôpital de Baie-Saint-Paul, city: Baie-Saint-Paul, state: Quebec, zip: G3Z 0K3, country: Canada, contacts name: Élise Duchesne, Ph. D., role: CONTACT, email: educhesn@uqac.ca, contacts name: Jacques Beaulieu, commissaire local aux plaintes, role: CONTACT, email: commissaire.plainte.ciussscn@ssss.gouv.qc.ca, contacts name: Xavier Rodrigue, M.D., role: SUB_INVESTIGATOR, geoPoint lat: 47.44109, lon: -70.49858, locations facility: CIUSSS de la Capitale-Nationale, Hôpital de La Malbaie, city: La Malbaie, state: Quebec, zip: G5A 1T1, country: Canada, contacts name: Élise Duchesne, Ph. D., role: CONTACT, email: educhesn@uqac.ca, contacts name: Jacques Beaulieu, commissaire local aux plaintes, role: CONTACT, email: commissaire.plainte.ciussscn@ssss.gouv.qc.ca, geoPoint lat: 47.654, lon: -70.15268, locations facility: CIUSSS du Centre-Sud-de-l'Île-de-Montréal, installation Centre de réadaptation Lucie-Bruneau, city: Montréal, state: Quebec, zip: H2H 2N8, country: Canada, contacts name: Élise Duchesne, Ph. D., role: CONTACT, email: educhesn@uqac.ca, contacts name: Céline Roy, commissaire local aux plaintes, role: CONTACT, phone: 514-593-3600, email: commissaireauxplaintes.ccsmtl@ssss.gouv.qc.ca, geoPoint lat: 45.50884, lon: -73.58781, locations facility: CIUSSS de la Capitale-Nationale, installation IRDPQ, city: Québec, state: Quebec, zip: G1M 2S8, country: Canada, contacts name: Élise Duchesne, Ph. D., role: CONTACT, phone: 418-590-3552, contacts name: Jacques Beaulieu, commissaire local aux plaintes, role: CONTACT, email: commissaire.plainte.ciussscn@ssss.gouv.qc.ca, contacts name: Xavier Rodrigue, M.D., role: SUB_INVESTIGATOR, geoPoint lat: 46.81228, lon: -71.21454, locations facility: Clinique des maladies neuromusculaires du Centre intégré universitaire de santé et de services sociaux (CIUSSS) du Saguenay-Lac-Saint-Jean, installation Hôpital Jonquière, city: Saguenay, state: Quebec, zip: G7X 7X2, country: Canada, contacts name: Élise Duchesne, role: CONTACT, phone: 418-590-3552, email: educhesn@uqac.ca, contacts name: Julie Bouchard, commissaire local aux plaintes, role: CONTACT, phone: 1 877 662-3963, email: guichetunique.slsj@ssss.gouv.qc.ca, contacts name: Jean-Denis Brisson, M.D., role: SUB_INVESTIGATOR, geoPoint lat: 48.41675, lon: -71.06573, hasResults: False

protocolSection identificationModule nctId: NCT06261411, orgStudyIdInfo id: 999430, secondaryIdInfos id: FOU2024-00038, type: REGISTRY, domain: Forskning och Utveckling (Region Uppsala), briefTitle: Lung Ultrasound as Alternative to Radiation in Thoracic Surgery, acronym: LUS-ART, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Uppsala University Hospital, class: OTHER, descriptionModule briefSummary: This projects aim is to study the effects of substitute conventional chest x-ray with lung ultrasound for patients undergoing thoracic surgery.Participants in the study will be randomized to either ultrasound or routine chest x-ray as the primary method of diagnosis after having received surgery to their lungs., conditionsModule conditions: Thoracic Surgery, conditions: Ultrasonography, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Case-Control, primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, maskingDescription: Inter-rater variability will be masked., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Lung Ultrasound, outcomesModule primaryOutcomes measure: Reduction in chest x-ray, secondaryOutcomes measure: Re-insertion of chest tube, secondaryOutcomes measure: Delayed removal of chest tube, secondaryOutcomes measure: Time to chest tube removal, secondaryOutcomes measure: Patient Satisfaction, otherOutcomes measure: Missed Care, otherOutcomes measure: Inter-rater variability, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Uppsala Akademiska sjukhuset, city: Uppsala, state: Uppland, zip: 751 85, country: Sweden, geoPoint lat: 59.85882, lon: 17.63889, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-02-02, uploadDate: 2024-02-07T05:12, filename: Prot_000.pdf, size: 806384, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-02-02, uploadDate: 2024-02-07T05:12, filename: ICF_001.pdf, size: 350352, hasResults: False

protocolSection identificationModule nctId: NCT06261398, orgStudyIdInfo id: 2023H0065, briefTitle: Better Birth Outcomes Through Technology, Education, and Reporting, acronym: BETTER, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2027-09, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Ohio State University, class: OTHER, collaborators name: American Heart Association, descriptionModule briefSummary: This is a pragmatic randomized control trial to evaluate the BETTER intervention compared to standard obstetrical care (control) to determine whether it helps to reduce maternal anemia and other adverse pregnancy outcomes. The BETTER intervention includes one motivational interviewing session and bi-weekly text messages to encourage patients to connect with resources that address their social needs, including housing, food, and transportation. Quantitative data will be used to study participant outcomes, including surveys, and electronic health record data., conditionsModule conditions: Pregnancy, conditions: Maternal Anemia, conditions: Pre-Term Birth, conditions: Hypertensive Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 550, type: ESTIMATED, armsInterventionsModule interventions name: BETTER: motivational interviewing and text messaging, interventions name: Standard of care, outcomesModule primaryOutcomes measure: Incidence of maternal anemia, secondaryOutcomes measure: Incidence of Pre-term birth, secondaryOutcomes measure: Incidence of Hypertensive disorders of pregnancy, secondaryOutcomes measure: Incidence of infection, secondaryOutcomes measure: Incidence of Cesarean Delivery, secondaryOutcomes measure: Incidence of Postpartum hemorrhage, secondaryOutcomes measure: Incidence Severe maternal morbidity, secondaryOutcomes measure: Incidence of maternal mortality, secondaryOutcomes measure: Incidence of Small for gestational age birth, secondaryOutcomes measure: Incidence of Large for gestational age, secondaryOutcomes measure: Incidence of NICU admission, secondaryOutcomes measure: Incidence of Perinatal mortality, secondaryOutcomes measure: Incidence of Prenatal care visits, secondaryOutcomes measure: Incidence of Antepartum admission, secondaryOutcomes measure: Length of stay (days), secondaryOutcomes measure: Postpartum re-admission, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Ohio State University Outpatient Care East, status: RECRUITING, city: Columbus, state: Ohio, zip: 43203, country: United States, contacts name: William Grobman, MD, MBA, role: CONTACT, phone: 614-293-4929, email: William.Grobman@osumc.edu, contacts name: Anna Bartholomew, BSN, RN, MPH, role: CONTACT, phone: 614-685-3229, email: Anna.Bartholomew@osumc.edu, geoPoint lat: 39.96118, lon: -82.99879, locations facility: McCampbell Hall, status: RECRUITING, city: Columbus, state: Ohio, zip: 43210, country: United States, contacts name: William Grobman, MD, MBA, role: CONTACT, phone: 614-293-4929, email: William.Grobman@osumc.edu, contacts name: Anna Bartholomew, BSN, RN, MPH, role: CONTACT, phone: 614-685-3229, email: Anna.Bartholomew@osumc.edu, geoPoint lat: 39.96118, lon: -82.99879, locations facility: The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine, status: RECRUITING, city: Columbus, state: Ohio, zip: 43210, country: United States, contacts name: William Grobman, MD, MBA, role: CONTACT, phone: 614-293-4929, email: William.Grobman@osumc.edu, contacts name: Anna Bartholomew, BSN, RN, MPH, role: CONTACT, phone: 614-685-3229, email: Anna.Bartholomew@osumc.edu, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False

protocolSection identificationModule nctId: NCT06261385, orgStudyIdInfo id: typology, briefTitle: Development of Typology-based Smoking Relapse Prevention: A Q-methodology and a Pilot Randomized Controlled Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-23, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: The University of Hong Kong, class: OTHER, collaborators name: Health and Medical Research Fund, descriptionModule briefSummary: This study aims to develop a typology-based intervention delivered by smoking cessation (SC) counselors to prevent smoking relapse in ex-smokers who recently quit. The two main research questions include (1) Can a typology-based smoking relapse prevention intervention be feasible and accepted by the smokers and SC counselors who deliver the new intervention? (2) What is the preliminary evidence on the efficacy of the typology-based smoking relapse prevention to increase tobacco abstinence in ex-smokers who have recently quit? If the intervention shows at least a small effect size (i.e. risk ratio\>1.3), or the intervention is feasible while modifications can potentially increase the efficacy, a future definitive RCT is warranted., conditionsModule conditions: Smoking Cessation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Outcome assessors at the telephone follow-up are blinded to the group allocation., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 510, type: ESTIMATED, armsInterventionsModule interventions name: typology-based intervention, outcomesModule primaryOutcomes measure: self-reported abstinence in the past 30 days at 2-month follow-up, primaryOutcomes measure: iScreen OFD Cotinine Saliva Test Kit (<30ng/ml) biochemical validated tobacco abstinence, primaryOutcomes measure: the difference of the feasibility and acceptability score of the typology-based intervention between the intervention and control group., secondaryOutcomes measure: Time required for the counselling, secondaryOutcomes measure: Compliance rate of the SC counsellors in following the intervention protocol, secondaryOutcomes measure: Proportion of screened clients who participate in the RCT, secondaryOutcomes measure: Dropout rate of the participants who consent to the RCT, secondaryOutcomes measure: Satisfaction on the SC counsellors, secondaryOutcomes measure: Satisfaction on the e-messages, secondaryOutcomes measure: Frequency of reading the e-messages, secondaryOutcomes measure: Perceived effectiveness on the intervention, secondaryOutcomes measure: Satisfaction on the enrolment procedures, secondaryOutcomes measure: Intention to recommend the intervention to other smokers, secondaryOutcomes measure: Satisfaction about the intervention from SC counsellor, secondaryOutcomes measure: Perceived appropriateness of the intervention length from SC counsellor, secondaryOutcomes measure: Satisfaction on the enrolment procedures from SC counsellor, secondaryOutcomes measure: Perceived effectiveness of the screening tool from SC counsellor, secondaryOutcomes measure: Perceived clients' acceptance of the intervention from SC counsellor, secondaryOutcomes measure: Intention to apply this intervention in other clients from SC counsellor, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: LKS Faculty of Medicine, status: RECRUITING, city: Hong Kong, zip: 00, country: Hong Kong, contacts name: Derek YT Cheung, PhD, role: CONTACT, phone: +852 3917 6652, email: derekcheung@hku.hk, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False

protocolSection identificationModule nctId: NCT06261372, orgStudyIdInfo id: KY2023PJ204, briefTitle: Mindfulness Meditation Combined With Progressive Muscle Relaxation Training for Uremic Sarcopenia, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-08-15, primaryCompletionDateStruct date: 2023-11-15, completionDateStruct date: 2023-11-15, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Ningbo Medical Center Lihuili Hospital, class: OTHER_GOV, descriptionModule briefSummary: To study the effect of mindfulness meditation combined with progressive muscle relaxation training on clinical efficacy and quality of life in maintenance hemodialysis (MHD) patients with sarcopenia. Eligible sarcopenic patients in our hospital were randomly assigned to a control group (n = 24) and an intervention group (n = 25). The control group received conventional dialysis treatment, while the intervention group received mindfulness meditation combined with progressive muscle relaxation training during the interdialysis period in addition to conventional dialysis treatment. The effect of the intervention was evaluated after 12 weeks.To observe whether the combined intervention training can improve the motor ability and quality of life of patients with sarcopenia in a short period of time., conditionsModule conditions: Hemodialysis Patients With Sarcopenia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 49, type: ACTUAL, armsInterventionsModule interventions name: The mindfulness meditation combined with progressive muscle relaxation training ., outcomesModule primaryOutcomes measure: 10 sit-to-stand test in seconds, primaryOutcomes measure: Grip strength in kilograms, primaryOutcomes measure: 6-meter walk test in metre per second, primaryOutcomes measure: KDQOLTM(Kidney Disease Quality of Life short Form) score, primaryOutcomes measure: interleukin-6 (IL-6), primaryOutcomes measure: high-sensitivity C-reactive protein (hsCRP), primaryOutcomes measure: albumin(ALB), primaryOutcomes measure: prealbumin (PA）, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Li Huili Hospital, Ningbo Medical Center, city: Ningbo, state: Zhejiang, zip: 315046, country: China, geoPoint lat: 29.87819, lon: 121.54945, hasResults: False

protocolSection identificationModule nctId: NCT06261359, orgStudyIdInfo id: CEND1-202, briefTitle: A Study of CEND-1 With Chemotherapy as First-Line Therapy in Patients With Pancreatic Ductal Adenocarcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2026-10, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Qilu Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the efficacy and safety of CEND-1 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo as first-line treatment in patients with Locally Advanced Unresectable or Metastatic Pancreatic Ductal Adenocarcinoma., conditionsModule conditions: Pancreatic Ductal Adenocarcinoma (PDAC), 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: 120, type: ESTIMATED, armsInterventionsModule interventions name: CEND-1, interventions name: Gemcitabine, interventions name: Nab paclitaxel, outcomesModule primaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Progression Free Survival(PFS), secondaryOutcomes measure: 6-month PFS rate, secondaryOutcomes measure: Duration Of Response (DOR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Incidence of AEs, SAEs and treatment-emergent adverse events (TEAEs), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chinese People's Liberation Army (PLA) General Hospital, city: Beijing, state: Beijing, zip: 100000, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False

protocolSection identificationModule nctId: NCT06261346, orgStudyIdInfo id: 20230420, briefTitle: Plasma Rich in Growth Factors in Corneal Endothelial Transplantation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Price Vision Group, class: INDUSTRY, descriptionModule briefSummary: The purpose of the study is to determine the safety and efficacy of brief intraoperative corneal endothelial graft incubation in plasma rich in growth factors (PRGF) for reducing postoperative endothelial cell loss. Subjects scheduled for endothelial keratoplasty will be enrolled and randomized to have the graft incubated in PRGF or not prior to graft implantation. The main outcome is the percentage central corneal endothelial cell loss 6 months after surgery., conditionsModule conditions: Fuchs' Endothelial Dystrophy, conditions: Corneal Edema, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: PRGF, outcomesModule primaryOutcomes measure: Endothelial cell loss at 6 months, secondaryOutcomes measure: Corneal endothelial cell density, secondaryOutcomes measure: Endothelial cell loss, secondaryOutcomes measure: Best corrected visual acuity, secondaryOutcomes measure: Re-bubble rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bascom Palmer Eye Institute, city: Miami, state: Florida, zip: 33136, country: United States, contacts name: Alfonso Sabater, MD, role: CONTACT, phone: 305-326-6326, email: asabater@med.miami.edu, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Price Vision Group, city: Indianapolis, state: Indiana, zip: 46260, country: United States, contacts name: Marianne Price, PhD, role: CONTACT, phone: 317-814-2990, email: mprice@cornea.org, geoPoint lat: 39.76838, lon: -86.15804, hasResults: False