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protocolSection identificationModule nctId: NCT06267833, orgStudyIdInfo id: MSKUSBFFTR01, briefTitle: The Effect of Trunk and Upper Extremity Exercises Added to the Otago Exercise Program, acronym: Otago Exercise, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Muğla Sıtkı Koçman University, class: OTHER, descriptionModule briefSummary: This study is designed to investigate the effect of adding trunk and upper extremity exercises in traditional and mobile game formats to the Otago exercise program on balance performance, fall risk, and fear in older adults. A randomized controlled, cross-sectional, single-blind (evaluator) study will be conducted with 36 older adults aged 65 and older enrolled at Muğla Sıtkı Koçman University (MSKÜ) Elderly Studies Application and Research Center. Participants will be divided into three randomized groups: control group (12 individuals receiving the Otago exercise program), study group 1 (12 individuals receiving additional trunk and upper extremity exercises with traditional methods added to the Otago exercise program), and study group 2 (12 individuals receiving additional trunk and upper extremity exercises with mobile game method added to the Otago exercise program). Participant demographics informations will be recorded in Form 1. Participants' cognitive functions, levels of independence in activities of daily living, fall risk, and fear of falling will be evaluated. Balance performance will be assessed using the Mini Balance Evaluation Systems Test (Mini-BESTest), portable computerized kinetic balance measurement (SportKAT 650-TS), "5 Times Sit-to-Stand" and "Four-Stage Balance Test" from the Otago Exercise Program. Participants' body sway will be assessed simultaneously with the second part of the Mini-BESTest using a mobile application. All assessments will be conducted by a researcher blinded to the exercises, both before and after the exercises, in a one-on-one face-to-face setting. In the exercise protocol, a personalized, home-based, 30-minute Otago exercise program consisting of strength, balance, and walking exercises performed three times a week will be implemented for 8 weeks with home visits and telerehabilitation sessions (via Videoconferencing) under the supervision of the responsible researcher. In addition to the Otago exercise program, trunk and upper extremity exercises (totaling 45 minutes) will be implemented in study group 1 using traditional methods and in study group 2 using the mobile game method. Telerehabilitation sessions will be conducted via an Android-based tablet if the study is supported by Tübitak 1002 A Rapid Support Module. Individual smartphones of participants will be used if the study is not supported. All questionnaires, scales, and tests used in the initial assessments will be repeated at the end of the 8-week exercise protocol for all participants., conditionsModule conditions: Geriatrics, conditions: Balance, conditions: Exercise, conditions: Fall Prevention, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: exercise, outcomesModule primaryOutcomes measure: Mini BESTest, secondaryOutcomes measure: Functional Reach Test, secondaryOutcomes measure: International Falls Efficacy Scale, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06267820, orgStudyIdInfo id: 2010, briefTitle: Postoperative Pain Control by Adding Ketorolac to Bupivacaine in Transversus Abdominis Plane Block in Children, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2023-12-01, completionDateStruct date: 2023-12-10, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: Control of of pain in children is fundamental. TAP block is associated with less side effects compared with other neuraxial techniques especially when done under ultrasound guidance.Ketorolac has analgesic effect comparable to morphine. Children were arranged randomly into two equal groups, forty-five children in each.Group (K) (n= 45): received ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg) and ketorolac (0.5 mg/kg).Group (T) (n =45): received ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg), conditionsModule conditions: Postoperative Pain, Acute, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ACTUAL, armsInterventionsModule interventions name: Bupivacain, interventions name: Ketorolac, outcomesModule primaryOutcomes measure: 1st analgesic requirement, primaryOutcomes measure: Number of patients who requested analgesia, secondaryOutcomes measure: heart rate, secondaryOutcomes measure: Total rescue analgesia, secondaryOutcomes measure: Satisfaction of the parents regarding their children analgesia, secondaryOutcomes measure: Number of children in each group who required analgesia in the first 24 h postoperatively, secondaryOutcomes measure: blood pressure, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Fouad Ibrahim Soliman, city: Sohag, zip: 52514, country: Egypt, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False

protocolSection identificationModule nctId: NCT06267807, orgStudyIdInfo id: 114369, secondaryIdInfos id: NL84520.091.23, type: OTHER, domain: Protocol ID METC, briefTitle: Lymphatic Phenotype in Noonan Syndrome Spectrum Disorders, acronym: LENS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-27, primaryCompletionDateStruct date: 2025-03-13, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Radboud University Medical Center, class: OTHER, descriptionModule briefSummary: To get a better insight into the central conducting lymphatic system in adult volunteers with Noonan Syndrome (NS) without clinical symptoms or signs of lymphatic disease compared to NS and CardioFacioCutaan syndrome patients with severe lymphatic disease, conditionsModule conditions: Lymphatic System Disorders Congenital, conditions: Lymphatic Diseases, conditions: Noonan Syndrome, conditions: Lymphatic Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Dynamic contrast-enhanced lymphangiography, outcomesModule primaryOutcomes measure: Central lymphatic system anatomy and flow descriptive parameters., primaryOutcomes measure: Diameter Thoracic duct, primaryOutcomes measure: Lymph flow velocity, otherOutcomes measure: Demographics age, otherOutcomes measure: Demographics gender, otherOutcomes measure: Demographics, otherOutcomes measure: Demographics weight, otherOutcomes measure: Demographics clinical history, otherOutcomes measure: Demographics genetic background, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Radboudumc, status: RECRUITING, city: Nijmegen, state: Gelderland, zip: 6500 HB, country: Netherlands, contacts name: Lotte ER Kleimeier, Msc, role: CONTACT, phone: 024036106873, email: lotte.kleimeier@radboudumc.nl, geoPoint lat: 51.8425, lon: 5.85278, hasResults: False

protocolSection identificationModule nctId: NCT06267794, orgStudyIdInfo id: ODISEA Study, briefTitle: Prolonged Release Pirfenidone Versus Placebo in Compensated Cirrhosis., acronym: ODISEA, statusModule overallStatus: COMPLETED, startDateStruct date: 2015-06-26, primaryCompletionDateStruct date: 2021-12-30, completionDateStruct date: 2023-03-24, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Jorge L Poo, class: OTHER, descriptionModule briefSummary: This will be a multicenter, double-blind clinical trial to evaluate the safety and efficacy of two doses of prolonged release pirfenidone, compared against placebo plus conventional therapy in patients with compensated liver cirrhosis. The study will be conducted in compliance with International Standard good clinical practices (GCPs) and the Declaration of Helsinki. The protocol is approved by a local Institutional Review Board and registered in clinical trials.gov., conditionsModule conditions: Liver Fibrosis, conditions: Cirrhosis, Liver, conditions: Chronic Liver Disease, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Double blind, placebo-controlled multicenter study, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Placebo will be identical to medication.Methods to assign treatment:Before assigning numbers to subjects, the researcher must confirm that the inclusion criteria have been met, that none of the exclusion criteria apply, that written and signed informed consent has been obtained, that the evaluations of the scrutiny (of admission) and that the required laboratory results are available and meet the admission criteria. To do this, the centers will be assisted with a check list format that contains all the selection criteria.The person responsible for the medication at the research site will contact the Randomization center, where the treatment will be assigned to the patient., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 180, type: ACTUAL, armsInterventionsModule interventions name: Pirfenidone 1200 mg, interventions name: Pirfenidone 1800 mg, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in liver fibrosis, primaryOutcomes measure: Clinical side effects, secondaryOutcomes measure: Improvement in Child Pugh score, secondaryOutcomes measure: Improvement in MELD score, secondaryOutcomes measure: Improvement in bilirrubin and albumin, secondaryOutcomes measure: Improvement in prothrombin time, secondaryOutcomes measure: Improvement in liver enzymes, secondaryOutcomes measure: Improvement in EuroQol Visual analog scales, secondaryOutcomes measure: Improvement in EuroQol five dimensions Scale, secondaryOutcomes measure: Improvement in modified fatigue impact scale (MFIS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06267781, orgStudyIdInfo id: TRANSPLANT-PRO, briefTitle: RRMS: Disease PROgression and Myeloid Profiling After Bone Marrow TRANSPLANTation and Second Line Therapies, acronym: TRANSPLANTPRO, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-09-02, primaryCompletionDateStruct date: 2027-09-02, completionDateStruct date: 2027-09-02, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: IRCCS San Raffaele, class: OTHER, descriptionModule briefSummary: To study whether highly effective therapies can halt disease progression in people with multiple sclerosis by modulating the peripheral myeloid landscape., conditionsModule conditions: Multiple Sclerosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Number of fading/disappearing paramagnetic rim lesions (PRLs), secondaryOutcomes measure: Surrogate biomarkers of disease progression (MSFC), secondaryOutcomes measure: Surrogate biomarkers of disease progression (sNfL), secondaryOutcomes measure: Surrogate biomarkers of disease progression (RNFL), secondaryOutcomes measure: Surrogate biomarkers of disease progression (cortical lesions), secondaryOutcomes measure: Surrogate biomarkers of disease progression (atrophy), secondaryOutcomes measure: Changes in myeloid landscape, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS San Raffaele, status: RECRUITING, city: Milan, zip: 20132, country: Italy, contacts name: Massimo Filippi, MD, role: CONTACT, phone: 00390226433054, email: filippi.massimo@hsr.it, contacts name: Anna A. Bellini, MD, role: CONTACT, phone: 00390226432154, email: bellini.anna@hsr.it, geoPoint lat: 45.46427, lon: 9.18951, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2022-05-03, uploadDate: 2024-02-15T03:19, filename: Prot_SAP_000.pdf, size: 10630791, hasResults: False

protocolSection identificationModule nctId: NCT06267768, orgStudyIdInfo id: REC Reference No.:HE-OT2023/13, secondaryIdInfos id: Proj.Ref.No.: 2023/3007-R7052, type: OTHER_GRANT, domain: Research Donation Fund, Hong Kong Metropolitan University, briefTitle: The Effects of Inspiratory Pressures on Diaphragmatic Contraction in People After Stroke, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-11-30, completionDateStruct date: 2025-11-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Hong Kong Metropolitan University, class: OTHER, collaborators name: Shenzhen Second People's Hospital, descriptionModule briefSummary: This is a cross-sectional study to determine the optimal inspiratory muscle training (IMT) intensity for stroke survivors. Participants will breathe through a pressure threshold inspiratory loading device with varying loads in random order. Each IMT intensity protocol consists of 10 breaths. During the test, accessory inspiratory muscle activity will be measured with surface electromyography (sEMG) and diaphragm thickness will be used to assessed with ultrasonography. Repeated-measures ANOVA will be used for statistical analysis to determine the most effective training intensity for future study., conditionsModule conditions: Stroke, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: Various intensities of inspiratory muscle training, outcomesModule primaryOutcomes measure: Diaphragmatic thickening fraction, secondaryOutcomes measure: Muscle activation of the sternocleidomastoid muscle, secondaryOutcomes measure: Perceived Exertion Borg scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-12-29, uploadDate: 2024-01-08T21:03, filename: Prot_SAP_000.pdf, size: 563906, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-12-29, uploadDate: 2024-02-15T09:59, filename: ICF_001.pdf, size: 197199, hasResults: False

protocolSection identificationModule nctId: NCT06267755, orgStudyIdInfo id: P.T.REC/012/004884, briefTitle: Efficacy of Extracorporeal Shockwave Therapy on Ultrasonography Changes of Upper Trapezius Myofascial Trigger Points in Patients With Non Specific Neck Pain, acronym: MTP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: this study will be conducted to investigate the effect of Extracorporeal Shockwave Therapy on Ultrasonography Changes of Upper Trapezius Myofascial Trigger Points in Patients With Non Specific Neck Pain, conditionsModule conditions: Neck Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: extracorporeal shockwave and traditional therapy, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: opaque sealed envelope, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Extracorporeal Shockwave therapy, interventions name: Traditional physical therapy, outcomesModule primaryOutcomes measure: muscle thickness, primaryOutcomes measure: hypoechoic area intensity, secondaryOutcomes measure: neck disability, secondaryOutcomes measure: pressure pain threshold, secondaryOutcomes measure: cervical range of motion, secondaryOutcomes measure: pain intensity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06267742, orgStudyIdInfo id: CHN097, briefTitle: Clinical Trial to Evaluate MDW for Early Detection of Sepsis, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-06-23, primaryCompletionDateStruct date: 2024-03-31, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Beckman Coulter, Inc., class: INDUSTRY, collaborators name: Peking Union Medical College Hospital, collaborators name: West China Hospital, collaborators name: Second Affiliated Hospital, School of Medicine, Zhejiang University, descriptionModule briefSummary: This study is intended to clinically verify Monocyte Distribution Width (MDW) parameter of DxH 900 Hematology Analyzer for use in early detection and risk assessment of sepsis, severe sepsis, and septic shock in critically ill patients in Emergency Department (ED). This study is also aimed to provide study supporting data for the product to be marketed in China., conditionsModule conditions: Sepsis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2200, type: ESTIMATED, armsInterventionsModule interventions name: Complete Blood Count (CBC) with Differential, outcomesModule primaryOutcomes measure: sensitivity, specificity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 89 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking Union Medical College Hospital, status: RECRUITING, city: Beijing, country: China, contacts name: Huadong Zhu, MD, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, locations facility: West China Hospital, Sichuan University, status: RECRUITING, city: Chengdu, country: China, contacts name: Yaxiong Zhou, MD, role: CONTACT, geoPoint lat: 30.66667, lon: 104.06667, locations facility: The Second Affiliated Hospital of Zhejiang University School of Medicine, status: RECRUITING, city: Hangzhou, country: China, contacts name: Mao Zhang, MD, role: CONTACT, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False

protocolSection identificationModule nctId: NCT06267729, orgStudyIdInfo id: D9660C00001, briefTitle: Study of AZD0754 in Participants With Metastatic Prostate Cancer, acronym: APOLLO, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2027-05-24, completionDateStruct date: 2027-05-24, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the safety, tolerability, and antitumour activity of AZD0754 CAR T-cell therapy in participants with metastatic prostate cancer., conditionsModule conditions: Metastatic Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Open-Label, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: AZD0754, outcomesModule primaryOutcomes measure: Incidence of participants with Dose-limiting Toxicity (DLTs)/DLT-like events, Adverse Events (AEs), including Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs)., primaryOutcomes measure: Presence of replication-competent lentivirus (RCL) in peripheral blood samples, secondaryOutcomes measure: Prostate-specific antigen (PSA) response rate - PSA50, secondaryOutcomes measure: PSA response rate - PSA90, secondaryOutcomes measure: Duration of PSA Response (DoPSA50, DoPSA90), secondaryOutcomes measure: Durable PSA Response Rate (DRRPSA50, DRRPSA90), secondaryOutcomes measure: Time to PSA Response (TTPSA50, TTPSA90), secondaryOutcomes measure: Time to PSA Progression (TTPSAP50, TTPSAP90), secondaryOutcomes measure: Best Overall Response (BOR), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Time to Response (TTR), secondaryOutcomes measure: Duration of Response (DoR), secondaryOutcomes measure: Durable Response Rate (DRR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Percentage change in tumor size, secondaryOutcomes measure: Radiographic Progression-free Survival (rPFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Time from AZD0754 Infusion to the first Symptomatic Skeletal-related Events (SSRE), secondaryOutcomes measure: Pharmacokinetics - maximum observed serum concentration (Cmax) of AZD0754, secondaryOutcomes measure: Pharmacokinetics - time taken to reach maximum serum concentration (Tmax) of AZD0754, secondaryOutcomes measure: Pharmacokinetics - Last measurable serum concentration (Clast) of AZD0754, secondaryOutcomes measure: Pharmacokinetics - time of last measurable serum concentration (Tlast) of AZD0754, secondaryOutcomes measure: Pharmacokinetics - Exposure of AZD0754, secondaryOutcomes measure: Biomarker - STEAP2 expression in Tumor, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 130 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, status: RECRUITING, city: Duarte, state: California, zip: 91010, country: United States, geoPoint lat: 34.13945, lon: -117.97729, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Tampa, state: Florida, zip: 33612, country: United States, geoPoint lat: 27.94752, lon: -82.45843, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Atlanta, state: Georgia, zip: 30322, country: United States, geoPoint lat: 33.749, lon: -84.38798, locations facility: Research Site, status: RECRUITING, city: Hackensack, state: New Jersey, zip: 07601, country: United States, geoPoint lat: 40.88593, lon: -74.04347, locations facility: Research Site, status: NOT_YET_RECRUITING, city: New York, state: New York, zip: 10065, country: United States, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, geoPoint lat: 39.95233, lon: -75.16379, locations facility: Research Site, status: RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Research Site, status: RECRUITING, city: East Melbourne, zip: 3002, country: Australia, geoPoint lat: -37.81667, lon: 144.9879, hasResults: False

protocolSection identificationModule nctId: NCT06267716, orgStudyIdInfo id: 274-2023, briefTitle: Pericapsular Nerve Block and Iliopsoas Fascial Plane Block in Hip Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-23, primaryCompletionDateStruct date: 2024-07-30, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Haseki Training and Research Hospital, class: OTHER, descriptionModule briefSummary: This prospective randomized interventional study aims to compare the effects of two peripheral nerve blocks, the periencapsular nerve block (PENG) and iliopsoas block (IPB), on analgesia and motor function after hip surgery.The main questions it aims to answer are the effectivity of postoperative pain management the preservation of motor movement.Participants will receive standardized general anesthesia and postoperative PENG or IPB in either Group.Researchers will compare the total amount of rescue analgesia and numeric rating scale with accompanying evaluating motor function at the same time intervals within 24 hour., conditionsModule conditions: Hip Fractures, conditions: Peripheral Nerve Block, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: prospective randomized standardized triple-blind, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: The participants under general anaesthesia and the orthopaedic surgeon responsible for the study will be blinded to the study groups and the specific block procedures. This surgeon will serve as the sole evaluator of postoperative outcomes. Intraoperative results will be recorded by the anaesthesia technician, who is present in the operating room and unaware of the block procedures. Moreover, the data analysis will be conducted before the data are unblinded., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: PENG block, interventions name: IPB, outcomesModule primaryOutcomes measure: postoperative motor block, secondaryOutcomes measure: pain scores, secondaryOutcomes measure: total analgesia, intraoperative, secondaryOutcomes measure: total rescue analgesia, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Haseki Training and Research Hospital, status: RECRUITING, city: Istanbul, state: Sultangazi, zip: 34000, country: Turkey, contacts name: Berna Caliskan, role: CONTACT, phone: +905067108770, email: caliskan.b@gmail.com, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False

protocolSection identificationModule nctId: NCT06267703, orgStudyIdInfo id: 2023-01939_VR, briefTitle: Multi-omics Analyses on Etiology and Early Detection of Stomach Cancer Precursor Lesions, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Karolinska Institutet, class: OTHER, descriptionModule briefSummary: The overall aim is to utilize multi-omics approach to identify novel etiopathogenesis and early detection biomarkers for stomach cancer precursor lesions. To achieve this aim, first the investigators will use stored serum samples to perform metabolomics profiling among 12,599 twin subjects, among whom 1034 were deemed to have chronic atrophic gastritis based on measured pepsinogen I and II levels. Logistic regression will be used to search for metabolites related to the risk of chronic atrophic gastritis. Second, the investigators will further measure serum proteome by using two quantitatively precise proteomics assays, among the above-mentioned twin subjects. Identified protein biomarkers will be combined with metabolomics biomarkers to create a prediction model for chronic atrophic gastritis. The results will hopefully improve our understanding of the etiological factors and provide promising early detection biomarkers for stomach cancer precursor lesions., conditionsModule conditions: Chronic Atrophic Gastritis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 12599, type: ACTUAL, armsInterventionsModule interventions name: Metabolomic profiling, outcomesModule primaryOutcomes measure: Chronic atrophic gastritis, eligibilityModule sex: ALL, minimumAge: 46 Years, maximumAge: 97 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Karolinska Institutet, city: Solna, state: Stockholm, zip: 17165, country: Sweden, geoPoint lat: 59.36004, lon: 18.00086, hasResults: False

protocolSection identificationModule nctId: NCT06267690, orgStudyIdInfo id: SYSUFAH2021025, briefTitle: A CT-based Radiomics Model to Predict Survival-graded Fibrosis in PDAC, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-13, primaryCompletionDateStruct date: 2023-08-31, completionDateStruct date: 2023-08-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital, Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: Tumor fibrosis plays an important role in chemotherapy resistance in pancreatic ductal adenocarcinoma (PDAC), however there remains a contradiction in the prognostic value of fibrosis. We aimed to investigate the relationship between tumor fibrosis and survival in patients with PDAC, classify patients into high- and low-fibrosis groups, and develop and validate a CT-based radiomics model to non-invasively predict fibrosis before treatment., conditionsModule conditions: Pancreatic Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 295, type: ACTUAL, armsInterventionsModule interventions name: surgery, outcomesModule primaryOutcomes measure: fibrosis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shi Siya, city: Guangzhou, state: Guangdong, zip: 510000, country: China, geoPoint lat: 23.11667, lon: 113.25, hasResults: False

protocolSection identificationModule nctId: NCT06267677, orgStudyIdInfo id: 2007/3928, briefTitle: Efficacy of Liquid Versus Powder Protein Supplementation to Optimize Protein Intake After Bariatric Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2008-01-02, primaryCompletionDateStruct date: 2008-04-18, completionDateStruct date: 2009-03-06, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Hospital Clinic of Barcelona, class: OTHER, descriptionModule briefSummary: The goal of this randomized control trial is to compare the effect of a liquid formula rich in nutrients and low in calories (supplement) with the progressive diet with conventional foods that we usually recommend in patients after surgery. The main question it aims to answer is if the addition of a high-protein, volume-controlled nutritional supplement as a fundamental part of the diet during the first two months after surgery will preserve the patient's nutritional status and prevent the appearance of nutritional deficits and associated complications.Participants will be evaluated at the beginning, at 1 month and at the end of the study (2m) and the following determinations will be made:* Analytical determination* Nitrogen balance by determining urea N2 in 24-hour urine* Anthropometric determinations* Body composition determined by impedanciometry* Resting energy expenditure and nutrient oxidation measured by indirect calorimetry.* Energy, protein and hydration intake.* Gastrointestinal tolerance through self-registration of symptoms. Researchers will compare the effect of a complete hypocaloric liquid formula group with the usual progressive diet group to see if they achieve the protein intake goal established for patients after obesity surgery, preservation of nutritional status and lean mass during the rapid phase of weight loss and the gastrointestinal tolerance during the first two months after surgery., conditionsModule conditions: Body Composition, conditions: Obesity, conditions: Protein Supplementation, conditions: Bariatric Surgery Candidate, conditions: Weight Loss, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ACTUAL, armsInterventionsModule interventions name: High protein liquid formula, outcomesModule primaryOutcomes measure: protein intake, primaryOutcomes measure: evaluate nutritional deficiencies, primaryOutcomes measure: Tolerance, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06267664, orgStudyIdInfo id: PI-GR-23-3263, briefTitle: Real-world Effectiveness and Tolerability of Triptans-Ditans-Gepants (TRIDIGEP), acronym: TRIDIGEP, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-04, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Hospital Clínico Universitario de Valladolid, class: OTHER, descriptionModule briefSummary: Migraine is the third most prevalent disease and the leading reason of years lived with disability in the most productive years of the life. Migraine associated disability can be alleviated by acute and preventive treatment. The migraine landscape has changed recently, with the approval of novel acute treatments, including oral Calcitonin gene-related peptide antagonists, the gepants (Rimegepant, Ubrogepant, Zavegepant) and 5-HT-1F antagonists, the Ditans (Lasmiditan). These have joined Triptans as acute "migraine-specific" drugs.The TRIDIGEP study will be an open-label, multiple attack, prospective cohort study.This study aims to describe 1) the effectiveness of the acute treatments of migraine attacks in routine clinical practice, 2) the tolerability of the drugs, and 3) to explore potential response and tolerability predictors.The endpoints recommended by the International Headache Society will be employed, including: 1) Pain freedom; 2) Absence of the most bothersome symptom; 3) Sustained pain freedom; 4) Total freedom from migraine; 5) Headache relief; 6) Duration of attacks; 7) Time lost due to an attack; 8) Need of rescue medication. The study endpoints will be assessed at 2, 8 and 24 hours after the acute drug use. Data will be collected by the patients themselves, with a validated data collection instrument within a RedCap questionnaire, using QR codes., conditionsModule conditions: Migraine, conditions: Migraine Disorders, conditions: Migraine With Aura, conditions: Headache Disorders, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1500, type: ESTIMATED, armsInterventionsModule interventions name: Patients with migraine treated with triptans, Lasmiditan or Gepants, outcomesModule primaryOutcomes measure: Pain freedom at 2 hours, primaryOutcomes measure: Absence of the most bothersome symptom, secondaryOutcomes measure: Pain freedom at 8 hours, secondaryOutcomes measure: Pain freedom at 24 hours, secondaryOutcomes measure: Sustained pain freedom, secondaryOutcomes measure: Total freedom from migraine at 2 hours, secondaryOutcomes measure: Total freedom from migraine at 8 hours, secondaryOutcomes measure: Total freedom from migraine at 24 hours, secondaryOutcomes measure: Headache relief at 2 hours, secondaryOutcomes measure: Headache relief at 8 hours, secondaryOutcomes measure: Headache relief at 24 hours, secondaryOutcomes measure: Time to meaningful relief, secondaryOutcomes measure: Time to pain freedom, secondaryOutcomes measure: Time to migraine freedom, secondaryOutcomes measure: Need of rescue medication at 2 hours, secondaryOutcomes measure: Need of rescue medication at 8 hours, secondaryOutcomes measure: Need of rescue medication at 24 hours, secondaryOutcomes measure: Tolerability of the drugs, secondaryOutcomes measure: Response predictors at 2 hours, secondaryOutcomes measure: Response predictors at 24 hours, secondaryOutcomes measure: Tolerability predictors, secondaryOutcomes measure: Time lost due to an attack, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Clínico Universitario de Valladolid, status: RECRUITING, city: Valladolid, zip: 47010, country: Spain, contacts name: David Garcia Azorin, MD, PhD, role: CONTACT, phone: +34665872228, email: davilink@hotmail.com, contacts name: Yesica González Osorio, role: CONTACT, phone: 634330426, email: yesgonzalezosorio@outlook.com, geoPoint lat: 41.65518, lon: -4.72372, hasResults: False

protocolSection identificationModule nctId: NCT06267651, orgStudyIdInfo id: Steroid in ulcerative colitis, briefTitle: Value Of ACE Index (Albumin, CRP And Endoscopy) In Predicting Intra Venous Steroid Response In Acute Severe Ulcerative Colitis In Assiut University Hospitals, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-01, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2027-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: 1. Determine if the ACE index can predict resoponse to I V steroid in Acute severe ulcerative colitis2. identify on admission a high-risk population who may beneft from earlier second line medical treatment or surgical intervention. ( steroid non responder groups ), conditionsModule conditions: Early Detection of Complication of Ulcerative Colitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 95, type: ESTIMATED, outcomesModule primaryOutcomes measure: Early prevention of complication of ulcerative colitis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06267638, orgStudyIdInfo id: Chomthong hospital, Thailand, briefTitle: Comparison of Postoperative Pain Score Between Perioperative Intravenous Ketamine and Placebo in Patients Undergoing Unilateral Total Knee Arthroplasty Under General Anesthesia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-22, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Ministry of Health, Thailand, class: OTHER_GOV, descriptionModule briefSummary: The goal of this clinical trial is to compare postoperative pain score between perioperative intravenous ketamine and placebo in patients undergoing unilateral total knee arthroplasty under general anesthesia. The main question\[s\] it aims to answer are:* Can perioperative intravenous ketamine reduce postoperative pain score during rest and movement at 0, 2, 4, 8, 12, 18, 24 hours better than no administration of Ketamine in patients undergoing Unilateral total knee arthroplasty under general anesthesia?* Can perioperative intravenous ketamine reduce morphine consumption in postoperative 24 hours, length of hospital stay, first time to receive opioid and side effect or complication from ketamine and opioid better than no administration of Ketamine in patients undergoing Unilateral total knee arthroplasty under general anesthesia? Participants will receive intravenous ketamine intraoperative TKA and comparison group will receive placebo that is normal saline. Researchers will compare perioperative intravenous ketamine and placebo to see postoperative pain score, morphine consumption in postoperative 24 hours, length of hospital stay, first time to receive opioid and side effect or complication from ketamine and opioid., conditionsModule conditions: Knee Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Ketamine group, interventions name: Placebo group, outcomesModule primaryOutcomes measure: Postoperative pain score at rest and movement, secondaryOutcomes measure: First time to receive intravenous analgesic drug, secondaryOutcomes measure: Morphine consumption, secondaryOutcomes measure: Length of hospital stay, secondaryOutcomes measure: side effect and complication from ketamine and opioid, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chomthong hospital, status: RECRUITING, city: Chiangmai, zip: 50160, country: Thailand, contacts name: Numphung Sukantarat, master, role: CONTACT, phone: 66855426519, email: phuang_007@yahoo.com, geoPoint lat: 18.79038, lon: 98.98468, hasResults: False

protocolSection identificationModule nctId: NCT06267625, orgStudyIdInfo id: Elderly Individuals, briefTitle: Physical Impairments in Elderly Individuals, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2026-03-15, completionDateStruct date: 2026-12-15, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Izmir Democracy University, class: OTHER, descriptionModule briefSummary: There are no studies in the literature reporting the dyspnea, posture, strength, physical activity, functional mobility and balance in elderly individuals. The aims of this observational study are; 1) to evaluate dyspnea, posture, strength, physical activity, functional mobility and balance in elderly individuals, 2) to reveal the relationships between these parameters of research group., conditionsModule conditions: Aging Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Physical Evaluations of individuals, outcomesModule primaryOutcomes measure: Dyspnea score, secondaryOutcomes measure: Posture score, secondaryOutcomes measure: Cough strength, secondaryOutcomes measure: Handgrip strength, secondaryOutcomes measure: Functional mobility score, secondaryOutcomes measure: Physical activity score, secondaryOutcomes measure: Functional Mobility score, secondaryOutcomes measure: Balance score, secondaryOutcomes measure: Cognitive function score, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Izmir Democracy University, city: İzmir, zip: 35140, country: Turkey, contacts name: GÜLŞAH BARĞI, Assoc.Dr., role: CONTACT, phone: +90 531 793 8766, email: gulsahbargi35@gmail.com, contacts name: ESRA SUDE AKIN, BSc, role: CONTACT, phone: +90 543 581 4690, email: esrasudeakin@gmail.com, geoPoint lat: 38.41273, lon: 27.13838, hasResults: False

protocolSection identificationModule nctId: NCT06267612, orgStudyIdInfo id: KY20231109-11, briefTitle: Corheart 6 LVAS Long-term Follow-up Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-10, primaryCompletionDateStruct date: 2030-06-30, completionDateStruct date: 2030-06-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Nanjing First Hospital, Nanjing Medical University, class: OTHER, descriptionModule briefSummary: The purpose of this clinical study is to explore the long-term efficacy and safety of the Corheart 6 Left Ventricular Assist System (LVAS) as a treatment for patients with advanced heart failure.The study will be a single-arm, prospective, single-center, non-blinded, and non-randomized study with a follow-up duration of five years., conditionsModule conditions: Heart Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Corheart 6 Left Ventricular Assist System, outcomesModule primaryOutcomes measure: Device implantaion success rate at 24 months post-implantation, secondaryOutcomes measure: Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23), secondaryOutcomes measure: Quality of Life as measured by the EuroQoL-5D-5L (EQ-5D-5L) questionnaire, secondaryOutcomes measure: Functional status as measured by the Six Minute Walk Test (6MWT), secondaryOutcomes measure: Functional status as measured by the New York Heart Association (NYHA) Classification, secondaryOutcomes measure: Stroke severity as assessed with the National Institutes of Health Stroke Scale (NIHSS) score, secondaryOutcomes measure: Stroke severity as assessed by the modified Rankin Scale (mRS) score, secondaryOutcomes measure: Adverse events, secondaryOutcomes measure: Device-related re-operations, secondaryOutcomes measure: Device-related re-hospitalizations, secondaryOutcomes measure: Overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nanjing First Hospital, city: Nanjing, state: Jiangsu, country: China, contacts name: Zhibing Qiu, role: CONTACT, email: qiuzhibing2009@163.com, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False

protocolSection identificationModule nctId: NCT06267599, orgStudyIdInfo id: ACAR-Style Bladder Suture, briefTitle: Bladder Suture in Uterus-Sparing Surgery and Hysterectomy for Placenta Percreta, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2023-12-01, completionDateStruct date: 2024-01-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Necmettin Erbakan University, class: OTHER, descriptionModule briefSummary: This study aimed to evaluate the short-term and long-term complications of placenta percreta with bladder invasion. This evaluation focuses on cases where bladder dissection and ACAR-style bladder sutures were applied in cases of placenta percreta with bladder invasion that underwent uterine-sparing surgery or hysterectomy., conditionsModule conditions: Placenta Percreta, conditions: Bladder Injury, conditions: Sutures, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 81, type: ACTUAL, armsInterventionsModule interventions name: ACAR-Style Bladder Suture, outcomesModule primaryOutcomes measure: Comparison of intraoperative bleeding and complication rates of the two groups, primaryOutcomes measure: Comparison of postoperative bleeding between two groups, primaryOutcomes measure: Comparison of complication rate between two groups, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Cemre Alan, city: Konya, country: Turkey, geoPoint lat: 37.87135, lon: 32.48464, hasResults: False

protocolSection identificationModule nctId: NCT06267586, orgStudyIdInfo id: PN23.007, briefTitle: Effects of PeptiSleep in Healthy Males and Females With Mild to Moderate Sleep Impairment, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2025-02-20, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Nuritas Ltd, class: INDUSTRY, collaborators name: RDC Clinical Pty Ltd, descriptionModule briefSummary: Examining the effects of PeptiSleep, a plant-based sleep aid, in healthy males and females with mild to moderate sleep impairment, conditionsModule conditions: Sleep, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, single-blind, placebo-controlled, parallel dose response study conducted over 70 days, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: Participants will be unaware of arm allocation however as each arm contains a different number of capsules to be consumed, the investigator will be aware of the arm allocation, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: PeptiSleep, interventions name: Placebo MCC micro-crystalline cellulose, outcomesModule primaryOutcomes measure: Safety and Tolerability of a dose range of PeptiSleep via adverse event reporting, secondaryOutcomes measure: Safety via electrolytes and liver function tests, secondaryOutcomes measure: Sleep Quality via Leeds Sleep Evaluation Questionnaire, secondaryOutcomes measure: Insomnia severity via the Insomnia Severity Index Questionnaire, secondaryOutcomes measure: Sleep onset time via self-reported recording in a Sleep Diary, secondaryOutcomes measure: Sleep pattern via self-reported recording in a Sleep Diary, secondaryOutcomes measure: Daytime Sleepiness via the Epworth Sleepiness Scale, secondaryOutcomes measure: Stress via the Perceived Stress Scale, secondaryOutcomes measure: Stress via self reported Profile of Mood States Questionnaire, secondaryOutcomes measure: Anxiety via self-reported Beck Anxiety Inventory questionnaire, secondaryOutcomes measure: Stress via Salivary cortisol test, secondaryOutcomes measure: Alertness via Reaction Time Test, secondaryOutcomes measure: Circadian cycles via melatonin and serotonin via blood test, secondaryOutcomes measure: Markers associated with inflammation via blood test, secondaryOutcomes measure: Sleep onset latency via wearable sleep tracker, secondaryOutcomes measure: Total sleep time spent in sleep phases via wearable sleep tracker, secondaryOutcomes measure: Blood pressure via blood pressure machine, secondaryOutcomes measure: Heart rate via blood pressure machine, secondaryOutcomes measure: Body Temperature via wearable sleep tracker, secondaryOutcomes measure: BMI via height and weight measurements, otherOutcomes measure: Bedtime via wearable sleep tracker, otherOutcomes measure: Total time awake via wearable sleep tracker, otherOutcomes measure: Sleep quantity via wearable sleep tracker, otherOutcomes measure: Sleep efficiency via wearable sleep tracker, otherOutcomes measure: Sleep score via wearable sleep tracker, otherOutcomes measure: Nocturnal heart rate via wearable sleep tracker, otherOutcomes measure: Heart Rate variability via wearable sleep tracker, otherOutcomes measure: Blood Oxygen sensing via sleep tracker, otherOutcomes measure: Respiratory rate via sleep tracker, otherOutcomes measure: Daily Readiness Score via sleep tracker, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: RDC Clinical, status: RECRUITING, city: Brisbane, state: Fortitude Valley Queensland, zip: 4006, country: Australia, contacts name: Amanda Rao, role: CONTACT, contacts name: Amanda Rao, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -27.46794, lon: 153.02809, hasResults: False

protocolSection identificationModule nctId: NCT06267573, orgStudyIdInfo id: Kerolos protocol, briefTitle: Thoracoabdominal Aortic Aneurysms, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2025-09-15, completionDateStruct date: 2026-09-10, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Evaluation of the effectiveness of the different modalities for treatment of thoracoabdominal aortic aneurysms. FEVAR and BEVAR devices are widely used now due to its feasability and wide range of use . We aim to evaluate the effectiveness of these new devices in the management of TAAA, conditionsModule conditions: Thoracoabdominal Aortic Aneurysm, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Fenestrated and branched endovascular devices for TAAA, outcomesModule primaryOutcomes measure: Successful cannulation of the target vessels with complete in-line flow to target organs., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06267560, orgStudyIdInfo id: CTQJ230A12303, briefTitle: Lp(a) Lowering Study of Pelacarsen (TQJ230) in US Black/African American and Hispanic Participants With Elevated Lp(a) and Established ASCVD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-27, primaryCompletionDateStruct date: 2027-06-21, completionDateStruct date: 2027-06-21, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Novartis Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: Study CTQJ230A12303 is a randomized, double-blind placebo-controlled, Phase IIIb study to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) 80 mg s.c. QM compared with placebo s.c. QM in US Black/African American and Hispanic participants with established ASCVD and elevated levels of Lp(a) who are treated for cardiovascular (CV) risk factors according to local practice/guidelines for the reduction of cardiovascular risk., conditionsModule conditions: Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Eligible participants will be randomized after the screening period or Guideline recommended SOC implementation period (if needed) in a 2:1 ratio to subcutaneous injections of pelacarsen (TQJ230) 80 mg QM or placebo QM either to be self-administered or administered by caregiver or site personnel approximately every 30 days for up to 12 months., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: TQJ230, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in log-transformed Lp(a) concentration from baseline at week 52, secondaryOutcomes measure: Incidence proportion of study discontinuations due to TEAEs, secondaryOutcomes measure: Incidence proportion of Treatment emergent adverse events (TEAEs) of special interest, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06267547, orgStudyIdInfo id: 2023P003522, briefTitle: Healthy Activities Improve Lives (HAIL), acronym: HAIL, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-23, primaryCompletionDateStruct date: 2026-12-01, completionDateStruct date: 2027-02-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, collaborators name: National Institute on Aging (NIA), descriptionModule briefSummary: The investigators have developed an online platform to support the 8-week, F\&S! exercise program called the Healthy Activity Improves Lives (HAIL) online platform. The aim of this study is to perform a cluster randomization of four racially diverse churches or senior centers to either the standard F\&S! program, or the combined HAIL Online Platform + F\&S! program to examine the efficacy of the HAIL online platform + F\&S! program for older adults in black communities., conditionsModule conditions: Physical Activity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: HAIL Online Platform, interventions name: Fit and Strong! Program, outcomesModule primaryOutcomes measure: Feasibility and Retention, primaryOutcomes measure: Acceptability, primaryOutcomes measure: Acceptability (Feedback Form), primaryOutcomes measure: Acceptability (Exit Interviews), secondaryOutcomes measure: Changes in Physical Activity (Steps), secondaryOutcomes measure: Changes in Physical Activity (MVPA), secondaryOutcomes measure: Changes in Aerobic Capacity, secondaryOutcomes measure: Changes in Physical Strength, secondaryOutcomes measure: Motivation to Change, secondaryOutcomes measure: Utilization of Healthcare Resources, secondaryOutcomes measure: Fall History, secondaryOutcomes measure: Chronic Conditions, secondaryOutcomes measure: Changes in Overall Wellbeing, secondaryOutcomes measure: Changes in Depression, secondaryOutcomes measure: Changes in Anxiety, secondaryOutcomes measure: Changes in Physical Functioning, secondaryOutcomes measure: Changes in Social Isolation, secondaryOutcomes measure: Changes in Confidence in Exercises, otherOutcomes measure: Satisfaction with program, otherOutcomes measure: Satisfaction with program, otherOutcomes measure: Use of online program, otherOutcomes measure: Use of online program, eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Roslindale Baptist Church, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02131, country: United States, contacts name: Lydia Townsend, role: CONTACT, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False

protocolSection identificationModule nctId: NCT06267534, orgStudyIdInfo id: YCH, briefTitle: Mindfulness-based Mobile Applications Program, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-09, primaryCompletionDateStruct date: 2022-09-22, completionDateStruct date: 2022-09-22, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Yu-Chien Huang, class: OTHER, descriptionModule briefSummary: The goal of this type of study: quasi-experimental clinical trial . The purpose of this study is to explore the effects of applying mindfulness-based mobile applications program to maintaining mental health of emergency nurses during providing care to COVID-19 patients. The main question\[s\] it aims to answer are:1. To explore the effect of mindfulness-based mobile device-assisted program on care stress of emergency nurses caring for COVID-19 patients.2. To explore the impact of mindfulness-based mobile device-assisted programs on the psychological distress of emergency nurses caring for COVID-19 patients.3. To explore the impact of a mindfulness-based mobile device-assisted program on compassion fatigue in emergency nurses caring for COVID-19 patients.Participants will Mindfulness-based mobile device is provided to experimental group as assistance for 2 weeks. In the contrary, no intervention measure was assigned in the control group. Scale exam was performed before and after the program in both groups at the same time., conditionsModule conditions: COVID-19, conditions: Cell Phone Use, conditions: Nurse, conditions: Mental Health, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 102, type: ACTUAL, armsInterventionsModule interventions name: mindfulness-based mobile applications program, outcomesModule primaryOutcomes measure: The impact of mindfulness-based mobile device assistance program on the care stress of emergency nursing staff caring for COVID-19 patients, primaryOutcomes measure: Effects of mindfulness-based mobile device assistance program on psychological distress among emergency nursing staff caring for COVID-19 patients, primaryOutcomes measure: Effects of a mindfulness-based mobile device-assisted program on compassion fatigue among emergency nursing staff caring for COVID-19 patients, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yu-Chien Huang, city: Taipei, state: Zhongzheng District, zip: 100, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False

protocolSection identificationModule nctId: NCT06267521, orgStudyIdInfo id: 2023-1473, secondaryIdInfos id: Protocol Version 2/8/2024, type: OTHER, domain: UW Madison, secondaryIdInfos id: L&S/PSYCHOLOGY/PSYCHOLOGY, type: OTHER, domain: UW Madison, secondaryIdInfos id: A487400, type: OTHER, domain: UW Madison, secondaryIdInfos id: AWD00000302, type: OTHER_GRANT, domain: US Department of Defense DARPA, briefTitle: The STRENGTHEN Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-06, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: University of Wisconsin, Madison, class: OTHER, collaborators name: United States Department of Defense, descriptionModule briefSummary: This study uses two different types of interventions including electrical brain stimulation delivered during sleep, and brief, daily meditation training. The investigators are trying to figure out whether these techniques, either alone or in combination with each other, can positively impact the brain networks that support our ability to think flexibly and to regulate our emotions. 48 participants will be enrolled and can expect to be on study for up to 9 months., conditionsModule conditions: Cognitive Flexibility, conditions: Emotional Regulation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, maskingDescription: Participants will not know whether they are in a group receiving active stimulation (groups 2, 3, and 4) or sham stimulation (group 1). However, participants will know whether they are performing meditation (groups 1, 3, and 4) or listening to only the didactic meditation material (group 2), and participants will be aware of how many nights they are undergoing stimulation (1 night per week for group 3, 2 nights per week for groups 1, 2, and 4). Thus, participants will be only partially blind to condition. Investigators will not be blind to condition., whoMasked: PARTICIPANT, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Healthy Minds Program, interventions name: Sham Meditation Didactic Material, interventions name: Sham Stimulation in Lab, interventions name: Stimulation in Lab, interventions name: MRI Scanner, outcomesModule primaryOutcomes measure: Change in Patient Health Questionnaire-9 (PHQ-9) Score, primaryOutcomes measure: Change in General Anxiety Disorder (GAD-7) Score, primaryOutcomes measure: Change in Single-item Suicide Question, primaryOutcomes measure: Change in Healthy Minds Index (HM Index), primaryOutcomes measure: Change in the Perceived Stress Scale (PSS) Score, primaryOutcomes measure: Change in Emotional Styles Questionnaire (ESQ) Score, primaryOutcomes measure: Change in Cognitive Flexibility Inventory (CFI) Score: Alternatives Subscale, primaryOutcomes measure: Change in Cognitive Flexibility Inventory (CFI) Score: Control Subscale, primaryOutcomes measure: Change in Difficulties in Emotion Regulation Scale-18 (DERS-18) Score, primaryOutcomes measure: Change in PROMIS Sleep Disturbance Score, primaryOutcomes measure: Change in PTSD Checklist for DSM-5 (PCL-5), primaryOutcomes measure: Change in World Health Organization-5 (WHO-5), primaryOutcomes measure: Change in Restorative Sleep Questionnaire (RSQ) Score, primaryOutcomes measure: Change in Sleep Depth Question (SDQ) Score, primaryOutcomes measure: Change in Pittsburgh Sleep Quality Index (PSQI) Score, primaryOutcomes measure: Change in Suicide Risk Survey, primaryOutcomes measure: Change in Brief Suicide Cognitions Scale (B-SCS) Score, primaryOutcomes measure: Change in Passive and Active Suicidal Ideation Scale (PASIS) Score, primaryOutcomes measure: Change in NIH Toolbox Loneliness Score, primaryOutcomes measure: Change in Five Facet Mindfulness Questionnaire (FFMQ) Score, primaryOutcomes measure: Change in Drexel Defusion Scale (DDS) Score, primaryOutcomes measure: Change in PROMIS Meaning and Purpose Score, primaryOutcomes measure: Change in Digital Working Alliance Inventory (D-WAI) Score, primaryOutcomes measure: Change in Perseverative Thinking Questionnaire (PTQ) Score, primaryOutcomes measure: Change in Experiences Questionnaire's Decentering subscale (EQ-D) Score, primaryOutcomes measure: Change in Experience Sampling / Ecological Momentary Assessment, primaryOutcomes measure: Change in Death Implicit Association Test Score, primaryOutcomes measure: Change in Reversal Learning Task Score, primaryOutcomes measure: Change in Multi-Source Interference Task Score, primaryOutcomes measure: Change in Emotional Stroop Score: Reaction Time, primaryOutcomes measure: Change in Emotional Stroop Score: Percent Correct, primaryOutcomes measure: Change in Meteor Mission Score: Mean Reaction Time, primaryOutcomes measure: Change in Meteor Mission Score: Coefficient of Variation, primaryOutcomes measure: Change in Meteor Mission Score: Percent Correct, primaryOutcomes measure: Change in Emotional Persistence Task Score, primaryOutcomes measure: Change in Change Your Mind Task Score: Mean Change, primaryOutcomes measure: Change in Change Your Mind Task Score: Accuracy, primaryOutcomes measure: Change in Change Your Mind Task Score: Response Time, secondaryOutcomes measure: Change in Spectral Power Density During Stimulation-Free Sleep, secondaryOutcomes measure: Resting-state fMRI Connectivity Z-Scores, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Center for Healthy Minds, status: RECRUITING, city: Madison, state: Wisconsin, zip: 53703, country: United States, geoPoint lat: 43.07305, lon: -89.40123, hasResults: False

protocolSection identificationModule nctId: NCT06267508, orgStudyIdInfo id: LMU-IMPH-LIFE2Scale, briefTitle: Increasing Neonatal HIV Test and Treat to Maximize the Long-Term Impact on Infant Health and Novel Infant Antiretroviral Treatment, acronym: LIFE2Scale, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Michael Hoelscher, class: OTHER, collaborators name: National Institute for Medical Research (NIMR) - Mbeya Medical Research Centre (MMRC), collaborators name: Instituto Nacional de Saúde (INS), Ministério da Saúde, collaborators name: University of Liverpool, descriptionModule briefSummary: This study aims to improve HIV healthcare services for mothers living with HIV and their newborns in Tanzania and Mozambique. The main questions it aims to answer are: 1) does enhancing screening with maternal HIV viral load monitoring at delivery identify more mother-child pairs at high-risk for HIV vertical transmission? and 2) are high-risk infants linked to appropriate prevention and care? The study will expand access to HIV testing services to more rural settings using a hub-and-spoke referral system., conditionsModule conditions: Vertical Human Immunodeficiency Virus Transmission, conditions: HIV Infection Pediatric, conditions: Infant Death, conditions: Infant Morbidity, conditions: Infant, Newborn, Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 6000, type: ESTIMATED, armsInterventionsModule interventions name: Maternal HIV viral load testing at delivery for VHT risk assessment, outcomesModule primaryOutcomes measure: Proportion of HIV-exposed infants correctly identified as low- or high-risk and receiving birth EID testing and ePNP or ART as appropriate within 7 days of life, secondaryOutcomes measure: Turnaround times for EID testing at birth, 4-6 weeks, and 14 weeks (time from sample collection to receipt of results by the health facility and communication of results to the mother/caregiver) and maternal PoC VL testing at delivery and 14 weeks, secondaryOutcomes measure: Proportion and rate of VHT at birth, week 4-8, and week 14, secondaryOutcomes measure: Risk-factors associated with VHT, secondaryOutcomes measure: Adherence to PNP and ePNP, secondaryOutcomes measure: Proportion and rate of clinical endpoints (mortality, morbidity) among HIV-positive infants at week 14, month 6, and month 12, secondaryOutcomes measure: Age at ART initiation among HIV-positive infants, secondaryOutcomes measure: Risk factors for poor ART adherence among high-risk mothers and infants, secondaryOutcomes measure: Proportion of HIV-positive infants virally suppressed at week 14, month 6, and month 12, secondaryOutcomes measure: Risk factors for poor viral suppression among HIV-positive infants, secondaryOutcomes measure: Proportion of HIV-positive infants on ART that experience grade III or greater laboratory ART toxicity, secondaryOutcomes measure: Retention to HIV EID and infant health care services, secondaryOutcomes measure: Proportion of pregnant women presenting with criteria considered high-risk for VHT at delivery, secondaryOutcomes measure: Proportion of mothers virally suppressed at week 14 post-partum, secondaryOutcomes measure: Proportion and rate of post-partum mothers newly fulfilling high-risk criteria based on socio-behavioural criteria (i.e., adherence issues), secondaryOutcomes measure: Characteristics of transmitted viral strains (lineages, subtypes, resistance mutations) among HIV-positive infants and in comparison to their mothers viral sequences, secondaryOutcomes measure: Proportion of HIV-positive infants who develop acquired drug resistance mutations during the study, secondaryOutcomes measure: Characteristics of infant and maternal HIV strains to be neutralized against a panel of known broadly neutralizing antibody candidates (e.g., VRC07, 10-1074) and maternal autologous antibodies at time of transmission, secondaryOutcomes measure: Average public healthcare and healthcare-related expenditures, secondaryOutcomes measure: Average health worker time needed to care for mothers and infants per clinic visit, including for enhanced counselling sessions, secondaryOutcomes measure: Cost per HIV-exposed infant fulfilling the primary outcome, secondaryOutcomes measure: Empirical cost-effectiveness (incremental cost-effectiveness ratio) relating intervention costs to life-years saved among HIV-positive infants, secondaryOutcomes measure: Average global and dimensional patient satisfaction, otherOutcomes measure: Hub-and-spoke model and provider satisfaction (health care personnel, focal point persons, counsellor), otherOutcomes measure: Socio-behavioural and personal aspects related to high-risk criteria for mother-child pairs (adherence, retention, disclosure, emotional well-being and health care satisfaction), otherOutcomes measure: Descriptions of tasks, functions, acceptability, challenge and workloads related to PVHT and neonatal HIV focal persons, otherOutcomes measure: Descriptions of tasks, functions, acceptability, challenge and workloads related to counsellors (enhanced high-risk counselling), otherOutcomes measure: Description on eHealth functionality, satisfaction, acceptance of linkage procedures, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centro de Investigacao Operacional de Beira (CIOB), Instituto Nacional de Saúde (INS), Ministério da Saúde,, city: Beira, country: Mozambique, contacts name: Joaquim Lequechane, role: CONTACT, contacts name: Ilesh Jani, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -19.84361, lon: 34.83889, locations facility: National Institute for Medical Research (NIMR), city: Mbeya, country: Tanzania, contacts name: Issa Sabi, MD, PhD, role: CONTACT, contacts name: Issa Sabi, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -8.9, lon: 33.45, hasResults: False

protocolSection identificationModule nctId: NCT06267495, orgStudyIdInfo id: EOCXLFE, briefTitle: Epithelium-on Cross-linking Versus Observation of Fellow Eyes of Patients With Unilateral Clinically Evident Keratoconus, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-01-01, primaryCompletionDateStruct date: 2024-01-31, completionDateStruct date: 2024-01-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Keratoconus (KC) is a bilateral asymmetric progressive corneal degenerative disease. The management of young patients, diagnosed with clinically evident KC in one eye and with no clinical signs of KC in the other eye, represents a real challenge for many ophthalmologists.The aim of the current study is to investigate the effectiveness and safety of epithelium-on accelerated CXL to stabilize the eye with no clinical signs of KC, in young patients with unilateral clinically evident KC, compared with standard care and follow-up only., conditionsModule conditions: Keratoconus, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Epithelium-on corneal cross-linking (epi-on CXL), outcomesModule primaryOutcomes measure: Steep keratometry value, primaryOutcomes measure: Maximum keratometry value, secondaryOutcomes measure: Corrected distance visual acuity, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 30 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Tiba Eye Center, city: Assiut, zip: 71516, country: Egypt, geoPoint lat: 27.18096, lon: 31.18368, hasResults: False

protocolSection identificationModule nctId: NCT06267482, orgStudyIdInfo id: 122311, briefTitle: Using ROSA for Challenging The TKA Standard of Care, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-16, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Lawson Health Research Institute, class: OTHER, collaborators name: Zimmer Biomet, descriptionModule briefSummary: This is a prospective, randomized controlled trial using the cruciate retaining, MC Persona to comparing the conventional TKA to ROSA assisted TKA. Patients will be randomized to one of three study trial arms.1. Standard of care medial parapetallar approach (Control)2. ROSA PSA medial parapetallar approach3. ROSA PSA medial subvastus approach Participants will be followed for 1 year post surgery with a combination of perioperative parameters, imaging, patient reported outcomes, functional outcomes, blood and tissue sampling for inflammatory information and activity levels., conditionsModule conditions: Knee Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: ROSA PSA Parapatellar Approach, interventions name: ROSA PSA Subvastus Approach, outcomesModule primaryOutcomes measure: Functional Outcome - Weight-bearing CT scan, primaryOutcomes measure: Functional Outcome - 3D Ultrasound, primaryOutcomes measure: Functional Outcome - Timed Up and Go test, primaryOutcomes measure: Patient health status - Knee Society Score, primaryOutcomes measure: Patient health status - EuroQuol Survey, primaryOutcomes measure: Patient health status - Knee Injury and Osteoarthritis Outcome Score, primaryOutcomes measure: Patient health status - Western Ontario and McMaster Universities Arthritis Index, primaryOutcomes measure: Patient health status - Global Assessment, secondaryOutcomes measure: Health Ecominics, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital, status: RECRUITING, city: London, state: Ontario, country: Canada, geoPoint lat: 42.98339, lon: -81.23304, hasResults: False

protocolSection identificationModule nctId: NCT06267469, orgStudyIdInfo id: Boutonniere deformity, briefTitle: Boutonniere Deformity Effectiveness of Thermoplastic and Fabricated Orthoses, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-06, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Magdalena Kolasińska, class: OTHER, collaborators name: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland, descriptionModule briefSummary: The goal of this study is to present the author's thumb orthosis with a butonier deformity and its effect on hand function, strength, dexterity and pain levels in relation to patients wearing factory-made orthopedic supplies. It is planned to include about 60 people in the study (30 people each in the group with thermoplastic orthoses and 30 participants with factory-made orthoses)The main questions it aims to answer are:1. How much improvement in dexterity will the patient wearing the orthosis get? 2. By how much will the grip strength of the whole hand and pincer grip strength improve with the orthosis? 3. How will wearing the orthosis affect the pain associated with the disease? Participants will1. measurement of grip strength of the right and left hands with a dynamometer in an orthosis and without an orthosis, at the time of the test conducted and at the appointed times.2. measurement of pincer grip strength with a dynamometer in an orthosis and without an orthosis, at the time of the test conducted and at the designated times.4. completion of the DASH questionnaire 6. assessment of the NRS pain scale in relation to the period of 6 months before the start of the study 7. Likert scale - evaluation of satisfaction with the use of the orthosis 8. the Kapandji scale Researchers will compare patients with thermoplastic orthosis and patients with fabric orthosis to see which is more functional., conditionsModule conditions: Orthotic Devices, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Thermoplastic orthosis, outcomesModule primaryOutcomes measure: Grip strength, primaryOutcomes measure: DASH -Disabilities of the Arm, Shoulder and Hand, primaryOutcomes measure: Likert scale, primaryOutcomes measure: Kapandji score, primaryOutcomes measure: NRS - Numerical Rating Scale, primaryOutcomes measure: pinch strength, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher, city: Warsaw, state: Mazowieckie, zip: 02-637, country: Poland, contacts name: Magdalena Kolasińska, Msc, role: CONTACT, phone: +48609219822, email: magdalena.kolasinska@awf.edu.pl, contacts name: Teresa Sadura-Sieklucka, Phd, role: CONTACT, email: teresa.sadura@awf.edu.pl, geoPoint lat: 52.22977, lon: 21.01178, locations facility: Terapia Ręki Magda Kolasińska, city: Warszawa, state: Mazowieckie, zip: 01-494, country: Poland, contacts name: Magdalena Kolasińska, Msc, role: CONTACT, phone: +48609219822, email: magdalena.kolasinska@awf.edu.pl, geoPoint lat: 52.22977, lon: 21.01178, hasResults: False

protocolSection identificationModule nctId: NCT06267456, orgStudyIdInfo id: HÜ- FTR- BD- 01, briefTitle: The Reliability of ULRT in Overhead Athletes and Its Relationship With Selected UEPT, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2023-01-01, completionDateStruct date: 2023-01-10, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, descriptionModule briefSummary: Upper Extremity Rotation Test is a new test the evaluates 90-90 position, which is one of the requirements for overhead throwing. The aim of the study was to evaluate the reliability of the Upper Extremity Rotation Test in overhead athletes and the relationship between the Closed Chain Upper Extremity Stability Test and the Upper Quarter Y Balance Test., conditionsModule conditions: Upper Limb Asymmetry, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: handball, volleyball and basketball players 18-30 years Someone who has been participating in sports for at least three years and trains at least three times a week, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ACTUAL, armsInterventionsModule interventions name: Upper Limb Rotation Test, interventions name: Closed Kinetic Chain Upper Extremity Stability Test, interventions name: Upper Quarter Y Balance Test, outcomesModule primaryOutcomes measure: The reliability of Upper Extremity Rotation Test, secondaryOutcomes measure: The Relationship Assessment of the Upper Extremity Rotation Test, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Birgül Dıngırdan, city: Kocaeli, state: İzmit, country: Turkey, geoPoint lat: 39.62497, lon: 27.51145, locations facility: Hacettepe University, city: Ankara, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False

protocolSection identificationModule nctId: NCT06267443, orgStudyIdInfo id: 2023/337, briefTitle: Erector Spina Block or Parasternal Block Plus Chest Tube Wound Infiltration for Cardiac Surgeries, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: TC Erciyes University, class: OTHER, descriptionModule briefSummary: Pain management is important after coronary artery bypass graft (CABG) surgery. Intravenous morphine is the gold standard for pain relief, but its sedation, cough suppression and decreased bowel movements limit its use. Analgesia with regional methods after surgery provides effective analgesia by reducing morphine consumption. In this study we have planned to compare the erector spina plane block with parasternal block +local infiltration to chest tube areas., conditionsModule conditions: Postoperative Pain, conditions: Postoperative Atelectasis, conditions: Analgesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Comparison of erector spina plane block, parasternal block plus local infiltration to the tube sides for postoperative analgesia, outcomesModule primaryOutcomes measure: postoperative analgesia, primaryOutcomes measure: postoperative atelectasia, secondaryOutcomes measure: postoperative mechanical ventilation duration, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06267430, orgStudyIdInfo id: NL85141.078.23, briefTitle: Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With a Severe CHD, acronym: LbH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2027-04-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Erasmus Medical Center, class: OTHER, descriptionModule briefSummary: Advances in prenatal and neonatal care have improved outcomes in children with severe congenital heart disease (CHD). With the increase in survival, neurocognitive problems such as executive functioning (EF) impairments have become more apparent in these children. EF problems have cascading negative effects on a child's development. New insights in EF development suggest that in otherwise physically healthy young children, EF can be improved by training. In a pilot study funded by Stichting Hartekind, the investigators studied the feasibility of a personalized EF training program called 'Kleuter Extra' and the results were promising. Therefore, the current study will investigate the effectiveness of this program in 4-6-year-old children with severe CHD. The researchers will also explore interactions between the parent-child relationship and EF development of the child as psychosocial difficulties in these children and their parent(s) and/or caretaker(s) may impact EF-development. If found effective, EF training for children with severe CHD will improve their developmental outcome., conditionsModule conditions: Congenital Heart Disease, conditions: Executive Dysfunction, conditions: Attention Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The psychologist testing all participants, will be blinded for the allocation of the participants., whoMasked: INVESTIGATOR, enrollmentInfo count: 141, type: ESTIMATED, armsInterventionsModule interventions name: Kleuter Extra training program, outcomesModule primaryOutcomes measure: Kleuter Extra test battery, secondaryOutcomes measure: EF functioning, secondaryOutcomes measure: Information processing, secondaryOutcomes measure: Executive functioning in daily life - completed by the parent(s), secondaryOutcomes measure: Behavioral and emotional difficulties of the child - completed by the parent(s), secondaryOutcomes measure: Quality of the child's life - completed by the parent(s), secondaryOutcomes measure: Emotional distress parent - completed by the parent(s), secondaryOutcomes measure: Parental trauma, secondaryOutcomes measure: Parenting behavior and quality parent-child relationship - completed by the parent(s), secondaryOutcomes measure: Child demographics teacher's perspective, secondaryOutcomes measure: Behavioral and emotional difficulties teacher's perspective, secondaryOutcomes measure: Executive functioning child in daily life teacher's perspective, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: University Medical Center - Beatrix children's hospital Groningen, city: Groningen, zip: 9713GZ, country: Netherlands, contacts name: Hessel Nijenhuis, role: CONTACT, email: h.p.nijenhuis@umcg.nl, geoPoint lat: 53.21917, lon: 6.56667, locations facility: Erasmus Medical Center Sophia Children's Hospital, city: Rotterdam, zip: 3015CN, country: Netherlands, contacts name: André Rietman, role: CONTACT, email: a.rietman@erasmusmc.nl, geoPoint lat: 51.9225, lon: 4.47917, locations facility: University Medical Center - Wilhelmina children's hospital Utrecht, city: Utrecht, zip: 3584EA, country: Netherlands, contacts name: Hans Breur, role: CONTACT, phone: +31 88 75 754 59, email: h.breur@umcutrecht.nl, geoPoint lat: 52.09083, lon: 5.12222, hasResults: False

protocolSection identificationModule nctId: NCT06267417, orgStudyIdInfo id: CCHE-AML-4/2023, briefTitle: Laser Therapy Effect as Preventive Measure for Oral Mucositis in Children With Hematological Malignancies, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-10, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Children's Cancer Hospital Egypt 57357, class: OTHER, descriptionModule briefSummary: Introduction:Among the most drastic complications of chemotherapy is oral mucositis(OM). It is a painful inflammatory, often ulcerative condition and may increase risk for systemic infections leading to prolonged hospital stays and interruptions of treatment protocol. Many treatment modalities have been introduced for the prevention and treatment of oral mucositis, of which low level laser therapy(LLLT) is gaining popularity. The use of LLLT as a prophylactic treatment for chemotherapy induced oral mucositis in pediatric cancer patients is still lacking robust evidence. Also, the parameters used have not been optimized and no standard method has yet been established. Based on this point, this study will compare photobiomodulation to the conventional preventive program of oral mucositis applied in 57357 children's cancer hospital foundation to determine which will be optimal for the prophylaxis of chemotherapy-induced OM.Aim:To assess the effectiveness of low level laser therapy in the prophylaxis of oral mucositis in pediatric patients diagnosed with Hematological cancers.Methods:This study is a randomized, prospective, double-blinded trial that will include acute Myeloid leukemia patients admitted to receive chemotherapy cycle between the age of 3 and 18years. These patients will be randomized into two groups: group 1 will receive low level laser therapy and group 2 will receive mock treatment. Patient will be followed to asses the development of oral mucositis on prespecified time points., conditionsModule conditions: Oral Mucositis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: The outcome evaluator will be a single personnel from the oncology team following up with the case, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: Laser therapy, interventions name: Mock treatment, outcomesModule primaryOutcomes measure: To measure incidence of oral mucositis in Laser arm versus Placebo arm., primaryOutcomes measure: To measure grade of oral mucositis in patients receiving laser arm placebo arm., eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Children Cancer Hospital 57357, status: RECRUITING, city: Cairo, zip: 11617, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False

protocolSection identificationModule nctId: NCT06267404, orgStudyIdInfo id: IShamsi, briefTitle: Effectiveness of Iliopsoas Positional Release Versus Conventional Exercises in the Management of Sub-acute Back Pain., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-21, primaryCompletionDateStruct date: 2025-02-15, completionDateStruct date: 2025-02-25, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: University of Karachi, class: OTHER, collaborators name: Sindh Institute of Physical Medicine and Rehabilitation, descriptionModule briefSummary: Recommended treatment for chronic non-specific LBP is exercise therapy, behavioral therapy including pain management, or a combination of these; There is not enough evidence to establish recommendations for which one is the most appropriate.The primary objective of this study is to explore the effects of Ilio-psoas Release on Sub-acute back pain, ROM \& functional disability, conditionsModule conditions: Back Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Iliopsoas Positional release therapy, interventions name: Conventional exercises, outcomesModule primaryOutcomes measure: VAS Visual Analogue Scale VAS Visual Analogue Scale, primaryOutcomes measure: Modified Schober's test, secondaryOutcomes measure: Roland-Morris Disability Questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Sindh Institute of Physical Medicine and Rehabilitation, status: RECRUITING, city: Karachi, state: Sindh, country: Pakistan, contacts name: Iram I Shamsi, MPhil, role: CONTACT, contacts name: Iram I Shamsi, MPhil, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 24.8608, lon: 67.0104, hasResults: False

protocolSection identificationModule nctId: NCT06267391, orgStudyIdInfo id: 898, briefTitle: Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals With Type II Diabetes, acronym: ReCET, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2026-10-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Endogenex, Inc., class: INDUSTRY, descriptionModule briefSummary: This study is designed to evaluate the safety and effectiveness of endoscopic intestinal re-cellularization therapy in individuals with type 2 diabetes (T2D) inadequately controlled on non-insulin glucose-lowering medications., conditionsModule conditions: Type 2 Diabetes Mellitus, conditions: Type2diabetes, conditions: Diabetes Mellitus, Type 2, conditions: Diabetes, conditions: Type 2 Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: The participants randomized in a 2:1 ratio to the ReCET treatment arm or the sham control arm., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 264, type: ESTIMATED, armsInterventionsModule interventions name: ReCET Treatment, interventions name: Sham Procedure, outcomesModule primaryOutcomes measure: HbA1c, secondaryOutcomes measure: HbA1c, secondaryOutcomes measure: HbA1c ≤7.0% without requiring rescue medication, secondaryOutcomes measure: Time-in Range (TIR), secondaryOutcomes measure: Total body weight loss (%TBWL), secondaryOutcomes measure: Incidence of adverse events, eligibilityModule sex: ALL, minimumAge: 22 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06267378, orgStudyIdInfo id: 1174/2022/NCTS, briefTitle: Assessing Frailty and Its Impacts on Patients Facing Major GI Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-30, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2029-12-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Doncaster And Bassetlaw Hospitals NHS Foundation Trust, class: OTHER, descriptionModule briefSummary: The study team will look at 3 new tests that will make it easier to measure frailty in patients awaiting surgery for cancer and compare them against standard clinical measures of frailty in a pilot study. The expected outcome is that evidence will be collated in order to apply for a major grant to look at improving the care of frail patients with cancer in the future., conditionsModule conditions: Bowel Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Frailty measure, outcomesModule primaryOutcomes measure: The sensitivity & specificity of digital motion data for the prediction of baseline clinical frailty levels & post-operative measures of frailty, mortality and adverse events, primaryOutcomes measure: The sensitivity & specificity of tissue senescence for the prediction of baseline clinical frailty levels & post-operative measures of frailty, mortality and adverse events, primaryOutcomes measure: The sensitivity & specificity of blood based biomarkers for the prediction of baseline clinical frailty levels & post-operative measures of frailty, mortality and adverse events, secondaryOutcomes measure: Blood biomarker correlation (baseline and post operative) with baseline frailty and poor outcomes (including length of stay and adverse events), secondaryOutcomes measure: Adverse events related to surgery assessed CTCAE classifications, secondaryOutcomes measure: Tissue senescence correlation between baseline frailty and poor outcomes (including length of stay and adverse events), secondaryOutcomes measure: Digital mobility outcomes correlation with baseline frailty and poor outcomes (including length of stay and adverse events), secondaryOutcomes measure: Physical function assessment after surgery at 6 weeks, 3 months using the WHO DAS 2.0., secondaryOutcomes measure: Quality of life at 6 weeks, 3 months after surgery using the EQ-5D-5L, secondaryOutcomes measure: Overall survival at 3 months and 5 years (the latter via cancer registry returns), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust, status: RECRUITING, city: Doncaster, state: South Yorkshire, zip: DN2 5LT, country: United Kingdom, contacts name: Doncaster Royal Infirmary, role: CONTACT, email: dbth.clinicalresearch@nhs.net, geoPoint lat: 53.52285, lon: -1.13116, hasResults: False

protocolSection identificationModule nctId: NCT06267365, orgStudyIdInfo id: 23-00766, briefTitle: Predictive Biomarker for Endoscopic Therapy in Chronic Pancreatitis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-27, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-09-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: NYU Langone Health, class: OTHER, collaborators name: National Institute of Neurological Disorders and Stroke (NINDS), descriptionModule briefSummary: This is an observational prospective study to develop predictive biomarkers for pain response in participants with chronic pancreatitis scheduled for endoscopic therapy. Participants will undergo baseline assessments including electroencephalography (EEG), quantitative sensory testing (QST), and psychosocial questionnaires. Response to endoscopic therapy will be assessed at approximately 3, 6, 12 and 18 months post-procedure using questionnaires., conditionsModule conditions: Chronic Pancreatitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Change from Baseline in Brief Pain Inventory (BPI) Score at Month 3 Post-Operation, secondaryOutcomes measure: Change from Baseline in BPI Score at Month 6 Post-Operation, secondaryOutcomes measure: Change from Baseline in BPI Score at Month 12 Post-Operation, secondaryOutcomes measure: Change from Baseline in BPI Score at Month 18 Post-Operation, secondaryOutcomes measure: Change from Baseline in Patient Reported Outcome System (PROMIS) - Physical Function - Short Form 6b Score at Month 3 Post-Operation, secondaryOutcomes measure: Change from Baseline in PROMIS - Physical Function - Short Form 6b Score at Month 6 Post-Operation, secondaryOutcomes measure: Change from Baseline in PROMIS - Physical Function - Short Form 6b Score at Month 12 Post-Operation, secondaryOutcomes measure: Change from Baseline in PROMIS - Physical Function - Short Form 6b Score at Month 18 Post-Operation, secondaryOutcomes measure: Number of Participants who use Opioids at Baseline, secondaryOutcomes measure: Number of Participants who use Opioids at Month 3, secondaryOutcomes measure: Number of Participants who use Opioids at Month 6, secondaryOutcomes measure: Number of Participants who use Opioids at Month 12, secondaryOutcomes measure: Number of Participants who use Opioids at Month 18, secondaryOutcomes measure: Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 3 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 6 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 12 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 18 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 3 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 6 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 12 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 18 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 3 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 6 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 12 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 18 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 3 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 6 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 12 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 18 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 3 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 6 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 12 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 18 Post-Procedure, secondaryOutcomes measure: Change from Baseline in Pain Catastrophizing Scale (PCS) Score at Month 3 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PCS Score at Month 6 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PCS Score at Month 12 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PCS Score at Month 18 Post-Procedure, secondaryOutcomes measure: Change from Baseline in Sleep Duration at Month 3 Post-Procedure, secondaryOutcomes measure: Change from Baseline in Sleep Duration at Month 6 Post-Procedure, secondaryOutcomes measure: Change from Baseline in Sleep Duration at Month 12 Post-Procedure, secondaryOutcomes measure: Change from Baseline in Sleep Duration at Month 18 Post-Procedure, secondaryOutcomes measure: Change from Baseline in Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) Score at Month 3 Post-Procedure, secondaryOutcomes measure: Change from Baseline in TAPS Score at Month 6 Post-Procedure, secondaryOutcomes measure: Change from Baseline in TAPS Score at Month 12 Post-Procedure, secondaryOutcomes measure: Change from Baseline in TAPS Score at Month 18 Post-Procedure, secondaryOutcomes measure: Change from Baseline in Patient Global Impression of Change (PGIC) Score at Month 3 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PGIC Score at Month 6 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PGIC Score at Month 12 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PGIC Score at Month 18 Post-Procedure, secondaryOutcomes measure: Change from Baseline in Patient Health Questionnaire-2 (PHQ-2) Score at Month 3 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PHQ-2 Score at Month 6 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PHQ-2 Score at Month 12 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PHQ-2 Score at Month 18 Post-Procedure, secondaryOutcomes measure: Change from Baseline in Generalized Anxiety Disorder 2 (GAD-2) Score at Month 3 Post-Procedure, secondaryOutcomes measure: Change from Baseline in GAD-2 Score at Month 6 Post-Procedure, secondaryOutcomes measure: Change from Baseline in GAD-2 Score at Month 12 Post-Procedure, secondaryOutcomes measure: Change from Baseline in GAD-2 Score at Month 18 Post-Procedure, secondaryOutcomes measure: Change from Baseline in Pain, Enjoyment of Life and General Activity (PEG) Scale at Month 3 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PEG Scale at Month 6 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PEG Scale at Month 12 Post-Procedure, secondaryOutcomes measure: Change from Baseline in PEG Scale at Month 18 Post-Procedure, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NYU Langone Health, status: RECRUITING, city: New York, state: New York, zip: 10016, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False

protocolSection identificationModule nctId: NCT06267352, orgStudyIdInfo id: 230097, briefTitle: Epidemiology and Genomic Surveillance of Staphylococcus Aureus in ICU Neonatology, acronym: NEOSAUR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University Hospital, Caen, class: OTHER, descriptionModule briefSummary: Newborns hospitalized in Neonatology are particularly vulnerable to infections, in particular healthcare associated infection (HAI). Staphylococcus aureus represents the 2nd microorganism responsible for sepsis, this infection is particularly serious and like any HAI, it increases the length of hospitalization of newborns and neonatal morbidity.In September 2020, the CDC published recommendations for the prevention and control of Staphylococcus aureus infections in neonatal intensive care unit/ICU. They specify the indications for implementing a MSSA surveillance strategy as well as the screening and management methods.Despite the absence of a defined strategy at the national level, our establishment chose to initiate management measures several years ago following serious infections and MSSA epidemics in neonatal intensive care unit/ICU.With the aim of improving the efficiency of care and evaluating the strategy chosen at the establishment, it is necessary to describing* the epidemiology of MSSA carriage and infections* cross-transmission of MSSA strains between patients* the success rate of decolonization* the sensitivity of detection of digestive carriage by stool swabbing in order to limit the number of samples from newborns., conditionsModule conditions: the Aim of This Study is to Describe Genomic Epidemiology of MSSA in Neonatal ICU, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, outcomesModule primaryOutcomes measure: frequency of MSSA cross transmission as assessed by WGS, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06267339, orgStudyIdInfo id: TD_tRNS, briefTitle: Effects of Transcranial Random Noise Stimulation on Motor Learning in Typically Developing Adolescents, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2026-08-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Burke Medical Research Institute, class: OTHER, descriptionModule briefSummary: The goal of this study is to compare motor learning rates on two different tasks, when combined with non-invasive brain stimulation., conditionsModule conditions: Children, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: transcranial random noise stimulation, interventions name: Sham stimulation, outcomesModule primaryOutcomes measure: Change in Grasp score, primaryOutcomes measure: Change in Reach score, secondaryOutcomes measure: Change in Graded Redefined Assessment of Strength, Prehension assessment (GRASSP), secondaryOutcomes measure: Change in score on second reaching task, eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Burke Neurological Institute, city: White Plains, state: New York, zip: 10605, country: United States, geoPoint lat: 41.03399, lon: -73.76291, hasResults: False

protocolSection identificationModule nctId: NCT06267326, orgStudyIdInfo id: Nasser institute, briefTitle: World Health Organization (WHO), COVID19 Case Series of Post Covid 19 Rhino Orbito Cerebral Mucormycosis in Egypt, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-05-23, primaryCompletionDateStruct date: 2022-06-12, completionDateStruct date: 2023-08-21, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Nasser Institute For Research and Treatment, class: OTHER_GOV, descriptionModule briefSummary: Objectives: identify and recognize clinical Characteristics, Pathophysiology, and management of a group of patients with rhino Rhino-Orbito-Cerebral Mucormycosis infection associated with Covid 19 viral infection, conditionsModule conditions: Mucormycosis; Rhinocerebral (Etiology), conditions: COVID-19, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: CARE_PROVIDER, enrollmentInfo count: 35, type: ACTUAL, armsInterventionsModule interventions name: debridment, outcomesModule primaryOutcomes measure: 35 patients suffering from mucormycosis infection post covid 19, primaryOutcomes measure: 25 patients were cured with comorbidity and 10 pateints died, primaryOutcomes measure: pain, secondaryOutcomes measure: Visual Analog Score for pain, eligibilityModule sex: ALL, minimumAge: 22 Years, maximumAge: 77 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Omar Elmonofy, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False

protocolSection identificationModule nctId: NCT06267313, orgStudyIdInfo id: 2023-078-PAU, briefTitle: Attention Training for COVID-19 Related Distress, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2027-02-19, completionDateStruct date: 2027-02-19, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Palo Alto University, class: OTHER, descriptionModule briefSummary: The study aims to test whether attention training (attention bias modification or attention control training) reduces distress or COVID-19 related anxiety compared to a neutral condition., conditionsModule conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Attention Bias Modification, interventions name: Attention Control Training, interventions name: Neutral training, outcomesModule primaryOutcomes measure: COVID-19 Anxiety Syndrome Scale, primaryOutcomes measure: COVID-19 Anxiety Syndrome Scale, primaryOutcomes measure: COVID-19 Anxiety Syndrome Scale, primaryOutcomes measure: COVID-19 Anxiety Syndrome Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Palo Alto University, status: RECRUITING, city: Palo Alto, state: California, zip: 94304, country: United States, contacts name: Mikael Rubin, PhD, role: CONTACT, phone: 650-433-3805, email: mrubin@paloaltou.edu, geoPoint lat: 37.44188, lon: -122.14302, hasResults: False

protocolSection identificationModule nctId: NCT06267300, briefTitle: Treatment of Post-COVID-19 With Hyperbaric Oxygen Therapy: a Randomized, Controlled Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-01, primaryCompletionDateStruct date: 2025-10-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Erasmus Medical Center, class: OTHER, collaborators name: Da Vinci Clinic, collaborators name: HGC Rijswijk, descriptionModule briefSummary: The goal of this clinical try is to investigate the effect of hyperbaric oxygen therapy (HBOT) on symptoms, quality of life and absence of work through sickness in patients with post-COVID on short- and mid-term, as well as to identify biochemical mechanisms of action.The main questions it aims to answer are:* What is the clinical relevance of improvements of symptoms and quality of life after treatment with HBOT for post-COVID?* What are the changes in absence from work after treatment with HBOT?* What is the cost-effectiveness of treatment with HBOT?* What are possible mechanisms of action of HBOT?Participants will undergo 40 sessions of HBOT. Researchers will compare HBOT with standard care alone (control group). In case of a positive outcome, patients in the control group can cross-over to the HBOT group after 6 months., conditionsModule conditions: Post-COVID-19 Syndrome, conditions: Post-COVID Syndrome, conditions: Post COVID-19 Condition, conditions: Post-COVID Condition, conditions: Post COVID-19 Condition, Unspecified, conditions: Long COVID, conditions: Long Covid19, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Randomized controlled trial comparing HBOT to standard care alone, with a cross-over from standard care to HBOT in case primary outcome is positive after 6 months follow-up., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Hyperbaric oxygen, outcomesModule primaryOutcomes measure: Physical and mental component scores of the 36-item Short Form Survey (SF-36), secondaryOutcomes measure: Euroqol-5D (EQ-5D), secondaryOutcomes measure: Activity tracking (through wrist band), monitoring heart rate, step count and sleep patterns, secondaryOutcomes measure: Biochemical parameters, secondaryOutcomes measure: Absence from work, secondaryOutcomes measure: Cost-effectiveness, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Da Vinci Clinic, city: Amersfoort, country: Netherlands, geoPoint lat: 52.155, lon: 5.3875, locations facility: Da Vinci Clinic, city: Geldrop, country: Netherlands, geoPoint lat: 51.42167, lon: 5.55972, locations facility: Da Vinci Clinic, city: Hoogeveen, country: Netherlands, geoPoint lat: 52.7225, lon: 6.47639, locations facility: HGC Rijswijk, city: Rijswijk, country: Netherlands, contacts name: Rutger Lalieu, Dr., role: CONTACT, geoPoint lat: 52.03634, lon: 4.32501, locations facility: Da Vinci Clinic, city: Rotterdam, country: Netherlands, contacts name: Nina Lansdorp, Dr., role: CONTACT, geoPoint lat: 51.9225, lon: 4.47917, locations facility: Erasmus MC, city: Rotterdam, country: Netherlands, contacts name: Merel Hellemons, Dr., role: CONTACT, geoPoint lat: 51.9225, lon: 4.47917, locations facility: Da Vinci Clinic, city: Waalwijk, country: Netherlands, contacts name: Nina Lansdorp, Dr., role: CONTACT, geoPoint lat: 51.6825, lon: 5.07083, hasResults: False

protocolSection identificationModule nctId: NCT06267287, orgStudyIdInfo id: 2023-4, briefTitle: Microbiological Structure of Pathogens of Periprosthetic Infection of Large Joints in the Post-Covid Period, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-01-01, primaryCompletionDateStruct date: 2022-12-31, completionDateStruct date: 2022-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty, class: OTHER, descriptionModule briefSummary: Background. Infection is the most common complication of complications after joint arthroplasty. During the COVID-19 pandemic increased used antibacterial drugs by adults, this could change the spectrum of infectious agents and their antimicrobial resistance. The purpose of the study is to evaluate the microbial diversity of pathogens of periprosthetic infection in the pre- and post-Covid period, determining the sensitivity of the leading pathogens to antibiotics. Materials and methods. A comprehensive comparative retrospective study was carried out on 342 cases of monomicrobial and polymicrobial periprosthetic infection (PPI) of limb joints with microbiological growth of microorganisms in the pre-Covid (2018-2019) and post-Covid (2021-2022) periods., conditionsModule conditions: Joint Infection, conditions: Periprosthetic Left Knee Joint Infection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 342, type: ACTUAL, armsInterventionsModule interventions name: Microbiological examination of the patient's biological material and determination of antibiotic resistance, outcomesModule primaryOutcomes measure: Structure of isolated pathogens of periprosthetic infection, primaryOutcomes measure: Structure of isolated pathogens of periprosthetic infection, secondaryOutcomes measure: Antibiotic resistance of isolated pathogens of periprosthetic infection, secondaryOutcomes measure: Antibiotic resistance of isolated pathogens of periprosthetic infection, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Federal Center for Traumatology, Orthopedics and Endoprosthetics, city: Cheboksary, state: Chuvashia, zip: 429500, country: Russian Federation, geoPoint lat: 56.13222, lon: 47.25194, hasResults: False

protocolSection identificationModule nctId: NCT06267274, orgStudyIdInfo id: MW230021, briefTitle: A Randomized, Double-blind, Parallel-group, Two-arm, Multiple Dose, Multicenter, Bioequivalence Study With Clinical Endpoint in the Treatment of Subjects With Chronic Open-angle Glaucoma or Ocular Hypertension in Both Eyes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Amneal Pharmaceuticals, LLC, class: INDUSTRY, collaborators name: CBCC Global Inc., collaborators name: Amneal EU, Limited, descriptionModule briefSummary: A randomized, double-blind, parallel-group, two-arm, multiple dose, multicenter, clinical endpoint bioequivalence study, conditionsModule conditions: Open-angle Glaucoma, conditions: Ocular Hypertension, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Subjects will be randomized in such way that ratio of treatment distribution will be nearer to 1:1 between the treatment arms, and within the combined stratification criteria., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: double-blind study, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 240, type: ESTIMATED, armsInterventionsModule interventions name: Bimatoprost Ophthalmic Solution, 0.01%, interventions name: LUMIGAN® (bimatoprost ophthalmic solution) 0.01%, outcomesModule primaryOutcomes measure: Primary Endpoint, secondaryOutcomes measure: Secondary Endpoint, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: West Coast Eye Institute, city: Bakersfield, state: California, zip: 93308, country: United States, contacts name: Sandeep Walia, MD, role: CONTACT, geoPoint lat: 35.37329, lon: -119.01871, locations facility: Eye Research Foundation, city: Newport Beach, state: California, zip: 92663, country: United States, contacts name: David Wirta, MD, role: CONTACT, geoPoint lat: 33.61891, lon: -117.92895, locations facility: Clayton Eye Research, city: Morrow, state: Georgia, zip: 30260, country: United States, contacts name: Kim Jong, MD, role: CONTACT, geoPoint lat: 33.58317, lon: -84.33937, locations facility: Houston Eye Associates, city: Houston, state: Texas, zip: 77008, country: United States, contacts name: Kevin Jong, MD, role: CONTACT, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False

protocolSection identificationModule nctId: NCT06267261, orgStudyIdInfo id: KOL-001, briefTitle: Efficacy of Face Mask in Reducing Respiratory Allergic Symptoms in Birch-allergic Subjects in ALYATEC Exposure Chamber, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-06-07, primaryCompletionDateStruct date: 2021-08-23, completionDateStruct date: 2021-10-25, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Alyatec, class: INDUSTRY, collaborators name: Medicom, descriptionModule briefSummary: There is no clinical evidence that face masks are efficient in birch pollen-induced asthma. As the use of face masks has become widespread worldwide to limit the spread of SARS-CoV-2, this study aims to demonstrate the clinical efficacy of medical masks in patients allergic to birch in the same way that clinical trial with drugs., conditionsModule conditions: Allergic Asthma, conditions: Allergic Rhinitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ACTUAL, armsInterventionsModule interventions name: KOLMI® surgical face mask (OP-Air), outcomesModule primaryOutcomes measure: Time to early asthma response (EAR), secondaryOutcomes measure: Frequency of EAR and late asthma response (LAR), secondaryOutcomes measure: Severity of EAR and LAR, secondaryOutcomes measure: Nasal Symptoms, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: ALYATEC, city: Strasbourg, country: France, geoPoint lat: 48.58392, lon: 7.74553, hasResults: False

protocolSection identificationModule nctId: NCT06267248, orgStudyIdInfo id: T05100, briefTitle: Spine Registration Using 3D-Scanning, acronym: BWH, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Advanced Scanners Inc., class: INDUSTRY, descriptionModule briefSummary: The primary objective is to assess the capability of the device as measured by its consistency, its accuracy, and feedback from surgical staff over the study period., conditionsModule conditions: Spine Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Optical 3D Scanner, outcomesModule primaryOutcomes measure: Spine Registration, secondaryOutcomes measure: Vertebral Shift Measurement, secondaryOutcomes measure: Determination Of Bony Exposure Requirements, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mass General Bringham, Hale Building for Transformative Medicine, city: Boston, state: Massachusetts, zip: 02115, country: United States, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False

protocolSection identificationModule nctId: NCT06267235, orgStudyIdInfo id: lowprotein, briefTitle: Dietary Protein Restriction and Health, acronym: LOWPRO, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-01-01, primaryCompletionDateStruct date: 2020-01-31, completionDateStruct date: 2024-01-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University of Copenhagen, class: OTHER, descriptionModule briefSummary: The incidence of type 2 diabetes worldwide has increased significantly over the past decades, which is associated with changing dietary habits and physical inactivity. According to the diet, so far there has been a great focus on the quality of carbohydrates and fat in relation to metabolic health, while the importance of protein has been neglected. The Danes' average protein intake is 1.5 g/kg/day, which is at the high end of the recommendations (0.8-1.5 g/kg/day) from the Nordic Nutrition Recommendations (NNR 2023). Recent studies in rodents have shown that protein restriction has positive effects on health, including improved glucose and insulin homeostasis and reduced fat mass, while a high intake of protein has a negative effect on insulin sensitivity. Previously the investigators have shown, in healthy young men, that consuming a diet low in protein (0.9 g/kg/day), compared to the participants usual diet (1.5 g/kg/day), over 7 days, resulted in an increased insulin sensitivity as well as a marked increase in the plasma fibroblast growth factor 21 (FGF21) concentration. The increased insulin sensitivity is thought to be mediated by the increase in plasma FGF21 concentration. However, the effect is not yet fully understood. It is also not clear whether the increase in plasma FGF21 concentration, as well as the mentioned metabolic effects on insulin and glucose homeostasis, will take place if the participants are kept weight stable on a eucaloric diet., conditionsModule conditions: Protein, conditions: Healthy, conditions: Diet, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Longitudinal study changing diet during the intervention 5 weeks restricted dietary protein + 5 weeks habitual dietary protein consumption, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 23, type: ACTUAL, armsInterventionsModule interventions name: Dietary protein restriction, outcomesModule primaryOutcomes measure: Energy balance, primaryOutcomes measure: Insulin sensitivity, secondaryOutcomes measure: Adipose tissue proteomics, secondaryOutcomes measure: Plasma FGF21, eligibilityModule sex: MALE, minimumAge: 25 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Copenhagen, city: Copenhagen, zip: 2100, country: Denmark, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False

protocolSection identificationModule nctId: NCT06267222, orgStudyIdInfo id: SCATDCS23, briefTitle: Trans-spinal Electrical Stimulation in Individuals With Spinocerebellar Ataxia, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Laura Alice Santos Oliveira, class: OTHER, collaborators name: Federal Institute of Rio de Janeiro, descriptionModule briefSummary: The main goal of this pragmatic clinical trial is to investigate the effects of trans-spinal tDCS in individuals with spinocerebellar ataxia (SCA) over some parameters of gait and postural control in real-world conditions, reflecting daily clinical practice. The main questions it aims to answer are:* If an extended number of tDCS sessions, beyond the typical 5 to 10 sessions described in scientific literature, applied concomitantly with exercises with progressive challenges, to yield positive outcomes over some parameters of gait and postural control in individuals with SCA and if there is retention of possible benefits one month later the end of this protocol.* If there is specific characteristics (including balance, gait, mobility, severity of ataxia, DNA test characteristics and non-ataxic signs) in individuals with SCA that can predict their improvement in postural control and gait following the 20 tDCS sessions. * Participants will receive 20 tDCS sessions concomitantly with exercises for gait and postural control with progressive challenges. * Postural control and gait of the participants will be assessed in two big sessions before (#assessment 1) and after the 20 sessions (#assessment 5) and 3 small sessions after every 5 sessions (#assessments 2, 3 and 4). Also, as a follow-up, they will be assessed a month after the end of the intervention (#assessment 6)., conditionsModule conditions: SCA, conditions: Postural Balance, conditions: Gait Ataxia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a pragmatic clinical trial that will be carried out using the CONSORT-Pragmatic Trials (Zwarenstein et al., 2008)., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: THE INVESTIGATOR NOT BE INFORMED ABOUT THE TREATMENT, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: TRANSCRANIAL DIRECT CURRENT STIMULATION + exercises, outcomesModule primaryOutcomes measure: Postural control, primaryOutcomes measure: Mobility, primaryOutcomes measure: Gait performance, secondaryOutcomes measure: The subjective experience of the participants regarding the protocol., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anna Fontes Baptista, city: Rio de Janeiro, state: RJ, zip: 21032-060, country: Brazil, geoPoint lat: -22.90278, lon: -43.2075, hasResults: False

protocolSection identificationModule nctId: NCT06267209, orgStudyIdInfo id: He-Modulation, briefTitle: Conditioned Pain Modulation in Patients With Hemophilia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2024-03-03, completionDateStruct date: 2024-04-20, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Investigación en Hemofilia y Fisioterapia, class: NETWORK, descriptionModule briefSummary: Introduction: Hemophilic arthropathy is characterized by functional alterations, disabling physical sequelae, and chronic pain. Conditioned pain modulation describes the net effect of endogenous pathways that enhance or diminish the effects of afferent noxious stimuli.Objectives: To describe conditioned pain modulation in patients with hemophilia and identify the best predictive model of conditioned pain modulation in these patients Methods: Cross-sectional cohort study. 51 patients with hemophilic arthropathy will be recruited in 3 regions of Spain. The main study variable will be the conditional pain modulation (Conditioned Pain Modulation Index, using an ischemic technique of the arm using the pain pressure threshold as a test stimulus), with age being the dependent variable. The secondary variables, estimated as modifying or confounding variables, will be kinesiophobia (Tampa Scale for Kinesiophobia), catastrophizing (Pain Catstrophizing Scale), trait and state anxiety (State-Trait Anxiety Inventory) and the main clinical, anthropometric, and sociodemographic.Expected results: Identify the degree of modulation conditioned by pain in patients with hemophilic arthropathy. Identify the best predictive model for conditioned pain modulation in these patients based on the study variables, conditionsModule conditions: Hemophilia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 51, type: ESTIMATED, armsInterventionsModule interventions name: Observational group, outcomesModule primaryOutcomes measure: Assess the Conditioned Pain Modulation Index, secondaryOutcomes measure: Assess the kinesiophobia with Tampa Scale of Kinesiophofia, secondaryOutcomes measure: Assess the catastrophizing with Pain catastrophizing scale, secondaryOutcomes measure: Assess the catastrophizing with State-Trait Anxiety Inventory, secondaryOutcomes measure: Assess the joint damage with Haemophilia Joint Health Score, secondaryOutcomes measure: Assess the joint pain with visual analog scale, secondaryOutcomes measure: Assess the pressure pain threshold with pressure algometer, secondaryOutcomes measure: Assess the functional capacity with the 6-Minute Walking test, eligibilityModule sex: MALE, minimumAge: 20 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Oviedo, 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: NCT06267196, orgStudyIdInfo id: CemilTascıogluERHO-AYAN, briefTitle: The Effect of the Stress Ball Used During Spinal Anesthesia on Pain and Anxiety, acronym: stressball, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-02, primaryCompletionDateStruct date: 2024-03-02, completionDateStruct date: 2024-03-15, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization, class: OTHER, descriptionModule briefSummary: The aim is to determine the impact of the stress ball used during spinal anesthesia on pain and anxiety levels, conditionsModule conditions: Pain, conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: The use of a stress ball, outcomesModule primaryOutcomes measure: stress ball and anxiety, primaryOutcomes measure: stress ball and pain, secondaryOutcomes measure: Stress ball and blood pressure, secondaryOutcomes measure: Stress ball and pulse, secondaryOutcomes measure: Stress ball and saturation, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Özge Sayın Ayan, status: NOT_YET_RECRUITING, city: Istanbul, state: Eyup, zip: 34065, country: Turkey, contacts name: özge sayın, role: CONTACT, phone: +905332965628, email: ozgesayinayan@gmail.com, contacts name: volkan özen, role: CONTACT, phone: +905309276094, email: vozen81@gmail.com, geoPoint lat: 41.01384, lon: 28.94966, locations facility: Prof.Dr.Cemil Tascioglu City Hospital, status: RECRUITING, city: Istanbul, state: Şişli, zip: 34360, country: Turkey, contacts name: özge sayın ayan, role: CONTACT, phone: +905332965628, email: ozgesayinayan@gmail.com, contacts name: volkan özen, role: CONTACT, phone: +905309276094, email: vozen81@gmail.com, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False

protocolSection identificationModule nctId: NCT06267183, orgStudyIdInfo id: SV001-101, briefTitle: A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of SV001 in Chinese Healthy Adult Volunteers., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-12, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Shanghai Synvida Biotechnology Co.,Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate safety, tolerability, PK and immunogenicity of SV001 compare to placebo in Chinese healthy adult volunteers., conditionsModule conditions: Idiopathic Pulmonary Fibrosis, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 53, type: ESTIMATED, armsInterventionsModule interventions name: SV001, interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events, secondaryOutcomes measure: Peak Plasma Concentration (Cmax), secondaryOutcomes measure: Peak time（Tmax）, secondaryOutcomes measure: Area under the plasma concentration versus time curve (AUC), secondaryOutcomes measure: half-life（T1/2）, secondaryOutcomes measure: Immunogenicity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Shanghai Xuhui District Central Hospital, status: RECRUITING, city: Shanghai, country: China, contacts name: Qian Chen, role: CONTACT, phone: 0086-021-54036058, email: qchen@shxh-centerlab.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False

protocolSection identificationModule nctId: NCT06267170, orgStudyIdInfo id: SCLC-RWS-001, briefTitle: A Multicenter, Real-world Study of Adebrelimab in the Treatment of Extensive Stage Small Cell Lung Cancer, acronym: SCLC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-25, primaryCompletionDateStruct date: 2025-02-25, completionDateStruct date: 2026-02-25, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Henan Cancer Hospital, class: OTHER_GOV, descriptionModule briefSummary: This study collected data on patients with extensive stage small cell lung cancer treated with Adebrelimab to investigate its safety and efficacy, conditionsModule conditions: SCLC,Extensive Stage, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 288, type: ESTIMATED, armsInterventionsModule interventions name: Adebrelimab, outcomesModule primaryOutcomes measure: Safety (Occurrence of ≥ Grade 3 AE), secondaryOutcomes measure: PFS, secondaryOutcomes measure: ORR, secondaryOutcomes measure: OS, secondaryOutcomes measure: DCR, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06267157, orgStudyIdInfo id: 2023/23, briefTitle: Breastfeeding Consultant Training in the Metvaverse Universe, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-05-20, completionDateStruct date: 2024-07-02, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Gulhane School of Medicine, class: OTHER, descriptionModule briefSummary: Although breastfeeding is an important and natural process in infant development, mothers may fail to manage the process. Nurses, who have an important place in helping to physically initiate and maintain breastfeeding, provide an in-depth knowledge of breast anatomy and breastfeeding physiology, practice and process breastfeeding techniques. Must have extensive management skills. Although the World Health Organization recommends that breastfeeding issues should be addressed in medical, nursing and midwifery schools, there is a lack of nurses' training curricula and breastfeeding training given in hospitals. Due to this deficiency, mothers have low self-confidence and insufficient knowledge about breastfeeding.The aim of this project is to develop a breastfeeding counseling model in the metaverse universe and to determine the effect of this model on nursing students' breastfeeding counseling skills, knowledge level and empathy skills. Giving breastfeeding education with the metaverse application compared to the application on real patients includes much less risk for the patient and the ability to practice until the right skill is acquired. In the project, it is expected that the breastfeeding counseling education model (LactaVerse), which is structured on virtual reality developed in the metaverse universe, is compared to the existing deficient and non-standardized breastfeeding education practice, enabling nurses to practice more and without errors during the undergraduate education, and to gain more effective skills in breastfeeding counseling. In this context, the project will support the ability of multiple users in the metaverse universe to examine the anatomy of the breast and apply breastfeeding counseling to the mother by transmitting their voices and movements with virtual glasses.In the preparation phase of the training to be developed in the virtual universe within the scope of the project, the breast anatomical modeling and the breastfeeding mother-baby duo project scenario will be developed and virtual glasses will be transferred. At this stage, expert opinions of the questionnaires to be used in the evaluation of educational effectiveness will be taken. Pre-application of data collection tools and LactaVerse training will be made. Experiment (n=40) and control (n=40) groups will be determined from the students by randomization. "Descriptive Characteristics Data Collection Form", "Breastfeeding Information Form", "Basic Empathy Level Scale", "Nursing Counseling Skill Scale" and "Presence Scale" will be applied to both groups. During the application phase, Lactaverse training method with virtual glasses will be applied to the experimental group, and a 2-hour theoretical classical training method will be applied to the control group. After 4 weeks of the training, the post-tests will be applied to the experimental group and the control group and they counseling will be given to the patient who plays the role of a nursing mother in the laboratory, and measurements will be made with the Breastfeeding Counseling Skill List and statistical analyzes will be applied.With the training developed in connection with the project, it is expected that nurses will have a high level of empathy development and breastfeeding counseling skills in a complex healthcare environment such as breastfeeding counseling before they graduate. In this way, the professional knowledge, counseling skills and empathy skills of nurses, who have an important role in breastfeeding, will increase, helping our society to increase the breastfeeding rates to the desired level., conditionsModule conditions: Breast Feeding, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: virtual reality training, interventions name: theoretical breastfeeding training, outcomesModule primaryOutcomes measure: Introductory Features Data Collection Form, primaryOutcomes measure: Breastfeeding Information Form, primaryOutcomes measure: Basic Empathy Level Scale, primaryOutcomes measure: Breastfeeding Teaching Skill Evaluation Form, primaryOutcomes measure: Presence Scale, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gulhane Faculty of Nursing, city: Ankara, country: Turkey, contacts name: Gulten Guvenc, role: CONTACT, email: gulten.guvenc@sbu.edu.tr, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False

protocolSection identificationModule nctId: NCT06267144, orgStudyIdInfo id: 23K237-001, briefTitle: Detection of Minimal Residual Disease in Resectable Stage II-IIIB Non-small Cell Lung Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-20, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-12-17, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: The First Hospital of Jilin University, class: OTHER, descriptionModule briefSummary: Predicting relapse and overall survival in potentially resectable Stage IIIA-IIIB Non-small Cell Lung Cancer (NSCLC) patients remains challenging. It is now widely recognized that patients with detectable MRD have a worse prognosis than those with undetectable MRD. Therefore, investigators performed this prospective clinical trial to evaluate the predictive value of MRD with increased risk of relapse and improves prediction of outcome in potentially resectable Stage IIIA-IIIB NSCLC with neoadjuvant chemoimmunotherapy. In this study, investigators will pay more attention to the long-term follow-up time and dynamic monitoring of MRD. The predictive value of MRD with Disease-free survival (DFS) rate was observed as the primary endpoint. Besides that, the correlation of MRD with major pathologic response (MPR) rate, pathologic complete response (pCR) rate，event-free survival(EFS) rate and overall survival (OS) were observed as the second endpoints. Investigators hope it will provide a new insight for these potentially resectable Stage IIA-IIIB NSCLC with neoadjuvant chemoimmunotherapy., conditionsModule conditions: Lung Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Sintilimab plus chemotherapy, outcomesModule primaryOutcomes measure: Event free survival(EFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Disease-Control Rate (DCR), secondaryOutcomes measure: Pathological complete response rate（PCR）, secondaryOutcomes measure: Major pathological response rate (MPR), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Hospital Of Jilin University, status: RECRUITING, city: Changchun, state: Jilin, zip: 130000, country: China, contacts name: Ma Kewei, role: CONTACT, phone: 0431-88782222, geoPoint lat: 43.88, lon: 125.32278, hasResults: False

protocolSection identificationModule nctId: NCT06267131, orgStudyIdInfo id: IRB 22-1286, briefTitle: Transcutaneous Pulse Oximetry Brain Monitoring Study (US), acronym: T-POT US, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-27, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Cyban Pty Ltd, class: INDUSTRY, descriptionModule briefSummary: This is a study of adult patients with a severe and sudden brain injury who have a drain placed in their brain to measure pressure. The purpose of the study is to monitor the pressure in the brain using a monitor placed on the forehead, and compare this to a drain placed in the brain., conditionsModule conditions: Acute Brain Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single center prospective observational cohort study, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Brain Pulse Oximeter, outcomesModule primaryOutcomes measure: Agreement of the brain oximeter levels compared with invasive ICP levels, secondaryOutcomes measure: Optical signal changes associated with periods of brain hypoxia and surrogate ICP waveform, secondaryOutcomes measure: Optical signal changes associated with non-convulsive seizures via EEG monitoring (Alpha, Beta, Theta), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cleveland Clinic, Neurological Institute, status: RECRUITING, city: Cleveland, state: Ohio, zip: 44195, country: United States, contacts name: Catherine Hassett, DO, role: CONTACT, phone: 216-445-1385, email: HASSETC@ccf.org, contacts name: Joao Gomes, MD, role: CONTACT, phone: 216-445-1385, email: GOMESJ@ccf.org, geoPoint lat: 41.4995, lon: -81.69541, hasResults: False

protocolSection identificationModule nctId: NCT06267118, orgStudyIdInfo id: Treatment of Bronchiolitis, briefTitle: Comparative Efficacy of Hypertonic Saline vs Adrenaline Nebulization in Acute Bronchiolitis, acronym: children, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Combined Military Hospital, Pakistan, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare the efficacy of hypertonic saline nebulization with adrenaline nebulization in the treatment of acute bronchiolitis in children. Main aim is to evaluate the following in both group of patients1. Improvement in Wood-Downes clinical score (WDF score) in bronchiolitis2. Length of Hospitalization, conditionsModule conditions: Acute Bronchiolitis Due to Respiratory Syncytial Virus, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients with acute bronchiolitis after informed written consent will be divided into two groups randomly. Group I will be nebulized with adrenaline every 6 hours and group II will nebulized with hypertonic saline every 6 hours. After 24 hours and 48 hours of nebulization, WDF score will be recorded by measuring respiratory rate, heart rate, chest retractions, chest auscultation findings and SPO₂ levels. Researcher will record all data on a specified Performa., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Investigator will make all the protocol and research Performa. Drugs will already be prepared for nebulization and labelled by investigator. Researcher /care provider will nebulize the patients of both groups randomly and record the results accordingly., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Hypertonic Saline Solution, 1 Ml, interventions name: Adrenaline, outcomesModule primaryOutcomes measure: Wood-Downes-Ferres clinical score calculation, secondaryOutcomes measure: total length of hospitalization, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 2 Years, stdAges: CHILD, contactsLocationsModule locations facility: Combined Military Hospital, status: RECRUITING, city: Nowshera, state: KPK, zip: 24110, country: Pakistan, contacts name: Syed Qamar Zaman, role: CONTACT, phone: 00923365307823, email: dr.qamarzaman@hotmail.com, contacts name: Shahid Mahmud, role: CONTACT, phone: 00923315301289, email: childspec@hotmail.com, contacts name: Syed Qamar Zaman, role: PRINCIPAL_INVESTIGATOR, hasResults: False

protocolSection identificationModule nctId: NCT06267105, orgStudyIdInfo id: A1-LORT, briefTitle: A Clinical Study to Compare Functional Outcomes After Surgery Using a Transverse or Longitudinal Surgical Incision in the Skin., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Corporacion Parc Tauli, class: OTHER, descriptionModule briefSummary: Trigger finger is a common pathology in the hand. Patients suffer from pain and depending on which tasks, patients have difficulty to perform them. Its treatment in initial and less serious phases includes conservative measures, but failure of these may require releasing the trigger finger with surgery. The surgical technique performed for trigger finger is the opening of the A1 pulley, the skin incisions used for this surgery are various (transverse, longitudinal, oblique). Trigger finger surgery presents good results in terms of resolution, but complications may also occur. The reason for this study is to assess whether there are functional differences using the Dash scale when we perform a transverse or longitudinal incision in trigger finger surgery., conditionsModule conditions: Functional Disturbance as Result, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Longitudinal incision, interventions name: Transverse incision, outcomesModule primaryOutcomes measure: Functional improvement of the patient after surgery, secondaryOutcomes measure: Surgeon comfort, secondaryOutcomes measure: Resolution, secondaryOutcomes measure: Flushed, secondaryOutcomes measure: Pain feeling, secondaryOutcomes measure: Contracture, secondaryOutcomes measure: Infection, secondaryOutcomes measure: Nerve injury, secondaryOutcomes measure: Return to work, secondaryOutcomes measure: Reincorporation to activities, secondaryOutcomes measure: Sensitivity Test, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06267092, orgStudyIdInfo id: NN9838-4944, briefTitle: A Study of How CagriSema Works on Appetite in People With Excess Body Weight, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2026-01-19, completionDateStruct date: 2026-01-19, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Novo Nordisk A/S, class: INDUSTRY, descriptionModule briefSummary: Part A: The study will look at participants appetite and energy intake and also look at the mechanisms of brain associated with appetite and food intake. Participants will not get any medicine and will be in a group that will be compared to another group receiving a weight-loss medicine. The study will last for about 6 months.Part B: The study will look at how CagriSema works on participants appetite and energy intake and will be compared with a ''dummy'' medicine. The study will also look at how participants brain works when participants take the medicine. Participants will either get CagriSema or ''dummy'' medicine., conditionsModule conditions: Overweight, conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Sponsor staff involved in the clinical trial is masked according to company standard procedures., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: No treatment given, interventions name: Cagrilintide and Semaglutide, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in mean postprandial appetite score based on visual analogue scale (VAS), secondaryOutcomes measure: Change in mean postprandial VAS ratings of: hunger, fullness, satiety and prospective food consumption, secondaryOutcomes measure: Change in average DAILY EATS questionnaire scores over one week for: average hunger, worst hunger, appetite, cravings, satiety and eating drivers index composite score, secondaryOutcomes measure: Change in control of eating questionnaire (COEQ), 4 domains: craving control score, positive mood score, craving for sweets score and craving for savoury food score, secondaryOutcomes measure: Change in power of food questionnaire for: food available score, food present score, food tasted score and composite score, secondaryOutcomes measure: Change in blood oxygen level dependant (BOLD) response to food cues in the brain reward areas, secondaryOutcomes measure: Relative change in total energy intake during ad libitum lunch, evening meal and snackbox, secondaryOutcomes measure: Change in percent energy intake of high fat, sweet food in total ad libitum energy intake in the evening snack box, secondaryOutcomes measure: Change in total energy intake during ad libitum lunch, evening meal and snackbox, secondaryOutcomes measure: Change in total amount of food consumed during ad libitum lunch, evening meal and snackbox, secondaryOutcomes measure: Change in body weight, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Charité Research Organisation GmbH, status: RECRUITING, city: Berlin, zip: 10117, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, hasResults: False

protocolSection identificationModule nctId: NCT06267079, orgStudyIdInfo id: core stability, briefTitle: Core Stability, Symmetrical Weight-bearing Stroke, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2023-09-05, completionDateStruct date: 2024-01-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: To evaluate the effect of core stability exercise on symmetrical weight bearing in chronic stroke patients?, conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: core stability exercise, outcomesModule primaryOutcomes measure: Each patient was assessed by Balance Berg scales pretreatment. and repeated Measurements were taken after treatment. Each patient was assessed by Digital weight scale and Balance Berg scales, primaryOutcomes measure: Each patient was assessed by Digital weight scale pre treatment and repeated Measurements were taken after treatment., eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: faculty of physical therapy Cairo university, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False

protocolSection identificationModule nctId: NCT06267066, orgStudyIdInfo id: MD-232-2022, briefTitle: Fractional Carbon Dioxide Laser: A Novel Therapeutic Option for Lichen Simplex Chronicus, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: The goal of this randomized control trial is to compare the use of fractional carbon dioxide (Co2) laser to topical corticosteroids to treat lichen simplex chronicus (LSC) patients presenting to Dermatology outpatient clinic, Faculty of Medicine, Cairo University.Participants will:* Be assessed clinically by doctor* Biopsies will be taken from them by doctor* Receive treatment as laser or topical steroids or both* Fill in depression questionnaire.Researchers will divide and compare groups as follows:Sixty patients will be divided randomly through closed envelop technique into 2 groups (Group A and B) each of 30 patients. Group A will be subdivided into 2 groups (1 and 2). All LSC lesions will be treated in any patient having multiple lesions.* Group 1 - A: Patients will receive 3 monthly laser sessions, in addition to the use of topical emollients only once daily in between the sessions.* Group 2 - A: Patients will receive 3 monthly laser sessions, in addition to topical steroids twice daily and topical emollient once daily in between the sessions.* Group B: Patients will be prescribed topical steroids twice daily and topical emollient once daily for 3 months.to see if:1. Pruritus severity scale.2. Scaling, erythema, lichenification excoriation scores3. Visual analogue scale.4. Investigator's Global Assessment.5. Itching mediators (Interleukin-31, Nerve Growth Factor and Substance P assays (itching mediators)6. Depressionimprove more in which group of patients after treatment., conditionsModule conditions: Lichen Simplex Chronicus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Sixty patients will be divided randomly through closed envelop technique into 2 groups (Group A and B) each of 30 patients. Group A will be subdivided into 2 groups (1 and 2) each of 15 patients. All LSC lesions will be treated in any patient having multiple lesions.Group 1 - A: Patients will receive 3 monthly laser sessions, in addition to the use of topical emollients only once daily in between the sessions.Group 2 - A: Patients will receive 3 monthly laser sessions, in addition to topical steroids twice daily and topical emollient once daily in between the sessions.Group B: Patients will be prescribed topical steroids twice daily and topical emollient once daily for 3 months., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Experienced dermatologist blinded to the interventions done will assess the patients' at the end of the treatment period., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Betamethasone Valerate 0.1% Cream, interventions name: SmartXide® fractional carbon dioxide laser, interventions name: Vaseline Topical Product, outcomesModule primaryOutcomes measure: Comparison between 2 groups regarding change in Pruritus severity scale, primaryOutcomes measure: Comparison between 2 groups regarding change in Visual analogue scale, primaryOutcomes measure: Comparison between 2 groups regarding change in Investigator's Global Assessment., primaryOutcomes measure: Comparison between 2 groups regarding change in Scaling score, primaryOutcomes measure: Comparison between 2 groups regarding change in Erythema score, primaryOutcomes measure: Comparison between 2 groups regarding change in Lichenification score, primaryOutcomes measure: Comparison between 2 groups regarding change in Excoriation score, secondaryOutcomes measure: change of depression score in both groups., secondaryOutcomes measure: change of itching mediators' levels (IL-31, Nerve Growth Factor and substance) between 2 groups, secondaryOutcomes measure: Comparison of itching mediator's levels in lesional, non-lesional skin and healthy controls, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lobna Alieldin, city: Cairo, zip: 11562, country: Egypt, contacts name: Noha Asem, professor, role: CONTACT, phone: 01003657120, phoneExt: 20, email: kasralainirec@yahoo.com, contacts name: Lobna Alieldin, MSc, role: CONTACT, phone: 01002279968, phoneExt: 20, email: Lobnaalieldin@gmail.com, contacts name: Lobna Alieldin, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.06263, lon: 31.24967, locations facility: Lobna Alieldin, city: Cairo, zip: 11562, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False

protocolSection identificationModule nctId: NCT06267053, orgStudyIdInfo id: 2023/469, briefTitle: Relationship Between Vitamins and Radiologic Stage in Knee Osteoarthritis, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2024-01-20, completionDateStruct date: 2024-01-20, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Bakirkoy Dr. Sadi Konuk Research and Training Hospital, class: OTHER_GOV, descriptionModule briefSummary: The aim of this study is to investigate the relationship between folic acid, vitamin B12 and 25-OH vitamin D levels and radiographic staging in patients diagnosed with primary gonarthrosis., conditionsModule conditions: Knee Osteoarthritis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 104, type: ACTUAL, armsInterventionsModule interventions name: Direct digital radiography, interventions name: 25-OH Vitamin D, interventions name: Vitamin B12, interventions name: Folic acid, outcomesModule primaryOutcomes measure: 25-OH Vitamin D (25(OH)D) and Kellgren Lawrence Grade, primaryOutcomes measure: Vitamin B12 and Kellgren Lawrence Grade, primaryOutcomes measure: Folic acid and Kellgren Lawrence Grade, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bakirkoy Dr. Sadi Konuk Research and Training Hospital, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False

protocolSection identificationModule nctId: NCT06267040, orgStudyIdInfo id: 17 Al-KindyCM, briefTitle: Linguistic and Clinical Validation of the Arabic Version of Acute Cystitis Symptom Score (ACCS), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2024-04-15, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Al-Kindy College of Medicine, class: OTHER, descriptionModule briefSummary: The goal of this prospective observational study is to provide an Arabic translation of the Acute Cystitis Symptom Score (ACSS) and to test the linguistic validity and clinical reliability of the translated Arabic version of ACCS (Arabic-ACCS) in Arabic-speaking women older than 18 years of age diagnosed with uncomplicated cystitis.The main questions it aims to answer are:* Do the questions of the Arabic-ACSS have sufficient clarity?* Can the Arabic-ACCS serve its purpose in identifying the presence of uncomplicated cystitis in Arabic-speaking women? The participant will be asked to fill out the Arabic-ACCS questionnaire at the time of diagnosis. The participants will be asked to fill out the second part of the Arabic-ACCS questionnaire 5-10 days later after receiving the appropriate treatment according to the local health policy as prescribed by the treating physician.Researchers will compare the results from the patients who filled out the first part of the questionnaire with the results of a comparable group of women who were presented with complaints unrelated to the lower urinary tract., conditionsModule conditions: Cystitis Acute, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Linguistic validity, primaryOutcomes measure: Clinical reliability, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Al-Elwiya Maternity Teaching Hospital, status: RECRUITING, city: Baghdad, zip: 10064, country: Iraq, contacts name: Zahraa Muhmmed Jameel Al-Sattam, FICMS (Gyn.), role: PRINCIPAL_INVESTIGATOR, contacts name: Weqar Akram Hussein, FICMS (Gyn.), role: SUB_INVESTIGATOR, geoPoint lat: 33.34058, lon: 44.40088, locations facility: Alkindy Teaching Hospital, status: RECRUITING, city: Baghdad, zip: 10064, country: Iraq, contacts name: Harth Mohamed Kamber, FICMS (Uro.), role: CONTACT, phone: +9647706029071, email: harthkamber@kmc.uobaghdad.edu.iq, contacts name: Harth Mohamed Kamber, FICMS (Uro.), role: PRINCIPAL_INVESTIGATOR, contacts name: Ahmed Abed Marzook, FICMS, role: SUB_INVESTIGATOR, geoPoint lat: 33.34058, lon: 44.40088, hasResults: False

protocolSection identificationModule nctId: NCT06267027, orgStudyIdInfo id: 2022/125, briefTitle: Comparison of Different Physical Therapy Modalities in Lateral Epicondylitis, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-07, primaryCompletionDateStruct date: 2023-09-15, completionDateStruct date: 2023-12-15, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Bakirkoy Dr. Sadi Konuk Research and Training Hospital, class: OTHER_GOV, descriptionModule briefSummary: Comparison of the effects of kinesiotaping and high intensity laser therapy in patients with lateral epicondylitis: a randomized controlled study, conditionsModule conditions: Lateral Epicondylitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: RANDOMIZED CONTROLLED STUDY, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 55, type: ACTUAL, armsInterventionsModule interventions name: Exercise, interventions name: Kinesiotaping, interventions name: High intensity laser therapy, outcomesModule primaryOutcomes measure: Patient Rated Tennis Elbow Evaluation (PRTEE), secondaryOutcomes measure: Visual Analogue Scale (VAS), secondaryOutcomes measure: Quick Disabilities of the Arm, Shoulder and Hand (qDASH), secondaryOutcomes measure: Jamar's handheld dynamometer, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: BakirkoySadiKonuk, city: Bakırköy, state: İstanbul, zip: 34147, country: Turkey, hasResults: False

protocolSection identificationModule nctId: NCT06267014, orgStudyIdInfo id: 2023-A02163-42, briefTitle: Use of a Virtual Reality Cognitive Stimulation Programme for Breast Cancer Patients Wishing to Restart or Maintain a Professional Activity, acronym: Cog-RV, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Centre Francois Baclesse, class: OTHER, descriptionModule briefSummary: The study concerns patients who have been treated for breast cancer, have cognitive problems and are planning to return to work or are currently working and wish to begin cognitive rehabilitation.Patients will follow the Virtual Reality program developed for the study, during the cognitive rehabilitation usually proposed in the establishment, at the rate of a weekly session of 10-15 minute for 6 weeks., conditionsModule conditions: Breast Cancer, conditions: Cancer-related Cognitive Difficulties, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Patients will follow the Virtual Reality program developed for the study, during the cognitive rehabilitation sessions, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 23, type: ESTIMATED, armsInterventionsModule interventions name: Virtual Reality sessions, outcomesModule primaryOutcomes measure: Proportion of patients adhering to the Virtual Reality program, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre François Baclesse, city: Caen, country: France, contacts name: Adeline MOREL, MD, role: CONTACT, geoPoint lat: 49.18585, lon: -0.35912, hasResults: False

protocolSection identificationModule nctId: NCT06267001, orgStudyIdInfo id: GO45006, secondaryIdInfos id: 2023-506696-10-00, type: REGISTRY, domain: EU CT, briefTitle: A Study of Tiragolumab Plus Atezolizumab Compared With Placebo Plus Atezolizumab in Participants With Completely Resected Non-small Cell Lung Cancer Who Have Received Adjuvant Platinum-based Chemotherapy, acronym: SKYSCRAPER-15, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-21, primaryCompletionDateStruct date: 2034-03-31, completionDateStruct date: 2039-06-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Hoffmann-La Roche, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab administered to participants with non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy., conditionsModule conditions: Non-small Cell Lung Cancer (NSCLC), 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: 1150, type: ESTIMATED, armsInterventionsModule interventions name: Atezolizumab, interventions name: Tiragolumab, interventions name: Placebo, outcomesModule primaryOutcomes measure: Disease-free Survival (DFS), secondaryOutcomes measure: Percentage of Participants With Adverse Events (AEs), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: DFS Rate, secondaryOutcomes measure: Percentage of Participants Who Maintained or Meaningfully Improved from Baseline in Patient-reported Role, Emotional, and Physical Functioning and Global Health Status (GHS)/Quality of Life (QoL), secondaryOutcomes measure: Serum Concentration of Tiragolumab, secondaryOutcomes measure: Serum Concentration of Atezolizumab, secondaryOutcomes measure: Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab, secondaryOutcomes measure: Percentage of Participants With ADAs to Atezolizumab, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Oncology Institute of Hope and Innovation; Cerritos, status: RECRUITING, city: Cerritos, state: California, zip: 90703, country: United States, geoPoint lat: 33.85835, lon: -118.06479, locations facility: University of California, San Francisco; Medical Center, status: RECRUITING, city: San Francisco, state: California, zip: 94158, country: United States, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital, status: RECRUITING, city: Marietta, state: Georgia, zip: 30060, country: United States, geoPoint lat: 33.9526, lon: -84.54993, locations facility: Springfield Clinic, status: RECRUITING, city: Springfield, state: Illinois, zip: 62702, country: United States, geoPoint lat: 39.80172, lon: -89.64371, locations facility: UNM Lovelace, status: RECRUITING, city: Albuquerque, state: New Mexico, zip: 87102, country: United States, geoPoint lat: 35.08449, lon: -106.65114, locations facility: University of New Mexico Cancer Center, status: RECRUITING, city: Albuquerque, state: New Mexico, zip: 87106, country: United States, geoPoint lat: 35.08449, lon: -106.65114, locations facility: Asante Rogue Regional Medical Center, status: RECRUITING, city: Medford, state: Oregon, zip: 97504-8332, country: United States, geoPoint lat: 42.32652, lon: -122.87559, locations facility: Hospital Britanico; Oncologia, status: RECRUITING, city: Buenos Aires, zip: C1280AEB, country: Argentina, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Centro Oncologico Korben; Oncology, status: RECRUITING, city: Ciudad Autonoma Buenos Aires, zip: C1426AGE, country: Argentina, geoPoint lat: -34.61315, lon: -58.37723, locations facility: CINME S.A. ? Centro de Investigaciones Metabolicas - Rx Trials LLC, status: RECRUITING, city: Ciudad Autonoma de Buenos Aires, zip: C1027AAP, country: Argentina, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Sunshine Coast University Hospital; The Adem Crosby Centre, status: RECRUITING, city: Birtinya, state: Queensland, zip: 4575, country: Australia, geoPoint lat: -26.74322, lon: 153.11913, locations facility: Greenslopes Private Hospital; Gallipoli Research Centre, status: RECRUITING, city: Greenslopes, state: Queensland, zip: 4120, country: Australia, geoPoint lat: -27.50815, lon: 153.04951, locations facility: Cancer Research SA, status: RECRUITING, city: Adelaide, state: South Australia, zip: 5000, country: Australia, geoPoint lat: -34.92866, lon: 138.59863, locations facility: Monash Health, status: RECRUITING, city: Clayton, state: Victoria, zip: 3168, country: Australia, geoPoint lat: -37.91667, lon: 145.11667, locations facility: Hospital de Cancer de Barretos, status: RECRUITING, city: Barretos, state: SP, zip: 14784-400, country: Brazil, geoPoint lat: -20.55722, lon: -48.56778, locations facility: Hospital A. C. Camargo; Oncologia, status: RECRUITING, city: Sao Paulo, state: SP, zip: 01509-010, country: Brazil, geoPoint lat: -23.5475, lon: -46.63611, locations facility: Changzhou First People's Hospital; Oncology, status: RECRUITING, city: Changzhou, zip: 213003, country: China, geoPoint lat: 31.77359, lon: 119.95401, locations facility: The First Affiliated Hospital of Sun Yat-sen University, status: RECRUITING, city: Guangzhou City, zip: 510080, country: China, locations facility: Guangdong General Hospital, status: RECRUITING, city: Guangzhou, zip: 510080, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Shandong Cancer Hospital, status: RECRUITING, city: Jinan, zip: 250117, country: China, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Yunnan Cancer Hospital, status: RECRUITING, city: Kunming, zip: 650118, country: China, geoPoint lat: 25.03889, lon: 102.71833, locations facility: The First Affiliated Hospital of Nanchang University, status: RECRUITING, city: Nanchang City, zip: 330008, country: China, locations facility: Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, status: RECRUITING, city: Nanjing City, zip: 210008, country: China, locations facility: Ningbo No.2 Hospital, status: RECRUITING, city: Ningbo, country: China, geoPoint lat: 29.87819, lon: 121.54945, locations facility: Zhongshan Hospital Fudan University, status: RECRUITING, city: Shanghai, zip: 200032, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Shanghai Pulmonary Hospital, status: RECRUITING, city: Shanghai, zip: 200433, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Liaoning Provincial Cancer Hospital, status: RECRUITING, city: Shengyang, zip: 110042, country: China, locations facility: Tianjin Cancer Hospital, status: RECRUITING, city: Tianjin, zip: 300060, country: China, geoPoint lat: 39.14222, lon: 117.17667, locations facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Technology, status: RECRUITING, city: Wuhan City, zip: 430030, country: China, locations facility: The Affiliated Hospital of Xuzhou Medical University, status: RECRUITING, city: Xuzhou, country: China, geoPoint lat: 34.18045, lon: 117.15707, locations facility: The First Affiliated Hospital of Zhengzhou University, status: RECRUITING, city: Zhengzhou, zip: 450052, country: China, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Kindai University Hospital, status: RECRUITING, city: Osaka, zip: 589-8511, country: Japan, geoPoint lat: 34.69374, lon: 135.50218, locations facility: Pusan National University Hospital, status: RECRUITING, city: Busan, zip: 602-739, country: Korea, Republic of, geoPoint lat: 35.10278, lon: 129.04028, locations facility: Chungbuk National University Hospital, status: RECRUITING, city: Cheongju si, zip: 28644, country: Korea, Republic of, geoPoint lat: 36.63722, lon: 127.48972, locations facility: Kyungpook National University Chilgok Hospital, status: RECRUITING, city: Daegu, zip: 41404, country: Korea, Republic of, geoPoint lat: 35.87028, lon: 128.59111, locations facility: St. Vincent's Hospital, status: RECRUITING, city: Gyeonggi-do, zip: 16247, country: Korea, Republic of, geoPoint lat: 37.58944, lon: 126.76917, locations facility: Pusan National University Yangsan Hospital, status: RECRUITING, city: Gyeongsangnam-do, zip: 50612, country: Korea, Republic of, locations facility: Chonnam National University Hwasun Hospital, status: RECRUITING, city: Jeollanam-do, zip: 58128, country: Korea, Republic of, locations facility: Seoul National University Bundang Hospital, status: RECRUITING, city: Seongnam-si, zip: 463-707, country: Korea, Republic of, geoPoint lat: 37.43861, lon: 127.13778, locations facility: Seoul National University Hospital, status: RECRUITING, city: Seoul, zip: 03080, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Severance Hospital, Yonsei University Health System, status: RECRUITING, city: Seoul, zip: 03722, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Asan Medical Center, status: RECRUITING, city: Seoul, zip: 05505, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Samsung Medical Center, status: RECRUITING, city: Seoul, zip: 06351, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Korea University Guro Hospital, status: RECRUITING, city: Seoul, zip: 08308, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Ulsan University Hosiptal, status: RECRUITING, city: Ulsan, zip: 44033, country: Korea, Republic of, geoPoint lat: 35.53722, lon: 129.31667, locations facility: Kaohsiung Medical Uni Chung-Ho Memorial Hospital; Dept of Internal Medicine, status: RECRUITING, city: Kaohsiung, zip: 807, country: Taiwan, geoPoint lat: 22.61626, lon: 120.31333, locations facility: Taichung Veterans General Hospital; Dept of Internal Medicine, status: RECRUITING, city: Taichung, zip: 407, country: Taiwan, geoPoint lat: 24.1469, lon: 120.6839, locations facility: Taipei Veterans General Hospital; Chest Dept, Section of Thoracic Oncology, status: RECRUITING, city: Taipei, zip: 112, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, locations facility: Tri-Service General Hospital; Dept. of Internal Medicine, status: RECRUITING, city: Taipei, zip: 114, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False

protocolSection identificationModule nctId: NCT06266988, orgStudyIdInfo id: SCVL-TFZ-1010, briefTitle: A Bioequivalence Study of Sacubitril/Valsartan Film-coated Tablets Under Fasting Conditions, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Viatris Inc., class: INDUSTRY, descriptionModule briefSummary: Primary objective is to is to evaluate the bioequivalence of two formulations, conditionsModule conditions: Chronic Heart Failure, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Sacubitril and Valsartan Tablets 97mg/103mg, interventions name: Entresto (Sacubitril and Valsartan Tablets 97mg/103mg), outcomesModule primaryOutcomes measure: Bioequivalence based on Cmax period (using the validated Phoenix® WinNonlin® software), primaryOutcomes measure: Bioequivalence based on AUC period (using the validated Phoenix® WinNonlin® software), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06266975, orgStudyIdInfo id: CKD pts in CML, briefTitle: Chronic Kidney Disease Patient in Chronic Myloied Leukemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2026-11, completionDateStruct date: 2026-11, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Sahar Mohammed Gad, class: OTHER, descriptionModule briefSummary: To study the Prevalence ,Characteristics and outcome of CKD in patiants with chronic myeloid leukemia ., conditionsModule conditions: Chronic Myeloid Leukemia in Remission, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Biobsy from kidney, outcomesModule primaryOutcomes measure: Chronic Kidney Disease Patient in Chronic Myloied Leukemia, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06266962, orgStudyIdInfo id: 3/24, briefTitle: Comparing the Efficiency of Two Approaches in Patients at Risk of Developing Intraoperative Floppy Iris Syndrome, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-07-01, primaryCompletionDateStruct date: 2022-09-30, completionDateStruct date: 2022-09-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University Hospital Olomouc, class: OTHER, collaborators name: Palacky University, descriptionModule briefSummary: Intraoperative Floppy Iris Syndrome (IFIS) is a potentially serious cataract surgery complication. IFIS is most commonly associated with the chronic use of tamsulosin and other alpha1-adrenergic receptor antagonists prescribed in low urinary tract symptoms. There are a number of guidelines for operative technique modifications with the aim to prevent the development of IFIS. The study focuses on two options for prophylactic strategies: the application of atropine drops and the instillation of intracameral epinephrine., conditionsModule conditions: Intraoperative Floppy Iris Syndrome, conditions: Cataract, conditions: Age-related Cataract, conditions: Adrenergic Receptor Antagonist Adverse Reaction, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 164, type: ACTUAL, armsInterventionsModule interventions name: 1% Atropine drops, interventions name: Epinephrine, outcomesModule primaryOutcomes measure: Development of IFIS, primaryOutcomes measure: Severity of IFIS, primaryOutcomes measure: Incidence of intraoperative complications, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Ophthalmology, University Hospital Olomouc, city: Olomouc, country: Czechia, geoPoint lat: 49.59552, lon: 17.25175, hasResults: False

protocolSection identificationModule nctId: NCT06266949, orgStudyIdInfo id: 11362, briefTitle: Perimetry Based on Eye-movements in Patients With (Supra)Sellar Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University Medical Center Groningen, class: OTHER, descriptionModule briefSummary: The purpose of this study is to assess wether the SONDA visual field test is suitable for patients with a supra sellar tumour., conditionsModule conditions: Pituitary Tumor, conditions: Visual Fields Hemianopsia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: SONDA, outcomesModule primaryOutcomes measure: Convert validity, primaryOutcomes measure: Test-retest reliability, secondaryOutcomes measure: Experience, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UMCG, city: Groningen, zip: 9713 GZ, country: Netherlands, geoPoint lat: 53.21917, lon: 6.56667, hasResults: False

protocolSection identificationModule nctId: NCT06266936, orgStudyIdInfo id: EssaiClinique_SL2i-MSC, briefTitle: Smart Life Smart Living Intercontinental - Medical Students' Cohort, acronym: SL2i-MSC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2044-09, completionDateStruct date: 2044-12, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University Hospital, Grenoble, class: OTHER, collaborators name: Université Grenoble-Alpes, descriptionModule briefSummary: The question of the well-being, quality of life and mental health of care students is unanimously considered to be a central issue among young adults. According to the French Ministry of Higher Education and Research, there will be 194,752 care students in France in 2021-2022. The quality of life and well-being of health students can be affected at several levels. The first is mental health. In France, the mental health of these students has deteriorated considerably in recent years. According to a 2017 survey of 21,768 French medical students, 66% of them had an anxiety disorder and 27% a depressive syndrome. In addition, a number of risk factors have been identified for the mental health of health students.The aim of the study is to carry out a longitudinal evaluation of the mental health status of care students during their university studies in France through anxiety, depression and perceived stress., conditionsModule conditions: Mental Health Issue, conditions: Student Burnout, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1564, type: ESTIMATED, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: Synthetic score on standardized assessment scale of anxiety, secondaryOutcomes measure: Synthetic score on standardized assessment scale of mental health, secondaryOutcomes measure: Synthetic score on standardized assessment scale of stress, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06266923, orgStudyIdInfo id: SPH6516-101, briefTitle: A Clinical Study of SPH6516 Tablets in the Treatment of Advanced Solid Tumors., statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-20, primaryCompletionDateStruct date: 2023-04-20, completionDateStruct date: 2023-11-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Shanghai Pharmaceuticals Holding Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: To evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of SPH6516 tablets in the treatment of advanced solid tumors., conditionsModule conditions: Advanced Solid Tumor, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ACTUAL, armsInterventionsModule interventions name: SPH6516 tablets, outcomesModule primaryOutcomes measure: MTD（Maximum tolerated dose）, secondaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events, secondaryOutcomes measure: Peak Plasma Concentration (Cmax）, secondaryOutcomes measure: Peak time（Tmax）, secondaryOutcomes measure: Area under the plasma concentration versus time curve (AUC), secondaryOutcomes measure: half-life（T1/2）, secondaryOutcomes measure: Objective response rate(ORR), secondaryOutcomes measure: Progression-free survival (PFS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-sen University Cancer Center, city: Guangzhou, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Ruijin Hospital, Shanghai Jiaotong University School Of Medicine, city: Shanghai, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False

protocolSection identificationModule nctId: NCT06266910, orgStudyIdInfo id: 2023KYPJ320, briefTitle: Effects of Autostereoscopic 3D Visual Training on Binocular Vision Function of Myopes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2024-10-10, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Zhongshan Ophthalmic Center, Sun Yat-sen University, class: OTHER, collaborators name: South China University of Technology, descriptionModule briefSummary: This study intends to conduct a relatively comprehensive binocular visual function examination and follow-up on two groups of myopic subjects, one receiving autostereoscopic 3D vision training and the other receiving 2D vision training as a control. The aim is to explore the impact of autostereoscopic 3D vision training on the accommodation and convergence functions of myopes. Additionally, synchronized EEG-fNIRS signals will be collected to investigate whether changes in binocular visual function are accompanied by corresponding alterations in brain function., conditionsModule conditions: Myopia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: By employing a single simulation technology for blinding, both the 2D group and the 3D group share identical training equipment and a consistent video background. The only distinction lies in the subtle variation in the configuration of training markers. It is difficult for participants to differentiate their respective groups., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Visual training video, outcomesModule primaryOutcomes measure: Accommodative facility, primaryOutcomes measure: Vergence facility, secondaryOutcomes measure: Negative and positive fusional vergence, secondaryOutcomes measure: Accommodative response, secondaryOutcomes measure: negative and positive relative accommodation, secondaryOutcomes measure: Near point of convergence, secondaryOutcomes measure: Accommodation amplitude, secondaryOutcomes measure: Electroencephalogram (EEG) node efficiency, secondaryOutcomes measure: Functional near-infrared spectroscopy (fNIRS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Zhongshan Opthalmic Center, Sun Yat-sen University, city: Guangzhou, state: Guangdong, zip: 510060, country: China, contacts name: Yehong Zhuo, role: CONTACT, phone: 13352828998, email: zhuoyh@mail.sysu.edu.cn, geoPoint lat: 23.11667, lon: 113.25, hasResults: False

protocolSection identificationModule nctId: NCT06266897, orgStudyIdInfo id: ZhujiangEM, briefTitle: A Study on the Correlation Between Endometriosis and Intra-tissue Microbiota, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-18, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Zhujiang Hospital, class: OTHER, descriptionModule briefSummary: Endometriosis (EM) is a common gynecological condition, but the pathogenesis of it has not yet been clarified. Here, the investigators wanted to investigate the correlation between endometriosis and the intra-tissue microbiota. The investigators planed to collect serum, vaginal swabs, cervical mucus, feces, peritoneal fluid, and endometrial tissue for sequencing and experiments., conditionsModule conditions: Endometriosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Metagenomics Next Generation Sequencing of the Intra-tissue Microbiota Composition, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 52 Years, stdAges: ADULT, contactsLocationsModule locations facility: Zhujiang Hospital, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510280, country: China, contacts name: Ying Ma, role: CONTACT, phone: +8613113361169, email: mayingwuzhuoyi@126.com, geoPoint lat: 23.11667, lon: 113.25, hasResults: False

protocolSection identificationModule nctId: NCT06266884, orgStudyIdInfo id: AgriIbrahimCecen, briefTitle: The Effect of Kangaroo Care on Father-Baby Attachment, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-12-15, primaryCompletionDateStruct date: 2023-06-15, completionDateStruct date: 2023-11-15, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Agri Ibrahim Cecen University, class: OTHER, collaborators name: Kahramanmaras Sutcu Imam University, descriptionModule briefSummary: The aim of the research is to evaluate the attachment level of fathers who received kangaroo care training in the antenatal period and applied kangaroo care in the postpartum period to their babies in the first and fourth months.The research will be conducted in a randomized controlled experimental type with educational intervention. The research will be conducted at Islahiye State Hospital with 25 experimental and 25 control group fathers who meet the inclusion criteria. Fathers in the experimental group will be given kangaroo care training during the antenatal period and postpartum kangaroo care will be applied. No intervention will be made to the control group fathers. The Paternal-Infant Attachment Questionnaire (PPAQ) will be applied to fathers in both groups in the first and fourth months and the results will be compared., conditionsModule conditions: Kangaroo Care, conditions: Attachment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The contact numbers of the prospective fathers will be taken and a training video and presentation on kangaroo care will be sent via WhatsApp. Kangaroo care will be applied to the fathers in the experimental group during birth., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ACTUAL, armsInterventionsModule interventions name: Kangaroo care, outcomesModule primaryOutcomes measure: Fathers' Attachment Level, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Agri Ibrahim Cecen University, city: Agri, country: Turkey, geoPoint lat: 39.71944, lon: 43.05139, hasResults: False

protocolSection identificationModule nctId: NCT06266871, orgStudyIdInfo id: WCH-2023-1625, briefTitle: SOX Combined With Tislelizumab and LDRT for Neoadjuvant Treatment of Locally Advanced Gastric Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-10, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-07-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: West China Hospital, class: OTHER, descriptionModule briefSummary: Neoadjuvant chemotherapy or chemoradiotherapy has become the standard neoadjuvant regimen for locally advanced G/GEJ cancer and has been recommended by a series of treatment guidelines. Although with clinical benefits of neoadjuvant chemotherapy or chemoradiotherapy, the pCR and long-term survival rates are still unsatisfactory and perioperative treatment mode for locally advanced G/GEJ cancer still needs further optimization. In this study, we will explore the efficacy and safety of chemotherapy combined with tislelizumab and LDRT in the neoadjuvant treatment for locally advanced G/GEJ cancer., conditionsModule conditions: Gastric Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: SOX+Tislelizumab+LDRT, outcomesModule primaryOutcomes measure: pCR rate, secondaryOutcomes measure: R0 resection rate, secondaryOutcomes measure: MPR rate, secondaryOutcomes measure: ORR, secondaryOutcomes measure: 2-year disease-free survival (DFS) rate, secondaryOutcomes measure: 2-year OS rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06266858, orgStudyIdInfo id: SYSKY-2022-407-02, briefTitle: Multimodality Imaging Assessment of the Severity of Mitral Regurgitation, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-12-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: To investigate to assess the severity of mitral regurgitation by multimodality imaging., conditionsModule conditions: Mitral Regurgitation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: rehydration, interventions name: UCG, interventions name: CMR, interventions name: fasting, outcomesModule primaryOutcomes measure: effective regurgitant orifice area (EROA), primaryOutcomes measure: mitral regurgitant volume (RVol), primaryOutcomes measure: mitral regurgitant fraction (RF), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510000, country: China, contacts name: Maohuan Lin, PhD, role: CONTACT, phone: 13580575861, email: maohuan_lin@163.com, geoPoint lat: 23.11667, lon: 113.25, hasResults: False

protocolSection identificationModule nctId: NCT06266845, orgStudyIdInfo id: 76082423.1.0000.8093, briefTitle: Efficacy of Gamification With Escape-Room for Arrhythmia Identification in Critical Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University of Brasilia, class: OTHER, descriptionModule briefSummary: Introduction: Health education provided through the escape-room is still a recent approach in educational methodology and tends to be a strategy that benefits nursing students, particularly in gaining knowledge and skills. However, few studies have explored the use of both in-person and virtual escape-room as an educational methodology in nursing. Objective: To assess the effectiveness of the gamification strategy through the in-person escape-room model compared to the virtual model in enhancing cognitive and affective competencies for recognizing cardiac arrhythmias in critical care patients within the nursing field. Method: A randomized clinical trial to be conducted with nursing students from higher education institutions in the Federal District, Brazil. Students will undergo a theoretical class on cardiac arrhythmias in critical patients and will then be randomized to experience either the in-person or virtual escape-room scenario. Knowledge tests, the Depression, Anxiety, and Stress Scale, Satisfaction and Self-confidence Scale in nursing management learning, and perceived gains will be administered pre and post-intervention. Results with p≤0.05 will be considered significant. Expected Results: It is anticipated that this study will contribute to the enhancement and broadening of cognitive and affective competencies in nursing students, improving the quality of care through an active educational strategy like the escape-room, and consequently reducing costs for the Unified Health System by minimizing errors in recognizing clinical changes in critical patients. Additionally, the study aims to address gaps in understanding the use of educational escape-rooms in the field of nursing., conditionsModule conditions: Arrythmia, conditions: Health Education, conditions: Escape-Room, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 53, type: ESTIMATED, armsInterventionsModule interventions name: In-person Escape Room, interventions name: Virtual Escape-Room, outcomesModule primaryOutcomes measure: Evaluate the feelings of stress and anxiety among nursing students after experiencing the in-person and virtual escape-room combined with an interactive lecture, primaryOutcomes measure: Perceived Gains Scale, primaryOutcomes measure: Student Satisfaction and Self-Confidence in Learning, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Alberto Augusto Martins Paiva, status: RECRUITING, city: Brasília, state: DF, zip: 71938360, country: Brazil, contacts name: Alberto Augusto M Paiva, Graduate, role: CONTACT, phone: +5561983470397, email: albertopaiva19@hotmail.com, geoPoint lat: -15.77972, lon: -47.92972, hasResults: False

protocolSection identificationModule nctId: NCT06266832, orgStudyIdInfo id: 20230727, briefTitle: The Efficacy and Safety of Short-course Radiation Combined With Adebrelimab and CAPEOX Neo-adjuvant Therapy for Organ-retention in Patients With MSS/pMMR Ultra Low Rectal Adenocarcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Sir Run Run Shaw Hospital, class: OTHER, descriptionModule briefSummary: To evaluate the efficacy, safety and organ retention rate of short-course radiation combined with Adebrelimab and CAPEOX neoadjuvant therapy in patients with MSS/pMMR ultra low rectal adenocarcinoma., conditionsModule conditions: Rectal Adenocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Adebrelimab, interventions name: Oxaliplatin, interventions name: Capecitabine, interventions name: Short-course Radiation, interventions name: Biopsy, outcomesModule primaryOutcomes measure: Organ retention rate, secondaryOutcomes measure: Total mesorectal excision rate, secondaryOutcomes measure: Total mesorectal excision rate after recurrence, secondaryOutcomes measure: Tumor regression grade, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Disease free survival, secondaryOutcomes measure: TRAEs, secondaryOutcomes measure: QoL, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310016, country: China, contacts name: Xiujun Cai, role: CONTACT, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False

protocolSection identificationModule nctId: NCT06266819, orgStudyIdInfo id: OU-HEM-LE-01, briefTitle: The Effect of Mint Flavored Chewing Gum on Hyperemesis Gravidarum Nausea Vomiting Severity, Coping With Stress and Anxiety Level in Pregnants With Hyperemesis Gravidarum, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: T.C. ORDU ÜNİVERSİTESİ, class: OTHER, descriptionModule briefSummary: In the research planned as a randomized controlled study, the experimental groups will be administered routine hyperemesis gravidarum (HG) treatment as well as chewing mint-flavored gum, while the control group will only receive routine HG treatment and no intervention will be performed. This study aims to contribute to the literature by investigating the effect of chewing mint-flavored gum on the severity of nausea and vomiting, coping with stress, and anxiety levels due to hyperemesis gravidarum in pregnant women., conditionsModule conditions: Hyperemesis Gravidarum, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: two groups with chewing mint gum experimental group and a control group, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: The study protocol in the research will be created using SPIRIT as a guide. Reporting of the trial will be structured according to the CONSORT checklist. Random distribution of pregnant women included in the study to the intervention and control groups will be made at www.randomizer.org. Which group will be the intervention or control group will be determined by drawing lots at the beginning of the study. Pregnant women in the intervention group will be given the practice of chewing mint-flavored gum.Since the researcher knows which group the pregnant women are included in, the data collection phase of the study is single blind. To avoid selection bias in this study, pregnant women will be randomly assigned to the intervention and control groups by randomization method. To prevent reporting bias, the analysis of the research data will be carried out by an expert statistician., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 78, type: ESTIMATED, armsInterventionsModule interventions name: chewing gum, outcomesModule primaryOutcomes measure: Pregnancy-Specific Nausea and Vomiting Severity Scale (PUQE-24), primaryOutcomes measure: Visual Analog Scale (VAS), secondaryOutcomes measure: Stress Coping Styles Scale (SCSS), secondaryOutcomes measure: State-Trait Anxiety Inventory (STAI), eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Özel Şar Hospital, status: RECRUITING, city: Rize, zip: 53100, country: Turkey, contacts name: M.Akif KUMBUZOĞLU, Uzm. Dr., role: CONTACT, phone: +90 464 212 11 03, email: info@sarhospital.com.tr, geoPoint lat: 41.02083, lon: 40.52194, hasResults: False

protocolSection identificationModule nctId: NCT06266806, orgStudyIdInfo id: OndokusMU55, briefTitle: The Effect of Breastfeeding Counseling on Social Support Perception, Breastfeeding Self-Efficacy and Outcomes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Ondokuz Mayıs University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to examine the effects of the Breastfeeding Self-Efficacy Resources Development Nurse Consultancy Program (EMÖZGEDAP), based on Dennis's Breastfeeding Self-Efficacy Theory along with the hypno-breastfeeding philosophy given to mothers and family relatives, on social support perception, breastfeeding self-efficacy and outcomes. The study will involve pregnant women and close others assigned randomly to the intervention (n=50) or control (n=50) groups in a state hospital in Turkey. Individual counseling will be provided to the intervention group within the scope of the EMÖZGEDAP, based on Denis's Breastfeeding Self-Efficacy theory and hypnobreastfeeding philosophy. EMÖZGEDAP, which will be applied to pregnant women and their family relatives, will consist of 5 sessions lasting 7.5 hours (2 sessions with the woman and her family relatives, two sessions with the woman alone, and one with her family relatives alone). The Antenatal Breastfeeding Self-Efficacy Scale will be evaluated before the counseling program is given in the antepartum period. Breastfeeding and Nutrition Results, Postpartum Breastfeeding Self-Efficacy Scale, Breastfeeding Self-Efficacy Scale for Fathers, Assessment Scale for Perceived Support of Close Others in Relation to Breastfeeding Self-Efficacy and Scale of Perception of Close Others' Support For Breastfeeding Self-Efficacy will be evaluated at the 1st, 3rd, and 6th months postpartum., conditionsModule conditions: Breastfeeding, Exclusive, conditions: Nurse's Role, conditions: Self Efficacy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A randomized controlled experimental study, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Nurse Consultancy Program to Develop Breastfeeding Self-Efficacy Resources, outcomesModule primaryOutcomes measure: Breastfeeding and Nutrition Results, primaryOutcomes measure: Antenatal Breastfeeding Self-Efficacy Scale Short Form, primaryOutcomes measure: Postpartum Breastfeeding Self-Efficacy Scale-Short Form, primaryOutcomes measure: Breastfeeding Self-Efficacy Scale for Fathers Short Form, primaryOutcomes measure: Assessment Scale for Perceived Support of Close Others in Relation to Breastfeeding Self-Efficacy, primaryOutcomes measure: Scale of Perception of Close Others' Support For Breastfeeding Self-Efficacy, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06266793, orgStudyIdInfo id: 2072488-2, briefTitle: Comparison of Holmium Laser and Thulium Laser for Mini PCNL, acronym: HOTLaser, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2027-06-01, completionDateStruct date: 2027-06-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: MaineHealth, class: OTHER, collaborators name: Boston Scientific Corporation, descriptionModule briefSummary: This is a single institution, single surgeon, randomized controlled trial to evaluate the Boston Scientific Lumenis Pulse 120H Moses 2.0 holmium laser versus the Olympus Soltive Superpulsed thulium fiber laser (TFL) for medium-to-large stones in the mini PCNL setting., conditionsModule conditions: Nephrolithiasis, conditions: Percutaneous Nephrolithotomy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 52, type: ESTIMATED, armsInterventionsModule interventions name: Holmium Laser, interventions name: Thulium Laser, outcomesModule primaryOutcomes measure: Laser Treatment Time, secondaryOutcomes measure: Retreatment rate, secondaryOutcomes measure: Total Operative Time, secondaryOutcomes measure: Stone-Free Rate, otherOutcomes measure: Length of stay, otherOutcomes measure: Safety Profile and Adverse Events, otherOutcomes measure: Subjective pain scores, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Maine Medical Center, city: Portland, state: Maine, zip: 04102, country: United States, contacts name: Danielle Landry, RN, role: CONTACT, phone: 207-662-0111, email: danielle.landry@mainehealth.org, geoPoint lat: 43.66147, lon: -70.25533, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-02-05, uploadDate: 2024-02-05T13:32, filename: Prot_SAP_000.pdf, size: 799007, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-02-05, uploadDate: 2024-02-05T13:23, filename: ICF_001.pdf, size: 397260, hasResults: False

protocolSection identificationModule nctId: NCT06266780, orgStudyIdInfo id: P1473-2023, briefTitle: Impact Evaluation of a Targeted mHealth Intervention to Improve Uptake of Postpartum Contraception in Kenya, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-02, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Jacaranda Health, class: OTHER, collaborators name: Harvard School of Public Health (HSPH), collaborators name: Jhpiego, collaborators name: IPSOS, descriptionModule briefSummary: The goal of this study is to explore approaches to improve postpartum contraceptive counseling, information, and uptake through a collaboration between the Harvard Chan School, Rutgers School of Public Health, Jacaranda Health, Jhpiego, and IPSOS, leveraging an existing mobile health platform for intervention delivery and Jacaranda's established partnership with the Kenyan Ministry of Health, county health offices and public maternity hospitals.Jacaranda's PROMPTS mHealth platform has reached over two million pregnant women and new mothers, providing them with needed, tailored information about prenatal and postpartum health along with access to a mobile helpdesk to triage users' questions. Using a targeted human-centered-design process with early postpartum mothers, we developed targeted messaging around family planning and contraceptive method options, with the goal of integrating this new content into Jacaranda's PROMPTS platform. We will conduct a randomized controlled trial with pregnant women engaged with the PROMPTS platform to determine the impact of the intervention package on information and utilization of postpartum contraception. If proven effective, the results of this intervention will be integrated into Jacaranda's PROMPTS system at full scale., conditionsModule conditions: Postpartum Family Planning, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 4190, type: ESTIMATED, armsInterventionsModule interventions name: PROMPTS Enhanced Family Planning Counselling, outcomesModule primaryOutcomes measure: Use of postpartum family planning at 3 months, primaryOutcomes measure: Use of postpartum family planning at 6 months, secondaryOutcomes measure: Knowledge of return to fertility, secondaryOutcomes measure: Knowledge of safe birth spacing, secondaryOutcomes measure: Knowledge of lactational amenorrhea (LAM) method, secondaryOutcomes measure: Intention to continue family planning method, secondaryOutcomes measure: Intended duration of continued family planning method use, secondaryOutcomes measure: Desired pregnancy spacing of two years or more, secondaryOutcomes measure: Short interpregnancy interval, secondaryOutcomes measure: Method satisfaction, secondaryOutcomes measure: Uptake of most effective family planning methods, secondaryOutcomes measure: Time to take-up of most effective methods, secondaryOutcomes measure: Discussion of FP at any prenatal visit, secondaryOutcomes measure: Discussion of FP at any postnatal visit, secondaryOutcomes measure: Reproductive empowerment: health care provider communication, otherOutcomes measure: Quality of helpdesk team in counselling on family planning, otherOutcomes measure: Quality of message flow on method selection, eligibilityModule sex: FEMALE, minimumAge: 15 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jacaranda Health, status: RECRUITING, city: Nairobi, zip: 00000, country: Kenya, contacts name: Anneka Wickramanayake, Masters, role: CONTACT, phone: +254700164229, email: awickramanayake@jacarandahealth.org, contacts name: Jessica Cohen, Ph.D, role: CONTACT, phone: +16174327577, email: cohenj@hsph.harvard.edu, geoPoint lat: -1.28333, lon: 36.81667, hasResults: False

protocolSection identificationModule nctId: NCT06266767, orgStudyIdInfo id: MRC-01-18-157, briefTitle: Programmed Intermittent Epidural Bolus (PIEB) Techniques for Labour Analgesia, acronym: PIEB, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2024-04-20, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Hamad Medical Corporation, class: INDUSTRY, descriptionModule briefSummary: Epidural Analgesia remains the most effective form of pain relief in labour. After initiating epidural analgesia, there are many epidural drug regimens that can be employed to maintain analgesia for the duration of labour using an epidural catheter. Due to recent advances in medical technology, new epidural pumps, which allow both patient controlled epidural analgesia boluses (PCEA, a common standard of care in many hospitals) and programmed intermittent epidural boluses (PIEB, automatic boluses given in addition to the PCEA bolus), are now available. In this randomized double-blind trial, we aim to evaluate the effects of different combinations of PIEB (epidural bolus volume) and PIEB (bolus volume and time interval) on labour patient-controlled epidural analgesia (PCEA) usage. In theory, the more effective the PIEB combination (the ideal drug volume and ideal time interval), the less PCEA boluses (extra epidural drug) will be used as well as less clinician boluses and less lower limb weakness (motor block) as assessed by the Bromage Score., conditionsModule conditions: Labor Pain, conditions: Obstetric Pain, conditions: Analgesia, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: We aim to use a pragmatic sequential optimization method as described by Sveticic et al. 2003. For the first round of recruitment, the research team will randomize women into 8 different groups of PIEB/PCEA regimens with six (n=6) women per group and set up the epidural pump for the maintenance of labor analgesia. This first round of recruitment will be called Complex #1. The PCEA bolus volume and lockout interval will stay the same for all groups.There will be 8 combinations of PIEB/PCEA using an epidural mixture of 0.1% levobupivacaine + 2mcg/ml Fentanyl (n=48). We will exclude the 2 worst performing groups (as assessed by our composite primary outcome). Using sequential optimization, 2 new groups with different combinations of PIEB volume / interval will be added to the remaining 6 groups. Complex 2 therefore will consist of 8 groups of 48 patients (n=6 per group). We anticipate 3 to 4 rounds of recruitment until our statistician determines the 2 best performing groups., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: TRIPLE, maskingDescription: This is a randomized double-blinded design. Patients and their attending physicians / clinical anaesthetists / data collection study member / midwives / nurses will be blinded to patient group allocation, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Levobupivacaine and Fentanyl, outcomesModule primaryOutcomes measure: The volume of local anaesthetic mixture for breakthrough pain (PCEA + clinician bolus) + the Bromage Score, secondaryOutcomes measure: Pain score, secondaryOutcomes measure: Total local anesthetic consumption, secondaryOutcomes measure: Need for supplementary epidural analgesia, secondaryOutcomes measure: Bromage score (lower limb weakness score), secondaryOutcomes measure: Type of delivery, secondaryOutcomes measure: Sensory block, secondaryOutcomes measure: Fetal Outcome, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hamad Medical Corporation (HMC), city: Doha, zip: 3050, country: Qatar, geoPoint lat: 25.28545, lon: 51.53096, hasResults: False

protocolSection identificationModule nctId: NCT06266754, orgStudyIdInfo id: OPV-IMMUNO-ADULT, briefTitle: The Non-Specific Immunological Effects of Providing Oral Polio Vaccine to Seniors in Guinea-Bissau, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-01-29, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Bandim Health Project, class: OTHER, collaborators name: Radboud University Medical Center, descriptionModule briefSummary: OPV is the live attenuated vaccine against polio virus. OPV has been key in almost eradicating polio infection. Intriguingly, OPV has been associated with lower all-cause mortality and morbidity. These beneficial OPV effects were seen in contexts with no circulating polio virus and thus have nothing to do with the specific effects of OPV against polio infection. They have been coined "non-specific effects" (NSEs). Such NSEs have also been observed for other live attenuated vaccines such as BCG vaccine and measles vaccine. The underlying immunological mechanisms are unknown. Other live vaccines with beneficial NSEs have been shown to induce epigenetic changes leading to "trained immunity". They have also been associated with decreased inflammation. In the present study it will be investigates whether OPV can induce trained immunity, reduce inflammation, and induce epigenetic modifications of the innate immune cells in senior citizens in Guinea-Bissau., conditionsModule conditions: Vaccine Reaction, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomised trial, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: A placebo will be used., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Oral polio vaccine, interventions name: Placebo, outcomesModule primaryOutcomes measure: Levels of in vitro proinflammatory cytokines such as IL1-beta, TNF-alfa and IFN-gamma after stimulation of peripheral blood mononuclear cells with non-OPV antigens and mitogens, primaryOutcomes measure: Levels of plasma markers of systemic inflammation such as TNF ligand superfamily member 12 (TWEAK) and sirtuin 2 (SIRT2), primaryOutcomes measure: Amount of pseudo-bulk ATACseq and RNAseq - indicating chromatin accessibility of interferon-stimulated genes associated with the interferon response pathway in PBMCs., primaryOutcomes measure: Proportions of immune cell subsets, eligibilityModule sex: MALE, minimumAge: 50 Years, maximumAge: 120 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bandim Health Project, Apartado 861, city: Bissau, country: Guinea-Bissau, geoPoint lat: 11.86357, lon: -15.59767, hasResults: False

protocolSection identificationModule nctId: NCT06266741, orgStudyIdInfo id: NCT093509350936, briefTitle: The Predictive Value of Lubricin in Patients With Infective Endocarditis, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-11, primaryCompletionDateStruct date: 2024-02-20, completionDateStruct date: 2026-02-20, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Aydin Adnan Menderes University, class: OTHER, descriptionModule briefSummary: The main goal of this study is to evaluate the predictability of the disease by measuring the serum lubricin levels in patients with infective endocarditis and in non-patients, conditionsModule conditions: Infective Endocarditis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Lubricin, outcomesModule primaryOutcomes measure: Valve damage indicative sign in infective endocarditis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sevil Gulasti, city: Aydın, state: Zafer, zip: 09010, country: Turkey, geoPoint lat: 37.84501, lon: 27.83963, hasResults: False

protocolSection identificationModule nctId: NCT06266728, orgStudyIdInfo id: IRB00006733, briefTitle: T30 for Astigmatism in Digital Device Users, acronym: T30FA, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-08-15, completionDateStruct date: 2024-08-18, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Southern College of Optometry, class: OTHER, collaborators name: Alcon Research, descriptionModule briefSummary: This study aims to determine if Total30 lenses for astigmatism can be successfully fit in participants who are heavy digital device users., conditionsModule conditions: Contact Lens Complication, conditions: Astigmatism, conditions: Refractive Errors, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This prospective, one-month, three-visit study will refit all participants into TOTAL30 for Astigmatism contact lenses., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Total30 for Astigmatism Contact Lenses, outcomesModule primaryOutcomes measure: Visual Analog Scale (VAS) Comfort Scores, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Kannar Eye Care, city: Pittsburg, state: Kansas, zip: 66762, country: United States, geoPoint lat: 37.41088, lon: -94.70496, locations facility: Coldwater VIsion Center, city: Coldwater, state: Mississippi, zip: 38618, country: United States, geoPoint lat: 32.71486, lon: -89.21423, hasResults: False

protocolSection identificationModule nctId: NCT06266715, orgStudyIdInfo id: NFEC-2024-070, briefTitle: Improvement of Depression With Use of ATP, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Nanfang Hospital, Southern Medical University, class: OTHER, descriptionModule briefSummary: This clinical study is a randomized, double-blind, placebo-controlled trial with an intervention period of 4 weeks. Participants will be patients with moderate to severe depression who meet the inclusion criteria during the screening period. After recruitment written informed consent form will be signed and the baseline evaluation will be done then the treatment period follows. The subjects will be randomly assigned to a control group (escitalopram plus normal saline(NA)) and an ATP group (escitalopram plus adenosine disodium triphosphate(ATP)) in a 1:1 ratio for treatment, with a total number of 120 recruited patients. Assessment will be carried out as an analysis of changes in Hamilton Depression Scale（HAMD-24）, cognitive function test, brain functional network, inflammatory markers, and other indicators in the first, second, and fourth week of intervention which will evaluate the effectiveness of ATP in improving moderate to severe depression preliminarily., conditionsModule conditions: Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: ATP Group, interventions name: Placebo Group, outcomesModule primaryOutcomes measure: HAMD-24, secondaryOutcomes measure: Diffusion Tensor Imaging, secondaryOutcomes measure: Diffusion Spectral Imaging, secondaryOutcomes measure: Quantitative susceptibility mapping, secondaryOutcomes measure: Monetary Incentive Delay Task, secondaryOutcomes measure: Emotional faces processing task, secondaryOutcomes measure: Resting state functional connectivity, secondaryOutcomes measure: Hamilton Anxiety Scale, secondaryOutcomes measure: Clinical Global Impression, secondaryOutcomes measure: Snaith-Hamilton Pleasure Scale, secondaryOutcomes measure: Insomnia Severity Index, secondaryOutcomes measure: Columbia-Suicide Severity Rating Scale, secondaryOutcomes measure: Antidepressants Side Effects, secondaryOutcomes measure: C-reactive protein, secondaryOutcomes measure: Tumor Necrosis Factor α, secondaryOutcomes measure: Interleukin- 6, secondaryOutcomes measure: N-back task, secondaryOutcomes measure: Attention network test, secondaryOutcomes measure: Psychomotor vigilance task, secondaryOutcomes measure: Hamilton Depression Scale, secondaryOutcomes measure: Montgomery and asberg Depression Rating Scale, secondaryOutcomes measure: Beck Depression Inventory, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nanfang Hospital, Southern Medical University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510515, country: China, contacts name: Qianqian Xin, role: CONTACT, phone: 17664175246, email: xinqianqian0126@163.com, geoPoint lat: 23.11667, lon: 113.25, hasResults: False

protocolSection identificationModule nctId: NCT06266702, orgStudyIdInfo id: BL71, briefTitle: Evaluation of a Nutritional Technology for Vitamin D Absorption, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Abbott Nutrition, class: INDUSTRY, descriptionModule briefSummary: This is a prospective, 2-group crossover, randomized, double-blind study to evaluate nutrient absorption., conditionsModule conditions: Nutrition, Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Experimental Oil with Phospholipids, interventions name: Control Polyunsaturated Oil Blend, outcomesModule primaryOutcomes measure: Vitamin D Absorption, secondaryOutcomes measure: Vitamin D Absorption - Peak, secondaryOutcomes measure: Vitamin D Absorption - AUC, otherOutcomes measure: Body Mass Index, otherOutcomes measure: Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Walsh University, city: North Canton, state: Ohio, zip: 44720, country: United States, geoPoint lat: 40.87589, lon: -81.40234, hasResults: False

protocolSection identificationModule nctId: NCT06266689, orgStudyIdInfo id: Pro00112671, briefTitle: Project humAn dieTary daTa rEtuRN, acronym: PATTERN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Duke University, class: OTHER, descriptionModule briefSummary: This study is designed to test the effects of diet data return on human dietary patterns. The investigators' working hypothesis is that returning diet data, collected via an empirical biomarker-based assessment method, will promote participant eating behavior changes towards a more healthful diet, and that these dietary patterns may also be reflected in the structure and function of the gut microbiome and in participant health outcomes. Here, the investigators will explore this hypothesis with participants supplying stool (poop) samples that will be used to assess their diet using the investigators' DNA-biomarker based method. Participants will have their diet data returned to them, and will then supply post-intervention stool samples for dietary assessment to investigate the efficacy of diet data return in impacting subject dietary patterns and health. It is anticipated that the investigators will enroll infants, children, and adults across the age span, including infants that are currently participating in Project HOPE 1000, a longitudinal observational study of mothers and infants from pregnancy through early childhood (Pro00100000). This study represents a minimal risk to subjects; namely, the potential loss of privacy involved with study participation., conditionsModule conditions: Diet Habit, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Personalized Diet Information, outcomesModule primaryOutcomes measure: Number of participants with diet improvement, primaryOutcomes measure: Number of participants with increased dietary diversity, secondaryOutcomes measure: Number of participants with changes in the composition and function of the gut microbiome, eligibilityModule sex: ALL, maximumAge: 12 Months, stdAges: CHILD, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06266676, orgStudyIdInfo id: 202301775B1, briefTitle: Mobile Micro-course Impact on Perioperative RNs in Heart Surgery Nursing., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-04-10, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Ting-Fang Yeh, class: OTHER, descriptionModule briefSummary: The goal of this clinical trialis to compare in learning effectiveness of nurses. The main questions it aims to answer are:1. Can the "Micro-course" teaching enhance the awareness of cardiac surgery nursing among operating room nurses?2. Can the "Micro-course" teaching boost the learning motivation and engagement of operating room nurses?3. What is the satisfaction level of nurses regarding the use of "Micro-course" in cardiac surgery nursing?4. What are the relevant factors influencing the effectiveness of the "Micro-course" teaching intervention?Participants will be divided into two groups. The control group will receive online presentations, while the experimental group will engage in mobile learning combined with micro-courses. Both groups of participants will undergo instruction through asynchronous online courses., conditionsModule conditions: periOperative, conditions: Cardiac Surgical Procedures, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: micro-course, interventions name: slide presentation, outcomesModule primaryOutcomes measure: Cognitive scale, primaryOutcomes measure: motivation scale, primaryOutcomes measure: Engagement Scale, secondaryOutcomes measure: learning satisfaction, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ChangGungMH, status: RECRUITING, city: Taoyuan City, zip: 33305, country: Taiwan, contacts name: Ting-Fang Yeh, role: CONTACT, phone: +88633281200, phoneExt: 2380, email: ytf812@cgmh.org.tw, geoPoint lat: 24.95233, lon: 121.20193, hasResults: False

protocolSection identificationModule nctId: NCT06266663, orgStudyIdInfo id: 2022-13788, secondaryIdInfos id: CNTO1275IBD4012, type: OTHER, domain: Janssen Scientific Affairs, LLC, briefTitle: Social Determinants of Health, Medication Use, and Quality of Life in Inflammatory Bowel Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Montefiore Medical Center, class: OTHER, collaborators name: Icahn School of Medicine at Mount Sinai, collaborators name: Janssen Scientific Affairs, LLC, descriptionModule briefSummary: Optimizing health related-quality of life (HRQoL) for patients with inflammatory bowel disease (IBD), who often experience a relapsing disease course, is an essential component of care. Improving IBD disease control is linked to increased health-related quality of life. Even as many effective pharmacotherapies to promote disease control are available, evidence suggests that Hispanic and Non-Hispanic Black IBD patients may not receive full benefit from these therapies compared to their Non-Hispanic White counterparts. Underlying mechanisms that contribute to observed disparities in the use of IBD medical therapies are likely multifactorial. Adequate access to treatment has been implicated. Hispanic and Non-Hispanic Black IBD patients are more likely to be Medicaid-insured, and Medicaid insurance has been associated with increased emergency room visits, a proxy for sub-optimal IBD control. Medication adherence has also been proposed as a potential mediating factor. IBD therapies can be time-consuming and costly, which can pose a challenge in achieving medication adherence. While previous studies suggest Black IBD patients have lower medication adherence than Non-Hispanic White patients, it is unclear the extent to which social factors contribute to this observation. The purpose of this study is to evaluate the association between social determinants of health, medication adherence, and HRQoL among Hispanic and Non-Hispanic Black IBD patients. Understanding potentially modifiable psychosocial factors that contribute to medication adherence and HRQoL will provide targets for later intervention towards the goal of health equity., conditionsModule conditions: Inflammatory Bowel Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Survey, outcomesModule primaryOutcomes measure: IBD medication adherence, primaryOutcomes measure: Health-related quality of life (HRQoL), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Montefiore Hutchinson Campus, status: RECRUITING, city: Bronx, state: New York, zip: 10461, country: United States, contacts name: Ruby Greywoode, MD, role: CONTACT, phone: 347-671-8205, email: rgreywoode@montefiore.org, contacts name: Sheila Benitez, role: CONTACT, phone: 347-429-0253, email: sheila.benitez@einsteinmed.edu, geoPoint lat: 40.84985, lon: -73.86641, locations facility: Icahn School of Medicine at Mount Sinai, status: NOT_YET_RECRUITING, city: New York, state: New York, zip: 10029, country: United States, contacts name: Zoe Gottlieb, MD, role: CONTACT, email: Zoe.Gottlieb@mountsinai.org, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False

protocolSection identificationModule nctId: NCT06266650, orgStudyIdInfo id: 19485, briefTitle: Unilateral vs Bilateral Application of Muscle Energy Techniques in Pelvic Somatic Dysfunction, acronym: PMEOMT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: The Touro College and University System, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare the efficacy of pelvic muscle energy technique online against the traditional full length osteopathic pelvic treatment protocol. The main question it aims to answer are• Can one single pelvic muscle energy technique can correct all pelvic somatic dysfunctions (SD)?Participants will* be positioned by the physician into the area of treatment into a position of resistance, which is the restrictive barrier.* be instructed to use the targeted muscles for 3-5 seconds in the direction of ease while the physician provides a counterforce.* be instructed to stop contracting their muscles and evaluate the area for decreased tension, then repositions the patient into their new restrictive barrier.* These steps are repeated three to five times and then the dysfunction is reevaluated.Subjects diagnosed with pelvic SD will be divided into two groups. One group will be treated with traditional one and be compared with the pelvic muscle energy group., conditionsModule conditions: Pelvic Somatic Dysfunction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Subjects diagnosed with pelvic SD will be divided into two groups. One group will be treated with traditional one-sided MET, the second group will be treated with combination MET. Results of post-treatment exams will be collected and statistically analyzed., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Osteopathic Treatment Technique- Muscle Energy Treatment, outcomesModule primaryOutcomes measure: Resolution of pelvic somatic dysfunction, secondaryOutcomes measure: Anterior anatomical landmarks assessment, secondaryOutcomes measure: Posterior anatomical landmarks assessment, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06266637, orgStudyIdInfo id: P.T.REC/012/004999, briefTitle: Effect of Scoliosis-Specific Exercise on Lower Limb Biomechanics, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-03-12, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-03-15, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Delta University for Science and Technology, class: OTHER, collaborators name: Benha University, descriptionModule briefSummary: PURPOSE: To examine the effect of Physiotherapeutic Scoliosis-Specific Exercise on limb biomechanical parameters in adolescents with idiopathic scoliosis. A randomised controlled trialBACKGROUND:Adolescent idiopathic scoliosis is one of the most common orthopaedic diseases affecting the spine during adolescence. The efficacy of exercise treatment is controversial. Although evidence suggests that PSSE, which include auto-correction in 3D, integration in daily life, stabilizing the corrected posture, and patient education, could improve some outcomes, effect of PSSE on related biomechanical alterations in lower limbs have not yet been examined.HYPOTHESES:Null hypothesis There are no statistically significant effect of Physiotherapeutic Scoliosis-Specific Exercise on lower limb biomechanics in scoliotic adolescents.RESEARCH QUESTION:What are the effect of Physiotherapeutic Scoliosis-Specific Exercise on lower limb biomechanics in scoliotic adolescents.?, conditionsModule conditions: Scoliosis Idiopathic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 56, type: ACTUAL, armsInterventionsModule interventions name: Conventional Physical Therapy Program, interventions name: Physiotherapeutic Scoliosis-Specific Exercise (Schroth), outcomesModule primaryOutcomes measure: Cobb's angle, primaryOutcomes measure: Coronal balance, primaryOutcomes measure: length of the the tibia and femur, primaryOutcomes measure: tibiofemoral angle, primaryOutcomes measure: knee joint line convergence angle, primaryOutcomes measure: lower limb mechanical axis; and mechanical axis deviation, eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Delta university for science and technology, city: Gamasa, state: Dakahleya, zip: 7731168, country: Egypt, geoPoint lat: 31.44112, lon: 31.53675, hasResults: False

protocolSection identificationModule nctId: NCT06266624, orgStudyIdInfo id: Tourniquet in HHT, briefTitle: Tourniquet-Test in HHT, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2020-09-25, primaryCompletionDateStruct date: 2023-07-30, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University Hospital, Essen, class: OTHER, descriptionModule briefSummary: The Tourniquet test is used as a diagnostic procedure for thrombocytopathies and vascular diseases. Currently, there is no evidence whether this test is also positive in hereditary haemorrhagic telangiectasia (HHT), a vasculopathy. The aim of this study was to investigate whether this non-invasive test could also be used as an additional diagnostic criterion in patients with HHT., conditionsModule conditions: HHT, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 92, type: ACTUAL, armsInterventionsModule interventions name: Tourniquet Test, outcomesModule primaryOutcomes measure: number of positive Tourniquet Test results in HHT patients, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Essen, city: Essen, state: Nordrhein Westphalen, zip: 45122, country: Germany, geoPoint lat: 51.45657, lon: 7.01228, hasResults: False

protocolSection identificationModule nctId: NCT06266611, orgStudyIdInfo id: 23-0982, briefTitle: Cannabis for Palliative Care in Cancer, acronym: ARCTiC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2028-07-31, completionDateStruct date: 2028-07-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Boulder, class: OTHER, descriptionModule briefSummary: Many cancer patients suffer from pain, sleep, and mood problems and are using cannabis to relieve these symptoms. Cannabis may provide such relief but may also produce negative side effects including cognitive impairment, an especially problematic issue for cancer patients, indicating more research on cannabis use in the cancer context is required. In this endeavor, the present study seeks to compare the use of hemp-derived CBD (Cannabidiol) with and without THC (Delta-9-tetrahydrocannabinol) versus placebo on measures of sleep, pain, mood, subjective and objective cognitive functioning, and quality of life within 185 cancer patients., conditionsModule conditions: Sleep, conditions: Anxiety, conditions: Depression, conditions: Pain, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 185, type: ESTIMATED, armsInterventionsModule interventions name: fsCBD Cannabidiol, interventions name: Placebo, interventions name: bsCBD Cannabidiol, outcomesModule primaryOutcomes measure: Pain Interference, primaryOutcomes measure: Pain Intensity, primaryOutcomes measure: Pain Inventory, primaryOutcomes measure: Sleep Disturbance, primaryOutcomes measure: Sleep-Related Impairment, primaryOutcomes measure: Depression/Anxiety, primaryOutcomes measure: Fatigue, primaryOutcomes measure: Health Related Quality of Life, primaryOutcomes measure: Cognitive Function, primaryOutcomes measure: Cognitive Function, primaryOutcomes measure: Cognitive Function, primaryOutcomes measure: Cognitive Function, primaryOutcomes measure: Plasma Cannabinoids, primaryOutcomes measure: PROMIS Pain Intensity (Right Now), primaryOutcomes measure: Drug Effects, primaryOutcomes measure: Drug Effects, primaryOutcomes measure: Drug Effects - Mood, primaryOutcomes measure: Drug Effects - Cognitive, primaryOutcomes measure: Drug Effects - Cognitive, primaryOutcomes measure: Drug Effects - Cognitive, primaryOutcomes measure: Drug Effects - Blood Cannabinoids, secondaryOutcomes measure: Polypharmacy, secondaryOutcomes measure: Polypharmacy, secondaryOutcomes measure: Polypharmacy, eligibilityModule sex: ALL, minimumAge: 25 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anschutz Health Sciences Building, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: Harmony Soffer, BA, role: CONTACT, phone: 925-334-4031, email: harmony.soffer@colorado.edu, geoPoint lat: 39.72943, lon: -104.83192, hasResults: False

protocolSection identificationModule nctId: NCT06266598, orgStudyIdInfo id: EU-TF-HA-01, briefTitle: Effectiveness of Antidiabetic Treatment Applied in Childhood Obesity, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-11-17, primaryCompletionDateStruct date: 2021-08-20, completionDateStruct date: 2021-10-27, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: HÜMEYRA ACIKAN, class: OTHER, descriptionModule briefSummary: In our study, there are 33 healthy children with normal weight (control group) and 52 obese children who will be treated with metformin. To observe the efficacy of the 3-month treatment before and after metformin treatment, Zn, Zinc α-2 Glycoprotein (ZAG), Peroxisome proliferation activating receptor γ (PPARγ), Leptin (LEP) and Adiponectin (ADIPO) levels were compared, as well as anthropometric measurements and routine biochemistry tests., conditionsModule conditions: Childhood Obesity, conditions: Insulin Resistance, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: In our study, there are 33 healthy children with normal weight (control group) and 52 obese children who will be treated with metformin. To observe the efficacy of the 3-month treatment before and after metformin treatment, Zn, Zinc α-2 Glycoprotein (ZAG), Peroxisome proliferation activating receptor γ (PPARγ), Leptin (LEP) and Adiponectin (ADIPO) levels were compared, as well as anthropometric measurements and routine biochemistry tests., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 52, type: ACTUAL, armsInterventionsModule interventions name: Metformin, outcomesModule primaryOutcomes measure: Insulin resistance (HOMA-IR) level, primaryOutcomes measure: Weight loss rate, eligibilityModule sex: ALL, minimumAge: 9 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Erciyes University, city: Kayseri̇, state: Melikgazi, zip: 38030, country: Turkey, geoPoint lat: 38.73222, lon: 35.48528, hasResults: False

protocolSection identificationModule nctId: NCT06266585, orgStudyIdInfo id: HX-B-2023090, briefTitle: Clinical Deterioration in Cerebral Venous Thrombosis: A Predictive Study, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-01-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Beijing Tiantan Hospital, class: OTHER, collaborators name: Beijing Chao Yang Hospital, collaborators name: Beijing Friendship Hospital, descriptionModule briefSummary: The objective of this retrospective, prospective, multicenter cohort study is to determine the risk factors for deterioration of CVT patients after admission and establish a scoring model for risk stratification of patients. This study included two stages, the first stage was to enroll CVT patients from a single center from 2017 to 2022 for modeling, and the second stage was to enroll CVT patients from three centers in 2023 for external validation, conditionsModule conditions: Cerebral Venous Thrombosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 273, type: ACTUAL, outcomesModule primaryOutcomes measure: Number of Participants with CVT deteriorated on radiology, primaryOutcomes measure: Number of Participants with altered neurological function, primaryOutcomes measure: Number of Participants with altered consciousness, secondaryOutcomes measure: Neurological function at 30th day after onset (mRS), secondaryOutcomes measure: Emergency surgery rates, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Capital Medical University Affiliated Beijing Tiantan Hospital, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False

protocolSection identificationModule nctId: NCT06266572, orgStudyIdInfo id: 1R43DA055182-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R43DA055182-01, briefTitle: Overcoming Stigma and Improving Outcomes for SUDs Through Education, Engagement, and Empowerment, acronym: OASIS, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-09-30, primaryCompletionDateStruct date: 2023-09-29, completionDateStruct date: 2023-09-29, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Center for Social Innovation, Massachusetts, class: OTHER, descriptionModule briefSummary: C4 Innovations (C4) and partners at Yale University (Yale) and the West Haven VA Medical Center (WHVA) proposed to develop and test OASIS (Overcoming and Addressing Stigma in Substance Use Disorders), a web-based educational platform for primary care clinicians and individuals with Opioid Use Disorder. The major aims of the study were to:1. Develop a prototype of OASIS for patients with Opioid Use Disorder (OUD) and primary care clinicians; conduct usability testing.2. Pilot OASIS with a small sample of individuals with untreated OUD and their clinicians to determine feasibility, acceptability, and preliminary product effectiveness for a Phase II effectiveness trial.After development of the prototype, the C4-Yale-WHVA team planned to test OASIS with patients (N = 30) and clinicians (N = 5) using validated measures and qualitative interviews to assess usability, satisfaction, knowledge, empowerment, and stigma., conditionsModule conditions: Opioid Use Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 19, type: ACTUAL, armsInterventionsModule interventions name: Overcoming and Addressing Stigma in Substance Use Disorders (OASIS), outcomesModule primaryOutcomes measure: Open Minds Scale for Health Care Providers, primaryOutcomes measure: Brief Opioid Stigma Scale, primaryOutcomes measure: Perceived Stigma of Addiction Scale, primaryOutcomes measure: Knowledge Check, primaryOutcomes measure: System Usability Scale, primaryOutcomes measure: Internalized Stigma of Mental Illness Scale, primaryOutcomes measure: Recovery Empowerment Scale, primaryOutcomes measure: Mental Health Seeking Attitudes Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: West Haven VA Medical Center, city: West Haven, state: Connecticut, zip: 06516, country: United States, geoPoint lat: 41.27065, lon: -72.94705, hasResults: False

protocolSection identificationModule nctId: NCT06266559, orgStudyIdInfo id: 202101896A3, briefTitle: Efficacy Evaluation of Chang Geng Healthy Drink on Patients With Non-alcoholic Fatty Liver Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-03-20, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Chang Gung Memorial Hospital, class: OTHER, descriptionModule briefSummary: For non-alcoholic fatty liver disease, there is currently no effective treatment options. Traditional Chinese medicine (TCM) has a long history of treating liver diseases. However, TCM treatment methods are diverse, and there is currently a lack of high-quality clinical research to confirm the efficacy of Chinese herbal medicine. Thereafter, Chang-Gung Healthy Drink which is a TCM based healthy drink may be used to alleviate the clinical adverse event of non-alcoholic fatty liver disease patients., conditionsModule conditions: Non-Alcoholic Fatty Liver Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Chang Geng Healthy Drink, outcomesModule primaryOutcomes measure: Fatigue Visual Analogue Scale - Current fatigue level, primaryOutcomes measure: Fatigue Visual Analogue Scale - Other daily specific task fatigue level, primaryOutcomes measure: Laboratory Data (Linver Function Index), primaryOutcomes measure: Liver stiffness measurement (kPa), primaryOutcomes measure: Controlled attenuation parameter (dB/m), secondaryOutcomes measure: Number of Participants With Clinical Significant Adverse Avent (Safety Measures), eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06266546, orgStudyIdInfo id: CRYOTXA, briefTitle: Prophylactic Endobronchial Tranexamic Acid to Reduce Bleeding in Transbronchial Cryobiopsy, acronym: CRYOTXA, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Ascension Via Christi Hospitals Wichita, Inc., class: OTHER, descriptionModule briefSummary: Transbronchial cryobiopsies are common procedures used to obtain tissue samples from airways for diagnostic purposes. While these procedures are safe, there is a risk of bleeding from the biopsy site. We are conducting a research study to assess the safety and effectiveness of using tranexamic acid prior to undergoing a transbronchial cryobiopsy., conditionsModule conditions: Hemorrhage Lung, conditions: Endobronchial Mass, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: The study will be a prospective, single-arm, non-randomized trial, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Tranexamic acid, outcomesModule primaryOutcomes measure: Major Hemorrhage, secondaryOutcomes measure: Early termination of the procedure due to bleeding, secondaryOutcomes measure: Rate of intermediate hemorrhage, secondaryOutcomes measure: Rate of minor hemorrhage, secondaryOutcomes measure: Inadequate tissue sampling due to bleeding, secondaryOutcomes measure: Graded use of other measures to control bleeding (not prophylactic), secondaryOutcomes measure: Unplanned hospital admission for bleeding complications, secondaryOutcomes measure: Acute cardiovascular side effects, secondaryOutcomes measure: All cause 28 day mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ascension Via Christi, city: Wichita, state: Kansas, zip: 67214, country: United States, geoPoint lat: 37.69224, lon: -97.33754, hasResults: False