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protocolSection identificationModule nctId: NCT06384872, orgStudyIdInfo id: 230042_RRI_Interv5, briefTitle: Effect of Shoe Cushioning Position and Properties on Running-related Injury Risk, acronym: RRI_Interv5, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-01, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Luxembourg Institute of Health, class: OTHER_GOV, collaborators name: DECATHLON SA, descriptionModule briefSummary: The main purpose of this project is to investigate the influence of cushioning material at both the rear and the forepart of running shoes on musculoskeletal complaints in leisure-time runners. Therefore, the objectives are to investigate if1. "Extra soft" cushioning materials can reduce injury risk compared to stiffer materials;2. Cushioning under the forepart of the shoe also influences injury risk, independently of the cushioning at the rear part;3. Effects of cushioning material and position depend on the runner's body mass;4. Perception of cushioning is related to both shoe cushioning and injury risk;5. Other weight-bearing locomotion activities (i.e., number of steps per day besides running practice) represents an independent risk factor for running-related injury.This study consists in a 6-month intervention trial during which leisure-time runners are required to follow their usual training schedule. Before the beginning of the study, the participants will receive a pair of running shoes. The three running shoe models will be exactly the same, except for their foam properties at the rear and forepart of the shoe, which will differ by 33 and 37%, respectively. The study shoes will be administered through random allocation. The participants will be required to use these shoes for all running sessions, and only for running activities.Participants will first fill out a baseline questionnaire. During the intervention, data on running practice will be downloaded from sports watches and their respective app via Strava. Information on the use of the study shoes will be collected via a weekly questionnaire. Participants will be asked to fill out a weekly questionnaire on any musculoskeletal complaints experienced during the past 7 days. A questionnaire on the perception of cushioning will be filled in by the participants at three time points (after 5h of running, 25h of running, and at the end of follow-up).Primary hypothesis:- Greater shock absorption properties at the rear part of running shoes are associated with a lower injury risk in recreational runners.Secondary hypothesis:* Greater shock absorption properties under the forepart of the shoe are also associated with lower injury risk in recreational runners.* Runners with low body mass experience a lower injury risk in shoes with greater shock absorption properties.* Greater perceived cushioning is related to lower injury risk., conditionsModule conditions: Running-related Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, maskingDescription: Participants will be stratified according to their sex. Two pre-established randomization list will be prepared by a statistician not involved in any other part of the study before the beginning of the study. To ensure allocation concealment, the study groups as well as the shoes will be coded and the randomization lists will be uploaded in the electronic system by an IT specialist who will not be involved in any other part of the study. The electronic system will provide the investigator with a study group code for each participant, according to the randomization lists. The investigator will upload the shoe ID according to shoe size and study group so that a cross validation will be performed by the electronic system. The investigators in charge of the recruitment, follow-up and data validity check, as well as the participants, will be blinded regarding the shoe version distributed. The shoe code will be broken after completion of data analysis., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1068, type: ESTIMATED, armsInterventionsModule interventions name: Shoe Cushioning Position and Properties, outcomesModule primaryOutcomes measure: First running-related injury with a duration of minimum one week, secondaryOutcomes measure: First one-day time loss running-related injury, secondaryOutcomes measure: First running-related musculoskeletal complaint to the lower limb, secondaryOutcomes measure: First substantial running-related injury, secondaryOutcomes measure: First overuse running-related injury, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Luxembourg Institute of Health, city: Strassen, zip: 1445, country: Luxembourg, contacts name: Laetitia Garcia, Msc, role: CONTACT, phone: +352 26970957, email: Laetitia.Garcia@lih.lu, geoPoint lat: 49.62056, lon: 6.07333, hasResults: False

protocolSection identificationModule nctId: NCT06384859, orgStudyIdInfo id: Pending, briefTitle: Effectiveness of Extracorporeal Shockwave Therapy Combined With Platelet-rich Plasma in the Treatment of Chronic Insertional Achilles Tendinopathy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-05-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Mahidol University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn about the effectiveness of extracorporeal shockwave(ESWT) combined with platelet-rich plasma(PRP) to treat chronic insertional tendinopathy. The main questions it aims to answer are:Does ESWT combined with PRP treatment reduce the symptom and improve functional score after treatment? What medical complication do participants have when receive the treatment?Researchers will compare ESWT combined with PRP to ESWT treatment alone to see if ESWT combined with PRP works to treat chronic insertional tendinopathy.Participants will:* Receive ESWT once a week for 4 weeks then receive PRP injection at a week later or ESWT once a week for 4 weeks* Visit the clinic at 6 weeks, 3 months, 6 months and 1 year after treatment for checkups and record functional score, conditionsModule conditions: Insertional Achilles Tendinopathy, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 94, type: ESTIMATED, armsInterventionsModule interventions name: ESWT, interventions name: PRP, outcomesModule primaryOutcomes measure: VAS, secondaryOutcomes measure: VAS-FA, secondaryOutcomes measure: FFI, secondaryOutcomes measure: FAAM, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ramathibodi hospital, city: Ratchathewi, state: Bangkok, zip: 10400, country: Thailand, contacts name: Prapan Wongrungrote, MD, role: CONTACT, phone: +66 0810688654, email: prapanw197@gmail.com, contacts name: Sukij Laohajaroensombat, MD, role: CONTACT, phone: +66 022011589, email: sukij.lah@mahidol.ac.th, geoPoint lat: 13.759, lon: 100.53358, hasResults: False

protocolSection identificationModule nctId: NCT06384846, orgStudyIdInfo id: AI ACS, briefTitle: AI Algorithms in Prediction of ACS Based on Leukocyte Properties, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2026-07-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: RobotDreams GmbH, class: INDUSTRY, descriptionModule briefSummary: The goal of this observational study is to find out if artificial intelligence (AI) can accurately predict acute coronary syndrome (ACS) using data on white blood cells in adults. The main question it aims to answer is:- Can AI algorithms based on white blood cell data predict ACS with accuracy comparable to that of high-sensitivity cardiac troponin (hs-cTn)? Researchers will look at how the AI model's predictions stack up against the standard hs-cTn blood tests to see which is more accurate in diagnosing ACS.Participants in this study will have already had blood tests as part of their usual care. Their previously collected health information and blood test results will be used to help train and test the AI algorithms. Participants will not undergo any new procedures for the study itself., conditionsModule conditions: Acute Coronary Syndrome, conditions: Angina Pectoris, conditions: NSTEMI - Non-ST Segment Elevation MI, conditions: STEMI - ST Elevation Myocardial Infarction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 2700, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Training of AI models, primaryOutcomes measure: Testing of AI models, secondaryOutcomes measure: Training of AI models, secondaryOutcomes measure: Testing of AI models:, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Landeskrankenhaus-Universitätsklinikum Graz, status: RECRUITING, city: Graz, state: Styria / Steiermark, zip: 8036, country: Austria, contacts name: Heiko Bugger, MD, role: CONTACT, phone: +43 316 385 30177, email: heiko.bugger@medunigraz.at, geoPoint lat: 47.06667, lon: 15.45, hasResults: False

protocolSection identificationModule nctId: NCT06384833, orgStudyIdInfo id: Rama, briefTitle: Combination of Vitamin C and N-Acetylcysteine to Improve Functional Outcome After Rotator Cuff Repair, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Mahidol University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn if vitamin C and N-acetylcysteine work to improve shoulder functional score after rotator cuff repair. It will also learn about the safety of vitamin C and N-acetylcysteine. The main questions it aims to answer are:Do vitamin C and N-acetylcysteine improve the shoulder functional score of participants? Do vitamin C and N-acetylcysteine improve healing of rotator tendon? Researchers will compare vitamin C and N-acetylcysteine to a placebo (a look-alike substance that contains no drug) to see if vitamin C and N-acetylcysteine works to improve shoulder functional score after rotator cuff repair.Participants will:Take vitamin C and N-acetylcysteine or a placebo every day for 45 days. Visit the OPD three times at 2 week, 6 month and 12 month after surgery for checkups and tests., conditionsModule conditions: Rotator Cuff Tears, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Ascorbic acid, interventions name: N-acetyl cysteine, interventions name: placebo, outcomesModule primaryOutcomes measure: ASES score, secondaryOutcomes measure: UCLA shoulder scale, secondaryOutcomes measure: WORC index, secondaryOutcomes measure: Tendon healing at 6 months postoperatively, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06384820, orgStudyIdInfo id: R3767-ONC-2330, secondaryIdInfos id: 2023-510514-38-00, type: REGISTRY, domain: EU CT Number, briefTitle: Study of Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Adult Participants With Peri-operative Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-11-14, primaryCompletionDateStruct date: 2026-06-08, completionDateStruct date: 2030-05-06, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Regeneron Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: This study is researching an investigational drug called REGN2810, also known as cemiplimab, when combined with another investigational drug called REGN3767, also known as fianlimab (each individually called a "study drug" or called "study drugs" when combined). The study is focused on a type of skin cancer known as cutaneous squamous cell carcinoma (CSCC).The aim of the study is to see if cemiplimab or cemiplimab in combination with fianlimab can eliminate or reduce the number of living cancer cells in tumor(s) if taken before surgery.The study is looking at several other research questions, including:* Whether taking cemiplimab or cemiplimab in combination with fianlimab before surgery may make it possible to have a less extensive surgery or a different treatment plan after surgery* Whether taking cemiplimab or cemiplimab in combination with fianlimab before surgery may make the cancer less likely to come back after surgery* What side effects may happen from taking the cemiplimab or cemiplimab in combination with fianlimab* How much of the cemiplimab or cemiplimab in combination with fianlimab is in the blood at different times* Whether the body makes antibodies against the study drug(s) (which could make the drug(s) less effective or could lead to side effects), conditionsModule conditions: Cutaneous Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: cemiplimab, interventions name: fianlimab, outcomesModule primaryOutcomes measure: Pathological complete response (pCR) rate by blinded independent pathological review (BIPR), secondaryOutcomes measure: pCR rate by local pathological review, secondaryOutcomes measure: Major pathological response (MPR), secondaryOutcomes measure: Event-free survival (EFS), secondaryOutcomes measure: Disease free survival (DFS), secondaryOutcomes measure: Objective response rate (ORR) prior to surgery, secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Occurrence of treatment-emergent adverse events (TEAEs), secondaryOutcomes measure: Occurrence of immune-mediated adverse events (imAEs), secondaryOutcomes measure: Occurrence of treatment-related TEAEs, secondaryOutcomes measure: Occurrence of adverse event of special interest (AESI), secondaryOutcomes measure: Occurrence of treatment-emergent serious adverse events (SAEs), secondaryOutcomes measure: Occurrence of laboratory abnormalities, secondaryOutcomes measure: Occurrence of death due to TEAE, secondaryOutcomes measure: Occurrence of interruption of study drug(s) due to TEAEs, secondaryOutcomes measure: Occurrence of discontinuation of study drug(s) due to TEAEs, secondaryOutcomes measure: Occurrence of cancellation of surgery due to TEAE, secondaryOutcomes measure: Occurrence of delay to surgery due to TEAE, secondaryOutcomes measure: Concentrations of cemiplimab in serum, secondaryOutcomes measure: Concentrations of fianlimab in serum, secondaryOutcomes measure: Concentrations of other experimental agents (as applicable) in serum, secondaryOutcomes measure: Incidence of anti-drug antibodies (ADA) to cemiplimab, secondaryOutcomes measure: Incidence of ADA to fianlimab, secondaryOutcomes measure: Incidence of ADA to other experimental agents (as applicable), secondaryOutcomes measure: Titer of ADA to cemiplimab, secondaryOutcomes measure: Titer of ADA to fianlimab, secondaryOutcomes measure: Titer of ADA to other experimental agents (as applicable), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06384807, orgStudyIdInfo id: BHV1510-101 (PBI-410-101), briefTitle: A Phase 1/2 Study of PBI-410 in Advanced Solid Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-02, completionDateStruct date: 2028-02, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Pyramid Biosciences, class: INDUSTRY, descriptionModule briefSummary: This is a Phase 1/2, first in human (FIH), open-label, multicenter study of PBI-410 in participants with previously treated, advanced solid tumors., conditionsModule conditions: Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SEQUENTIAL, interventionModelDescription: Dose escalation followed by enrollment in signal-finding cohorts., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 170, type: ESTIMATED, armsInterventionsModule interventions name: PBI-410, outcomesModule primaryOutcomes measure: Phase 1: Number of patients with adverse events (AEs), primaryOutcomes measure: Phase 1: Recommended dose for expansion (RDE) and maximum tolerated dose (MTD), primaryOutcomes measure: Phase 2: Objective Response Rate (ORR), primaryOutcomes measure: Phase 2: Number of patients with AEs, primaryOutcomes measure: Phase 2: Duration of Response (DoR), secondaryOutcomes measure: Phase 1 and 2: Maximum Plasma Concentration (Cmax) of PBI-410, secondaryOutcomes measure: Phase 1 and 2: Area Under the Concentration versus time Curve (AUClast) from the end of infusion to the last measurable concentration of PBI-410, secondaryOutcomes measure: Phase 1 and 2: Area Under the Concentration versus time curve extrapolated to infinity (AUCinf), secondaryOutcomes measure: Phase 1 and 2: Elimination half-life (t1/2) of PBI-410 in plasma, secondaryOutcomes measure: Phase 1: ORR, secondaryOutcomes measure: Phase 1: Duration of Response (DoR), secondaryOutcomes measure: Phase 1 and 2: Immunogenicity of PBI-410, secondaryOutcomes measure: Phase 2: Disease control rate (DCR), secondaryOutcomes measure: Phase 2: Progression free survival (PFS), secondaryOutcomes measure: Phase 2: Overall survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06384794, orgStudyIdInfo id: 2211-VLC-157-MD, briefTitle: Study of the ZyMōt Sperm Selection Method and Its Effect on Embryo Ploidy., acronym: ZYMOT2, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-29, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Instituto Valenciano de Infertilidad, IVI VALENCIA, class: OTHER, collaborators name: IVI Madrid, descriptionModule briefSummary: It has been described that 11% of men with semen values within the normal range established by the World Health Organization (WHO) have sperm DNA fragmentation. This has been associated with a lower fertilization rate, lower embryo development and, therefore, lower reproductive success. Focusing on the study of the integrity of the male genome can provide us information to diagnose infertility in the couple. The use of conventional sperm selection methods such as swim-up or density gradients has been a great advance in the improvement of male fertility. However, these methods use centrifugation in their protocol, a procedure that has been associated with sperm DNA damage. The ZyMōt is a chip based on microfluidic properties that allows the recovery of spermatozoa with lower DNA fragmentation rate without centrifugation of the semen sample. This new sperm selection method maintains all the advantages of conventional techniques, but decreasing DNA fragmentation associates to sperm recoveries techniques eventually improving reproductive rates. This quality would be beneficial for patients with unexplained infertility, recurrent pregnancy loss or clinical varicocele, factors that have been associated with a higher index of DNA fragmentation. However up to date there is evidence-based data supporting such improvement. The main objective of the present project is to evaluate the ZyMōt as a new non-invasive sperm selection device and to see its impact on the euploidy rate, comparing it with a sperm selection technique that is routinely used in the clinic: swim-up. At the same time, the effect that this new chip may have on sperm and other reproductive variables will be analyzed clinically, and molecularly with immunohistochemical and transcriptomic analyses in order to observe the impact of SDF(sperm DNA fragmentation) at the molecular and genomic level in oocytes with low reparative potential oocytes., conditionsModule conditions: Infertility, Male, conditions: Sperm Count, Low, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multicentric, prospective, experimental study., primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, maskingDescription: Embryologists performing IVF/ICSI are blinded to the treatment the sample has undergone. All samples are labeled with the patients Identification number. This is a unique code per patient that does not allow identification of which arm the sample belongs to., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Sperm capacitation through the ZyMōt®Sperm Separation Device®, interventions name: Swim-up, outcomesModule primaryOutcomes measure: EUPLOIDY RATE, secondaryOutcomes measure: MOBILITY RATE, secondaryOutcomes measure: VITALITY RATE, secondaryOutcomes measure: DNA FRAGMENTATION RATE, secondaryOutcomes measure: SPERM RETRIEVAL RATE, secondaryOutcomes measure: FERTILIZATION RATE, secondaryOutcomes measure: USEFUL BLASTOCYS RATE, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ivirma Madrid, status: RECRUITING, city: Madrid, zip: 28023, country: Spain, contacts name: MONICA TORIBIO, role: CONTACT, phone: +34 651 79 10 00, email: IVESMADRID@IVIRMA.COM, contacts name: Alberto Pacheco, PhD, role: SUB_INVESTIGATOR, contacts name: Lucía Sánchez, MSc, role: SUB_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Ivirma Valencia, status: RECRUITING, city: Valencia, zip: 46015, country: Spain, contacts name: Maria Jose Delossantos, PhD, role: CONTACT, phone: 34963050900, email: mariajose.delossantos@ivi.es, contacts name: Laura Caracena, Mrs, role: CONTACT, phone: 34963050900, phoneExt: 11054, email: laura.caracena@ivirma.com, contacts name: Maria Jose Delossantos, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: José María Delosantos, PhD, role: SUB_INVESTIGATOR, contacts name: Angel Martín, MSc, role: PRINCIPAL_INVESTIGATOR, contacts name: David Ortega, MSs, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.46975, lon: -0.37739, hasResults: False

protocolSection identificationModule nctId: NCT06384781, orgStudyIdInfo id: 2130836, secondaryIdInfos id: R61DA059892-01, type: NIH, link: https://reporter.nih.gov/quickSearch/R61DA059892-01, briefTitle: Development, Refinement, and Validation of a Peer Support Specialist Checklist for Individuals With Opioid Use Disorder / STAMPS: South Carolina Buprenorphine Treatment Initiation, Adherence, and Retention Utilizing Mobile Health Units and Peer Support Specialists, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Prisma Health-Upstate, class: OTHER, collaborators name: Clemson University, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: This study seeks to develop a tool to better guide and operationalize peer recovery coaching service delivery specifically for patients with opioid use disorder. This study will entail the initial development, acceptability, and validity of this tool in a sample of both peer support specialists (PSSs) and patients with opioid use disorder (OUD). This checklist will be adapted from ACE model PSS interventions for SUD broadly. Open-ended qualitative research questions regarding PSSs roles and responsibilities, patients' needs for recovery support, and perceptions of the checklist will be administered. Participants (PSSs and individuals with OUD) will also answer survey questions in which they indicate their satisfaction and likely to use the tool with the proposed services offered in the checklist. Outcome measures include satisfaction, perceived use of use, and perceived helpfulness of the checklist. We hypothesize that using both PSS and patient input will result in a validated intervention protocol with demonstrated acceptability using it with patients with OUD., conditionsModule conditions: Opioid Use Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Phase 1: Conceptualization, primaryOutcomes measure: Phase 2: Conceptulization, primaryOutcomes measure: Phase 3: Refinement, primaryOutcomes measure: Phase 4: Validation, primaryOutcomes measure: Phase 5: Preliminary efficacy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prisma Addiction Medicine Center - Mobile Health Clinic, status: RECRUITING, city: Clinton, state: South Carolina, zip: 29325, country: United States, contacts name: Marisol A Miranda, BS, role: CONTACT, phone: 864-501-9693, email: marisol.miranda@prismahealth.org, contacts name: Kaileigh A Byrne, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.47263, lon: -81.88066, locations facility: Prisma - Addiction Medicine Center Mobile Health Clinic, status: RECRUITING, city: Seneca, state: South Carolina, zip: 29672, country: United States, contacts name: Marisol A Miranda, BS, role: CONTACT, phone: 864-501-9693, email: marisol.miranda@prismahealth.org, contacts name: Kaileigh A Byrne, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.68566, lon: -82.9532, hasResults: False

protocolSection identificationModule nctId: NCT06384768, orgStudyIdInfo id: EBIst, secondaryIdInfos id: 1919B012104428, type: OTHER_GRANT, domain: TUBITAK, briefTitle: Video Training on Pre-Pregnancy Fear of Birth in Male Partners, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-02-01, primaryCompletionDateStruct date: 2022-05-01, completionDateStruct date: 2022-08-30, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Istanbul University - Cerrahpasa (IUC), class: OTHER, descriptionModule briefSummary: This study aimed to evaluate the effect of an online video training on fears surrounding childbirth given to male partners before the pregnancy of their spouses. The study conducted with 43 male (22 intervention; 21 control) participants. Participants were divided into intervention and control groups. The intervention group was given video training on pregnancy and the birth process. \"Descriptive Information Form\" and the "Male-Childbirth Fear Prior to Pregnancy Scale" was used for data collection. Before the intervention, it was found that the fear level of childbirth was low. The video training given to male partners before the pregnancy of their spouses diminished the fear of birth but did not create a significant difference. These findings support long-term training that includes video tutorials for parents before birth. Interactive, participatory birth preparation training is likely to enhance the training's appeal for male partners., conditionsModule conditions: Fear of Childbirth, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 43, type: ACTUAL, armsInterventionsModule interventions name: Video training, outcomesModule primaryOutcomes measure: Fear of Childbirth, eligibilityModule sex: MALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istinye University, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False

protocolSection identificationModule nctId: NCT06384755, orgStudyIdInfo id: 645788, secondaryIdInfos id: 2022_HE2_409659, type: OTHER_GRANT, domain: The Dam Foundation, secondaryIdInfos id: 645788, type: OTHER, domain: Regional Ethics Committee (REK), South-East Norway, briefTitle: Honest Open Proud for Psychotic and Bipolar Disorder in Norway, acronym: HOP-NOR, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Oslo University Hospital, class: OTHER, collaborators name: University of Oslo, descriptionModule briefSummary: The purpose of this pilot study is to evaluate the feasibility, acceptability and efficacy of a Norwegian adaptation of the group-based intervention 'Honest Open Proud' among adults with psychotic and bipolar disorders in an outpatient setting., conditionsModule conditions: Psychotic Disorders, conditions: Bipolar Disorder, conditions: Disclosure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Honest Open Proud program, outcomesModule primaryOutcomes measure: Stigma Stress Scale (Rüsch, Corrigan, Wassel et al., 2009; Rüsch, Corrigan, Powell et al., 2009), secondaryOutcomes measure: Disclosure Distress (Rüsch et al., 2014a), secondaryOutcomes measure: Warwick and Edinburgh Wellbeing Scale (WEMWBS) (Tennant et al 2007), secondaryOutcomes measure: Satisfaction with life (Lehman, 1988), secondaryOutcomes measure: The Questionnaire about the Process of Recovery - 15 (QPR-15) (Niel et al 2007), secondaryOutcomes measure: Internalised Stigma of Mental Illness Inventory (ISMI-10) (Boyd, Otilingam, & Deforge, 2014), secondaryOutcomes measure: Patient Health Questionnaire-4 (PHQ-9) (Kroenke et al 2009), secondaryOutcomes measure: Generalized Anxiety disorder (GAD-7) (Spitzer et al, 2006), otherOutcomes measure: Disclosure, otherOutcomes measure: Feasibility of HOP program, otherOutcomes measure: Acceptability of HOP program participants, otherOutcomes measure: Acceptability of HOP peer facilitators, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nydalen DPS, Division of Mental Health and Addiction, Oslo University Hospital, status: RECRUITING, city: Oslo, zip: 0351, country: Norway, contacts name: Mari Husa, MD, role: CONTACT, phone: 0047 95837846, email: mahusa@ous-hf.no, contacts name: Magnus Engen, PhD, role: CONTACT, phone: 0047 41004660, email: UXENMF@ous.hf.no, geoPoint lat: 59.91273, lon: 10.74609, locations facility: Søndre Oslo DPS, Division of Mental Health and Addiction, Oslo University Hospital, status: NOT_YET_RECRUITING, city: Oslo, zip: 1281, country: Norway, contacts name: Hilde Daler, MSc, role: CONTACT, phone: 0047 23023100, email: uxruhi@ous-hf.no, contacts name: Marit Haram, PhD, role: CONTACT, phone: 0047 21077000, email: mharam@ous.hf.no, geoPoint lat: 59.91273, lon: 10.74609, hasResults: False

protocolSection identificationModule nctId: NCT06384742, orgStudyIdInfo id: K23HL157698, type: NIH, link: https://reporter.nih.gov/quickSearch/K23HL157698, briefTitle: Shift Worker Intervention for Sleep Health, acronym: SWISH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Oregon State University, class: OTHER, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: The aim of this study is to pilot test a comprehensive, personalized, media-augmented telehealth intervention ("SWISH") designed to improve sleep health among shift workers., conditionsModule conditions: Shift Work Type Circadian Rhythm Sleep Disorder, conditions: Insomnia, Psychophysiological, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Participants are asked to refrain from mentioning any information about the treatment they receive when interacting with the investigator or outcomes assessors. Participants are asked not to share details of their treatment with other individuals at their workplace., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Shift Worker Intervention for Sleep Health, outcomesModule primaryOutcomes measure: Retention Rate, primaryOutcomes measure: Session Attendance, primaryOutcomes measure: Implementation Assessment Measure, secondaryOutcomes measure: Patient Adherence, secondaryOutcomes measure: Therapist Fidelity, secondaryOutcomes measure: Acceptability of Study Procedures and SWISH, secondaryOutcomes measure: Mean 24-hour sleep duration and efficiency, secondaryOutcomes measure: Change in Fatigue Severity Scale, secondaryOutcomes measure: Change in Epworth Sleepiness Scale, secondaryOutcomes measure: Executive functioning, secondaryOutcomes measure: PROMIS Sleep Related Impairment, secondaryOutcomes measure: PROMIS Sleep Disturbances, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Oregon State University, city: Corvallis, state: Oregon, zip: 97331-1102, country: United States, contacts name: Jessee Dietch, PhD, role: CONTACT, phone: 541-737-1358, email: jessee.dietch@oregonstate.edu, contacts name: Jessee Dietch, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.56457, lon: -123.26204, hasResults: False

protocolSection identificationModule nctId: NCT06384729, orgStudyIdInfo id: 123, briefTitle: Effectiveness of the EXOPULSE Mollii Ⓡ Suit in Patients With Multiple Sclerosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Universidad Europea de Madrid, class: OTHER, descriptionModule briefSummary: Abstract:Background:Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system with unknown etiology, causing a variety of symptoms including impaired balance, coordination, and walking difficulties. The Exopulse Mollii Ⓡ suit is an innovative approach for non-invasive, self-administered electrical stimulation designed to alleviate spasticity and improve motor function in various neurological conditions.Objective:To determine the effectiveness of the Exopulse Mollii Ⓡ suit in improving motor control in patients with MS.Methods:A randomized, double-blind clinical trial will be conducted, recruiting patients diagnosed with MS, aged 18 or above, with a Functional Ambulation Category (FAC) score between 2 and 4. Patients will be randomly assigned to two groups receiving either inactive or active Exopulse Mollii Ⓡ treatment for 60 minutes, three times a week, for three weeks. Outcome measures include pain, balance, gait speed, risk of falls, perception of walking difficulties, and quality of life assessed using validated scales. Statistical analysis will be performed using SPSS v.29.0.0.0.Results:Data on age, sex, weight, and MS-related factors will be collected at baseline. Primary outcomes include changes in pain, balance, and gait speed, while secondary outcomes encompass risk of falls, perception of walking difficulties, and quality of life. Analysis will compare mean differences between groups using appropriate statistical tests.Conclusion:This study aims to evaluate the efficacy of the Exopulse Mollii Ⓡ suit in enhancing motor function in MS patients. Findings may contribute to the development of novel therapeutic strategies for managing MS-related symptoms and improving patients' quality of life., conditionsModule conditions: Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: A randomized, double-blind clinical trial is proposed, in which two researchers will conduct the intervention, and a third researcher will be responsible for programming the suits and attaching the belt to the suit. The data will be analyzed by a fourth researcher., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: EXOPULSE Mollii Ⓡ, outcomesModule primaryOutcomes measure: referred pain, primaryOutcomes measure: Balance, primaryOutcomes measure: gait speed and distance, secondaryOutcomes measure: fall risk, secondaryOutcomes measure: perception of walking difficulties, secondaryOutcomes measure: perceived quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cecilia Estrada Barranco, status: RECRUITING, city: Villaviciosa De Odón, state: Madrid, zip: 28670, country: Spain, contacts name: Cecilia Estrada Barranco, PhD, role: CONTACT, phone: 686166483, email: cecilia.estrada@universidadeuropea.es, geoPoint lat: 40.35692, lon: -3.90011, hasResults: False

protocolSection identificationModule nctId: NCT06384716, orgStudyIdInfo id: CEB, briefTitle: Evaluation of the Influence of a Core Muscle Control-Based Rehabilitation Program Patients With Multiple Sclerosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Universidad Europea de Madrid, class: OTHER, descriptionModule briefSummary: Given the structural relationship of the CORE as a whole, in this study we propose an intervention based on the global motor control of all the structures that make up the CORE to assess its effectiveness on urinary incontinence, sexual dysfunction and balance, as well as its relationship with respiratory function. According to our hypothesis, a global intervention could also be taken into account during conventional treatment in the future, helping to prevent genitourinary dysfunctions derived from alterations in motor control., conditionsModule conditions: Multiple Sclerosis, conditions: Pelvic Floor Disorders, conditions: Incontinence, Urinary, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a randomised clinical trial. The research will be conducted in accordance with the framework of application of the Helsinki declaration (21) and the law on Personal Data Protection and guarantee of digital rights (Organic Law 3/2018) . The design of this project will follow the definition of the standard elements of a clinical trial protocol: SPIRIT declaration, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: rehabilitation programme based on motor control of core muscles, outcomesModule primaryOutcomes measure: Difference in the percentage of initial and final maximum activity of the pelvic floor muscles., primaryOutcomes measure: - Differences between the initial and final thickness of the oblique abdominis and transverse oblique muscles by ultrasound., primaryOutcomes measure: - Differences in the assessment of health-related quality of life before and after the intervention measured with the I-QOL questionnaire., primaryOutcomes measure: - Differences in the assessment of female UI before and after intervention using the I-CIQ questionnaire, secondaryOutcomes measure: - Difference in the percentage of initial and final maximum activity of the paravertebral musculature activity., secondaryOutcomes measure: - Differences between initial and final amplitude of initial and final diaphragmatic excursion by ultrasound., secondaryOutcomes measure: - Difference between initial and final FVC/- Differences between the initial and final peak expired volume (FEV1), secondaryOutcomes measure: differences between peak expiratory pressure (PEM) and minimum initial and end inspiratory pressure (MIP)., secondaryOutcomes measure: balance, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cecilia Estrada Barranco, status: RECRUITING, city: Madrid, country: Spain, contacts name: Cecilia Estrada-Barranco, PhD, role: CONTACT, phone: 686166483, email: cecilia.estrada@universidadeuropea.es, contacts name: Esther Delgado, PhD, role: CONTACT, email: esther.delgado@universidadeuropea.es, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False

protocolSection identificationModule nctId: NCT06384703, orgStudyIdInfo id: 201518015, briefTitle: The Relationship Between Microbiota and Coronary Ectasia, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-11-03, primaryCompletionDateStruct date: 2021-04-25, completionDateStruct date: 2021-06-18, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Konya Beyhekim Training and Research Hospital, class: OTHER_GOV, collaborators name: Necmettin Erbakan University, descriptionModule briefSummary: Introduction: It is now known that the microbiota is far beyond the microbial communities living in certain parts of our body and functions like a metabolic organ. In addition, the microbiota, through its metabolites, is involved in the pathophysiology or progression of a wide range of diseases, from atherosclerotic diseases to metabolic diseases and even neurological diseases. Among these metabolites, trimethylamine n-oxide metabolite has been shown to be particularly effective on atherosclerotic heart diseases., conditionsModule conditions: Coronary Ectasia, conditions: Microbial Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 2, type: ACTUAL, armsInterventionsModule interventions name: Taking blood for kit study, outcomesModule primaryOutcomes measure: death, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Necmettin Erbakan University, city: Konya, zip: 42050, country: Turkey, geoPoint lat: 37.87135, lon: 32.48464, hasResults: False

protocolSection identificationModule nctId: NCT06384690, orgStudyIdInfo id: 4331899, briefTitle: Generating Health Evidence From Dietary Supplementation With a Micro-vegetable Blend, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2025-08-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University of Exeter, class: OTHER, collaborators name: Advanced Growers Limited, collaborators name: Ecog Pro Limited, descriptionModule briefSummary: Micro-vegetables (MV) are seedlings of larger vegetables. They can be grown quickly and are a concentrated source of micronutrients. MV are thought to have broad health benefits, including many inflammatory conditions. These include metabolic, cardiovascular, and cognitive diseases. This could have important implications for the health of an ageing UK population. Less than a third of British adults consume 5 portions of fruit and vegetables per day; this is the level that reduces risk of morbidity and mortality. Vegetables, including MV may - at least in part - exert their health effects by changing the level and type of bacteria in the mouth and gut. Despite their promise, the MV scientific literature is not yet extensive enough to support definitive health claims. It requires the addition of high-quality studies that are relevant to humans. This study will firstly investigate the anti-inflammatory effects on skeletal muscle and adipose tissue in older adults, using a proteomics approach. Second, this study will assess concentrations of circulating inflammatory markers in the sera collected from participants at baseline and at the conclusion of a 6-week period. Further, this study will describe the effects of six weeks MV consumption on cognition, and the oral and gut microbiome. As the bioactive compounds in the MV are owed to the potential beneficial effects for human health, these will be characterised in sera collected from participants., conditionsModule conditions: Inflammation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Micro-vegetable blend, interventions name: Placebo, outcomesModule primaryOutcomes measure: Tandem Mass Tag (TMT) global proteomics, secondaryOutcomes measure: Concentration of broad panel of inflammatory cytokines, secondaryOutcomes measure: Concentration of circulating bioactive components, secondaryOutcomes measure: Microbiome, secondaryOutcomes measure: Simple Reaction Time, secondaryOutcomes measure: Digit Vigilance, secondaryOutcomes measure: Choice Reaction Time, secondaryOutcomes measure: Pattern Separation, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Public Health and Sports Sciences, University of Exeter, status: RECRUITING, city: Exeter, state: Devon, zip: EX1 2LU, country: United Kingdom, contacts name: Cealan Henry, role: CONTACT, email: c.henry3@exeter.ac.uk, geoPoint lat: 50.7236, lon: -3.52751, hasResults: False

protocolSection identificationModule nctId: NCT06384677, orgStudyIdInfo id: 03.03.2023/371, briefTitle: Comparison of Postoperative Analgesia Methods in Patients Undergoing Major Intraabdominal Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-04-20, primaryCompletionDateStruct date: 2024-02-01, completionDateStruct date: 2024-02-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Marmara University, class: OTHER, descriptionModule briefSummary: This study aims to examine the effects of M-TAPA applied for postoperative analgesia in patients who had major intraabdominal surgery on the postoperative pain score, the change in the postoperative total opioid requirement and the side effects., conditionsModule conditions: Abdominal Cancer, conditions: Abdomen Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 43, type: ACTUAL, armsInterventionsModule interventions name: M-Tapa Block, outcomesModule primaryOutcomes measure: Opioid Consumption, secondaryOutcomes measure: NRS Scores, secondaryOutcomes measure: the need for rescue analgesia, secondaryOutcomes measure: side effects, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Marmara University Pendik Research and Training Hospital, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False

protocolSection identificationModule nctId: NCT06384664, orgStudyIdInfo id: HUM00241242, briefTitle: Cryoablation Effects on Acute and Chronic Pain After Thoracotomy and Thoracoscopy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2028-04, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University of Michigan, class: OTHER, collaborators name: AtriCure, Inc., descriptionModule briefSummary: The researchers will compare the common methods of post-surgical pain control, such as epidural or intercostal nerve block with a newer method called cryoablation. The research team is conducting this study to determine if cryoablation provides more effective pain control when compared to an epidural or intercostal nerve block., conditionsModule conditions: Pain, Postoperative, conditions: Intrathoracic Procedure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Atricure's crysoSPHERE probe, interventions name: Standard of Care, outcomesModule primaryOutcomes measure: Severity of pain in the peri-operative period, primaryOutcomes measure: Inflammatory cytokine levels as measured by blood samples, primaryOutcomes measure: Inflammatory cytokines (IL-1, IL-6, TNF-a) levels correlations to pain score, primaryOutcomes measure: Peri-operative pain scores between different surgical incisions (posterolateral thoracotomy vs thoracoscopy), primaryOutcomes measure: Peri-operative nerve function between different surgical incisions (posterolateral thoracotomy vs thoracoscopy), secondaryOutcomes measure: Quality of life score as measured by SF-36 Health questionnaire, secondaryOutcomes measure: Cost (including postoperative epidural management, narcotic pain medication, and outpatient pain management), secondaryOutcomes measure: Workflow/time, otherOutcomes measure: Complications following surgery, otherOutcomes measure: Length of stay, otherOutcomes measure: Time to ambulation, otherOutcomes measure: Chronic Pain medication use through 6 months, otherOutcomes measure: Chronic pain through 6 months., otherOutcomes measure: Chronic pain through 6 months., otherOutcomes measure: Chronic pain through 6 months., otherOutcomes measure: Incentive spirometry volumes in the peri-operative period (POD 1 and 2), otherOutcomes measure: Oxygen requirement, otherOutcomes measure: Hospital charges and hospital reimbursement by different payors, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Michigan, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, contacts name: Shari L Barnett, role: CONTACT, phone: 734-936-4561, email: shbailey@umich.edu, contacts name: Rishindra Reddy, MD, MBA, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.27756, lon: -83.74088, hasResults: False

protocolSection identificationModule nctId: NCT06384651, orgStudyIdInfo id: PRO00037789, briefTitle: Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty, acronym: IOTAA, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-13, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: The Methodist Hospital Research Institute, class: OTHER, descriptionModule briefSummary: The purpose of this study is to compare two different antibiotic regimens and techniques during total ankle arthroplasty (TAA).Primary Objective: Comparable levels of vancomycin will be found in bone, soft tissue, and systemic samples between patient groups.Secondary Objective: Compare 30 day and 90 day post-operative complication rates (infection) between the control (standard IV administration of vancomycin) vs the interventional group (intraosseous administration of vancomycin). The investigators hypothesize that there will be no difference in complication (infection) rates between groups., conditionsModule conditions: Infections, conditions: Ankle Arthritis, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study is a prospective, randomized, single-blinded, controlled trial. 20 patients in each treatment arm: 20 patients will be given IV vancomycin, 20 patients will be given IO vancomycin, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: single blind patient is blinded. Surgeon is not blinded. Lab technician measuring tissue concentrations are blinded. Research coordinator is not blinded., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Intraosseous Vancomycin Injection, interventions name: Intravenous Vancomycin, outcomesModule primaryOutcomes measure: Systemic Sample Vancomycin Tissue Concentration - Start of Case, primaryOutcomes measure: Systemic Sample Vancomycin Tissue Concentration - End of Case, primaryOutcomes measure: Capsule or Synovium Sample Vancomycin Tissue Concentration, primaryOutcomes measure: Distal Tibia Sample Vancomycin Tissue Concentration, primaryOutcomes measure: Talar Bone Sample Vancomycin Tissue Concentration, secondaryOutcomes measure: 90 day post-operative wound complication and infection rates, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Houston Methodist Hospital, status: RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Thomas C Sullivan, BS, role: CONTACT, phone: 346-238-1603, email: tsullivan@houstonmethodist.org, contacts name: Jason S Ahuero, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Kevin Varner, MD, role: SUB_INVESTIGATOR, contacts name: Kwan J Park, MD, role: SUB_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False

protocolSection identificationModule nctId: NCT06384638, orgStudyIdInfo id: coconut periodontitis, briefTitle: Coconut Oil in Treatment of Periodontitis, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-02-15, primaryCompletionDateStruct date: 2024-01-16, completionDateStruct date: 2024-02-09, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Misr University for Science and Technology, class: OTHER, descriptionModule briefSummary: Virgin Coconut Oil (VCO) is a vegetable oil extracted from coconut fleshcontains unsaturated fatty acids in the form of oleic acid and linoleic acid and flavonoids which function as anti-inflammatory. Periodontitis is an inflammatory disease of the periodontal tissues with a high prevalence worldwide. The main etiology of plaque periodontitis is biofilm containing colonies of pathogenic microorganisms. The aim of the study is to evaluate and compare the effect of scaling and root debridement alone versus the use of topically applied coconut oil as adjunctive to scaling and root debridement in treatment of Stage II and III Grade B periodontitis., conditionsModule conditions: Periodontal Diseases, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 34, type: ACTUAL, armsInterventionsModule interventions name: topical application of coconut oil, interventions name: scaling and debridement, outcomesModule primaryOutcomes measure: clinical parameters, primaryOutcomes measure: clinical parameters, secondaryOutcomes measure: Biological parameters, eligibilityModule sex: ALL, minimumAge: 35 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of dentistry at MUST, city: Giza, zip: 02, country: Egypt, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False

protocolSection identificationModule nctId: NCT06384625, orgStudyIdInfo id: 361378, briefTitle: Air Pollution Intervention for Cardiovascular Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-02-01, completionDateStruct date: 2025-02-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University of Montana, class: OTHER, collaborators name: Providence Heart Institute, descriptionModule briefSummary: This pilot study (n=20) is a prospective evaluation of the implementation of an indoor air pollution intervention among patients who have undergone recent percutaneous coronary intervention procedures. The intervention, called Air Improvement and Real-time Monitoring for Wellness through Interactive Strategies and Education (AIRWISE), is focused on improving indoor air quality through air filtration, education, and behavioral recommendations. All participants will receive the AIRWISE intervention with the objective of evaluating acceptance and use of the individual intervention components. This implementation study will inform the submission of a larger NIH proposal for a randomized trial. The central study hypothesis is that an intervention program with educational strategies and visual behavioral cues will increase knowledge and awareness of air pollution exposures among the participants and lead to improved intervention compliance., conditionsModule conditions: Coronary Heart Disease, conditions: Cardiovascular Diseases, conditions: Environmental Exposure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: AIRWISE, outcomesModule primaryOutcomes measure: Evaluate the implementation of an indoor air pollution intervention., secondaryOutcomes measure: Fine particulate matter (PM2.5), secondaryOutcomes measure: Life's Essential 8, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06384612, orgStudyIdInfo id: Adnan Menderes U, briefTitle: The Effect Of The Use Of Pocket Cards In An Undergraduate Nursıng, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-09-13, primaryCompletionDateStruct date: 2022-05-22, completionDateStruct date: 2023-07-13, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Aydin Adnan Menderes University, class: OTHER, descriptionModule briefSummary: The aim of this study is to examine the effect of the use of pocket cards by students taking the "Care of a Child with Special Needs" course on students' self-efficacy perceptions and course success.1. H01. There is no difference between the self-efficacy perception scores of the students in the group who use pocket cards in the care of children with special needs course and the students in the group who do not use pocket cards.2. H02. There is no significant difference between the course success scores of the students in the group who use pocket cards in the care of children with special needs course and the students in the group who do not use pocket cards., conditionsModule conditions: Student, conditions: Self Efficacy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: experimental, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 128, type: ACTUAL, armsInterventionsModule interventions name: use of pocket cards, outcomesModule primaryOutcomes measure: Self-Efficacy Perception Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 22 Years, stdAges: ADULT, contactsLocationsModule locations facility: Bircan Kahraman Berberoğlu, city: Efeler, state: Aydin, zip: 0900, country: Turkey, hasResults: False

protocolSection identificationModule nctId: NCT06384599, orgStudyIdInfo id: CS-190, briefTitle: VT Cryoablation System Post-Market Clinical Follow-up (PMCF) Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-06-01, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Adagio Medical, class: INDUSTRY, descriptionModule briefSummary: The PMCF is a prospective, single-arm, multi-center, controlled study of up to 130 patients designed to collect safety and performance data regarding the use of the Adagio VT Cryoablation System in the treatment of recurrent ventricular tachycardia., conditionsModule conditions: Ventricular Tachycardia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: VT Cryoablation System, outcomesModule primaryOutcomes measure: Primary Performance Endpoint, primaryOutcomes measure: Primary Safety Endpoint, secondaryOutcomes measure: Secondary Performance Endpoint, secondaryOutcomes measure: Secondary Safety Endpoint, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Essex Cardiothoracic Centre, city: Basildon, state: Essex, zip: SS16 5NL, country: United Kingdom, contacts name: Neil Srinivasan, role: CONTACT, geoPoint lat: 51.56844, lon: 0.45782, hasResults: False

protocolSection identificationModule nctId: NCT06384586, orgStudyIdInfo id: CD J8855, briefTitle: Investigation of Dietary Supplement Liquid Shot Products on Mental Energy, Cognition (Acuity),and Mood, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-17, primaryCompletionDateStruct date: 2022-12-22, completionDateStruct date: 2022-12-22, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: The Water Street Collective, class: INDUSTRY, collaborators name: HCD Research, collaborators name: British American Tobacco (Investments) Limited, descriptionModule briefSummary: This is a single center, randomized, double blind, placebo-controlled, crossover study to determine the acute effect of a developmental dietary supplement liquid shot product on cognitive task performance and perceived effect measures related to mood and mental energy. The study will be conducted in healthy participants., conditionsModule conditions: Cognition, conditions: Mental Fatigue, conditions: Mood, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 45, type: ACTUAL, armsInterventionsModule interventions name: Placebo shot, interventions name: Functional energy shot, outcomesModule primaryOutcomes measure: Mental energy via Cognitive Demand Battery (CDB) Performance Index; for the functional energy shot versus placebo shot., secondaryOutcomes measure: Mental energy via Cognitive Demand Battery (CDB) Accuracy score for the functional energy shot versus placebo shot., secondaryOutcomes measure: Change in performance on Corsi blocks task for functional energy shot versus placebo, secondaryOutcomes measure: Change in performance on Rapid Visual Information Processing (RVIP) for functional energy shot versus placebo, secondaryOutcomes measure: Change in performance on Numeric working memory for functional energy shot versus placebo, secondaryOutcomes measure: Change in performance on Serial subtraction task for functional energy shot versus placebo, secondaryOutcomes measure: Change in Mood via Visual Analogue Scales (VAS) during Cognitive Demand Battery (CDB), for functional energy shot versus placebo, secondaryOutcomes measure: Change in physiological state via Profile Of Mood States (POMS) during Cognitive Demand Battery (CDB), for functional energy shot versus placebo, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Schlesinger Group New Jersey, city: Iselin, state: New Jersey, zip: 08330, country: United States, geoPoint lat: 40.57538, lon: -74.32237, hasResults: False

protocolSection identificationModule nctId: NCT06384573, orgStudyIdInfo id: DIAN-TU-003, secondaryIdInfos id: The Alzheimer's Association, type: OTHER_GRANT, domain: DIAN-TU-OLE-21-725093, briefTitle: DIAN-TU Amyloid Removal Trial (ART) in Dominantly Inherited Alzheimer's Disease, acronym: DIAN-TU, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2029-11, completionDateStruct date: 2029-11, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Washington University School of Medicine, class: OTHER, collaborators name: Alzheimer's Association, collaborators name: Eisai Inc., descriptionModule briefSummary: This is an open label study to treat dominantly inherited Alzheimer's disease (DIAD) mutation carrier participants from the DIAN-TU-001 gantenerumab Open Label Extension (OLE) period with lecanemab to determine the effects of amyloid removal on age of onset and clinical progression compared to external controls, if amyloid plaque as measured by amyloid PET can be fully removed in DIAD, and the effects of amyloid removal on biomarkers of disease progression., conditionsModule conditions: Alzheimer's Disease, conditions: Dementia, conditions: Alzheimer's Disease, Familial, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 65, type: ESTIMATED, armsInterventionsModule interventions name: lecanemab, outcomesModule primaryOutcomes measure: The primary endpoint for the final analysis is the time to recurrent progression of Clinical Dementia Rating - Sum of Boxes (CDR-SB)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Alabama in Birmingham, city: Birmingham, state: Alabama, zip: 35294, country: United States, contacts name: Erik Roberson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.52066, lon: -86.80249, locations facility: University of California San Diego Medical Center, city: La Jolla, state: California, zip: 92037, country: United States, contacts name: Doug Galasko, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.84727, lon: -117.2742, locations facility: Indiana University School of Medicine, city: Indianapolis, state: Indiana, zip: 46202, country: United States, contacts name: Jared Brosch, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.76838, lon: -86.15804, locations facility: Washington University in St. Louis, city: Saint Louis, state: Missouri, zip: 63110, country: United States, contacts name: Barbara Snider, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.62727, lon: -90.19789, locations facility: University of Pittsburgh, city: Pittsburgh, state: Pennsylvania, zip: 15213, country: United States, contacts name: Sarah Berman, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.44062, lon: -79.99589, locations facility: University of Washington, city: Seattle, state: Washington, zip: 98195, country: United States, contacts name: Suman Jayadev, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.60621, lon: -122.33207, locations facility: Neuroscience Research Australia, city: Randwick, state: New South Wales, zip: 2031, country: Australia, contacts name: William Brooks, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -33.91439, lon: 151.24895, locations facility: The National Hospital for Neurology and Neurosurgery, city: London, state: Greater London, zip: WC1B 3BG, country: United Kingdom, contacts name: Catherine Mummery, role: CONTACT, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False

protocolSection identificationModule nctId: NCT06384560, orgStudyIdInfo id: 2023-508707-20-00, briefTitle: Neoadjuvant Triple Treatment for Borderline Resectable Pancreatic Cancer (PREOPANC-5), acronym: PREOPANC-5, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2028-03, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Amsterdam UMC, location VUmc, class: OTHER, collaborators name: Maastricht University Medical Center, collaborators name: Erasmus Medical Center, collaborators name: St. Antonius Hospital, descriptionModule briefSummary: Since patients with borderline resectable pancreatic cancer (BRPC) have a limited life expectancy, it is important to improve treatment strategies. Therefore, the objective of this study is to investigate whether neoadjuvant triple treatment chemotherapy, immunotherapy and radiotherapy, followed by surgery and chemotherapy and immunotherapy survival in patients with BRPC., conditionsModule conditions: Borderline Resectable Pancreatic Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: Pembrolizumab, outcomesModule primaryOutcomes measure: Percentage of patients with progression free survival at 18 months (RECIST 1.1), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06384547, orgStudyIdInfo id: VRDN-001-303, briefTitle: A Randomized, Active Controlled, Safety and Tolerability Study of VRDN-001 in Participants With Thyroid Eye Disease (TED), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Viridian Therapeutics, Inc., class: INDUSTRY, descriptionModule briefSummary: The investigational drug, VRDN-001, is a monoclonal antibody that inhibits the activity of a cell surface receptor called insulin-like growth factor-1 receptor (IGF-1R). Inhibition of IGF-1R may help to reduce the inflammation and associated tissue swelling that occurs in patients with thyroid eye disease (TED). The primary objective of this clinical trial is to evaluate the safety and tolerability of VRDN-001 in patients with TED., conditionsModule conditions: Thyroid Eye Disease, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A randomized, active controlled, safety and tolerability study of VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in participants with thyroid eye disease (TED), primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 212, type: ESTIMATED, armsInterventionsModule interventions name: VRDN-001 10 mg/kg, interventions name: VRDN-001 3 mg/kg, outcomesModule primaryOutcomes measure: Treatment Emergent Adverse Event (TEAE) incidence rate, secondaryOutcomes measure: Change from baseline in proptosis in the study eye as measured by exophthalmometer at Week 15, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: United Medical Research Institute, city: Inglewood, state: California, zip: 90301, country: United States, contacts name: James Peace, MD, role: CONTACT, phone: 310-645-4673, geoPoint lat: 33.96168, lon: -118.35313, hasResults: False

protocolSection identificationModule nctId: NCT06384534, orgStudyIdInfo id: PVD_6MWD_SOT, briefTitle: Exercise Performance on Ambient Air vs. Low-Flow Oxygen Therapy in Pulmonary Vascular Disease (PVD), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-11, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University of Zurich, class: OTHER, descriptionModule briefSummary: The investigators aim to study the effect of SOT in Swiss residents with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH)., conditionsModule conditions: Pulmonary Vascular Disorder, conditions: Chronic Thromboembolic Pulmonary Hypertension, conditions: Pulmonary Arterial Hypertension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Each participant is its own control, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: 6-minute walk distance (6MWD) test on ambient air, interventions name: 6-minute walk distance test with supplemental oxygen, outcomesModule primaryOutcomes measure: 6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air, secondaryOutcomes measure: SpO2 at rest and peak 6MWD with SOT vs. ambient air, secondaryOutcomes measure: Heart rate at rest and peak 6MWD with SOT vs. ambient air, secondaryOutcomes measure: Borg dyspnea scale at rest and peak 6MWD with SOT vs. ambient air, secondaryOutcomes measure: Borg leg fatigue scale at rest and peak 6MWD with SOT vs. ambient air, secondaryOutcomes measure: Blood pressure at rest and peak 6MWD with SOT vs. ambient air, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Zürich, city: Zurich, zip: 8091, country: Switzerland, contacts name: Silvia Ulrich, Prof. Dr., role: CONTACT, phone: 0041 44 255 22 20, email: silvia.ulrich@usz.ch, contacts name: Mona Lichtblau, Dr., role: CONTACT, phone: +41442552220, email: mona.lichtblau@usz.ch, contacts name: Silvia Ulrich, Prof. Dr., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.36667, lon: 8.54999, hasResults: False

protocolSection identificationModule nctId: NCT06384521, orgStudyIdInfo id: STUDY00000500, briefTitle: Lifestyle MIND- Feasibility for Randomized Wait-list Control Trial, acronym: MIND, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: The University of Texas Health Science Center at San Antonio, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to examine if it is feasible to randomly assign people into two groups and participate in Lifestyle MIND (Mental Illness and/N' Diabetes) at two different times. Lifestyle MIND is a diabetes lifestyle intervention recently developed for people with serious mental illness (SMI). It is known to be helpful for people with SMI who complete it, but the investigators do not know the effect in comparison to those who do not participate in it. The main questions it aims to answer are:* Does Lifestyle MIND improve diabetes control among people with SMI?* Will the effect of Lifestyle MIND be sustained 10 weeks after program completion?* From the provider's perspective, what are the barriers of achieving optimal diabetes treatment outcomes for patients with SMI?Researchers will compare outcomes of participants in the intervention with those in the wait-list control arm, to see if there will be significant differences in blood glucose level, compliance of diabetes self-management, time staying active, number of emergency department (ED) visits and psychiatric hospitalization, and subjective well-being., conditionsModule conditions: Type 2 Diabetes Mellitus, conditions: Serious Mental Illness, conditions: Schizophrenia, conditions: Major Depression, conditions: Bipolar Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Lifestyle MIND, outcomesModule primaryOutcomes measure: Hemoglobin A1c (HbA1c), primaryOutcomes measure: Summary of Diabetes Self-Care Activities (SDSCA) Questionnaire, primaryOutcomes measure: Hours of Active and Sedentary Behavior, primaryOutcomes measure: Number of emergency department (ED) visits and psychiatric hospitalizations, primaryOutcomes measure: Satisfaction with Life Scale (SWLS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Texas Health Science Center at San Antonio, city: San Antonio, state: Texas, zip: 78229, country: United States, contacts name: Chinyu Wu, PhD, role: CONTACT, phone: 210-567-8890, email: wuc7@uthscsa.edu, contacts name: Chinyu Wu, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Bradley Tragord, ScD, role: SUB_INVESTIGATOR, geoPoint lat: 29.42412, lon: -98.49363, hasResults: False

protocolSection identificationModule nctId: NCT06384508, orgStudyIdInfo id: NL83340.058.23, briefTitle: Decrease Trauma-related Shame With Virtual Reality: The Effectiveness of SHINE-VR, acronym: SHINE-VR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Universiteit Leiden, class: OTHER, collaborators name: University of Amsterdam, descriptionModule briefSummary: Suffering from PTSD in childhood can have detrimental formative consequences. Researchers have been eager to develop effective interventions and to enhance treatment motivation since the introduction of the diagnosis of PTSD in the DSM. With evolving understanding of the disorder, its definition and criteria have changed over the course of time. The most recent change involves the addition of the criterium D of negative affects or emotions in relation to PTSD, the feeling of shame amongst others. Individuals experiencing interpersonal trauma, such as sexual abuse, are at high-risk developing trauma-related shame, which in turn can impact the course and effectiveness of PTSD treatment. Shame-inducing situations are typically being avoided, and the feelings are not disclosed to peers and other people. Hence, acknowledging and sharing feelings of shame as well as practicing self-compassion have been proposed to reduce the impact of that negative self-conscious emotion. These aspects get partially tackled in evidence-based trauma therapies, however, there appears to be a need for a more specific trauma-related shame intervention in addition to existing treatments. Recent research has focused on developing such interventions for adults and has reported positive effects.To our knowledge, there is no intervention specifically tackling trauma-related shame in adolescents. Virtual Reality (VR) is a promising tool for such an intervention. Findings suggest that including VR in a treatment results in high treatment satisfaction and that it is highly motivating for its users, which is a crucial component for treatment success.The goal of this study is to test the effectiveness of a short-term VR shame intervention (SHINE-VR) for adolescents suffering from PTSD after having experienced sexual abuse. The primary objectives of this study to assess the effect of SHINE-VR on trauma-related shame, self-compassion, and PTSD symptom reduction, to investigate whether treatment motivation, an increase in self-compassion, and a decrease in trauma-related shame are associated with PTSD symptom reduction, and the evaluation of SHINE-VR by assessing the feasibility of the intervention., conditionsModule conditions: Shame, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Single Case Experimental Design (ABC) with two different baseline lengths, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The participants are unaware of different baseline lengths, whoMasked: PARTICIPANT, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: SHINE-VR, outcomesModule primaryOutcomes measure: Trauma-related shame, primaryOutcomes measure: Self-compassion, secondaryOutcomes measure: PTSD symptoms, secondaryOutcomes measure: Treatment motivation, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: iMindU Practice for Child, Adolescent and Adult Psychiatry, city: Leiden, state: South Holland, zip: 2311 EX, country: Netherlands, contacts name: Marie-Jose van Hoof, MD PhD, role: CONTACT, contacts name: Marie-Jose van Hoof, MD PHD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.15833, lon: 4.49306, locations facility: LEVVEL, city: Amsterdam, country: Netherlands, contacts name: Ramon Lindauer, Prof. Dr., role: CONTACT, geoPoint lat: 52.37403, lon: 4.88969, hasResults: False

protocolSection identificationModule nctId: NCT06384495, orgStudyIdInfo id: STUDY00021475, briefTitle: How Does Cerebellar tDCS Alter Intracortical Inhibition Over Time?, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-15, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University of Minnesota, class: OTHER, descriptionModule briefSummary: Combining cortical tDCS with behavioral interventions has been shown to have beneficial outcomes in individuals post-stroke. However, cerebellar tDCS is a fairly new approach for individuals with unilateral cortical stroke and there has not been reports of duration of effect of tDCS applied to the cerebellum in this population.Information gained from this study will serve to fill knowledge gaps on the duration of effect of cerebellar tDCS and the effects of polarity.The purpose of this study is to determine the duration of effect of ventro-lateral cerebellar transcranial direct current stimulation (tDCS) in healthy adults through cortical excitability (CE), cognitive, language and motor assessment measures. Primary aim: Compare baseline CE from left motor cortex of first dorsal interosseous (FDI) and orbicularis oris (OO) areas to CE post cerebellar tDCS at 15 minutes, 45 minutes and 75 minutes. Single-pulse and paired-pulse transcranial magnetic stimulation (TMS) will be used to measure and compare stimulus response curve (S/R curve), cortical silent period (CSP) and short-interval intracortical inhibition (SICI) in the hand area and facial area of the left primary motor cortex at each time point.Secondary aim: Compare baseline performance on cognition, motor learning and language tasks to performance at 15, 45 and 75 minutes after receiving tDCS. Digit Symbol Substitution Test (DSST), Serial Reaction Time Test (SRTT) and Lexical Decision tasks will be presented via a computer interface., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: REAL-A, interventions name: REAL-C, interventions name: SHAM, outcomesModule primaryOutcomes measure: stimulus/response curve (S/R Curve), primaryOutcomes measure: Cortical Silent Period (CSP), primaryOutcomes measure: Short-interval Intracortical Inhibition (SICI)., secondaryOutcomes measure: Digit Symbol Substitution Test (DSST), secondaryOutcomes measure: Serial Reaction Time Test (SRTT), secondaryOutcomes measure: Lexical Decision Task, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06384482, orgStudyIdInfo id: SNC115-DLL3 CART-101, briefTitle: SNC115 Injections in Patients With Recurrent/Refractory Small Cell Lung Cancer and Lung Large Cell Neuroendocrine Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Shanghai Simnova Biotechnology Co.,Ltd., class: INDUSTRY, collaborators name: Shanghai Chest Hospital, descriptionModule briefSummary: This study is a FIH dose escalation clinical study, with single arm, open label and design, in order to observe the preliminary safety and Pharmacokinetic of SNC115 Injection in participants with Recurrent/refractory small cell lung cancer and Lung large cell neuroendocrine carcinoma., conditionsModule conditions: Recurrent/Refractory Small Cell Lung Cancer Lung Large Cell Neuroendocrine Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: SNC115 injection, outcomesModule primaryOutcomes measure: Safety of SNC115 Injection, primaryOutcomes measure: Safety of SNC115 Injection, secondaryOutcomes measure: -Efficacy of SNC115 Injection, secondaryOutcomes measure: -Efficacy of SNC115 Injection, secondaryOutcomes measure: -Efficacy of SNC115 Injection, secondaryOutcomes measure: -Efficacy of SNC115 Injection, secondaryOutcomes measure: -Efficacy of SNC115 Injection, secondaryOutcomes measure: -Efficacy of SNC115 Injection, otherOutcomes measure: -PK characteristic of SNC115 Injection., otherOutcomes measure: -PK characteristic of SNC115 Injection., otherOutcomes measure: PK characteristic of SNC115 Injection., otherOutcomes measure: PK characteristic of SNC115 Injection., otherOutcomes measure: PK characteristic of SNC115 Injection., otherOutcomes measure: PK characteristic of SNC115 Injection., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Chest Hospital, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200030, country: China, contacts name: Hua Zhong, MD/PhD, role: CONTACT, phone: 021-22200000, email: ctqxkyy@163.com; eddiedong8@hotmail.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False

protocolSection identificationModule nctId: NCT06384469, orgStudyIdInfo id: 98984697615, briefTitle: The Impact of Rhinoplasty Approach and Used Autologous Cartilage Grafts on the Nasal Skin-soft Tissue Envelope Metabolism, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-01-02, primaryCompletionDateStruct date: 2026-01-02, completionDateStruct date: 2026-09-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University Hospital "Sestre Milosrdnice", class: OTHER, descriptionModule briefSummary: This is a prospective observation cohort investigation. Patients, that is participants, undergoing primary functional rhinoplasty will be evaluated in terms of measuring capillary blood lactic acid concentration in the nasal skin-soft tissue envelope immediately after the procedure and 7 days after the procedure.The aim of our study is to test whether or not different rhinoplasty approaches and volume of the used autologous cartilage grafts impact the nasal skin-soft tissue metabolism., conditionsModule conditions: Rhinoplasty, conditions: Nasal Skin-soft Tissue Envelope Metabolism, conditions: Lactic Acid, conditions: Autologous Cartilage Grafting, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Difference of capillary blood lactic acid concentration in the nasal skin-soft tissue envelope depending on the rhinoplasty approach, primaryOutcomes measure: Correlation between the used autologous cartilage graft volume and lactic acid concentration in the nasal skin-soft tissue envelope, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06384456, orgStudyIdInfo id: 23-5708, briefTitle: Topical TRanexamic Acid vs. Placebo on Acute Postoperative Pain Following DRF Fixation, acronym: TRADR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-09, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University Health Network, Toronto, class: OTHER, descriptionModule briefSummary: The goal of this study is to find out whether the use of topical tranexamic acid (TXA) into the surgical wound will result in less post-operative pain, less pain killer use, and better post-operative use of the wrist in people undergoing surgery for a wrist fracture compared to not using topical TXA (placebo)., conditionsModule conditions: Distal Radius Fractures, 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: 90, type: ESTIMATED, armsInterventionsModule interventions name: Topical TRanexamic Acid, interventions name: Placebo, outcomesModule primaryOutcomes measure: acute post-op pain, secondaryOutcomes measure: opioid use, secondaryOutcomes measure: persistent pain, secondaryOutcomes measure: unscheduled hand-related procedures, secondaryOutcomes measure: Patient reported function, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Toronto Western Hospital, city: Toronto, state: Ontario, country: Canada, contacts name: Ryan Paul, MD, role: CONTACT, email: ryan.paul2@uhn.ca, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False

protocolSection identificationModule nctId: NCT06384443, orgStudyIdInfo id: 01001099646, briefTitle: Proton Pump Inhibitors in Cirrhotic Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-10-01, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-03-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: National Liver Institute, Egypt, class: OTHER, descriptionModule briefSummary: Proton pump inhibitors (PPIs) inappropriate use, in patients with cirrhosis, presents a significant clinical challenge. This study evaluates overprescription and misuse of PPIs in cirrhotic patients. The patterns of use of PPIs will be classified into two groups based on adherence to the proven indications: Group A: Inappropriate use of PPI, Group B: Appropriate use of PPI. We will estimate the prevalence of PPI misuse in cirrhotics and correlate it with different factors., conditionsModule conditions: Proton Pump Inhibitor Adverse Reaction, conditions: Liver Cirrhosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 1000, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Inappropriate use of PPIs, primaryOutcomes measure: Predictors for inappropriate use of PPIs, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Liver institute - Menoufia University, city: Shibīn Al Kawm, state: Menoufia, zip: 32511, country: Egypt, geoPoint lat: 30.55258, lon: 31.00904, hasResults: False

protocolSection identificationModule nctId: NCT06384430, orgStudyIdInfo id: MuğlaSKU-NKO, briefTitle: Subacromial Impingement Syndrome, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Muğla Sıtkı Koçman University, class: OTHER, descriptionModule briefSummary: Subacromial impingement syndrome is a common shoulder pain disorder. In this study, among the patients who applied to the Physical Medicine and Rehabilitation outpatient clinic of Muğla Training and Research Hospital and were diagnosed with subacromial impingement by anamnesis and clinical tests, inclusion criteria (being between 18-70 years of age, positivity for subacromial impingement syndrome in clinical evaluation (Neer's test, Hawkins Kennedy, supraspinatus palpation test)) and exclusion criteria (under 18 years of age, over 70 years of age, rheumatologic disease diagnosis, symptomatic shoulder osteoarthritis, shoulder instability; shoulder pain in active, passive cervical spine movements, previous shoulder surgery, those with adhesive capsulitis findings (\>50% passive range of motion restriction in 2 planes or full-thickness rotator cuff tear detected on ultrasound), those who received physiotherapy or intra-articular injections in the last 3 months, those with type 2 diabetes or hypothyroidism) will be included in the study. Demographic data of the patients will then be recorded. DASH (Disabilities of the Arm, Shoulder and Hand) and Constant Murley scores will be calculated. 4 years of musculoskeletal ultrasound experience will be recorded by a radiologist using ultrasound (Siemens® V8, LA2-14A probe) in modified Crass position (positioning with the palm of the examined side on the posterior iliac wing) by measuring subacromial bursa thickness, supraspinatus tendon thickness, acromiohumeral distance, supraspinatus tendon thickness/acromiohumeral distance ratio. Demographic data of the patients will then be recorded. DASH (Disabilities of the Arm, Shoulder and Hand) and Constant Murley scores will be calculated., conditionsModule conditions: To Show the Relationship Between Ultrasound Parameters and Shoulder Functional Tests, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Shoulder functional tests and ultrasound, outcomesModule primaryOutcomes measure: subacromial bursa thickness, primaryOutcomes measure: supraspinatus tendon thickness, primaryOutcomes measure: acromiohumeral distance, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mugla Egitim Arastima, status: RECRUITING, city: Mugla, country: Turkey, contacts name: Nihal KARAYER OZGUL, 1, role: CONTACT, geoPoint lat: 37.21807, lon: 28.3665, hasResults: False

protocolSection identificationModule nctId: NCT06384417, orgStudyIdInfo id: STUDY00024858, briefTitle: Using an End-of-life Conversation Game to Engage Patients With Cancer in Advance Care Planning: Phase 2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Milton S. Hershey Medical Center, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to explore feasibility, acceptability, and effectiveness of end-of-life conversation game "Hello" as a tool to help individuals with various solid cancer types (including: breast, gastro-intestinal, lung, melanoma, head and neck, and/or genito-urinary cancers) treated at Penn State Health clinics and their loved ones perform advance care planning (ACP). The main questions it aims to answer are:What modifications and/or adaptations are necessary to Hello for use in cancer populations?What impact does participation in Hello event have on health care usage (e.g., number of hospitalizations, ICU admissions, emergency department visits, etc.)? How feasible is it to randomize participants to play either Hello for Cancer or Table Topics?Participants will:* Complete pre-game questionnaires* Play either Hello or Table Topics game* Complete post-game questionnaires* Participate in a focus group* Complete a telephone follow up interview 1-4 months after their eventThis study is a continuation of NCT06028152., conditionsModule conditions: Breast Cancer, conditions: Lung Cancer, conditions: Genito-Urinary Cancer, conditions: Colorectal Cancer, conditions: Gastric Cancer, conditions: Pancreatic Cancer, conditions: Liver Cancer, conditions: Head and Neck Cancer, conditions: Melanoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Hello for Cancer game, interventions name: Table Topics game, outcomesModule primaryOutcomes measure: Feasibility and Acceptability of modified Hello game, primaryOutcomes measure: Healthcare Utilization, secondaryOutcomes measure: Advance Care Planning Engagement Measure, secondaryOutcomes measure: Advance Care Planning Surrogate Decision Maker Engagement Measure, secondaryOutcomes measure: Satisfaction of Intervention Measure, secondaryOutcomes measure: Acceptability of Intervention Measure, secondaryOutcomes measure: Preliminary efficacy of Hello on ACP behaviors., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Penn State Cancer Institute, city: Hershey, state: Pennsylvania, zip: 17033, country: United States, contacts name: Michael Hayes, PhD, role: CONTACT, phone: 717-531-8521, email: mhayes3@pennstatehealth.psu.edu, contacts name: Michael Hayes, PhD, role: SUB_INVESTIGATOR, contacts name: Monika Joshi, role: SUB_INVESTIGATOR, geoPoint lat: 40.28592, lon: -76.65025, hasResults: False

protocolSection identificationModule nctId: NCT06384404, orgStudyIdInfo id: 2023-14741, briefTitle: Upfront Surgical Resection for Osteosarcoma, acronym: UFSR for OS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Montefiore Medical Center, class: OTHER, descriptionModule briefSummary: The goal of this pilot study is to learn about patients with newly diagnosed osteosarcoma of an extremity, and whether surgically removing the tumor prior to the administration of any chemotherapy will improve functional outcomes. In order to learn about the patient's experience, the study team will administer questionnaires to the patient and surgeon at various timepoints to assess recovery and the function of the extremity., conditionsModule conditions: Osteosarcoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Questionnaire, outcomesModule primaryOutcomes measure: Change in Health-Related Quality of Life (HRQoL) score from Historical Controls, secondaryOutcomes measure: Event Free Survival, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 40 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Montefiore Medical Center, status: RECRUITING, city: Bronx, state: New York, zip: 10467, country: United States, contacts name: Rebecca Zylber, role: CONTACT, phone: 718-741-2356, email: rzylber@montefiore.org, contacts name: Alice Lee, M.D., role: PRINCIPAL_INVESTIGATOR, contacts name: David Geller, M.D., role: SUB_INVESTIGATOR, geoPoint lat: 40.84985, lon: -73.86641, hasResults: False

protocolSection identificationModule nctId: NCT06384391, orgStudyIdInfo id: 4-2023-1730, briefTitle: Intestinal Ultrasound, Magnetic Resonance Enterography, and Conventional Assessment Tools Before and After Treatment of Intestinal Behcet's Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Yonsei University, class: OTHER, descriptionModule briefSummary: Background: The "treat-to-target" approach has recently been adopted in the treatment of inflammatory bowel disease (IBD). The basic premise is to define specific measurable targets and then adjust treatment until these targets are achieved and maintained. According to the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE)-Ⅱ statement published in 2021, the long-term treatment targets for IBD are clinical remission, endoscopic healing, absence of disability, restoration of quality of life, and normal growth in children. Symptomatic relief and normalization of serum and fecal markers were determined as short-term targets. Transmural healing in Crohn's disease and histological healing in ulcerative colitis are not formal targets but should be assessed as measures of the remission depth.While endoscopic examination assesses the mucosal inflammatory status of the bowel wall, transmural inflammatory status needs to be evaluated with ultrasound, computed tomography (CT), or magnetic resonance enterography (MRE). Ultrasound is advantageous as it does not utilize ionizing radiation and is less costly and uncomfortable for patients, allowing more frequent use. Recent studies suggest that intestinal ultrasound is beneficial in treatment response assessment and planning in patients with Crohn's disease and ulcerative colitis. However, there is a paucity of study regarding the effectiveness of intestinal ultrasound in management of intestinal Behcet's disease. Furthermore, despite its accuracy and comprehensive imaging capabilities without radiation risk, MRE has not been widely used in the diagnosis and follow-up of the patients with intestinal Behcet's disease, and no studies have reported changes in MRE findings after treatment., conditionsModule conditions: Intestinal Behcet Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 55, type: ESTIMATED, outcomesModule primaryOutcomes measure: Accuracy of intestinal ultrasound in identifying endoscopic remission at 26 weeks after initiation of medical treatment, secondaryOutcomes measure: Accuracy of intestinal ultrasound in identifying clinical remission at 26 weeks after initiation of medical treatment, secondaryOutcomes measure: Accuracies of magnetic resonance enterography in identifying endoscopic and clinical remission at 26 weeks after initiation of medical treatment, secondaryOutcomes measure: Accuracies of magnetic resonance enterography in identifying endoscopic and clinical responses at 26 weeks after initiation of medical treatment, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 79 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yonsei University Health system, Severance Hospital, status: RECRUITING, city: Seoul, zip: 03722, country: Korea, Republic of, contacts name: Hyun Kyung Yang, role: CONTACT, phone: 82-2-2228-7400, email: hkyang@yuhs.ac, geoPoint lat: 37.566, lon: 126.9784, hasResults: False

protocolSection identificationModule nctId: NCT06384378, orgStudyIdInfo id: FP00006640, briefTitle: Systemic and Central Inflammation in AD, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-17, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: The Methodist Hospital Research Institute, class: OTHER, descriptionModule briefSummary: Inflammation could provide a new focus for therapeutic intervention. In this study, we will measure blood and cerebrospinal fluid (CSF) inflammation biomarkers and compare them to measurements of brain glial activation obtained by positron emission tomography (PET). In addition, we will determine the effect of low-dose interleukin-2 (IL-2) immunotherapy, given over 22 weeks, on these inflammation biomarkers., conditionsModule conditions: Alzheimer Disease, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: 11C-ER176, outcomesModule primaryOutcomes measure: Blood inflammation biomarker levels, primaryOutcomes measure: CSF inflammation biomarker levels, primaryOutcomes measure: Voxel-wise, regional and total brain TSPO VT/fP measured with 11C-ER176 PET, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 86 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Houston Methodist Research Institute, status: RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Alireza Faridar, role: CONTACT, phone: 713-441-1150, email: afaridar@houstonmethodist.org, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False

protocolSection identificationModule nctId: NCT06384365, orgStudyIdInfo id: 706014-4, briefTitle: Interaction of Inflammation, Taste Perception and Preferences as a Function of Physical Activity and Body Composition, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Vienna, class: OTHER, descriptionModule briefSummary: The aim of this study is to investigate whether differences in taste perception and preference behavior can be attributed to inflammatory processes induced by physical activity. The focus will be on sweet taste and the perception of fat. A non-invasive, observational study design will be used., conditionsModule conditions: Taste, Altered, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: Physical activity, outcomesModule primaryOutcomes measure: Taste sensitivity, primaryOutcomes measure: Taste preference, primaryOutcomes measure: Body composition, primaryOutcomes measure: Low-grade inflammation, secondaryOutcomes measure: Oxidative Stress, secondaryOutcomes measure: fungiform papillae density, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Christian Doppler Laboratory for Taste Research, status: RECRUITING, city: Vienna, zip: 1090, country: Austria, contacts name: Barbara Lieder, PhD, role: CONTACT, phone: +431427770611, email: Barbara.Lieder@univie.ac.at, geoPoint lat: 48.20849, lon: 16.37208, hasResults: False

protocolSection identificationModule nctId: NCT06384352, orgStudyIdInfo id: YL211-INT-101-01, briefTitle: A Phase I Study to Evaluate the Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-08, primaryCompletionDateStruct date: 2027-04-07, completionDateStruct date: 2029-04-07, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: MediLink Therapeutics (Suzhou) Co., Ltd., class: INDUSTRY, collaborators name: Hoffmann-La Roche, descriptionModule briefSummary: This is a multicenter, open-label, Phase 1 study. The study will enroll subjects with advanced solid tumors. It consists of three parts. Part 1 is dose-escalation part. In part 1, the safety and tolerability of YL211 in patients with selected advanced solid tumors will be evaluated and the MTD and RED will be determined.Part 2 is backfill enrollment part. We will further estimate the safety and efficacy of YL211 in patients with selected adcance tumor to select the RED(s) of YL211.Part 3 is dose-expansion part. In this part, we will further evaluate the safety and efficacy of YL211 at the MTD/RED(s) in patients with selected advanced solid tumors YL211 will be administered intravenously (IV) until criteria of treatment discontinuation are met., conditionsModule conditions: Advanced Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 155, type: ESTIMATED, armsInterventionsModule interventions name: YL211, outcomesModule primaryOutcomes measure: To evaluate nature and frequency of AEs of YL211 in patients with advanced solid tumors according to NCI CTCAE version 5.0, primaryOutcomes measure: To evaluate nature and frequency of DLTs in part 1., primaryOutcomes measure: ORR assessed using RECIST version 1.1, primaryOutcomes measure: To determine the MTD and select the recommended expansion dose(s) (RED(s)) of YL211 in patients with advanced solid tumors, secondaryOutcomes measure: To characterize the AUC of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload, secondaryOutcomes measure: To characterize the Cmax of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload, secondaryOutcomes measure: To characterize the Ctrough of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload, secondaryOutcomes measure: To characterize the Tmax of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload, secondaryOutcomes measure: To characterize the CL of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload, secondaryOutcomes measure: To characterize the Vd of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload, secondaryOutcomes measure: To characterize the t1/2 of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload, secondaryOutcomes measure: To evaluate the anti-drug immune response after treatment with YL211, secondaryOutcomes measure: To evaluate DCR of YL211 in patients with advanced solid tumors using RECIST version 1.1, secondaryOutcomes measure: To evaluate DoR of YL211 in patients with advanced solid tumors using RECIST version 1.1, secondaryOutcomes measure: To evaluate SD of YL211 in patients with advanced solid tumors using RECIST version 1.1, secondaryOutcomes measure: To evaluate TTR of YL211 in patients with advanced solid tumors using RECIST version 1.1, secondaryOutcomes measure: To evaluate PFS of YL211 in patients with advanced solid tumors using RECIST version 1.1, secondaryOutcomes measure: To evaluate OS of YL211 in patients with advanced solid tumors using RECIST version 1.1, secondaryOutcomes measure: To evaluate percent change in target lesion of YL211 in patients with advanced solid tumors using RECIST version 1.1, otherOutcomes measure: Characterization of genomic alterations that are predictive of response to YL211, otherOutcomes measure: The use of circulating tumor DNA (ctDNA) to monitor response to YL211 treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NEXT San Antonio, city: San Antonio, state: Texas, zip: 78229, country: United States, contacts name: Site Coordinator, role: CONTACT, geoPoint lat: 29.42412, lon: -98.49363, hasResults: False

protocolSection identificationModule nctId: NCT06384339, orgStudyIdInfo id: ID-ClimAct-1, briefTitle: ID-ClimAct. Influence of Social Motives of Clients and Staff on the Social Climate of Secure Settings, acronym: ID-ClimAct, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-31, primaryCompletionDateStruct date: 2024-09-20, completionDateStruct date: 2024-10-20, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University Psychiatric Clinics Basel, class: NETWORK, collaborators name: University of Basel, descriptionModule briefSummary: The social climate in secure settings is an essential element to successful rehabilitation. Previous studies indicate that staff characteristics are a relevant factor contributing to a beneficial social climate. Yet, secure settings form a specific and challenging work environment. Staff members are faced with clients who present a variety of difficult emotional and behavioural problems. Social motives for caring and cooperation can be blocked in a threatening environment, favouring dysfunctional interpersonal dynamics between individuals. This observational study explores the reciprocal influences of social motives between clients and staff on the social climate within secure settings., conditionsModule conditions: Social Environment, conditions: Correctional Institutions, conditions: Rehabilitation of Criminals, conditions: Social Dominance, conditions: Interpersonal Relations, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: CSIV, Social motive, interventions name: Interpersonal messages and behavior, interventions name: CCS, Social motive, outcomesModule primaryOutcomes measure: Social Climate Perception, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Psychiatric Clinics Basel, Clinic for Forensics, city: Basel, state: Basel-Stadt, zip: 4002, country: Switzerland, geoPoint lat: 47.55839, lon: 7.57327, hasResults: False

protocolSection identificationModule nctId: NCT06384326, orgStudyIdInfo id: bagattoni3, briefTitle: Parental Perceptions and Acceptance of Silver Diamine Fluoride in Spain and Italy, acronym: SDF, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-09-01, primaryCompletionDateStruct date: 2023-07-01, completionDateStruct date: 2023-08-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University of Bologna, class: OTHER, descriptionModule briefSummary: Assessing parental aesthetic acceptability of Silver Diamine Fluoride (SDF) staining is crucial for its potential implementation in paediatric dentistry. This study represents the third part of a wider project initially focused on evaluating SDF aesthetic acceptability in Italy, then comparing it between Spanish and Italian parents, conditionsModule conditions: Comparative Study, conditions: Aesthetic Perception, conditions: Acceptability, conditions: SDF, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 501, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Comparison of SDF's overall acceptance between Spanish and Italian parents, secondaryOutcomes measure: Comparison of SDF's specific acceptability in different scenarios of child's behavior between Spain and Italy, secondaryOutcomes measure: Parental overall acceptability of SD staining according to demographic background, eligibilityModule sex: ALL, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Servizio di Assistenza Odontoiatrica per disabili in età evolutiva e di odontoiatria infantile, city: Bologna, zip: 40125, country: Italy, geoPoint lat: 44.49381, lon: 11.33875, hasResults: False

protocolSection identificationModule nctId: NCT06384313, orgStudyIdInfo id: NL86266.068.24, briefTitle: Butyrate-enriched Triglyceride and Diabetes Prevention, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2027-09-01, completionDateStruct date: 2027-09-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Maastricht University Medical Center, class: OTHER, descriptionModule briefSummary: A body of animal studies as well as observational studies in humans demonstrated that butyrate is one SCFA that has pronounced positive effects on body weight control, inflammation, and insulin resistance. Even though the SCFA hexanoate is less researched, it has been shown to be involved in anti-inflammatory processes. Of note, acute human studies showed that fibre-induced metabolic improvements are linked to higher SCFA levels in the systemic circulation. We previously showed that a butyrate/hexanoate-enriched triglyceride oil enhanced systemic butyrate and hexanoate concentrations for a prolonged time. Yet, it remains to be determined whether a chronic increase in circulating butyrate and hexanoate concentrations translate into long-term benefits. We hypothesize that a chronic increase of butyrate/hexanoate in the circulation may improve host metabolism and metabolic health by improving adipose tissue function, reducing systemic lipid overflow and inflammation thereby increasing peripheral insulin sensitivity in individual with overweight/obesity and prediabetes., conditionsModule conditions: Type 2 Diabetes, conditions: PreDiabetes, conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: butyrate/hexanoate-enriched triglycerides, outcomesModule primaryOutcomes measure: Peripheral insulin sensitivity, secondaryOutcomes measure: hepatic insulin sensitivity, secondaryOutcomes measure: adipose tissue insulin sensitivity, secondaryOutcomes measure: Energy expenditure (indirect calorimetry), secondaryOutcomes measure: Substrate oxidation (indirect calorimetry), secondaryOutcomes measure: circulating SCFA, secondaryOutcomes measure: Faecal SCFA, secondaryOutcomes measure: Faecal microbiota composition, secondaryOutcomes measure: Circulating hormones such as insulin, secondaryOutcomes measure: Circulating metabolites such as glucose, secondaryOutcomes measure: body composition, secondaryOutcomes measure: body weight, secondaryOutcomes measure: Gut permeability, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06384300, orgStudyIdInfo id: BMSF, briefTitle: Financial Incentives and Motivational Intervention to Improve Gastric Cancer Screening in China, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2027-01-31, completionDateStruct date: 2027-07-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Peking University, class: OTHER, descriptionModule briefSummary: Gastric cancer, also known as stomach cancer, is a serious disease that affects the stomach. It's one of the most common types of cancer, and sadly, many people die from it each year. But there's hope! We can catch gastric cancer early with a special test called endoscopy. This test helps doctors find cancer or pre-cancerous changes in the stomach early, when it's easier to treat. However, not enough people get this test, especially in places where healthcare isn't easily available. That's why we're doing this study.We want to find out if we can encourage more people to get the endoscopy test for gastric cancer. We're going to try two different ways to encourage people to get the test. First, we'll give some people money or other incentives to help cover the costs of getting the test. Second, we'll give others information and support to help them understand why the test is important and how it can help them.We'll be doing this study in two provinces in China, where gastric cancer is a big problem. We'll ask thousands of people to join the study, and we'll randomly assign them to one of the two groups. Then, we'll see if more people in one group get the endoscopy test compared to the other group.Our hope is that by finding out what works best, we can help more people catch gastric cancer early and get the treatment they need. This could save many lives and make a big difference in fighting this disease., conditionsModule conditions: Gastric Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 5000, type: ESTIMATED, armsInterventionsModule interventions name: Financial Incentives, interventions name: Motivational Intervention, interventions name: Mixed Intervention, outcomesModule primaryOutcomes measure: Primary Outcome 1, primaryOutcomes measure: Primary Outcome 2, secondaryOutcomes measure: Secondary Outcome, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06384287, orgStudyIdInfo id: APHP231342, briefTitle: Peripheral Tissue Perfusion in Intensive Care, acronym: INPPEREA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-05, completionDateStruct date: 2027-05, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Tissue perfusion has been identified as an early prognosis factor in patients admitted to intensive care. However, little is known about the effects of different hemodynamic interventions performed in clinical routine on peripheral tissue perfusion.The aim of this work is to study the kinetics of CRT and local skin blood flow following therapeutic intervention (fluid challenge, vasopressor or inotropic drug)., conditionsModule conditions: Acute Circulatory Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Skin blood flow variations, secondaryOutcomes measure: Capillary refill time, secondaryOutcomes measure: Mottling score, secondaryOutcomes measure: correlation between Skin blood flow and CRT (baseline and variations), secondaryOutcomes measure: correlation between skin blood flow and Cardiac output, secondaryOutcomes measure: correlation between skin blood flow and mean arterial pressure, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06384274, orgStudyIdInfo id: NEUniversity, briefTitle: The Effect of Emotional Freedom Technique and Virtual Reality Glasses on Anxiety and Vital Signs, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Necmettin Erbakan University, class: OTHER, descriptionModule briefSummary: The aim of the study was to examine the effects of the emotional freedom technique and virtual reality glasses applied to individuals receiving hyperbaric oxygen therapy for the first time on anxiety and vital signs. The hypotheses of this research are that there is a difference between the emotional liberation technique and virtual reality glasses groups and the control group in terms of anxiety and vital signs., conditionsModule conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: Emotional Freedom Technique, interventions name: Virtual Reality Glasses, outcomesModule primaryOutcomes measure: State Anxiety Inventory (STAI), secondaryOutcomes measure: Blood Pressure, secondaryOutcomes measure: Pulse, secondaryOutcomes measure: Respiration, secondaryOutcomes measure: Body Temperature, secondaryOutcomes measure: Oxygen Saturation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Gülsüm Gürsoy Açikgöz, city: Konya, state: Meram, country: Turkey, contacts name: gülsüm GÜRSOY AÇIKGÖZ, role: CONTACT, phone: 05535553934, email: 2gulsum5@gmail.com, geoPoint lat: 37.87135, lon: 32.48464, hasResults: False

protocolSection identificationModule nctId: NCT06384261, orgStudyIdInfo id: OV-AML-1231, briefTitle: A Study Comparing Venetoclax and Azacitidine Plus Cusatuzumab to Venetoclax and Azacitidine in Newly Diagnosed AML Ineligible for Intensive Therapy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-01, completionDateStruct date: 2027-06, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: OncoVerity, Inc., class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to learn if participants treated with the experimental drug cusatuzumab added to venetoclax and azacitidine works to treat acute myeloid leukemia (AML) compared to venetoclax and azacitidine. Venetoclax and azacitidine are drugs commonly used to treat AML in patients that are unable to receive chemotherapy to treat AML. The main question the clinical trial aims to answer is does cusatuzumab added to venetoclax and azacitidine prolong the length of time participants live compared to venetoclax and azacitidine?, conditionsModule conditions: Leukemia, Myeloid, Acute, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Cusatuzumab, interventions name: Venetoclax, interventions name: Azacitidine, outcomesModule primaryOutcomes measure: Overall survival, secondaryOutcomes measure: Complete Remission rate (CR), secondaryOutcomes measure: Event-free survival (EFS), secondaryOutcomes measure: Composite CR rate (CRc), secondaryOutcomes measure: Rate of CRh and CRi, secondaryOutcomes measure: Duration of CR, secondaryOutcomes measure: Time to first CR, secondaryOutcomes measure: Rate of minimal residual disease (MRD) negativity in patients achieving CR, CRh, or CRi, secondaryOutcomes measure: Proportion of participants proceeding to hematopoietic stem cell transplantation (HSCT), secondaryOutcomes measure: OS in participants undergoing HSCT, secondaryOutcomes measure: Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to study drug discontinuation, secondaryOutcomes measure: Incidence of dose modifications due to AEs, secondaryOutcomes measure: Number of participants with abnormal laboratory test results, secondaryOutcomes measure: Incidence of anti-drug antibodies (ADA) and neutralizing antibodies (NAb), secondaryOutcomes measure: Overall survival in subgroups of participants according to specified AML risk stratification models, secondaryOutcomes measure: Complete Remission rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06384248, orgStudyIdInfo id: LTC004-205, briefTitle: Phase II Clinical Study of LTC004 in Patients With Advanced Sarcoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-26, primaryCompletionDateStruct date: 2025-12-28, completionDateStruct date: 2025-12-28, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Letolab, class: INDUSTRY, descriptionModule briefSummary: This is a phase II clinical study to evaluate the safety, tolerability and preliminary antitumor activity of LTC004 in patients with locally advanced or metastatic sarcoma；Enrollment of 10 evaluable subjects in Phase I. If ≥2 subjects experience objective remission or SD lasting \>12 weeks, proceed to Phase II to enroll an additional 20 evaluable subjects to further evaluation of the safety and efficacy of LTC004, conditionsModule conditions: Unresectable or Metastatic Sarcoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: LTC004, outcomesModule primaryOutcomes measure: ORR, secondaryOutcomes measure: DOR, secondaryOutcomes measure: PFS rate, secondaryOutcomes measure: OS, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06384235, orgStudyIdInfo id: LTC004-203, briefTitle: Phase II Clinical Study of LTC004 in Patients With mCRC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2025-08-23, completionDateStruct date: 2025-08-23, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Letolab, class: INDUSTRY, descriptionModule briefSummary: This is a phase II clinical study to evaluate the safety and antitumor activity of LTC004 in patients with locally advanced or metastatic CRC，Enrollment of 10 evaluable subjects in Phase I. If ≥2 subjects experience objective remission，proceed to Phase II to enroll an additional 20 evaluable subjects to further evaluation of the safety and efficacy of LTC004, conditionsModule conditions: Locally Advanced or Metastatic CRC, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: LTC004, outcomesModule primaryOutcomes measure: ORR, secondaryOutcomes measure: DOR, secondaryOutcomes measure: PFS, secondaryOutcomes measure: OS, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06384222, orgStudyIdInfo id: 235513, secondaryIdInfos id: NCI-2024-03418, type: REGISTRY, domain: NCI Clinical Trials Reporting Program (CTRP), briefTitle: Hyperpolarized (HP) 13C Pyruvate Magnetic Resonance Imaging (MRI) MRI as a Response Monitoring Tool to Neoadjuvant Abiraterone, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-30, primaryCompletionDateStruct date: 2027-07-31, completionDateStruct date: 2027-07-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Ivan de Kouchkovsky, MD, class: OTHER, descriptionModule briefSummary: This study will evaluate the use of hyperpolarized 13C MRI (HP 13C MRI) and the HP-derived 13C pyruvate-to-lactate conversion rate constant (kPL) as an early response biomarker in men with treatment-naïve, high-risk, localized or locally advanced prostate cancer receiving neoadjuvant therapy., conditionsModule conditions: High Risk Prostate Carcinoma, conditions: Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Abiraterone acetate, interventions name: Prednisone, interventions name: Hyperpolarized [1-13C] pyruvate (HP 13C), interventions name: Magnetic Resonance Imaging (MRI), interventions name: Non-investigational radical prostatectomy (RP), interventions name: Prostate-Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) PET/Computerized tomography (CT), outcomesModule primaryOutcomes measure: Mean changes in intratumoral KPL, secondaryOutcomes measure: Pathological response rate, secondaryOutcomes measure: Proportion of participants with treatment-related adverse events, secondaryOutcomes measure: Proportion of participants completing RP, secondaryOutcomes measure: Median Time to Biochemical Recurrence, secondaryOutcomes measure: Proportion of participants with a >=50% decline in PSA level from baseline (PSA50) response, secondaryOutcomes measure: Proportion of participants with a >=90% decline in PSA level from baseline (PSA90) response, secondaryOutcomes measure: Mean PSA nadir, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of California, San Francisco, city: San Francisco, state: California, zip: 94143, country: United States, contacts name: Maya Aslam, role: CONTACT, phone: 415-514-8987, email: Maya.Aslam@ucsf.edu, contacts name: Ivan de Kouchkovsky, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.77493, lon: -122.41942, hasResults: False

protocolSection identificationModule nctId: NCT06384209, orgStudyIdInfo id: FBplus2024, briefTitle: The Friendship Bench Plus Trial, acronym: FB+, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2026-12-28, completionDateStruct date: 2027-02-28, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University of Bern, class: OTHER, collaborators name: University of Zimbabwe, collaborators name: Swiss National Science Foundation, descriptionModule briefSummary: The goal of this randomised controlled trial is to enhance the Friendship Bench intervention with antidepressants in adults with moderate to severe depression. The main questions it aims to answer are:1. Is the combination of the Friendship Bench with nurse-led antidepressants prescribing superior to the Friendship Bench alone?2. What are the barriers and enablers for the prescription of antidepressants by non-specialists in primary care?Type of study: Randomized controlled superiority trialParticipants will be randomly selected and allocated into the control arm or intervention arm. Participants in the control arm will receive six sessions of the Friendship Bench Problem Solving Therapy while those in the intervention arm will receive the Friendship Bench intervention plus Fluoxetine (Sertraline for breastfeeding women)., conditionsModule conditions: Major Depressive Disorder, conditions: Severe Depressive Episode Without Psychotic Symptoms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 296, type: ESTIMATED, armsInterventionsModule interventions name: Friendship Bench intervention, interventions name: Antidepressants -Fluoxetine, outcomesModule primaryOutcomes measure: Treatment response, secondaryOutcomes measure: Remission, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Zimbabwe, city: Harare, country: Zimbabwe, contacts name: Rukudzo Mwamuka, Mbchb,MMed(Psychiatry), role: CONTACT, phone: +263777065549, email: ruemwamuka.tsungu@gmail.com, contacts name: Jermaine Dambi, PhD, role: CONTACT, phone: +263773444911, email: jermaine.dambi@friendshipbench.io, geoPoint lat: -17.82772, lon: 31.05337, hasResults: False

protocolSection identificationModule nctId: NCT06384196, orgStudyIdInfo id: PID2022-138902OB-I00, briefTitle: Identity-Based Transdiagnostic Therapy for Young People With Anxiety and Depression, acronym: IBTTYOUNG, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-02, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-11-02, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University of Barcelona, class: OTHER, collaborators name: Badalona Serveis Assistencials, collaborators name: Nou Barris Mental Health Center, descriptionModule briefSummary: Depression and anxiety are the most prevalent mental disorders among both the general population and young adults, and transdiagnostic treatments for these patients are mostly based on cognitive-behavioral therapy (CBT). Based on common (transdiagnostic) principles of treatment (e.g., emotional exposure), these approaches have proliferated and demonstrated their efficacy in comparison to disorder-specific treatments. Although there are a few transdiagnostic approaches for children and adolescents, we could not find anyone targeting young people. For this reason, we propose the Identity-Based Transdiagnostic Therapy (IBTT) as a new treatment modality ideally created to address the challenge of improving the outcomes of psychotherapy for young adults with anxiety and/or depression. The IBTT is a psychological treatment for emotional disorders specifically designed for the youths in terms of their attitudes to treatment (attractiveness, engagement), and highly personalized to their construal of self and others. This project will allow testing the hypothesis that a novel brief psychotherapeutic intervention, IBTT, will be more efficacious in the treatment of the anxiety and/or depression of young adults than the well-established CBT-based Unified Protocol., conditionsModule conditions: Depression, conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The main study of this project proposal is a multi-center, single-blind, parallel-group randomized clinical trial (RCT) conducted in Catalonia (Spain)., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 138, type: ESTIMATED, armsInterventionsModule interventions name: Identity-Based Transdiagnostic Therapy (IBTT), interventions name: Unified Protocol, outcomesModule primaryOutcomes measure: Depression, Anxiety and Stress Scales (DASS-21), secondaryOutcomes measure: Clinical Outcomes in Routine Evaluation-Short Form B (CORE-SFB), secondaryOutcomes measure: Mini International Neuropsychiatric Interview (MINI), secondaryOutcomes measure: Session Rating Scale 3.0 (SRS 3.0), secondaryOutcomes measure: Life Satisfaction Scale (LSS), secondaryOutcomes measure: Self-Concept Clarity Scale (SCCS), secondaryOutcomes measure: Rosenberg Self-Esteem Scale (RSES), secondaryOutcomes measure: Metacognition Self-Assessment Scale (MSAS), secondaryOutcomes measure: Problem definition form, secondaryOutcomes measure: Change Interview, secondaryOutcomes measure: Consumer Reports Effectiveness Scale (CRES-4), eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 29 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Badalona Serveis Assistencials, city: Badalona, zip: 08911, country: Spain, contacts name: Irene Alvarez, PhD, role: CONTACT, email: iatomas@bsa.cat, geoPoint lat: 41.45004, lon: 2.24741, locations facility: Associació Centre Higiene Mental Nou Barris, city: Barcelona, zip: 08042, country: Spain, contacts name: Giuseppina Rametti, PhD, role: CONTACT, email: giusi.rametti@csm9b.com, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False

protocolSection identificationModule nctId: NCT06384183, orgStudyIdInfo id: KS-1000, briefTitle: Kerecis Real World Registry, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2027-06, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Kerecis Ltd., class: INDUSTRY, descriptionModule briefSummary: Multi-center, observational (i.e., non-interventional), open-label, real-world Registry on the Use of Kerecis Devices, conditionsModule conditions: Wounds, conditions: Pressure Ulcer, conditions: Diabetic Foot Ulcer, conditions: Venous Leg Ulcer, conditions: Surgical Wound, conditions: Soft Tissue Reinforcement, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: OTHER, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Kerecis Fish Skin Graft, outcomesModule primaryOutcomes measure: Fish Skin Graft Device Related failure, primaryOutcomes measure: Fish Skin Graft Device related allergy, primaryOutcomes measure: Target Wound Infection, secondaryOutcomes measure: Complete Wound Healing, secondaryOutcomes measure: Complete Wound Closure, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06384170, orgStudyIdInfo id: IRB00442113, briefTitle: Closed Loop Spinal Cord Stimulation for Neuromodulation of Upper Motor Neuron Lesion Spasticity, acronym: CLONUS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, collaborators name: Saluda Medical Pty Ltd, descriptionModule briefSummary: Spasticity is characterized by increased muscle tension and is a classic consequence of upper motor neuron (UMN) damage in the central nervous system, such as from stroke or trauma. Clinically, it presents as muscle resistance to passive stretching, along with clasp-knife rigidity, clonus, increased tendon reflexes, and muscle spasms. An imbalance of the descending inhibitory and muscle stretch reflexes is thought to be the cause of spasticity. Post-stroke spasticity is a common condition that occurs in 37.5-45% of cases in the acute stage and 19-57.4% in the subacute stage after a stroke. At 6 months post-stroke, spasticity develops in 42.6-49.5% of cases, and at one year, it affects 35-57.4% of individuals. In patients with cerebral palsy (CP), incidence is almost 80% while in those living with spinal cord injury the number approaches up to 93%. Traumatic brain injury (TBI) patients have a higher prevalence on initial admission to neurorehabilitation but one in three patients will have chronic spasticity. However, the Defense and Veterans Brain Injury Center report a rate of TBIs amongst deployed veterans to be around 11-23% mostly from blast and explosive trauma.There have been studies as early as the 1980s exploring the efficacy of SCS for spasticity control, however, the credibility of many of these studies is constrained due to an incomplete comprehension of spasticity's underlying mechanisms, outdated research methods, and early limitations in implantable device technology. Intrathecal pumps for baclofen have remained as the mainstay for refractory spasticity, however, it comes with associated risks such as chemical dependence leading to acute baclofen withdrawal and requiring frequent refill requirement. Most importantly, it does not yield functional improvement of muscle activity, just suppression of spasticity. Botox is also routinely used but due to heterogeneity in muscle involvement as well as variability in provider skill, results may be inconsistent and short-lasting, requiring frequent clinic visits for repeat injections to the affected muscle groups. SCS may be able to address that gap in spasticity management., conditionsModule conditions: Chronic Pain, conditions: Spasticity as Sequela of Stroke, conditions: Upper Motor Neuron Lesion, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Spinal Cord Stimulation- Closed loop, outcomesModule primaryOutcomes measure: Pain as assessed by Visual Analog Score, secondaryOutcomes measure: Spasticity Reduction as assessed by the Modified Ashworth's Score, secondaryOutcomes measure: Short Form 36 Health Survey (SF-36) score, secondaryOutcomes measure: Medication Use, secondaryOutcomes measure: Health Status as assessed by the EuroQol 5 Dimension 5 Level (EQ-5D-5L), otherOutcomes measure: Spinal cord neurophysiological wave morphology, otherOutcomes measure: Spinal cord neurophysiological Current (mA/mV), otherOutcomes measure: Spinal Cord Neurophysiological Characteristic- Conduction Velocity (m/s), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Johns Hopkins Hospital, city: Baltimore, state: Maryland, zip: 21287, country: United States, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False

protocolSection identificationModule nctId: NCT06384157, orgStudyIdInfo id: INDV-2000-201, briefTitle: Proof of Concept and Dose-ranging Study of INDV-2000 in Individuals With Moderate to Severe Opioid Use Disorder, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Indivior Inc., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to measure safety and efficacy and to determine dose-response relationship for INDV-2000 in participants with moderate to severe Opioid Use Disorder (OUD) who are new to treatment, have recently initiated or completed short-term medically supervised withdrawal with transmucosal (TM) buprenorphine, and are interested in transitioning to a non opioid treatment., conditionsModule conditions: Opioid Use Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: This is a randomized, double-blind, placebo-controlled study where the investigator, assessor, sponsor and participant are masked., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: INDV-2000, interventions name: Placebo, outcomesModule primaryOutcomes measure: Proportion (probability) of participants without treatment failure by the end of Week 12 (Day 85)., secondaryOutcomes measure: Proportion (probability) of visits with opioid abstinence while participants are on IMP alone., secondaryOutcomes measure: Participant's percentage of visits with opioid abstinence during the whole study follow-up., secondaryOutcomes measure: Incidence, severity and relatedness of adverse events, treatment-emergent adverse events, serious adverse events and events leading to discontinuation and deaths., secondaryOutcomes measure: Opioid Craving Assessment, secondaryOutcomes measure: Cmax on Day 1 and Day 15/16, secondaryOutcomes measure: Tmax on Day 1 and Day 15/16, secondaryOutcomes measure: AUC0-24 on Day 1 and Day 15/16, secondaryOutcomes measure: Cavg on Day 1 and Day 15/16, secondaryOutcomes measure: Cmin on Day 1 and Day 15/16, secondaryOutcomes measure: CL/F on Day 1 and Day 15/16, secondaryOutcomes measure: Clinical Opiate Withdrawal Scale (COWS) score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06384144, orgStudyIdInfo id: 23QC8155, briefTitle: Machine Learning Miscarriage Management Clinical Decision Support Tool Study, acronym: MLMM, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Imperial College London, class: OTHER, descriptionModule briefSummary: Machine learning used to develop an algorithm to determine chance of success with expectant or medical management for an individual patient. Taking into account the following objective measures:* Demographics: Maternal Age, Parity* History: Previous CS, Previous SMM/MVA, Previous Myomectomy* Gestation by LMP* Presenting symptoms: Bleeding score, Pain score* USS Measurements: CRL, GS, RPOC 3 dimensions, Vascularity* Discrepancy between gestation by CRL and LMPAudit to collate 1000 cases and identify features contributing to an algorithm that can predict outcome of miscarriage management for individualized case management., conditionsModule conditions: Miscarriage in First Trimester, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Expectant Management of First Trimester Miscarriage, interventions name: Medical Management of First Trimester Miscarriage, outcomesModule primaryOutcomes measure: Machine learning predictive model development for miscarriage management outcomes., secondaryOutcomes measure: Prospective audit to test and validate predictive model, eligibilityModule sex: FEMALE, minimumAge: 16 Years, maximumAge: 55 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Imperial College Heatlhcare NHS Trust, status: RECRUITING, city: London, zip: W12 0HS, country: United Kingdom, contacts name: Sughashini Murugesu, role: CONTACT, phone: 07988390772, email: sughashini.murugesu@nhs.net, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False

protocolSection identificationModule nctId: NCT06384131, orgStudyIdInfo id: ABI-4334-102, secondaryIdInfos id: 2024-511051-18, type: EUDRACT_NUMBER, briefTitle: A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-4334 in Subjects With Chronic Hepatitis B Virus Infection, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2025-04-22, completionDateStruct date: 2025-04-22, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Assembly Biosciences, class: INDUSTRY, descriptionModule briefSummary: This is a randomized, blinded, placebo-controlled, dose-ranging Phase 1b study of the safety, PK, and antiviral activity of ABI-4334 in treatment-naïve or off-treatment chronic Hepatitis B virus (cHBV) subjects that are Hepatitis B e antigen (HBeAg) positive or negative. The study will enroll up to 5 sequential cohorts of 10 subjects each, for a total of up to 50 subjects, randomized 8:2 to receive ABI-4334 or placebo., conditionsModule conditions: Chronic Hepatitis B, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Triple (Participant, Care Provider, Investigator), whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: ABI-4334, interventions name: Placebo, outcomesModule primaryOutcomes measure: Primary Outcome Measure, secondaryOutcomes measure: Maximum Plasma Concentration (Cmax) of ABI-4334 in subjects with cHBV, secondaryOutcomes measure: Minimum Plasma Concentration (Cmin) of ABI-4334 in subjects with cHBV, secondaryOutcomes measure: Area Under Plasma Concentration-Time Curve (AUC) of ABI-4334 in subjects with cHBV, secondaryOutcomes measure: Time to Maximum Plasma Concentration (Tmax) of ABI-4334 in subjects with cHBV, secondaryOutcomes measure: Elimination half-life (t1/2) of ABI-4334 in subjects with cHBV, secondaryOutcomes measure: To evaluate the changes in HBV DNA (IU/mL or Log IU/mL) in subjects with cHBV, secondaryOutcomes measure: Proportion of subjects with HBV DNA < lower limit of quantification (LLOQ) and/or limit of detection (LOD), secondaryOutcomes measure: Mean time elapsed to subjects achieving HBV DNA < LLOQ and/or LOD, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06384118, orgStudyIdInfo id: YZUHL20220047, briefTitle: Effects of a Health Intervention on Hypoglycemic Coping : a Pilot Study, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2024-01-17, completionDateStruct date: 2024-01-17, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Yating Liu, class: OTHER, descriptionModule briefSummary: From August 2023 to January 2024, 100 patients with type 2 diabetes who met the inclusion and exclusion criteria were selected from the endocrinology department of The purpose of this study was to construct a hypoglycemia coping intervention program for type 2 diabetic patients based on the IMB theory and to investigate the feasibility, acceptability, and initial effects of the program., conditionsModule conditions: Type 2 Diabetes Mellitus, conditions: Hypoglycemia, conditions: Health Education, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ACTUAL, armsInterventionsModule interventions name: Impact of an IMB theory-based health education intervention on hypoglycemic coping in patients with type 2 diabetes: a pilot study, outcomesModule primaryOutcomes measure: The hypoglycemic coping style, secondaryOutcomes measure: hypoglycemic fear behavioral, secondaryOutcomes measure: Hypoglycemia fear worry, secondaryOutcomes measure: Level of health information access behavior, secondaryOutcomes measure: Level of health beliefs, secondaryOutcomes measure: Level of diabetes knowledge, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ya ting Liu, city: Yangzhou, state: 未选择, country: China, geoPoint lat: 32.39722, lon: 119.43583, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-08-01, uploadDate: 2024-04-16T10:45, filename: Prot_SAP_000.pdf, size: 233766, hasResults: False

protocolSection identificationModule nctId: NCT06384105, orgStudyIdInfo id: PRDE1, briefTitle: Study of the Patient Radiation Dose During Five Endourological Procedures, acronym: PRDE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-19, primaryCompletionDateStruct date: 2024-12-18, completionDateStruct date: 2024-12-18, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Universiteit Antwerpen, class: OTHER, descriptionModule briefSummary: In the medical world more and more procedures are performed with the use of ionizing radiation (x-ray), both diagnostic and therapeutic. The main and most known risk is the development of malignancies as a result of the use of ionizing radiation.Purpose of this study: To examine the patient radiation dose (PRD) if the frames per second (FPS) are set differently during the five most performed endourological procedures where fluoroscopy is used (insertion/replacement of ureteral stent, (mini-)percutaneous nephrolithotomy (PCNL/PNL), ureterorenoscopy (URS) and extracorporeal shock wave lithotripsy (ESWL/SWL)) and to propose an acceptable PRD for these procedures in a multicentric study., conditionsModule conditions: Radiation Exposure, conditions: Urolithiasis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 870, type: ESTIMATED, armsInterventionsModule interventions name: frames per second, outcomesModule primaryOutcomes measure: Dose limit, secondaryOutcomes measure: Difference in PRD, secondaryOutcomes measure: PRD different centres, secondaryOutcomes measure: PRD difference complicated cases, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: AZ Klina, status: RECRUITING, city: Brasschaat, state: Antwerp, zip: 2930, country: Belgium, contacts name: Vincent De Coninck, MD, role: CONTACT, phone: +32 3 650 50 56, phoneExt: +32, email: vincent.de.coninck@klina.be, geoPoint lat: 51.2912, lon: 4.49182, locations facility: UZA, status: RECRUITING, city: Edegem, state: Antwerp, zip: 2650, country: Belgium, contacts name: Stefan De Wachter, MD, role: CONTACT, phone: +32 3 821 33 68, phoneExt: +32, email: stefan.de.wachter@uza.be, geoPoint lat: 51.15662, lon: 4.44504, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-07-06, uploadDate: 2024-04-22T15:53, filename: ICF_000.pdf, size: 735146, hasResults: False

protocolSection identificationModule nctId: NCT06384092, orgStudyIdInfo id: NB240005-NB-V, briefTitle: Process Validation in Dermatology: Assessing Methods for UV Exposure (Artificial Source vs. Sunlight) and Efficacy Evaluation of Anti-Tanning Agents, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-03-07, primaryCompletionDateStruct date: 2024-03-13, completionDateStruct date: 2024-03-13, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: NovoBliss Research Pvt Ltd, class: OTHER, descriptionModule briefSummary: The rationale of this study is to establish a robust method for assessing sun protection product efficacy in preventing erythema and tanning. Employing both artificial ultraviolet-A Irradiation and natural direct sunlight exposure, the investigation seeks to provide a reliable methodology, ensuring reproducibility and enabling a direct comparison between these methods. Meticulously determining optimal UV dosages, the study prioritizes inducing skin responses for evaluation while avoiding adverse effects like blistering. The localized validation of UV exposure techniques, tailored to the Indian population, contributes significantly to the field by addressing diverse skin types and environmental conditions. By incorporating both artificial and natural (direct sunlight) UV exposure methods, the study aspires to enhance the safety and effectiveness of future dermatological investigations, benefiting both the scientific community and the broader population., conditionsModule conditions: Skin Pigmentation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Proof of science/concept, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 6, type: ACTUAL, armsInterventionsModule interventions name: Test Sun Protection Cream, interventions name: Benchmark Sun Protection Cream, outcomesModule primaryOutcomes measure: Changes in Melanine index using instrumental assessment, primaryOutcomes measure: Change in erythema index using instrumental assessment, secondaryOutcomes measure: Change in skin erythema/dryness/wrinkles and oedema using draize scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: NovoBliss Research Pvt Ltd, city: Gandhinagar, state: Gujarat, zip: 382421, country: India, geoPoint lat: 23.21667, lon: 72.68333, hasResults: False

protocolSection identificationModule nctId: NCT06384079, orgStudyIdInfo id: STU00219828, briefTitle: Duration of Ureteral Rest Prior to Ureteral Reconstruction Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-11, completionDateStruct date: 2030-11, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Northwestern University, class: OTHER, descriptionModule briefSummary: Our objective is to assess the effect of duration of ureteral rest, defined as time from conversion of ureteral stent to percutaneous nephrostomy, on stricture length prior to ureteral reconstruction surgery., conditionsModule conditions: Ureteral Stricture, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Antegrade and retrograde pyelogram, outcomesModule primaryOutcomes measure: Ureteral stricture length measured by antegrade or retrograde pyelogram, secondaryOutcomes measure: Ureteral Stricture Quality will be graded as either narrowed or obliterated segment., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Northwestern University, status: RECRUITING, city: Chicago, state: Illinois, zip: 60611, country: United States, contacts name: Emily Ji, role: CONTACT, phone: 312-695-8146, email: emily.ji@nm.org, contacts name: Ziho Lee, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.85003, lon: -87.65005, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-10-25, uploadDate: 2024-03-01T13:40, filename: Prot_000.pdf, size: 140931, hasResults: False

protocolSection identificationModule nctId: NCT06384066, orgStudyIdInfo id: STU00219774, briefTitle: Mobile Health Application to Improve Patient Satisfaction After Urethroplasty, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Northwestern University, class: OTHER, descriptionModule briefSummary: Create a custom urethroplasty mobile application that will guide patients through through the surgical process., conditionsModule conditions: Urethral Stricture, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: GetWell Mobile Application, interventions name: Standard of Care, outcomesModule primaryOutcomes measure: Improve patient satisfaction, education and reported outcomes, primaryOutcomes measure: Change in rate of patient phone calls and messages, primaryOutcomes measure: Rate of emergency department visits, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 89 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-10-04, uploadDate: 2024-03-01T13:15, filename: Prot_000.pdf, size: 9077970, hasResults: False

protocolSection identificationModule nctId: NCT06384053, orgStudyIdInfo id: SAHARA Trial, briefTitle: Skin Cancer and Hyperthermia and Radiotherapy, acronym: SAHARA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2026-07-01, completionDateStruct date: 2028-07-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Kantonsspital Winterthur KSW, class: OTHER, collaborators name: Luzerner Kantonsspital, descriptionModule briefSummary: The SAHARA trial assesses wether combining ultrahypofractionated accelerated radiotherapy (RT) with hyperthermia is as effective as standard hypofractionated high-dose radiation in treating non-melanoma skin cancer (NMSC)., conditionsModule conditions: Basal Cell Carcinoma, conditions: Squamous Cell Carcinoma Skin, conditions: Non-melanoma Skin Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combined, interventions name: Radiotherapy (RT), outcomesModule primaryOutcomes measure: Local control, secondaryOutcomes measure: Analysis, secondaryOutcomes measure: Late toxicities, secondaryOutcomes measure: Quality of life assessment, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kantonsspital Winterthur, city: Winterthur, state: Kanton Zuerich, zip: 8401, country: Switzerland, geoPoint lat: 47.50564, lon: 8.72413, locations facility: Luzerner Kantonsspital, city: Luzern, zip: 6000, country: Switzerland, contacts name: Winfried Arnold, MD, role: CONTACT, geoPoint lat: 47.05048, lon: 8.30635, hasResults: False

protocolSection identificationModule nctId: NCT06384040, orgStudyIdInfo id: GR-2019-12370692, briefTitle: Immuno-based Profiling of knEe OA Patients to Predict reSponse to Regenerative Treatment, acronym: IMPRESA, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-11-01, primaryCompletionDateStruct date: 2023-09-04, completionDateStruct date: 2024-10-30, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Istituto Clinico Humanitas, class: OTHER, collaborators name: Istituto Ortopedico Rizzoli, descriptionModule briefSummary: Osteoarthritis (OA) is a highly prevalent degenerative musculoskeletal disease and a major cause of chronic disability worldwide. Its multifactorial origin contributes to determine the heterogeneous phenotypes and one unmet need is the lack of biomarkers to predict the individual response. Platelet-rich-plasma (PRP) injection is a minimally invasive autologous blood-derived approach for which we plan to define specific knee profiles predictive of response. We will take advantage of a unique multidisciplinary approach aimed at analysing clinics, imaging, and biomarkers of associated with clinical response. We will focus on inflammatory (Wnt system, IL1 pathway, PTX3) and antioxidant (primarily, DPP3/Keap1/Nrf2) pathways. We foresee that our results will allow a better allocation of immunomodulatory and regenerative therapies for a personalized approach in knee OA thus maximising the effectiveness of the healthcare allocation., conditionsModule conditions: Osteoarthritis, Knee, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 105, type: ESTIMATED, armsInterventionsModule interventions name: platelet-rich plasma knee injection, outcomesModule primaryOutcomes measure: knee OA patients focusing on changes in Wnt and IL1-ß signalling and PTX3 expression, secondaryOutcomes measure: To assess the overall oxidative status and antioxidant capacity of the enrolled OA patients and its possible prognostic role with respect to response to PRP treatment, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Clinico Humanitas, status: RECRUITING, city: Rozzano, state: Milano, zip: 20089, country: Italy, contacts name: Berardo Di Matteo, role: CONTACT, phone: 02 82241, email: reumatologia@humanitas.it, geoPoint lat: 45.38193, lon: 9.1559, hasResults: False

protocolSection identificationModule nctId: NCT06384027, orgStudyIdInfo id: VNI_USG_2024, briefTitle: Effects of Non-invasive Ventilation on Function Diaphragmatic and Caval Distension, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-05, primaryCompletionDateStruct date: 2024-04-17, completionDateStruct date: 2024-06-10, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Federal University of Paraíba, class: OTHER, descriptionModule briefSummary: Introduction: Understanding how the applicability of non-invasive ventilation can directly affect the anatomy and diaphragmatic function, as well as the opening diameter of the inferior vena cava in healthy individuals is fundamental to knowing how this therapy can interfere with treatment results. Objective: Identify the acute effects of PEEP and ventilatory support pressure on thickening fraction, diaphragmatic mobility and vena cava distension in healthy people. Methods: This is a crossover, randomized study, blinded to the evaluator and the researcher responsible for the statistical analysis. Volunteers will undergo a NIV session, randomized into groups: CPAP, Bi-level and spontaneous breathing, without NIV support (control). The outcomes evaluated will be diaphragmatic ultrasound and inferior vena cava distensibility. The CPAP levels will be: 5, 10 and 15 cmH2O after 5 minutes of use and in the Bi-level group we will maintain the PEEP value at 5cmH2O and modify the pressure support values to the values: 5, 7 and 10 cmH2O pressure support, with all outcomes also being assessed after 5 minutes. Participants will remain in a supine position, with the right upper limb positioned behind the head, throughout the protocol and all measurements will be collected in the inspiratory and expiratory phases with volumes basal currents. For statistical analysis, intention-to-treat analysis will be employed and groups will be compared using Student's t-test, for continuous variables, or chi-square, for categorical variables. ANOVA split-plot, repeated measures for primary occurrences. Analyzes of covariance to identify differences between groups using baseline scores as covariates. Effect sizes and confidence intervals will be calculated using eta squared (η²). Expected results: Elucidate the effects of different blood pressure levels on diaphragmatic function and inferior vena cava distension., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: This is a crossover, randomized study, blinded, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Non-invasive ventilation, outcomesModule primaryOutcomes measure: Diaphragmatic thickening fraction, secondaryOutcomes measure: Diaphragmatic mobility, otherOutcomes measure: Ultrasound of inferior vena cava distension, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Federal University of Paraiba, status: RECRUITING, city: João Pessoa, state: Paraiba, zip: 58051-900, country: Brazil, contacts name: Eduardo França, PhD, role: CONTACT, phone: 5583996575859, geoPoint lat: -7.115, lon: -34.86306, hasResults: False

protocolSection identificationModule nctId: NCT06384014, orgStudyIdInfo id: 2024/56, briefTitle: Examining the Effect of Different Filling Techniques on Healing in Lesional Teeth, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: TC Erciyes University, class: OTHER, descriptionModule briefSummary: Microorganisms are an important factor in the development of periradicular diseases. The goal of non-surgical endodontic treatment is to eliminate microorganisms and their byproducts from the root canal system and to create an effective barrier between the root canal system and surrounding tissues. If there is no healing in the periradicular tissues after non-surgical endodontic treatment or if retreatment becomes impossible, surgical endodontic treatment is required. Apical resection is a surgical technique that involves removing the root tip of the tooth and closing the apical portion of the root canal system. An ideal retrograde filling material should be non-toxic, non-carcinogenic and biocompatible. It must also have dimensional stability and sealing properties. Amalgam, glass ionomer cements, and zinc oxide-eugenol based materials have been used for root end fillings in periapical surgery, but the desired success was not achieved. Today, Mineral Trioxide Aggregate (MTA) is preferred as a retrograde filling material due to its superior sealing properties, ability to harden in the presence of blood and moisture, antibacterial effects, biocompatibility and radiopacity.In the researchers' study, the effect of apical resection after orthograde canal filling and retrograde canal filling during apical resection on postoperative recovery will be compared. In both canal filling techniques, Sure-Seal Root MTA (Sure Dent Corporation-Korea) will be used as the filling material. Sure-Seal Root MTA is a calcium silicate based paste that is typically pre-mixed and ready to apply, exhibits excellent physical properties and does not show shrinkage during the curing process. As the manufacturer states, it is hydrophilic, biocompatible, has ideal setting and working time.Our faculty has piezosurgical ultrasonics (Mectron ®, Grassobbio BG, Italy). After the root tip resection is performed, the retrograde cavity will be prepared with Woodpecker ultrasonic tips (Guilin, China) compatible with this device. In our study using these materials and devices, a comparative analysis of the effects of different canal filling techniques on lesion healing and improvement in clinical symptoms will be made., conditionsModule conditions: Apical Cyst, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: İki farklı grupta farklı kanal dolum teknikleri uygulandıktan sonra apikal rezeksiyon yapılarak lezyon iyileşmesinin değerlendirilmesi, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: retrograde and orthograde root canal filling, outcomesModule primaryOutcomes measure: Comparison of lesion healing rate after apical resection using different root canal filling techniques, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erciyes Üniversitesi Diş Hekimliği Fakültesi, status: RECRUITING, city: Kayseri, zip: 38039, country: Turkey, contacts name: ERASLAN AKYÜZ, role: CONTACT, phone: 4447138, phoneExt: 0352, email: ipekemamak@hotmail.com, geoPoint lat: 38.73222, lon: 35.48528, hasResults: False

protocolSection identificationModule nctId: NCT06384001, orgStudyIdInfo id: STUDY00004032, briefTitle: Meditation for Older Adults With Chronic Low Back Pain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-10, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Florida State University, class: OTHER, descriptionModule briefSummary: This pilot randomized controlled trial aims to recruit 66 community-dwelling older adults with chronic low back pain and follow up them for 8 weeks. This study aims to test the preliminary effect of a mindfulness-based meditation (MBM) intervention on pain and symptoms among community-dwelling older adults with chronic low back pain, and also to test the effect of the MBM intervention on the host Gut-Brain Axis (GBA)., conditionsModule conditions: Chronic Low Back Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: Active MBM, interventions name: Sham MBM, outcomesModule primaryOutcomes measure: Change in pain intensity and interference, secondaryOutcomes measure: Change in pain sensitivities, secondaryOutcomes measure: Change in pain modulation, secondaryOutcomes measure: Change in chronic pain self-efficacy, secondaryOutcomes measure: Change in anxiety, secondaryOutcomes measure: Change in cognitive complaints, secondaryOutcomes measure: Change in depression, secondaryOutcomes measure: Change in fatigue, secondaryOutcomes measure: Change in sleep disturbance, secondaryOutcomes measure: Change in pain-related cortical response, secondaryOutcomes measure: Measurement and comparison of fecal microbiota alpha diversity, beta diversity, and abundance of microbial taxa in the human gut, secondaryOutcomes measure: Chang in inflammatory cytokines, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 89 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06383988, orgStudyIdInfo id: IRB000112187, secondaryIdInfos id: NCI-2023-10870, type: OTHER, domain: NCI Trial Identifier, secondaryIdInfos id: Lead Organization Identifier, type: OTHER, domain: WF-2301CD, briefTitle: A Web-based Program to Help Caregivers of Lung Patients Learn About Available Supportive Care Resources, acronym: CONNECT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2025-10, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Wake Forest University Health Sciences, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: Clinical trial that tests the feasibility of a web based caregiver support resource, along with caregiver navigation sessions for caregivers of patients with stage II-IV lung cancer. The Caregiver Oncology Needs Evaluation Tool (CONNECT) is a novel web-based intervention designed for the community oncology setting, to systematically connect lung cancer caregivers with tailored supportive care resources. Lung cancer caregivers provide critical and challenging care for their loved ones and are at risk for their own negative psychosocial and physical outcomes. Implementing the CONNECT program along with caregiver navigation may provide additional support to caregivers of patients with stage II-IV lung cancer., conditionsModule conditions: Stage II Lung Cancer, conditions: Stage III Lung Cancer, conditions: Stage IV Lung Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 240, type: ESTIMATED, armsInterventionsModule interventions name: Support for Caregiver - Generic List, interventions name: Support for Caregiver - Personalized List, interventions name: Internet-Based Intervention - CONNECT, interventions name: Patient Navigation, outcomesModule primaryOutcomes measure: Caregiver retention at 12 weeks, secondaryOutcomes measure: Caregiver accrual rate, secondaryOutcomes measure: Caregiver participation, secondaryOutcomes measure: Caregiver retention at 24 weeks, secondaryOutcomes measure: Caregiver acceptability, secondaryOutcomes measure: Average time (minutes) needed for training for Local Practice Referral Coordinator, secondaryOutcomes measure: Desired modality for training (e.g., live webinar, recorded video, paper materials) for Local Practice Referral Coordinator, secondaryOutcomes measure: Average time (minutes) needed to identify and enter local resources into the Caregiver Oncology Needs Evaluation Tool (CONNECT) database, secondaryOutcomes measure: Frequency of needed resource updates in the CONNECT database, secondaryOutcomes measure: Average time (minutes) spent by the Central Caregiver Navigator and Local Practice Referral Coordinators with each caregiver in the CONNECT arm, secondaryOutcomes measure: Modality of contact (e.g. phone, virtual web meeting, email) made by the Central Caregiver Navigator and Local Practice Referral Coordinators with each caregiver in the CONNECT arm, secondaryOutcomes measure: Number of contacts made by the Central Caregiver Navigator and Local Practice Referral Coordinators with each caregiver in the CONNECT arm, secondaryOutcomes measure: Number of referrals facilitated by the Local Practice Referral Coordinator and Central Caregiver Navigator, secondaryOutcomes measure: Type of referrals (e.g., in person, online) facilitated by the Local Practice Referral Coordinator and Central Caregiver Navigator, secondaryOutcomes measure: Average time (minutes) needed to communicate for Central Caregiver Navigator and Local Practice Referral Coordinator, secondaryOutcomes measure: Modalities used for communication (e.g., phone, virtual web meeting, email) for Central Caregiver Navigator and Local Practice Referral Coordinator, secondaryOutcomes measure: Improvements for the future trial from Local Practice Referral Coordinator's perspectives from a survey at the end of the study, otherOutcomes measure: Patient accrual rate, otherOutcomes measure: Patient participation rate, otherOutcomes measure: Patient retention at 12 weeks, otherOutcomes measure: Patient retention at 24 weeks, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06383975, orgStudyIdInfo id: CIV-24-01-045634, briefTitle: VEin of MArshall Ethanolization vs Extended Pulmonary Vein PULSEd Field Ablation After Failed PVI for Persistent AF, acronym: VEMAPULSE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-29, primaryCompletionDateStruct date: 2027-04-30, completionDateStruct date: 2027-04-30, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Sebastien Knecht, class: OTHER, collaborators name: Boston Scientific Corporation, descriptionModule briefSummary: The goal of this clinical trial is to compare two ablation techniques to treat patients with persistent atrial fibrillation (irregular and often very rapid heart rhythm). An ablation is a procedure during which some scars are made on the inside of the heart to break up the electrical signals that cause the irregular heartbeat. In this trial researchers will compare a new technique, which uses tiny electric shocks to make the scars, to the standard technique, which uses heat.The main question the trial aims to answer is:• Does the new technique work as well as the standard technique to prevent the irregular heartbeat from returning within one year of the procedure?Participants will:* Undergo an ablation with either the new or the standard technique* Visit the hospital 1, 3, 6, 9 and 12 months after the procedure for a check-up* Wear a device to register their heart rhythm for 24 hours before the 3 month visit and for 72 hours before the 6, 9 and 12 month visit* Record their heart rhythm at home every week* Complete a questionnaire 3, 6, 9 and 12 months after the procedure, conditionsModule conditions: Persistent Atrial Fibrillation, 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: Pulsed field ablation with posterior wall isolation, interventions name: Radiofrequency ablation and vein of Marshall ethanolization, outcomesModule primaryOutcomes measure: Atrial tachyarrhythmia recurrence within 12 months, secondaryOutcomes measure: Safety and procedural related adverse event, secondaryOutcomes measure: Duration of the ablation procedure, secondaryOutcomes measure: Fluoroscopy time, secondaryOutcomes measure: Fluoroscopy dose, secondaryOutcomes measure: Effect of the procedure on quality of life, secondaryOutcomes measure: Incidence of repeat ablation, secondaryOutcomes measure: Unscheduled visits and hospitalization, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: AZ Sint-Jan Brugge AV, city: Brugge, zip: 8000, country: Belgium, contacts name: Emma Christiaen, role: CONTACT, email: emma.christiaen@azsintjan.be, contacts name: Sébastien Knecht, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.20892, lon: 3.22424, hasResults: False

protocolSection identificationModule nctId: NCT06383962, orgStudyIdInfo id: CP 21-001-UK02, briefTitle: Post-Market Data Collection to Evaluate the Performance of the Synergy Disc®, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2029-09-01, completionDateStruct date: 2034-09-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Synergy Spine Solutions, class: INDUSTRY, collaborators name: MCRA, descriptionModule briefSummary: This is a real world data collection observational study at a single site. There are both prospective and retrospective cohorts. The study will examine the safety and effectiveness of the Synergy cervical disc system in patients with degenerative cervical disc disease., conditionsModule conditions: Cervical Degenerative Disc Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Synergy cervical spine disc replacement, outcomesModule primaryOutcomes measure: Neck Disability Index (NDI), primaryOutcomes measure: Device Related or Device Procedure Related Adverse Events, secondaryOutcomes measure: Neck and Arm Pain Measurement, secondaryOutcomes measure: Patient Satisfaction, secondaryOutcomes measure: Motor and Sensory Function in the Arm, secondaryOutcomes measure: Nurick's Criteria, secondaryOutcomes measure: Odom's criteria, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Royal Orthopaedic Hospital, city: Birmingham, country: United Kingdom, contacts name: Sam Papadopoullos, role: CONTACT, email: sam.papadopoullos@nhs.net, contacts name: Timothy Knight, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Shahnawaz Haleem, MD, role: SUB_INVESTIGATOR, geoPoint lat: 52.48142, lon: -1.89983, hasResults: False

protocolSection identificationModule nctId: NCT06383949, orgStudyIdInfo id: CP 21-001-IRE01, briefTitle: Real World Data Collection on the Synergy Disc, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-23, primaryCompletionDateStruct date: 2028-02-23, completionDateStruct date: 2033-02-23, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Synergy Spine Solutions, class: INDUSTRY, collaborators name: MCRA, descriptionModule briefSummary: This is a real world data collection observational study at a single site. There are both prospective and retrospective cohorts. The study will examine the safety and effectiveness of the Synergy cervical disc system in patients with degenerative cervical disc disease., conditionsModule conditions: Cervical Degenerative Disc Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Synergy Cervical Disc system, outcomesModule primaryOutcomes measure: Neck Disability Index (NDI), primaryOutcomes measure: Device Related or Device Procedure Related Adverse Events, secondaryOutcomes measure: Neck and Arm Pain Measurement, secondaryOutcomes measure: Patient Satisfaction, secondaryOutcomes measure: Motor and Sensory Function in the Arm, secondaryOutcomes measure: Nurick's Criteria, secondaryOutcomes measure: Odom's criteria, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mater Misericordiae University Hospital, status: RECRUITING, city: Dublin, country: Ireland, contacts name: Jake McDonnell, MD, role: CONTACT, email: jackmcdonnell@rcsi.ie, contacts name: Joseph Butler, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Stacy Darwish, MD, role: SUB_INVESTIGATOR, geoPoint lat: 53.33306, lon: -6.24889, hasResults: False

protocolSection identificationModule nctId: NCT06383936, orgStudyIdInfo id: FAST-K II, briefTitle: FAldini Sport Total Joint Arthroplasty-Knee II, acronym: FAST-K II, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Istituto Ortopedico Rizzoli, class: OTHER, descriptionModule briefSummary: The majority of patients undergoing total knee arthroplasty are elderly individuals with low functional demands, aiming to alleviate pain. However, there exists a subgroup of younger patients, under the age of 65, with higher functional demands. The purpose of this study is to evaluate the return to sports activities in this patient group following a non-cemented total knee arthroplasty procedure and a specific rehabilitation protocol. The investigators expect that with the use of non-cemented prostheses and a specific rehabilitation protocol, many of these patients will safely resume sports activities., conditionsModule conditions: Knee Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: intensive rehabilitation after uncemented TKA, outcomesModule primaryOutcomes measure: number of patients returning to sports activities assessed by questionnaire, primaryOutcomes measure: clinical and functional outcomes measured as the variation in the Knee Society Score, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06383923, orgStudyIdInfo id: BYSYDL2022015, briefTitle: Risk Factors, Prognosis and Prediction Models for Placenta Accreta Without Prior Cesarean Section, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Peking University Third Hospital, class: OTHER, descriptionModule briefSummary: 1. Identify the risk factors for Placenta accreta spectrum (PAS) disorders in women without prior caesarean section (CS).2. Clarify the prognostic factors of the disease and explore individualized treatment options to improve the prognosis of patients with this type of disease;3. Use the cohort's biological sample database to conduct serology, cytology, and histology studies to explore the abnormal uterine immune microenvironment and the impact on uterine spiral artery remodeling in non-scar uterine-placenta accreta disease., conditionsModule conditions: Placenta Accreta Spectrum, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Placenta Accreta Spectrum, secondaryOutcomes measure: Amount of bleeding, secondaryOutcomes measure: Hemostatic measures, secondaryOutcomes measure: hysterectomy, secondaryOutcomes measure: blood transfusion volume, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University Third Hospital, status: RECRUITING, city: Beijing, country: China, contacts name: Wang Yan, M.D.Ph.D., role: CONTACT, phone: 13501282029, email: wjgqhn@263.net, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False

protocolSection identificationModule nctId: NCT06383910, orgStudyIdInfo id: 10.185.1.58, briefTitle: The Effect Of Square Stepping Exercise Training On Cognitive Functions And Quality Of Life In Geriatric Individuals, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-10-12, primaryCompletionDateStruct date: 2023-12-27, completionDateStruct date: 2024-01-05, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Pamukkale University, class: OTHER, descriptionModule briefSummary: This study was designed to investigate the effects of Square-Stepping Exercise Training on cognitive functions and quality of life in geriatric individuals. The volunteer participants in the study were randomly divided into two groups: a square-stepping exercise group and a control group.In the study, participants in the exercise training groups received square stepping exercises three days a week for six weeks, while those in the control group did not undergo any training. Both groups were assessed before and six weeks after the training period.The investigators used several assessment tools including Hodkinson's Mental Test, Montreal Cognitive Assessment, Stroop Test, Trail Making Test, and the Turkish World Health Organization Quality-of-Life Scale., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 56, type: ACTUAL, armsInterventionsModule interventions name: Square Stepping Exercise, outcomesModule primaryOutcomes measure: Change on Cognitive Functions from Base on the Montreal Cognitive Assessment In 6 Weeks, primaryOutcomes measure: Change on Cognitive Functions from Base on the Stroop Test In 6 Weeks, primaryOutcomes measure: Change on Cognitive Functions from Base on the Trail Making Test In 6 Weeks, primaryOutcomes measure: Change on Quality of Live from Base on the World Health Organization Quality-of-Life Scale Turkish version In 6 Weeks, eligibilityModule sex: ALL, minimumAge: 65 Years, maximumAge: 75 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pamukkale University, city: Denizli, country: Turkey, geoPoint lat: 37.77417, lon: 29.0875, hasResults: False

protocolSection identificationModule nctId: NCT06383897, orgStudyIdInfo id: HS-10398-101, briefTitle: Phase 1 Study in Healthy Participants and Participants With Kidney Dysfunction, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-31, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Jiangsu Hansoh Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: A randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and the impact of food on pharmacokinetics of oral HS-10398 in Chinese healthy participants, and a clinical trial to assess the pharmacokinetic characteristics of oral HS-10398 in Chinese participants with kidney dysfunction, conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 116, type: ESTIMATED, armsInterventionsModule interventions name: HS-10398, interventions name: HS-10398 Placebo, outcomesModule primaryOutcomes measure: Incidence and severity of adverse events (AEs), primaryOutcomes measure: Serious adverse events (SAEs), secondaryOutcomes measure: Observed maximum plasma concentration (Cmax), secondaryOutcomes measure: Time to reach maximum plasma concentration (Tmax), secondaryOutcomes measure: Elimination Halflife (T1/2), secondaryOutcomes measure: Apparent clearance（CL/F）, secondaryOutcomes measure: Apparent Volume of Distribution（Vd/F）, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: The Affiliated Hospital of Qingdao University, city: Qingdao, country: China, contacts name: Xiaolei Zhang, role: CONTACT, phone: 0532-82912611, email: qingyilunli@126.com, geoPoint lat: 36.06488, lon: 120.38042, hasResults: False

protocolSection identificationModule nctId: NCT06383884, orgStudyIdInfo id: 2024-02-134, briefTitle: Patritumab Deruxtecan in Patients With Solid Tumor Harboring an NRG1 Fusion, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2027-04-30, completionDateStruct date: 2029-04-30, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Samsung Medical Center, class: OTHER, descriptionModule briefSummary: The NRG1 gene is located on chromosome 8 (8p12 region) and encode NRG1. NRG1 gene is translated to generate six different proteins (I-VI) and at least 31 isoforms. NRG1 proteins are structurally related to EGF and contain an EGF-like motif that binds and activates ErbB3 and ErbB4. Upon ligand binding, these receptors form homodimers or heterodimers, which results in phosphorylation of the intrinsic kinase domain, and activation of the PI3K-AKT, MAPK, and other pathways.The overall incidence of NRG1 fusions is very rare. In many tumor types, only limited numbers of NRG1 fusion variant have been identified. By percentage, there is no organ dominance of the presence of NRG1 fusions. In an analysis of 21, 858 tumor specimens that underwent anchored multiplex PCR for targeted RNA sequencing, the prevalence of NRG1 fusions was 0.2%. Of these, CD74 was the most common partner (29%), followed by ATP1B1 (10%), SDC4 (7%), and RBPMS (5%), and most CD74-NRG1 fusions have been reported in patients with lung IMA. NRG1 fusions result in aberrant expression of the epidermal growth factor (EGF)-like domain of neuregulin-1 (NRG1) on the cell surface binds primarily to ErbB3 and ErbB4, leading to heterodimerization or oligomerization with other ERBB family members. NRG1-mediated activation of ErbB3 promotes dimerization with EGFR, ErbB2, and ErbB4. These partners phosphorylate ErbB3, forming docking sites for SH2-domain proteins, leading to pathologic activation of multiple signal transduction pathways, including the phosphoinositide 3-kinase (PI3K) pathway. Subsequently, ErbB3 expression was noted at high levels, and the proteins were phosphorylated, in fusion-positive cases. Targeting ErbB3 signaling therefore represents a promising therapeutic approach for patients with NRG1 fusion-positive malignancies., conditionsModule conditions: Solid Tumor, Adult, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Patritumab Deruxtecan, outcomesModule primaryOutcomes measure: Objective response rate(ORR), secondaryOutcomes measure: Duration of response (DoR), secondaryOutcomes measure: Progression-free survival(PFS), secondaryOutcomes measure: Disease-control rate(DCR), secondaryOutcomes measure: Best percentage change in the SoD of measurable tumors, secondaryOutcomes measure: Overall survival(OS), otherOutcomes measure: Incidence of Adverse events (CTCAE v5.0), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Samsung Medical Center, city: Seoul, zip: 06351, country: Korea, Republic of, contacts name: Se-Hoon Lee, MD, PhD, role: CONTACT, phone: +82-10-4579-7640, email: sehoon.lee@samsung.com, geoPoint lat: 37.566, lon: 126.9784, hasResults: False

protocolSection identificationModule nctId: NCT06383871, orgStudyIdInfo id: HRS-7058-101, briefTitle: A Phase I Clinical Study of HRS-7058 in Patients With Advanced Malignant Tumour, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Shandong Suncadia Medicine Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This study is a multicentre, open phase I clinical study of dose escalation, dose extension and efficacy extension of HRS-7058 in subjects with advanced malignant tumour. To evaluate the safety, tolerability, pharmacokinetics and efficacy of HRS-7058., conditionsModule conditions: Advanced Malignant Tumour, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 151, type: ESTIMATED, armsInterventionsModule interventions name: HRS-7058 capsule/ HRS-7058 tablet, outcomesModule primaryOutcomes measure: Dose-limiting toxicity (DLT), primaryOutcomes measure: maximum tolerated dose (MTD), primaryOutcomes measure: Phase II recommended dose (RP2D), primaryOutcomes measure: Safety endpoints: adverse events (AE), secondaryOutcomes measure: Efficacy endpoints: Objective response rate (ORR) assessed based on RECIST v1.1 criterion, secondaryOutcomes measure: Efficacy endpoints: duration of response (DoR) assessed based on RECIST v1.1 criterion, secondaryOutcomes measure: Efficacy endpoints: disease control rate (DCR) assessed based on RECIST v1.1 criterion, secondaryOutcomes measure: Efficacy endpoints: progression-free survival (PFS) assessed based on RECIST v1.1 criterion, secondaryOutcomes measure: Efficacy endpoints: overall survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06383858, orgStudyIdInfo id: [2023] Ethics Review NO.151, briefTitle: The Project of Gestational Hypertension and Preeclampsia Screening and Prevention Center, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: The Third Affiliated Hospital of Guangzhou Medical University, class: OTHER, descriptionModule briefSummary: Preeclampsia is the main cause of illness and death in pregnant women and fetuses. Currently, there is no effective treatment for preeclampsia in clinical practice, and the fundamental treatment is still termination of pregnancy and placental delivery.Therefore, early prediction of preeclampsia and targeted strengthening of high-risk pregnant women supervision, early intervention and diagnosis and treatment can greatly reduce the serious obstetric complications and perinatal maternal and fetal deaths caused by preeclampsia, which has significant social and clinical significance., conditionsModule conditions: Preeclampsia, conditions: Maternal Deaths, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Preeclampsia, secondaryOutcomes measure: Premature birth, secondaryOutcomes measure: Fetal Growth Restriction, secondaryOutcomes measure: Severe complications of preeclampsia, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: FANG HE, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510150, country: China, contacts name: FANG HE, M.D, role: CONTACT, phone: 13724831279, email: hefangjnu@126.com, contacts name: Qingwen Nie, Master, role: CONTACT, phone: 15622149953, email: qw0621n@163.com, geoPoint lat: 23.11667, lon: 113.25, hasResults: False

protocolSection identificationModule nctId: NCT06383845, orgStudyIdInfo id: MAS ESLI, briefTitle: Comparison of Erector Spinae Plane Block vs Intravenous Lidocaine for Chronic Pain Post Mastectomy., statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-01-31, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University Tunis El Manar, class: OTHER, descriptionModule briefSummary: Patients undergoing breast surgery were divided into two groups: Intravenous Lidocaine (Lido-IV) vs Erector Spinae Block (ESP).For Lido-IV group, patients received a loading dose of Lidocaine than a continuous infusion till the end of surgery.For ESP group, an ultrasound guided ESP Block was perormed before anesthetic induction.Persistant pain post mastectomy was assessed by SFM-PQ score at 1, 3 and 6 months post surgery., conditionsModule conditions: Breast Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Erector spinae plane block VS intravenous lidocaine., primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Lido-IV, interventions name: ESP Block, outcomesModule primaryOutcomes measure: Item 5 of Brief Pain inventory score (BPI Score), secondaryOutcomes measure: Acute pain assessed by Simple Verbal Scale (SVS), secondaryOutcomes measure: Postoperative nausea and vomiting, secondaryOutcomes measure: Hospital length of stay, secondaryOutcomes measure: DN4 questionnaire (DN4), secondaryOutcomes measure: The short-form McGill Pain Questionnaire (SFM-PQ), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tunisia, city: Nabeul, zip: 8000, country: Tunisia, geoPoint lat: 36.45606, lon: 10.73763, hasResults: False

protocolSection identificationModule nctId: NCT06383832, orgStudyIdInfo id: 20240310_GY, briefTitle: Effect of Dapagliflozin on Body Weight in Overweight Women Consuming Different Proportions of Carbohydrate Diet., statusModule overallStatus: COMPLETED, startDateStruct date: 2021-10-28, primaryCompletionDateStruct date: 2023-12-26, completionDateStruct date: 2023-12-26, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Sun Jia, class: OTHER, descriptionModule briefSummary: In recent years, the prevalence of overweight and obesity has increased dramatically worldwide, of which 34.3% and 16.4% of adults in China are overweight and obese, respectively, ranking first in the world's obese population. Dapagliflozin is a sodium-glucose transporter 2 Inhibitors that inhibits glucose reabsorption and promotes urinary glucose excretion by inhibiting renal proximal tubular sodium-glucose transporter 2 Inhibitors for the treatment of type 2 diabetes mellitus. The urinary glucose excretion induced by dapagliflozin can induce weight loss through energy loss or body water loss caused by osmotic diuresis. In addition, in patients with type 2 diabetes, dapagliflozin may also induce weight loss by reducing body fat as well as subcutaneous and visceral fat.In a randomized controlled trial, type 2 diabetes patients treated with sodium-glucose transporter 2 Inhibitors lost approximately 1-3 kg. Also, sodium-glucose transporter 2 Inhibitors have shown good weight loss in obese people without type 2 diabetes. In real-world studies, a minority of type 2 diabetes patients taking dapagliflozin experienced weight gain. The American Lipid Association defines a low carbohydrate diet as the calorie intake of carbohydrates accounting for 10-25% of the total daily energy intake. In a randomized controlled trial, a low-carbon diet showed a more significant decrease in body weight, fat mass index, whole body fat, and visceral fat after 8 weeks compared to the standard diet. So, this study intends to investigate whether the weight loss effect of dapagliflozin is affected by different dietary structures., conditionsModule conditions: Overweight, conditions: Carbohydrate, conditions: Sodium-glucose Transporter 2 Inhibitors, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This study included a total sample size of 36 subjects and underwent a 12 week intervention with dapagliflozin. Then, subgroup analysis was conducted. According to the 24-hour dietary review method on the 3rd day of each week during the introduction period, the low carbohydrate group accounted for 10-25% of the total energy intake due to carbohydrates, while the non low carbohydrate group accounted for 26% or more of the total energy intake due to carbohydrates., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ACTUAL, armsInterventionsModule interventions name: Dapagliflozin, outcomesModule primaryOutcomes measure: Changes in Body mass index (BMI) i, secondaryOutcomes measure: Changes in fasting blood glucose., secondaryOutcomes measure: Changes in waist circumference., secondaryOutcomes measure: Changes in insulin resistance index., secondaryOutcomes measure: Changes in waist-to-hip ratio., secondaryOutcomes measure: Changes in abdominal circumference., secondaryOutcomes measure: Changes in Blood triglycerides, secondaryOutcomes measure: Changes in total cholesterol, secondaryOutcomes measure: Changes in low-density lipoprotein、high-density lipoprotein, secondaryOutcomes measure: Changes in body fat percentage., secondaryOutcomes measure: Changes in subcutaneous fat volume., secondaryOutcomes measure: Changes in body fat volume., secondaryOutcomes measure: Changes in the relative abundance of gut microbiota., secondaryOutcomes measure: Changes in urine., secondaryOutcomes measure: Changes in β-hydroxybutyric acid., secondaryOutcomes measure: Changes in muscle mass., secondaryOutcomes measure: Changes in fasting insulin., secondaryOutcomes measure: Changes in visceral fat volume., secondaryOutcomes measure: Changes in hip circumference., secondaryOutcomes measure: The incidence of adverse events., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Zhujiang Hospital of Southern Medical University, city: Guangzhou, state: Guangdong, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Zhujiang Hospital, city: Guangzhou, state: Guangdong, country: China, geoPoint lat: 23.11667, lon: 113.25, hasResults: False

protocolSection identificationModule nctId: NCT06383819, orgStudyIdInfo id: Long-Cov-III-21, briefTitle: Efficacy and Safety of Longidaza® for the Treatment of Patients With Residual Changes in the Lungs After COVID-19, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-04-08, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: NPO Petrovax, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical study is to evaluate the efficacy and safety of Longidaza®, lyophilizate for preparation of solution for injection, at a dose of 3000 IU compared to placebo in the treatment of adult patients with residual changes in the lungs after COVID-19 infection, conditionsModule conditions: Post-Acute COVID-19 Syndrome, conditions: Lung Disease With Polymyositis, conditions: Fibrosis, conditions: Lung Diseases, Interstitial, conditions: Lung; Disease, Interstitial, With Fibrosis, 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: 392, type: ACTUAL, armsInterventionsModule interventions name: Longidaza®, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in Forced vital capacity (FVC) (visit 4), secondaryOutcomes measure: Slowing the decline in respiratory function, secondaryOutcomes measure: Change in FVC (visit 5), secondaryOutcomes measure: The proportion of patients with an increase in the FVC (%), secondaryOutcomes measure: Dynamics of hemoglobin oxygen saturation (SpO2), secondaryOutcomes measure: The proportion of patients with SpO2 ≥ 93% and < 93%, secondaryOutcomes measure: The proportion of patients with desaturation, secondaryOutcomes measure: The proportion of patients with an increase in the distance of 6MWT, secondaryOutcomes measure: The proportion of patients with a decrease in the severity of dyspnea on the Borg scale, secondaryOutcomes measure: The proportion of patients with a decrease in the severity of dyspnea on the Modified Medical Research Council Dyspnea Scale (mMRC), secondaryOutcomes measure: Change in cough severity on the Visual Analogue Scale (VAS), secondaryOutcomes measure: Change in the assessment of the quality of life according to the European Quality of Life 5-Dimension 5-Level Questionnaire (EuroQol-5D-5L), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: State Autonomous Healthcare Institution of the Sverdlovsk region "Aramil City Hospital", city: Aramil, zip: 624000, country: Russian Federation, geoPoint lat: 56.6977, lon: 60.8369, locations facility: Private healthcare institution "Clinical Hospital "RZD-Medicine" of the city of Chelyabinsk", city: Chelyabinsk, zip: 454000, country: Russian Federation, geoPoint lat: 55.15402, lon: 61.42915, locations facility: State Budgetary Healthcare Institution "Regional Clinical Hospital No. 3", city: Chelyabinsk, zip: 454021, country: Russian Federation, geoPoint lat: 55.15402, lon: 61.42915, locations facility: Ural research Institute of Phthisiopulmonology, city: Ekaterinburg, zip: 620039, country: Russian Federation, geoPoint lat: 56.8519, lon: 60.6122, locations facility: Alliance Biomedical-Ural Group LLC, city: Izhevsk, zip: 426061, country: Russian Federation, geoPoint lat: 56.84976, lon: 53.20448, locations facility: Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University" of the Ministry of Health of the Russian Federation. The State Autonomous healthcare institution "Hospital for War Veterans of Kazan", city: Kazan, zip: 420012, country: Russian Federation, geoPoint lat: 55.78874, lon: 49.12214, locations facility: Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University" of the Ministry of Health of the Russian Federation, city: Kazan, zip: 420012, country: Russian Federation, geoPoint lat: 55.78874, lon: 49.12214, locations facility: State Autonomous Healthcare Institution "Kuzbass Clinical Hospital of Emergency Medical Care named after M.A. Podgorbunsky", city: Kemerovo, zip: 650000, country: Russian Federation, geoPoint lat: 55.33333, lon: 86.08333, locations facility: Medical Center Rhevma-Med LLC, city: Kemerovo, zip: 650070, country: Russian Federation, geoPoint lat: 55.33333, lon: 86.08333, locations facility: Federal State Budgetary Educational Institution of Higher Education "Kirov State Medical University" of the Ministry of Health of the Russian Federation, city: Kirov, zip: 610027, country: Russian Federation, geoPoint lat: 58.59665, lon: 49.66007, locations facility: Federal State Budgetary Institution "National Medical Research Center for Therapy and Preventive Medicine" of the Ministry of Health of the Russian Federation, city: Moscow, zip: 101990, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Federal Budgetary Institution of Science "Central Research Institute of Epidemiology" of the Federal Service for Supervision of Consumer Rights Protection and Human Well-being, city: Moscow, zip: 111123, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Unimed-S Zao, city: Moscow, zip: 119571, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: I.M. Sechenov First Moscow State Medical University, city: Moscow, zip: 119991, country: Russian Federation, geoPoint lat: 55.75222, lon: 37.61556, locations facility: ErSi Medical LLC, city: Novosibirsk, zip: 630005, country: Russian Federation, geoPoint lat: 55.0415, lon: 82.9346, locations facility: Professorial Clinic LLC, city: Perm, zip: 614070, country: Russian Federation, geoPoint lat: 58.01046, lon: 56.25017, locations facility: Energia Zdoroviya LLC, city: Saint Petersburg, zip: 194156, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Medical Center Reavita Med SPb LLC, city: Saint Petersburg, zip: 194354, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Reavita Med SPb Medical Center LLC, city: Saint Petersburg, zip: 194354, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: St. Petersburg State Budgetary Healthcare Institution "City Consultative and Diagnostic Center No. 1"., city: Saint Petersburg, zip: 194354, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Eco-Safety Research Center LLC, city: Saint Petersburg, zip: 196143, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Federal State Budgetary Institution "Consultative and Diagnostic Center with Polyclinic" of the Office of the President of the Russian Federation, city: Saint Petersburg, zip: 197110, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: St. Petersburg State Budgetary Healthcare Institution "Consultative and Diagnostic Center No.85", city: Saint Petersburg, zip: 198260, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Astarta LLC, city: Saint Petersburg, zip: 199226, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Federal State Budgetary Educational Institution of Higher Education "Saratov State Medical University named after V.I. Razumovsky" of the Ministry of Health of the Russian Federation, city: Saratov, zip: 410012, country: Russian Federation, geoPoint lat: 51.54056, lon: 46.00861, locations facility: Regional State budgetary healthcare institution "Clinical Hospital No. 1", city: Smolensk, zip: 214006, country: Russian Federation, geoPoint lat: 54.7818, lon: 32.0401, locations facility: Federal State Budgetary Educational Institution of Higher Education "Siberian State Medical University" of the Ministry of Health of the Russian Federation, city: Tomsk, zip: 634050, country: Russian Federation, geoPoint lat: 56.49771, lon: 84.97437, locations facility: Budgetary healthcare institution of the Voronezh region "Voronezh Regional Clinical Hospital No. 1", city: Voronezh, zip: 394066, country: Russian Federation, geoPoint lat: 51.67204, lon: 39.1843, locations facility: Medical Center for Diagnosis and Prevention plus LLC, city: Yaroslavl, zip: 150040, country: Russian Federation, geoPoint lat: 57.62987, lon: 39.87368, locations facility: The State Autonomous Healthcare Institution of the Yaroslavl region "Clinical Hospital No. 9", city: Yaroslavl, zip: 150042, country: Russian Federation, geoPoint lat: 57.62987, lon: 39.87368, hasResults: False

protocolSection identificationModule nctId: NCT06383806, orgStudyIdInfo id: STU00219933, secondaryIdInfos id: 315-SR-23, type: OTHER_GRANT, domain: American Academy of Sleep Medicine Foundation, briefTitle: Decreasing Nightmares in Adults With Narcolepsy, acronym: DAWN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2026-09, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Northwestern University, class: OTHER, descriptionModule briefSummary: The purpose of this clinical trial is learn whether a behavioral (non-medication) treatment can reduce nightmares in adults with narcolepsy. All participants will receive the treatment and will complete three assessments. Half of the participants will receive the treatment after the first assessment, and half will receive it after the second assessment., conditionsModule conditions: Narcolepsy, conditions: Narcolepsy Type 1, conditions: Narcolepsy With Cataplexy, conditions: Narcolepsy Without Cataplexy, conditions: Nightmare, conditions: Nightmare Disorder With Associated Other Sleep Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Waitlist control, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Imagery Rehearsal Therapy (IRT), outcomesModule primaryOutcomes measure: Disturbing Dream and Nightmare Severity Index (DDNSI), primaryOutcomes measure: Nightmare frequency (sleep diary), secondaryOutcomes measure: PROMIS Anxiety, secondaryOutcomes measure: PROMIS Depression, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06383793, orgStudyIdInfo id: Northjiangsu000, briefTitle: Comparative Analysis of Short-Term Therapeutic Effects Between the π-Shaped and Overlap Methods for Esophagogastrostomy in Totally Laparoscopic Total Gastrectomy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Northern Jiangsu People's Hospital, class: OTHER, descriptionModule briefSummary: As of now, although the safety of π-shaped anastomosis and the overlap method has been separately discussed in different contexts, there have been few studies considering a direct comparison of the results of these two methods.This article aims to explore the differences in the short-term therapeutic effects, surgical effectiveness, and safety between laparoscopic total gastrectomy with esophagogastrostomy using the overlap method and the π-shaped method. The goal is to provide new reference points for surgeons in the clinical decision-making process regarding the choice of anastomotic techniques during totally laparoscopic total gastrectomy., conditionsModule conditions: Gastric Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: overlap, outcomesModule primaryOutcomes measure: 1 year survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yifan Cheng, status: RECRUITING, city: Yangzhou, state: Jiangsu, zip: 225000, country: China, contacts name: Yifan Cheng, role: CONTACT, phone: 8615267258283, email: cyfchengyifan528@sina.com, geoPoint lat: 32.39722, lon: 119.43583, hasResults: False

protocolSection identificationModule nctId: NCT06383780, orgStudyIdInfo id: SYSKY-2023-901-01, briefTitle: Tislelizumab in Combination With GP or TPC Regimen for the Treatment of Nasopharyngeal Carcinoma With Bone Metastasis., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: XIANG YANQUN, class: OTHER, descriptionModule briefSummary: This is a prospective, open-label phase III clinical trial evaluating the efficacy and safety of the GP（Gemcitabine combined with cisplatin） regimen in combination with Tislelizumab versus the TPC（cisplatin, nab-paclitaxel and capecitabine）regimen in combination with Tislelizumab for the first-line treatment of Nasopharyngeal Carcinoma patients With Bone Metastasis., conditionsModule conditions: Nasopharyngeal Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Active Comparator:Drug:GP（Gemcitabine combined with cisplatin）regimen combined with Tislelizumab Experimental:Drug：TPC（cisplatin, nab-paclitaxel and capecitabine）regimen combined with Tislelizumab, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: GP combined with Tislelizumab, interventions name: TPC combined with Tislelizumab, outcomesModule primaryOutcomes measure: 1-year progression-free survival rate, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: incidence of adverse events, secondaryOutcomes measure: rate of skeletal-related events, secondaryOutcomes measure: Biomarker response (EBV-DNA, bone metabolic markers), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: SunYat-senU, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510060, country: China, contacts name: Yanqun Xiang, MD, role: CONTACT, phone: +86-18666096623, email: xiangyq@sysucc.org.cn, contacts name: Weixiong Xia, MD, role: CONTACT, phone: +86-18520415699, email: xiawx@sysucc.org.cn, geoPoint lat: 23.11667, lon: 113.25, hasResults: False

protocolSection identificationModule nctId: NCT06383767, orgStudyIdInfo id: ESG401-301, briefTitle: A Phase III Study of ESG401 for Locally Advanced or Metastatic HR+/HER2- Breast Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-30, primaryCompletionDateStruct date: 2026-07-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Shanghai Escugen Biotechnology Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: The aim of this study is to evaluate the efficacy and safety of ESG401 in patients with unresectable locally advanced or metastatic HR+/HER2- breast cancer., conditionsModule conditions: Metastatic Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 378, type: ESTIMATED, armsInterventionsModule interventions name: ESG401, interventions name: Eribulin, capecitabine, gemcitabine or vinorelbine (Treatment of Physician's Choice), outcomesModule primaryOutcomes measure: Progression-free survival (PFS) assessed by IRC per RECIST 1.1, secondaryOutcomes measure: Progression-free survival (PFS) assessed by the investigators per RECIST V 1.1, secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Clinical Benefit Rate (CBR), secondaryOutcomes measure: Duration of Response (DoR), secondaryOutcomes measure: Quality of life evaluated using the NCC-BC-A scale, secondaryOutcomes measure: Adverse events(AEs) and severe adverse events (SAEs), secondaryOutcomes measure: Clearance, secondaryOutcomes measure: Volume of distribution, secondaryOutcomes measure: ADA, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cancer Hospital Chinese Academy of Medical Sciences, city: Beijing, state: Beijing, zip: 100021, country: China, contacts name: Fei Ma, PhD, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False

protocolSection identificationModule nctId: NCT06383754, orgStudyIdInfo id: Clove, briefTitle: Clareon Intraocular Lens Stability in Vitrectomy Patients: CLOVE Study, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-06-07, primaryCompletionDateStruct date: 2024-03-08, completionDateStruct date: 2024-03-15, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: The University of Hong Kong, class: OTHER, descriptionModule briefSummary: This prospective randomized controlled trial will be conducted to investigate Clareon intraocular lens (IOL) stability in vitrectomy patients. The investigator plans to target the patients undergoing cataract surgery. A randomized study will be conducted with 2 arms, one with Clareon IOL versus a second arm using the Tecnis 1 In this non-inferiority study, the investigator will compare Clareon IOL from Alcon with the existing Tecnis 1 IOL from Precision Lens which is the commonly used intraocular lens in combined vitrectomy cases in Hong Kong., conditionsModule conditions: Senile Cataract, conditions: Epiretinal Membrane, conditions: Vitreous Hemorrhage, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Patients are randomised and masked from the treatment, whoMasked: PARTICIPANT, enrollmentInfo count: 50, type: ACTUAL, armsInterventionsModule interventions name: Clareon, interventions name: Tecnis 1, outcomesModule primaryOutcomes measure: Position stability of Clareon and Tecnis 1 IOL, secondaryOutcomes measure: Visual acuity, secondaryOutcomes measure: Refraction, secondaryOutcomes measure: Axial movement, secondaryOutcomes measure: Decentration, secondaryOutcomes measure: Compare intra operative and post operative complication, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Grantham Hospital, city: Hong Kong, country: Hong Kong, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False

protocolSection identificationModule nctId: NCT06383741, orgStudyIdInfo id: 2023-00541, briefTitle: Predicting Outcomes in ICH Patients on Direct Factor Xa Inhibitors, acronym: FIRE-Xa, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-10, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Insel Gruppe AG, University Hospital Bern, class: OTHER, descriptionModule briefSummary: This study focuses on direct factor Xa inhibitors (apixaban, edoxaban, rivaroxaban) and the thrombin inhibitor dabigatran, commonly used for stroke prevention in atrial fibrillation. Despite lower intracranial bleeding risks with these drugs, around 0.2-1.0% of patients annually experience intracranial hemorrhage (ICH), predominantly intracerebral.Treatment options for factor-Xa inhibitor-associated ICH, such as prothrombin complex concentrate (PCC) and andexanet alfa, lack direct comparison evidence except for ongoing trials like ANNEXA-I. This trial assesses hemostatic efficacy and 30-day functional outcomes but leaves gaps regarding anticoagulant activity's role and long-term effects, especially in patients presenting late after drug intake.The measurement of anti-FXa levels helps guide decisions, yet their link to hematoma expansion remains unknown. Efforts to streamline measurement within 30 minutes for acute decisions have shown variability in levels, with some patients exhibiting high levels even beyond 12 hours post-intake. This lack of data poses challenges, particularly for patients potentially benefiting from treatment beyond the current strict time window.Early hematoma expansion strongly predicts poor outcomes, but preventing it faces challenges like recurrent events (up to 5% by 3 months) and rehabilitation intensity, potentially negating its benefits. The ANNEXA-I trial evaluates short-term outcomes, highlighting the need for additional data to comprehend long-term ICH prognosis.The study's objectives involve linking hematoma expansion to anti-FXa levels, determining late-presenting patients' risk of expansion, and identifying predictors of favorable outcomes at 3, 6, and 12 months. Primary endpoints include functional outcomes, while secondary ones encompass expansion rates, anticoagulant activity, and various events at 12 months.This research aims to bridge gaps in understanding factor-Xa inhibitor-related ICH, addressing both immediate and prolonged outcomes to enhance clinical decision-making., conditionsModule conditions: Intra Cerebral Hemorrhage, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Good functional outcome, primaryOutcomes measure: Good functional outcome, primaryOutcomes measure: Good functional outcome, secondaryOutcomes measure: Haematoma expansion, secondaryOutcomes measure: Number of patients with significant anticoagulant activity arriving late, secondaryOutcomes measure: Absolute haematoma expansion (in ml) between baseline and follow-up imaging, secondaryOutcomes measure: Symptomatic haematoma expansion, secondaryOutcomes measure: Resumption of anticoagulant therapy after haemorrhage, secondaryOutcomes measure: Patients living at home, secondaryOutcomes measure: Functionally independent patients (mRS 0-2), secondaryOutcomes measure: Excellent outcome (mRS 0-1), secondaryOutcomes measure: Arterial and venous events at 12 months, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Insel Gruppe AG, Inselspital Bern, status: RECRUITING, city: Bern, zip: 3010, country: Switzerland, contacts name: David J. Seiffge, Prof. Dr. med., role: CONTACT, phone: +41 31 664 05 09, email: david.seiffge@insel.ch, contacts name: Janis P. Rauch, PD Dr. med., role: CONTACT, email: janispatricia.rauch@insel.ch, geoPoint lat: 46.94809, lon: 7.44744, hasResults: False

protocolSection identificationModule nctId: NCT06383728, orgStudyIdInfo id: ES-2024-014-02, briefTitle: Osimertinib as Neoadjuvant Therapy in Patients With Resectable Stage II-IIIB EGFR-mutated Lung Squamous Cell Carcinoma, acronym: GALAXY-02, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-10-31, completionDateStruct date: 2029-04-30, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital of Guangzhou Medical University, class: OTHER, descriptionModule briefSummary: Previous trials, such as ADURA and CTONG, have demonstrated the benefits of neoadjuvant targeted therapy in patient with EGFR mutations, which can effectively reduce the extent of tumors and improve the survival outcomes. However, clinical trials of neoadjuvant targeted therapy in NSCLC have rarely enrolled patients with EGFR-mutated lung squamous cell carcinoma due to its rarity, which means that the safety and feasibility of neoadjuvant osimertinib in patients with resectable stage II-IIIB EGFR-mutated lung squamous cell carcinoma remains relatively unknown., conditionsModule conditions: Lung Cancer, conditions: Carcinoma, Squamous Cell, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Patients with resectable stage II-IIIB EGFR-mutated lung squamous cell carcinoma receive osimertinib (80mg/d, ≥9 weeks), primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 51, type: ESTIMATED, armsInterventionsModule interventions name: Osimertinib, outcomesModule primaryOutcomes measure: Objective Response Rate, ORR, primaryOutcomes measure: Safety: frequency of severe adverse events, secondaryOutcomes measure: Major pathologic response, MPR, secondaryOutcomes measure: R0 rate, secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Duration of remission (DOR), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Guangzhou Medical University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510120, country: China, contacts name: Shuben Li, Doctor, role: CONTACT, email: 13500030280@163.com, geoPoint lat: 23.11667, lon: 113.25, hasResults: False

protocolSection identificationModule nctId: NCT06383715, orgStudyIdInfo id: 2024-624, briefTitle: Congitive Behavioral Therapy Workshop for Content Moderators, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Universidad Europea de Valencia, class: OTHER, descriptionModule briefSummary: Professional content moderators play a critical role in preventing Internet users from being exposed to more sensitive content. However, recent literature has shown that this work places content moderators at increased risk for several psychological outcomes, including intrusive thoughts and vicarious stress trauma. This pilot study will assess the acceptability and feasibility of a brief (4-session) cognitive-behavioral workshop to reduce these risks., conditionsModule conditions: Work-Related Condition, conditions: Work-Related Stress Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive-Behavioral Therapy Workshop for Content Moderators, outcomesModule primaryOutcomes measure: The Kessler Psychological Distress Scale (K10), secondaryOutcomes measure: Work Satisfaction Scale, JobStat'73, secondaryOutcomes measure: Coping Mechanisms Scale, secondaryOutcomes measure: PTSD Checklist-Civilian Version (PCL-C), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MEGA cloud services, status: RECRUITING, city: Salamanca, zip: 37002, country: Spain, contacts name: Valentina Sirna, role: CONTACT, phone: +34 685 34 79 07, email: support@mega.nz, contacts name: Carlos López-Pinar, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.96882, lon: -5.66388, hasResults: False

protocolSection identificationModule nctId: NCT06383702, orgStudyIdInfo id: HEX1939-002, briefTitle: Phase III Trial to Evaluate the Efficacy and Safety of Pregabalin in the Treatment of Painful Diabetic Peripheral Neuropathy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-04-15, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: CSPC Ouyi Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This study is designed to evaluate the efficacy and safety of pregabalin extended-release tablets in the treatment of neuropathic pain associated with diabetic peripheral neuropathy. Pregabalin has been approved in more than 130 countries for neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, and neuralgia associated with spinal cord injury. Pregabalin extended-release tablets were administered once daily, as a single dose after dinner. Compared with pregabalin capsule formulation, it reduces the frequency of medication and improves patient compliance., conditionsModule conditions: Neuropathic Pain Associated With Diabetic Peripheral Neuropathy, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel design, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 358, type: ESTIMATED, armsInterventionsModule interventions name: pregabalin sustained-release tablets, interventions name: Placebo, outcomesModule primaryOutcomes measure: NRS mean change at week 13, secondaryOutcomes measure: NRS mean change at Weeks 1-12 and 14, secondaryOutcomes measure: Proportion of subjects with NRS reduction, secondaryOutcomes measure: MOS-SS score, secondaryOutcomes measure: HADS score, secondaryOutcomes measure: PGIC score, secondaryOutcomes measure: CGIC score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06383689, orgStudyIdInfo id: Az. 297/23-EP, briefTitle: Placebo Optimization of the Presurgical Long-term Video-EEG Monitoring, acronym: OPERA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University Hospital, Bonn, class: OTHER, descriptionModule briefSummary: The notion of genuine placebo effects on epileptic seizure events (i.e., effects beyond methodological study artifacts) is incompatible with the standard model of epilepsy seizure genesis. In this single-blind controlled study, the effectiveness of a covered placebo on (1) the timing of the occurrence of a first epileptic seizure ("seizure pill") versus (2) the subjective well-being ("comfort pill") during pre-surgical video-EEG monitoring will be examined. It is hypothesized that a placebo effect on subjective well-being can be demonstrated, but that epileptic seizure events are not influenced by placebo., conditionsModule conditions: Symptomatic Epilepsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: monocentric single-blinded randomized clinical study on the effectiveness of covered placebo on epileptic seizure occurrence and emotional well-being with 3 study conditions: "seizure pill" (PCB-S), "well-being pill" (PCB-W) and no pill (control), primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, maskingDescription: Like in psychological studies, only patients can participate in the study who consent to accept that complete study information can only be provided after the entire study was finished (with an option to withdraw consent at that point) as information on ingredients of the study pill (which is placebo) must be concealed for inherent reasons (study on effects of covered placebo)., whoMasked: PARTICIPANT, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Seizure placebo pill, interventions name: Well-being placebo pill, outcomesModule primaryOutcomes measure: Latency to first epileptic seizure, secondaryOutcomes measure: Occurrence of an epileptic seizure, secondaryOutcomes measure: Early occurrence of an epileptic seizure within the first 72 hours, secondaryOutcomes measure: Number of epileptic seizures during the video-EEG, secondaryOutcomes measure: Number of early occurring epileptic seizures, secondaryOutcomes measure: Daily average frequency of epileptic seizures, secondaryOutcomes measure: Very early first epileptic seizure, secondaryOutcomes measure: Early epileptic seizure, secondaryOutcomes measure: Epileptic seizure within the first three days, secondaryOutcomes measure: Emotional well-being, secondaryOutcomes measure: Dissociative non-epileptic seizures, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Epileptology, University Hospital Bonn, city: Bonn, state: NRW, zip: 53127, country: Germany, contacts name: Rainer Surges, Prof., role: CONTACT, phone: +49 228 287-15727, email: rainer.surges@ukbonn.de, contacts name: Christian Hoppe, PD Dr., role: CONTACT, phone: +49 228 287-16172, email: christian.hoppe@ukbonn.de, geoPoint lat: 50.73438, lon: 7.09549, hasResults: False

protocolSection identificationModule nctId: NCT06383676, orgStudyIdInfo id: 1, briefTitle: Effect Of Functional Balance Exercise İn Elderly, acronym: RCT, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-04-20, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2025-05-30, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Tarsus University, class: OTHER, descriptionModule briefSummary: The elderly population is increasing in Turkey and in the world. Many health problems, such as a decrease in physical and psychological abilities and an increase in chronic problems, occur with aging. It is important to encourage and support practices for the development of exercises to increase physical and cognitive capacity in order to early recognize and reduce the effects of problems that develop with aging. To the best of our knowledge, there is no exercise training to increase reaction time in the elderly in the literature., conditionsModule conditions: Older People, conditions: Exercise, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study was planned as a randomized controlled study, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Study participants are unaware of their assigned group, whoMasked: PARTICIPANT, enrollmentInfo count: 28, type: ACTUAL, armsInterventionsModule interventions name: Functional reaction balance training, interventions name: Functional balance training, outcomesModule primaryOutcomes measure: The Montreal Cognitive Assessment (MoCA), primaryOutcomes measure: Stroop Test, primaryOutcomes measure: The Simple Reaction Time, secondaryOutcomes measure: The Four Square Step Test (FSST), secondaryOutcomes measure: The short physical performance battery (SPPB), secondaryOutcomes measure: Timed Up and Go Test (TUG), secondaryOutcomes measure: Falls Efficacy Scale ( FES), secondaryOutcomes measure: Mini-BESTest: Balance Evaluation Systems Test, eligibilityModule sex: ALL, minimumAge: 65 Years, maximumAge: 85 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fatma Kübra ÇEKOK, city: Ankara, zip: 06000, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False

protocolSection identificationModule nctId: NCT06383663, orgStudyIdInfo id: 308-2019-04-01, briefTitle: A RCT of Supraclavicular Lymph Node Dissection vs. No-dissection in Supraclavicular Lymph Node Metastatic Breast Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: The purpose of this study was to compare the efficacy of surgical dissection of supraclavicular lymph nodes combined with radiotherapy versus radiotherapy alone in patients with ipsilateral supraclavicular lymph node metastasis., conditionsModule conditions: Breast Cancer, conditions: Ipsilateral Supraclavicular Lymph Node Metastasis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Supraclavicular lymph node dissection combined with radiotherapy versus radiotherapy alone, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 452, type: ESTIMATED, armsInterventionsModule interventions name: Supraclavicular lymph node dissection combined with radiotherapy, interventions name: radiotherapy, outcomesModule primaryOutcomes measure: DFS, secondaryOutcomes measure: PFS, secondaryOutcomes measure: OS, otherOutcomes measure: pCR rate, eligibilityModule sex: FEMALE, minimumAge: 35 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06383650, orgStudyIdInfo id: 124532, briefTitle: Use of 81 vs 325mg of ASA in Treatment of BCVI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: London Health Sciences Centre, class: OTHER, collaborators name: Western University, descriptionModule briefSummary: Blunt cerebrovascular injury (BCVI), or injury to the carotid and vertebral arteries, occurs in 1-3% of blunt traumas, often as a result of injury to the head, neck, or chest. If unrecognized or untreated, BCVI can lead to stroke, which occurs in approximately 20% of untreated patients, potentially causing significant and sometimes permanent disability. Early diagnosis and treatment significantly reduce the risk of stroke.Currently, there is wide variation across centers and trauma care providers in treatment strategies for BCVI and the most recent guidelines are unable to make specific recommendations about the optimal agent and/or dose of treatment to reduce the risk of stroke after BCVI while minimizing bleeding complications in patients with multiple traumatic injuries. Recent systematic reviews and meta-analyses evaluating the most common treatment strategies for BCVI have shown similar stroke rates with the use of anticoagulants (usually heparin) vs. antiplatelets (usually aspirin/ASA), however, treatment with antiplatelets was associated with a lower risk of bleeding complications. The optimal dose of ASA for stroke prevention while minimizing bleeding complications is unknown, and more research is required to inform future care.This project will investigate two doses of antiplatelet therapy (81 mg daily vs. 325 mg daily aspirin) for BCVI treatment, and will look at the risk of stroke and bleeding complications with each strategy. The goal of the research is to determine whether a large-scale study looking at this question is feasible, which will ultimately help determine the best medical therapy for patients with BCVI., conditionsModule conditions: Carotid Artery Injuries, conditions: Traumatic Injury, conditions: Vertebral Artery Injury, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Acetylsalicylic Acid, outcomesModule primaryOutcomes measure: Study feasibility, secondaryOutcomes measure: Incidence of stroke, secondaryOutcomes measure: Incidence of Bleeding Complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06383637, orgStudyIdInfo id: KAP-ABR-Interns, briefTitle: Antibiotic Use and Resistance KAP Among Dental Interns, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-11-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: The study is designed as a cross-sectional online-based questionnaire, and it will be distributed among dental interns. Assess the following among dental interns (1) The knowledge, attitude, and practices (KAP) towards antibiotics and antibiotic resistance; (2) The correlation between their KAP score and where they spend their internship year? (4) Development of the curriculum to provide sufficient training and information about antibiotics and antibiotic resistance., conditionsModule conditions: Antibiotic Side Effect, conditions: Antibiotic Resistant Infection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 343, type: ESTIMATED, outcomesModule primaryOutcomes measure: Knowledge of dental interns regarding antibiotic use and resistance, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06383624, orgStudyIdInfo id: RC18-4-2023, briefTitle: Impact Of Maternal Spinal Anesthesia-Induced Hypotension At Scheduled Cesarean Delivery On Risk Development Of Transient Tachypnea Of Newborn And Fetal Acidosis, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-04-01, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-03-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Benha University, class: OTHER, descriptionModule briefSummary: We will evaluate the association between transient tachypnea of newborns and fetal acidosis development to the degree and duration of maternal hypotension and anesthesia to delivery time during spinal anesthesia at scheduled cesarean delivery., conditionsModule conditions: Transient Tachypnea of Newborn and Fetal Acidosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: PROSPECTIVE, enrollmentInfo count: 115, type: ACTUAL, outcomesModule primaryOutcomes measure: Association between transient tachypnea of newborns development to the degree and duration of maternal hypotension during spinal anesthesia at scheduled cesarean delivery, primaryOutcomes measure: Association between fetal acidosis development to the degree and duration of maternal hypotension and anesthesia to delivery time during spinal anesthesia at scheduled cesarean delivery, eligibilityModule sex: ALL, minimumAge: 1 Minute, maximumAge: 6 Hours, stdAges: CHILD, contactsLocationsModule locations facility: Benha University Hospital, city: Cairo, zip: 13511, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False

protocolSection identificationModule nctId: NCT06383611, orgStudyIdInfo id: OTX-0303, briefTitle: Expanded Access to Cyclic Irrigation in Patients Undergoing Exchange Arthroplasty, acronym: APEX-EAP, statusModule overallStatus: AVAILABLE, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Osteal Therapeutics, Inc., class: INDUSTRY, descriptionModule briefSummary: The objective of the protocol is to provide access to the VT-X7 (Vancomycin, Tobramycin Exchanged in 7 Days) system for subjects with periprosthetic joint infection (PJI) of the hip or knee who lack therapeutic treatment alternatives., conditionsModule conditions: Prosthetic-joint Infection, designModule studyType: EXPANDED_ACCESS, armsInterventionsModule interventions name: VT-X7 Treatment System, eligibilityModule sex: ALL, minimumAge: 22 Years, maximumAge: 84 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06383598, orgStudyIdInfo id: 2022KT74-ZY01, briefTitle: PD-L1 Specific [68Ga]-Nb-1 Nanobody Probe for PET Imaging in Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-09, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Peking University Cancer Hospital & Institute, class: OTHER, descriptionModule briefSummary: The objective of the study is to constrcut a noninvasive approach 68Ga-Nb-1 PET/CT to detect the PD-L1 expression of tumor lesions in patients with solid tumors and to identify patients benefiting from anti-PD-L1 treatment., conditionsModule conditions: Solid Tumor, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: 18F-FDG, outcomesModule primaryOutcomes measure: Standardized uptake value（SUV）, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Cancer Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100142, country: China, contacts name: Hua Zhu, role: CONTACT, phone: +861088196495, email: zhuhuananjing@163.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False

protocolSection identificationModule nctId: NCT06383585, orgStudyIdInfo id: 24-001367, briefTitle: 3D DL Ozteo in the Detection of Osseous Changes in Patients With Inflammatory Arthritis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, collaborators name: GE Healthcare, descriptionModule briefSummary: This project intends to explore and validate the utility of new MRI pulse sequence, 3D DL oZTEo, in the detection of osseous erosions of the hand in patients with inflammatory arthritis. The detection of osseous structural changes, such as erosive disease, is routinely assessed in patients with rheumatic conditions such as rheumatoid arthritis, as it alters clinical management, and in some cases assists in diagnosis. Currently, this is most often assessed with radiography and conventional MRI., conditionsModule conditions: Inflammatory Arthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: oZTEo, outcomesModule primaryOutcomes measure: The binary (yes/no) presence of bony erosions as detected by hand MRI with and without the addition of the 3D DL oZTEo sequence., secondaryOutcomes measure: The number of erosions (continuous) as detected by hand MRI with and without the addition of the 3D DL oZTEo sequence., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Rochester, city: Rochester, state: Minnesota, zip: 55905, country: United States, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False