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protocolSection identificationModule nctId: NCT06266533, orgStudyIdInfo id: Pro2023002473, briefTitle: Dismantling the U.S. Social Norm of the "Kids' Food" Archetype (REACH Project), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-21, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Rutgers, The State University of New Jersey, class: OTHER, descriptionModule briefSummary: This project is the first stage of a health promotion campaign to shift social norms about marketing and feeding children ultra-processed foods. Embedded within a longitudinal ethnographic study using photo-elicitation techniques, mothers of preschool-age children will be randomly assigned to arts-based or traditional education about ultra-processed food., conditionsModule conditions: Food Selection, conditions: Environmental Exposure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomly assigned to a conventional nutrition education or an arts-based education group., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 38, type: ESTIMATED, armsInterventionsModule interventions name: Conventional Ultra-processed Food Nutrition Education, interventions name: Arts-based Ultra-processed Food Nutrition Education, outcomesModule primaryOutcomes measure: Ultra-Processed Food Knowledge, primaryOutcomes measure: Environmental assessment of ultra-processed food, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Leaguers Inc. Head Start, status: RECRUITING, city: Newark, state: New Jersey, zip: 07102, country: United States, contacts name: Aurthur Nabi, role: CONTACT, phone: 973-643-0300, email: "arthuarthur_nabi@theleaguers.org, geoPoint lat: 40.73566, lon: -74.17237, hasResults: False

protocolSection identificationModule nctId: NCT06266520, orgStudyIdInfo id: DongyangH, briefTitle: MNK Therapy in Releasing the Superficial Fascia for Patients With AAS: an Assessor-blinded, Randomised Controlled Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Sen-wei Lu, class: OTHER, descriptionModule briefSummary: The goal of this type of randomized controlled trial, employing a blinded evaluator methodology, to verify the clinical efficacy and safety of MNK therapy. This aims to provide a reference for clinical practitioners and AAS patients in their decision-making process.Participants will randomly allocated into two groups using a random number table method, with forty patients in each group. The experimental group (Group 1) underwent MNK therapy to release the superficial fascia, while the control group (Group 2) received conventional acupuncture treatment., conditionsModule conditions: Acute Ankle Sprain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: MNK therapy to release the superficial fascia, interventions name: acupuncture, outcomesModule primaryOutcomes measure: Visual Analogue Scale (VAS), primaryOutcomes measure: Kofoed Ankle Score, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 55 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: The Affiliated Dongyang Hospital of Wenzhou Medical University, Dongyang, Zhejiang, China, status: RECRUITING, city: Dongyang, state: Zhejiang, zip: 322100, country: China, contacts name: Sen-wei Lu, Dr., role: CONTACT, phone: +8613989441117, email: lswlsw1121@163.com, geoPoint lat: 29.26778, lon: 120.22528, hasResults: False

protocolSection identificationModule nctId: NCT06266507, orgStudyIdInfo id: 169, briefTitle: Examining the Effect of Occupational Therapy-Based Parent Coaching on Feeding Problems in Children With a Preterm Birth, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2025-02-15, completionDateStruct date: 2025-03-15, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Ankara Medipol University, class: OTHER, descriptionModule briefSummary: Feeding problems are common in children with a history of premature birth, and these problems continue into early childhood. Feeding problems are affected by many biopsychosocial factors, and the context in which feeding takes place and the attitudes and behaviors of parents can also be effective in the emergence or continuation of these problems. The aim of our study is to evaluate the effects of occupational therapy-based parent coaching intervention on mothers and their children, who are considered to be primarily responsible for the feeding of children in our country. 46 mothers with premature children will be included in our study and participants will be randomly assigned to intervention/control groups. Mothers will fill out a sociodemographic information form, Behavioral Pediatric Feeding Assessment Scale, Sensory Profile Questionnaire - Oral Sensory Processing Subtest, Family Feeding Strategies Scale and Parental Self-Efficacy Scale via Google forms. Mothers in the research group will be given online occupational therapy-based parent coaching training for 10 weeks. Second evaluations will be carried out after the training; Final evaluations will be applied after 1 month of follow-up., conditionsModule conditions: Feeding Behavior, conditions: Mother-Child Relations, conditions: Feeding and Eating Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: Ergotherapy Based Parent Coaching, interventions name: Informative Brochure Distribution, outcomesModule primaryOutcomes measure: Behavioral Pediatric Feeding Assessment Scale, primaryOutcomes measure: Sensory Profile Questionnaire - Oral Sensory Processing Test, secondaryOutcomes measure: Feeding Strategies Quesstionnaire, secondaryOutcomes measure: Parental Self-Efficacy Scale, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ankara Medipol University, city: Ankara, state: Ankara/ Altındağ, zip: 06110, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False

protocolSection identificationModule nctId: NCT06266494, orgStudyIdInfo id: 23-1349, secondaryIdInfos id: CDMRP-DM220077, type: OTHER_GRANT, domain: Department of Defense, briefTitle: Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis, acronym: Frostbite, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-08, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Denver, class: OTHER, collaborators name: Congressionally Directed Medical Research Programs, descriptionModule briefSummary: This study will compare the effectiveness of two different treatments for preventing infection from frostbite injuries. These two treatments are A) aloe vera and B) long-acting silver wound dressings. The investigators will also study the safety and effectiveness of Dalbavancin, an FDA approved antibiotic used for treating people who develop frostbite wound infections, as well as evaluate how frostbite damage to individuals' bodies may affect how fast their kidney clear drugs from their systems., conditionsModule conditions: Frostbite, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Long-Acting silver dressings, interventions name: Aloe Vera, interventions name: Dalbavancin, outcomesModule primaryOutcomes measure: The number of positive microbial wound cultures on admission, primaryOutcomes measure: The number of positive microbial wound cultures on hospital day 4, primaryOutcomes measure: The number of positive microbial wound cultures on hospital day 8, primaryOutcomes measure: The number of positive microbial wound cultures on hospital day 12, primaryOutcomes measure: The number of positive microbial wound cultures on hospital day 16, primaryOutcomes measure: The number of positive microbial wound cultures on hospital day 20, primaryOutcomes measure: The number of positive microbial wound cultures on hospital day 24, primaryOutcomes measure: The number of positive microbial wound cultures on hospital day 28, primaryOutcomes measure: The number of positive microbial wound cultures on hospital day 32, primaryOutcomes measure: The number of positive microbial wound cultures on hospital day 36, primaryOutcomes measure: The number of positive microbial wound cultures on hospital day 40, primaryOutcomes measure: The number of positive microbial wound cultures on hospital day 44, primaryOutcomes measure: The number of positive microbial wound cultures on hospital day 48, primaryOutcomes measure: The number of positive microbial wound cultures on hospital day 52, primaryOutcomes measure: The number of positive microbial wound cultures on hospital day 56, primaryOutcomes measure: The number of positive microbial wound cultures on hospital day 60, primaryOutcomes measure: Number of gram positive cultures at admission, primaryOutcomes measure: Number of gram positive cultures on hospital day 4, primaryOutcomes measure: Number of gram positive cultures on hospital day 8, primaryOutcomes measure: Number of gram positive cultures on hospital day 12, primaryOutcomes measure: Number of gram positive cultures on hospital day 16, primaryOutcomes measure: Number of gram positive cultures on hospital day 20, primaryOutcomes measure: Number of gram positive cultures on hospital day 24, primaryOutcomes measure: Number of gram positive cultures on hospital day 28, primaryOutcomes measure: Number of gram positive cultures on hospital day 32, primaryOutcomes measure: Number of gram positive cultures on hospital day 36, primaryOutcomes measure: Number of gram positive cultures on hospital day 40, primaryOutcomes measure: Number of gram positive cultures on hospital day 44, primaryOutcomes measure: Number of gram positive cultures on hospital day 48, primaryOutcomes measure: Number of gram positive cultures on hospital day 52, primaryOutcomes measure: Number of gram positive cultures on hospital day 56, primaryOutcomes measure: Number of gram positive cultures on hospital day 60, primaryOutcomes measure: Change in serum concentration of dalbavancin in plasma (mcg/ml) over time, primaryOutcomes measure: Dalbavancin concentrations in subcutaneous tissue, primaryOutcomes measure: Change in presence of Augmented Renal Clearance, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Colorado Denver Anschutz Medical Campus, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: Blaire Balstad, role: CONTACT, phone: 303-724-7803, email: blaire.balstad@cuanschutz.edu, contacts name: Tracey MacDermott, role: CONTACT, phone: 303-724-2757, email: tracey.macdermott@cuanschutz.edu, geoPoint lat: 39.72943, lon: -104.83192, hasResults: False

protocolSection identificationModule nctId: NCT06266481, orgStudyIdInfo id: pua04202312313157, briefTitle: Topical Dexamethasone Versus Topical Lidocaine Spray to Reduce POST in Shoulder Arthroscopic Surgeries: A Comparative Study, acronym: post, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Pharos University in Alexandria, class: OTHER, descriptionModule briefSummary: postoperative sore throat is the most frequent side effects after anaesthesia intubation. Dexamethasone and 10% lidocaine spray used prior to surgery has shown useful in managing these complications at the moment. In order to examine the prophylactic impact of local Dexamethasone and lidocaine on postoperative sore throat, this study was conducted., conditionsModule conditions: Postoperative Sore Throat, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Topical dexamethasone, interventions name: 10% lidocaine was sprayed over the tube for the second group, outcomesModule primaryOutcomes measure: Topical dexamethasone versus topical lidocaine spray to reduce post-intubation sore throat in shoulder arthroscopic surgeries: A comparative study, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Pharos University, status: RECRUITING, city: Alexandria, zip: 21348, country: Egypt, contacts name: mona el. massoud, ph anesthesia, role: CONTACT, phone: 002+01005542232, email: mona.elsaid@pua.edu.eg, contacts name: hatem a. attalla, ph anaesthesia, role: CONTACT, phone: 002+1001445568, email: hatattalla@hotmail.com, contacts name: mona el. massoud, lecture, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.21564, lon: 29.95527, hasResults: False

protocolSection identificationModule nctId: NCT06266468, orgStudyIdInfo id: STUDY00149178, briefTitle: Nutricity: An mHealth Nutrition Intervention to Improve Diet Quality Among Latino Children, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-21, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University of Kansas Medical Center, class: OTHER, descriptionModule briefSummary: The overall objective of this application is to pilot test an mHealth nutrition intervention within pediatric clinics serving Latino families and evaluate its potential for implementation. The investigators hypothesize the intervention will improve child diet quality and will be feasible for use within the clinic setting. To test this hypothesis, the investigators will pursue 3 specific aims and 1 exploratory aim:1. Aim 1: Pilot Nutricity with 40 Latino families (English or Spanish speaking) vs. 40 waitlist control in primary care clinics and estimate differences in child diet quality at 3 month's post Nutricity exposure. Preliminary data will inform power calculations for a future larger Nutricity intervention.2. Aim 2: Evaluate other individual (dyad) level factors including reach, engagement, and changes in secondary effectiveness outcomes (e.g. nutrition literacy, BMI, skin carotenoid, psychosocial constructs) at 3 months post exposure.3. Aim 3: Evaluate organizational-level factors (adoption, implementation, and organizational-level maintenance) in Latino-serving pediatric clinics that may support or inhibit future uptake of Nutricity. The investigators will seek to understand the context of interventions and scalability to other clinics using mixed methods.4. Exploratory Aim 1: Explore the relationship among nutrition literacy, psychosocial constructs and diet quality outcomes; and explore how engagement and satisfaction influence outcomes., conditionsModule conditions: Diet Quality, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The intervention study model is a 2-arm randomized control trial with a 1:1 allocation of participants to the treatment group (Nutricity) or the control group (usual care without Nutricity). After 12 weeks in the control group, participants will be introduced to Nutricity., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Nutricity, outcomesModule primaryOutcomes measure: Change in Diet quality (Healthy Eating Index) (child), secondaryOutcomes measure: Nutrition Literacy (parent), secondaryOutcomes measure: Body Mass Index (child), secondaryOutcomes measure: Skin Carotenoid, secondaryOutcomes measure: Feeding Behaviors of Parent and Children, secondaryOutcomes measure: Mediation of Children's Media Use, secondaryOutcomes measure: Parent Self-Efficacy, secondaryOutcomes measure: Parent Nutrition Attitudes, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06266455, orgStudyIdInfo id: Pro00000615, briefTitle: Individualized Nutrition to Optimize Preterm Infant Growth and Neurodevelopment, acronym: THRIVE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2034-01, completionDateStruct date: 2034-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Children's National Research Institute, class: OTHER, descriptionModule briefSummary: Human milk has several well-established benefits but does not adequately meet the increased nutritional demands of the growing preterm infant, necessitating additional nutrient supplementation in a process known as fortification. In U.S. neonatal intensive care units (NICUs), human milk is primarily supplemented using standardized fortification, in which a multicomponent fortifier is added to human milk to achieve assumed nutrient content based on standard milk reference values. However, this method does not account for the significant variability in human milk composition or in preterm infant metabolism, and up to half of all very premature infants experience poor growth and malnutrition using current nutritional practices. Poor postnatal growth has adverse implications for the developing preterm brain and long-term neurodevelopment.Recent advances allow for individualized methods of human milk fortification, including adjustable and targeted fortification. Adjustable fortification uses laboratory markers of protein metabolism (BUN level) to estimate an infant's protein requirements. In targeted fortification, a milk sample is analyzed to determine its specific macronutrient and energy content, with additional macronutrient supplementation provided as needed to achieve goal values. Emerging data suggest that both methods are safe and effective for improving growth, however information on their comparable efficacy and neurodevelopmental implications are lacking, particularly using advanced quantitative brain MRI (qMRI) techniques.Through this prospective, randomized-controlled trial, the investigators will compare the impact of individualized human milk fortification on somatic growth and neurodevelopment in preterm infants. Infants will be randomized to receive one of three nutritional interventions: standardized (control group), adjustable, or targeted human milk fortification. Infants will undergo their assigned nutritional intervention until term-equivalent age or discharge home, whichever is achieved first. Brain qMRI will be performed at term-corrected age, and neurodevelopmental follow-up will be performed through 5 years of age., conditionsModule conditions: Very Preterm Maturity of Infant, conditions: Very Low Birth Weight Infant, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective, randomized-controlled trial comparing the impact of individualized human milk fortification on somatic growth and neurodevelopment in preterm infants randomized to receive one of three nutritional interventions: standardized (control), adjustable, or targeted human milk fortification., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: Due to the nature of the nutritional interventions, the clinical and research teams will not be blinded to study intervention. The radiologist and research team members performing MRI interpretation, post-acquisition processing, and quantitative analysis will be blinded to study nutritional intervention arm. Similarly, teams performing neurodevelopmental follow-up will also be blinded to study nutritional intervention arm., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Standardized Fortification, interventions name: Adjustable Fortification, interventions name: Adjustable Fortification, outcomesModule primaryOutcomes measure: Weight Gain Velocity, primaryOutcomes measure: Length Growth Velocity, primaryOutcomes measure: Head Circumference Growth Velocity, primaryOutcomes measure: Total and Regional Brain Volumes, primaryOutcomes measure: Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS), primaryOutcomes measure: Mullen Scales of Early Learning (MSEL), primaryOutcomes measure: Mullen Scales of Early Learning (MSEL), primaryOutcomes measure: Wechsler Preschool and Primary Scale of Intelligence (4th edition) (WPPSI-IV), primaryOutcomes measure: Differential Abilities Scale (2nd edition)-(DAS-II), eligibilityModule sex: ALL, maximumAge: 4 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: Children's National Hospital, city: Washington, state: District of Columbia, zip: 20010, country: United States, contacts name: Catherine Limperopoulos, Ph.D., role: CONTACT, phone: 202-476-5293, email: CLimpero@childrensnational.org, contacts name: Katherine M. Ottolini, M.D., role: CONTACT, phone: 202-476-8905, email: KOttolin@childrensnational.org, contacts name: Catherine Limperopoulos, Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.89511, lon: -77.03637, hasResults: False

protocolSection identificationModule nctId: NCT06266442, orgStudyIdInfo id: Mav-WGS, briefTitle: M. Avium WGS During Mav-PD Treatment, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2026-09, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University Health Network, Toronto, class: OTHER, collaborators name: Western University, Canada, collaborators name: Public Health Ontario Laboratory, Canada, descriptionModule briefSummary: This is a prospective observational study using whole genome sequencing (WGS) to investigate whether new strains (other than the initially identified strain(s)) of M. avium are responsible for persistently culture positive sputum during treatment (refractory disease), or the reversion to culture positive sputum after prior conversion to negative. The study will further investigate for differences between participants living in the Toronto/York region versus participants living elsewhere.The primary goal of this prospective observational study is to understand why some patients with M. avium lung disease have persistent or recurrent M. avium in their sputum despite treatment. The aim is to understand whether it is usually due to treatment failure or new infection., conditionsModule conditions: Mycobacterium Avium, conditions: Mycobacterium Infections, Nontuberculous, conditions: Mycobacterium Infections, conditions: Nontuberculous Mycobacterial Lung Disease, conditions: Respiratory Tract Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Whole genome sequencing testing, outcomesModule primaryOutcomes measure: Proportion of patients with persistent culture-positive sputum despite antimicrobial therapy, secondaryOutcomes measure: Whether patients with Mav-PD have evidence of polyclonal infection as demonstrated by the presence of >1 strain of M. avium in the pre-treatment sputum or a sputum sample during treatment, secondaryOutcomes measure: Whether there is a source of infection from the home water environment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Health Network, status: RECRUITING, city: Toronto, state: Ontario, zip: M5G, country: Canada, contacts name: Matty Mehrabi, B.Sc. M. Ed, role: CONTACT, phone: 416-603-5726, email: matty.mehrabi@uhn.ca, contacts name: Theodore Marras, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False

protocolSection identificationModule nctId: NCT06266429, orgStudyIdInfo id: STUDY00001304, briefTitle: Metabolomic Profiling of Racial Disparity, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Olubukola Nafiu, class: OTHER, descriptionModule briefSummary: Tonsillectomy ± adenoidectomy (T\&A) is one of the most common surgical operations with over 500,000 pediatric T\&As performed annually in the United States. Unfortunately, despite advances in anesthetic and surgical techniques, moderate-severe post-tonsillectomy pain (PTP) remains a significant problem affecting up to 62% of children. PTP is thought to arise from pharyngeal mucosal inflammation, which produces local nerve irritation and pharyngeal muscle spasm. Patient factors and surgical techniques also play major roles. Race is an important phenotypic risk factor for moderately severe early PTP. The underlying molecular basis of this differential pain experience is presently unknown. This gap in knowledge means that therapies are poorly targeted and often unsuccessful. Indeed, treatment options for PTP have not advanced substantively for many years. Metabolomics provides novel opportunities to investigate common and unique "metabolic signature" of PTP through the analysis of low molecular weight compounds produced in response to tissue injury. Therefore, the central themes of this proposal are that (1) PTP is a complex process that may be determined by molecular level factors such as preoperative systemic inflammation and metabolic profile, and (2) these molecular level factors may explain the excess burden of PTP among minority children. Here the investigators seek to utilize a combined clinical, biological and untargeted metabolomics approach to identify candidate small and large serum molecules that may influence the frequency and severity of PTP in children across racial groups. This approach to exploring the molecular basis of PTP is novel and knowledge from the study should substantially enhance understanding of the mechanisms underlying pediatric PTP - and narrow the racial disparities in post-operative pain., conditionsModule conditions: Adenoid Hypertrophy, conditions: Tonsillar Hypertrophy, conditions: Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Blood collection, outcomesModule primaryOutcomes measure: Mean fold-change of metabolomics markers by race using untargeted reverse-phase liquid-chromatographic mass spectrometry, primaryOutcomes measure: Highest pain score, primaryOutcomes measure: Last pain score, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06266416, orgStudyIdInfo id: 115207, briefTitle: IMARA for Black Male Caregivers and Girls Empowerment (IMAGE), acronym: IMAGE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2027-05-31, completionDateStruct date: 2028-05-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Illinois at Chicago, class: OTHER, collaborators name: University of Michigan, descriptionModule briefSummary: The scientific premise of this research is that individual, interpersonal, and structural factors impact Black girls' sexual reproductive health outcomes (sexually transmitted infection (STI) and Human Immunodeficiency Virus (HIV)) and experience of sexual violence. This study expands STI/HIV prevention programs to include Black male caregivers, a potentially valuable yet underutilized resource to protect Black girls and reduce their exposure to STI/HIV and sexual violence., conditionsModule conditions: Sexually Transmitted Infections (Not HIV or Hepatitis), conditions: HIV Infections, conditions: Sexual Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study will evaluate the efficacy of IMAGE with 14-18-year-old Black girls (n=300) and male caregivers (n=300) in a 2-arm individually randomized controlled trial. The researchers will compare SRH outcomes (STI incidence, self-reported sexual behavior) at 6- and 12-months among girls randomized to IMAGE or a time-matched general health promotion control program (FUEL).The researchers will simultaneously evaluate implementation determinants (barriers, facilitators, constraints) and processes at Community Based Organizations working through the 3 steps of the implementation model (Prepare, Roll out, and Sustain)., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 612, type: ESTIMATED, armsInterventionsModule interventions name: IMARA for Black Male Caregivers and Girls Empowerment, interventions name: Time-matched control program, outcomesModule primaryOutcomes measure: STI Incidence in Participants, secondaryOutcomes measure: Rate of STI History among Participants, secondaryOutcomes measure: Number of Participants Using Condoms, secondaryOutcomes measure: Number of Sexual Partners of Participants, eligibilityModule sex: ALL, minimumAge: 14 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Illinois Chicago, city: Chicago, state: Illinois, zip: 60612, country: United States, contacts name: LIsa Sharp, PhD, role: CONTACT, phone: 312-966-1819, email: sharpl@uic.edu, contacts name: Sue Littau, role: CONTACT, phone: 312.996.3932, email: slittau@uic.edu, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False

protocolSection identificationModule nctId: NCT06266403, orgStudyIdInfo id: STUDY00024154, briefTitle: Evaluating Verbal Communication in Structured Interactions: Theoretical and Clinical Implications, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2029-03, completionDateStruct date: 2029-03, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Penn State University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn about the effect of communicative interaction on verbal communication in people with amyotrophic lateral sclerosis (ALS) and age-matched speakers.The question is, What are the effects of communicative interaction on verbal communication in people with ALS?Participants will read words and sentences while they are in a solo setting and interactive setting., conditionsModule conditions: Amyotrophic Lateral Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: PALS and age-matched adults will participate in one solo speech production task (clear speech) and three interactive tasks (structured communicative interaction, unstructured communicative interaction, and clear speech structured communicative interaction) in which they work with an unfamiliar, naive interlocutor. This study is designed to examine the differences in speech produced in the four tasks. Comparisons of speech produced by PALS and age-matched adults will clarify whether differences in speech observed across the four tasks are a function of the speech difficulties experiences by PALS.Plans for Assignment - This is a single group study in which all participants will engage in the same tasks., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Structured Communicative Interaction, interventions name: Clear Speech, interventions name: Unstructured communicative interaction, interventions name: Clear Speech Structured Communicative Interaction, outcomesModule primaryOutcomes measure: Formant frequencies of speech sounds, primaryOutcomes measure: Intelligibility of recorded speech, primaryOutcomes measure: Syntactic properties, primaryOutcomes measure: Pragmatic Properties, primaryOutcomes measure: Duration of speech sounds, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06266390, orgStudyIdInfo id: 855007, briefTitle: Engaging sgACC With TMS for Depression, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-30, primaryCompletionDateStruct date: 2026-01-30, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University of Pennsylvania, class: OTHER, collaborators name: National Institutes of Health (NIH), descriptionModule briefSummary: The purpose of this study is to investigate the responses of the brain region known as the subgenual anterior cingulate cortex (sgACC) during transcranial magnetic stimulation (TMS) in individuals with depression. Specifically, investigators aim to determine whether the sgACC is engaged when TMS is delivered to specific targets and if the engagement of sgACC changes throughout a full TMS treatment intervention. To achieve this goal, the investigators will employ a combination of TMS and Magnetic Resonance Imaging (MRI) procedures.Study participation will include completing various questionnaires, clinical assessments, receiving a full transcranial magnetic stimulation (TMS) treatment intervention (every weekday for 4-6 weeks), and undergoing MRI scans, both with and without concurrent TMS., conditionsModule conditions: Depression, conditions: Major Depressive Disorder, conditions: Persistent Depressive Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will receive rTMS to one of two targets. Participants will be randomly assigned to receive the TMS treatment intervention in one of two target conditions: half to their positive sgACC correlation target, while the remaining half to their negative sgACC correlation target., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, maskingDescription: Participants will not be informed on which target they have been assigned to., whoMasked: PARTICIPANT, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Transcranial Magnetic Stimulation (TMS), outcomesModule primaryOutcomes measure: sgACC Blood Oxygen Level Dependent (BOLD) signal change following single-pulse fMRI-guided TMS (TMS On vs TMS Off), secondaryOutcomes measure: Change in sgACC evoked response Pre/Post TMS treatment with positive and negative sgACC correlated targets, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Pennsylvania, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: Almaris Figueroa-González, role: CONTACT, email: almaris.figuera-gonzalez@pennmedicine.upenn.edu, contacts name: Ethan Hammett, role: CONTACT, email: ethan.hammett@pennmedicine.upen.edu, contacts name: Desmond J Oathes, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False

protocolSection identificationModule nctId: NCT06266377, orgStudyIdInfo id: 11122023, briefTitle: AUT-MENU: Improving Meal Experience of Subjects With Autism Spectrum Disorder, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-11-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University of Pavia, class: OTHER, collaborators name: Consiglio per la ricerca in agricoltura e l'analisi dell'economia agraria (CREA), descriptionModule briefSummary: The main goal of this multi-center interventional study is to improve the meal experience of children and adolescents with autism spectrum disorder trough the development of menus for collective catering targeted to their nutritional and sensory needs and the drafting of nutritional indications that can be a reference for collective catering nationwide. After an initial assessment of participants' consumption of meals in the collective service, menus adapted to their nutritional and sensory needs will be administered, and consumption between the initial and adapted menus will be compared. A population subgroup will also be selected whose caregivers will be invited to participate in a nutrition education course with the aim of providing parents of subjects with ASD, with knowledge tools to learn how to identify, manage and reduce their children's attitudes of food selectivity., conditionsModule conditions: Autism Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Non-randomized multi-center intervention with a single arm. Study participants will receive new adapted canteen menus according to the nutritional and sensory needs of the target population., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Administration of menus of collective catering adapted to the sensory and nutritional needs of subjects with Autism Spectrum Disorder, interventions name: Nutrition education course aimed at caregivers of individuals with Autism Spectrum Disorder, outcomesModule primaryOutcomes measure: Food acceptance of canteen menus by individuals enrolled in the study, secondaryOutcomes measure: Reduction in food selectivity as a result of the targeted nutrition education course, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 19 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Milano Ristorazione S.p.A., city: Milano, zip: 20139, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Istituto I.P.S.E.O.A. "Tor Carbone - A. Narducci"., city: Roma, zip: 00178, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Istituto Tecnico Agrario Statale "Giuseppe Garibaldi", city: Roma, zip: 00178, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False

protocolSection identificationModule nctId: NCT06266364, orgStudyIdInfo id: IRB-24-22, briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA], statusModule overallStatus: WITHHELD, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: [Redacted], hasResults: False

protocolSection identificationModule nctId: NCT06266351, orgStudyIdInfo id: LASIKIOP, briefTitle: EVALUATION OF CATS TONOMETER PRISM IN LASIK SUBJECTS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Intuor Technologies, Inc., class: INDUSTRY, descriptionModule briefSummary: The CATS Tonometer prism clinical study is intended to determine repeatability of intraocular pressure measurement in human corneas which have undergone a LASIK procedure when compared to a standard Goldmann prism, validating the human LASIK eye findings comparing CATS Tonometer and Goldmann prisms to intracameral pressure in cadaver eyes., conditionsModule conditions: Glaucoma, conditions: Ocular Hypertension, conditions: Normal Tension Glaucoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: This is observational IOP measurement, outcomesModule primaryOutcomes measure: IOP measurement difference between CATS and GAT in LASIK patients, eligibilityModule sex: ALL, minimumAge: 22 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Arizona Eye Consultants, city: Tucson, state: Arizona, zip: 85710, country: United States, geoPoint lat: 32.22174, lon: -110.92648, locations facility: Eye Specialty Group, city: Memphis, state: Tennessee, zip: 38120, country: United States, contacts name: Sean Dodson, role: CONTACT, phone: 520-327-3487, email: sjmccafferty66@hotmail.com, geoPoint lat: 35.14953, lon: -90.04898, hasResults: False

protocolSection identificationModule nctId: NCT06266338, orgStudyIdInfo id: STU-2023-1118, briefTitle: Study of Pembrolizumab and Lenvatinib in Metastatic and Recurrent Cervix Cancer (LenPem Cervix), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2025-10-31, completionDateStruct date: 2026-10-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: University of Texas Southwestern Medical Center, class: OTHER, collaborators name: Merck Sharp & Dohme LLC, descriptionModule briefSummary: The main purpose of this study is to gather information about an investigational drug combination, Lenvatinib in combination with pembrolizumab, that may help to treat cervical cancers. In this study, we are looking to see whether the combination of lenvatinib and pembrolizumab has any effect on slowing tumor growth in cervical cancer tumors., conditionsModule conditions: Cervix Cancer, conditions: Cervical Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Pembrolizumab, interventions name: Lenvatinib, outcomesModule primaryOutcomes measure: Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors v1.1, secondaryOutcomes measure: Progression Free Survival (PFS) assessed by Response Evaluation Criteria in Solid Tumors v1.1, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UT Southwestern Medical Center, status: RECRUITING, city: Dallas, state: Texas, zip: 75390, country: United States, contacts name: Annette Paulsen, role: CONTACT, phone: 214-648-7097, contacts role: CONTACT, email: annette.paulsen@utsouthwestern.edu, geoPoint lat: 32.78306, lon: -96.80667, hasResults: False

protocolSection identificationModule nctId: NCT06266325, orgStudyIdInfo id: 6138, briefTitle: Development and Validation of a Dementia Life Expectancy Tool, statusModule overallStatus: COMPLETED, startDateStruct date: 2010-04-01, primaryCompletionDateStruct date: 2022-12-31, completionDateStruct date: 2022-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: University of Toronto, class: OTHER, collaborators name: Sunnybrook Research Institute, collaborators name: Ottawa Hospital Research Institute, collaborators name: ICES, descriptionModule briefSummary: Individuals with dementia and their caregivers are faced with challenging decisions throughout the course of the disease. These decisions may be about medical care (e.g., continuation of routine cancer screening, pursuit of cardiopulmonary resuscitation, initiation of palliative care services), institutionalization (i.e., transition to a long-term care facility), or financial planning. These inherently difficult decisions are made more difficult by prognostic uncertainty. Indeed, life expectancy is challenging to predict in dementia. Consequently, prognosis is infrequently discussed by healthcare providers with individuals with dementia and their families, which compromises their ability to plan for the future. A lack of prognostic awareness makes it difficult for patients, their caregivers, and their healthcare providers to make medical decisions that strike the appropriate balance between prolonging life and promoting the quality of it. A clinical prediction tool has the promise to provide personalized and accurate estimations of life expectancy in individuals with dementia. Therefore, similar to the existing clinical prediction tools on our Project Big Life platform (www.projectbiglife.ca), we seek to create and to test a statistical model to predict survival, and to implement the model as a user-friendly, web-based calculator. The calculator will use self-reported sociodemographic, clinical, cognitive, functional, and nutritional information that is entered by patients, their caregivers, and/or their healthcare providers to output an estimated life expectancy. This estimate could inform the shared decision-making process, thereby empowering decisions that are compatible with a patient's clinical reality and concordant with their life goals., conditionsModule conditions: Dementia, conditions: Death, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 202217, type: ACTUAL, armsInterventionsModule interventions name: There is no intervention. Exposures are predictor variables of mortality., outcomesModule primaryOutcomes measure: Mortality, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06266312, orgStudyIdInfo id: Maastricht UMC+, briefTitle: Feasibility of a Preoperative, Multimodal Lifestyle Intervention in Patients With Breastcancer, acronym: APRIORI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Maastricht University Medical Center, class: OTHER, collaborators name: Nationaal Fonds tegen Kanker, descriptionModule briefSummary: The primary objective of this study is to investigate the feasibility of a multimodal prehabilitation programme consisting of MIET during neoadjuvant intravenous chemotherapy infusion, HITT and strength training during the last six weeks prior to surgery, and optimising nutritional intake throughout the total preoperative period in patients with breast cancer with respect to recruitment, adherence, dropout, safety and acceptance. The secondary objective is to provide a preliminary evaluation of participant responses to a preoperative multimodal lifestyle intervention, on cardiorespiratory fitness, muscle strength, nutritional status, and fatigue in patients with breast cancer receiving neoadjuvant chemotherapy., conditionsModule conditions: Breast Cancer, conditions: Breast Neoplasms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: A prospective, single-centre, longitudinal mixed-methods feasibility study will be performed to investigate the feasibility of a multimodal prehabilitation programme consisting of MIET during neoadjuvant intravenous chemotherapy infusion, HITT and strength training during the last six weeks prior to surgery, and optimising nutritional intake throughout the total preoperative period in patients with breast cancer., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 11, type: ESTIMATED, armsInterventionsModule interventions name: A multimodal prehabilitation programme, outcomesModule primaryOutcomes measure: Recruitment rate (%), primaryOutcomes measure: Characteristics of included participants, primaryOutcomes measure: Attendance rate for MIET sessions (%), primaryOutcomes measure: Adherence rate, exercise relative dose intensity (ExRDI) MIET (%), primaryOutcomes measure: Reasons for not having executed a training session as intended, primaryOutcomes measure: Attendance rate HIIT + strength sessions (%), primaryOutcomes measure: Adherence rate, ExRDI HIIT training (%), primaryOutcomes measure: Adherence rate, ErXDI strength training (%), primaryOutcomes measure: Attendance rate for dietary consultations (%), primaryOutcomes measure: Percentage of use of the digital food diary 'Mijn Eetmeter'(%), primaryOutcomes measure: Percentage of days on which nutritional requirements were achieved (%), primaryOutcomes measure: Reasons for not achieving the nutritional requirements as intended, primaryOutcomes measure: Drop-out rate (%), primaryOutcomes measure: Time point of drop-out, primaryOutcomes measure: Reasons for drop-out, primaryOutcomes measure: Serious adverse events (SAE), primaryOutcomes measure: Study related adverse events, primaryOutcomes measure: Acceptance - Experiences with the multimodal lifestyle intervention, primaryOutcomes measure: Acceptance - Suitability of the multimodal lifestyle intervention and study procedures, primaryOutcomes measure: Acceptance - Barriers and enablers regarding participation in the study, secondaryOutcomes measure: Fatigue, secondaryOutcomes measure: Cardiorespiratory fitness, secondaryOutcomes measure: Muscle strength, secondaryOutcomes measure: Nutritional status, secondaryOutcomes measure: Weight (kg), secondaryOutcomes measure: Height (cm), secondaryOutcomes measure: Body Mass Index (BMI), secondaryOutcomes measure: Energy and protein intake (absolute kcal and gr and gr/kg body weight per day), secondaryOutcomes measure: Energy requirements (kcal), secondaryOutcomes measure: Protein requirements, secondaryOutcomes measure: Circumference of upper arm and waist (cm), otherOutcomes measure: Chemotherapy Relative Dose Intensity (RDI), otherOutcomes measure: Treatment-related Side effects, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06266299, orgStudyIdInfo id: 2269-001, briefTitle: A Study of KK2269 in Adult Participants With Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-25, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Kyowa Kirin, Inc., class: INDUSTRY, descriptionModule briefSummary: This is a first-in-human study of KK2269. Part 1 and Part 2 will be conducted as a multicenter, open-label, non-randomized, dose-escalation study. Participants with advanced or metastatic solid tumors for which no standard therapy is available will be enrolled in Part 1. In Part 1, the primary objective is to assess the safety and tolerability of KK2269.In Part 2, only participants with gastric adenocarcinoma, GEJ adenocarcinoma, esophageal adenocarcinoma, or NSCLC who have experienced at least one systemic therapy will be enrolled. In Part 2, the primary objective is to assess the safety and tolerability of KK2269 in combination with docetaxel and to determine the recommended dose(s) and dose interval(s) of KK2269 in combination with docetaxel for subsequent studies.In both Part 1 and Part 2, participants who refuse to undergo standard therapy are also eligible., conditionsModule conditions: Advanced Solid Tumor, conditions: Metastatic Solid Tumor, conditions: Gastric Adenocarcinoma, conditions: Gastroesophageal Junction Adenocarcinoma, conditions: Esophageal Adenocarcinoma, conditions: Non Small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 71, type: ESTIMATED, armsInterventionsModule interventions name: KK2269, interventions name: Docetaxel, outcomesModule primaryOutcomes measure: Number of Subjects Experiencing Dose-limiting Toxicity, primaryOutcomes measure: Number of Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Cancer Center Hospital East, status: RECRUITING, city: Kashiwa City, state: Chiba, zip: 277-8577, country: Japan, geoPoint lat: 35.86224, lon: 139.97732, locations facility: National Cancer Center Hospital, status: RECRUITING, city: Chuo-ku, state: Tokyo, zip: 104-0045, country: Japan, geoPoint lat: 35.57779, lon: 139.71685, hasResults: False

protocolSection identificationModule nctId: NCT06266286, orgStudyIdInfo id: 2022-A00233-40, briefTitle: EXOPULSE Mollii Suit & Cerebral Palsy, acronym: EXOCEP, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-13, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-10-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Institut De La Colonne Vertebrale Et Des Neurosciences, class: OTHER, descriptionModule briefSummary: Spasticity is a frequent and debilitating symptom in patients with cerebral palsy. It can alter the patients' balance, mobility, as well as their quality of life (QoL). The available therapeutic strategies for treating spasticity and related symptoms are usually faced with limited efficacy and numerous side effects. For these reasons, non-invasive stimulation techniques, namely transcutaneous electric nerve stimulation using EXOPULSE Mollii suit, might be of help in this context., conditionsModule conditions: Cerebral Palsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: The investigators designes a randomized crossover, sham-controlled, double- blind trial to demonstrate the improvement of motor functions and cerebral palsy related symptoms following two weeks of daily sessions of "active" versus "sham" EXOPULSE Mollii suit. A two-week washout period should be enough to prevent a potential carry- over effect.Two weeks after the end of this phase (phase 1), a second phase of this trial, an open label phase, will be proposed for all patients to understand the effects of EXOPULSE Mollii suit and will consist of six months of active stimulation (sessions performed on a daily basis with the same parameters used for the active session in phase 1) on cerebral palsy related symptoms.Summary:* Phase 1: randomized sham controlled crossover study (active versus sham condition)* Phase 2: Open label study (active condition), primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: EXOPULSE MOLLII SUIT (active), interventions name: EXOPULSE MOLLII SUIT (sham), outcomesModule primaryOutcomes measure: Improvement in balance using the PBS (Pédiatric Balance Scale) before and after active and sham stimulation, secondaryOutcomes measure: Evaluation of the cumulative effects of EXOPULSE Mollii suit on balance using the PBS, secondaryOutcomes measure: Evaluation of the effects of EXOPULSE Mollii suit on spasticity using the Modified Ashworth Scale (MAS), secondaryOutcomes measure: Evaluation of the effects of EXOPULSE Mollii suit on mobility using the Timed Up and Go test (TUG), secondaryOutcomes measure: Quality of life will be measured using the EuroQol 5 dimensions quality of life questionnaire for youth (EQ-5D-Y), secondaryOutcomes measure: Pain will be assessed using the Pain Scale Chart (PSC), secondaryOutcomes measure: Evaluation of overall improvement using the Clinical Global Impression (CGI), eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Centre Hospitalier Intercommunal D'Aix Pertuis, status: RECRUITING, city: Aix-en-Provence, country: France, contacts name: PASCAL GRANIER, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: HELENE RAUSCENT, MD, role: SUB_INVESTIGATOR, geoPoint lat: 43.5283, lon: 5.44973, locations facility: Centre Medico Chirurgical de Readaptation Des Massues, status: NOT_YET_RECRUITING, city: Lyon, country: France, contacts name: EMMANUELLE CHALEAT - VALAYER, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Marie-Charlotte D'ANJOU, MD, role: SUB_INVESTIGATOR, geoPoint lat: 45.74848, lon: 4.84669, locations facility: Centre de Sante Rossetti, status: RECRUITING, city: Nice, country: France, contacts name: GAUTIER DE CHELLE, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70313, lon: 7.26608, locations facility: Centre de Readaptation Pediatrique D'Oleron, status: RECRUITING, city: Saint-Trojan-les-Bains, country: France, contacts name: SOLENE VIOT, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.84134, lon: -1.20728, hasResults: False

protocolSection identificationModule nctId: NCT06266273, orgStudyIdInfo id: SBA 23/442, briefTitle: Investigating the Development, Validity, and Reliability of the Avoidance of Sports Activities Photo Scale, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, descriptionModule briefSummary: "Investigating the Development, Validity, and Reliability of the Avoidance of Sports Activities Photo Scale" is crucial in determining the specific functional status of the shoulder joint, especially for overhead athletes experiencing shoulder pain, to identify which sporting activities restrict them the most and to fill the gap in the literature. Additionally, visually indicating activities through photographs will provide visual feedback, making it easier to assess functional status. Our study aims to develop a specific functional survey for the shoulder joint in overhead athletes, examine the validity and reliability of this scale, and contribute to the literature., conditionsModule conditions: Questionnaire, conditions: Athletes, conditions: Shoulder Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 170, type: ESTIMATED, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: Investigating the Development, Validity, and Reliability of The Sports Activity Avoidance Photo Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Elif Turgut, status: RECRUITING, city: Ankara, zip: 06300, country: Turkey, contacts name: Elif Turgut, Assoc. Prof., role: CONTACT, phone: +90 (544) 264 56 00, email: elif.turgut.pt@gmail.com, contacts name: Birgül DINGIRDAN, Master, role: SUB_INVESTIGATOR, contacts name: Büşra PAKÖZ, Master, role: SUB_INVESTIGATOR, contacts name: Kübra ÇAYLAN GÜRSES, Master, role: SUB_INVESTIGATOR, contacts name: Pınar KUYULU HAKSAL, Master, role: SUB_INVESTIGATOR, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False

protocolSection identificationModule nctId: NCT06266260, orgStudyIdInfo id: 5486, briefTitle: Evaluation of the Performance of Direct Portal Pressure Measurement by Endoscopic Ultrasound in a Large Cohort of Patients With Advanced Chronic Liver Disease of Different Etiologies and Newly Diagnosed Clinically Significant Portal Hypertension (EVADIPP), acronym: EVADIPP, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-11, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: A minimally invasive procedure to directly assess portal pressure gradient under endoscopic ultrasound guidance (EUS-PPG) has become available and initial data have proved the technique to be safe. Aims of our proposal are: (i) to assess performance of EUS-PPG as compared to HVPG in evaluating hemodynamic response to non selective betablockers (NSBBs) in a large cohort of patients with CSPH;(ii) identification of markers of hemodynamic response(iii) identification of factors potentially affecting the accuracy of PPG measurement., conditionsModule conditions: Portal Hypertension, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: EUS PPG measurement, outcomesModule primaryOutcomes measure: Measurement of the portal pressure gradient though endoscopic ultrasound (EUS) and hepatic venous pressure gradient (HVPG) to evaluate the hemodynamic response to non-selective beta blockers (NSBBs), primaryOutcomes measure: Measurement of the portal pressure gradient though endoscopic ultrasound (EUS) and hepatic venous pressure gradient (HVPG) to evaluate the hemodynamic response to non-selective beta blockers (NSBBs), secondaryOutcomes measure: Markers of hemodynamic response, secondaryOutcomes measure: Markers of hemodynamic response, secondaryOutcomes measure: Markers of hemodynamic response, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Policlinico Gemelli IRCCS, status: RECRUITING, city: Roma, zip: 00168, country: Italy, contacts name: Francesco Santopaolo, MD, role: CONTACT, phone: +393492754288, email: francesco.santopaolo@policlinicogemelli.it, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False

protocolSection identificationModule nctId: NCT06266247, orgStudyIdInfo id: 06-2023/16, secondaryIdInfos id: KMU-BAP, type: OTHER, domain: KMU, briefTitle: How Sirtuin Levels Change During Behçet Disease, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-10-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Karamanoğlu Mehmetbey University, class: OTHER, descriptionModule briefSummary: Our primary aim in our study is to evaluate the relationship between the activity, which will be evaluated by clinical and standard phase reactants, and the IL-6 and TNF-α levels, which will be measured in serum, in Behçet\'s patients. Our secondary aim was to evaluate Sirtuin-1 in Behcet\'s patients and compare it with the normal population. Our third aim is to find out whether there is a relationship between these values and organ involvement., conditionsModule conditions: Behçet Disease, conditions: Inflammation, conditions: Vasculitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Take blood samples, outcomesModule primaryOutcomes measure: Our primary aim is to evaluate the relationship between the activity to be evaluated with clinical and standard acute phase reactants and the IL-6 and TNF-α levels to be measured in serum in Behçet's patients., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Karamanoğlu Mehmetbey University, city: Karaman, country: Turkey, geoPoint lat: 37.18111, lon: 33.215, hasResults: False

protocolSection identificationModule nctId: NCT06266234, orgStudyIdInfo id: APHP230600, secondaryIdInfos id: 10723253 Bis, type: OTHER, domain: CESREES, briefTitle: Characterization by Automated System on Infantile Spasmes, acronym: REASSESS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, collaborators name: OSO-AI, descriptionModule briefSummary: Infantile spasms are defined by the occurrence of epileptic episodes characterized by the appearance of very specific motor seizures, made up of rapid, repeated contractions in flexion or extension known as spasms. This syndrome is of high concern as it will lead to mental retardation if it is not early identified and treated. Most often, spasms are characterized by sudden contractions of the body in flexion. More rarely, spasms occur in extension: the neck and legs suddenly tense, and the arms move upwards or sideways. Spasms may be accompanied by eye revulsion. They are brief, lasting 0.5 to 2 seconds each. At the start of the attack, they may be isolated, but then may occur in series lasting up to several tens of minutes.Because of its nature and duration, infantile spasm is often difficult to identify and is often confused with benign motor manifestations in children, such as hiccups or muscular jerks. This difficulty often leads to delays in diagnosis. Indeed, patients are often seen at the stage when cognitive regression has set in.The gold standard for diagnosing infantile spasms is to capture them on video-EEG to confirm the ictal correlate of the seizure. Although multiple variations are known, the ictal correlation is often a diffuse slow wave of high amplitude with subsequent electrodecrement. Yet continuous video electroencephalogram is an expensive and time-consuming resource often unavailable in developing countries and in many parts of the developed world. Furthermore, in an appropriate clinical scenario, continuous video-EEG may be unnecessary. For example, a home video examination with typical spasms combined with a definitively epileptic ambulatory EEG may certainly be adequate for the diagnosis of infantile spasmsAs part of Mr. Diop's thesis, the study team have developed a system for analyzing videos acquired in 2 dimensions from a simple smartphone or webcam and highlighting the existence of spasms in a child. The principle is to use computer vision and computer learning model to identify the spasms from these videos. The first prototype of this system achieved a positive predictive value of 77%, which is very good considering the small sample used (\< 100) but quite insufficient to obtain a diagnostic prediction for medical use, for which we hope for sensitivity and specificity of around 95%.The aim is to achieve a sensitivity and specificity of over 95% so that we can offer this detection system to healthcare professionals and parents of children who do not have rapid access to diagnosis. The aim is to develop a system enabling broad screening at the population level so that identified children can be more rapidly directed towards the healthcare system and appropriate treatment for their disease.To achieve this goal, we need access to a standardized reference database that currently exists in the various pediatric electrophysiology laboratories of the Assistance Publique - Hôpitaux de Paris and the Île-de-France region. we propose using the films stored in these laboratories to teach the computer to recognize spasms that have already been formally identified by electrophysiologists and by ictal concordance., conditionsModule conditions: Infantile Spasm, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 5000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Automated computer detection of the spasms > 95%, secondaryOutcomes measure: Automated computer detection of the non spasms > 95%, eligibilityModule sex: ALL, maximumAge: 3 Years, stdAges: CHILD, contactsLocationsModule locations facility: Department of paediatric neurological care and intensive care unity (PICU), Raymond Poincaré hospital - APHP, status: RECRUITING, city: Garches, zip: 92380, country: France, geoPoint lat: 48.84226, lon: 2.18232, hasResults: False

protocolSection identificationModule nctId: NCT06266221, orgStudyIdInfo id: APHP200073, secondaryIdInfos id: 2022-000712-59, type: EUDRACT_NUMBER, briefTitle: Severe Erythema Multiforme - CORTICO, acronym: SEMCORTICO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-06-01, completionDateStruct date: 2027-11-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Erythema multiforme (EM) is an acute and often recurrent mucocutaneous disease. EM is considered a hypersensitivity immune-mediated reaction. The two main known triggering factors are Herpes simplex virus (HSV) and Mycoplasma pneumoniae (MP) infections. Typical target skin lesions characterize EM, especially oral MMs. EM is in fact mainly linked to the oral MM involvement, including intense mucosal pain, impaired food intake, weight loss, hospitalization and potential risk of fibrotic sequelae (oral, ocular, genital, oesophageal, respiratory tract) and recurrences.The objectives of treatment for severe EM in the acute phase are to reduce the duration of lesions, prevent complications and mucosal sequelae. However, despite the lack of evidence and consensus some medical teams often use a short regimen of SCS hoping to obtain a quicker improvement of the condition. However, the use of SCS at the acute phase is not codified and remains debated according to the existent literature. Current studies are mostly retrospective and based on small cohorts or case reports. A randomized, controlled trial would be therefore essential to properly evaluate the benefit of SCS in this pathology and provide strong support to clinicians in their decision making in severe EM during the acute phase.This research will be a Phase III randomized, multicentric, double-blind, controlled trial with two parallel groups. The efficacy of prednisone, oral at 1 mg/kg/day for 3 days, tapered to 0.75 mg/kg/day for 3 days, 0.50 mg/kg/day for 3 days, 0.25 mg/kg/day for 3 days is compared to that of placebo, oral for 12 days or IV methylprednisolone if oral route is impossible because of the self-reported inability for the patient to swallow due to the impacts of the oral lesions, with dosage equivalence at 0.8 mg/kg/day for 3 days, tapered to 0.6 mg/kg/day for 3 days, 0.4 mg/kg/day for 3 days, 0.2 mg/kg/day for 3 days, then stopped, compared to that of placebo.A stratification according to the food intake classification (0,1,2 vs 3) will be performed.An interim analysis is planned after the inclusion of 50 patients. Results of the interim analysis will be presented to the DSMB. During the interim analysis, inclusions may continue., conditionsModule conditions: Erythema Multiforme, 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: 96, type: ESTIMATED, armsInterventionsModule interventions name: Prednisone 20 Mg, interventions name: Oral Placebo, interventions name: Methylprednisolone 120 Mg, interventions name: IV Placebo, outcomesModule primaryOutcomes measure: Time to success, primaryOutcomes measure: Evaluation of Pain, primaryOutcomes measure: Food intake, primaryOutcomes measure: Rescue therapy intake, secondaryOutcomes measure: Time to clear or almost clear healing of all sites, secondaryOutcomes measure: Time to fever resolution, secondaryOutcomes measure: Length of hospital stay, secondaryOutcomes measure: Number of days of consumption of level III analgesics, secondaryOutcomes measure: Evaluation of pain, secondaryOutcomes measure: Chopped or solid food intake resumption, secondaryOutcomes measure: Rate of patients in the two groups with need for a rescue therapy, secondaryOutcomes measure: Rate of sequelae, secondaryOutcomes measure: Rate of adverse events during the treatment and follow-up, secondaryOutcomes measure: Evaluation of the quality of life, eligibilityModule sex: ALL, minimumAge: 15 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06266208, orgStudyIdInfo id: UCV/2021-2022/201, briefTitle: Utility of High-resolution Ultrasound to Evaluate Dorsal Osteophyte, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-04-15, completionDateStruct date: 2024-07-15, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Fundación Universidad Católica de Valencia San Vicente Mártir, class: OTHER, descriptionModule briefSummary: This study will evaluate the usefulness of ultrasonography in detecting dorsal osteophytes associated with claw nails compared to radiographs. The hypothesis will be that the larger the size of the osteophyte, the greater the nail curvature.Nail curvature and osteophyte height will be measured in patients with clamp nails. Nail-phalange distance will also be measured with radiography and ultrasonography.The investigators to find a positive correlation between nail curvature and osteophyte height. Furthermore, a strong agreement is expected between both imaging techniques to measure nail-phalange distance.Ultrasonography could constitute a safe and effective alternative to radiology for detecting dorsal osteophytes in claw nails, especially in mild cases, follow-ups or young patients., conditionsModule conditions: Exostosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Exostectomy, interventions name: Cut fingernail, outcomesModule primaryOutcomes measure: Nail-phalange distance, secondaryOutcomes measure: Nail Curvature Index, secondaryOutcomes measure: Thickness of the nail plate, secondaryOutcomes measure: Dorsal Osteophyte Height, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Enieto podologos, status: RECRUITING, city: Logroño, state: La Rioja, zip: 26003, country: Spain, contacts name: Eduardo Nieto-Garcia, Dr, role: CONTACT, phone: 941 25 55 66, email: clinica@enietopodologos.com, contacts name: eduardo Nieto-Garcia, Dr, role: CONTACT, phone: 941 25 55 66, email: eduardo.nieto@ucv.es, contacts name: Eduardo Nieto-Garcia, Dr, role: SUB_INVESTIGATOR, geoPoint lat: 42.46667, lon: -2.45, locations facility: Centro podológico Valencia, status: RECRUITING, city: Valencia, state: València, zip: 46001, country: Spain, contacts name: Martín Redón, role: CONTACT, phone: 96 352 63 41, email: info@podologomartinredon.com, contacts name: Emma Guillem-escámez, role: CONTACT, phone: 96 352 63 41, email: em_chec@mail.ucv.es, contacts name: emma Guillem-Escamez, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.46975, lon: -0.37739, locations facility: Clinicas UCV, status: RECRUITING, city: Valencia, state: València, zip: 46001, country: Spain, contacts name: Pablo Vera-Ivars, Dr., role: CONTACT, phone: 963 92 06 24, email: clinicas.ucv@ucv.es, contacts name: Cristina Mico-Salcedo, role: CONTACT, phone: 963 92 06 24, email: clinicas.ucv@ucv.es, contacts name: Javier Ferrer-Torregrosa, Dr, role: PRINCIPAL_INVESTIGATOR, contacts name: Juan Vicente-Mampel, Dr., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.46975, lon: -0.37739, locations facility: Clinica Pasito a pasito, status: RECRUITING, city: Valencia, zip: 46008, country: Spain, contacts name: Javier Ferrer-Torregrosa, Dr, role: CONTACT, phone: 963855535, email: clinicaspasitoapasito@gmail.com, contacts name: Javier Ferrer-Torregrosa, Dr, role: CONTACT, phone: 644733882, email: javier.ferrer@ucv.es, contacts name: JAVIER Ferrer- TORREGROSA, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.46975, lon: -0.37739, hasResults: False

protocolSection identificationModule nctId: NCT06266195, orgStudyIdInfo id: 5452, briefTitle: Spectroscopic Profiling of Extracellular Vesicles By Resonant Gold Nanostructures in the Infrared, acronym: PROVEIR_1, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-15, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2025-02-28, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: Extracellular vesicles, due to their ease of extraction and ability to represent the cells from which they originate, have high potential in the field of personalized medicine, especially in the identification of new early bio-markers of cancer, including hepatocellular carcinoma. Nevertheless, the development of high-throughput diagnostic methods in this area is still in its infancy, and the design of new integrated technological solutions is of great interest and topicality. The main hypothesis of this study is that the development of a novel technology integrating resonant gold nanostructures in the mid-infrared can significantly contribute to the development of new approaches for the diagnosis of hepatocellular carcinoma., conditionsModule conditions: Vesicle, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: sierological test, outcomesModule primaryOutcomes measure: primary endpoint, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: FPGemelliIRCCS, status: RECRUITING, city: Roma, state: Lazio, zip: 00168, country: Italy, contacts name: Fabrizio Pizzolante, MD PhD, role: CONTACT, phone: +390630151, email: fabrizio.pizzolante@policlinicogemelli.it, contacts name: Gabriele Ciasca, Professor, role: CONTACT, phone: +390630151, email: gabriele.ciasca@unicatt.it, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False

protocolSection identificationModule nctId: NCT06266182, orgStudyIdInfo id: 2020/39/B/HS6/01927, briefTitle: The Effect of an Online ACT Intervention on Meaning-Making Process in Cancer Patients Following Hematopoietic Cell Transplantation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: University of Social Sciences and Humanities, Warsaw, class: OTHER, collaborators name: National Science Centre, Poland, descriptionModule briefSummary: This trial aimed to test internet-based Acceptance and Commitment Therapy (ACT) intervention to induce a meaning-making process in cancer patients following hematopoietic cell transplantation (HCT). ACT includes identifying personal values and engaging in activities consistent with these values, developing acceptance, as well as focusing on the present moment or performing activities with greater awareness. In total, 192 patients following the first (autologous or allogeneic) HCT will be randomly assigned in equal numbers to either the ACT intervention or an education session. Participants in both conditions will take part in 14-day training (about 5-10 minutes a day). The outcomes will be measured at baseline, during the intervention, immediately, 1 month, and 3 months after the intervention. Moreover, 6-9 additional participants will be randomly assigned to pre-intervention measurement length (1-3 weeks) before completing ACT intervention, followed by 7-day observations at each post-intervention measure. The researchers hypothesized that ACT intervention would foster a meaning-making process and thus reduce distress induced by the discrepancy between global and situational meaning as compared to education., conditionsModule conditions: Hematopoietic Cell Transplantation Recipient, conditions: Acceptance and Commitment Therapy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This trial is enhanced by a single-case experimental design (SCED), in which all study participants will receive the same intervention (i.e., intervention study model: single group). In SCED, there is no masking. The estimated total number of participants to be enrolled in SCED is 6-9., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 192, type: ESTIMATED, armsInterventionsModule interventions name: Acceptance and Commitment Therapy, interventions name: Education, outcomesModule primaryOutcomes measure: Distress (Global Meaning Violation Scale; GMVS), secondaryOutcomes measure: Illness perception (Brief-Illness Perception Questionnaire; B-IPQ), secondaryOutcomes measure: Global meaning (Meaning in Life Questionnaire; MLQ), secondaryOutcomes measure: Psychological flexibility (Comprehensive Assessment of Acceptance and Commitment Therapy Processes-9; CompACT-9), secondaryOutcomes measure: Coping self-efficacy (Coping Self-Efficacy Scale; CSE - selected items), secondaryOutcomes measure: Deliberate meaning-making (Core Beliefs Inventory; CBI), secondaryOutcomes measure: Automatic meaning-making (Event-Related Rumination Inventory; ERRI - intrusive ruminations subscale), secondaryOutcomes measure: Post-traumatic growth (the "current standing" Post-Traumatic Growth Inventory-Short Form; C-PTGI-SF ), secondaryOutcomes measure: Meanings made (Meaning of Loss Codebook; MLC), secondaryOutcomes measure: Anxiety and depressive symptoms (Patient Health Questionnaire-4; PHQ-4), secondaryOutcomes measure: Loneliness (The Revised UCLA Loneliness Scale; R-UCLA - selected items), secondaryOutcomes measure: Loneliness (the Community Life Survey), secondaryOutcomes measure: Health-related quality of life (Quality of Life Questionnaire of the European Organization for Research and Treatment of Cancer; EORTC QLQ-C3), secondaryOutcomes measure: Daily subjective health (Daily Subjective Health Scale), secondaryOutcomes measure: Daily affect (Daily Positive and Negative Affect Scale), secondaryOutcomes measure: Daily meaning-making (Event-Related Rumination Inventory-daily form; ERRI-daily form), secondaryOutcomes measure: Daily meanings made (Meaning of Loss Codebook-daily form; MCL-daily form), secondaryOutcomes measure: Daily psychological flexibility (Comprehensive Assessment of Acceptance and Commitment Therapy Processes-daily form; CompACT-daily form), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Maria Skłodowska-Curie National Research Institute of Oncology Gliwice Branch, Department of Bone Marrow Transplantation and Oncohematology, city: Gliwice, zip: 44-102, country: Poland, contacts name: Małgorzata Sobczyk-Kruszelnicka, MD, role: CONTACT, phone: 011 48 322788520, email: malgorzata.sobczyk-kruszelnicka@gliwice.nio.gov.pl, contacts name: Małgorzata Sobczyk-Kruszelnicka, MD, role: SUB_INVESTIGATOR, geoPoint lat: 50.29761, lon: 18.67658, hasResults: False

protocolSection identificationModule nctId: NCT06266169, orgStudyIdInfo id: fpc-2023-ivf-01, briefTitle: Application of Spectral Methods to Assess Gametes, Embryos, and Human Reproductive Capabilities, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-20, primaryCompletionDateStruct date: 2024-02-28, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Family Planning Center of Women's Welfare Clinic #44 of Pushkin District, class: OTHER_GOV, descriptionModule briefSummary: Relevance of the research topic: At present, in the world, a kind of "plateau" in the efficiency of assisted reproductive technologies has been achieved, which ensures a birth rate of 30% per embryo transfer. At the same time, a relatively high (15-20%) and stable rate of miscarriages is preserved. Until now, no effective methods for assessing the potential of gametes and embryos, as well as human reproductive capabilities, have been offered. In these conditions, to increase the rate of births after IVF, clinicians have to increase the number of transferred embryos at a time, however, this leads to a sharp increase in complications of IVF, such as multiple pregnancy. In addition, until today, the clinical effectiveness of assessing the potential of endometrium using gene expression determination methods has not been shown. Therefore, to ensure the effectiveness and safety of infertility treatment, it is necessary to develop methods for predicting the potential of gametes and embryos, as well as human reproductive capabilities. For this purpose, the investigators assume to use Raman spectroscopy of the environment obtained from the objects of research, as well as fluorescent spectroscopy of endometrium. The objects of the research are gametes (spermatozoa) and embryos, used culture medium, endometrium. The subject of the study is the set of factors, that exists in the objects of research and their ability to determine the outcomes of infertility treatment., conditionsModule conditions: Infertility, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: For the retrospective (observational) stage of the study:Embryos: 424 samples of the culture medium used from individually cultured blastocysts that were fresh and frozen before transferring a single embryo from the institution's internal biobank. Each sample is attributed based on the presence or absence of progressing pregnancy after transfer at 12-14 weeks.Semen: 340 samples of sperm from the internal biobank of couples undergoing ICSI, each sample is attributed based on the success or failure of the embryological stage.Endometrium: 300 samples of luminescent and visible spectra of patients' endometrium undergoing embryo transfer, each sample is attributed based on the presence or absence of ongoing pregnancy after transfer.For the prospective (interventional) stage of the study:For each object of study, the size of the dataset for prospective testing can only be determined after passing the observational part of the study., primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 1064, type: ESTIMATED, armsInterventionsModule interventions name: making artificial intelligence based decisions of gamete, embryo and endometrial potential, outcomesModule primaryOutcomes measure: Embryonic model performance, primaryOutcomes measure: Gamete model performance, primaryOutcomes measure: Endometrial model performance, primaryOutcomes measure: Embryonic model clinical efficiency, primaryOutcomes measure: Endometrial model clinical efficiency, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 44 Years, stdAges: ADULT, contactsLocationsModule locations facility: Family planning center, status: RECRUITING, city: Saint Petersburg, state: Pushkin, zip: 196608, country: Russian Federation, contacts name: Alexey Gryaznov, role: CONTACT, phone: +7(812)414-57-09, email: libra19831010@mail.ru, geoPoint lat: 59.93863, lon: 30.31413, hasResults: False

protocolSection identificationModule nctId: NCT06266156, orgStudyIdInfo id: BMU-HTUNC-01, briefTitle: Evaluation of The Effect of Consecutive Dental Visits on Dental Anxiety of Paediatric Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-08-05, primaryCompletionDateStruct date: 2023-11-03, completionDateStruct date: 2023-12-27, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Burdur Mehmet Akif Ersoy University, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about in effect of consecutive dental visits on dental anxiety of paediatric patients.The main question\[s\]it aims to answer are:* Did the anxiety level of pediatric patients decrease in consecutive treatment sessions?* Were there changes in the physiological parameters related to stress level of pediatric patients in consecutive treatment sessions?Participants will fill out the questionnaire about dental anxiety in each dental treatment sessions before and after dental treatment.Researchers will compare paeditric patients have two caries on mandibular molars to see if changes dental anxiety levels and physiological parameters such as heart rates and oxygen saturations during dental treatments in consecutive dental treatment sessions., conditionsModule conditions: Dental Anxiety, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 240, type: ACTUAL, armsInterventionsModule interventions name: Score of anxiety questionnaire, interventions name: Heart rate, interventions name: Oxygen saturation, outcomesModule primaryOutcomes measure: Determination of sample size., primaryOutcomes measure: Inviting participants to the study., primaryOutcomes measure: Determination of dental anxiety score of participants before dental treatment in first dental session, primaryOutcomes measure: Heart rate measuring in first dental session., primaryOutcomes measure: Oxygen saturation measuring in first dental session., primaryOutcomes measure: Determination of dental anxiety score of participants after dental treatment in first dental session, primaryOutcomes measure: Determination of dental anxiety score of participants before dental treatment in second dental session, primaryOutcomes measure: Heart rate measuring in second dental session., primaryOutcomes measure: Oxygen saturation measuring in second dental session., primaryOutcomes measure: Determination of dental anxiety score of participants after dental treatment in second dental session, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 9 Years, stdAges: CHILD, contactsLocationsModule locations facility: Burdur Mehmet Akif Ersoy University Faculty of Dentistry, city: Burdur, state: Centrum, zip: 15100, country: Turkey, geoPoint lat: 37.72028, lon: 30.29083, hasResults: False

protocolSection identificationModule nctId: NCT06266143, orgStudyIdInfo id: Y101D03, briefTitle: A Trial of Y101D in Combination With Gemcitabine and Albumin Paclitaxel in Patients With Advanced Pancreatic Cancer, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-02-08, primaryCompletionDateStruct date: 2024-07-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Wuhan YZY Biopharma Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The Phase Ib/II study is an open-label, single-arm, multicenter trial designed to assess the efficacy and safety of Y101D in combination with Gemcitabine and Albumin Paclitaxel as first-line systemic treatment for advanced pancreatic cancer patients. The Phase Ib portion of the study aims to evaluate the safety of escalating doses of Y101D in combination with the standard regimen of Gemcitabine and Albumin Paclitaxel and determine the recommended phase 2 dose (RP2D). The Phase II portion of the study aims to evaluate the effectiveness of this combination treatment in a small population of patients., conditionsModule conditions: Advanced Pancreatic Adenocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 71, type: ACTUAL, armsInterventionsModule interventions name: Y101D, outcomesModule primaryOutcomes measure: Dose Limiting Toxicities (DLTs), primaryOutcomes measure: RP2D, primaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Peak Serum Concentration (Cmax), secondaryOutcomes measure: Trough Serum Concentration (Ctrough), secondaryOutcomes measure: Area under the serum concentration versus time curve (AUC) during one treatment cycle (21 days), secondaryOutcomes measure: The TGF-β concentration in serum, secondaryOutcomes measure: The CA19-9 concentration in serum, secondaryOutcomes measure: The positive rate of Anti-Drug Antibody (ADA) and Neutralizing antibody (Nab), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, city: Wuhan, state: Hubei, zip: 430022, country: China, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False

protocolSection identificationModule nctId: NCT06266130, orgStudyIdInfo id: EM-11-050087, briefTitle: Digital Bonding vs. Direct Bonding Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2026-08, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: 3M, class: INDUSTRY, descriptionModule briefSummary: This is a prospective, 2-armed, randomized, multi-site clinical study to demonstrate that digital bonding is a more efficient treatment method than direct placement of brackets., conditionsModule conditions: Orthodontic Brackets, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: There are two groups, treatment group (digital bonding) and control group (direct bonding). Subjects will be enrolled and randomized into treatment or control group at each orthodontic practice., primaryPurpose: OTHER, maskingInfo masking: NONE, maskingDescription: Due to the nature of the devices, Investigator blinding is not feasible for the study., enrollmentInfo count: 178, type: ESTIMATED, armsInterventionsModule interventions name: Treatment Group Digital Bonding Tray, interventions name: Control Group Direct Bonding, outcomesModule primaryOutcomes measure: Prep-and-bonding time, secondaryOutcomes measure: Number of adjustment visits to complete treatment, secondaryOutcomes measure: Overall chair time, eligibilityModule sex: ALL, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06266117, orgStudyIdInfo id: SBF-HMS-GES-03, briefTitle: Pain, Anxiety, and Comfort Levels in Coronary Angiography, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2024-03-30, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Abant Izzet Baysal University, class: OTHER, descriptionModule briefSummary: The study was designed as a descriptive study. The universe of the study is İzzet Baysal Training and Research Hospital; It consists of patients who underwent coronary angiography in the coronary intensive care unit., conditionsModule conditions: Pain, conditions: Anxiety, conditions: Nursing Caries, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 216, type: ESTIMATED, outcomesModule primaryOutcomes measure: Pain level, primaryOutcomes measure: Anxiety, primaryOutcomes measure: Comfort, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Abant Izzet Baysal University Faculty of Health Science, city: Bolu, state: Merkez, zip: 14100, country: Turkey, geoPoint lat: 40.73583, lon: 31.60611, hasResults: False

protocolSection identificationModule nctId: NCT06266104, orgStudyIdInfo id: Protocol V1.4_04012024, briefTitle: Image Enhanced Endoscopy IBD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-03, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Royal Perth Hospital, class: OTHER, descriptionModule briefSummary: Dye- spray chromoendoscopy remains the recommended gold standard approach for IBD dysplasia surveillance colonoscopy however recently published European and American guidelines recommend either dye-spray or virtual chromoendoscopy can be used for surveillance. The newer Imaged Enhanced Endoscopy technologies TXI and LCI have not formally been evaluated in IBD surveillance in a randomised controlled trial setting. These modes can easily be applied during colonoscopy and if demonstrated to be effective may save time and eliminate the need for dye-spray chromoendoscopy in the future., conditionsModule conditions: Inflammatory Bowel Diseases, conditions: Dysplasia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 270, type: ESTIMATED, armsInterventionsModule interventions name: Image Enhanced Endoscopy Filters, outcomesModule primaryOutcomes measure: Dysplasia Detection Rate, secondaryOutcomes measure: Withdrawal times, secondaryOutcomes measure: Characterisation of lesions, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Royal Perth Hosptial, status: RECRUITING, city: Perth, state: Western Australia, zip: 6000, country: Australia, contacts name: Sherman Picardo, MBBS, role: CONTACT, phone: 92242244, geoPoint lat: -31.95224, lon: 115.8614, hasResults: False

protocolSection identificationModule nctId: NCT06266091, orgStudyIdInfo id: M70102, briefTitle: Treat Malignant Ascites Caused by Gastrointestinal or Ovarian Cancer With M701 Bispecific Antibody, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2021-11-24, primaryCompletionDateStruct date: 2024-03-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Wuhan YZY Biopharma Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: A Phase II, Randomized, Open-label, Controlled, Multicenter Study to Evaluate the Efficacy and Safety of M701 in treating Patients with Malignant Ascites Caused by Gastrointestinal or Ovarian Cancer combined with Systemic Therapy., conditionsModule conditions: Malignant Ascites, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: M701, interventions name: paracentesis, outcomesModule primaryOutcomes measure: Puncture-free survival, PuFS, secondaryOutcomes measure: objective response rate (ORR) of malignant ascites, secondaryOutcomes measure: Progression-free Survival, PFS, secondaryOutcomes measure: Overall survival, OS, secondaryOutcomes measure: Quality of Life, QoL, secondaryOutcomes measure: Safety profiles, secondaryOutcomes measure: Positive rate of ADA and Nab in serum, secondaryOutcomes measure: The EpCAM expression in ascites, secondaryOutcomes measure: Trough serum concentration (Ctrough), secondaryOutcomes measure: Peak serum concentration (Cmax), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Medical Center of Chinese PLA General Hospital, city: Beijing, state: Beijing, zip: 100141, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False

protocolSection identificationModule nctId: NCT06266078, orgStudyIdInfo id: School of Nursing, briefTitle: A Human Factors Simulation Study Protocol for the Assessment of Usability of Innovative Personal Protective Equipment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-12-15, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University of Campinas, Brazil, class: OTHER, descriptionModule briefSummary: Background: Many factors influence Personal Protective Equipment (PPE) compliance for use in health care, specifically the PPE usability and related human factors. It is known that issues related to the usability of new technologies, including professional behavioral and attitudinal patterns, the technologies adoption within the workflow and teamwork strengths can be investigated by using Simulation-Based Research (SBR) before its implemented. This study aims to develop and validate a simulation protocol for the assessment of human factors and usability of innovative PPEs used in critical care units. The ultimate goals is to define a standard method for PPEs assessment and comparison worldwide. Method: methodological study with a quantitative approach to be carried out in two phases: a) development and validation by experts of a simulation protocol; b) piloting of the simulation protocol. For the protocol validation phase, 14 experts with experience in the themes of infection prevention and control or clinical simulation will be included. The experts will be invited via email and will assess the simulation protocol content using the criteria of pertinence, clarity and relevance. To ensure that the simulation protocol is feasible and reliable, a piloting phase will take place at the simulation center in São Paulo and 36 health professionals with work experience in critical care units will be included. The health professionals will perform specific tasks assigned to them, wearing pre-defined PPEs in each simulation round. Errors and difficulties during PPE assembly, donning and doffing; performance of individual and team activities, as well as communication problems and self-contamination risk, will be observed during the tasks. At the end of the simulation round, the participants will take part in a debriefing, where they will answer questionnaires about comfort, perception of safety, thermal sensations, usability and perceived workload related to the PPE used. Content validity index (CVI) and intraclass correlation coefficient (ICC) will be calculated. This study protocol was approved by the Research Ethics Committee of the School of Nursing, University of São Paulo. The informed consent form will be applied both to the experts and to the health care workers., conditionsModule conditions: Personal Protective Equipment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Firstly, a minimum of 14 experts will validate the content, using the Delphi technique of two tools (A) The innovative PPE assessment tool; and B) the simulation scenario script.After reaching consensus among the experts, the protocol will be piloted. Two identical sessions will be conducted using the cross-over method with all participants, so that the same participant performs the tasks using the innovative PPE and the comparative PPE, allowing the participants compare characteristics of both PPE. The PPE use sequence and the PPE type will be randomized to minimize biases. Between both sessions there will a 30-minute break for the participants.For the purpose of the development and piloting of this simulation protocol, the innovative PPE were selected according to compliance with the specifications required by the World Health Organization. It will enrolled 36 healthcare workers in piloting test., primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 9, type: ESTIMATED, armsInterventionsModule interventions name: Innovative PPE, interventions name: Traditional PPE, outcomesModule primaryOutcomes measure: Content Validity of the items included in the "Innovative PPE assessment tool" and in the "Simulation scenario script", primaryOutcomes measure: Errors during PPE assembly/preparation, donning and doffing, primaryOutcomes measure: Communication impairments while using PPE, primaryOutcomes measure: Self-contamination risk in the professional while using and doffing the PPE, primaryOutcomes measure: Influence of PPE on individual performance, primaryOutcomes measure: Influence of PPE on team performance and behavioral changes, primaryOutcomes measure: Changes in mobility and comfort while using PPE, primaryOutcomes measure: Thermal sensations, primaryOutcomes measure: Perception regarding safety and satisfaction of the PPE user, primaryOutcomes measure: Perceived workload, primaryOutcomes measure: Usability, secondaryOutcomes measure: Complementary Content Analysis - qualitative data, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06266065, orgStudyIdInfo id: 8.1-23/260-2;02/013AG, briefTitle: Impact of Coronary Sinus Flow Reducer on Coronary Microcirculation and Myocardial Ischemia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-27, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Clinical Hospital Centre Zagreb, class: OTHER, descriptionModule briefSummary: The increasing number of coronary revascularization procedures, coupled with improvements in drug therapy, has significantly extended the lifespan of patients with coronary artery disease (CAD). However, there remains a significant number of CAD patients who experience disability due to chronic refractory angina pectoris. These patients typically have severe diffuse CAD and are not candidates for further revascularization involving surgical coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI).The installation of a coronary sinus reducer (CSR) represents a new option for percutaneous treatment of patients with refractory angina pectoris who are not suitable for surgical or percutaneous revascularization. The CSR device is designed as an hourglass-shaped stent that is positioned transcatheterally in the distal part of the coronary sinus. This increases intramyocardial venous pressure, which is believed to lead to a more favorable perfusion ratio between the ischemic subendocardial and non-ischemic subepicardial myocardium. Previous research has demonstrated that the implantation of CSR is a safe and relatively straightforward procedure. However, broader implementation and better patient selection are still limited by the fact that the exact mechanism of action remains controversial. It has not been determined why some patients have better outcomes compared to others with seemingly similar coronary artery disease. It is known that patients with atherosclerotic changes in the epicardial coronary arteries also have a certain degree of coronary microcirculation disease (the coronary vascular bed encompassing vessels with a diameter \< 200 μm), which cannot be assessed through standard coronary angiography. This study aims to assess changes in coronary microcirculation after the implantation of CSR by measuring coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) before and 6 months after the procedure. Furthermore, our goal is to associate these changes with clinical symptoms and myocardial ischemia., conditionsModule conditions: Coronary Artery Disease, conditions: Angina Pectoris, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single-Center Prospective Study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Coronary Sinus Reducer, outcomesModule primaryOutcomes measure: Impact of Coronary Sinus Reducer on Coronary Microcirculation, secondaryOutcomes measure: Myocardial Ischemia assessment, secondaryOutcomes measure: Angina assessment, secondaryOutcomes measure: Functional capacity assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Centre Zagreb, status: RECRUITING, city: Zagreb, zip: 10000, country: Croatia, contacts name: Josko Bulum, MD, PhD, role: CONTACT, phone: +385981714090, email: jbulum@gmail.com, contacts name: Luka Percin, MD, role: CONTACT, phone: +385917917252, email: luka.percin555@gmail.com, geoPoint lat: 45.81444, lon: 15.97798, hasResults: False

protocolSection identificationModule nctId: NCT06266052, orgStudyIdInfo id: 2019/04, briefTitle: Evaluation of the Effects of Four Different Flap Designs on Tissue Healing in Lower Third Molar Surgery, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-01-20, primaryCompletionDateStruct date: 2024-03-20, completionDateStruct date: 2024-04-20, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Recep Tayyip Erdogan University, class: OTHER, descriptionModule briefSummary: The aim of this study is to prospectively evaluate the effectiveness of 4 different flap types used during mandibular impacted wisdom teeth surgery on postoperative quality of life, soft tissue and hard tissue healing at the end of the 3rd month., conditionsModule conditions: Soft Tissue Injuries, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Triangular Flap, interventions name: Berwick Flap, interventions name: Saurez Flap, interventions name: Heitz Flap, outcomesModule primaryOutcomes measure: Eudema Amount, primaryOutcomes measure: Pain Level, primaryOutcomes measure: Trismus Level, primaryOutcomes measure: Halitosis Amount, primaryOutcomes measure: bone healing condition, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: RTEU Faculty of Dentistry, city: Rize, country: Turkey, geoPoint lat: 41.02083, lon: 40.52194, hasResults: False

protocolSection identificationModule nctId: NCT06266039, orgStudyIdInfo id: 2022-0328-01, secondaryIdInfos id: 2022-A02616-37, type: OTHER, domain: French National Agency for the Safety of Medicines (ANSM), briefTitle: Introduction of Long Acting Buprenorphine in France, acronym: OBAP, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-31, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University of Bordeaux, class: OTHER, descriptionModule briefSummary: The current available pharmacological treatment formulations (i.e., daily formulations of buprenorphine or methadone) for OUD in France may have several inconveniences, such as: compliance, burden of daily intake, and risk of misuse; that may hinder their effectiveness. Long acting formulations of buprenorphine (LAB) such as Buvidal have been developed to favor retention and compliance and minimize the risk of diversion. Previous studies are promising on the advantage of LAB to treat opioid addiction, however more evidence is needed in the French healthcare context. However, in addition to randomized clinical trials, the French National Healthcare Agency (HAS "Haute Autorité de Santé") recommends conducting "real-life" studies (i.e., in naturalistic conditions) during the development of a medication and the use of "Patient Reported Outcome Measures" (PROMs) to analyze patient quality of life and/or other measures relevant to patients (e.g., severity, efficiency), without interpretation of the answers by a health professional. In this regard, our study proposes to use the Addiction Severity Index (ASI) self-report questions and several scales on treatment satisfaction and quality of life to collect the patient's opinion of perceived changes following the use of Buvidal.Main objectives:The objectives of this prospective open observational study, in naturalistic conditions, are to examine in individuals with an opioid use disorder, over a period of 6 months after LAB treatment initiation: the change in substance addiction severity and the changes in health-related quality of life, craving, opioids and other substance and non-substance uses and misuses, alcohol, tobacco and non-substance addiction severity, satisfaction with LAB treatment, severity of others domains related to addiction severity (i.e., medical, social, psychological) and psychiatric comorbiditiesMain hypotheses:1. Hypothesize was that LAB will be associated with a stable (if prior remission) or a reduction of the CS of "Drug use" (i.e., substance addiction severity) at 6 months compared to baseline.2. Hypothesize was that LAB will be associated with a stable (if prior remission) or a reduction of opioids and other substance and non-substance uses and misuses, other substances and non-substances addiction severity, craving, severity of others domains related to addiction (i.e., medical status, employment and support, family/social status, psychological status), an improvement of quality of life and a good satisfaction with treatment at follow-ups compared to baseline., conditionsModule conditions: Addiction Opiate, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 223, type: ESTIMATED, outcomesModule primaryOutcomes measure: The change in the composite score of the "Drug use" section from the Addiction Severity Index (ASI) at 6 months after treatment initiation, secondaryOutcomes measure: The change in addiction severity at 6 months after treatment initiation, secondaryOutcomes measure: The change in quality of life with EuroQoL-5 Dimensions-5 Levels (EQ-5DL-5L) at 6 months after treatment initiation, secondaryOutcomes measure: The change in quality of life with the 12-Item Short Form Survey (SF-12) at 6 months after treatment initiation, secondaryOutcomes measure: The change in quality of life with nottingham health profile part 1 and part 2 (NHP1 and NHP2) at 6 months after treatment initiation, secondaryOutcomes measure: The change in quality of life with assisted quality of life assessment chart (TEAQV) at 6 months after treatment initiation, secondaryOutcomes measure: The change in other use at 6 months after treatment initiation, secondaryOutcomes measure: The change in craving at 6 months after treatment initiation, secondaryOutcomes measure: The change in other domains of addiction severity at 6 months after treatment initiation, secondaryOutcomes measure: The change in Treatment Satisfaction Questionnaire for Medication (TSQM) at 6 months after treatment initiation, secondaryOutcomes measure: Cues - craving - use links and others factors variations measure with EMA after treatment initiation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Bordeaux, status: RECRUITING, city: Bordeaux, state: Gironde, zip: 33000, country: France, contacts name: Marc Auriacombe, Professor, role: CONTACT, phone: +33556561738, email: marc.auriacombe@u-bordeaux.fr, geoPoint lat: 44.84044, lon: -0.5805, hasResults: False

protocolSection identificationModule nctId: NCT06266026, orgStudyIdInfo id: ThermoBreast, briefTitle: ThermoBreast - Non-contact Breast Cancer Imaging Using AI-enhanced Thermography., acronym: ThermoBreast, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-11, primaryCompletionDateStruct date: 2028-12, completionDateStruct date: 2029-12, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: ThermoMind Ltd., class: INDUSTRY, collaborators name: Assuta Medical Centers Ltd., collaborators name: Hospital of Lithuanian University of Health Sciences Kaunas Clinics, collaborators name: Institut Gustav Roussy, collaborators name: M.D. Anderson Cancer Center, collaborators name: Sheba Medical Center, collaborators name: The Holy Family Hospital Nazareth, collaborators name: University College Cork, collaborators name: Univerzitetni klinicni center Maribor, collaborators name: Academisch Ziekenhuis Groningen, collaborators name: Technical University of Munich, collaborators name: Technion, Israel Institute of Technology, collaborators name: Vrije Universiteit Brussel, collaborators name: Cancer Patients Europe, collaborators name: University Hospital Heidelberg, descriptionModule briefSummary: Breast cancer is one of the most worrisome health concerns facing women. Early detection and active patient monitoring are crucial to survival. The chances of a cure are high when detected and treated in the early stages. Standard breast cancer diagnostic methods such as mammography, ultrasound, and MRI have limitations such as ionizing radiation, high false-positive rates, and/or high expenses.Medical Thermography might overcome these limitations: It is a non-invasive, adjunctive physiologic imaging technology that uses a high-resolution infrared camera and computer processing to produce an image (thermogram) of a patient's skin surface temperatures. It is a non-contact screening method, which does not involve radiation exposure or invasive procedures, and is safe for both the patient and the trained personnel performing the screening. While mammography and ultrasound depend primarily on structural and anatomical variation of the tumor from the surrounding breast tissue, thermography detects pathophysiological changes within the breast such as metabolic and vascular changes caused by cancer. The heat transfer in the body is conducted by the circulatory system; hence, pathologies identified by thermography are generally associated with changes in blood perfusion.To date, there has been no completed or ongoing large-scale, prospective, multicenter, international study that evaluates the diagnostic performance of thermal video streams coupled with advanced Artificial Intelligence algorithms for early-stage breast cancer screening and diagnosis. The proposed study will be crucial for the development of a new imaging modality that aims to be both cost-effective and to carry a minimal level of risk, facilitating screening of women of all age groups and breast densities, enabling early detection of abnormalities caused by malignant processes and improving patient monitoring., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 28000, type: ESTIMATED, armsInterventionsModule interventions name: ThermoBreast - AI-based evaluation of dynamic breast thermography imaging, outcomesModule primaryOutcomes measure: Sensitivity (true-positive rate), primaryOutcomes measure: Specificity (true-negative rate), secondaryOutcomes measure: Cancer detection rate, secondaryOutcomes measure: Detection rate of ductal carcinoma in situ (DCIS), secondaryOutcomes measure: Detection rate of tumor category pT1, secondaryOutcomes measure: Recall rate, secondaryOutcomes measure: Sensitivity, secondaryOutcomes measure: Specificity, secondaryOutcomes measure: Positive-predictive value, secondaryOutcomes measure: Negative-predictive value, secondaryOutcomes measure: Diagnostic performance in the three trial cohorts, secondaryOutcomes measure: Proportion of breast quadrant localization, secondaryOutcomes measure: Proportion of correct histopathologic subtype identification, secondaryOutcomes measure: Proportion of correct tumorbiologic subtype identification, secondaryOutcomes measure: Proportion of correct axillary lymph node involvement identification, secondaryOutcomes measure: Effect of hormonal status on diagnostic performance, secondaryOutcomes measure: Effect of breast density on diagnostic performance, secondaryOutcomes measure: Effect of ethnicity on diagnostic performance, secondaryOutcomes measure: Timing of ThermoBreast, secondaryOutcomes measure: Screening time, secondaryOutcomes measure: Cost-effectiveness, secondaryOutcomes measure: Lived Experience, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Heidelberg University Hospital, status: RECRUITING, city: Heidelberg, country: Germany, contacts name: André Pfob, MD, role: CONTACT, geoPoint lat: 49.40768, lon: 8.69079, hasResults: False

protocolSection identificationModule nctId: NCT06266013, orgStudyIdInfo id: 009, briefTitle: Influence of an Inspiratory Muscle Fatigue Protocol on Older Adults on Respiratory Muscle Strength, Muscle Oxygen Saturation, and Functional Capacity, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-14, primaryCompletionDateStruct date: 2024-02-19, completionDateStruct date: 2024-03-10, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Sierra Varona SL, class: OTHER, collaborators name: Universidad Europea de Madrid, descriptionModule briefSummary: Respiratory muscle training represents an effective method increasingly utilized in both sports and healthcare domains, employing various devices, among which threshold devices are prominent. The aim of this study is to determine the relationship between diaphragmatic fatigue and muscular strength in upper and lower limbs, in both healthy and pathological subjects, as well as the association between such fatigue and other variables, including maximal inspiratory pressure, functionality and muscle tissue oxygen levels.According to our hypothesis, the execution of a protocol inducing diaphragmatic fatigue in older adults could influence muscular strength, cardiorespiratory function, exercise capacity, and muscle tissue oxygenation.In this study, subjects will be divided into three groups: the experimental group, the activation group and the control group.Measurements of variables, such as maximal inspiratory pressure, peripheral muscle tissue oxygen levels, diaphragmatic strength (ultrasound image) and functional capacity, will be conducted., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: the outcome assessor will not know in which group is each participant, and the investigator will receive the data without knowing which data is from which group, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: inspiratory muscle training, outcomesModule primaryOutcomes measure: Muscle oxygen saturation (SmO2), primaryOutcomes measure: Functional mobility, primaryOutcomes measure: Respiratory muscle strength, primaryOutcomes measure: Diaphragmatic thickness and thickening fraction, primaryOutcomes measure: Functional capacity, primaryOutcomes measure: Diaphragm movement curve, eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06266000, orgStudyIdInfo id: PROPAL, briefTitle: Comparison of 2 Extracts of Saw Palmetto Versus Placebo on BPH Symptoms, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: RDC Clinical Pty Ltd, class: INDUSTRY, descriptionModule briefSummary: A randomized, double-blind, placebo-controlled, parallel group study to compare 2 extracts of saw palmetto versus placebo on the symptoms of benign prostate hyperplasia (BPH) in 120 generally healthy participants, 45 - 80 years., conditionsModule conditions: Benign Prostatic Hyperplasia, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Saw palmetto extract 320mg per day, interventions name: Commercial Saw palmetto extract 320mg per day, interventions name: Palm Oil capsule, outcomesModule primaryOutcomes measure: International Prostate Symptom Score (IPSS), primaryOutcomes measure: Daily Urinary Frequency Diary, secondaryOutcomes measure: Brief Sexual Function Inventory (BSFI), secondaryOutcomes measure: International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms Module (ICIQ-MLUTS), secondaryOutcomes measure: Electrolytes (E/LFT) blood test, secondaryOutcomes measure: Liver Function (E/LFT) blood test, secondaryOutcomes measure: Inflammatory marker - JM27, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Pulse rate, secondaryOutcomes measure: Adverse event frequency, secondaryOutcomes measure: Adverse event severity, secondaryOutcomes measure: Discontinuation due to adverse events, eligibilityModule sex: MALE, minimumAge: 45 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: RDC Clinical Pty Ltd, status: RECRUITING, city: Brisbane, state: Queensland, zip: 4006, country: Australia, contacts name: Amanda Rao, PhD, role: CONTACT, phone: +61 414 488 559, email: amanda@rdcglobal.com.au, contacts name: David Briskey, PhD, role: CONTACT, phone: +61 421 784 077, email: david@rdcglobal.com.au, geoPoint lat: -27.46794, lon: 153.02809, hasResults: False

protocolSection identificationModule nctId: NCT06265987, orgStudyIdInfo id: ECHOQUALITY2, briefTitle: Maternal and Fetal Characteristics Influencing Image Quality in Prenatal Ultrasonography, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2024-01-01, completionDateStruct date: 2024-01-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Poitiers University Hospital, class: OTHER, descriptionModule briefSummary: The objective of this observational study is to identify maternal and fetal characteristics that impact image quality in prenatal ultrasonography. The investigators have assembled a retrospective cohort of 198 patients, each contributing three ultrasound images taken between 18 and 18 weeks and 6 days of gestation. For each image, the investigators assess the quality of two distinct elements as well as the overall image through both subjective and objective evaluations.The primary questions the study seeks to address are:What maternal and fetal characteristics influence image quality in prenatal ultrasonography?, conditionsModule conditions: Ultrasonography, conditions: Obstetrics, conditions: Fetus, conditions: Pregnant Women, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 198, type: ACTUAL, outcomesModule primaryOutcomes measure: Maternal and fetal characteristics can influence quality image in ultrasonography, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital La MILETRIE, city: Poitiers, zip: 86000, country: France, geoPoint lat: 46.58333, lon: 0.33333, hasResults: False

protocolSection identificationModule nctId: NCT06265974, orgStudyIdInfo id: ECHOQUALITY, briefTitle: Evaluation of Image Quality in Obstetrical Ultrasonography: Comparison Between Subjective Assessment and Contrast-to-noise Ratio, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2024-01-01, completionDateStruct date: 2024-01-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Poitiers University Hospital, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to determine whether the subjective assessment of the quality of obstetrical ultrasonography pictures can be similar to that of an objective tool.The main question it aims to answer is:Is the subjective assessment of the quality of obstetrical ultrasonography pictures by a young practitioner and an experienced one can be similar to that of an objective tool, such as the contrast-to-noise ratio (CNR)? The contrast-to-noise ratio is commonly used in radiology to evaluate image quality by assessing the ability to distinguish differences between two elements.The investigators selected a retrospective cohort of 198 patients, including three pictures per fetus screened between 18 and 18 weeks and 6 days. For each picture, the investigators assessed the quality of two different elements and the entire image, and then calculated the CNR using software. The investigators will compare the three assessment between them, conditionsModule conditions: Ultrasonography, conditions: Obstetrics, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 198, type: ACTUAL, outcomesModule primaryOutcomes measure: The comparability between a subjective and objective assessment of the contrast to noise ratio of an obstetric ultrasound image, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital La MILETRIE, city: Poitiers, zip: 86000, country: France, geoPoint lat: 46.58333, lon: 0.33333, hasResults: False

protocolSection identificationModule nctId: NCT06265961, orgStudyIdInfo id: 02.01.2024_39, briefTitle: Efficiency of the Bibliotherapy Method in Developing Cultural Intelligence and Competencies of Nurses, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Eskisehir Osmangazi University, class: OTHER, descriptionModule briefSummary: The study aims to evaluate the effectiveness of the developmental bibliotherapy method in developing the cultural intelligence and competence of nurses.The study will be carried out in an embedded intervention research model using a combination design (Quantitative + Qualitative) in the intervention design, which is one of the advanced mixed methods designs. In the embedded mixed research model where the quantitative approach is dominant, randomized controlled experimental research and qualitative research will be conducted simultaneously.1.1. Research questions for the qualitative phase 1.1.1. Research questions for the exploratory phase Q1. How successful are nurses in distinguishing the cultural differences of the individuals they care for? Q2. What are nurses\&#39; views on cross-cultural nursing care? Q4. How do nurses approach the culturally-based behaviors of the individuals they care for? Q5. What are the cultural experiences that nurses have with the individuals they care for?1.1.2. Research questions for the integrative phase Q1. What are the contributions of the books read to the cultural intelligence and competence of nurses? Q2. What are the contributions of the stories read to the cultural intelligence and competence of nurses? Q3. What are the contributions of the watched movie to the cultural intelligence and competence of nurses?1.1.3. Research questions for the explanatory phase Q1. What effect did bibliotherapy practice have on nurses\&#39; cultural intelligence? Q2. What impact did bibliotherapy practice have on nurses\&#39; cultural competence?1.2. Research hypotheses of the quantitative phase1. H1. Bibliotherapy intervention will increase the cultural intelligence levels of the nurses in the study group.2. H1. The cultural intelligence levels of the nurses in the study group will be higher than the nurses in the control group.3. H1. Bibliotherapy intervention will increase the cultural competence of the nurses in the study group.4. H1. The cultural competence of the nurses in the study group will be higher than the nurses in the control group., conditionsModule conditions: Cultural Competency, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: Mixed methods research is defined as "a research approach used in the field of health, social and behavioral sciences in which the researcher collects both quantitative and qualitative data to understand the research problems, integrates two data sets, and then draws conclusions using the advantages of integrating these two data sets." The study will be carried out in an embedded intervention research model using a combination design (Quantitative + Qualitative) in the intervention design, which is one of the advanced mixed methods designs. In the embedded mixed research model where the quantitative approach is dominant, randomized controlled research and qualitative research will be conducted simultaneously., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Education, interventions name: Bibliotherapy, outcomesModule primaryOutcomes measure: Cultural intelligence, primaryOutcomes measure: Cultural competence, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Eskisehir Osmangazi University, city: Eskisehir, state: Odunpazarı, zip: 26040, country: Turkey, geoPoint lat: 39.77667, lon: 30.52056, hasResults: False

protocolSection identificationModule nctId: NCT06265948, orgStudyIdInfo id: comparsion drugs in cancer, briefTitle: Comparsion Between Intravenous Infusion of Ketofol and Inhalational Anasthetics in Abdominal Cancer Surgeries for Post Operative Analgesia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: ( post operative pain between intravenous infusion ketofol and standard inhalational general anesthesia in abdominal cancer surgeries ), conditionsModule conditions: Abdominal Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: post operative pain, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06265935, orgStudyIdInfo id: Ataturk Unıversıty - Neslihan, briefTitle: Effect of Diaphragmatic Breathing Exercise on Fatigue and Quality of Life in Pregnant Women With Gestational Diabetes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-08-15, completionDateStruct date: 2024-10-15, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Ataturk University, class: OTHER, descriptionModule briefSummary: Gestational diabetes mellitus (GDM) is one of the most common medical complications of pregnancy. GDM, which is in the high-risk pregnancy category, causes fatigue during pregnancy due to both hormonal changes and pregnancy complications (1). Fatigue is a general complaint that occurs in almost all physical and mental diseases. Fatigue also negatively affects an individual's well-being, daily performance, activities of daily living (ADLs) and relationships. Fatigue is one of the symptoms that, if not controlled, negatively affects the individual's daily living activities and quality of life (2). While breathing itself is a way of relaxation, it is also a part of all relaxation exercises and is an exercise that can be used in daily life. Breathing correctly and deeply is the first step in learning to relax. (3). It is important to identify fatigue, minimize it, plan daily living activities and improve quality of life in patients with GDM. This study will be conducted as a randomized controlled study to determine the fatigue and quality of life of diaphragmatic breathing exercises, one of the non-pharmacological methods, on pregnant women with gestational diabetes., conditionsModule conditions: Gestational Diabetes Mellitus in Pregnancy, conditions: Pregnancy in Diabetic, conditions: Fatigue, conditions: Quality of Life, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomize, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: The sample size was calculated as 60 pregnant women by performing GPower analysis, taking into account the tests to be used to calculate the minimum sample size to be included in the study. The sampling will include a total of 60 primiparous pregnant women, including 30 pregnant women diagnosed with gestational diabetes who meet the inclusion criteria for the study, who agree to participate in the study, and 30 pregnant women diagnosed with gestational diabetes who are applied diaphragmatic breathing exercise and who are not applied diaphragmatic breathing exercise., whoMasked: PARTICIPANT, enrollmentInfo count: 2, type: ESTIMATED, armsInterventionsModule interventions name: Experimental Group, outcomesModule primaryOutcomes measure: SF-36 Quality of Life Scale:, secondaryOutcomes measure: Visual Similarity Scale for Fatigue, eligibilityModule sex: FEMALE, minimumAge: 19 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06265922, orgStudyIdInfo id: P.T.REC/012/003937, briefTitle: Cerebellar rTMS in Patients With Multiple Sclerosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-18, primaryCompletionDateStruct date: 2024-04-18, completionDateStruct date: 2024-06-02, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: To determine the efficacy of high frequency cerebellar repetitive transcranial magnetic stimulation on coordination in patients with multiple sclerosis., conditionsModule conditions: Patients With Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Participant masking as patients will be divided into two groups High frequecy cerebellar repetitive transcranial magnetic stimulation and Sham repetitive transcranial magnetic stimulation by placing the coil in perpendicular way away from the cerebellum.Care provider masking as the physical therapist treating patients will be blind from the application of repetitive transcranial magnetic stimulation, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: High frequency repetitive transcranial magnetic stimulation, interventions name: Sham repetitive transcranial magnetic stimulation, outcomesModule primaryOutcomes measure: Biodex balance system, secondaryOutcomes measure: Berg balance scale, secondaryOutcomes measure: Nine-Hole Peg Test (9-HPT), secondaryOutcomes measure: Four square step test (FSST), eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06265909, orgStudyIdInfo id: PRW001, briefTitle: Prospective Real World Study on Therapy Prediction Algorithm Training, statusModule overallStatus: COMPLETED, startDateStruct date: 2015-03-01, primaryCompletionDateStruct date: 2022-12-31, completionDateStruct date: 2022-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Mobio Interactive PTE LTD, class: INDUSTRY, descriptionModule briefSummary: This study examines the impact of using an algorithm to select therapy content for patients engaged with the mobile mental health platform AmDTx (Mobio Interactive). The algorithm is to be trained with three separate sources of data. Two sources of data come from self-reports by the patients themselves, provided before and after engaging with therapy content. The third source of data comes from an objective measurement of psychological stress, made possible through artificial analysis of computer vision data captured from the mobile device camera as the patient completes a 30 second selfie video before and after engaging with therapy content., conditionsModule conditions: Stress, conditions: Emotional Wellbeing, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 67, type: ACTUAL, armsInterventionsModule interventions name: AmDTx, outcomesModule primaryOutcomes measure: Objective Stress Level (OSL), primaryOutcomes measure: Self-Reported Stress (SRS), primaryOutcomes measure: Self-Reported Mood (SRM), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 66 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mobio Interactive Pte Ltd, city: Singapore, zip: 389637, country: Singapore, geoPoint lat: 1.28967, lon: 103.85007, hasResults: False

protocolSection identificationModule nctId: NCT06265896, orgStudyIdInfo id: P.T.REC/012/004948, briefTitle: Effect of Kinesiotaping on Activation of Abdominal Muscles in Female Patients With Stress Urinary Incontinence, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: This study will be conducted to evaluate the effect of kinesiotaping on activation of abdominopelvic cavity for management of stress urinary incontinence females' patients., conditionsModule conditions: Stress Urinary Incontinence, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Kinesio taping, interventions name: Pelvic floor exercise training, outcomesModule primaryOutcomes measure: Pelvic floor impact questionnaire- short form 7 (PFIQ-7), primaryOutcomes measure: King's Health Questionnaire (KHQ), secondaryOutcomes measure: Assessment of pelvic floor muscle strength, eligibilityModule sex: FEMALE, minimumAge: 30 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Cairo University, city: Giza, country: Egypt, contacts name: Mai N. Mamdouh, M.Sc. Student, role: CONTACT, phone: 01014924808, email: G01014924808@gmail.com, contacts name: Dalia M. Kamel, Prof., role: CONTACT, phone: 01273990045, email: dr-daliakamel@cu.edu.eg, contacts name: Ahmed S. Ebrahim, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False

protocolSection identificationModule nctId: NCT06265883, orgStudyIdInfo id: MIIR-16-Retro, briefTitle: Lenvatinib Plus DEB-TACE With/Without FOLFOX-HAIC for Large HCC With PVTT, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-07-01, primaryCompletionDateStruct date: 2022-12-31, completionDateStruct date: 2022-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital of Guangzhou Medical University, class: OTHER, collaborators name: Zhongshan People's Hospital, Guangdong, China, collaborators name: Affiliate Hospital of Guangdong Medical University, collaborators name: Jieyang People's Hospital, collaborators name: Huizhou Municipal Central Hospital, collaborators name: Guangzhou Development District Hospital, collaborators name: Shenzhen Traditional Chinese Medicine Hospital, collaborators name: First People's Hospital of Foshan, descriptionModule briefSummary: This multicenter retrospective study evaluated consecutive patients with large HCC and PVTT who received lenvatinib plus DEB-TACE with/without FOLFOX-HAIC between July 2019 and June 2021. Tumor response, time to progression (TTP), overall survival (OS), and treatment-related adverse events (TRAEs) were compared between the two groups., conditionsModule conditions: Hepatocellular Carcinoma Non-resectable, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 205, type: ACTUAL, armsInterventionsModule interventions name: Len+DEB-TACE+HAIC, interventions name: Len+DEB-TACE, outcomesModule primaryOutcomes measure: Time to progression (TTP), secondaryOutcomes measure: objective response rate (ORR), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: overall survival, secondaryOutcomes measure: treatment-related adverse events (TRAEs), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Second Affiliated Hospital of Guangzhou Medical University, city: Guangzhou, state: Guangdong, zip: 510260, country: China, geoPoint lat: 23.11667, lon: 113.25, hasResults: False

protocolSection identificationModule nctId: NCT06265870, orgStudyIdInfo id: Parasite in Eosinophilia, briefTitle: Specific Versus Empirical Anthelminthic Treatment in Eosinophilia, acronym: Eosinophilia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Prince of Songkla University, class: OTHER, descriptionModule briefSummary: There are a few guidelines recommend about management of eosinophilia worldwide, most of guielines recommend a thorough history-taking and physical examination. Subsequently, investigations are requested based on suspected causes. In cases where parasite infection is suspected, particularly in developing countries, stool microscopy and serology are recommended. However, limitations such as low sensitivity of stool microscopy, the inconvenience of collecting multiple stool samples, and the high cost and unavailability of serology may arise. Consequently, some physicians opt for empiric anthelminthic regimens in managing eosinophilic patients, even without stool tests or if stool test results are normal. If subsequent complete blood count (CBC) results show a recovery of absolute eosinophil count, it is assumed that eosinophilia was caused by a parasite infection. While some studies demonstrate the efficacy and simplicity of this approach, there is a risk of overestimating parasite infection in eosinophilic patients, potential adverse drug reactions from unnecessary anthelminthic treatment, and the possibility of drug resistance due to inappropriate dosing. To address this gap, no study has yet compared the efficacy between specific anthelminthic treatment based on test results and empirical anthelminthic treatment in eosinophilic patients. Therefore, the investigators are conducting this study., conditionsModule conditions: Eosinophilia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 700, type: ESTIMATED, armsInterventionsModule interventions name: Albendazole, interventions name: Ivermectin or albendazole, outcomesModule primaryOutcomes measure: Eosinophilia recovery, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06265857, orgStudyIdInfo id: IOE-naoxiaoxueguan, briefTitle: Effect of Multifunctional Nutrition Tube on Cerebral Small Vessel Disease Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Zeng Changhao, class: OTHER, descriptionModule briefSummary: Nasogastric tube feeding (NGT) has been widely used in cerebral small vessel disease (CSVD) patients with dysphagia but has a significant risk of complications. Intermittent Oro-esophageal Tube Feeding (IOE) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. This study aims to explore the clinical effect of IOE vs. NGT on CSVD Patients with Dysphagia. Compared to NGT, IOE, as an enteral nutrition support mode, in CSVD Patients with Dysphagia who received comprehensive rehabilitation therapy, showed advantages in improvement in dysphagia, nutritional status, ADL, QOL, pneumonia, and adverse events, which should be considered as the preferred approach., conditionsModule conditions: Cerebral Small Vessel Diseases, conditions: Dysphagia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 88, type: ESTIMATED, armsInterventionsModule interventions name: Intermittent Oro-esophageal Tube Feeding, interventions name: Nasogastric Tube Feeding, interventions name: comprehensive rehabilitation therapy, outcomesModule primaryOutcomes measure: Video Fluoroscopic Swallowing Study, secondaryOutcomes measure: Functional Oral Intake Scale, secondaryOutcomes measure: Body mass index, secondaryOutcomes measure: Serum albumin, secondaryOutcomes measure: Hemoglobin, secondaryOutcomes measure: Pneumonia, secondaryOutcomes measure: Activities of daily living, secondaryOutcomes measure: World Health Organization Quality of Life Assessment Instrument Brief Version, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Thai Rehabilitation Community Center, status: RECRUITING, city: Ban Phon Ko, country: Thailand, contacts name: Cop Kun, role: CONTACT, hasResults: False

protocolSection identificationModule nctId: NCT06265844, orgStudyIdInfo id: IOE-Biyanai, briefTitle: Multifunctional Nutrition Tube in Dysphagia for Nasopharyngeal Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Zeng Changhao, class: OTHER, descriptionModule briefSummary: This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy for NPC. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received IOE while the control group received NGT for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life (QOL) after treatment as well as adverse events are compared., conditionsModule conditions: Dysphagia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Intermittent Oral-esophageal Tube Feeding, interventions name: Nasogastric Tube Feeding, interventions name: comprehensive rehabilitation therapy, outcomesModule primaryOutcomes measure: Hemoglobin, primaryOutcomes measure: Serum albumin, primaryOutcomes measure: Body Mass Index, primaryOutcomes measure: Serum prealbumin, secondaryOutcomes measure: Depression, secondaryOutcomes measure: Functional Oral Intake Scale, secondaryOutcomes measure: Penetration-Aspiration Scale, secondaryOutcomes measure: Swallowing-Quality of Life questionnaire, secondaryOutcomes measure: Feeding amount, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Saint Martin Hospital, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Xi Maheen, Master, role: CONTACT, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False

protocolSection identificationModule nctId: NCT06265831, orgStudyIdInfo id: BU-FHS-NC-03, briefTitle: The Effect of Face Hand Fan Application on Dyspnea, acronym: HandfanCOPD, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-04-01, primaryCompletionDateStruct date: 2023-11-30, completionDateStruct date: 2024-03, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Bartın Unıversity, class: OTHER, collaborators name: The Scientific and Technological Research Council of Turkey, descriptionModule briefSummary: Diagnosing and managing dyspnea in patients with COPD is very important. Although pharmacological and non-pharmacological methods are used in the management of dyspnea, it is recommended that pharmacological methods be supported by non-pharmacological methods. Hand fan application, which is one of the non-pharmacological methods used in dyspnea management, provides an increase in self-efficacy in patients in addition to the stimulation of cold air flow to the trigeminal nerve branches, mucosa and skin. Although there are studies reporting that applying cold air to the face with a hand fan is effective in reducing the severity of dyspnea in different patient groups, the number of studies examining the effectiveness of applying cold air to the face with a hand fan in patients with COPD is quite limited. This project was planned to determine the effect of applying cold air to the face with a fan on the severity of dyspnea and quality of life in COPD patients., conditionsModule conditions: COPD, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel group: two groups, an intervention group and a control group, receiving complementary therapy., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: Hospitalized patients with a diagnosis of COPD will be randomized into two groups. The intervention group will have a hand fan applied to the face and be monitored for a week, and the control group will receive routine care at the clinic. Investigators will evaluate outcome measures., whoMasked: PARTICIPANT, enrollmentInfo count: 61, type: ACTUAL, armsInterventionsModule interventions name: Hand-fan application to the face, outcomesModule primaryOutcomes measure: Modified Borg Scale, secondaryOutcomes measure: Saint George Respiratory Questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Necmiye ÇÖMLEKÇİ, city: Bartın, zip: 74100, country: Turkey, geoPoint lat: 41.63583, lon: 32.3375, hasResults: False

protocolSection identificationModule nctId: NCT06265818, orgStudyIdInfo id: 2024-KY-0126, briefTitle: The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder, acronym: ABE-S, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Zeng Changhao, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to explore The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will be given Active Breathing Exercises. Researchers will compare dysphagia of two groups., conditionsModule conditions: Respiratory Rhythm Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Rehabilitation training, interventions name: Active Breathing Exercises, outcomesModule primaryOutcomes measure: The Penetration-Aspiration Scale, secondaryOutcomes measure: The Functional Oral Intake Scale, secondaryOutcomes measure: Yale Pharyngeal Residue Severity Rating Scale, secondaryOutcomes measure: Fiberoptic Endoscopic Dysphagia Severity Scale, secondaryOutcomes measure: Murray Secretion Scale, secondaryOutcomes measure: Swallowing Quality of Life, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Center Rehabilitation Hospital, status: RECRUITING, city: Seoul, country: Korea, Republic of, contacts name: Wei Liu, Master, role: CONTACT, geoPoint lat: 37.566, lon: 126.9784, hasResults: False

protocolSection identificationModule nctId: NCT06265805, orgStudyIdInfo id: 2024-KY-0125-015, briefTitle: Effect of Different Feeding Modes on Psychological Condition and Experience in Stroke Patients, acronym: IOE-Xinli, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Zeng Changhao, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare the differences on Psychological Condition and Experience in ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare Psychological Condition and Experience of two groups., conditionsModule conditions: Ischemic Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: comprehensive rehabilitation therapy, interventions name: Intermittent Oro-esophageal Tube Feeding, interventions name: Nasogastric Tube Feeding, outcomesModule primaryOutcomes measure: Generalized Anxiety Disorder 7, secondaryOutcomes measure: Patient Health Questionnaire-9, secondaryOutcomes measure: Self-made questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hsinchu Rehabilitation Hospital, status: RECRUITING, city: Xinzhu, country: Taiwan, contacts name: Haim Liu, Master, role: CONTACT, geoPoint lat: 22.46205, lon: 120.47335, hasResults: False

protocolSection identificationModule nctId: NCT06265792, orgStudyIdInfo id: 2024-KY-0125, briefTitle: Efficacy of Stellate Ganglion Block in Obstructive Sleep Apnea, acronym: OSA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2024-12-15, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Zeng Changhao, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test the efficacy of stellate ganglion block in Obstructive Sleep Apnea. The main question it aims to answer are:• Can stellate ganglion block improve Obstructive Sleep Apnea? Patients were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study., conditionsModule conditions: Obstructive Sleep Apnea, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: routine rehabilitation treatment, interventions name: Stellate ganglion block, outcomesModule primaryOutcomes measure: Epworth Sleepiness Scale, secondaryOutcomes measure: Apnea-Hypopnea Index, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Center Rehabilitation Hospital, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False

protocolSection identificationModule nctId: NCT06265779, orgStudyIdInfo id: 2024-KY-0122, briefTitle: Transcranial Direct Current Stimulation Combined With Intermittent Oral to Esophageal Tube on Dysphagia, acronym: IOE+JLCJ-S, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2024-12-15, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Zeng Changhao, class: OTHER, descriptionModule briefSummary: The study is a double-blind randomized controlled trial, lasting for 15 days for each participant. Patients with post-stroke dysphagia who receive treatment at the Rehabilitation Department are selected as the study subjects. The patients are randomly assigned to either the experimental group or the placebo group. All patients receive routine rehabilitation therapy and swallowing rehabilitation training, along with enteral nutrition support using Intermittent Oro-esophageal Tube. In addition to these interventions, patients in the experimental group receive transcranial direct current stimulation, while the instruments used for patients in the placebo group only illuminate an indicator light without any actual effect., conditionsModule conditions: Cerebral Infarction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: Comprehensive rehabilitation therapy, interventions name: Intermittent Oro-esophageal Tube Feeding, interventions name: Transcranial direct current stimulation, outcomesModule primaryOutcomes measure: Penetration Aspiration Scale, secondaryOutcomes measure: Functional Oral Intake Scale, secondaryOutcomes measure: Swallowing Quality of Life Questionnaire, secondaryOutcomes measure: Patient Health Questionnaire-9, secondaryOutcomes measure: Body weight, secondaryOutcomes measure: Nutritional status-total protein, secondaryOutcomes measure: Nutritional status-albumin, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Center Rehabilitation Hospital, status: RECRUITING, city: Seoul, country: Korea, Republic of, contacts name: Wei Liu, Master, role: CONTACT, geoPoint lat: 37.566, lon: 126.9784, hasResults: False

protocolSection identificationModule nctId: NCT06265766, orgStudyIdInfo id: NL85511.041.24, secondaryIdInfos id: 85511, type: OTHER, domain: ABR number, briefTitle: Brain STimulation for Arm Recovery After Stroke 2, acronym: B-STARS2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2029-03-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Jord Vink, class: OTHER, descriptionModule briefSummary: Rationale: Every year, about 40,000 people in the Netherlands have a stroke. After the initial admission to the hospital, about 15% of stroke survivors is admitted to a rehabilitation center because of remaining disabilities. Three out of four of these patients have upper limb dysfunction, hampering activities of daily living. Upper limb function plays a critical role in the performance of most daily life activities. In our phase II trial B-STARS, continuous theta burst stimulation (cTBS) treatment led to an absolute additional recovery of upper limb function of 17%, as measured with the Action Research Arm Test (ARAT) score three months after stroke. This improvement exceeds the minimal clinically important difference of 10%. cTBS treatment also resulted in a significant improvement in measures of activities and participation (of similar magnitude) and a reduction in the mean length of stay at the rehabilitation center by 18 days.Objective: To assess the effectiveness and cost effectiveness of cTBS treatment in promoting upper limb recovery after stroke in patients admitted to a rehabilitation center.Study design: A phase III, multi-center, double-blind, randomized, sham-controlled, clinical trial.Study population: 454 patients aged 18 years or older with a first-ever ischemic stroke or intracerebral hemorrhage and a unilateral arm paresis, defined by a Motricity Index between 9 and 99, in whom cTBS treatment can be started within 3 weeks after stroke onset.Intervention: 10 daily sessions of cTBS delivered over the contralesional primary motor cortex during a period of 2 weeks, delivered immediately before regular care physical therapy of the affected upper limb.Main study parameters/endpoints: The primary endpoint will be the score on the upper extremity section of the Fugl-Meyer assessment (FM-UE) at 90 days after stroke. Secondary endpoints will include the score on the FM-UE at one year and the scores on the Action Research Arm Test, Nine Hole Peg Test, Stroke Impact Scale, EuroQol 5 Dimensions and modified Rankin Scale at 90 days and one year after stroke, conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Sham cTBS treatment is delivered with a sham TMS-coil., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 454, type: ESTIMATED, armsInterventionsModule interventions name: cTBS, outcomesModule primaryOutcomes measure: Upper extremity section of the Fugl-Meyer Assessment, secondaryOutcomes measure: Upper extremity section of the Fugl-Meyer Assessment, secondaryOutcomes measure: Action Research Arm Test, secondaryOutcomes measure: modified Rankin Scale, secondaryOutcomes measure: Hand section of Stroke Impact Scale, secondaryOutcomes measure: Participation section of Stroke Impact Scale, secondaryOutcomes measure: EuroQol-5D, secondaryOutcomes measure: Nine Hole Peg Test, secondaryOutcomes measure: Ipsilesional corticospinal excitability, secondaryOutcomes measure: iMTA medical consumption and productivity cost questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Reade, city: Amsterdam, country: Netherlands, contacts name: Marijn Mulder-Kampen, role: CONTACT, geoPoint lat: 52.37403, lon: 4.88969, locations facility: Revalidatie Friesland, city: Beetsterzwaag, country: Netherlands, contacts name: Wietske Rienstra, role: CONTACT, geoPoint lat: 53.05914, lon: 6.07711, locations facility: Revant, city: Breda, country: Netherlands, contacts name: Marissa Riemens, role: CONTACT, geoPoint lat: 51.58656, lon: 4.77596, locations facility: Tolbrug, city: Den Bosch, country: Netherlands, contacts name: Cynthia Klinkers, role: CONTACT, geoPoint lat: 51.27, lon: 5.59167, locations facility: Basalt, city: Den Haag, country: Netherlands, contacts name: Kangdi Zhu, role: CONTACT, geoPoint lat: 52.07667, lon: 4.29861, locations facility: MRC Aardenburg, city: Doorn, country: Netherlands, contacts name: Lisa Kruisheer, role: CONTACT, geoPoint lat: 52.03343, lon: 5.34571, locations facility: Libra Blixembosch, city: Eindhoven, country: Netherlands, contacts name: Daphne Stranders, role: CONTACT, geoPoint lat: 51.44083, lon: 5.47778, locations facility: University Medical Center Groningen, city: Groesbeek, country: Netherlands, contacts name: Henk Meulenbelt, role: CONTACT, geoPoint lat: 51.77667, lon: 5.93611, locations facility: Merem, city: Hilversum, country: Netherlands, contacts name: Maijke van Bloemendaal, role: CONTACT, contacts name: Karin Peek, role: CONTACT, geoPoint lat: 52.22333, lon: 5.17639, locations facility: Adelante, city: Hoensbroek, country: Netherlands, geoPoint lat: 50.92387, lon: 5.92528, locations facility: Basalt, city: Leiden, country: Netherlands, contacts name: Annelies Mantje, role: CONTACT, geoPoint lat: 52.15833, lon: 4.49306, locations facility: Sint Maartenskliniek, city: Nijmegen, country: Netherlands, contacts name: Nelleke Kooiman, role: CONTACT, geoPoint lat: 51.8425, lon: 5.85278, locations facility: Libra Leijpark, city: Tilburg, country: Netherlands, contacts name: Iris Habets, role: CONTACT, geoPoint lat: 51.55551, lon: 5.0913, locations facility: De Hoogstraat, city: Utrecht, country: Netherlands, contacts name: Mirjam Kouwenhoven, role: CONTACT, geoPoint lat: 52.09083, lon: 5.12222, locations facility: Heliomare, city: Wijk Aan Zee, country: Netherlands, contacts name: Deborah Wit, role: CONTACT, geoPoint lat: 52.4936, lon: 4.59409, locations facility: Vogellanden, city: Zwolle, country: Netherlands, contacts name: Bente Visser, role: CONTACT, geoPoint lat: 52.5125, lon: 6.09444, hasResults: False

protocolSection identificationModule nctId: NCT06265753, orgStudyIdInfo id: Gastrocimemius spasticity, secondaryIdInfos id: E-60116787-020-474196, type: REGISTRY, domain: Pamukkale University Ethics Comitee, briefTitle: Gastrocinemius Function Massage on Lower Extemity Spasticity, acronym: Spasticity, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-23, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Pamukkale University, class: OTHER, descriptionModule briefSummary: This study aimed to investigate gastrocinemius function massage on physical parameters of stroke patients., conditionsModule conditions: Stroke, conditions: Stroke Ischemic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In the study, 2 different groups (experimental and control) will be formed by using randomisation method. In addition to 45 minutes of classical physiotherapy exercises, 10 minutes of gastrocinemius function massage will be applied to the experimental group, while 10 minutes of sham massage and 45 minutes of classical physiotherapy exercises will be applied to the control group. The application will continue 2 days a week for 6 weeks. Spasticity, gait parameters and fall risks of the participants will be evaluated before and after the treatment with the help of various tests.Translated with www.DeepL.com/Translator (free version), primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: Gastrocinemius Function Massage, interventions name: Sham application, outcomesModule primaryOutcomes measure: Spasticity, primaryOutcomes measure: Gait parameters and fall risk, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Address, city: Denizli, state: Muş Alparslan University, zip: 20100, country: Turkey, geoPoint lat: 37.77417, lon: 29.0875, hasResults: False

protocolSection identificationModule nctId: NCT06265740, orgStudyIdInfo id: RBHP 2023 GALLOT (PREMABIOTE), secondaryIdInfos id: 2023-A02466-39, type: OTHER, domain: 2023-A02466-39, briefTitle: Early Diagnosis of Premature Births by Analysis of the Vaginal Microbiota, acronym: PREMABIOTE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-11, completionDateStruct date: 2025-11, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University Hospital, Clermont-Ferrand, class: OTHER, descriptionModule briefSummary: Objectives: to assess the relevance of the "RiboTaxa" algorithm coupled with neural network learning based on analysis of vaginal microbiota metagenomic sequencing data for predicting prematurity in an identified at-risk population.Study description: Longitudinal follow-up of a cohort of pregnant women, with collection of biological samples, and a posteriori case-control comparison based on the occurrence of an event (premature birth)., conditionsModule conditions: Premature Birth, conditions: Vaginal Flora, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: vaginal swab, outcomesModule primaryOutcomes measure: Early diagnosis of preterm birth using vaginal microbiota analysis, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de Clermont-Ferrand, city: Clermont-Ferrand, country: France, contacts name: Lise Laclautre, role: CONTACT, contacts name: Denis Gallot, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.77966, lon: 3.08628, hasResults: False

protocolSection identificationModule nctId: NCT06265727, orgStudyIdInfo id: CRB-701-01, briefTitle: A Phase 1/2 Study to Investigate CRB-701 in Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-01-16, completionDateStruct date: 2027-01-27, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Corbus Pharmaceuticals Inc., class: INDUSTRY, collaborators name: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd., descriptionModule briefSummary: The goal of this clinical trial is to define a safe and effective dose of CRB-701 for participants with solid tumors that are expressing a protein called nectin-4.The main questions it aims to answer are:What is the the safe and effective dose of CRB-701 when used alone? What cancers can be treated effectively with CRB-701?Participants will be asked to attend clinic and be given a intravenous infusion of CRB-701 on its own. They will have blood tests and other assessments to measure whether CRB-701 will have CT or MRI scans to measure the effect on tumors., conditionsModule conditions: Solid Tumor, Adult, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: A three part study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 420, type: ESTIMATED, armsInterventionsModule interventions name: CRB-701, outcomesModule primaryOutcomes measure: Part A: To confirm the safety and tolerability and determine MTD and PADR for CRB-701, primaryOutcomes measure: Part B & C : To evaluate efficacy in terms of Disease Control Rate (DCR), primaryOutcomes measure: Part B & C: To evaluate efficacy in terms of Objective Response Rate (ORR), secondaryOutcomes measure: Parts A, B, % C: To characterize the safety profile of CRB-701, secondaryOutcomes measure: Maximum observed plasma concentration of CRB-701 [total ADC] (Cmax), secondaryOutcomes measure: Maximum observed plasma concentration of free MMAE (Cmax), secondaryOutcomes measure: Maximum observed plasma concentration of Total CRB-701 antibody [Tab] (Cmax), secondaryOutcomes measure: Time to reach Cmax of Total CRB-701 [Total ADC] (Tmax), secondaryOutcomes measure: Time to reach Cmax of free MMAE (Tmax), secondaryOutcomes measure: Time to reach Cmax of Total CRB-701 antibody [Tab] (Tmax), secondaryOutcomes measure: Time to reach Cmax of Total CRB-701 antibody [Tab] (Cmax), secondaryOutcomes measure: Total Area Under the plasma concentration-time curve of Total CRB-701 [total ADC] (AUC), secondaryOutcomes measure: Total Area Under the plasma concentration-time curve of free MMAE (AUC), secondaryOutcomes measure: Total Area Under the plasma concentration-time curve of Total CRB-701 antibody [Tab] (AUC), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Moores Cancer Centre at UC San Diego Health, status: NOT_YET_RECRUITING, city: San Diego, state: California, zip: 92037, country: United States, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 32.71533, lon: -117.15726, locations facility: Helen Diller Family Comprehensive Cancer Center - UCSF, status: NOT_YET_RECRUITING, city: San Francisco, state: California, zip: 94115, country: United States, contacts name: Rodney Carter, role: CONTACT, email: clinical@corbuspharma.com, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Rocky Mountain Cancer Centres, status: NOT_YET_RECRUITING, city: Denver, state: Colorado, zip: 80218, country: United States, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 39.73915, lon: -104.9847, locations facility: Yale Cancer Center, status: NOT_YET_RECRUITING, city: New Haven, state: Connecticut, zip: 06510, country: United States, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 41.30815, lon: -72.92816, locations facility: Florida Cancer Specialists, status: NOT_YET_RECRUITING, city: Orlando, state: Florida, zip: 32806, country: United States, contacts name: Rodney Carter, role: CONTACT, email: clinical@corbuspharma.com, geoPoint lat: 28.53834, lon: -81.37924, locations facility: University of Chicago, status: NOT_YET_RECRUITING, city: Chicago, state: Illinois, zip: 60637, country: United States, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Hope and Healing Cancer Center, status: RECRUITING, city: Hinsdale, state: Illinois, zip: 60521, country: United States, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 41.80086, lon: -87.93701, locations facility: Dana-Faber Cancer Institute, status: NOT_YET_RECRUITING, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Rodney Carter, role: CONTACT, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Nebraska Hematology Oncology, status: RECRUITING, city: Lincoln, state: Nebraska, zip: 68506, country: United States, contacts name: Rodney Carter, role: CONTACT, email: clinical@corbuspharma.com, geoPoint lat: 40.8, lon: -96.66696, locations facility: Carolina BioOncology Institute, status: RECRUITING, city: Huntersville, state: North Carolina, zip: 28078, country: United States, contacts name: Rodney Carter, role: CONTACT, email: clinical@corbuspharma.com, geoPoint lat: 35.41069, lon: -80.84285, locations facility: Texas Oncology, status: NOT_YET_RECRUITING, city: Tyler, state: Texas, zip: 75702, country: United States, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 32.35126, lon: -95.30106, locations facility: Virginia Cancer Specialists, status: NOT_YET_RECRUITING, city: Fairfax, state: Virginia, zip: 22031, country: United States, contacts name: Rodney Carter, role: CONTACT, email: clinical@corbuspharma.com, geoPoint lat: 38.84622, lon: -77.30637, locations facility: Barcelona IOB Hospital Quironsalud (NEXT), status: NOT_YET_RECRUITING, city: Barcelona, zip: 08023, country: Spain, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Vall d-Hebron Institut d'Oncologia, status: NOT_YET_RECRUITING, city: Barcelona, zip: 08035, country: Spain, contacts name: Rodney Carter, role: CONTACT, email: clinical@corbuspharma.com, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Fundacion Jimenez Diaz (START), status: NOT_YET_RECRUITING, city: Madrid, zip: 28040, country: Spain, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Clinico Universitario de Valencia, status: NOT_YET_RECRUITING, city: Valencia, zip: 46010, country: Spain, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 39.46975, lon: -0.37739, locations facility: Adana Numune Egitim ve Arastirma Hastanesi (Adana City Education and Research Hospital), status: NOT_YET_RECRUITING, city: Adana, zip: 83114, country: Turkey, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 37.00167, lon: 35.32889, locations facility: Ankara Etlik City Hospital, status: NOT_YET_RECRUITING, city: Ankara, country: Turkey, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 39.91987, lon: 32.85427, locations facility: Ankara University, status: NOT_YET_RECRUITING, city: Ankara, country: Turkey, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 39.91987, lon: 32.85427, locations facility: Istanbul Medeniyet University, status: NOT_YET_RECRUITING, city: Istanbul, zip: 34720, country: Turkey, contacts name: Rodney Carter, role: CONTACT, email: Clincal@corbuspharma.com, geoPoint lat: 41.01384, lon: 28.94966, locations facility: University of Birmingham NHS Foundation Trust, status: NOT_YET_RECRUITING, city: Birmingham, zip: B15 2TH, country: United Kingdom, contacts name: Rodney Carter, role: CONTACT, email: clinical@corbuspharma.com, geoPoint lat: 52.48142, lon: -1.89983, locations facility: University of Cambridge NHS Foundation Trust, status: NOT_YET_RECRUITING, city: Cambridge, zip: CB2 0QQ, country: United Kingdom, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 52.2, lon: 0.11667, locations facility: Velindre Cancer Centre, status: NOT_YET_RECRUITING, city: Cardiff, zip: CF15 7QZ, country: United Kingdom, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 51.48, lon: -3.18, locations facility: Leeds University Hospitals NHS Trust, status: NOT_YET_RECRUITING, city: Leeds, zip: LS9 7LP, country: United Kingdom, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 53.79648, lon: -1.54785, locations facility: Guy's and St Thomas' Clinical Research Facility, status: NOT_YET_RECRUITING, city: London, zip: SE1 9RT, country: United Kingdom, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Imperial Experimental Cancer Medicine Centre, status: NOT_YET_RECRUITING, city: London, zip: W12 0NN, country: United Kingdom, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 51.50853, lon: -0.12574, locations facility: The Christie Hospital, status: NOT_YET_RECRUITING, city: Manchester, zip: M20 4BX, country: United Kingdom, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 53.48095, lon: -2.23743, locations facility: University of Southampton, status: NOT_YET_RECRUITING, city: Southampton, zip: SO16 6YD, country: United Kingdom, contacts name: Rodney Carter, role: CONTACT, email: clinical@corbuspharma.com, geoPoint lat: 50.90395, lon: -1.40428, locations facility: University of Liverpool - Clatterbridge Medical Centre, status: NOT_YET_RECRUITING, city: Wirral, zip: CH63 4JY, country: United Kingdom, contacts name: Rodney Carter, role: CONTACT, email: Clinical@corbuspharma.com, geoPoint lat: 53.37616, lon: -3.10501, hasResults: False

protocolSection identificationModule nctId: NCT06265714, orgStudyIdInfo id: LB.02.01/VII/005/KEP005/2022, briefTitle: The IndONEsia ICCU Registry: a Multicenter Cohort of Intensive Cardiovascular Care Units Patients in Indonesia, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-07-23, primaryCompletionDateStruct date: 2023-09-06, completionDateStruct date: 2023-09-23, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Indonesia University, class: OTHER, descriptionModule briefSummary: Patients in the Intensive Cardiovascular Care Unit (ICCU) often present with cardiovascular disease (CVD) issues accompanied by various non-cardiovascular conditions. However, a widely applicable scoring system to predict patient outcomes in the ICCU is lacking. Therefore, developing and validating scores for predicting ICCU patient outcomes are warranted. The aims of the IndONEsia ICCU (One ICCU) registry include developing an epidemiological registry of ICCU patients and establishing a multicentre research network to analyse patient outcomes.This nationwide multicenter cohort will capture data from patients receiving cardiovascular critical care treatment in 10 Indonesian hospitals with ICCU facilities. Recorded data will encompass demographic characteristics, physical examination findings at hospital and ICCU admission, diagnoses at ICCU admission, therapy, intervention, complications on days 3 and 5 of in-ICCU care, in-hospital outcomes, and 30-day outcomes. The One ICCU is a large, prospective registry describing the care process and advancing clinical knowledge in ICCU patients. It will serve as an investigational platform for predicting the mortality of ICCU patients., conditionsModule conditions: Cardiovascular Diseases, conditions: Acute Coronary Syndrome, conditions: Heart Failure, conditions: Heart Disease, Coronary, conditions: Infections, conditions: Sepsis, conditions: Stroke, conditions: Shock, conditions: Chronic Kidney Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 12950, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Alive, primaryOutcomes measure: Death, primaryOutcomes measure: Readmitted to ICCU, primaryOutcomes measure: Rehospitalization, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prof. dr. I.G.N.G. Ngoerah General Hospital, city: Denpasar, state: Bali, country: Indonesia, geoPoint lat: -8.65, lon: 115.21667, locations facility: Dr. Kariadi General Hospital, city: Semarang, state: Central Java, country: Indonesia, geoPoint lat: -6.99306, lon: 110.42083, locations facility: Dr. Saiful Anwar General Hospital, city: Malang, state: East Java, country: Indonesia, geoPoint lat: -7.9797, lon: 112.6304, locations facility: Dr. Iskak General Hospital, city: Tulung Agung, state: East Java, country: Indonesia, geoPoint lat: -5.3578, lon: 105.04623, locations facility: Prof. Dr. R. D. Kandou Manado General Hospital, city: Manado, state: North Sulawesi, country: Indonesia, geoPoint lat: 1.48218, lon: 124.84892, locations facility: Dr. Wahidin Sudirohusodo General Hospital, city: Makassar, state: South Sulawesi, country: Indonesia, geoPoint lat: -5.14861, lon: 119.43194, locations facility: Dr. M. Djamil Padang General Hospital, city: Padang, state: West Sumatra, country: Indonesia, geoPoint lat: -0.94924, lon: 100.35427, locations facility: National Cardiovacular Center Harapan Kita, city: Jakarta, country: Indonesia, geoPoint lat: -6.21462, lon: 106.84513, locations facility: Sardjito General Hospital, city: Yogyakarta, country: Indonesia, geoPoint lat: -7.80139, lon: 110.36472, hasResults: False

protocolSection identificationModule nctId: NCT06265701, orgStudyIdInfo id: IRB0148200, briefTitle: Does a Novel Intervention Targeting Derailment Decrease Depressive Symptoms?, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-03-12, completionDateStruct date: 2024-03-12, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Cornell University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to explore the efficacy of a reflective journaling intervention-"Me Through Time"- in decreasing levels of derailment, and its impact on downstream depressive symptoms., conditionsModule conditions: Depression, conditions: Depressive Symptoms, conditions: Derailment, conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Investigators will utilize a single-blind approach where participants will not be made aware of the purpose of the intervention. Participants in both arms will be told that the purpose of the study is "to determine the efficacy of a novel five-session journaling intervention, which explores concepts related to self-continuity". This is partly true for those in the experimental arm. The main purpose of the study is twofold: (1) to explore the efficacy of the experimental journaling intervention's in reducing levels of derailment and (2) to test the hypothesis that decreasing derailment- a temporal discordance of the self- will lead to a decrease in depressive symptoms., whoMasked: PARTICIPANT, enrollmentInfo count: 116, type: ACTUAL, armsInterventionsModule interventions name: Derailment-Focused Reflective Journaling, interventions name: Everyday Tasks Reflective Journaling, outcomesModule primaryOutcomes measure: Change from Pre-Assessment in Depressive Symptoms on the Beck Depression Inventory II (BDI-II) at Week 2 (Session 6/Post-Assessment), primaryOutcomes measure: Change from Pre-Assessment in Levels of Derailment on the Derailment Scale at Session 5, secondaryOutcomes measure: Change from Pre-Assessment in Anxiety Symptoms on the Generalized Anxiety Disorder - 7 (GAD-7) at Week 2 (Session 6/Post-Assessment), secondaryOutcomes measure: Change from Pre-Assessment in Levels of Positive and Negative Affect on the Positive and Negative Affect Schedule (PANAS) at Week 2 (Session 6/Post-Assessment), secondaryOutcomes measure: Change from Pre-Assessment in Levels of Perceived Stress on the Perceived Stress Scale (PSS) at Week 2 (Session 6/Post-Assessment), secondaryOutcomes measure: Change from Pre-Assessment in Levels of Optimism Versus Pessimism on the Life Orientation Test - Revised (LOT - Revised) at Week 2 (Session 6/Post-Assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 29 Years, stdAges: ADULT, contactsLocationsModule locations facility: Cornell University, city: Ithaca, state: New York, zip: 14850, country: United States, geoPoint lat: 42.44063, lon: -76.49661, hasResults: False

protocolSection identificationModule nctId: NCT06265688, orgStudyIdInfo id: CTMX-2051-101, briefTitle: First In Human Study of CX-2051 in Advanced Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2027-11-30, completionDateStruct date: 2029-03-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: CytomX Therapeutics, class: INDUSTRY, descriptionModule briefSummary: The purpose of this first-in-human study, CTMX-2051-101, is to characterize the safety, tolerability, and antitumor activity of CX-2051 in adult participants with advanced solid tumors., conditionsModule conditions: Solid Tumor, Adult, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 124, type: ESTIMATED, armsInterventionsModule interventions name: CX-2051, outcomesModule primaryOutcomes measure: Safety and tolerability of CX-2051, primaryOutcomes measure: Determine the recommended Phase 2 dose (RP2D), secondaryOutcomes 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: Duration of disease control (DODC), secondaryOutcomes measure: Overall survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dana-Farber Cancer Institute, status: NOT_YET_RECRUITING, city: Boston, state: Massachusetts, zip: 02215, country: United States, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Carolina BioOncology Institute, PLLC, status: RECRUITING, city: Huntersville, state: North Carolina, zip: 28078, country: United States, geoPoint lat: 35.41069, lon: -80.84285, locations facility: Sarah Cannon Research Institute, LLC, status: RECRUITING, city: Nashville, state: Tennessee, zip: 37203, country: United States, geoPoint lat: 36.16589, lon: -86.78444, hasResults: False

protocolSection identificationModule nctId: NCT06265675, orgStudyIdInfo id: E1-4066/2023, briefTitle: Comparison of the Efficacy of Phenol Block and Corticosteroid-Local Anesthetic Block Applied to the Genicular Nerve, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-24, primaryCompletionDateStruct date: 2025-01-24, completionDateStruct date: 2025-06-24, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital, class: OTHER, descriptionModule briefSummary: There are different neurolysis methods. Aim of this study is to compare two different methods, phenol block and corticosteroid local anesthetic block., conditionsModule conditions: Knee Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 88, type: ESTIMATED, armsInterventionsModule interventions name: Phenol, interventions name: Celestone, interventions name: Lidocain, outcomesModule primaryOutcomes measure: Numeric Rating Scale (NRS), secondaryOutcomes measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC), secondaryOutcomes measure: Patient Global Impression of Change (PGIC), secondaryOutcomes measure: Sixt Minute Walk Test (6MWT), secondaryOutcomes measure: The Timed-Up and Go test, secondaryOutcomes measure: Frequency of analgesic usage, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gaziler, status: RECRUITING, city: Ankara, state: Çankaya, country: Turkey, contacts name: Rabia Layık, Assist. Dr., role: CONTACT, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False

protocolSection identificationModule nctId: NCT06265662, orgStudyIdInfo id: 66701100301, briefTitle: A Digital Health Program for Non-Communicable Disease Prevention in a Workplace Setting in Thailand, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Chulalongkorn University, class: OTHER, descriptionModule briefSummary: The goal of this quasi-experimental study is to test the effectiveness of a digital health program designed to prevent non-communicable diseases (NCDs) in employees within a workplace setting in Thailand. The main questions it aims to answer are:* Can a digital health program help participants lose weight?* Does the digital health program improve other health outcomes such as Body Mass Index (BMI), blood lipid levels (triglycerides and LDL), blood sugar levels (HbA1c or fasting plasma glucose), and blood pressure? Is the digital health program feasible and acceptable in the Thai workplace setting, as measured by participation rates, usage, and participant satisfaction?Participants will:* Attend four group health education sessions, each lasting one hour, scheduled over a six-month period.* Have unlimited access to individual chat consultations with a healthcare team, including doctors, dietitians, fitness coaches, and psychologists, available from 9:00 AM to 5:00 PM on workdays, excluding public holidays., conditionsModule conditions: Chronic Disease, conditions: Noncommunicable Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single-arm quasi-experimental study for evaluating the effectiveness of a digital health program in weight reduction for the prevention of non-communicable diseases in the Thai workplace setting., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: A Digital Health Program for Non-Communicable Disease Prevention in a Workplace Setting in Thailand, outcomesModule primaryOutcomes measure: Weight, secondaryOutcomes measure: BMI, secondaryOutcomes measure: Total cholesterol, secondaryOutcomes measure: Triglycerides, secondaryOutcomes measure: HDL, secondaryOutcomes measure: LDL, secondaryOutcomes measure: HbA1c, secondaryOutcomes measure: Fasting plasma glucose, secondaryOutcomes measure: blood pressure, secondaryOutcomes measure: Feasibility (number of consented participants to all eligible participants ratio), secondaryOutcomes measure: Acceptability, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06265649, orgStudyIdInfo id: NOM-ALCD, briefTitle: Comparison of NOM for ACLD Between Medical and Surgical Ward, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-03, completionDateStruct date: 2024-03, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Ospedali Riuniti Trieste, class: OTHER, descriptionModule briefSummary: In Europe, patients with acute left colon diverticulitis (ALCD) are usually admitted to surgical wards even when only medical treatment is required. The study compares ALCD non-operative management (NOM) between surgical and non-surgical environments regarding clinical outcomes, hospitalization length(LOS), and follow-up., conditionsModule conditions: Diverticulitis, conditions: Colon Disease, conditions: Acute Diverticulitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 175, type: ESTIMATED, armsInterventionsModule interventions name: NOM, outcomesModule primaryOutcomes measure: Hospitalization length, secondaryOutcomes measure: Follow-up and recurrences, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Manuela Mastronardi, status: RECRUITING, city: Trieste, state: TS, zip: 34149, country: Italy, contacts name: Manuela Mastronardi, MD, role: CONTACT, phone: 0403994152, phoneExt: 0039, email: manuela.mastronardi@gmail.com, contacts name: Alan Biloslavo, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Margherita Sandano, MD, role: SUB_INVESTIGATOR, contacts name: Paola Germani, MD, role: SUB_INVESTIGATOR, contacts name: Stefano Fracon, MD, role: SUB_INVESTIGATOR, contacts name: Davide Cosola, MD, role: SUB_INVESTIGATOR, contacts name: Selene Bogoni, MD, role: SUB_INVESTIGATOR, contacts name: Nicolò de Manzini, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Marina Troian, MD, role: SUB_INVESTIGATOR, contacts name: Nicola Artusi, MD, role: SUB_INVESTIGATOR, geoPoint lat: 45.64953, lon: 13.77679, hasResults: False

protocolSection identificationModule nctId: NCT06265636, orgStudyIdInfo id: 2006202325523, briefTitle: Electrical Stimulation of the Mandibular Nerve for Pain and Function Management in Temporomandibular Disorders, acronym: Origenkine, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-17, primaryCompletionDateStruct date: 2024-12-20, completionDateStruct date: 2026-05-15, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: OrigenKinesis fisioterapia, class: OTHER, collaborators name: Universidad Rey Juan Carlos, descriptionModule briefSummary: Temporomandibular disorders (TMD) encompass dysfunction and pain of the masticatory muscles and temporomandibular joint (TMJ). Pain in the TMJ, restricted jaw movement, and joint sounds are common conditions in this disorder. This can impact patients' ability to perform daily activities such as eating, speaking, laughing, or yawning, significantly affecting their quality of life.The TMJ and masticatory muscles are innervated by the auriculotemporal branch and the mandibular nerve (V3), a branch of the trigeminal nerve. An estimated 60% to 70% of the population shows signs of TMD, of which up to 12% report intense symptoms requiring treatment.Percutaneous electrical nerve stimulation (PENS) could be a clinically relevant therapy in TMD patients applied through minimally invasive physiotherapy. To our knowledge, there are no trials evaluating the non-surgical clinical efficacy of PENS on the mandibular nerve.The project's objective is to assess the effectiveness of PENS on the mandibular nerve in this type of condition., conditionsModule conditions: Temporomandibular Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Subjects who participate in the study will receive, in the case of the experimental group, 10 minutes of manual therapy and exercises and 10 minutes of percutaneous electrical nerve stimulation (PENS) guided by ultrasound. In the case of the control group, they will receive 20 minutes of manual therapy and exercises. The treatment will consist of one session per week for three weeks (a total of 3 sessions). Each session will last 30 minutes, of which 10 minutes will be used for the initial evaluation and 20 minutes for the assigned treatment. Two weeks after the last session, a final evaluation without treatment will be performed., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Percutaneous nerve stimulation, interventions name: Manual therapy, interventions name: exercise, outcomesModule primaryOutcomes measure: pain intensity, primaryOutcomes measure: Pressure pain thresholds (PPT), primaryOutcomes measure: Pain-free mandibular opening range of motion, secondaryOutcomes measure: Self-reported quality of life (SF-12), secondaryOutcomes measure: Electromyographic activation rate of the masseter muscle., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-07-25, uploadDate: 2024-02-10T07:04, filename: Prot_SAP_000.pdf, size: 142975, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-07-25, uploadDate: 2024-02-10T07:19, filename: ICF_001.pdf, size: 185452, hasResults: False

protocolSection identificationModule nctId: NCT06265623, orgStudyIdInfo id: UKE-IKPT 2024/01, briefTitle: Intermittent Hypoxemia, Lung Function Decline, Morbidity, and Mortality in COPD (PROSA Study)., acronym: PROSA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2028-09-30, completionDateStruct date: 2029-09-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Universitätsklinikum Hamburg-Eppendorf, class: OTHER, descriptionModule briefSummary: This study aims to analyze if patients with chronic obstructive lung disease who experience a decline of blood oxygen saturation during physical exercise have a disease course different from that of COPD patients who do not experience a decline in blood oxygen saturation during exercise. Patients will be followed for a total of 3 years., conditionsModule conditions: Chronic Obstructive Pulmonary Disease (COPD), designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 148, type: ESTIMATED, armsInterventionsModule interventions name: No active intervention, but observational follow-up, outcomesModule primaryOutcomes measure: Difference in FEV1(% of LLN) between baseline and end-of-follow-up, secondaryOutcomes measure: Difference in all-cause mortality during follow-up between groups, secondaryOutcomes measure: Difference in COPD-related mortality during follow-up between groups, secondaryOutcomes measure: Difference in frequency of hospital admissions for exacerbation of COPD during follow-up between groups, secondaryOutcomes measure: Difference in frequency of hospital admissions for causes other than exacerbation of COPD during follow-up between groups, secondaryOutcomes measure: Sensitivity of plasma biomarkers (spec. ADMA and SDMA) to predict the prevalence of exertional desaturation in COPD patients, secondaryOutcomes measure: Sensitivity and specificity of plasma biomarkers (spec. ADMA and SDMA) measured at baseline to prospectively predict the slope of lung function decline in COPD patients, secondaryOutcomes measure: Sensitivity and specificity of plasma biomarkers at baseline to prospectively predict the mortality rate in COPD patients, secondaryOutcomes measure: Difference in incidence and extent of exercise hypoxemia between carriers and non-carriers of single nucleotide polymorphisms (SNPs) in genes of the L-arginine - dimethylarginine pathway, secondaryOutcomes measure: Difference in positive and negative predictive value of bicycle ergometry, 6-minute walk test, and 15-sec breath-hold test to discriminate between COPD patients with exertional desaturation versus those without exertional desaturation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Medical Center Hamburg-Eppendorf, Institute of Clinical Pharmacology and Toxicology, city: Hamburg, zip: 20246, country: Germany, contacts name: Rainer Böger, MD, role: CONTACT, email: boeger@uke.de, contacts name: Juliane Hannemann, PhD, role: CONTACT, email: j.hannemann@uke.de, geoPoint lat: 53.57532, lon: 10.01534, hasResults: False

protocolSection identificationModule nctId: NCT06265610, orgStudyIdInfo id: 2022/186, briefTitle: A Comparison Of The Effect Of Target-Controlled Infusion Anesthesia And Inhalation Anesthesia, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-01, primaryCompletionDateStruct date: 2023-09-01, completionDateStruct date: 2023-10-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: TC Erciyes University, class: OTHER, descriptionModule briefSummary: A total of 70 patients who underwent angiographic examination, ASD closure, VSD closure, PDA closure and aortic balloon dilatation were included in this study., conditionsModule conditions: Pediatric Patients, conditions: Cardiology, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 70, type: ACTUAL, armsInterventionsModule interventions name: TIVA/TCI, outcomesModule primaryOutcomes measure: intraoperative period, primaryOutcomes measure: postoperative period, primaryOutcomes measure: hemodynamic parameters, secondaryOutcomes measure: Modified Aldrete Recovery Score, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Sibel Seçkin Pehlivan, city: Kayseri, state: Talas, zip: 38039, country: Turkey, geoPoint lat: 38.73222, lon: 35.48528, hasResults: False

protocolSection identificationModule nctId: NCT06265597, orgStudyIdInfo id: EU-SBE-DŞ-01, briefTitle: The Effect of Healthy Nutrition and Yoga Program on Obese Children, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2022-09-14, primaryCompletionDateStruct date: 2024-08-02, completionDateStruct date: 2024-12-02, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: TC Erciyes University, class: OTHER, descriptionModule briefSummary: This study was planned to examine the effects of a healthy nutrition and yoga program given to obese children on nutritional behavior, physical activity and anthropometric measurements., conditionsModule conditions: Obesity, Childhood, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: There is a control and intervention group., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Healthy Nutrition and Yoga Program, outcomesModule primaryOutcomes measure: Anthropometric Measurements and Child Follow-up Form, primaryOutcomes measure: Family Nutrition and Physical Activity Scale, primaryOutcomes measure: Adolescent Identification Form, eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 14 Years, stdAges: CHILD, contactsLocationsModule locations facility: Karaman Provincial Directorate of National Education, city: Karaman, zip: 70200, country: Turkey, geoPoint lat: 37.18111, lon: 33.215, hasResults: False

protocolSection identificationModule nctId: NCT06265584, orgStudyIdInfo id: IRB-300011730 (UAB2370), briefTitle: Trial of 2 Step ATG for Prevention of Acute GVHD Post Allogeneic Stem Cell Transplant, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-28, primaryCompletionDateStruct date: 2028-02, completionDateStruct date: 2028-05, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, descriptionModule briefSummary: In an effort to reduce graft versus host disease (GVHD) and enhance graft versus leukemia (GVL) effect post allogenic hematopoietic stem cell transplantation (AHSCT), recent research has focused on host immune cell depletion. Frame shifting anti-thymocyte globulin (ATG) backwards to earlier days before days 0 can result in deeper host and less graft T-cell depletion, leading to better immune reconstitution. Preliminary data where 80% of the ATG dose is given on days -6,-5,-4 and 20% given on day -1, showed effective prevention of severe acute GVHD, chronic GVHD and favorable early immune reconstitution. We hypothesize that our 2 step ATG dosing platform when combined with standard tacrolimus and mini methotrexate can prevent grade III-IV acute GVHD and chronic GVHD, resulting in improvement of GVHD/relapse free survival at one year post transplant., conditionsModule conditions: Acute Leukemia, conditions: Myelodysplastic Syndrome, conditions: Myeloproliferative Disorders, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: ATG dosing platform when combined with standard tacrolimus and mini methotrexate, outcomesModule primaryOutcomes measure: Rate of GRFS (graft versus host disease GVHD, relapse free survival) at one year post transplant., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Alabama at Birmingham, city: Birmingham, state: Alabama, zip: 35294, country: United States, contacts name: Zaid Al Kadhimi, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Manuel Espinoza-Gutarra, MD, role: SUB_INVESTIGATOR, contacts name: Donna Salzman, MD, role: SUB_INVESTIGATOR, contacts name: Antonio Di Stasi, MD, role: SUB_INVESTIGATOR, contacts name: Lauren Shea, MD, role: SUB_INVESTIGATOR, contacts name: Omar Jamy, MD, role: SUB_INVESTIGATOR, geoPoint lat: 33.52066, lon: -86.80249, hasResults: False

protocolSection identificationModule nctId: NCT06265571, orgStudyIdInfo id: EskisehirUO, briefTitle: Postoperative Pain in Shoulder Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-11-15, primaryCompletionDateStruct date: 2021-06-15, completionDateStruct date: 2021-07-15, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Eskisehir Osmangazi University, class: OTHER, descriptionModule briefSummary: After the approval of the ethics committee, the files of the patients who underwent arthroscopic shoulder surgery between 01.01.2019 and 01.03.2020 were evaluated retrospectively.Data were recorded including age, gender, duration of anesthesia, duration of surgery, postoperative analgesia consumption, complications such as respiratory distress due to hemidiaphragmatic paralysis and complications such as hematoma and nerve damage due to block intervention., conditionsModule conditions: Pain, Postoperative, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: perineural injection, outcomesModule primaryOutcomes measure: rescue analgesia, primaryOutcomes measure: difference between the analgesic methods, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ferda YAMAN, city: Eskişehir, state: Odunpazarı, zip: 26040, country: Turkey, geoPoint lat: 39.77667, lon: 30.52056, hasResults: False

protocolSection identificationModule nctId: NCT06265558, orgStudyIdInfo id: PROICM 2023-08 TPN, briefTitle: Prevention of Postoperative Complications by Negative Pressure Therapy After Complex Breast Cancer Surgery, acronym: TPN-SEIN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2027-02, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Institut du Cancer de Montpellier - Val d'Aurelle, class: OTHER, descriptionModule briefSummary: There is little scientific data concerning the use of negative pressure therapy after immediate breast reconstruction.That strategy of treatment-reconstruction has expanded increasingly since the last years.The current literature reports only 3 studies on the use of preventive negative pressure therapy in oncologic breast surgery.Moreover, all three are retrospective, case-control studies with serious limitations.The largest published series reports a reduction in the overall complication rate from 15.9% to 8.5%, and a significant reduction in several criteria: infection, scar dehiscence and necrosis. However, the study presents significant biases, with non-comparable populations in terms of comorbidities, surgical procedure performed, inclusion periods (and therefore experience in performing oncological surgery).There was also a high probability of under-assessment or postponement of post-operative complications, which is typical of published retrospective surgical studies.The published results therefore strongly encourage further investigation of negative pressure therapy in oncological breast surgery., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 254, type: ESTIMATED, armsInterventionsModule interventions name: Negative pressure therapy (NPT), interventions name: Dressing, outcomesModule primaryOutcomes measure: Rate of patients with post-operative scarring trouble, secondaryOutcomes measure: Rate of patients with a surgical site infection, secondaryOutcomes measure: Surgical revision rate, secondaryOutcomes measure: Rate of patients with at least one rehospitalization, secondaryOutcomes measure: Surgical complication rate by Clavien-Dindo classification, secondaryOutcomes measure: Time to initiation of adjuvant therapy, secondaryOutcomes measure: Quality of life evaluated by questionnaire QLQ-C30 (Version 3), secondaryOutcomes measure: Quality of life evaluated by questionnaire QLQ-BReast cancer (BR23), secondaryOutcomes measure: Patient satisfaction about cosmetic result evaluated using the BR23 questionnaire, secondaryOutcomes measure: Medical cost of post-surgery care, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Hospitalier de Nîmes, city: Nîmes, state: Gard, zip: 30900, country: France, contacts name: Fanny BECHARD, MD, role: CONTACT, email: fanny.bechard@hotmail.fr, contacts name: Fanny BECHARD, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.83333, lon: 4.35, locations facility: Centre Hospitalier de Montpellier, city: Montpellier, state: Hérault, zip: 34090, country: France, contacts name: Martha DURAES, MD, role: CONTACT, email: m-duraes@chu-montpellier.fr, contacts name: Martha DURAES, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.61092, lon: 3.87723, locations facility: Institut régional du Cancer de Montpellier, city: Montpellier, state: Hérault, zip: 34298, country: France, contacts name: Mathias NERON, MD, role: CONTACT, phone: 467614813, phoneExt: +33, email: mathias.neron@icm.unicancer.fr, contacts name: Mathias NERON, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.61092, lon: 3.87723, hasResults: False

protocolSection identificationModule nctId: NCT06265545, orgStudyIdInfo id: RR-AML-2023, briefTitle: Multicenter, Platform-type Clinical Study of Refractory/Recurrent Acute Myeloid Leukemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2026-01-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Institute of Hematology & Blood Diseases Hospital, China, class: OTHER, descriptionModule briefSummary: To study the optimal therapeutic strategies for salvage treatment of refractory/relapsed AML, and to clarify the effectiveness and safety of various salvage treatment options. A prospective, multicenter, platform-type study was conducted to explore the overall response rate, tolerability, and survival of patients with R/R AML with different treatment regimens., conditionsModule conditions: AML, conditions: Refractory, conditions: Relapsed, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Ivosidenib,Venetoclax,gilteritinib,Selinexor, outcomesModule primaryOutcomes measure: Complex response (CRc) rate (including CR and CRi), secondaryOutcomes measure: mortality associated with salvage treatment (30 days, 60 days), secondaryOutcomes measure: MRD-negative complete response rate, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Event-free survival, secondaryOutcomes measure: Relapse-free survival, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Blood Hospital, city: Tianjin, zip: 300020, country: China, contacts name: hui wei, MD, role: CONTACT, phone: 86-13132507161, email: weihui@ihcams.ac.cn, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False

protocolSection identificationModule nctId: NCT06265532, orgStudyIdInfo id: Pro00060157, secondaryIdInfos id: R33HL158540, type: NIH, link: https://reporter.nih.gov/quickSearch/R33HL158540, briefTitle: Collagen-targeted Positron Emission Tomography (PET) Imaging for Assessment of EGCG Effect, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-07, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Hal Chapman, class: OTHER, collaborators name: Cornell University, collaborators name: Massachusetts General Hospital, collaborators name: University of Michigan, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: The primary purpose of this substudy is to determine if collagen-targeted PET using the type 1 collagen-targeted PET probe, Gallium-68 (68Ga)-labeled collagen binding probe 8 (CBP8) can inform as to drug effect of EGCG and assist in dose selection., conditionsModule conditions: Idiopathic Pulmonary Fibrosis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: This is an optional substudy to the phase I study: "Dose ranging study of oral epigallocatechin-3-gallate (EGCG) given daily for 12 weeks to patients with Idiopathic Pulmonary Fibrosis (IPF) evaluating safety, PK interactions with standard of care drugs, and biomarkers of drug effect." Up to twenty-two participants participating in the aforementioned study will be enrolled into this sub-study. This substudy will be conducted at a select number of sites with capabilities for performing \[68Ga\]CBP8 PET., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: All participants will be on one of the standard of care drugs (nintedanib or pirfenidone) and blindly given EGCG or placebo., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: EGCG 300 mg, interventions name: Placebo for EGCG 300 mg, interventions name: EGCG 600 mg, interventions name: Placebo for EGCG 600 mg, outcomesModule primaryOutcomes measure: Change in collagen probe uptake over the entire lungs, otherOutcomes measure: Change in peak enhancement over the entire lungs, otherOutcomes measure: Change in the rate of contrast washin over the entire lungs, otherOutcomes measure: Change in the area under the curve at 60 seconds over the entire lungs, otherOutcomes measure: Change in the full width at half maximum over the entire lungs, otherOutcomes measure: Change in the rate of contrast washout over the entire lungs, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Massachusetts General Hospital, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02114, country: United States, contacts name: Sydney Montesi, MD, role: CONTACT, phone: 617-724-4030, email: SBMONTESI@PARTNERS.ORG, contacts name: Caroline Fromson, role: CONTACT, phone: 617-643-3260, email: CFROMSON@MGH.HARVARD.EDU, contacts name: Sydney Montesi, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False

protocolSection identificationModule nctId: NCT06265519, orgStudyIdInfo id: MAR.UAD.008, briefTitle: Association of Urine BDNF and NGF With Lower Urinary System Parameters, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2025-02-01, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Marmara University, class: OTHER, descriptionModule briefSummary: Histologically, BPH is a benign proliferative process involving both epithelial and stromal elements and is characterised by progressive enlargement of the prostate. Symptom complex including increased frequency of urination, sudden feeling of urge to urinate, nocturia, difficulty in urinating, feeling of incomplete emptying of the bladder, decreased flow rate and intermittent urination are called lower urinary tract symptoms (LUTS). The most important cause of LUTS in men is BPH. Many structural and physiological changes occur in the lower urinary system with bladder outlet obstruction. Detrusor hypertrophy and bladder hyperactivity may occur due to bladder outlet obstruction. Although the density of afferent and efferent nerves in the bladder decreases after urethral obstruction, enlargement of their trunks indicates that changes occur in these nerves. In addition, changes also occur in the neural pathways of the central nervous system following lower urinary tract obstruction. Nerve growth factor (NGF) and brain derived neurotropin factor (BDNF) are trophic proteins that act as retrograde messengers between peripheral effector tissue and the nerves that innervate it. In peripheral tissues, the source of NGF and BDNF is presumed to be the target tissues innervated by nerves. Smooth muscle cells, fibroblasts, astrocytes and other cells synthesise NGF and BDNF in culture medium. Many potential stimuli that increase NGF in the lower urinary system have been identified. These are denervation, inflammation and mechanical tension. This information has led to the idea that autonomic innervation changes in the bladder may be related with changing NGF levels. Altered afferent and adrenergic innervation in the obstructed bladder increases the possibility that NGF plays an important role in this neural growth because this type of nerves are highly sensitive to this neurotrophin.In this study, we investigated NGF ve BDNF levels in urine samples obtained before surgery (Transurethral Prostate Resection, Prostate Enucleation with Holmium Laser and Prostate Enucleation with Thulium Fibre Laser) and after removal of obstruction in patients with bladder outlet obstruction secondary to benign prostatic enlargement using ELISA method, We aimed to determine the role of NGF and BDNF in bladder outlet obstruction and bladder changes secondary to obstruction by comparing with control patients without obstruction., conditionsModule conditions: Benign Prostatic Hyperplasia With Outflow Obstruction, conditions: Lower Urinary Tract Obstructive Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, maskingDescription: 0, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Holmium laser enucleation of the prostate, outcomesModule primaryOutcomes measure: Uroflowmetry, secondaryOutcomes measure: International prostate symptom score, otherOutcomes measure: Urodynamic, eligibilityModule sex: MALE, minimumAge: 50 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Marmara University Hospital, status: RECRUITING, city: Istanbul, country: Turkey, contacts name: Haydar Kamil Çam, Prof., role: CONTACT, phone: +905323259547, email: kamilcam@hotmail.com, contacts name: Kader Ada Doğan, MD, role: CONTACT, phone: +905323845598, email: kader.dogan11@gmail.com, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False

protocolSection identificationModule nctId: NCT06265506, orgStudyIdInfo id: 20320, secondaryIdInfos id: R01AA031013, type: NIH, link: https://reporter.nih.gov/quickSearch/R01AA031013, briefTitle: Virtual Incentive Treatment for Alcohol, acronym: VITA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2027-04-03, completionDateStruct date: 2028-04-04, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Washington State University, class: OTHER, collaborators name: The University of Texas Health Science Center at San Antonio, collaborators name: Weill Medical College of Cornell University, collaborators name: National Institute on Alcohol Abuse and Alcoholism (NIAAA), descriptionModule briefSummary: The overall objective of this program of research is to utilize phosphatidylethanol (PEth), a blood-based biomarker that can detect alcohol use for up to 28 days to deliver a feasible telehealth-based 26-week CM intervention. This study will test a telehealth PEth-based CM model in a sample of adults with AUD (n=200), recruited via online platforms by randomizing individuals to six months of 1) an online cognitive behavioral therapy for AUD (CBT4CBT) and telehealth PEth-based CM (CM condition) or 2) CBT4CBT and reinforcers for submitting blood samples (no abstinence required) (control condition). Investigators will assess group differences in PEth-defined abstinence and regular excessive drinking (PEth \>= 200 ng/mL), and alcohol-related harms (e.g., smoking, drug use). This study will address important gaps in CM research by assessing outcomes during a 12-month follow-up, which is much longer than most previous CM studies; using a conceptual model to identify predictors of post-treatment abstinence. Investigators will conduct an economic analysis to place the cost of this model in the context of downstream CM-associated cost-offsets and improvements in personal and public health., conditionsModule conditions: Alcohol Use Disorder, conditions: Alcohol Drinking, conditions: Alcohol Abuse, conditions: Alcohol Dependence, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: We will test the efficacy of our CM model against an evidence-based online intervention, CBT4CBT, by randomizing participants to six months of:1. CBT4CBT and reinforcement for submitting blood samples (no requirement for abstinence) (Control Condition), or2. CBT4CBT and reinforcement for PEth tests that are consistent with alcohol abstinence (CM Condition)., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Contingency Management, interventions name: Computer Based Training for Cognitive Behavioral Therapy for AUD (CBT4CBT), outcomesModule primaryOutcomes measure: Aim 1) Alcohol Abstinence & Aim 3) Predictors: PEth-Defined Alcohol Abstinence During CM (Aim 1) and Follow-Up (Aim 3), primaryOutcomes measure: Aim 2) Alcohol-Related Harms: Addiction Severity Index (ASI) Lite, primaryOutcomes measure: Aim 2) Alcohol-Related Harms: Patient Health Questionnaire-9 (PHQ-9), primaryOutcomes measure: Aim 2) Alcohol-Related Harms: Generalized Anxiety Disorder-7 (GAD-7), primaryOutcomes measure: Aim 2) Alcohol-Related Harms: Short Form Health Survey-12 (SF-12), primaryOutcomes measure: Aim 2) Alcohol-Related Harms & Aim 4) Cost Analysis: Non-study Medical and Other Services (NMOS) form, primaryOutcomes measure: Aim 2) Alcohol Related Harms: Fagerstrom, primaryOutcomes measure: Aim 2) Alcohol Related Harms: Urine Drug Tests, primaryOutcomes measure: Aim 2) Alcohol Related Harms: Perceived Stress Scale (PSS-10), primaryOutcomes measure: Aim 3) Predictors: Demographics, primaryOutcomes measure: Aim 3) Predictors: Addictions Neuroclinical Assessment (ANA) Questionnaire, primaryOutcomes measure: Aim 3) Predictors: TestMyBrain, primaryOutcomes measure: Aim 3) Predictors: Positive Negative Affect Schedule (PANAS), primaryOutcomes measure: Aim 3) Predictors: Situational Confidence Questionnaire-8 (SCQ-8), primaryOutcomes measure: Aim 3) Predictors: Alcohol Craving VAS, primaryOutcomes measure: Aim 4) Cost Analysis: Drug Abuse Treatment Cost Analysis Program (DATCAP), primaryOutcomes measure: Aim 4) Cost Analysis: PROPr, secondaryOutcomes measure: Aim 1) Alcohol Abstinence: Regular excessive drinking, otherOutcomes measure: Aim 1) Alcohol Abstinence: uEtG-Defined Alcohol Abstinence, otherOutcomes measure: Aim 1) Alcohol Abstinence: Self-reported Alcohol Abstinence and Heavy Drinking, otherOutcomes measure: Additional Implementation Data: Attrition, otherOutcomes measure: Additional Implementation Data: CSQ-8, otherOutcomes measure: Adverse Events, otherOutcomes measure: Computer Based Training for Cognitive Behavioral Health (CBT4CBT) Program Use, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Washington State University, city: Spokane, state: Washington, zip: 99201, country: United States, contacts name: Michael McDonell, PhD, role: CONTACT, phone: 509-368-6967, email: mmcdonell@wsu.edu, geoPoint lat: 47.65966, lon: -117.42908, hasResults: False

protocolSection identificationModule nctId: NCT06265493, orgStudyIdInfo id: PLAGH-AOC-L02, briefTitle: Postoperative Infectious Complications Calculator for Elderly Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-06-01, primaryCompletionDateStruct date: 2023-06-30, completionDateStruct date: 2023-09-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Weidong Mi, class: OTHER, descriptionModule briefSummary: The investigators established a first-ever convenient scoring system for clinicians to assess the risk of Postoperative infectious complications (PICs) for elderly patients. Our scoring system can aid in the early detection of potential risks for postoperative infections. Higher-score patients were more likely to experience postoperative infections., conditionsModule conditions: Postoperative Infection, conditions: Geriatrics, conditions: Prediction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 37230, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Postoperative Infectious Complications Calculator for Elderly Patients, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Depatment of Anesthesiology, The First Medical Center Affiliation: Chinese PLA General Hospital, city: Beijing, state: Beijing, zip: 100853, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False

protocolSection identificationModule nctId: NCT06265480, orgStudyIdInfo id: 2023-04577-01, briefTitle: FallFitness Fallprevention Program for Older Adults, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Dalarna University, class: OTHER, collaborators name: Sormland County Council, Sweden, descriptionModule briefSummary: The overall aim with this project is to collaborate with four organisations for retired persons located in a small region of middle Sweden. The project aims to test and evaluate a newly developed group-based fall prevention exercise program regarding the effects and experiences of both leading and participating in the intervention. The design of the study is a randomised controlled trial including a total of 100 participants (60+), 50 participants in the intervention and 50 participants in the control group., conditionsModule conditions: Fall Injury, conditions: Fall, conditions: Self Efficacy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomised Controlled Trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Study will be singled blinded (assessors), whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: FallFitness intervention group, outcomesModule primaryOutcomes measure: Physical function by Short Physical Performance Battery, secondaryOutcomes measure: Self-efficacy (balance confidence), secondaryOutcomes measure: Fear of Falling, secondaryOutcomes measure: EuroQoL-5 Dimension Questionnaire (EQ-5D), secondaryOutcomes measure: Fallfrequency, secondaryOutcomes measure: Falling techniques, secondaryOutcomes measure: Handgrip strength, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Marina Arkkukangas, status: RECRUITING, city: Eskilstuna, state: Sormland, country: Sweden, contacts name: Marina Arkkukangas, PhD, role: CONTACT, phone: +46 (0)706468868, email: maau@du.se, contacts name: Michail Tonkonogi, Professor, role: CONTACT, phone: +46(0)708206435, email: mtn@du.se, geoPoint lat: 59.36661, lon: 16.5077, hasResults: False

protocolSection identificationModule nctId: NCT06265467, orgStudyIdInfo id: 28909108800228, briefTitle: Evaluation of Two Different Techniques for Sinus Elevation, Open Versus Closed ., statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2023-02-01, completionDateStruct date: 2023-07-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Misr International University, class: OTHER, collaborators name: Suez Canal University, descriptionModule briefSummary: A clinical Trial, comparing two different techniques to elevate the maxillary sinus floor membrane to allow for simultaneous dental implant placement in the severely atrophied maxillary ridges.Both using allogenic bone substitute as the bone graft material. One technique is the open lateral window technique and the second is the closed crestal technique., conditionsModule conditions: Alveolar Ridge Augmentation, conditions: Sinus Floor Augmentation, conditions: Maxillary Sinus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Assignment, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: it is a double blinded study, both the outcome assessor and statistician will be blinded, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Closed Sinus Elevation, interventions name: Open Sinus Elevation, outcomesModule primaryOutcomes measure: Implant Stability, secondaryOutcomes measure: Radiographic bone gain, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Suez Canal University, city: Ismailia, zip: 41522, country: Egypt, geoPoint lat: 30.60427, lon: 32.27225, hasResults: False

protocolSection identificationModule nctId: NCT06265454, orgStudyIdInfo id: LDAED IN MC, briefTitle: Low Dose Atropine Eye Drops in Myopic Egyptian Children, acronym: LAMP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2026-03-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: Previous Studies reported that low concentration atropine eye drops may be effective in increasing the choroidal blood flow and thickness and this slows myopia progression.purpose of the study is to compare changes in axial length, anterior chamber depth, choroidal thickness, central corneal thickness and anterior scleral thickness among myopic children receiving atropine 0.05% or 0.01% and placebo., conditionsModule conditions: Myopia Progression, conditions: Axial Length, Eye, conditions: Sclera Thickness, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: low dose atropine eye drops, interventions name: Placebo, outcomesModule primaryOutcomes measure: change in the average Choroidal Thickness over follow up period., eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Ain shams university, city: Cairo, state: Abbasia, zip: 11517, country: Egypt, contacts name: Aya MA Abd El wahab, Masters, role: CONTACT, phone: 1009192526, phoneExt: +20, email: ayamah711@gmail.com, contacts name: Marwa M Abd al Karim, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False

protocolSection identificationModule nctId: NCT06265441, orgStudyIdInfo id: MS42/2024, briefTitle: Comparison of Pain Relief Post Knee Arthroscopy Using IPACK + Adductor Canal Block vs. Adductor Canal Block Alone, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: In this study, the invistigators aim to compare postoperative analgesia effectiveness between combined interspace between the popliteal artery and posterior capsule of the knee block (IPACK) and Adductor canal block vs. Adductor canal block alone after Arthroscopic knee surgeries focusing on VAS score assessment at 8 hours postoperative., conditionsModule conditions: Postoperative Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Group A will receive adductor canal block after spinal anesthesia under a high-frequency ultrasound guidance in which the adductor canal is identified and 20 ml of 0.25% bupivacaine will be injected, interventions name: Group B will receive adductor canal block under ultrasound guide 20 ml bupivacaine 0.25% and IPACK block under direct visualization of ultrasound of 20 ml bupivacaine 0.25%, outcomesModule primaryOutcomes measure: Assessment of pain using the visual analogue scale (VAS) upon first ambulation after 8 hours from the completion of the surgical procedure and skin closure., secondaryOutcomes measure: Total analgesics consumption, secondaryOutcomes measure: The time till first analgesic requirement, secondaryOutcomes measure: The range of movement (ROM), secondaryOutcomes measure: The number of steps, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ain Shams University, city: Cairo, state: Abbassia, zip: 00202, country: Egypt, contacts name: Mohamed Morsi, M.B.B.CH, role: CONTACT, phone: +201116618163, email: MohamedMorsi@med.asu.edu.eg, contacts name: Mohamed Morsi, M.B.B.CH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False

protocolSection identificationModule nctId: NCT06265428, orgStudyIdInfo id: DB-1303-O-3001, secondaryIdInfos id: CTR20233403, type: OTHER, domain: CENTER FOR DRUG EVALUATION, NMPA, briefTitle: A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-29, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-02, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: DualityBio Inc., class: INDUSTRY, collaborators name: BioNTech SE, descriptionModule briefSummary: This study is designed to compare efficacy and safety of DB-1303/BNT323 versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer patients previously treated with trastuzumab and taxane., conditionsModule conditions: HER2-positive Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 224, type: ESTIMATED, armsInterventionsModule interventions name: DB-1303/BNT323, interventions name: T-DM1, outcomesModule primaryOutcomes measure: Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Progression Free Survival (PFS) by Investigator assessment per RECIST 1.1, secondaryOutcomes measure: Objective response rate (ORR) by BICR and investigator assessment per RECIST 1.1, secondaryOutcomes measure: Duration of response (DoR) by BICR and investigator assessment per RECIST 1.1, secondaryOutcomes measure: PK parameters: maximum observed concentration (Cmax), secondaryOutcomes measure: PK parameters: time to maximum concentration (Tmax), secondaryOutcomes measure: Adverse events (AEs), secondaryOutcomes measure: Patient reported outcomes (PROs): European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) - C30, secondaryOutcomes measure: Patient reported outcomes (PROs): EORTC QLQ-BR45, secondaryOutcomes measure: Patient reported outcomes (PROs): European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L), secondaryOutcomes measure: European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L), secondaryOutcomes measure: Anti-drug antibodies (ADA), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Fifth Medical Center of the Chinese People's Liberation Army General Hospital, status: NOT_YET_RECRUITING, city: Beijing, state: Beijing, zip: 100039, country: China, contacts name: Zefei Jiang, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Fudan University Shanghai Cancer Center, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200032, country: China, contacts name: Jian Zhang, role: CONTACT, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False

protocolSection identificationModule nctId: NCT06265415, orgStudyIdInfo id: Soh-Med-24-01-07MS, briefTitle: Comparative Study of Intravenous Labetalol Versus Intravenous Nitroglycerin Versus Sublingual Nifedipine, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2025-03-30, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: Pre-eclampsia (PE) is one of the most frequent pregnancy complications and is one of the main causes of maternal and fetal morbidity and mortality in its severe form.control of blood pressure is of crucial importance to avoid maternal and fetal complications.Therapeutic modalities that can target the underlying pathophysiological changes and reverse the endothelial dysfunction could help to ameliorate the systemic manifestations in patients with severe PE. Either Intravenous labetalol and nitroglycerine as well as sublingual nifedipine have been frequantly used for the management of acute severe hypertension in PE, conditionsModule conditions: Severe Preeclampsia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Labetalol, interventions name: Nitroglycerine, interventions name: Nifedipine, outcomesModule primaryOutcomes measure: duration of control blood pressure, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06265402, orgStudyIdInfo id: 36264, briefTitle: Retrolaminar Block Versus Tab Block in Abdomioasty, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2025-10-15, completionDateStruct date: 2025-12-15, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Tanta University, class: OTHER, descriptionModule briefSummary: The aim of the study is to compare the analgesic efficacy of Us guided retrolaminar block versus transversus abdominis plane block in patient under going abdominal plastic surgery, conditionsModule conditions: Block, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Tab block versus retrolaminar block in abdominal plastic surgery, outcomesModule primaryOutcomes measure: Total dose of morphine consumption in the first postoperative 24hours, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: TantaU U, status: RECRUITING, city: Tanta, country: Egypt, contacts name: Hadeel Elsagheer, Master, role: CONTACT, geoPoint lat: 30.78847, lon: 31.00192, hasResults: False

protocolSection identificationModule nctId: NCT06265389, orgStudyIdInfo id: Pentoxifylline in pneumonia, briefTitle: Pentoxifylline as an Adjuvant Therapy in the Treatment of Pediatric Pneumonia; A New Perspective of an Old Drug, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-10-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Tanta University, class: OTHER, descriptionModule briefSummary: Pentoxifylline is a xanthine-derived, commercially produced drug approved for the management of intermittent claudication in patients suffering from a chronic occlusive arterial disease of the limbs. Pentoxifylline has been documented to display anti-inflammatory and immunomodulatory effects, as well as some antithrombotic and antiviral effects. This drug has also been shown to reduce lung fibrosis in patients with COVID-19, as well as to prevent thromboembolic events. This work aims to assess the benefit of oral Pentoxifyllin supplementation, in addition to standard antibiotic and other supportive therapy, in the management of hospitalized children with community-acquired pneumonia, conditionsModule conditions: Pentoxifylline as an Adjunct Therapy in the Treatment of Pneumonia, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Pentoxifylline Oral Tablet, outcomesModule primaryOutcomes measure: Respiratory distress, primaryOutcomes measure: Temperature, primaryOutcomes measure: Oxygen saturation, primaryOutcomes measure: CRP, primaryOutcomes measure: LDH, primaryOutcomes measure: D-dimer, primaryOutcomes measure: Interleukin 6, secondaryOutcomes measure: Hospital stays, secondaryOutcomes measure: Pneumonia complications, otherOutcomes measure: Surgical intervention, eligibilityModule sex: ALL, minimumAge: 2 Months, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06265376, orgStudyIdInfo id: IRB22-046, briefTitle: Do Patient Educational Videos Improve Pain and Recovery After Laparoscopic Hysterectomy?, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-13, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Benaroya Research Institute, class: OTHER, descriptionModule briefSummary: The use of multi-model patient education has been used in a variety of medical specialties to educate patients on expectations for various medical procedures and improve patients' understanding of their own health care. However, it is unknown what type of audio and/or visual materials work best in a given clinical setting. By surveying overall pain/post-operative recovery satisfaction we can measure how well our video intervention educates and reinforces post-operative management at home when compared to the current method of education that patients receive at the pre-operative visit prior to laparoscopic hysterectomy at this institution., conditionsModule conditions: Pain, Postoperative, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Educational Video, outcomesModule primaryOutcomes measure: Overall satisfaction score (5 point Likert scale) with post operative pain control after laparoscopic hysterectomy, secondaryOutcomes measure: Pain score at the time of survey completion (0=no pain 10=worst pain, secondaryOutcomes measure: Average pain score for the first 7 days as perceived by the patients (likert scale), secondaryOutcomes measure: Number of post-op phone calls received, secondaryOutcomes measure: Number of post-op emergency room visits, secondaryOutcomes measure: Number of readmissions, secondaryOutcomes measure: Number of patients with steri-strips still in place, secondaryOutcomes measure: Number opioids taken since surgery, secondaryOutcomes measure: Overall satisfaction with pre-operative education regarding surgery (5 point Likert scale), secondaryOutcomes measure: ding surgery (5 point likert scale) Overall satisfaction with educations regarding what to expect post-operatively (5 point Likert scale), eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Virginia Mason Medical Center, status: RECRUITING, city: Seattle, state: Washington, zip: 98101, country: United States, contacts name: Michelle Gruttadauria, MD, role: CONTACT, phone: 206-223-6191, email: Michelle.Gruttadauria@virginiamason.org, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False

protocolSection identificationModule nctId: NCT06265363, orgStudyIdInfo id: Turkey BigROP Study, briefTitle: Evaluation of the Frequency, Risk Factors, and Outcomes of ROP in Infants With a BW >1500 Grs or GA ≥33 Wks in Turkey., acronym: TR-BigROP, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Baskent University Ankara Hospital, class: OTHER, collaborators name: Hacettepe University, collaborators name: Gazi University, collaborators name: Gaziosmanpasa Research and Education Hospital, collaborators name: Celal Bayar University, collaborators name: Selcuk University, collaborators name: Recep Tayyip Erdogan University, collaborators name: Karadeniz Technical University, collaborators name: Istinye University, collaborators name: Biruni University, collaborators name: T.C. ORDU ÜNİVERSİTESİ, collaborators name: Dr. Lutfi Kirdar Kartal Training and Research Hospital, collaborators name: Pamukkale University, collaborators name: Kanuni Sultan Suleyman Training and Research Hospital, collaborators name: Konya City Hospital, collaborators name: Kecioren Education and Training Hospital, collaborators name: Ataturk University, collaborators name: Meda Hospital, collaborators name: Eskisehir Osmangazi University, collaborators name: Necmettin Erbakan University, collaborators name: Kırıkkale University, collaborators name: Sisli Hamidiye Etfal Training and Research Hospital, collaborators name: Acibadem Atakent University Hospital, collaborators name: Balikesir Ataturk City Hospital, collaborators name: Kocaeli University, collaborators name: Acibadem Maslak Hospital, collaborators name: Erzurum City Hospital, collaborators name: Afyon Karahisar Hospital, collaborators name: Ankara Koru Hospital, collaborators name: University of Health Sciences Gulhane Hospital, collaborators name: Bursa Yüksek İhtisas Education and Research Hospital, collaborators name: Namik Kemal University, collaborators name: Bursa City Hospital, collaborators name: Kayseri City Hospital, collaborators name: Ankara Etlik City Hospital, collaborators name: Zonguldak Bulent Ecevit University, collaborators name: Gazi Yasargil Training and Research Hospital, collaborators name: Inonu University, collaborators name: Dr. Behcet Uz Children's Hospital, collaborators name: Ankara Training and Research Hospital, collaborators name: Tepecik Training and Research Hospital, collaborators name: Aydin Adnan Menderes University, collaborators name: Dicle University, collaborators name: Akdeniz University, collaborators name: Umraniye Education and Research Hospital, collaborators name: Ankara Bilkent City Hospital, collaborators name: Afyonkarahisar University of Health Sciences Health Application and Research Center, collaborators name: Harran University, collaborators name: Sanliurfa Mehmet Akif Inan Education and Research Hospital, collaborators name: Istanbul University - Cerrahpasa (IUC), collaborators name: Uludag University, collaborators name: şanlıurfa training and research Hospital, collaborators name: Dokuz Eylul University, collaborators name: Bursa Doruk Yıldırım Hospital, collaborators name: Malatya Turgut Ozal University, collaborators name: Abant Izzet Baysal University, collaborators name: Alanya Training and Research Hospital, collaborators name: İstanbul Training and Research Hospital, collaborators name: Baskent Univeristy Adana Hospital, collaborators name: Kahramanmaras Sutcu Imam University, collaborators name: Batman Training and Research Hospital, collaborators name: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital, collaborators name: Acıbadem Atunizade Hospital, collaborators name: Adiyaman Training and Research Hospital, collaborators name: Zeynep Kamil Maternity and Pediatric Research and Training Hospital, collaborators name: Ondokuz Mayıs University, collaborators name: Trakya University, collaborators name: Trabzon Kanuni Education and Research Hospital, collaborators name: Seyhan Hospital, collaborators name: Esenyurt University Hospital, collaborators name: Başakşehir Çam & Sakura City Hospital, collaborators name: Sakarya University, collaborators name: Mardin Training and Research Hospital, collaborators name: Karabuk University, collaborators name: Giresun Training and Research Hospital, collaborators name: Koc University Hospital, collaborators name: Tekirdağ City Hospital, collaborators name: Medipol University Mega Hospital, collaborators name: Adana City Training and Research Hospital, collaborators name: Istanbul University, collaborators name: Marmara University Pendik Training and Research Hospital, collaborators name: Medikal Park Ankara Hospital, collaborators name: Medipol University Bahcelievler Hospital, collaborators name: Muğla Sıtkı Koçman University, collaborators name: Yuzuncu Yıl University, collaborators name: Sanko University, collaborators name: Antalya Training and Research Hospital, collaborators name: Firat University, collaborators name: Ankara Güven Hospital, collaborators name: Private Batman Hospital, collaborators name: İstanbul Bağcılar Training and Research Hospital, collaborators name: Istanbul Aydın University, collaborators name: Mersin City Hospital, descriptionModule briefSummary: The study includes preterm infants who are being screened for ROP between August 1,2023 and August 1, 2024 in 94 neonatal intensive care units (NICUs) in Turkey. Infants with birth weight (BW) of \>1500 g or ≥ 33 weeks' gestation who are screened for retinopathy of prematurity are included. The incidence of any ROP, severe ROP and treatment modalities will be determined. The risk factors for ROP development will also be evaluated., conditionsModule conditions: Retinopathy of Prematurity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Incidence of ROP, secondaryOutcomes measure: The role of being SGA in infants in the development of ROP, secondaryOutcomes measure: The role of sepsis in infants in the development of ROP, secondaryOutcomes measure: The role of mechanical ventilation in infants in the development of ROP, secondaryOutcomes measure: The role of chorioamnionitis in infants in the development of ROP, secondaryOutcomes measure: Laser photocoagulation treatment, secondaryOutcomes measure: Anti-VEGF treatment, secondaryOutcomes measure: Vitreoretinal surgery, eligibilityModule sex: ALL, minimumAge: 28 Days, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Baskent University, status: RECRUITING, city: Ankara, country: Turkey, contacts name: Sezin Unal, role: CONTACT, phone: 0090532, email: sezinunal@gmail.com, contacts name: Esin Koc, Prof, role: PRINCIPAL_INVESTIGATOR, contacts name: Ahmet Y Bas, Prof, role: PRINCIPAL_INVESTIGATOR, contacts name: İbrahim M Hirfanoğlu, Prof, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False

protocolSection identificationModule nctId: NCT06265350, orgStudyIdInfo id: Liver Project 5, briefTitle: Cryoablation Combined With Cardonilizumab and Bevacizumab in Hepatocellular Carcinoma With Pulmonary Metastases, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-02, primaryCompletionDateStruct date: 2026-01-30, completionDateStruct date: 2027-01-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: This study intends to evaluate the efficacy and safety of cryoablation combined with Cardonilizumab and Bevacizumab in hepatocellular carcinoma with pulmonary metastases., conditionsModule conditions: Hepatocellular Carcinoma, conditions: Liver Cancer Stage IV, conditions: Pulmonary Metastases, conditions: Cadonilimab, conditions: Bevacizumab, conditions: Cryoablation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Cadonilimab, interventions name: Bevacizumab, interventions name: Cryoablation, outcomesModule primaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Progression free survival (PFS), secondaryOutcomes measure: Overall survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-sen University Cancer Center, status: RECRUITING, city: Guanzhou, state: Guangdong, zip: 510000, country: China, contacts name: Qunfang Zhou, MD, role: CONTACT, phone: 86 19868000115, email: zhouqun988509@163.com, locations facility: Sun Yat-sen University Cancer Center, status: RECRUITING, city: Guanzhou, state: Guangdong, zip: 510000, country: China, contacts name: Qunfang Zhou, MD, role: CONTACT, phone: 8619868000115, email: zhouqun988509@163.com, hasResults: False

protocolSection identificationModule nctId: NCT06265337, orgStudyIdInfo id: LAMETA-OGTT, briefTitle: Does Co-administration of Lactate to an Oral Glucose Tolerance Test Lower the Glucose Response?, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University of Aarhus, class: OTHER, descriptionModule briefSummary: To investigate whether co-administration of lactate with a glucose load affects postprandial glucose levels/handling, gastrointestinal hormones, gastric emptying, and appetite sensations in individuals with pre-diabetes when compared to placebo.Hypothesis:Oral lactate administration improves/lowers glucose excursions following an oral glucose tolerance test (OGTT) by stimulating insulin secretion and delaying glucose absorption., conditionsModule conditions: PreDiabetes, conditions: Metabolic Syndrome, conditions: Insulin Resistance, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: In a randomized, double-blinded, placebo-controlled crossover trial, we will investigate the effect of addition of 25 g lactate vs. placebo to an OGTT on two trial days separated by a minimum of fourteen days and a maximum of one month. We will include 12 individuals with pre-diabetes \[9\], having HbA1c 39-47 mmol/L and being above 40 years of age., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Lactate, interventions name: Placebo, outcomesModule primaryOutcomes measure: Difference in integrated glucose concentrations between CTR and LAC following an OGTT, secondaryOutcomes measure: Difference in glucose absorption, secondaryOutcomes measure: Difference in insulin sensitivity, secondaryOutcomes measure: Difference in insulin secretion, secondaryOutcomes measure: Difference in free fatty acids concentration, secondaryOutcomes measure: Difference in ventricular emptying rate, secondaryOutcomes measure: Difference in subjective appetite sensation, secondaryOutcomes measure: Difference in integrated GLP-1 concentrations, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06265324, orgStudyIdInfo id: Soh-Med-23-12-04MD, briefTitle: Drug-coated Balloon Treatment in Coronary Lesions, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-10, primaryCompletionDateStruct date: 2024-06-10, completionDateStruct date: 2025-02-10, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: This study is multicenter registry for drug-coated balloon treatment for de novo and in-stent restenosis lesions, conditionsModule conditions: Drug-coated Balloon, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Angioplasty, outcomesModule primaryOutcomes measure: Major adverse cardiac events at 6 months, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sohag faculty of medicine, city: Sohag, country: Egypt, contacts name: Sharaf Eldin Shazly, PHD, role: CONTACT, phone: 0112 9999792, contacts name: Imran Saber, MA, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False

protocolSection identificationModule nctId: NCT06265311, orgStudyIdInfo id: 20221307-2, briefTitle: IDUS in CBD Stone Recurrence High Risk Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-11-02, primaryCompletionDateStruct date: 2024-01-31, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Shanghai Municipal Hospital of Traditional Chinese Medicine, class: OTHER, descriptionModule briefSummary: This study is designed to observed CBD stones cases with high recurrence risks applying IDUS or not during ERCP.Patients with CBD stone high recurrence risks were enrolled in this study, and prospectively randomized into IUDS group and control group during lithotomy.Operation time, radiation time, hospitalization cost, retain of nasobiliary tube, deployment of stent were recorded.Symptoms and conditions after ERCP were also followed up including blood amylase, routine blood test, abdominal pain, post-ERCP pancreatitis, resection of gallbladder, recurrence of CBD stone and onset of cholangitis., conditionsModule conditions: Choledocholithiasis, conditions: Cholangiopancreatography, Endoscopic Retrograde, conditions: Ultrasonography, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: IDUS examination, outcomesModule primaryOutcomes measure: recurrence of bile duct stone or cholangitis, primaryOutcomes measure: need for a nasobiliary tube, primaryOutcomes measure: need for stents, secondaryOutcomes measure: operation time, secondaryOutcomes measure: radiation time, secondaryOutcomes measure: hospitalization cost, secondaryOutcomes measure: Questionnaire of Symptoms and conditions after ERCP, secondaryOutcomes measure: White blood cell count, secondaryOutcomes measure: Red blood cell count, secondaryOutcomes measure: Platelet count, secondaryOutcomes measure: total bilirubin, direct bilirubin, secondaryOutcomes measure: Liver function test (ALT, AST), secondaryOutcomes measure: albumin, secondaryOutcomes measure: total protein, secondaryOutcomes measure: Gamma-glutamyl transferase (GGT) test, secondaryOutcomes measure: An alkaline phosphatase (ALP) test, secondaryOutcomes measure: whether have a resection of gallbladder checklist, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shang General Hospital, status: RECRUITING, city: Shanghai, zip: 200080, country: China, contacts name: Hang Zhao, role: CONTACT, phone: 18621186288, email: drzhaohang@163.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False

protocolSection identificationModule nctId: NCT06265298, orgStudyIdInfo id: RECHMPL23_0099, briefTitle: Implementation of a Protocol for the Transdifferentiation of Buccal Mucosal Epithelium Into Corneal Epithelium, acronym: TransBuCor, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University Hospital, Montpellier, class: OTHER, collaborators name: Institute for Neuroscience Montpellier, descriptionModule briefSummary: Objectives The transparent surface of the eye, called the cornea, plays a crucial role in transmitting light to the retina and in protecting the eye. On its external surface, the cornea is composed of a constantly renewing multistratified epithelium. This mechanism is fueled by stem cells located in the limbus (the transition zone between the cornea and the sclera). Limbal Stem Cell Deficiency (LSCD) is characterized by a decrease or cessation of epithelial renewal and neovascularization of the cornea. Consequently, the cornea loses its integrity and transparency. This visually impairing condition is currently in a therapeutic impasse as only autologous limbal or allogeneic corneal grafts are viable options, but they pose significant risks to patients.Studies have shown that the oral cavity contains stem cells that can be isolated, cultured, and transdifferentiated into limbal stem cells (LSCs). However, to date, these studies are limited, and no protocol has been validated. In this study, the advantage of the accessibility of the oral cavity is used to develop a protocol for differentiating cells from the oral mucosa into limbal stem cells (LSCs) for use in a future clinical trial with patients.Methodology This prospective monocentric study will be conducted on patients from the ophthalmology department of the Montpellier University Hospital who have an indication for conjunctival reconstruction. After obtaining consent from the patients, cells from the oral wall will be sent to the tissue bank of the Montpellier University Hospital, where they will be cultured. Finally, the transdifferentiation steps will be analyzed by the "Eye" research team at the Institute of Neuroscience in Montpellier, which is collaborating on the project. The investigators have established objective factors to assess the success of the developed protocol based on the literature : (i) \> 3% of stem cells in primary cultures, (ii) \<10% aborted colonies, (iii) Expression of LSC markers (Pax6, Krt14, p63)., conditionsModule conditions: Limbal Stem Cell Deficiency, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: transversal and fondamental study, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 4, type: ESTIMATED, armsInterventionsModule interventions name: Conjunctival reconstruction, outcomesModule primaryOutcomes measure: Successful Transdifferentiation, primaryOutcomes measure: Successful Transdifferentiation, primaryOutcomes measure: Successful Transdifferentiation, primaryOutcomes measure: Successful Transdifferentiation, primaryOutcomes measure: Successful Transdifferentiation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU Gui de Chauliac - Service d'Ophtamologie, city: Montpellier, state: Occitanie, zip: 34295, country: France, contacts name: Vincent DAIEN, Pr, role: CONTACT, email: v-daien@chu-montpellier.fr, contacts name: Vincent Daien, Pr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.61092, lon: 3.87723, hasResults: False

protocolSection identificationModule nctId: NCT06265285, orgStudyIdInfo id: MC230716, secondaryIdInfos id: NCI-2024-00637, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 23-009663, type: OTHER, domain: Mayo Clinic Institutional Review Board, secondaryIdInfos id: MC230716, type: OTHER, domain: Mayo Clinic in Florida, briefTitle: Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: This phase II trial compares the impact of subcutaneous (SC) nivolumab given in an in-home setting to an in-clinic setting on cancer care and quality of life. Currently, most drug-related cancer care is conducted in clinic type centers or hospitals which may isolate patients from family, friends and familiar surroundings for many hours per day. This separation adds to the physical, emotional, social, and financial burden for patients and their families. Traveling to and from medical facilities costs time, money, and effort and can be a disadvantage to patients living in rural areas, those with low incomes or poor access to transport. Studies have shown that cancer patients often feel more comfortable and secure being cared for in their own home environments. SC nivolumab in-home treatment may be safe, tolerable and/or effective when compared to in-clinic treatment and may reduce the burden of cancer and improve the quality of life in cancer patients., conditionsModule conditions: Advanced Esophageal Squamous Cell Carcinoma, conditions: Advanced Renal Cell Carcinoma, conditions: Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8, conditions: Clinical Stage IIB Cutaneous Melanoma AJCC v8, conditions: Clinical Stage IIC Cutaneous Melanoma AJCC v8, conditions: Clinical Stage III Cutaneous Melanoma AJCC v8, conditions: Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8, conditions: Clinical Stage IV Cutaneous Melanoma AJCC v8, conditions: Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8, conditions: Esophageal Carcinoma, conditions: Gastroesophageal Junction Adenocarcinoma, conditions: Hepatocellular Carcinoma, conditions: Locally Advanced Urothelial Carcinoma, conditions: Lung Non-Small Cell Carcinoma, conditions: Malignant Solid Neoplasm, conditions: Metastatic Colorectal Carcinoma, conditions: Metastatic Cutaneous Melanoma, conditions: Metastatic Esophageal Squamous Cell Carcinoma, conditions: Metastatic Head and Neck Squamous Cell Carcinoma, conditions: Metastatic Urothelial Carcinoma, conditions: Recurrent Esophageal Squamous Cell Carcinoma, conditions: Recurrent Head and Neck Squamous Cell Carcinoma, conditions: Renal Cell Carcinoma, conditions: Stage III Renal Cell Cancer AJCC v8, conditions: Stage IV Colorectal Cancer AJCC v8, conditions: Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8, conditions: Stage IV Renal Cell Cancer AJCC v8, conditions: Unresectable Cutaneous Melanoma, conditions: Unresectable Esophageal Squamous Cell Carcinoma, conditions: Urothelial Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Home Health Encounter, interventions name: Nivolumab, interventions name: Patient Monitoring, interventions name: Questionnaire Administration, outcomesModule primaryOutcomes measure: Change in patient-reported rating of Cancer CARE Cancer Connected Access and Remote Expertise (CARE) after 8 weeks, secondaryOutcomes measure: Patient preferred treatment location, secondaryOutcomes measure: Patient level of comfort with receiving injections at home, secondaryOutcomes measure: Patient-reported symptoms - PRO-CTCAE, secondaryOutcomes measure: Patient-reported function - EORTC QLQ-F17, secondaryOutcomes measure: Patient-reported side effect impact - GP5, secondaryOutcomes measure: Incidence of Adverse Events (AEs), secondaryOutcomes measure: Emergency room visits and hospitalizations, secondaryOutcomes measure: Overall survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Florida, status: RECRUITING, city: Jacksonville, state: Florida, zip: 32224-9980, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: mayocliniccancerstudies@mayo.edu, contacts name: Roxana S. Dronca, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.33218, lon: -81.65565, hasResults: False

protocolSection identificationModule nctId: NCT06265272, orgStudyIdInfo id: 2022P002594, briefTitle: Value of [68Ga]Ga-PSMA-11 PET/MRI in the Assessment of Liver Cirrhosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-10, primaryCompletionDateStruct date: 2026-12-19, completionDateStruct date: 2026-12-19, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, descriptionModule briefSummary: A total of fifty-five (55) patients with liver cirrhosis will be enrolled in this study to produce and validate dedicated Ga-PSMA-PET/MRI acquisition protocols.The specific hypotheses include:* Ga-PSMA PET/MRI may allow robust and reproducible noninvasive in vivo quantitation of hepatic macro and microhemodynamics in cirrhotic patients* Dedicated simultaneously acquired DWI sequences might quantitate liver fibrosis and improve hemodynamic quantitation.* Ga-PSMA PET/MRI may allow noninvasive and reproducible quantitation of portal venous hypertension and predict its evolution, as well as response to treatments* Ga-PSMA PET/MRI may improve noninvasive and reproducible qualitative and quantitative assessment of liver function, structure, nodules and predict evolution of cirrhosis, conditionsModule conditions: Liver Cirrhosis, conditions: Hepatic Cell Carcinoma, conditions: Portal Hypertension, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Injection of a gadolinium contrast agen, interventions name: Radiotracer Injection, interventions name: Imaging, outcomesModule primaryOutcomes measure: Assessment of LI-RADS with Ga-PSMA-PET/MRI, secondaryOutcomes measure: Quantification of Macro- and Microperfusion in Cirrhotic Liver with Ga-PSMA-PET/MRI, secondaryOutcomes measure: Quantification of liver fibrosis with Ga-PSMA-PET/MRI vs. MRI and stand-alone PET, secondaryOutcomes measure: PET/MR protocol in liver cirrhosis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, status: RECRUITING, city: Charlestown, state: Massachusetts, zip: 02129, country: United States, contacts name: Onforio Catalano, MD, Ph.D, role: CONTACT, phone: 617-724-4030, email: ocatalano@mgh.harvard.edu, contacts name: Diandrea Galloway, role: CONTACT, phone: 617-643-1407, email: dgalloway@mgh.harvard.edu, geoPoint lat: 42.37787, lon: -71.062, hasResults: False

protocolSection identificationModule nctId: NCT06265259, orgStudyIdInfo id: 31-05-2023/25481, briefTitle: Efficacy of the Use of Vasopressin as a Primary Vasoconstrictor in Critically Ill Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-15, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of Thessaly, class: OTHER, descriptionModule briefSummary: Current guidelines recommend the inititaion of noradrenaline and if shock is refractory, then vasopressin should be administered. Data indicate that the earlier use of vasopressin may improve survival. Two large randomized controlled trial failed to prove a survival benefit from the early use of vasopressin. The present study will investigate the effect of an early initiation protocol of vasopressin (as the first vasoconstrictor drug) on the degree of multiorgan failure improvement and also on the course of sepsis (if in septic patients) versus early initiation of noradrenaline as first vasoconstrictor drug in hemodynamically unstable patients., conditionsModule conditions: Circulatory Shock, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 145, type: ESTIMATED, armsInterventionsModule interventions name: Initiation of vasopressine as a first vasoconstrictive drug, interventions name: Initiation of noradrenaline as a first vasoconstrictive drug, outcomesModule primaryOutcomes measure: Multiorgan failure improvement assessment, secondaryOutcomes measure: Sepsis course, secondaryOutcomes measure: Sepsis course, secondaryOutcomes measure: Sepsis course, secondaryOutcomes measure: Duration of administration of vasoconstrictors, secondaryOutcomes measure: laboratory tests, secondaryOutcomes measure: laboratory tests, secondaryOutcomes measure: laboratory tests, secondaryOutcomes measure: laboratory tests, secondaryOutcomes measure: laboratory tests, secondaryOutcomes measure: laboratory tests, secondaryOutcomes measure: laboratory tests, secondaryOutcomes measure: laboratory tests, secondaryOutcomes measure: laboratory tests, secondaryOutcomes measure: laboratory tests, secondaryOutcomes measure: laboratory tests, secondaryOutcomes measure: Cardiac enzymes, secondaryOutcomes measure: Cardiac enzymes, secondaryOutcomes measure: renal function, secondaryOutcomes measure: renal function, secondaryOutcomes measure: renal function, secondaryOutcomes measure: Mechanical ventilation duration, secondaryOutcomes measure: length of ICU stay, secondaryOutcomes measure: 28 day mortality, secondaryOutcomes measure: ICU mortality, secondaryOutcomes measure: Adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: General University Hospital of Larissa, Intensive Care Unit, status: RECRUITING, city: Larissa, state: Thessaly, zip: 41110, country: Greece, contacts name: Vasiliki Tsolaki, role: CONTACT, phone: 00306972804419, email: vasotsolaki@yahoo.com, contacts name: Epaminondas Zakynthinos, Prof, role: CONTACT, phone: 00302413501280, email: ezakynth@yahoo.com, contacts name: Vasiliki TSOLAKI, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Asimina Valsamaki, MD, Msc, role: SUB_INVESTIGATOR, contacts name: Epaminondas Zakynthinos, Prof, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.63689, lon: 22.41761, hasResults: False

protocolSection identificationModule nctId: NCT06265246, orgStudyIdInfo id: 104993, briefTitle: Impact of Milk and Yogurt Supplementation on Bone Health, Body Composition, and Gut Microbiota in Canadian Young Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2028-05-15, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University of Saskatchewan, class: OTHER, collaborators name: Dairy Farmers of Canada, collaborators name: Agriculture and Agri-Food Canada, descriptionModule briefSummary: Milk and dairy products contain significant amounts of nutrients that contribute to optimal health - nutrients like calcium, vitamin D, and high-quality protein. Fermented milk products or fermented dairy products are dairy foods that have been fermented with certain bacteria. Yogurt is a fermented dairy product containing millions of beneficial bacteria. In this study, the invesgitagtors will look at the effect of milk (a non-fermented dairy product) and yogurt (a fermented dairy product) supplementation on bone health and the amount of fat and muscle mass in Canadian young adults over a 24-month period. While dairy products contain significant amounts of nutrients, the scientific community does not know the impact of long-term supplementation of fermented (i.e., yogurt) or non-fermented (i.e., milk) dairy food on bone health and the amount of fat and muscle mass in young adults. To fill this knowledge gap, the investigators will recruit participants with low calcium intake and assign them to three different groups: 1) milk (intervention) group; 2) yogurt (intervention) group; and 3) control group. The investigators will ask the participants in the milk group to drink 1.5 servings (375 mL) of milk per day for 24 months. Participants in the yogurt group will consume 2 servings (350 g) of yogurt per day for 24 months. Those in the control group will continue their usual diets. Using a randomized controlled trial design, the investigators will measure bone health parameters, hormonal indices related to bone metabolism, body composition (e.g., muscle mass, fat mass), and the number and composition of bacteria living in the gastrointestinal (GI) tract. The hypothesis is that supplementation with yogurt will have more positive effects on bone health indices, particularly femoral neck BMD as the primary outcome, than milk in Canadian adults aged 19-30 years. The secondary hypothesis is that supplementation with yogurt, as a fermented milk product, will have a more beneficial effect than milk on body composition measures. The data will provide valuable information for developing targeted health initiatives and marketing strategies regarding the benefits of fermented and non-fermented dairy product consumption., conditionsModule conditions: Osteoporosis, conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In this 24-month randomized controlled trial, the investigators will follow the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Ninety-nine free-living adults aged 19-30 years with low dietary calcium intake will be randomly assigned to one of the following three intervention arms.1. Habitual diet (control) (n=33)2. Habitual diet + 1.5 servings of milk providing approx. 500 mg Ca/day (either 1% fat milk, or 2% fat milk) (n=33)3. Habitual diet + 2 servings of yogurt providing approx. 500 mg Ca/day (either 1% fat plain yogurt, 2% fat plain yogurt, 1% fat flavoured yogurt, 2% fat flavoured yogurt) (n=33), primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 99, type: ESTIMATED, armsInterventionsModule interventions name: Habitual Diet + Milk, interventions name: Habitual Diet + Yogurt, outcomesModule primaryOutcomes measure: Femoral neck bone mineral density, secondaryOutcomes measure: Bone mineral density (total hip, lumbar spine, whole body), secondaryOutcomes measure: Bone mineral content (total hip, femoral neck, lumbar spine, whole body), otherOutcomes measure: Bone structure, otherOutcomes measure: Bone geometry, otherOutcomes measure: Serum bone alkaline phosphatase (biochemical indices of bone turnover), otherOutcomes measure: Serum osteocalcin (biochemical indices of bone turnover), otherOutcomes measure: Serum procollagen type 1 N-propeptide (biochemical indices of bone turnover), otherOutcomes measure: Serum N-terminal telopeptide of type 1 collagen (biochemical indices of bone turnover), otherOutcomes measure: Serum C-terminal telopeptide of type 1 collagen (biochemical indices of bone turnover), otherOutcomes measure: Serum PTH (hormonal indices related to bone metabolism), otherOutcomes measure: Serum 25(OH)D (hormonal indices related to bone metabolism), otherOutcomes measure: Serum IGF-1 (hormonal indices related to bone metabolism), otherOutcomes measure: Saliva IGF-1 (hormonal indices related to bone metabolism), otherOutcomes measure: Fat mass and lean mass, otherOutcomes measure: Height, otherOutcomes measure: Weight, otherOutcomes measure: Gut microbiota via general lactobacillus and bifdobacterium, otherOutcomes measure: Dietary assessment, otherOutcomes measure: Physical activity, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False