In this prospective randomized controlled blinded multicenter trial, a total of 120 high-risk cardiac surgery patients will receive either standard of care + OMEGAVEN at 0.20 g/kg ideal body weight (IBW) versus placebo + standard of care. conditions: Cardiac Surgery conditions: High Risk Patients conditions: Intensive Care Unit conditions: Cardiopulmonary Bypass conditions: Valve Surgeries studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomization will be stratified by site, employing a web-based system using a 1:1 ratio to either intravenous FO- based lipid emulsion (Omegaven®), or placebo. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Researchers and clinical staff will be blinded to study intervention allocation. Unblinded delegate at each site will be able to prepare and dispense the investigational drug or placebo. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Long-chain n-3 fatty acids name: Intravenous 0.9% Sodium Chloride measure: Atrial fibrillation measure: Weaning from cardiopulmonary bypass (CPB) measure: Time to discharge alive measure: Persistent Organ Dysfunction + Death measure: Days alive and out of hospital measure: Hospital length of stay measure: ICU length of stay measure: Simplified Acute Physiology Score measure: Therapeutic Intervention Scoring System measure: ICU and Hospital Readmission rates measure: Delta Sequential Organ Failure Assessment Score (SOFA) Score measure: Mechanical ventilation measure: Stroke measure: Acute Kidney Injury measure: Infections rate measure: Clinical frailty scale measure: Development of delirium measure: Survival status measure: Physical activity assessment measure: Quality of Life (SF-36) measure: Adverse Events measure: Postoperative bleeding measure: Optional-Ultrasound measurement measure: Optional-Functional Status Score for Intensive Care Unit measure: Optional-Short Physical Performance Battery test measure: Optional-Hand grip dynamometer measure: Optional-Hand held dynamometer measure: Optional-Manual Muscle Testing measure: Optional-Left ventricular ejection function measure: Optional-Markers of inflammation measure: Optional-Hemodynamics measure: Sub-study sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RWTH Aachen University status: NOT_YET_RECRUITING city: Aachen country: Germany name: Moritz Immohr, M.D role: CONTACT email: mimmohr@ukaachen.de name: Aileen Hill, M.D role: CONTACT email: ahill@ukaachen.de lat: 50.77664 lon: 6.08342 facility: Charité Universitätsmedizin Berlin status: NOT_YET_RECRUITING city: Berlin country: Germany name: Sascha Ott, M.D role: CONTACT email: sascha.ott@dhzc-charite.de name: Maren Kleine-Brüggeney, M.D role: CONTACT email: maren.kleine-brueggeney@dhzc-charite.de lat: 52.52437 lon: 13.41053 facility: University of Bonn status: NOT_YET_RECRUITING city: Bonn country: Germany name: Markus Velten, M.D role: CONTACT email: markus.velten@ukbonn.de name: Maria Wittmann, M.D role: CONTACT email: Maria.Wittmann@ukbonn.de lat: 50.73438 lon: 7.09549 facility: Universität Göttingen status: NOT_YET_RECRUITING city: Göttingen country: Germany name: Reiner Wäschle, M.D role: CONTACT email: Reiner.Waeschle@med.uni-goettingen.de name: Anselm Bräuer, M.D. role: CONTACT email: abraeue@gwdg.de lat: 51.53443 lon: 9.93228 facility: University Medical Center Schleswig-Holstein status: NOT_YET_RECRUITING city: Kiel country: Germany name: Elke Gunnar, M.D role: CONTACT email: Gunnar.Elke@uksh.de name: Matthias Lindner, M.D role: CONTACT email: Matthias.Lindner@uksh.de lat: 54.32133 lon: 10.13489 facility: University of Muenster status: RECRUITING city: Münster country: Germany name: Alexander Zarbock, M.D role: CONTACT email: zarbock@uni-muenster.de name: Carola Wempe, M.D role: CONTACT email: Carola.Wempe@ukmuenster.de lat: 51.96236 lon: 7.62571 hasResults: False

 nctId: NCT06279780 id: PI18/00932 briefTitle: Gut Microbiota, Mitochondrial Function and Metabolic Health in Obesity overallStatus: ACTIVE_NOT_RECRUITING date: 2019-01-01 date: 2023-12-31 date: 2024-08-31 date: 2024-02-28 date: 2024-02-28 name: Celia Bañuls class: OTHER name: Instituto de Salud Carlos III briefSummary: It has been suggested that individuals with the condition known as metabolically healthy obesity (MHO) may not have the same increased risk of developing metabolic abnormalities as their non-metabolically healthy counterparts. In addition, to date, the identification of metabolic biomarkers and microbiota underlying the MHO state is limited. In this study, our goal is to provide insight into the underlying metabolic pathways affected by obesity. To achieve this, we will compare the metabolic profile, inflammatory parameters and mitochondrial function, as well as metabolomic analysis and differential expression of microbiota in obese patients categorized as metabolically healthy vs. non healthy. In parallel, the effect of a hypocaloric diet on obese subjects' metabolism and microbiota will be assessed to approve their use in the treatment of said disorder. Specifically, we propose an observational, clinical-basic, comparative and interventional study in a population of 80 obese (BMI\>35 kg/m2) patients clustered in two groups according to the presence or absence of altered metabolism (altered fasting glycemia, hypertension, atherogenic dyslipidemia). Anthropometric and clinical variables and biological samples (serum, plasma, peripheral blood cells and feces) will be collected for the determination of biochemical parameters (glucose, lipid and hormonal profile by enzymatic techniques) and protein-based peripheral biomarkers of mitochondrial function \[total and mitochondrial reactive oxygen species (ROS) production, mitochondrial membrane potential, glutathione levels by static cytometry\], markers of mitochondrial dynamics \[Mitofusin 1 (MFN1), Mitofusin 2 (MFN2), Mitochondrial fision protein 1 (FIS1) and Dynamin-related protein 1 (DRP1) by RT-PCR and Western Blot\], markers of inflammation \[Interleukin 6 (IL6), Tumoral necrosis factor alpha (TNFα), IL1b, adiponectin, resistin, plasminogen activator inhibitor 1 (PAI-1), Monocyte chemoattractant protein-1 (MCP-1), caspase 1 and NLRP3 by Western Blot and technology XMAP), metabolomic assay (NMR spectroscopy and PLS-DA), as well as gut microbiota content and diversity (16S rRNA, MiSeq sequencing). Finally, we will evaluate the effect of a dietary weight loss intervention on these biomarkers. conditions: Obesity Adult Onset studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 109 type: ACTUAL name: very low-calorie diet measure: Analyze the changes in the diversity of the intestinal microbiota after dietetic intervention. measure: Evaluate the differences in the diversity of the intestinal microbiota depending on whether patients present metabolically healthy obesity (MHO) or metabolically unhealthy obesity (MUHO). measure: Evaluate significant changes in body fat mass percentage after the dietetic intervention. measure: Assess significant changes in high-sensitivity C-reactive protein (hs-CRP) as an inflammatory parameter after the dietetic intervention. measure: Evaluate significant changes in C3 protein as an inflammatory parameter after the dietetic intervention. measure: Assess significant changes in plasmatic homocysteine as an inflammatory parameter after the dietetic intervention. measure: Evaluate significant changes in interleukin 1-beta (IL-1B) levels as a pro-inflammatory molecule after the dietetic intervention. measure: Evaluate significant changes in interleukin 6 (IL-6) levels as a pro-inflammatory molecule after the dietetic intervention. measure: Evaluate significant changes in tumor necrosis factor alpha (TNF-alpha) levels as a pro-inflammatory molecule after the dietetic intervention. measure: Assess significant changes in superoxide dismutase (SOD) levels after the dietetic intervention. measure: Analyze the significant differences between metabolomic profile before and after the dietetic intervention. measure: Evaluate if there is a significant reduction after the dietetic intervention in total ROS levels. measure: Assess if there is a significant reduction after the dietetic intervention in glutathione levels. measure: Analyze if there is a significant change after the dietetic intervention in total free radicals and superoxide levels. measure: Analyze if there is a significant reduction after the dietetic intervention in mitochondrial ROS production. measure: Evaluate if there is a significant improvement after the dietetic intervention in mitochondrial membrane potential. measure: Analyze the proportion of subjects achieving at least 10% reduction in weight compared with baseline. sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: FISABIO city: Valencia zip: 46020 country: Spain lat: 39.46975 lon: -0.37739 hasResults: False

 nctId: NCT06279767 id: 2022-SR-557 briefTitle: Efficacy and Safety of TMZ Plus 6-MP in the Patients With Recurrent Glioblastoma overallStatus: RECRUITING date: 2022-07-01 date: 2025-07-01 date: 2025-07-31 date: 2024-02-28 date: 2024-02-28 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: Glioblastoma, the most prevalent malignant tumor in the central nervous system, is characterized by high invasiveness and a propensity to recur, contributing to a relatively elevated mortality rate. Patients diagnosed with high-grade glioblastomas typically experience a median survival period of less than 14 months. Presently, the standard treatment for glioblastoma involves surgical resection combined with postoperative radiotherapy and chemotherapy, with postoperative chemotherapy playing a pivotal role in enhancing patient prognosis. Temozolomide (TMZ), a cutting-edge oral alkylating agent known for its advantageous properties, including easy traversal of the blood-brain barrier, induces DNA alkylation in tumor cells, fostering apoptosis. Currently, it serves as a frontline medication for postoperative chemotherapy in glioblastoma. However, clinical resistance to TMZ chemotherapy significantly hampers its efficacy in later stages. We have recently discovered and validated that 5-aminoimidazole-4-carboxamide (AICA), derived from TMZ, can transform into 5-aminoimidazole-4-carboxamide ribonucleotide-5-phosphate (AICAR) in GBM cells. Hypoxanthine phosphoribosyltransferase 1 (HPRT1) has been identified as the catalyst for the AICA reaction, generating AICAR. AICAR acts as an endogenous activator of AMP-activated protein kinase (AMPK), fostering chemoresistance in glioblastoma through the activation of the AMPK signaling pathway. 6-mercaptopurine (6-MP) competes effectively to inhibit HPRT1 activity, thereby impeding TMZ-induced AMPK activation and significantly heightening glioblastoma cell sensitivity to TMZ. In this project, we propose an innovative strategy involving the combination of 6-MP with TMZ for the treatment of glioblastoma. conditions: Glioblastoma conditions: Cancer conditions: Temozolomide studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 27 type: ESTIMATED name: 6-mercaptopurine measure: PFS measure: OS measure: Safety evaluation sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Neurosurgery of The First Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu zip: 210029 country: China name: Yongping You, PhD role: CONTACT phone: 13770694258 email: YYPL3@sohu.com lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06279754 id: ZLXGBXKYXM-031-01 briefTitle: Recombinant Human Endostatin Combined With Envafolimab and Synchronal Radiochemotherapy overallStatus: NOT_YET_RECRUITING date: 2024-02-18 date: 2024-06-18 date: 2025-12-18 date: 2024-02-28 date: 2024-02-28 name: The First Affiliated Hospital of Xinxiang Medical College class: OTHER briefSummary: This study is a prospective, single arm, single center open clinical study aimed at evaluating the efficacy and safety of recombinant human endostatin and envafolimab combined with synchronal radiochemotherapy in patients with locally advanced squamous non-small cell lung cancer who cannot undergo surgery in stage III. conditions: Locally Advanced Squamous Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Recombinant Human Endostatin Injection measure: objective response rate measure: Overall survival measure: Progression-free survival sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06279741 id: EVENEW id: 2022-500293-34 type: EUDRACT_NUMBER id: U1111-1291-0283 type: OTHER domain: Universal Trial Number briefTitle: Safety and Efficacy of MSC-EVs in the Prevention of BPD in Extremely Preterm Infants acronym: EVENEW overallStatus: RECRUITING date: 2023-12-28 date: 2027-01-31 date: 2029-12-31 date: 2024-02-28 date: 2024-02-28 name: EXO Biologics S.A. class: INDUSTRY briefSummary: The phase 1/2 trial aims to evaluate the safety and efficacy of EXOB-001 consisting of extracellular vesicles derived from umbilical cord mesenchymal stromal cells in the prevention of bronchopulmonary dysplasia (BPD) in extremely premature neonates. The study population includes babies born between 23 and 28 (27 + 6 days) weeks of gestational age and body weight between 500g and 1,500 g. Thirty-six subjects will receive one or three administrations of the three doses of EXOB-001 via the endotracheal route in phase 1. In phase 2, two dosages based on the results of phase 1 will be selected and a total of 203 subjects will be randomised to receive either EXOB-001 or placebo (saline solution).

Infants will be followed up to 2 years of corrected age (end of study). conditions: Bronchopulmonary Dysplasia studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase 1 is an open-labelled, dose-escalated, and single-arm of EXOB-001. Phase 2 is a randomised, double-blind, placebo-controlled, and dose-finding of EXOB-001. primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Phase 1 is an open-label, dose-escalation and single-arm study. In phase 2, Investigators will remain blinded to each subject's assigned treatment throughout the study. The Sponsor will put in place procedures to maintain this blind. Indeed, to ensure the blinding of the groups, the preparation and administration of the test product will be organized by different teams. In the event of a Quality Assurance audit, the auditor(s) will be allowed access to unblinded study treatment records at the site(s) to verify that randomisation/dispensing has been done accurately. Blinding will be broken by the Investigator for emergency purposes only, where knowledge of the blinded treatment could influence further subject care. In addition, subjects will be unblinded for safety reports, as per regulatory requirements. Study blind will be broken after the database lock. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 265 type: ESTIMATED name: Endotracheopulmonary Instillation, Suspension measure: Number of subjects with treatment-emergent adverse events (phase 1) measure: Number of subjects with BPD grade II-III incidence rate per groups (phase 2). measure: Assessment of medium-term safety of EXOB-001 (phase 1/2) measure: Number of subjects with dose-limiting toxicity (DLT) (phase 1) measure: Number of subjects needing for oxygen and ventilation for BPD incidence (phase 1/2) measure: Assessment of immune markers (phase 2) measure: Assessment of BPD incidence and severity (phase 1/2) measure: Safety evaluation (phase 1/2) measure: Assessment of lung ultrasound score (phase 1/2) measure: Number of subjects with complications of prematurity (phase 1/2) measure: Assessment of the respiratory morbidity (phase 1/2) measure: Assessment of neurodevelopment (phase 1/2) sex: ALL maximumAge: 10 Days stdAges: CHILD facility: Cliniques Universitaires Saint-Luc (UCLouvain) status: NOT_YET_RECRUITING city: Brussels zip: 1200 country: Belgium name: Olivier Danhaive, M.D. role: CONTACT phone: +32 2 764 79 00 email: olivier.danhaive@saintluc.uclouvain.be name: Olivier Danhaive, M.D. role: PRINCIPAL_INVESTIGATOR lat: 50.85045 lon: 4.34878 facility: ISPPC CHU Charleroi status: NOT_YET_RECRUITING city: Charleroi zip: 6000 country: Belgium name: Serge Vanden Eijnden, M.D. role: CONTACT phone: +32 7 192 12 43 email: serge.vandeneijnden@chu-charleroi.be name: Serge Vanden Eijnden, M.D. role: PRINCIPAL_INVESTIGATOR lat: 50.41136 lon: 4.44448 facility: Clinique CHC Montlégia status: NOT_YET_RECRUITING city: Liège zip: 4000 country: Belgium name: Pierre Maton, M.D. role: CONTACT phone: +32 4 355 56 17 email: pierre.maton@chc.be name: Pierre Maton, M.D. role: PRINCIPAL_INVESTIGATOR lat: 50.63373 lon: 5.56749 facility: AOU Careggi status: NOT_YET_RECRUITING city: Florence country: Italy name: Carlo Dani, M.D. role: CONTACT phone: +39 055 7948421 email: carlo.dani@unifi.it name: Carlo Dani, M.D. role: PRINCIPAL_INVESTIGATOR lat: 43.77925 lon: 11.24626 facility: IRCCS Instituto Giannina Gaslini status: NOT_YET_RECRUITING city: Genova country: Italy name: Giorgia Brigati, M.D. role: CONTACT phone: +39 010 56362218 email: giorgiabrigati@gaslini.org name: Giorgia Brigati, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.40478 lon: 8.94438 facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico status: NOT_YET_RECRUITING city: Milan country: Italy name: Anna Lavizzari, M.D. role: CONTACT email: anna.lavizzari@policlinico.mi.it role: CONTACT phone: +39 025 5032907 name: Anna Lavizzari, M.D. role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 facility: AOU Policlinico di Modena status: NOT_YET_RECRUITING city: Modena country: Italy name: Alberto Berardi, M.D. role: CONTACT phone: +39 333 1053301 email: alberto.berardi@unimore.it name: Alberto Berardi, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.64783 lon: 10.92539 facility: Unità di Fase I della UOC Terapia Intensiva e Patologia Neonatale, Assistenza Neonatale (TINI) dell'Azienda Ospedale Università di Padova status: RECRUITING city: Padua zip: 35128 country: Italy name: Eugenio Baraldi, Prof role: CONTACT phone: +39 049 8213578 email: eugenio.baraldi@unipd.it name: Eugenio Baraldi, Prof role: PRINCIPAL_INVESTIGATOR lat: 45.40797 lon: 11.88586 hasResults: False

 nctId: NCT06279728 id: DS1062-0003-EAP-MA briefTitle: Medical Access Program for Datopotamab Deruxtecan in NSCLC Patients overallStatus: AVAILABLE date: 2024-02-28 date: 2024-04-08 name: Daiichi Sankyo class: INDUSTRY name: AstraZeneca briefSummary: The purpose of this Medical Access Program (also referred to as an Expanded Access Program in the USA) is to provide access to Dato-DXd for eligible patients with previously treated advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who, in their treating physician's opinion, have an unmet clinical need, are unlikely to obtain optimal benefit from currently approved and commercially available drugs, and who cannot enter a suitable clinical trial. conditions: Advanced Non-Small Cell Lung Cancer conditions: Metastatic Non Small Cell Lung Cancer studyType: EXPANDED_ACCESS name: Datopotamab deruxtecan sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Queen's Medical Center status: AVAILABLE city: Honolulu state: Hawaii zip: 96813 country: United States name: Principal Investigator role: CONTACT lat: 21.30694 lon: -157.85833 hasResults: False

 nctId: NCT06279715 id: 3437 briefTitle: DFI and Aneuploidies overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-19 date: 2024-12-31 date: 2025-02-01 date: 2024-02-28 date: 2024-02-28 name: Clinique Ovo class: INDUSTRY briefSummary: IVF is the most commonly employed form of assisted reproductive technologies (ART) for the 10-15% of couples who face difficulties becoming pregnant. Many individuals elect to have their IVF-derived embryos analyzed using pregenetic implantation testing for aneuploidies (PGT-A). The use of PGT-A is particularly beneficial for patients at higher risk for aneuploidy, such as those of advanced maternal age and those faced with recurrent pregnancy loss or recurrent implantation failure.

Segmental aneuploidies are generated when a small piece of a chromosome is gained or lost during cell division, resulting in subchromosomal copy number (CN) changes. The frequency of segmental aneuploidies during the cleavage stage varies between studies, from as low as 3.9% to 15% and up to 70 % with no reported correlation with maternal age. This can be explained by the fact that, unlike whole chromosome aneuploidies, segmental aneuploidies most often involve paternally inherited chromosomes. conditions: Embryo Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 800 type: ESTIMATED name: Preimplantation Genetic Testing for Aneuploidy measure: DFI association and aneuploidy sex: ALL minimumAge: 18 Years maximumAge: 43 Years stdAges: ADULT facility: Clinique ovo city: Montreal state: Quebec zip: H4P 2S4 country: Canada lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06279702 id: OCalisir briefTitle: Serious Game Simulation and Comics in School Students overallStatus: ACTIVE_NOT_RECRUITING date: 2023-07-19 date: 2025-07-19 date: 2025-07-19 date: 2024-02-28 date: 2024-02-28 name: TC Erciyes University class: OTHER briefSummary: The aim of the study is to determine the effect of first aid training for injuries given to secondary school students through serious game simulation and comic books on knowledge, skills and motivation.

Hypotheses:

H1: First aid training given through simulation applications affects the level of knowledge.

H2: First aid training given through simulation applications affects the skill level.

H3: First aid training given with simulation application affects motivation.

H4: First aid training given with comics affects the level of knowledge.

H5: First aid training given with comic books affects the skill level.

H6: First aid training given with comics affects motivation.

METHOD: The research will be conducted as a randomized controlled experimental study with a pre-test-post-test design with children studying in the 5th and 6th grades of schools in the central district of Aksaray. One group will be given first aid training for injuries prepared with serious games, the other group will be given first aid training for injuries prepared with comic books. No intervention will be made to the control group. Serious game scenario software prepared based on the literature will be integrated into the computer. Appropriate statistics will be made after the research by applying the prepared data collection tools. With this research, the gap in the literature will be filled, children's first aid knowledge and skills in injuries will be increased, and school health nurses will be provided with up-to-date teaching material. conditions: First Aid studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: serious game and comics primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 54 type: ACTUAL name: SERIOUS GAME name: COMICS measure: Motivation Scale for Teaching Materials measure: Student Knowledge Level Evaluation Form for First Aid Application in Injuries measure: Student Skill Level Evaluation Form for First Aid Application in Injuries sex: ALL minimumAge: 9 Years maximumAge: 12 Years stdAges: CHILD facility: Özlem Çalışır city: Aksaray state: Center zip: 68200 country: Turkey lat: 38.37255 lon: 34.02537 hasResults: False

 nctId: NCT06279689 id: CJTCDZ2301 briefTitle: Echography Study_Anthropometric Measurements overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-06 date: 2024-06 date: 2024-02-28 date: 2024-02-28 name: Crossject class: INDUSTRY briefSummary: This is a multi-center, exploratory, estimation study in both adult and pediatric populations. There is no investigational product injection during this study The exploratory objective of this study is to evaluate the anatomical characteristics of both anterolateral thighs in healthy adult and healthy pediatric populations (2 to 17 years old) by ultrasound scan before and while applying a force similar to the ZENEO® triggering force.

In the healthy adult population, anatomical characteristics of one shoulder (deltoid) and one upper arm (biceps and triceps) will also be evaluated by ultrasound scan before and while applying a force similar to ZENEO® triggering force.

Only ultrasound procedures will be performed using an investigational ultrasound system. All subjects will be asked to undergo 1 on site visit (Study Visit) during which the eligibility assessment and the ultrasound scans will be performed. conditions: Healthy Subjects studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 90 type: ESTIMATED name: Ultrasound scans measure: STBD : Skin To Bone Distance measure: STMD: Skin To Muscle Distance measure: Thickness of skin layers (dermis, hypodermis) measure: Thickness of muscle layers measure: Circumferences measurements (thigh, upper arm, waist, hip) sex: ALL minimumAge: 2 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06279676 id: SaFeGreff briefTitle: Improvement of Women's Health After Allogeneic Stem Cell Transplantation acronym: SaFeGreff overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2028-07 date: 2028-12 date: 2024-02-28 date: 2024-02-28 name: Ciusss de L'Est de l'Île de Montréal class: OTHER name: Centre hospitalier de l'Université de Montréal (CHUM) briefSummary: The aim of this prospective research project is to better understand vulvovaginal cGVHD to improve care of allografted women. The expected outcomes include better knowledge of the incidence and manifestations of vulvovaginal cGVHD, risk factors, response to treatments and impact on sexual health of allotransplanted female patients. The knowledge acquired will allow transplant clinicians to make more precise recommendations for gynecological management of future allografted women. conditions: GVHD, Chronic studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Define the incidence and describe clinical presentation of vulvovaginal cGVHD after allogeneic stem cell transplants reflecting modern transplant practice. measure: Evaluate genital cGVHD treatment response measure: Evaluate the frequency of premature ovarian failure measure: Measure the incidence and prevalence of HPV infection measure: Evaluate the quality of life (QoL) of allografted women measure: Evaluate intimacy within relationships of allografted women measure: Evaluate sexual function of allografted women measure: Evaluate sexual distress of allografted women sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06279663 id: NSTE-ACS Multivessel Trial briefTitle: Management Tactics for Patients High Risk With Acute Coronary Syndrome Without ST Segment Elevation and Multivessel Coronary Artery Disease acronym: NSTE-ACSMT overallStatus: RECRUITING date: 2024-02-29 date: 2028-12-31 date: 2029-12-31 date: 2024-02-28 date: 2024-03-13 name: Federal State Budgetary Institution National Medical Research Center named after academician E.N. Me class: OTHER_GOV name: Kemerovo Cardiology Center, Tarasov Roman Sergeevich name: Tomsk National Research Medical Center of the Russian Academy of Sciences, Ryabov Vyacheslav Valeryevich briefSummary: The study will include patients with acute coronary syndrome without ST segment elevation and multivessel CA lesion, who are subject to surgical treatment according to KG data (Syntax Score 23 - 32 points with significant damage to the anterior descending artery and/or trunk of the left coronary artery). The patient should be suitable for both CABG and PCI (confirmed by an X-ray surgeon and a cardiac surgeon). An X-ray surgeon and a cardiac surgeon, within the framework of planning the volume of revascularization, strives for the fullest feasible volume. Complete myocardial revascularization (that is, the desire for the absence of hemodynamically significant coronary arteries after revascularization, with a diameter of \> 2.5 mm, that is, residual coronary artery stenosis of no more than 60%). Thus, patients will be randomized into groups in a ratio of 1:1. Each group will need to include 230 patients (a total of 460). In the main group, revascularization will be performed by PCI, in the control group by CABG. conditions: Coronary Syndrome, Acute, Non-ST Elevation, High Risk Patients studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 460 type: ESTIMATED name: Revascularization measure: Death from any cause measure: Combined endpoint (death from cardiovascular causes, MI, Stroke, repeated unplanned myocardial revascularization) measure: target LDL level measure: Myocardial infarction measure: Stroke measure: Repeated unplanned myocardial revascularization measure: Duration of the hospital period measure: Intra/perioperative complications measure: Significant hemorrhagic complications (grade 3 or more on the BARC scale) measure: Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anton status: RECRUITING city: Novosibirsk state: Novosibirsk Obl zip: 630055 country: Russian Federation name: Anton Obedinskiy, 1 role: CONTACT phone: +73833476099 phoneExt: 1 email: a_obedinskij@meshalkin.ru lat: 55.0415 lon: 82.9346 facility: Anton status: RECRUITING city: Novosibirsk state: Rechkunovskaya Str. zip: 630055 country: Russian Federation name: Anton Obedinskiy role: CONTACT phone: 89139322885 email: a_obedinskij@meshalkin.ru lat: 55.0415 lon: 82.9346 hasResults: False

 nctId: NCT06279650 id: 2022-2741 briefTitle: Self-hypnosis Training for Chronic Pain Management overallStatus: RECRUITING date: 2024-02-01 date: 2024-06 date: 2024-12 date: 2024-02-28 date: 2024-02-28 name: Ciusss de L'Est de l'Île de Montréal class: OTHER briefSummary: Title: Self-hypnosis training in chronic pain management: A pilot study Our primary objective concerns the effect of hypnosis intervention on change in 24h pain between T0 (pre-intervention) and T4 (3-month follow-up). The secondary objectives concern the effects of the intervention on (i) change in 24h pain between T0 and T5 (6-month follow-up), (ii) changes from T0 in measures of the functional impact of pain, (iii) changes from T0 in anxiety-depression scores and (iv) changes from T0 in quality of life.

The study design is a Randomized efficacy pilot study. The study focuses on patients practicing self-hypnosis within HMR groups. The study population is pain clinic patients. The sample size is 60 pain clinic patients. Study duration: February 2024 - December 2024. Center responsible for the study: Centre de Recherche de l'Hôpital Maisonneuve-Rosemont (CR-HMR) - CEMTL, Montreal, Quebec, Canada.

Adverse events: none expected. conditions: Hypnosis, Chronic Pain Management studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Self-hypnosis name: Psycho-education and cognitive Bahavioral therapy (CBT) measure: Time 1 : Numerical Rating Scale (NRS) from 0 to 10 measure: Time 1 : Questionnaire Brief Pain Inventory (BPI) measure: Time 1 : Hospital anxiety and depression scale (HADS) measure: Time 1 : SF-36 (36-Item Short Form Survey) measure: Time 1 : Questionnaire socio-demographic and clinical measure: Time 2 : Numerical Rating Scale (NRS) from 0 to 10 measure: Time 2 : Questionnaire Brief Pain Inventory (BPI) measure: Time 2 : Hospital anxiety and depression scale (HADS) measure: Time 2 : SF-36 (36-Item Short Form Survey) measure: Time 3 : Numerical Rating Scale (NRS) from 0 to 10 measure: Time 3 : Questionnaire Brief Pain Inventory (BPI) measure: Time 3 : Hospital anxiety and depression scale (HADS) measure: Time 3 : SF-36 (36-Item Short Form Survey) measure: Time 4 : Numerical Rating Scale (NRS) from 0 to 10 measure: Time 4 : Questionnaire Brief Pain Inventory (BPI) measure: Time 4 : Hospital anxiety and depression scale (HADS) measure: Time 4 : SF-36 (36-Item Short Form Survey) measure: Time 5 : Numerical Rating Scale (NRS) from 0 to 10 measure: Time 5 : Questionnaire Brief Pain Inventory (BPI) measure: Time 5 : Hospital anxiety and depression scale (HADS) measure: Time 5 : SF-36 (36-Item Short Form Survey) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: 5415 Bd de l'Assomption status: RECRUITING city: Montréal state: Quebec zip: H1T 2M4 country: Canada name: David Ogez role: CONTACT email: david.ogez@umontreal.ca lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06279637 id: PRO00046457 briefTitle: Joint Patient and Caregiver Intervention for Older African Americans With Type 2 Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-03-04 date: 2026-07 date: 2026-07 date: 2024-02-28 date: 2024-02-28 name: Medical College of Wisconsin class: OTHER briefSummary: This study will test the preliminary efficacy of a joint patient/informal caregiver telephone-delivered intervention that includes diabetes education; problem solving around social needs; and behavioral activation for older African Americans with poorly controlled type 2 diabetes by randomizing 100 patient/caregiver dyads to the Joint Home intervention (n=50) and usual care (n=50) arms.

The aims of the study are:

Aim 1: To test the preliminary efficacy of home-based, joint patient and caregiver intervention (Joint Home-DM-BAT) on patient clinical outcomes (hemoglobin A1c, blood pressure, and LDL-Cholesterol).

Aim 2: To test the preliminary efficacy of home-based, joint patient and caregiver intervention (Joint Home-DM-BAT) Joint Home DM-BAT on patient quality of life.

Aim 3: To test the preliminary efficacy of home-based, joint patient and caregiver intervention (Joint Home-DM-BAT) on caregiver quality of life and caregiver burden. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Joint Home-DM-BAT Intervention name: Usual Care measure: Glycemic Control (Hemoglobin A1C [HbA1C]) sex: ALL minimumAge: 50 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06279624 id: NRCT9-4 briefTitle: Effectiveness of the PCV13 in Older Thai Adults overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-03 date: 2025-06 date: 2024-02-28 date: 2024-02-29 name: Mahidol University class: OTHER name: National Research Council of Thailand briefSummary: This is the matched 1:2 case-control study, prospectively collect case and control who are diagnosed with pneumococcal or non-pneumococcal community acquired pneumonia (CAP), accordingly from November 2023 through October 2024. The investigators define a CASE as a person aged ≥60 years due to pneumococcal confirmed CAP either in-patients or out-patients by doctor in charge. While a CONTROL is defined as a person aged ≥60 years due to non-pneumococcal confirmed CAP either in-patients or out-patients by doctor in charge.

The goal of this observational study is to evaluate the effectiveness of the 13-valent pneumococcal conjugate vaccine (PCV13) in pneumococcal CAP in Thai adults aged ≥ 60 years with or without any medical conditions.

The main questions it aims to answer is:

• What are the effectiveness of PCV13 for preventing all typed, vaccine typed, or non-vaccine typed of pneumococcal CAP among Thai older adults?

The investigators retrospectively collect cases and control who are diagnosed with CAP accordingly from January 2012 through October 2023. The investigators define case and control the same as prospective method, but all data were retrieved from archive database.

-The investigators select a 1:2 matched control with criteria as follows; 10-year-interval of age, ward (the same patient care such as out or in-patient, or admitted in the same level ward).

Participants will be

* collated from hospital database regarding their CAP illnesses by pneumococcal and non-pneumococcal pneumonia condition.
* explored their vaccine status by either vaccine book checking or hospital database.

Researcher will compare the effectiveness of PCV13 to prevent all typed, vaccine typed and non-vaccine typed pneumococcal pneumonia. conditions: Community-acquired Pneumonia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 840 type: ESTIMATED measure: Vaccine effectiveness of PCV13 on all types of pneumococcal CAP measure: Vaccine effectiveness of PCV13 on PCV13 (vaccine typed) and non-PCV13 (non-vaccine typed) pneumococcal CAP sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06279611 id: LY007C1101 briefTitle: An Evaluation of LY007 Cell Injection for r/r B-NHL acronym: r/r B-NHL overallStatus: RECRUITING date: 2021-12-25 date: 2024-08-31 date: 2026-05-31 date: 2024-02-28 date: 2024-02-28 name: Shanghai Longyao Biotechnology Inc., Ltd. class: OTHER name: The First Affiliated Hospital with Nanjing Medical University name: Ruijin Hospital briefSummary: An evaluation of LY007 cell injection for recurrent/refractory CD20 was positive Tolerability, safety, and efficacy of B-cell non-Hodgkin lymphoma in open, single-arm Phsea I Clinical research conditions: B-NHL studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: LY007 measure: Maximum tolerated dose or clinically recommended dose measure: Dose limiting toxicity measure: Adverse Events , Serious Adverse Events , Adverse Events of Particular Concern measure: PK aspect measure: PK aspect measure: PD aspect measure: therapeutic effect measure: Anti LY007 antibody measure: The titer of human anti mouse antibody measure: Exploratory study endpoint sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ruijin hospital status: RECRUITING city: Shanghai state: Shanghai country: China name: zhao weili, MD role: CONTACT phone: 13512112076 phoneExt: 610707 email: zwl_trial@163.com name: yan zixun, MD role: CONTACT phone: +8613482056727 phoneExt: 610707 email: yanzixun125@163.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06279598 id: UniversityGroningen briefTitle: PT-STRESS Study: Predicting Treatment Success and Dealing With Non-response in the Treatment of PTSD acronym: PT-STRESS overallStatus: RECRUITING date: 2024-01-01 date: 2031-05-20 date: 2032-08-31 date: 2024-02-28 date: 2024-02-28 name: University of Groningen class: OTHER name: Dimence briefSummary: The aim of this study is to increase understanding of the effectiveness and efficiency of psychological treatment for adult patients with posttraumatic stress disorder -PTSD- and to make it more personalized.

Key questions:

1. Which predictors of treatment success influence treatment outcome of patients with PTSD who receive the three psychotherapeutic treatments investigated in this study?
2. Which specific moderators can be identified with regard to the different psychotherapies (Eye Movement Desensitization and Reprocessing -EMDR-; Prolonged Exposure -PE-; and Interpersonal Psychotherapy -IPT- in the second phase)?
3. In patients with PTSD, does offering another proven effective form of trauma-focused psychotherapy (PE after EMDR, or EMDR after PE) improve symptoms following insufficient response to a first trauma-focused treatment?
4. Is switching from a trauma-focused therapy to a non-trauma-focused treatment (IPT) a more effective strategy for dealing with non-response to a first proven effective psychotherapeutic treatment compared to switching to another trauma-focused therapy?
5. Are there differences in treatment tolerance and differences in dropout rates between PE, EMDR and IPT?

Secondary goals:

* Investigating the extent to which therapist allegiance to a specific therapy method affects outcomes;
* Investigating whether the quality of therapy implementation or the treatment integrity ('adherence/ competence') affects treatment outcomes;
* Investigating how much the quality of the therapeutic alliance influences outcomes.

Participants receive treatment and will complete questionnaires. The study is conducted in two phases. Its aim is to compare two different trauma-focused treatments (EMDR and PE) for patients with PTSD to one another and with a nontrauma-focused psychotherapy (IPT) and to investigate possible predictors and moderators for treatment success. Patients will first be randomized to PE or EMDR in the first treatment phase. After this first phase, non-responders are re-randomized for a second phase of treatment. They receive either the alternative phase 1 trauma-focused psychotherapy or IPT as non-trauma-focused therapy. In phase 1 researchers will compare the PE and EMDR group to see which treatment is most effective for whom. In phase 2 researchers will compare the trauma-focused treatments (PE and EMDR group) with the nontrauma-focused treatment (IPT group) to see which treatment is most effective for whom. conditions: Stress Disorders, Post-Traumatic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study is a randomized controlled trial (RCT) conducted in two phases. Patients with PTSD will first be randomized to PE or EMDR in the first treatment phase. After this first phase of treatment, non-responders are re-randomized for a second phase of treatment. They receive either the alternative phase 1 trauma-focused psychotherapy or IPT as non-trauma-focused therapy for PTSD. In both phases (phase 1 and 2) the treatment lasts 8 weeks. Patients receive 14 sessions of 1 hour in 8 weeks. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 442 type: ESTIMATED name: Prolonged Exposure therapy name: Eye Movement Desensitization Reprocessing (EMDR) name: Interpersonal Psychotherapy (IPT) measure: PTSD Checklist for DSM-5 (PCL-5) measure: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) measure: International Trauma Questionnaire (ITQ) measure: Hospital Anxiety and Depression Scale (HADS) measure: Mental Health Continuum Short Form (MHC-SF) measure: Positive and Negative Experiences of Psychotherapy questionnaire (PNEP) measure: Age measure: Gender measure: Education measure: Employment measure: Marital status measure: Ethnicity/race measure: Medication use measure: Treatment history measure: Mini-Schedules for Clinical Assessment in Neuropsychiatry (mini-SCAN) measure: Life Events Checklist for DSM-5 (LEC-5) measure: The Childhood Trauma Questionnaire-Short Form (CTQ-SF) measure: Symptom Checklist-90 (SCL-90), Hostility subscale measure: Experiences in Close Relationships-Relationship Structures (ECR-RS) measure: The Brief Experiental Avoidance Questionnaire (BEAQ) measure: Improving Access to Psychological Therapies (IAPT) measure: Posttraumatic Cognitions Inventory (PTCI) measure: Trauma Related Guilt Inventory (TRGI) measure: Trauma Related Shame Iventory (TRSI) measure: Working Alliance Questionnaire shortened version (WAV-12) measure: Expectancy rating (patients and therapists) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dimence status: RECRUITING city: Deventer country: Netherlands name: Maarten K van Dijk, PhD role: CONTACT phone: +31 0570-604000 email: m.vandijk@dimence.nl name: Dominique Jonkers, Master role: CONTACT phone: +31 038-4692300 email: d.jonkers@dimence.nl lat: 52.255 lon: 6.16389 hasResults: False

 nctId: NCT06279585 id: ECA GVHD briefTitle: Physical Therapy in Patients Undergoing Allo-HSCT With cGVHD overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12 date: 2025-09 date: 2024-02-28 date: 2024-02-28 name: University of Seville class: OTHER briefSummary: Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT) represents the only curative option for many patients diagnosed with various hematologic neoplasms. Procedure-related morbidity and mortality pose challenges to long-term outcomes and quality of life, especially among patients who develop chronic graft-versus-host disease (cGVHD). There is a gap in healthcare that comprehensively addresses the specific needs of these patients. Physical therapy as an adjuvant treatment, through therapeutic exercise involving muscle strength and cardiorespiratory endurance, has shown positive influences on health markers and serves as a strong medical ally in similar profiles. Although these strategies could be reproducible and potentially beneficial for cGVHD patients, research has been limited to date, with the role of physical therapy possibly underutilized in this field. Justification: Unaddressed medical gap with no rigorously scientific responses specific to cGVHD. Objectives: This project aims to conduct the first randomized clinical trial from a physical therapy perspective as an adjuvant treatment for patients undergoing alloHSCT diagnosed with cGVHD. conditions: Graft-versus-host-disease conditions: Graft Versus Host Disease, Chronic conditions: Stem Cell Transplant Complications conditions: Hematological Malignancy conditions: Hematologic Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 108 type: ESTIMATED name: Physical therapy measure: Health-related quality of life measure: Chronic Graft-Versus-Host Disease (cGVHD) symptom burden measure: Muscular strength measure: Cardiorespiratory fitness measure: Functional status measure: Distress measure: Mood measure: Anxiety measure: Biological markers measure: Responses to medical treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Seville; Manuel Siurot Avenue, no number city: Seville zip: 41013 country: Spain name: Raquel P Aguilar, Ph.D.cand. role: CONTACT phone: 955 013 260 phoneExt: 34 email: raquelijorml@gmail.com name: José Antonio P Simón, PhD role: CONTACT phone: 955 013 260 phoneExt: 34 email: josea.perez.simon.sspa@juntadeandalucia.es lat: 37.38283 lon: -5.97317 hasResults: False

 nctId: NCT06279572 id: 20-011624 id: NCI-2022-09618 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 20-011624 type: OTHER domain: Mayo Clinic Institutional Review Board briefTitle: Immune Profile of Acute Myeloid Leukemia Patients Receiving Azacitidine Plus Venetoclax Induction Chemotherapy overallStatus: RECRUITING date: 2021-04-22 date: 2025-12-31 date: 2026-12-31 date: 2024-02-28 date: 2024-02-28 name: Mayo Clinic class: OTHER briefSummary: This study investigates the immune profile of patients receiving treatment with venetoclax plus azacitidine for acute myeloid leukemia (AML). Studying the information gathered from the immune profile from blood and bone marrow samples may help researchers understand the associated responses to the treatment of patients undergoing therapy of venetoclax plus azacitidine and create future immune based treatment approaches. conditions: Acute Myeloid Leukemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Biospecimen Collection name: Bone Marrow Aspirate name: Electronic Health Record Review measure: Immune profile of treatment naive acute myeloid leukemia (AML) patients receiving azacitidine plus venetoclax chemotherapy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Arizona status: NOT_YET_RECRUITING city: Scottsdale state: Arizona zip: 85259 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Cecilia Y. Arana Yi, M.D. role: PRINCIPAL_INVESTIGATOR lat: 33.50921 lon: -111.89903 facility: Mayo Clinic in Florida status: RECRUITING city: Jacksonville state: Florida zip: 32224-9980 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Talha Badar, M.D. role: PRINCIPAL_INVESTIGATOR lat: 30.33218 lon: -81.65565 facility: Mayo Clinic in Rochester status: NOT_YET_RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Mithun V. Shah, M.D., Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06279559 id: MTinHRP_v1_10/01/2023 briefTitle: Music Therapy and High-risk Pregnancy overallStatus: RECRUITING date: 2023-06-01 date: 2024-12-01 date: 2024-12-01 date: 2024-02-28 date: 2024-02-28 name: Istituto Giannina Gaslini class: OTHER briefSummary: The objective of this clinical trial is to assess the impact of a music therapy intervention on reactive psychological components related to the risk of preterm birth in hospitalized pregnant women. The primary inquiries it seeks to address are:

1. Can a music therapy intervention during high-risk pregnancy mitigate reactive psychological components (perceived emotional state, state anxiety and trait anxiety, depressive symptoms, perceived stress) related to the risk of preterm birth in hospitalized pregnant women?
2. Does music therapy intervention during high-risk pregnancy positively influence the development of the attachment bond between the mother and the child?
3. How does the risk of preterm birth modulate the future attachment bond between mother and child?

Participants will be categorized into three groups: a clinical experimental group (pregnant women at risk of preterm birth undergoing music therapy intervention), a clinical control group (pregnant women at risk of preterm birth receiving standard ward care), and a non-clinical control group (pregnant women with a physiologically progressing pregnancy).

Upon signing the informed consent, all three groups will be required to complete five self-report questionnaires assessing perceived positive and negative feelings, depressive symptoms, state anxiety and trait anxiety, perceived stress, and the mother-fetus attachment bond. Subsequently, the clinical experimental group will undergo ten online music therapy sessions, while the clinical control group will receive routine ward care. Following the music therapy sessions, both clinical groups will reassess the aforementioned measures. The non-clinical control group will complete the same self-report questionnaires with the same timing as the clinical groups. All three groups will be contacted three months after childbirth to complete a self-report questionnaire evaluating the postnatal attachment bond.

Researchers will compare the outcomes of the two clinical groups to address the first two research questions, while the comparison between the clinical control group and the non-clinical control group outcomes will be employed to answer the third research question. conditions: High Risk Pregnancy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 72 type: ESTIMATED name: Music-therapy measure: Depressive symptoms measure: State anxiety and trait anxiety measure: Perceived stress measure: Perceived positive and negative feelings measure: Mother-fetus attachment bond measure: Mother-child attachment bond sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Giannina Gaslini status: RECRUITING city: Genova zip: 16147 country: Italy name: Cristina Venturino role: CONTACT phone: 010 5636.2346 email: cristinaventurino@gaslini.org lat: 44.40478 lon: 8.94438 hasResults: False

 nctId: NCT06279546 id: IECED-12345 briefTitle: Artificial Intelligence vs Endoscopist Identification in EUS Normal Anatomy overallStatus: COMPLETED date: 2023-05-01 date: 2023-10-01 date: 2024-01-26 date: 2024-02-28 date: 2024-02-28 name: Instituto Ecuatoriano de Enfermedades Digestivas class: OTHER name: The Methodist Hospital Research Institute name: Baylor Saint Luke's Medical Center name: Beth Israel Deaconess Medical Center name: Barra Life Medical Center, Brazil name: Hospital Clinico Universitario de Santiago name: Universitair Ziekenhuis Brussel name: Hospital Civil de Morelia, Michoacan name: ELIAS Emergency University Hospital name: Larkin Community Hospital name: Carol Davila University of Medicine and Pharmacy name: mdconsgroup, Guayaquil, Ecuador briefSummary: Endoscopic ultrasound (EUS) visual impression is operator-dependant and can hinder diagnostic accuracy, especially in less experienced endoscopists. The implementation of artificial intelligence can potentially mitigate operator dependency and interpretation variability, helping or improving the overall accuracy.

The investigators therefore aim to compare diagnostic accuracy between artificial intelligence (AI)-based model and the endoscopists when identifying normal anatomical structures in EUS-procedures. conditions: Gastrointestinal Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 30 type: ACTUAL name: Detection of structures measure: Diagnostic accuracy measure: Interobserver agreement sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IECED city: Guayaquil state: Guayas zip: 090505 country: Ecuador lat: -2.20584 lon: -79.90795 hasResults: False

 nctId: NCT06279533 id: LV232-02 briefTitle: Safety and Pharmacokinetics Study of Multiple Ascending Doses and Food Effect of LV232 Capsules overallStatus: RECRUITING date: 2024-02-27 date: 2024-07 date: 2024-07 date: 2024-02-28 date: 2024-04-24 name: Vigonvita Life Sciences class: INDUSTRY briefSummary: This study is divided into two parts: the safety, tolerability, pharmacokinetic profiles of LV232 capsules after multiple ascending doses (hereinafter referred to as "PK characteristics of multiple ascending doses study ") and food effect study (hereinafter referred to as "FE study"). A total of 48 subjects are planned to be enrolled. The two parts of the study can be carried out simultaneously, and there is no order requirement. conditions: Healthy Subjects studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: PK characteristics of multiple ascending doses study is parallel design, and FE study is crossover design primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: PK characteristics of multiple ascending doses study is double-blinded, placebo-controlled design, and FE study is open-label design whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 48 type: ESTIMATED name: LV232/Placebo name: LV232 measure: Tmax measure: Cmax measure: T1/2 measure: AUC0-t measure: AUC0-24h measure: AUC0-∞ measure: Number of participants with treatment emergent treatment-related adverse event(s) measure: Laboratory test measure: Vital signs measure: Number of participants with ECG findings of potential clinical importance sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Shanghai Xuhui Central Hospital status: RECRUITING city: Shanghai country: China name: Chen Yu role: CONTACT lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06279520 id: 2023-08-003 briefTitle: Driving Ability Evaluation System to Improve the Conditional Driving License System: Safety and Feasibility Study. overallStatus: RECRUITING date: 2024-02-19 date: 2024-12-31 date: 2024-12-31 date: 2024-02-28 date: 2024-02-28 name: Seoul National University Hospital class: OTHER briefSummary: The primary objective of this study is to verify the safety and validity of a VR driving simulator developed for evaluating the driving abilities in healthy adults.

This study also aims to establish indicators in VR driving simulator to evaluate high-risk group for driving, such as cognitive and physical abilities. Therefore, this study aims to measure the physical driving function and cognitive function of healthy drivers. to identify the correlation between their outcomes and the VR driving simulator's result conditions: Automobile Driving studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 100 type: ESTIMATED name: VR Driving Simulator name: Computerized Neurocognitive Function Test name: Driver Test Station name: On-road field driving Test measure: Feasibility of VR driving simulator measure: Driving performance in simulator, measured by driving errors sex: ALL minimumAge: 19 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul National University Hospital status: RECRUITING city: Seoul country: Korea, Republic of name: Ja-Ho Leigh, M.D. Msc. role: CONTACT email: mazican@gmail.com lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06279507 id: PMK-00007 briefTitle: Efficacy of Hyaluronic Acid Injection in Knee Osteoarthritis overallStatus: RECRUITING date: 2024-02-10 date: 2025-01-31 date: 2025-06-30 date: 2024-02-28 date: 2024-02-28 name: Phramongkutklao College of Medicine and Hospital class: OTHER name: Chulalongkorn University name: Khon Kaen University name: Police General Hospital briefSummary: The aim of this clinical trial study is to compare the efficacy of Hyaluronic injection in patients with symptomatic knee osteoarthritis. The main questions it aims to answer are:

* Is Hyaluronic acid injection improve pain symptom, joint stiffness, and joint function in patients with knee osteoarthritis
* Is Hyaluronic acid injection improve knee performance status and health-related quality of life in patients with knee osteoarthritis

Participants will be allocated to receive one treatments; either Hyaluronic acid or normal saline injections after receiving glucocorticoid injection.

Researchers will compare the Hyaluronic acid with normal saline injection to see if the former show superior effect in terms of pain, joint stiffness, function, as well as health-related quality of life comparing with placebo. conditions: Knee Osteoarthritis conditions: Pain, Joint conditions: Stiffness of Knee, Not Elsewhere Classified conditions: Quality of Life studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The participants would be allocated into one treatment group;

* Intervention group : Hyaluronic acid injection
* Placebo group : Normal saline primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Participants will not know what treatment they receive. Co-investigators will not know what the participants are injected. Outcome assessor will not know which treatment participant receive. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 176 type: ESTIMATED name: Sodium Hyaluronate name: Normal Saline name: Triamcinolone Acetonide 10mg/mL measure: Pain outcome measurement measure: Joint stiffness and function measurement measure: Overall symptom assessment measure: Knee performance evaluation measure: Quality of life assessment sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Phramongkutklao Hospital status: RECRUITING city: Bangkok zip: 10400 country: Thailand name: Suthee Panichkul role: CONTACT phone: 6623547600 phoneExt: 93681 email: suthee99@yahoo.com lat: 13.75398 lon: 100.50144 hasResults: False

 nctId: NCT06279494 id: Sirolimus for GVHD prophylaxis briefTitle: Sirolimus+Abatacept+Mycophenolate Mofetil for Prophylaxis of aGVHD in Patients Receiving Haplo-HSCT Who Are Intolerant to Calcineurin Inhibitors overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2025-03 date: 2024-02-28 date: 2024-03-21 name: Peking University People's Hospital class: OTHER briefSummary: Graft-versus-host disease (GVHD) is an important complication after transplantation, with an incidence of 40-60%, which can increase non-relapse mortality if poorly controlled. At present, the standard prophylaxis for GVHD is cyclosporine combined with methotrexate. However, calcineurin inhibitors (CNI) can cause some vital side effects, which are not tolerated by some patients. Therefore, this study aims to explore the safety and efficacy of Sirolimus in combination with Abatacept and Mycophenolate Mofetil for the prophylaxis of GVHD in patients with haplo-HSCT who are intolerant to calcineurin inhibitors. conditions: Acute Leukemia conditions: Myelodysplastic Syndromes conditions: Severe Aplastic Anemia studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 6 type: ESTIMATED name: Sirolimus name: Abatacept name: MMF name: ATG measure: Incidence of Grade 2-4 aGVHD within 100 days post transplantation measure: Incidence of chronic GVHD (cGVHD) within 1 year post transplantation measure: Incidence of thrombotic microangiopathy within 1 year post transplantation measure: Cumulative incidence of relapse measure: Transplant-related mortality measure: Overall survival measure: Incidence of cytomegalovirus (CMV) and Epstein-Barr virus (EBV) sex: ALL minimumAge: 14 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06279481 id: PUMCH-K2458 briefTitle: Effect of Virtual Reality (VR) on Pain Relieve During Colonoscopy overallStatus: RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-02-28 date: 2024-02-28 name: Peking Union Medical College Hospital class: OTHER briefSummary: Purpose: To evaluate the effectiveness and safety of virtual reality (VR) technology in alleviating pain during colonoscopy.

Design and Methods: In the context of a single-centered, prospective, randomized controlled study, the pain levels experienced during colonoscopy are compared between the VR group and the control group. conditions: Pain conditions: Colonoscopy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: a single-centered, prospective, randomized controlled study primaryPurpose: TREATMENT masking: NONE count: 98 type: ESTIMATED name: Nonpharmacological method measure: Comparison of Visual Analogue Scale Mean Scores by Groups measure: Comparison of State Trait Anxiety Inventory Mean Scores by Groups measure: Comparison of Vital Signs between Groups: Pulse Rate measure: Comparison of Vital Signs between Groups: Blood Pressure measure: Comparison of Vital Signs between Groups: Respiration Rate measure: Comparison of Vital Signs between Groups: Oxygen Saturation measure: Comparison of Patient Satisfaction of Colonoscopy between Groups measure: Comparison of Patient Willingness of Future Colonoscopy between Groups measure: Comparison of Adverse Effects in both groups sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences status: RECRUITING city: Beijing state: Beijing zip: 100010 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06279468 id: I-23PJ2232 briefTitle: Clinical Effectiveness of Intervertebral Disc Release in Treating Lenke 5 Adolescent Idiopathic Scoliosis overallStatus: RECRUITING date: 2024-01-01 date: 2026-06-01 date: 2026-06-01 date: 2024-02-28 date: 2024-02-28 name: Peking Union Medical College Hospital class: OTHER briefSummary: Adolescent idiopathic scoliosis (AIS) poses challenges in achieving optimal three-dimensional correction. While posterior fusion with pedicle screws has shown success, osteotomy techniques, such as Ponte osteotomy, have further improved outcomes. However, residual vertebral rotation remains a concern, impacting long-term complications. Intervertebral disc release (IDR) presents a potential solution to enhance derotation and reduce fusion levels, particularly in Lenke Type 5 AIS. This prospective randomized controlled trial aims to evaluate the clinical effectiveness of IDR in treating Lenke 5 AIS, comparing it to Ponte osteotomy. The study focuses on axial vertebral rotation correction, coronal curve improvement, blood loss, hospital stay, and adverse events. Participants aged 10-18 with Lenke 5 AIS will undergo either IDR or Ponte osteotomy, randomly assigned. Outcome measures include axial rotation correction rate, radiographic parameters, and clinical assessments. A total of 132 participants will be recruited. The IDR technique, through posterior disc removal, presents a promising approach to optimize derotation in Lenke 5 AIS. While offering potential advantages, challenges like limited working space and bleeding risks require careful consideration. The study's findings aim to provide robust clinical evidence, enhancing treatment strategies for Lenke 5 AIS and offering innovative approaches for AIS as a whole. conditions: Adolescent Idiopathic Scoliosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 132 type: ESTIMATED name: intervertebral disc release name: Ponte osteotomy measure: The correction rate of axial rotation of the apex vertebrae measure: Lumbar curve measure: UIV tilt measure: C7-CSVL measure: Lumbar lordosis measure: SVA measure: Radiographic parameters measured by CT scan: LIV and LIV+1 translation measure: LIV tilt measure: The lowest instrumented vertebra disc angle measure: Age measure: Gender measure: Risser grade of the patients at the time of surgery measure: number of fused spinal levels measure: length of operation measure: Scoliosis Research Society-22,SRS-22 score measure: the MOS item short from health survey, SF-36 score measure: EuroQol Five Dimensions Questionnaire, EQ-5D score measure: Perioperative total blood loss measure: Visible blood loss measure: Perioperative transfusion amounts measure: Perioperative transfusion rates measure: Rate of postoperative infection measure: The incidence of nerve damage measure: The incidence of loss of correction sex: ALL minimumAge: 10 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Peking Union Medical College Hospital status: RECRUITING city: Beijing state: Beijing zip: 100035 country: China name: Qianyu Zhuang, Professor role: CONTACT phone: +86 15200838996 email: baizhuosong@126.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06279455 id: E-74555795-050.01.04-392120 briefTitle: Pelvic Floor Muscle Exercise During Pregnancy overallStatus: COMPLETED date: 2022-12-05 date: 2023-03-06 date: 2023-10-30 date: 2024-02-28 date: 2024-04-03 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: This study was conducted to evaluate the effects of pelvic floor muscle exercises during pregnancy on sexual function, lower urinary tract symptoms and birth process. The research was conducted with pregnant women who applied to the Pregnancy Outpatient Clinic of Istanbul University-Cerrahpasa Cerrahpasa Faculty of Medicine Hospital. Power analysis was performed to determine the number of samples to be included in the study. It was determined that 29 pregnant women should be included in each group (experimental and control). Considering the possibility of data loss, 50 pregnant women were included in each group. As a result of the exclusion of 8 women who withdrew from participating in the study, 5 women due to risky pregnancies (bleeding, preeclampsia and gestational diabetes) and 17 women due to cesarean delivery, the data of 35 pregnant women in the experimental group and 35 pregnant women in the control group were obtained. Pregnant women in the experimental group were gestational aged 18-20. Two sessions of training were given on female reproductive and urinary system anatomy, physiological changes during pregnancy and their effects on sexual life, and pelvic floor muscle exercises, using the "Pelvic Floor Health \& Sexual Life Training Booklet during Pregnancy" and the pelvic floor muscle exercise training video developed by the researcher between the weeks of pregnancy. Pregnant women were asked to perform pelvic floor muscle exercises, 3 sets a day, 3 days a week, for 12 weeks, starting from the 20th week of pregnancy, and record them in the Pelvic Floor Muscle Exercise Follow-up Form created by the researcher. Pregnant women in the control group were not given any training and were routinely monitored in the outpatient clinic. Pregnant women who apply to the outpatient clinic are examined by nurses, with their vital signs taken and anamnesis taken by the physician. Recommendations are made regarding the complaints of pregnant women. Non-stress tests are routinely applied to pregnant women who are at the 36th week of pregnancy and above. conditions: Lower Urinary Tract Symptoms conditions: Sexual Function studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Pelvic Floor Muscle Exercise Group primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 70 type: ACTUAL name: Pelvic Floor Muscle Exercise measure: Sexual Function measure: Lower Urinary Tract Symptoms measure: Birth Process sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Istanbul University-Cerrahpasa city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06279442 id: LACOG 0723 briefTitle: Adrenal Project: Clinical and Epidemiological Characterization of Adrenocortical Carcinoma in a Brazilian Cohort overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-08 date: 2025-08 date: 2024-02-28 date: 2024-02-28 name: Latin American Cooperative Oncology Group class: OTHER briefSummary: This is a retrospective observational cohort study. The clinical, pathological and treatment data of participants identified with adrenocortical carcinoma from the year 2000 onwards will be evaluated. Participants recruited for this study will be identified at the participating sites. conditions: Carcinoma Adrenal conditions: Carcinoma, Adrenocortical Recurrent studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 150 type: ESTIMATED measure: Demographic and Clinical Characterization of Adrenocortical Carcinoma in Brazil measure: Assessment of the Association Between Clinical, Pathological, Epidemiological Factors, and Therapeutic Modalities with Prognosis and Outcomes such as Overall Survival or Recurrence-Free Survival measure: Evaluating the Impact of Adjuvant Mitotane Use on Progression-Free Survival and Overall Survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: A.C. Camargo Cancer Center city: São Paulo zip: 01.509-001 country: Brazil name: Milena Shizue Tariki role: PRINCIPAL_INVESTIGATOR lat: -23.5475 lon: -46.63611 hasResults: False

 nctId: NCT06279429 id: KTGH11137 briefTitle: Sucrosomial Iron on Insomnia in Non-dialysis Chronic Kidney Disease Patients With Iron Deficiency Anemia overallStatus: RECRUITING date: 2022-05-31 date: 2024-12-31 date: 2024-12-31 date: 2024-02-28 date: 2024-02-29 name: Kuang Tien General Hospital class: OTHER briefSummary: Insomnia or sleep disturbance is a common disorder in patients with chronic kidney disease (CKD), but is often unrecognized and undertreated. It is known that sleep disorders may indirectly cause a variety of diseases and affect quality of life. The most common sleep disorders that occur in CKD are insomnia, excessive daytime sleepiness, obstructive or central sleep apnea (SA), and sleep disorders. This study evaluates the effectiveness and safety of Sideral® Sucrosomial Iron and iron chewable tablets 100mg commonly used in health insurance on sleep disorders in patients with CKD and iron deficiency anemia. conditions: CKD conditions: Sleep Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Sideral® Sucrosomial Iron name: Iron chewable tablet measure: Insomnia Severity Index (ISI) measure: Pittsburgh Sleep Quality Index (PSQI) measure: Epworth sleepiness Scale (ESS) measure: Hemoglobin measure: Ferritin measure: Serum Iron measure: Transferrin Saturation measure: Erythrocyte sedimentation rate sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kuang Tien General Hospital status: RECRUITING city: Taichung zip: 433 country: Taiwan name: Nai-Hwei Wang, MD role: CONTACT phone: 886426885599 email: fengcheese@gmail.com name: Chun-Pai Yang, MD role: PRINCIPAL_INVESTIGATOR lat: 24.1469 lon: 120.6839 hasResults: False

 nctId: NCT06279416 id: 2023-31 briefTitle: Expected Difficult Airway Management overallStatus: RECRUITING date: 2023-12-30 date: 2024-12 date: 2024-12 date: 2024-02-28 date: 2024-03-08 name: Kocaeli City Hospital class: OTHER_GOV briefSummary: In this study, the investigators will evaluate the advanced airway methods applied in the anesthesiology and reanimation clinic of the hospital to patients who met the criteria for awake intubation specified in the ASA 2022 difficult airway management guideline or who could not be intubated after induction of anesthesia in another center. The advanced airway method applied to the difficult airway patient expected in the operating room, the duration, success and complications of the method will be observed and recorded. conditions: Awake Intubation conditions: Advanced Airway Techniques studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 108 type: ESTIMATED name: fiberoptic intubation name: laryngeal mask airway-mediated aintree catheter name: videolaryngoscopy measure: Comparison of advanced airway methods in the awake patient with difficult airway. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kocaeli City Hospital status: RECRUITING city: Kocaeli country: Turkey lat: 39.62497 lon: 27.51145 hasResults: False

 nctId: NCT06279403 id: IIT-2023-0277 briefTitle: Upfront Immune Checkpoint Inhibitors With Deferred Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2029-03-01 date: 2024-02-28 date: 2024-02-28 name: RenJi Hospital class: OTHER briefSummary: Study Objective: To determine the efficacy of upfront immune checkpoint inhibitors combined with deferred cytoreductive nephrectomy in treating metastatic renal cell carcinoma.

Primary Endpoint: Pathological Major Response (MPR), defined as the percentage of residual tumor cells \<10% in the primary tumor after nephrectomy.

Study Design:

Population: Participants meeting the diagnostic criteria with biopsy-proven clear cell renal cell carcinoma, IMDC score ≤3, or ≤5 metastatic lesions involving ≤3 organs.

Sample Size: 20 participants.

Patient Grouping: Non-randomized.

Interventions: Eligible participants will receive upfront treatment with a combination of Axitinib and Toripalimab for 4 cycles. After 2 cycles of treatment, radiological assessment will be conducted using RECIST 1.1 criteria. If disease progression is observed, the clinical trial will be terminated, and second-line treatment will be initiated according to guidelines. If disease progression is not observed, treatment will continue for 2 additional cycles followed by repeat radiological assessment before undergoing surgery. conditions: Clear-cell Metastatic Renal Cell Carcinoma conditions: Immune Checkpoint Inhibitors conditions: Cytoreductive Nephrectomy studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Toripalimab name: Cytoreductive Nephrectomy name: Axitinib measure: Pathological Major Response (MPR) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06279390 id: 202305126RINC briefTitle: PRE-DELIRIC Prediction Model Plus SMART Care to Reduce the Incidence of Delirium in ICU Patients overallStatus: COMPLETED date: 2023-06-08 date: 2023-10-30 date: 2023-10-30 date: 2024-02-28 date: 2024-02-28 name: National Taiwan University Hospital class: OTHER briefSummary: Delirium is a severe acute brain dysfunction characterised by sudden confusion, inattention and fluctuating level of consciousness, which mainly affects intubated intensive care patients. It increases the risk of self-extubation, prolongs ICU stay and increases mortality. The incidence of delirium in ICUs varies, with approximately 33.3% of patients affected, and rates of new-onset and pre-existing delirium range from 4% to 89%. Accurate diagnosis is challenging, with 60-80% of patients remaining undiagnosed. Early detection is critical for intervention and improved outcomes.

To address these issues, the PREdiction of DELIRium (PRE-DELIRIC) model incorporates 10 risk factors and predicts delirium within 24 hours of ICU admission, allowing risk stratification into low to very high risk categories. It recalibrates predictive values with a sensitivity of 91.3% and specificity of 64.4% using a cut-off score of 27%. However, its integration into delirium management is underexplored. Delirium risk stratification supports efficient resource allocation, cost control, workload reduction and ethical care, while promptly identifying high-risk patients.

In this study, Investigators evaluate the integration of the PRE-DELIRIC model into a comprehensive delirium management approach called PRE-DELIRIC-guided SMART/SmART care. SMART care includes improving familiarity, assessing pain and anxiety, reducing equipment discomfort and cognitive stimulation. Patients with PRE-DELIRIC scores \>30% receive SMART care and multidisciplinary involvement, based on the American Delirium Society. conditions: Intensive Care Unit Delirium studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 381 type: ACTUAL measure: the incidence of delirium measure: duration of ventilator use measure: rate of unplanned self-extubation measure: day of physical restraint measure: level of mobility measure: cumulative dose of sedatives sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Taiwan University Hospital city: Taipei zip: 100 country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06279377 id: Katip Celebi University briefTitle: Examining the Effectiveness of Exercise Training After Cervical Laminoplasty Surgery overallStatus: RECRUITING date: 2023-05-05 date: 2024-09-15 date: 2025-05-15 date: 2024-02-28 date: 2024-02-28 name: Izmir Katip Celebi University class: OTHER briefSummary: The goal of this clinical trial is to compare the effects of the stabilization exercise program applied after cervical laminoplasty surgery compared to standard exercise on pain, dysfunction, normal joint movement, proprioception, balance, muscle endurance, postural alignment and related factors (kinesiophobia, awareness, quality of life, disability, physical activity level). The main question\[s\] it aims to answer are:

* Does the exercise program applied after cervical laminoplasty surgery have an effect on pain, dysfunction, normal joint movement, proprioception, balance, muscle endurance, postural alignment and related factors (kinesiophobia, awareness, quality of life, disability, physical activity level)?
* Does the stabilization exercise program applied after cervical laminoplasty surgery have an effect on pain, dysfunction, normal joint movement, proprioception, balance, muscle endurance, postural alignment and related factors (kinesiophobia, awareness, quality of life, disability, physical activity level)?

Patients will start their first exercise session on the day they will be discharged from the hospital. Patients in both exercise groups will be provided with cervical normal joint movement (ROM), posture and patient education on the day of discharge. They will be asked to do posture exercises and neck exercises under the guidance of a physiotherapist. Patients in the stabilization exercise group (experiment) will undergo stabilization exercises under the supervision of a physiotherapist, in addition to the practices in the standard exercise group. Both groups will do a warm-up program before exercise and a cool-down program afterwards. Patients will be asked to do the exercises face to face with a physiotherapist 3 days a week. The first evaluations will be made on the day they come to the outpatient clinic for examination before surgery. Post-surgical evaluations will be made routinely after the exercise program is completed, when they are called by the physician for a check-up (6th week).

Researchers will compare the standard exercise group with the stabilization exercise group to see if pain, dysfunction, normal joint movement, proprioception, balance, muscular endurance, postural alignment and related factors (kinesiophobia, awareness, quality of life, disability, physical activity level) are different. conditions: Cervical Spine Disease conditions: Surgery conditions: Rehabilitation conditions: Exercise studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: Stabilization Exercises name: Standard Exercises measure: Pain intensity measure: Dysfunction measure: Joint Range of Motion measure: Proprioception measure: Balance measure: Neck Extensor Muscle Endurance measure: Neck Flexor Muscles Endurance measure: Postural Alignment measure: Kinesiophobia measure: Neck Awareness measure: Life Quality measure: Disability measure: Physical Activity Level measure: Sociodemographic İnformation measure: Sociodemographic İnformation BMI measure: Health-related Habits measure: Dominant Side sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Izmir Katip Celebi University Ataturk Education and Research Hospital status: RECRUITING city: İzmir country: Turkey name: Hasan Kamil SUCU, Prof. Dr. role: CONTACT name: Hilal UZUNLAR, MSc, RC role: PRINCIPAL_INVESTIGATOR name: Sevtap GUNAY UCURUM, Assoc. Dr. role: PRINCIPAL_INVESTIGATOR name: Ismail Ertan SEVİN, Prof. Dr. role: SUB_INVESTIGATOR lat: 38.41273 lon: 27.13838 hasResults: False

 nctId: NCT06279364 id: SKB264-Ⅲ-11 briefTitle: A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2026-07 date: 2026-07 date: 2024-02-28 date: 2024-02-28 name: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. class: INDUSTRY briefSummary: The aim of the study is to evaluate the efficacy and safety of SKB264 as first-line treatment for patients with unresectable recurrent or metastatic triple-negative breast cancer (TNBC) whose tumors do not express programmed cell death ligand 1 (PD-L1) or in patients with PD-L1 positive tumors who received prior anti-programmed cell death 1 (PD-1)/PD-L1 inhibitor in early setting conditions: Triple Negative Breast Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomised in a 1:1 ratio to one of two intervention groups. primaryPurpose: TREATMENT masking: NONE count: 524 type: ESTIMATED name: SKB264 name: Paclitaxel name: Nab-paclitaxel name: Capecitabine name: Eribulin name: Carboplatin measure: Overall Survival (OS) measure: Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) measure: Objective Response Rate (ORR) measure: Duration of Response (DoR) measure: Progression-Free Survival (PFS) assessed by Investigator measure: Disease control rate (DCR) measure: Time to Response (TTR) measure: Adverse events(AEs) and severe adverse events (SAEs) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University Shanghai Cancer Center city: Shanghai state: Shanghai country: China name: Zhimin Shao role: CONTACT email: szm@163.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06279351 id: Thalicolorectal briefTitle: Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-28 date: 2024-02-28 name: Xinqiao Hospital of Chongqing class: OTHER name: Chongqing Medical University briefSummary: 1. To verify that thalidomide can increase the efficacy of cetuximab plus chemotherapy in the treatment of stage IV RAS and BRAF wild-type unresectable left colorectal cancer, which has important clinical significance and provides a basis for subsequent large-scale research and clinical application.
2. To evaluate the changes of cytokines and verify the effect of some cytokines on the efficacy of cetuximab +FOLFIRI, so as to provide a scientific basis for the subsequent precise therapy using cytokines antibodies. conditions: Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 96 type: ESTIMATED name: Thalidomide+cetuximab+FOLFOX/FOLFIRI measure: ETS measure: ORR measure: DCR measure: PFS sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06279338 id: [2023] No.0969 briefTitle: A Novel Conditioning Regimen for Myelodysplastic Syndrome With Moderate High IPSS-M Score overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-01-31 date: 2026-01-31 date: 2024-02-28 date: 2024-02-28 name: Wuhan Union Hospital, China class: OTHER briefSummary: Figure out the Efficacy and Safety of Azacitidine Combined with BUCY2 Conditioning Regimen Before Allogeneic Hematopoietic Stem Cell Transplantation for Myelodysplastic Syndrome with Moderate High IPSS-M Score conditions: Myelodysplastic Syndromes studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Azacitidine Injection measure: Progression-free survival (PFS) at 18 months post-transplant, month measure: Overall survival (OS) at 18 months post-transplant, month sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06279325 id: C.I. PI23/637 briefTitle: Effects of a Computerized Cognitive Stimulation Intervention Adapted to the Level of Cognitive Reserve overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-05-31 date: 2025-01-15 date: 2024-02-28 date: 2024-02-28 name: Universidad de Zaragoza class: OTHER briefSummary: Normal ageing presents subtle cognitive changes that can be detected before meeting the criteria for Mild cognitive impairment (MCI). Older people with low cognitive reserve and who receive limited cognitive stimulation are at greater risk of deterioration. In this regard, cognitive stimulation (CS) has been identified as an intervention that reduces this risk, provided that its design considers the differences in the level of cognitive reserve (CR) acquired throughout life and the baseline level of cognitive functioning. The general objective of this study is to evaluate, through a randomized clinical trial, the effectiveness of a computerized cognitive stimulation program, designed and adapted from Occupational Therapy based on the level of cognitive reserve in older adults in Primary Care. 100 participants will be randomized in a stratified manner according to the level of cognitive reserve (high/low), assigning 50 participants to the control group and 50 participants to the intervention group. The intervention group will carry out a computerized cognitive stimulation intervention designed and adapted from occupational therapy according to the level of cognitive reserve, through the "stimulus" platform. The main result expected to be achieved is the improvement of higher brain functions. As secondary results, the investigators expect that those cognitive aspects most vulnerable to ageing will decrease more slowly (in areas such as memory, executive function, attention and processing speed) and that the cognitive reserve of the participants will increase, in addition to being able to balance gender differences in these aspects. The investigators think that these results can positively impact the creation of adapted, meaningful and stimulating CS programs in older adults to prevent MCI and experience healthier ageing. conditions: Mild Cognitive Impairment conditions: Cognitive Dysfunction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Computerized cognitive stimulation program name: Face-to-face training-explanatory session measure: MEC-35 (Spanish version of Folstein's Mini-Mental) measure: Cognitive Reserve Questionnaire (CRQ) measure: Set-Test measure: The SDMT or Symbols and Digits Test measure: Color Word Stroop Test (CWST) measure: Verbal Learning Test (TAVEC) measure: Mobile Device Proficiency Questionnaire in Short Form (MDPQ-16) sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06279312 id: N202311065 briefTitle: The Effect of Adaptogen Elixir on Sleep Improvement overallStatus: RECRUITING date: 2024-02-26 date: 2024-07-31 date: 2024-12-31 date: 2024-02-28 date: 2024-03-15 name: TCI Co., Ltd. class: INDUSTRY briefSummary: This study aims to examine the effectiveness of Adaptogen Elixir herbal drink in relieving emotions and improving sleep quality. Participants will be randomly assigned to either the placebo group or the Adaptogen Elixir herbal drink group, with 25 participants in each group. On the day of the experiment (week 0), participants are required to collect blood and saliva samples, fill out questionnaires assessing sleep disorders and stress condition, and use a sleep monitoring system to track their sleep and autonomic nervous system conditions. Subsequently, participants will be given the experimental samples and instructed to consume them continuously for 4 weeks following the instruction. Follow-up assessments will be conducted in the 2nd and 4th weeks, participants are required to collect blood and saliva samples, fill out questionnaires assessing sleep disorders and stress condition, and use a sleep monitoring system to track their sleep and autonomic nervous system conditions. conditions: Sleep Disorder conditions: Anxiety Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 50 type: ESTIMATED name: Placebo drink name: Adaptogen Elixir drink measure: Sleep monitoring measure: Sleeping qualityy measure: Sleeping disorders measure: Neuropeptide Y concentration measure: Cortisol concentration measure: Anxiety measure: Low Frequency/High Frequence (LF/HF) ratio sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taipei Medical University status: RECRUITING city: Taipei country: Taiwan name: Hsin-Chien Lee, Doctor role: CONTACT phone: +886-02-22490088 phoneExt: 79213/8158 email: ellalee@tmu.edu.tw lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06279299 id: LLND briefTitle: Lateral Pelvic Lymph Node Dissection for Rectal Neuroendocrine Neoplasms Undergoing Laparoscopic Total Mesenteric Excision overallStatus: RECRUITING date: 2022-08-01 date: 2028-08-01 date: 2028-08-01 date: 2024-02-28 date: 2024-02-28 name: National Cancer Center, China class: OTHER briefSummary: The purpose of this study is to investigate the metastatic status of lateral pelvic lymph nodes in rectal neuroendocrine neoplasms (rNENs) undergoing laparoscopic total mesenteric excision (TME). The hypothesis is that the rate of lateral lymph node metastasis is underestimated in rNENs undergoing TME, necessitating concurrent lateral Pelvic lymph node dissection. conditions: Rectal Neuroendocrine Neoplasm studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: lateral pelvic lymph node dissection measure: The rate of lateral pelvic lymph node metastasis measure: The rate of lymph node metastasis measure: Disease-free survival rate measure: Overall survival rate measure: Locoregional recurrence free survival rate measure: Radical resection (R0) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Center status: RECRUITING city: Beijing state: Beijing zip: 100000 country: China name: Haitao Zhou, M.D. role: CONTACT phone: +8613381167333 email: zhouhaitao01745@163.com name: Yueyang Zhang, M.D. role: CONTACT phone: +8613552910035 email: yyzhang0129@163.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06279286 id: HS-10506-201 briefTitle: Phase Ⅰb/Ⅱ Study of HS-10506 in Chinese Participants With Insomnia Disorder overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-01 date: 2025-01 date: 2024-02-28 date: 2024-04-23 name: Jiangsu Hansoh Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: The primary purpose of this phase Ⅰb/Ⅱ study is to investigate the safety, tolerability, pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) after multiple dose administration and the efficacy of HS-10506 (change versus placebo) on latency to persistent sleep (LPS) measured by polysomnography (PSG) in Chinese adult participants with insomnia disorder. conditions: Insomnia Disorder studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 312 type: ESTIMATED name: HS-10506 name: Placebo measure: Incidence and severity of adverse events (AE) measure: Incidence and severity of serious adverse events (SAE) measure: Changes in laboratory test before and after drug administration measure: Changes in ECG before and after drug administration measure: Changes in Karolinska Sleepiness Scale (KSS) scores before and after drug administration measure: Change from baseline in the mean LPS measured by PSG on Night 13 and Night 14 measure: The maximum plasma concentration (C[max]) measure: Time to reach the maximum plasma concentration (T[max]) measure: Area under the plasma concentration-time curve from time zero to last time of quantifiable concentration (AUC[0-t]) measure: Terminal elimination half-life (t1/2) measure: Change in latency to persistent sleep (LPS) relative to baseline on night 5 of PSG monitoring measure: Change in Wake After Sleep Onset (WASO) relative to baseline on night 5 of PSG monitoring measure: Change from baseline in mean LPS measured by PSG measure: Change from baseline in mean TST measured by PSG measure: Change from baseline in mean WASO measured by PSG measure: Change from baseline in the mean values of self-reported sleep-onset latency (sSOL) recorded in the sleep diary measure: Change from baseline in the mean values of self-reported total sleep time (sTST) recorded in the sleep diary measure: Incidence and severity of adverse events (AE) measure: Incidence and severity of serious adverse events (SAE) sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: Xuanwu Hospital Capital Medical University city: Beijing country: China name: yuping Wang, PhD role: CONTACT email: wangyuping01@sina.cn lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06279273 id: NZhong-005 briefTitle: A Study for the Risky Decision-making Deficits Among Methamphetamine Dependence Individuals and Treatment overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-01 date: 2024-07-31 date: 2025-12-31 date: 2024-02-28 date: 2024-02-28 name: Shanghai Mental Health Center class: OTHER name: Wuhan Mental Health Centre name: Wuhan Judicial Bureau Hanyang Compulsory Isolated Detoxification Center briefSummary: The risky decision-making deficits is the core feature of the methamphetamine (MA) dependence. Our previous research found that MA dependents have network abnormalities such as decision-making and rewarding. The feedback-related negativity amplitude in the prefrontal central area of MA users becomes smaller and blunted after a loss. Moreover, the neural modulation over the prefrontal cortex showed potent to decrease the craving, and the functional connectivity between frontal cortex and subparietal lobules increases. It suggests that there is a correlation between the decision-making network and the reward network of MA addicts, but there is no real-time observation of the dynamic changes of these brain network activities, so it is difficult to correct the interaction mechanism.

In order to clarify the dynamic brain network mechanism of the risky decision-making deficits among MA dependents, firstly, based on magneto-encephalography source information reconstruction methods, firstly, based on magneto-encephalography source information reconstruction methods, the investigators will observe the sequence and interaction among decision-making network, rewarding network, and emotion network. Besides, the investigators clarify that the trans-cranial current stimulation over prefrontal cortex could improve the speed and intensity of the key network interactions among MA dependents, which could improve risky decision-making and craving. The successful implementation of the study is expected to provide important clues for elucidating the pathological mechanism of risky decision-making deficits in MA dependents and providing a theoretical basis for the treatment of addiction. conditions: Methamphetamine Use Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Transcranial direct current stimulation measure: Frontal lobe activation level measure: cue-induced craving measure: Cognitive function measure: Attention bias towards methamphetamine sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Shanghai Mental Health Center city: Shanghai country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06279260 id: 2023.295RMH21343Protocol_V2.0 briefTitle: National Robotics-Assisted Radical Prostatectomy Database overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2029-12 date: 2030-12 date: 2024-02-28 date: 2024-04-25 name: Melbourne Health class: OTHER name: Peter MacCallum Cancer Centre, Australia name: Epworth Healthcare name: St Vincent's Hospital name: Austin Health briefSummary: Surgical notes are detailed reports written by surgeons during and after surgeries. These notes cover everything from the techniques, instruments used, any issues with the surgical procedure and post-surgical care for the patient. This information is a treasure trove for researchers because they can study it to understand how surgeries go, what works best, and how certain treatments affect patients.

By looking closely at these notes, researchers can find patterns and trends, helping them in understanding what makes surgeries successful and identify the best ways to perform them. This information is crucial for creating guidelines based on solid evidence. Also, these surgical notes are a goldmine for looking back at past surgeries to see how they have affected patients in the long run.

The real power for research comes when we combine these surgical notes within the Electronic Medical Records (EMR) and research databases. This makes it easy to collect information systematically, making it simpler for researchers to study a large number of cases. Unfortunately, not many people have paid attention to this idea for a long time, leading to big gaps in the data collection.

To address this issue, we aim to create a database that collects information from surgical notes effortlessly. This includes details about how surgeons are trained and how they progress. It's important to make sure that doctors work aligns with research - which is the best way to address data collection issues. This data can also help record different technical aspects of surgery and different surgeons' learning curve, making it easier to compare and improve training. Thus, we aim to standardise notes that are the same across different hospitals conducting robotic-assisted surgeries for prostatectomy. conditions: Database conditions: Prostate Cancer conditions: Robotic-assisted Radical Prostatectomy conditions: Surgical Outcomes conditions: Oncological Outcomes conditions: Patient Reported Outcome Measures conditions: Learning Curve studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 10000 type: ESTIMATED measure: To provide a standardized framework, enabling robust evidence strengthening & analyses, trend identification, and the formulation of evidence-based guidelines for the individualized management of PCa. measure: Patient reported quality of life outcome measures measure: Surgical measure: Oncological sex: MALE minimumAge: 16 Years maximumAge: 90 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Austin Healthcare city: Melbourne state: Victoria zip: 2084 country: Australia name: Damien Bolton role: CONTACT lat: -37.814 lon: 144.96332 facility: E.J Whitten Prostate Cancer Centre, Epworth Healthcare city: Melbourne state: Victoria zip: 3002 country: Australia lat: -37.814 lon: 144.96332 facility: St. Vincent's Private Hospital city: Melbourne state: Victoria zip: 3002 country: Australia name: Lih-Ming Wong role: CONTACT lat: -37.814 lon: 144.96332 facility: Peter MacCallum Cancer Centre city: Melbourne state: Victoria zip: 3050 country: Australia name: Marlon Perara role: CONTACT lat: -37.814 lon: 144.96332 facility: Royal Melbourne Hospital city: Melbourne state: Victoria zip: 3050 country: Australia name: Nathan Lawrentschuk role: CONTACT lat: -37.814 lon: 144.96332 hasResults: False

 nctId: NCT06279247 id: KYLL-202212-011 briefTitle: Proteomics and Metabolomics of Body Fluid in Patients With Narcolepsy overallStatus: RECRUITING date: 2022-09-01 date: 2024-09 date: 2024-09 date: 2024-02-28 date: 2024-03-15 name: Qilu Hospital of Shandong University class: OTHER briefSummary: Narcolepsy (NRL) is a rare chronic central nervous system dysfunction disease, which is more common in children and adolescents, and less common in adults. Its typical clinical features include excessive daytime sleep, paroxysmal cataplexy, sleep paralysis and sleep hallucination. In addition to the above typical manifestations, patients with narcolepsy can also manifest as hyperappetite, weight gain, multiple dreams, sleep fragmentation, anxiety and depression and other emotional disorders. In particular, in narcolepsy type 1 with cataplexy, cataplexy episodes can be confused with falls caused by seizures, transient ischemic attacks or neuromuscular disorders, or even mental conversion disorders. Due to its diverse clinical symptoms, it is easy to be missed and misdiagnosed.

At present, the pathogenesis of narcolepsy is still unclear, and its pathogenesis may be related to immune, genetic, environmental, infection, central nervous system degeneration and other factors. This study aims to investigate the changes of body fluid proteomics and metabolomics in patients with narcolepsy, and to provide an important basis for the pathogenesis of narcolepsy. conditions: Narcolepsy studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED measure: To screen potential molecular markers related to the biological characteristics and prognosis of narcolepsy. sex: ALL minimumAge: 5 Years maximumAge: 100 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Qilu Hospital of Shandong University status: RECRUITING city: Jinan state: Shandong zip: 250012 country: China name: Wenjing Jiang role: CONTACT phone: 18560082210 email: jiangwenjing@qiluhospital.com lat: 36.66833 lon: 116.99722 hasResults: False

 nctId: NCT06279234 id: C4001002 briefTitle: A Study to Learn How Different Amounts of PF-06954522 Are Tolerated and Act in Adults With Type 2 Diabetes Mellitus overallStatus: RECRUITING date: 2024-02-20 date: 2024-12-31 date: 2024-12-31 date: 2024-02-28 date: 2024-04-11 name: Pfizer class: INDUSTRY briefSummary: The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple escalating oral doses of PF-06954522 in adult participants with inadequately controlled type 2 diabetes mellitus (T2DM) on metformin (Part A) and optionally in non-diabetic participants with obesity (Part B). conditions: Type 2 Diabetes Mellitus (T2DM) conditions: Obesity studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 122 type: ESTIMATED name: Placebo name: Rosuvastatin name: Midazolam name: Omeprazole name: PF-06954522 measure: Number of Participants Reporting Adverse Events measure: Number of Participants with Clinically Significant Change From Baseline in Laboratory Abnormalities measure: Number of Participants With Clinically Significan Change From Baseline in Vital Signs measure: Number of Participants With Clinically Significant Change From Baseline in 12-Lead ECGs measure: Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS) measure: Number of Participants With Change From Baseline in Physical Examination measure: Maximum Observed Plasma Concentration (Cmax) measure: Area Under the Curve from Time Zero to end of dosing interval (AUCtau) measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) measure: Plasma Decay Half-Life (t1/2) measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) measure: Percentage of Dose of PF-06751979 Excreted Unchanged in the Urine Over the Dosing Interval Tau (Aetau%) measure: Renal Clearance (CLr) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anaheim Clinical Trials, LLC status: RECRUITING city: Anaheim state: California zip: 92801 country: United States lat: 33.83529 lon: -117.9145 facility: Qps-Mra, Llc status: RECRUITING city: South Miami state: Florida zip: 33143 country: United States lat: 25.7076 lon: -80.29338 hasResults: False

 nctId: NCT06279221 id: B7981055 briefTitle: Litfulo Capsules Special Investigation overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2030-06-25 date: 2030-06-25 date: 2024-02-28 date: 2024-02-28 name: Pfizer class: INDUSTRY briefSummary: The objective of this Study is to confirm the safety during the long-term use of this drug and the effectiveness during the use of this drug under the actual use in the patients treated with this drug. conditions: Alopecia Areata studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 850 type: ESTIMATED name: LITFULO measure: Proportion of participants with adverse events (AEs) measure: Percentage of patients achieving SALT≤20 [SALT score (absolute value) 20 or less] sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06279208 id: 2023-A00272-43 briefTitle: Phosphoproteomic Profile of Children With Down Syndrome acronym: PEPS overallStatus: RECRUITING date: 2024-03-18 date: 2024-09 date: 2024-09 date: 2024-02-28 date: 2024-04-01 name: Perha Pharmaceuticals class: INDUSTRY name: Proteas Bioanalytics name: Göteborg University briefSummary: One of the major causes of cognitive disorders limiting the learning abilities of children with Down's syndrome is excess activity of the DYRK1A protein kinase, whose gene is located on chromosome 21. Consequently, variations in the level of phosphorylation, and hence activity, of DYRK1A target proteins involved in synaptic transmission, could identify mechanisms underlying these cognitive disorders.

Several studies have shown that plasma proteins can reflect a pathophysiological brain state. The investigators plan to carry out a phosphoproteomic study to determine the phosphorylation profile of plasma proteins in children with Down's syndrome, and identify potential DYRK1A-dependent pathophysiological mechanisms and biomarkers involved in the natural course of cognition in children with Down's syndrome. conditions: Down Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Blood sample measure: Phosphoproteomic profile measure: Identification of brain proteins measure: Impact of environnement on phosphoproteomic profile measure: Impact of DYRK1A on Down Syndrome specific proteomic profile sex: MALE minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: CHU Grenoble status: NOT_YET_RECRUITING city: Grenoble country: France name: Dr Marey role: CONTACT phone: 0476767285 lat: 45.16667 lon: 5.71667 facility: Hospices Civils de Lyon status: RECRUITING city: Lyon country: France name: Dr Sanlaville role: CONTACT phone: 0427855573 lat: 45.74848 lon: 4.84669 facility: Institut Jérôme Lejeune status: RECRUITING city: Paris country: France name: Dr Cieuta-Walti role: CONTACT phone: 0156586300 lat: 48.85341 lon: 2.3488 facility: CHU Rennes status: RECRUITING city: Rennes country: France name: Dr Jean-Marçais role: CONTACT phone: 0299266744 lat: 48.11198 lon: -1.67429 facility: CHU Saint-Etienne status: NOT_YET_RECRUITING city: Saint-Etienne country: France name: Dr Touraine role: CONTACT phone: 0477828116 lat: 45.43389 lon: 4.39 hasResults: False

 nctId: NCT06279195 id: EH23-326 briefTitle: Phenotyping of Idiopathic Pelvic Pain With Real-time Uterine Imaging and Relugolix-Combination Therapy Treatment overallStatus: NOT_YET_RECRUITING date: 2024-04-05 date: 2025-08-02 date: 2025-08-02 date: 2024-02-26 date: 2024-02-28 name: NorthShore University HealthSystem class: OTHER name: Pfizer briefSummary: The mechanisms underlying variable efficacy of Relugolix-Combination Therapy (REL-CT) in mitigating unexplained pelvic pain will be evaluated with uterine imaging techniques and quantitative sensory testing. conditions: Pelvic Pain studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants in two groups with different conditions will be give REL-CT. primaryPurpose: BASIC_SCIENCE masking: NONE count: 60 type: ESTIMATED name: Relugolix (40 mg) /estradiol (1 mg)/norethisterone acetate (0.5 mg) oral tablet measure: Correlation between post-treatment pelvic pain and baseline uterine contraction frequency measure: Correlation between post-treatment pelvic pain and baseline sensory hypersensitivity Z-score. sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: NorthShore University HealthSystem city: Evanston state: Illinois zip: 60201 country: United States name: Kevin Hellman, PhD role: CONTACT phone: 847-570-2622 email: khellman@northshore.org lat: 42.04114 lon: -87.69006 hasResults: False

 nctId: NCT06279182 id: IRB-FY2024-106 briefTitle: Impact of Barre Stretching Among Dental Hygiene Students overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-03 date: 2024-04 date: 2024-02-26 date: 2024-02-26 name: Idaho State University class: OTHER briefSummary: The healthcare profession of dental hygiene can be a highly stressful academic path and occupation. Physical stressors can quickly lead to postural disturbances and musculoskeletal disorders (MSDs) due to instrument grasping while under muscle tension, working with vibrating instruments, and performing repetitive micromovements. Chronic, high stress levels have the potential to lead to burnout, fatigue, and other health problems, which can impact a student's ability to perform well in their clinical rotations and didactic studies and may translate into their workforce experiences after graduation.

The purpose of this study is to determine whether a relationship exists between Barre stretching and reported stress and pain levels among entry-level dental hygiene students.

This study will be a 6-week experimental randomized control trial (RCT) where participants will be assigned to a 15-minute Barre stretching and breathing video two times a week for the experimental group or control group. The continuous dependent variables in this study will be the reported stress levels and reported pain levels of the entry-level dental hygiene students. The independent variable will be the Barre stretching intervention. The participants will include students at two universities enrolled in an entry-level dental hygiene program as first-year students.

Baseline data collection for each participant will be obtained, and the study will be analyzed using descriptive statistics, a paired t-test and independent t-test. The statistical significance level will be set at P=0.05. conditions: Musculoskeletal Disorders conditions: Stress Management conditions: Perceived Stress conditions: Reported Stress conditions: Perceived Pain conditions: Reported Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The experimental group will receive the Barre stretching intervention. The control group will not receive any intervention. primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 63 type: ESTIMATED name: Barre Stretching Intervention measure: Self-Reported Stress (Perceived Stress Scale) measure: Self-Reported Pain (Numerical Pain Rating Scale/Visual Analog Scale) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Idaho State University city: Pocatello state: Idaho zip: 83209 country: United States name: Crystal Kanderis Lane, MS role: CONTACT phone: 208-282-4209 email: crystalkanderisla@isu.edu name: Leciel Bono, PhD(s) role: CONTACT phone: (208)282-3076 email: lecielbono@isu.edu lat: 42.8713 lon: -112.44553 hasResults: False

 nctId: NCT06279169 id: 2023-BRT-SBF-113355 briefTitle: The Effect of Heart Sound and White Noise on Pain and Physiological Parameters During Hepatitis B Vaccine Injection overallStatus: RECRUITING date: 2024-04-24 date: 2025-08-29 date: 2025-08-29 date: 2024-02-26 date: 2024-04-26 name: Bartın Unıversity class: OTHER briefSummary: It can cause physiological and behavioral changes in infants such as pain, tachycardia, hypoxemia, increased blood pressure, grimacing, prolonged crying, and irritability. Vaccination is an important part of neonatal nursing care. Newborns express their pain nonverbally and behaviorally. Therefore, any pain assessment is based on the ability of others to recognize pain symptoms. This randomized controlled trial was planned to evaluate the effect of heart sound and white noise on pain and physiological parameters during intramuscular injection of hepatitis B vaccine in newborns. This randomized controlled study used parallel trial design. conditions: Pain, Acute conditions: Newborn; Vitality studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 99 type: ESTIMATED name: Heart Sound name: White Noise measure: The Newborn Infant Pain Scale (NIPS) measure: oxygen saturation measure: heart rate measure: Crying Time sex: ALL minimumAge: 2 Days maximumAge: 28 Days stdAges: CHILD facility: Bartın University status: RECRUITING city: Bartın country: Turkey name: Fatma Dinç, Asst.Prof. role: CONTACT phone: +9005383555685 email: fatmadinc@bartin.edu.tr name: Aylin Kurt, Asst.Prof. role: CONTACT phone: +9005382087211 email: aylinkurt67@gmail.com lat: 41.63583 lon: 32.3375 hasResults: False

 nctId: NCT06279156 id: MTU-EC-IM-0-014/65 briefTitle: Optimal Frequency of Total Body Water Measurements by Bioelectrical Impedance Analysis to Prevent Intradialytic Hypotension overallStatus: COMPLETED date: 2022-06-01 date: 2023-02-28 date: 2023-02-28 date: 2024-02-26 date: 2024-03-06 name: Thammasat University Hospital class: OTHER briefSummary: The goal of this clinical trial was to compare the efficiencies of bioelectrical impedance analysis (BIA) measurement frequency in preventing intradialytic hypotension in end-stage renal disease (ESRD) patients undergoing regular hemodialysis. The main question aimed to answer about the optimum frequency of BIA measurements to prevent intradialytic hypotension.

Participants underwent BIA measurements to determine their appropriate dry weight, and factors affecting intradialytic hypotension.

Researchers compared the efficiencies of BIA measurements between the every-1-month group and the every-2-month group to prevent intradialytic hypotension. conditions: Intradialytic Hypotension conditions: End Stage Renal Disease on Dialysis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: NONE count: 94 type: ACTUAL name: Bioelectrical Impedance Analysis (BIA) measure: incidence rate ratio of intra-dialytic hypotension of every-1-month BIA to every-2-month BIA measure: factors affecting intra-dialytic hypotension sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Thammasat University Hospital city: Pathum Thani zip: 12120 country: Thailand lat: 14.01346 lon: 100.53049 hasResults: False

 nctId: NCT06279143 id: dOCT-pBCC briefTitle: The Diagnostic Accuracy of Advanced Imaging in Identifying Suspected Skin Cancer (Basal Cell Carcinoma) Around the Eyes acronym: dOCT-pBCC overallStatus: RECRUITING date: 2024-04-04 date: 2026-08-31 date: 2026-11-30 date: 2024-02-26 date: 2024-04-25 name: Vejle Hospital class: OTHER briefSummary: The purpose is to investigate the diagnostic value (sensitivity and specificity) of dermal-Optical Coherence Tomography (D-OCT, VivoSight Dx), in patients with clinically suspected BCC lesions inside the periocular region and compare these results to previous reports using D-OCT in diagnosing lesions outside the periocular area.

The Hypotheses:

* The sensitivity and specificity of D-OCT in diagnosing BCC inside the periocular region is comparable to previous reports on BCC lesions outside the periocular region when the standard D-OCT probe is used.
* The sensitivity and specificity of D-OCT in diagnosing BCC inside the periocular region is increased when the customised D-OCT probe is used.
* The sensitivity and specificity of D-OCT in diagnosing periocular BCC is comparable to punch biopsy when both standard and the customised D-OCT probes are used.
* D-OCT with the 10 and 20-millimeter standoff is capable of subtyping periocular BCC.
* The inter-observer variation in diagnosing and sub-typing periocular BCC decreases with increasing experience in the scanning procedure.
* The number of scans to correctly interpret D-OCT decreases with increasing experience in the scanning procedure.
* Delineation of periocular BCC tumour extension is possible using both D-OCT probes conditions: BCC - Basal Cell Carcinoma conditions: BCC conditions: Skin Diseases conditions: Eyelid Tumor conditions: Eyelid Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 210 type: ESTIMATED measure: Diagnostic accuracy of D-OCT in diagnosing BCC inside the periocular region, compared to previous reports on lesions outside the periocular region measure: Comparative diagnostic accuracy of D-OCT´s standard vs customized probe for diagnosing BCC measure: Comparative diagnostic accuracy of D-OCT´s standard vs customized probe for subtyping BCC measure: Observer agreement in identifying presence/absence of BCC lesions, using D-OCT measure: Observer agreement in classifying BCC lesions into subtypes, using D-OCT measure: Observer agreement in mapping BCC lesions prior to surgery, using D-OCT measure: Quantification of learning curve in correctly diagnosing BCC over time with increasing experience with D-OCT measure: Quantification of learning curve in correctly identifying BCC subtypes over time with increasing experience with D-OCT measure: Quantification of skills in correctly demarcating BCC over time with increasing experience with D-OCT measure: Accuracy of D-OCT in delineation of periocular BCC extension prior to surgery sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Ophthalmology, University Hospital of Southern Denmark, Vejle Hospital status: RECRUITING city: Vejle state: Region Of Southern Danmark zip: 7100 country: Denmark name: Sveina B Karlsdóttir, MD role: CONTACT phone: 53420448 phoneExt: 0045 email: sveina@outlook.dk name: Susanne Støvring role: CONTACT phone: 79406461 phoneExt: 0045 email: susanne.stoevring@rsyd.dk lat: 55.70927 lon: 9.5357 hasResults: False

 nctId: NCT06279130 id: N23NEO briefTitle: Pan-tumor Neoadjuvant Basket Study of Immune Check-point Inhibition and Novel Immuno-oncology Combinations acronym: NEOASIS overallStatus: RECRUITING date: 2024-01-29 date: 2029-01-29 date: 2034-01-29 date: 2024-02-26 date: 2024-02-26 name: The Netherlands Cancer Institute class: OTHER name: Agenus Inc. briefSummary: In this study, the efficacy of botensilimab and balstilimab in mismatch repair deficient (dMMR) and mismatch repair proficient (pMMR) tumors will be assessed. conditions: Resectable MMR-deficient Solid Tumors conditions: Resectable MMR-proficient Solid Tumors studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Basket, open-label primaryPurpose: TREATMENT masking: NONE count: 92 type: ESTIMATED name: botensilimab name: balstilimab measure: Major pathological response rate measure: Pathological response rates measure: Event free survival measure: Disease free survival measure: Overall survival measure: Radiological response sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Netherlands Cancer Institute status: RECRUITING city: Amsterdam state: Noord-Holland zip: 1066 CX country: Netherlands name: Marieke van de Belt, MsC role: CONTACT name: Myriam Chalabi, MD PhD role: PRINCIPAL_INVESTIGATOR lat: 52.37403 lon: 4.88969 hasResults: False

 nctId: NCT06279117 id: 2023/9/8 briefTitle: The Effect of Therapeutic Touch on Exam Anxiety overallStatus: RECRUITING date: 2024-01-15 date: 2024-02-23 date: 2024-03-10 date: 2024-02-26 date: 2024-02-26 name: Dokuz Eylul University class: OTHER briefSummary: Aim: This study was planned to determine the effect of therapeutic touch applied to nursing students on test anxiety.

Method: Students who met the inclusion criteria were divided into therapeutic touch and control groups using the randomization method. After the groups were determined, the students filled out the Introductory Information Form and the State Exam Anxiety Scale. 30 minutes before the exam, therapeutic touch was applied to each of the students, who were divided into groups, for 20 minutes. No application was made to the control group, and they were told to wait in the classroom where the group was waiting as they wished.Immediately after the application was completed, the scale was re-applied to both groups. conditions: Test Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised controlled clinical trial primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 50 type: ESTIMATED name: therapeutic touch measure: Text Anxiety measure: Text Anxiety sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Gizem Göktuna status: RECRUITING city: İzmir zip: 35000 country: Turkey name: Gizem Göktuna role: CONTACT phone: +905448303393 email: gizemgoktuna@gmail.com lat: 38.41273 lon: 27.13838 hasResults: False

 nctId: NCT06279104 id: 2023-TJ-OCCC briefTitle: A Comparative Study of the Treatment of Real-world Patients With Clear Cell Carcinoma of the Ovary overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-05-01 date: 2025-05-01 date: 2024-02-26 date: 2024-02-26 name: Tongji Hospital class: OTHER name: Wuhan Union Hospital, China name: Henan Cancer Hospital name: Qilu Hospital of Shandong University name: Hubei Cancer Hospital name: Anhui Provincial Cancer Hospital name: Peking University Cancer Hospital & Institute name: Hunan Province Tumor Hospital name: First Affiliated Hospital of Suzhou Medical College name: Shandong Tumor Hospital name: Chongqing University Cancer Hospital name: First Affiliated Hospital of Zhongshan Medical University name: Peking University Shenzhen Hospital briefSummary: The goal of this observational study is to learn about the treatment effectiveness of physician's choice of chemotherapy and the immune checkpoint inhibitor (ICI)-based therapy in patients with relapsed/refractory ovarian clear cell carcinoma (OCCC), and compare the treatment response with the phase II, single-arm clinical trial INOVA to investigate the efficacy of combinational therapy of sintilimab plus bevacizumab. The main questions it aims to answer are:

* What is the efficacy of physician's choice of chemotherapy in relapsed/refractory OCCC patients in the real world?
* Is ICI-based therapy more effective than physician's choice of chemotherapy in real-world for relapsed/refractory OCCC patients?
* Dose the combinational regimens of sintilimab plus bevacizumab in Sintilimab Plus Bevacizumab in Recurrent/Persistent Ovarian Clear Cell Carcinoma (INOVA) trial more effective than physician's choice of chemotherapy?

Participants will be respectively retrieved and extracted de-identified, longitudinal electronic health records (EHR)-derived data. conditions: Ovarian Clear Cell Carcinoma studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 150 type: ESTIMATED name: physician's choice of chemotherapy name: immune checkpoint inhibitor based therapy measure: tumor response rate measure: progression-free survival (PFS) measure: time to response (TTR) measure: duration of response (DOR) measure: disease control rate (DCR) sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06279091 id: A0104023PP briefTitle: Correlation of Children and Parental Anxiety and Effectiveness of Breathing Exercises on Anxiety Reduction overallStatus: ACTIVE_NOT_RECRUITING date: 2023-05-23 date: 2023-11-05 date: 2024-05-23 date: 2024-02-26 date: 2024-02-26 name: Mansoura University class: OTHER briefSummary: The purpose of this study to evaluate the correlation between children and parental dental anxiety as well as to evaluate the effectiveness of breathing exercises on anxiety reduction. conditions: Dental Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Selected children will be divided randomly into 3 groups:

Control group (Group I). Diaphragmatic Breathing group (Group II). Bubble Blower Breathing group (Group III). primaryPurpose: OTHER masking: NONE count: 90 type: ESTIMATED name: Diaphragmatic Breathing name: Bubble Blower Breathing name: Tell Show Do measure: scale of dental anxiety by Corah Dental Anxiety Scale (CDAS) measure: scale of dental anxiety by Facial Image Scale (FIS) measure: scale of dental anxiety by Venham Clinical Anxiety Scale (VCAS) measure: scale of dental anxiety by Pulse Oximeter sex: ALL minimumAge: 5 Years maximumAge: 8 Years stdAges: CHILD facility: Mansura University city: Mansoura state: Dakahlia zip: 35511 country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False

 nctId: NCT06279078 id: AJOUIRB-DB-2023-446 briefTitle: Long-term Effect of Steroid on Metabolic Diseases in Asthmatics overallStatus: RECRUITING date: 2023-12-30 date: 2024-12-30 date: 2025-06-30 date: 2024-02-26 date: 2024-02-26 name: Ajou University School of Medicine class: OTHER name: AstraZeneca briefSummary: The goal of this retrospective/observational study is to compare the clinical outcomes between the high-cumulative-dose group and the low- cumulative-dose group of oral/inhaled corticosteroid in the long-term management of asthma patients. The main hypothesis are:

i. High cumulative dose of corticosteroid is related to the prevalence of osteoporosis/osteoporosis in the long-term management of adult asthma.

ii. High cumulative dose of corticosteroid can affect populations that have a high-risk of osteoporosis (females over 50 years of age).

iii. High cumulative dose of corticosteroid is related to the prevalence of diabetes mellitus, hypertension, and hyperlipidemia in the long-term management of adult asthma.

iv. High cumulative dose of corticosteroid affects bone metabolism-related diagnostic tests and laboratory values and the prescription rate of bone metabolism-related medications. conditions: Asthma conditions: Osteoporosis, Osteopenia conditions: Osteoporosis Risk conditions: Osteoporotic Fractures studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 20000 type: ESTIMATED name: Corticosteroid measure: Prevalence of osteoporosis/osteopenia measure: Bone mineral density (BMD) score measure: Total alkaline phosphatase measure: Corrected calcium measure: Serum phosphate measure: Serum albumin measure: prevalence of steroid related comorbidities(Diabetes Mellitus, Hypertension, Hyperlipidemia, etc.) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ajou University Medical Center status: RECRUITING city: Suwon state: Gyeonggi zip: 16499 country: Korea, Republic of name: Hyun-Seob Jeon, M.D. role: CONTACT phone: +82-31-219-4612 email: googlingpenguin@gmail.com name: Hae-Sim Park, M.D., Ph.D. role: CONTACT phone: +82-31-219-4779 email: hspark@ajou.ac.kr lat: 37.29111 lon: 127.00889 hasResults: False

 nctId: NCT06279065 id: 373/23-EP briefTitle: Investigation of the Influence of the Human Microbiome on the Pathogenesis and Recurrence Probability in Giant Cell Arteritis acronym: GCA-Biom overallStatus: RECRUITING date: 2024-02-18 date: 2026-02-18 date: 2028-02 date: 2024-02-26 date: 2024-02-26 name: University of Bonn class: OTHER briefSummary: The longitudinal observational study aims to assess the impact of the microbiome especially the gut-microbiome in the emergence and course of giant cell arteritis (GCA) patients. At diagnosis and 6 month follow up we will analyze the oral, blood and gut microbiome from GCA patients and healthy controls. Thereby identified potential candidate commensal will be further analyzed for possible interactions and influence on the immune system. conditions: Giant Cell Arteritis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Analysis of blood and microbiome samples (stool, oral lavage) measure: Significant differences in the composition of the microbiome measure: Influence of the microbiome on therapy response e.g. increased probability of recurrence with accumulation of specific microbiome species measure: potential association of microbiom composition with application of immune modulating drugs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinic of Internal Medicine III, Department of Oncology, Haematology, Rheumatology and Clinical Immunology, University Hospital Bonn status: RECRUITING city: Bonn state: North Rhine-Westphalia zip: 53127 country: Germany name: Valentin S. Schäfer, Dr. med. role: CONTACT phone: +49 228 287-17000 email: rheumatologie@ukbonn.de lat: 50.73438 lon: 7.09549 facility: University Hospital Bonn status: RECRUITING city: Bonn zip: 53127 country: Germany name: Valentin Schäfer, MD role: CONTACT phone: +28 287 17000 email: rheumatologie@ukbonn.de name: Maike Adamson role: CONTACT phone: +28 287 17000 email: rheumatologie@ukbonn.de lat: 50.73438 lon: 7.09549 hasResults: False

 nctId: NCT06279052 id: RC31/23/0535 briefTitle: Adolescent Projections During Transition in Prader-Willi Syndrome acronym: APT-WILL overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-01 date: 2024-12-01 date: 2024-02-26 date: 2024-02-28 name: University Hospital, Toulouse class: OTHER briefSummary: Single-center, cross-sectional qualitative study seeking to collect the experience of adolescence and the transition to adulthood of people affected by Prader-Willi syndrome in a population. To do this, the present will carry out a qualitative study with a reflexive thematic analysis of the data collected through semi-structured interviews using an interview guide. conditions: Prader-Willi Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 20 type: ESTIMATED name: Phone interview measure: Experience of the disease and aspirations regarding the future sex: ALL minimumAge: 15 Years maximumAge: 20 Years stdAges: CHILD stdAges: ADULT facility: CHU de Toulouse city: Toulouse country: France name: Grégoire BENVEGNU role: CONTACT email: benvegnu.g@chu-toulouse.fr name: Dalil Benkanoun role: CONTACT email: dalil.benkanoun@hotmail.fr lat: 43.60426 lon: 1.44367 hasResults: False

 nctId: NCT06279039 id: KY20230116-06 briefTitle: Clinical Observation of Exosomes in Patients After Q-switched Laser Surgery overallStatus: RECRUITING date: 2022-09-01 date: 2024-08-31 date: 2024-12-31 date: 2024-02-26 date: 2024-02-26 name: Nanjing First Hospital, Nanjing Medical University class: OTHER briefSummary: the goal of this half-face controlled study is to evaluate the effect of exosome-containing liquid dressings on the recovery of patients after Nd:YAG laser 532 treatment. conditions: Exosome conditions: Skin Regeneration conditions: Laser studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 38 type: ESTIMATED name: Exosome liquid dressing measure: Global Aesthetic Improvement Scale score measure: Dermatology Quality of life index measure: post-inflammatory hyperpigmentation sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Jie Dai status: RECRUITING city: Nanjing state: Jiangsu zip: 210006 country: China name: jie dai role: CONTACT phone: 02552271117 email: karry_dj@126.com lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06279026 id: PG-006-5 briefTitle: UTAA17 Injection in the Treatment of Relapsed/Refractory Multiple Myeloma overallStatus: RECRUITING date: 2024-04-01 date: 2027-04-01 date: 2027-07-01 date: 2024-02-26 date: 2024-02-26 name: PersonGen BioTherapeutics (Suzhou) Co., Ltd. class: INDUSTRY name: Second Affiliated Hospital of Soochow University briefSummary: The clinical trial was designed as a single-arm, open-label clinical study, with the main purpose of exploring the safety, pharmacokinetics, and best recommended dose (RP2D) of the UTAA17 injection in the treatment of relapsed or refractory multiple myeloma (r/r MM) subjects, and also the efficacy will be observed. Eligible subjects will accept the infusion of UTAA17 injection after pretreatment, and their blood will be collected before and after infusion for evaluation of pharmacokinetics, immunogenicity and safety. This study plans to evaluate efficacy using the revised Evaluation of Efficacy in multiple myeloma -IMWG criteria (2016), which will be evaluated at 4w, 2m, 3m, 6m, and 6 to 24m (at a frequency of Q3m) after cell reinfusion, in addition to the baseline period. Efficacy evaluation continues until one of the following occurs: subject disease progression (PD), acceptance of a new antitumor therapy, death, occurrence of intolerable toxicity, investigator decision, or patient decision to withdraw. conditions: Relapsed/Refractory Multiple Myeloma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: UTAA17 injection primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: UTAA17 Injection measure: DLT measure: RP2D sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Soochow University status: RECRUITING city: Suzhou state: Jiangsu zip: 215000 country: China name: Huimin Meng, doctor role: CONTACT phone: +86-18015580390 email: huimin.meng@persongen.com.cn lat: 31.30408 lon: 120.59538 hasResults: False

 nctId: NCT06279013 id: NRG-CC012CD id: NCI-2023-10831 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: NRG-CC012CD type: OTHER domain: NRG Oncology id: NRG-CC012CD type: OTHER domain: DCP id: NRG-CC012CD type: OTHER domain: CTEP id: R01CA279472 type: NIH link: https://reporter.nih.gov/quickSearch/R01CA279472 briefTitle: Comparing Telephone Symptom Monitoring Interventions for Managing Symptoms and Psychological Distress During Oral Anti-Cancer Treatment overallStatus: NOT_YET_RECRUITING date: 2024-06-16 date: 2027-02-01 date: 2028-05-01 date: 2024-02-26 date: 2024-02-28 name: NRG Oncology class: OTHER name: National Cancer Institute (NCI) briefSummary: In this clinical trial, symptom monitoring (interactive voice response \[IVR\] is compared to automated telephone symptom management \[ATSM\] and telephone interpersonal counseling \[TIPC\]) for reducing symptom burden and psychological distress (depressive and anxiety symptoms) among people receiving oral anti-cancer treatment. Symptoms are the number one driver of treatment interruptions and unscheduled health services use. To reduce the risk of these events, symptom monitoring and management are necessary. However, these services are not implemented routinely, especially in the community oncology settings. Further, depressive and anxiety symptoms are a key barrier to enacting symptom self-management strategies. IVR is a form of symptom monitoring where patients, when called, enter their symptom ratings over the phone. Their symptom summary is sent to their provider, and patients may be advised to reach out to their oncology provider, based on their symptoms. The ATSM intervention combines IVR assessments with a Symptom Management and Survivorship educational handbook with self-management strategies. Patients receiving ATSM enter their symptom ratings over the phone and have their symptoms reported to their provider, but patients are also directed to the handbook for strategies to manage elevated symptoms. Patients receiving ATSM who report being anxious, discouraged, or sad will also receive TIPC, which targets psychological distress and its connection to social support and interpersonal communication. Information gathered from this study may help researchers learn more about the best ways to manage patient symptoms and improve patient outcomes. conditions: Hematopoietic and Lymphoid System Neoplasm conditions: Malignant Solid Neoplasm studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Cluster randomized primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: Interviewers will be blinded to the study arm; IVR is automated. whoMasked: OUTCOMES_ASSESSOR count: 516 type: ESTIMATED name: Counseling name: Health Education name: Interview name: Medical Chart Review name: Monitoring name: Questionnaire Administration measure: Symptom Severity/Toxicity Index measure: Incidence of Unscheduled Health Services Usage measure: Practice personnel time to address weekly interactive voice response (IVR) symptom reports measure: Treatment fidelity measure: Cost measure: Patient financial burden sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06279000 id: CTU 22/025 briefTitle: Colchicine in Patients at Cardiac Risk Undergoing Major Non-Cardiac Surgery acronym: COLCAT overallStatus: NOT_YET_RECRUITING date: 2024-10-01 date: 2027-09-30 date: 2028-09-30 date: 2024-02-26 date: 2024-02-28 name: Cantonal Hospital of St. Gallen class: OTHER briefSummary: Perioperative myocardial injury/infarction (PMI) and major adverse cardiovascular events (MACE) are common causes of morbidity and mortality in patients at increased cardiovascular risk undergoing non-cardiac surgery.

However, research in recent years has yielded limited preventive and therapeutic measures for PMI/MACE. Recent studies in patients with chronic and acute coronary artery disease have shown that colchicine administration can reduce the risk of cardiovascular events.

These encouraging results in non-surgical patients ask for a similar investigation in patients undergoing major non-cardiac surgery. The aim of the proposed study is to investigate the effects of perioperative colchicine administration on the incidence of PMI/MACE. conditions: Cardiovascular Diseases conditions: Cardiovascular Complication conditions: Perioperative Complication conditions: Myocardial Infarction studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized, triple-blinded, placebo-controlled, multicenter primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Patients, anaesthesia providers and all other health care workers involved in the treatment and the study personal will be blinded to the group allocation by provision of equal looking study drugs (verum and placebo), which are repacked for blinding. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 880 type: ESTIMATED name: Colchicine name: Placebo measure: Perioperative Myocardial Injury/Infarction measure: Major Adverse Cardiovascular Events measure: New onset Atrial fibrillation measure: postoperative high sensitive cardiac Troponin T concentrations measure: long term cardiovascular outcome measure: Gastrointestinal adverse events sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06278987 id: ANES-2024-32661 briefTitle: Comparison of Cryoablation of Pericapsular Nerve Group (PENG) to Fascia Iliaca Catheter in Patients With a Hip Fracture overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-06-01 date: 2026-12-01 date: 2024-02-26 date: 2024-03-19 name: University of Minnesota class: OTHER briefSummary: The purpose of this study is to determine if patients with hip fractures who undergo cryoablation of the PENG have improved pain control 30 days from surgery when compared to those who have a fascia iliaca catheter. conditions: Hip Fractures studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a randomized prospective controlled trial. This will be single blinded trial. Randomization will be 1:1 primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 150 type: ESTIMATED name: PENG block and cryoablation name: fascia iliaca compartment block measure: Maximum pain score on Post-operative day 30 measure: Opioid use measure: functional pain scores measure: number of patients using opioids measure: Length of Hospital Stay measure: Time to first ambulation measure: Number of patients returned home by Post Operative Day 30 sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06278974 id: PDSFGOCLMC-2023-001 briefTitle: Comparing Myopia Treatments in Youth: Defocus Spectacles, Glasses, and Ortho-K overallStatus: RECRUITING date: 2023-11-10 date: 2025-05-01 date: 2025-05-01 date: 2024-02-26 date: 2024-02-26 name: He Eye Hospital class: OTHER briefSummary: The research project titled "A Comparative Study on the Clinical Efficacy, Quality of Life, and Cost of Use of Peripheral Defocus Spectacles, Frame Glasses, and Orthokeratology Lenses in Myopic Children and Adolescents" aims to evaluate different non-surgical myopia correction methods in children. It focuses on assessing the impact of peripheral defocus spectacles, frame glasses, and orthokeratology lenses on the quality of life, clinical effectiveness, and costs associated with each method. The study is a prospective cohort study involving 300 children aged 13-17 years with myopia ranging from -1.00D to -6.00D. It aims to compare the psychological, social, and educational aspects of these correction methods, alongside their costs and clinical outcomes over a period of one year. conditions: Myopia conditions: Cost-effectiveness Analysis conditions: Quality of Life studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED measure: Improvement in Quality of Life Scores measure: Cost-Effectiveness Analysis measure: Clinical Effectiveness Analysis sex: ALL minimumAge: 13 Years maximumAge: 17 Years stdAges: CHILD facility: HeEyeHospital status: RECRUITING city: Shenyang state: Liaoning zip: 110000 country: China name: Lan Hu, Master role: CONTACT phone: 15940406919 email: hulan@hsyk.com.cn lat: 41.79222 lon: 123.43278 hasResults: False

 nctId: NCT06278961 id: IRB 2021-4329 briefTitle: Families Filming Infants Learning Movement acronym: FILM overallStatus: RECRUITING date: 2021-01-28 date: 2024-09-30 date: 2024-09-30 date: 2024-02-26 date: 2024-02-26 name: Ann & Robert H Lurie Children's Hospital of Chicago class: OTHER name: Northwestern University name: IRCCS Fondazione Stella Maris name: University of Melbourne name: University of Sydney briefSummary: The study objective is to improve accuracy in the early detection of neurodevelopmental impairment, especially CP, by evaluating the timepoint (in weeks post term age) that the Prechtl GMA is most useful for prediction of neurodevelopmental impairment at two years of age in children with and without medical complexity. The study team plans to recruit 100 healthy, term-born infants and 250 infants at risk of developing CP for a total of 350 enrolled infants. conditions: Infant Development conditions: Cerebral Palsy conditions: Motor Disorders conditions: Neurological Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 350 type: ESTIMATED name: Observational measure: Fidgety Movements in healthy, term born infants measure: Fidgety Movements in children with a range of medical complexities measure: Fidgety Movements and two-year Neurodevelopmental outcomes in health, term born infants measure: Fidgety Movements and two-year Neurodevelopmental outcomes in children with a range of medical complexities sex: ALL minimumAge: 10 Weeks maximumAge: 20 Weeks stdAges: CHILD facility: Feinberg School of Physical Therapy and Human Movement Sciences status: RECRUITING city: Chicago state: Illinois zip: 60611 country: United States name: Ryan Millman, B.S. role: CONTACT phone: 847-530-2319 email: ryan.millman@northwestern.edu lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06278948 id: LRP23023-depigmenting cream briefTitle: Efficacy and Tolerability of Test Product Versus Cysteamine 5% in Treatment of Facial Epidermal Melasma overallStatus: RECRUITING date: 2023-10-06 date: 2024-06 date: 2024-06 date: 2024-02-26 date: 2024-02-26 name: Cosmetique Active International class: INDUSTRY briefSummary: This interventional, randomized, investigator blinded, controlled study conducted in one centre consists in a 4-month evaluation period within the same season avoiding sunny season on 140 subjects with facial epidermal melasma. conditions: Melasma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 140 type: ESTIMATED name: Group TP name: Group CYS measure: change in mMASI scoring measure: change in Investigator's Global Assessment (IGA) measure: change in Subject Global Assessment of Improvement (SGAI) sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: MS Clinical Research Pvt. Ltd status: RECRUITING city: Bangalore country: India lat: 12.97194 lon: 77.59369 hasResults: False

 nctId: NCT06278935 id: APP-24-00887 briefTitle: Lifestyle Tailored Offloading for Diabetic Foot Ulcers overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-02-26 date: 2024-04-02 name: University of Southern California class: OTHER briefSummary: The goal of this pilot clinical trial is to develop and test a tailored occupational therapist-led lifestyle-focused intervention to aid patients in improving diabetic foot ulcer care. The main questions it aims to answer are to determine the acceptability and feasibility of taking a tailored lifestyle-focused approach as part of comprehensive diabetic foot ulcer management. Patient participants with DFUs who require offloading treatment will receive the tailored lifestyle-focused self-management intervention. conditions: Diabetic Foot Ulcer conditions: Diabetic Foot studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Lifestyle-based intervention by a occupational therapist measure: Participant satisfaction measure: Diabetes distress measure: Factors affecting offloading treatment measure: DFU-related outcomes sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06278922 id: STUDY00001149 id: R01AA031010 type: NIH link: https://reporter.nih.gov/quickSearch/R01AA031010 briefTitle: Evaluating Signs of Safety: A Deaf-Accessible Therapy Toolkit for AUD and Trauma overallStatus: NOT_YET_RECRUITING date: 2024-09-30 date: 2028-09-30 date: 2028-09-30 date: 2024-02-26 date: 2024-02-26 name: University of Massachusetts, Worcester class: OTHER name: National Institute on Alcohol Abuse and Alcoholism (NIAAA) briefSummary: The U.S. Deaf community - a group of more than 500,000 Americans who communicate using American Sign Language (ASL) - experiences nearly triple the rate of lifetime problem drinking and twice the rate of trauma exposure compared to the general population. Although there are several treatments for alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) in hearing populations, none have been developed for or tested with Deaf clients. To address these barriers, the study team developed Signs of Safety, a Deaf-accessible therapy toolkit for treating AUD and PTSD. Their aims are to conduct a nationwide, virtual clinical trial to compare (1) Signs of Safety with (2) treatment as usual and (3) a no treatment control, to collect data on clinical outcomes, and to explore potential mediators and moderators of outcome. conditions: PTSD conditions: Alcohol; Use, Problem studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The PI and all Co-Is will be masked to study condition. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 144 type: ESTIMATED name: Seeking Safety + Signs of Safety toolkit name: Treatment as usual measure: Change from Baseline Percent Drinking Days Per Month at Immediate Post-Treatment as Measured by the Alcohol Timeline Followback measure: Change from Baseline Percent Drinking Days Per Month at Three-month Follow-up as Measured by the Alcohol Timeline Followback measure: Change from Baseline Percent Drinking Days Per Month at Six-month Follow-up as Measured by the Alcohol Timeline Followback measure: Change from Baseline Percent Binge Drinking Days Per Month at Immediate Post-Treatment as Measured by the Alcohol Timeline Followback measure: Change from Baseline Percent Binge Drinking Days Per Month at Three-month Follow-up as Measured by the Alcohol Timeline Followback measure: Change from Baseline Percent Binge Drinking Days Per Month at Six-month Follow-up as Measured by the Alcohol Timeline Followback measure: Change from Baseline Number of Drinks Per Month at Immediate Post-Treatment as Measured by the Alcohol Timeline Followback measure: Change from Baseline Number of Drinks Per Month at Three-month Follow-up as Measured by the Alcohol Timeline Followback measure: Change from Baseline Number of Drinks Per Month at Six-month Follow-up as Measured by the Alcohol Timeline Followback measure: Change from Baseline Past 30-day PTSD Severity to Immediate Post-Treatment as Measured by the PCL-5 measure: Change from Baseline Past 30-day PTSD Severity to Three-month Follow-up as Measured by the PCL-5 measure: Change from Baseline Past 30-day PTSD Severity to Six-month Follow-up as Measured by the PCL-5 measure: Change from Baseline Diagnostic and Statistical Manual (DSM)-5 diagnostic criteria for Alcohol Use Disorder to Immediate Post-Treatment as measured by the DSM-5 AUD Assessment Tool measure: Change from Baseline Percent Days of Drug Use Per Month at Immediate Post-Treatment as Measured by the Timeline Followback - Drugs, Cigarettes, and Marijuana measure: Change from Baseline Number of Instances of Drug Use Per Month at Immediate Post-Treatment as Measured by the Timeline Followback - Drugs, Cigarettes, and Marijuana measure: Change from Baseline Percent Days of Marijuana Use Per Month at Immediate Post-Treatment as Measured by the Timeline Followback - Drugs, Cigarettes, and Marijuana measure: Change from Baseline Number of Instances of Marijuana Use Per Month at Immediate Post-Treatment as Measured by the Timeline Followback - Drugs, Cigarettes, and Marijuana measure: Change from Baseline Percent Days of Tobacco Use Per Month at Immediate Post-Treatment as Measured by the Timeline Followback - Drugs, Cigarettes, and Marijuana measure: Change from Baseline Number of Instances of Tobacco Use Per Month at Immediate Post-Treatment as Measured by the Timeline Followback - Drugs, Cigarettes, and Marijuana measure: Change from Baseline Substance-related Problems at Immediate Post-Treatment as Measured by the Short Inventory of Problems Revised (SIPS-R) measure: Change from Baseline Alcohol Craving at Immediate Post-Treatment as Measured by the Brief Addiction Monitor - Revised (BAM-R) measure: Change from Baseline Drug Craving at Immediate Post-Treatment as Measured by the Brief Addiction Monitor - Revised (BAM-R) measure: Change from Baseline Marijuana Craving at Immediate Post-Treatment as Measured by the Brief Addiction Monitor - Revised (BAM-R) measure: Change from Baseline Tobacco Craving at Immediate Post-Treatment as Measured by the Brief Addiction Monitor - Revised (BAM-R) measure: Change from Baseline Psychosocial Functioning at Immediate Post-Treatment as Measured by the Outcome Questionnaire (OQ-30.2) for Adults sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-02-16 uploadDate: 2024-02-16T10:27 filename: Prot_SAP_000.pdf size: 2163767 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-08-21 uploadDate: 2024-02-16T10:29 filename: ICF_001.pdf size: 85664 hasResults: False

 nctId: NCT06278909 id: 6036699 briefTitle: Trigeminal Nerve Stimulation in Treatment-resistant Generalized Anxiety Disorder: a Feasibility Study overallStatus: RECRUITING date: 2024-01-18 date: 2025-01-30 date: 2025-06-30 date: 2024-02-26 date: 2024-03-26 name: Dr. Rafael Freire class: OTHER briefSummary: This is a feasibility study for trigeminal nerve stimulation (TNS) in patients with treatment-resistant generalized anxiety disorder (TR-GAD). Ten participants will receive TNS for 8 weeks as an augmentation strategy to pharmacological treatment for generalized anxiety disorder (GAD).

* The primary objective is to ascertain if TNS is a safe and well-tolerated treatment for patients with TR-GAD.
* The secondary objective will be to monitor changes in GAD symptom severity throughout the study.

Results from this study will inform a randomized controlled trial to be conducted in the future. conditions: Generalized Anxiety Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a traditional feasibility study, which evaluates preliminary safety and effectiveness information. It does not meet the definition of a "device feasibility" study. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Trigeminal Nerve Stimulation measure: Incidence of treatment-emergent adverse events measure: Incidence of treatment-emergent side effects measured with the NSEC measure: Response to treatment defined by CGI-I score below 3 measure: Remission defined by CGI-S score below 3 measure: Change in anxiety severity measured by CGI-S measure: Change of anxiety symptoms measured with GAD-7 measure: Change of anxiety symptoms measured with PSWQ measure: Change of anxiety symptoms measured with BAI sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kingston Health Sciences Centre status: RECRUITING city: Kingston state: Ontario country: Canada name: Yan Deng role: CONTACT phone: +1-613-548-7839 email: yan.deng@queensu.ca name: Rafael Freire, MD PhD role: PRINCIPAL_INVESTIGATOR name: Elisa Brietzke, MD PhD role: SUB_INVESTIGATOR name: Claudio Soares, MD PhD role: SUB_INVESTIGATOR lat: 44.22976 lon: -76.48101 hasResults: False

 nctId: NCT06278896 id: 23-684-END briefTitle: Early Neutropenic Fever De-escalation of Antibiotics Study acronym: END overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2028-03-01 date: 2024-02-26 date: 2024-02-26 name: Brigham and Women's Hospital class: OTHER name: Dana-Farber Cancer Institute briefSummary: This is a randomized, open label clinical trial among individuals with hematologic conditions. The trial aims to evaluate the safety and clinical outcomes of de-escalating antibiotic therapy among stable individuals diagnosed with neutropenic fever, in which no bacterial infection has been identified. conditions: Hematologic Malignancy conditions: Febrile Neutropenia conditions: Antibiotic Stewardship studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 260 type: ESTIMATED name: Cessation of antibiotics measure: Mortality, transfer to the ICU, septic shock, culture-confirmed bacteremia measure: Antibiotic utilization measure: Mortality post F&N measure: Drug resistance measure: Clostridium difficile infection measure: Candidiasis measure: Adverse Events measure: Allergic Reactions measure: Bacteremia measure: Neutropenia measure: Length of stay measure: Readmissions measure: Fever sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06278883 id: Pro00115007 id: R01HG011794 type: NIH link: https://reporter.nih.gov/quickSearch/R01HG011794 briefTitle: Genomic Medicine Risk Assessment Care for Everyone - Implementation Phase acronym: GRACE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-06-30 date: 2025-06-30 date: 2024-02-26 date: 2024-03-27 name: Duke University class: OTHER name: National Human Genome Research Institute (NHGRI) briefSummary: The "Genomic medicine Risk Assessment Care for Everyone" (GRACE)" intervention project will develop a scalable end-to-end solution for risk assessment and management that meets the needs of those populations living in low resource settings. The long-term goal is to increase access to and uptake of risk-informed evidence-based guidelines that will improve population health through better patient outcomes, higher quality of life, and decreased costs. The three primary aims are:

Aim 1: Develop a scalable implementation framework that guides each unique clinical setting, including low resource settings, in deploying GRACE effectively for the needs of their patients and providers.

Aim 2: Facilitate the potential for genomic medicine to promote population health by broadening access to and uptake of genomic risk assessment by the general population through a pragmatic implementation-effectiveness trial of GRACE.

Aim 3: Reduce health disparities related to genomic medicine by allowing individual adaption of GRACE to suit their level of resources, education, and access within a pragmatic implementation-effectiveness trial.

Three sets of participants will be engaged: patients (n=750), providers (n=25), and family members of "probands" (i.e., patients that have a genetic change that increases risk, n\~500).

Patient participants will be asked to complete a baseline survey, enter their family health history information into MeTree (a family health history web-based platform) and complete a survey about their experience using the platform. Subsequent study procedures will depend on: 1) the results of their MeTree risk evaluation, 2) their acceptance/declination of genetic testing (for those categorized as needing testing by MeTree), and 3) the results of the test (for those accepting testing).

Provider participants will be providers who are the primary care physicians treating one or more patients enrolled in the patient participant group. Providers will be notified on a patient by patient basis once the patient participant under their care has complete the risk assessment process and the risk report is available from MeTree. At study completion, provider participants will be asked to complete a survey about their demographics, practice, and experiences with the study.

Blood relatives of the probands who are identified by the proband as open to engaging with the study will be contacted and offered genetic counseling and genetic testing. conditions: Cardiovascular Diseases conditions: Cancer conditions: Liver Diseases conditions: Hyperthermia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Everyone who consents is enrolled in the risk assessment pipeline. primaryPurpose: SCREENING masking: NONE count: 750 type: ESTIMATED name: Disease Risk Assessment measure: Reach of genomic risk assessment measure: Utility of genomic risk assessment measure: Uptake of genetic counseling risk recommendations by the participant measure: Uptake of genetic testing recommendations by the provider sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UF Health Callahan city: Callahan state: Florida zip: 32011 country: United States lat: 30.56218 lon: -81.83066 facility: UF Health Murray Hill city: Jacksonville state: Florida zip: 32205 country: United States lat: 30.33218 lon: -81.65565 facility: UF Health Normandy city: Jacksonville state: Florida zip: 32221 country: United States lat: 30.33218 lon: -81.65565 facility: UF Health Kernan Square city: Jacksonville state: Florida zip: 32246 country: United States lat: 30.33218 lon: -81.65565 facility: UF Health Augustine Oaks city: Jacksonville state: Florida zip: 32258 country: United States lat: 30.33218 lon: -81.65565 hasResults: False

 nctId: NCT06278870 id: SYSKY-2023-431-02 briefTitle: Disitamab Vedotin + Pyrotinib Versus THP in the First-line Treatment for HER2+ Advanced Breast Cancer Clinical Trial overallStatus: RECRUITING date: 2023-09-06 date: 2031-06-30 date: 2031-06-30 date: 2024-02-26 date: 2024-02-26 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: The goal of this multicentre, randomized, double-blind controlled, phase III clinical trial is to compare the efficacy and safety of disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of paclitaxel in combination with trastuzumab and pertuzumab (THP) for newly diagnosed recurrent/metastatic Human epidermal growth factor receptor 2 (HER2) positive advanced breast cancer, and to explore the impact of biomarkers on clinical efficacy and safety. The main questions it aims to answer are:

* Analyse the efficacy and safety of disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of THP.
* Explore the impact of biomarkers on clinical efficacy and safety of the combination of disitamab vedotin in combination with pyrotinib treatment.

Participants in the experimental group will receive disitamab vedotin in combination with pyrotinib for 6-8 cycles (each cycle lasting 28 days), followed by maintenance treatment with trastuzumab in combination with pyrotinib. Participants in the control group will receive paclitaxel in combination with trastuzumab and pertuzumab for 6-8 cycles (each cycle lasting 21 days), followed by maintenance treatment with trastuzumab and pertuzumab.

Researchers will compare disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of paclitaxel in combination with trastuzumab and pertuzumab to see if disitamab vedotin in combination with pyrotinib could be a new option for first-line treatment of HER2-positive metastatic breast cancer. conditions: HER2-positive Metastatic Breast Cancer conditions: First-line Treatment studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 312 type: ESTIMATED name: disitamab vedotin name: Pyrotinib name: trastuzumab name: Pertuzumab name: taxane drug measure: Progression Free Survival (PFS) measure: Overall Survival (OS) measure: Disease control rate (DCR) measure: Objective Response Rate (ORR) measure: Clinical Benefit rate (CBR) measure: Adverse Events (Based on CTCAE 5.0 standards) measure: Quality of Life (QoL) by Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B) measure: Exploration of biomarkers sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen Memorial Hospital,Sun Yat-sen University status: RECRUITING city: Guangzhou state: Guangdong zip: 510000 country: China name: Herui Yao, PhD role: CONTACT phone: +86 13500018020 email: yaoherui@mail.sysu.edu.cn lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06278857 id: QCGC-001/2023 briefTitle: SATELLITE Study (feaSibility sAfeTy Efficacy dostarLimab earLy-stage defIcient endomeTrial cancEr) acronym: SATELLITE overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-06-30 date: 2028-06-30 date: 2024-02-26 date: 2024-02-26 name: Queensland Centre for Gynaecological Cancer class: OTHER_GOV name: GlaxoSmithKline Research & Development Limited briefSummary: The main goal of this clinical trial is to evaluate dostarlimab, an immunotherapy drug, as a potential alternative to surgery for early-stage endometrial cancer with Mismatch Repair deficiency, a genetic cause for 20-30% of cases. The study aims to establish dostarlimab's efficacy and safety in early-stage endometrial cancer, exploring its potential as a non surgical option for those unsuitable or unwilling to undergo major surgery, allowing for fertility preservation or addressing specific health conditions.

Participants will have seven dostarlimab sessions over 12 months. The treatment plan involves four cycles every three weeks, followed by a three-week break, and then three cycles every six weeks.

This research is a promising step toward a new, less invasive treatment choice for patients with specific genetic traits. It expands the range of care options for endometrial cancer. conditions: Endometrial Cancer Stage I conditions: Mmr Deficiency conditions: Endometrioid Endometrial Adenocarcinoma conditions: Immune-related Adverse Event studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a non-randomised, prospective, pilot, open-label, single arm study. Participation in this trial involves seven dostarlimab sessions over 12 months, with a treatment protocol of four cycles every three weeks, followed by a three-week break, and then three cycles every six weeks. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Dostarlimab-Gxly 50 MG/1 ML Intravenous Solution [JEMPERLI] measure: Determine the absence endometrial cancer following protocol treatment regimen of dostarlimab. measure: Determine the safety and tolerability of dostarlimab in participants with early-stage MMR deficient endometrioid endometrial adenocarcinoma. measure: TEAEs/irAEIs Leading to Study Drug Discontinuation measure: TEAEs/irAEIs Leading to Study Withdrawal measure: Clinically Significant Changes in Haematology measure: Clinically Significant Changes in Clinical Chemistry measure: Clinically Significant Changes in Thyroid Function measure: Abnormal Vital Signs measure: Abnormal Electrocardiogram (ECG) Parameters measure: Clinically Significant Abnormal Physical Examination measure: Concomitant Medications measure: Study Feasibility Outcome: Recruitment Rate measure: Study Feasibility Outcome: Rationale for Treatment Discontinuation measure: Study Feasibility Outcome: Study Withdrawal Rate measure: Study Feasibility Outcome: Incidence of Immune-Related Adverse Events (irAEs) measure: Study Feasibility Outcome: Number of Cycles of dostarlimab Completed measure: Qualitative Evaluation by Semi-Structured Interview to gather valuable consumer feedback to inform future clinical research programs. measure: Participant Burden Assessment measure: Participant Burden Assessment - Adverse Events measure: Evaluation of Fertility Outcomes/Pregnancy Plans for WOCBP compare to their pre-treatment reproductive plans. measure: Correlate clinical efficacy (pCR) with irAEs. measure: Fertility outcome within the fertility preservation population - pregnancy rates measure: Fertility outcome within the fertility preservation population - pregnancy loss rates measure: Fertility outcome within the fertility preservation population - live birth rates measure: Fertility outcome within the fertility preservation population - rates of maternal and fetal complications/abnormalities sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Westmead Hospital city: Sydney state: New South Wales zip: 2145 country: Australia name: Sara Baniahmadi role: CONTACT phone: 07 3346 5073 email: s.baniahmadi@uq.edu.au name: Alison Brand, Professor role: PRINCIPAL_INVESTIGATOR lat: -33.86785 lon: 151.20732 facility: Royal Brisbane and Women's Hospital city: Brisbane state: Queensland zip: 4029 country: Australia name: Sara Baniahmadi role: CONTACT phone: 07 3346 5073 email: s.baniahmadi@uq.edu.au name: Vanessa Behan role: CONTACT phone: 07 3346 5590 email: v.behan@uq.edu.au name: Jeffrey Goh, Associate Professor role: PRINCIPAL_INVESTIGATOR lat: -27.46794 lon: 153.02809 facility: Peter MacCallum Cancer Centre city: Melbourne state: Victoria zip: 3000 country: Australia name: Sara Baniahmadi role: CONTACT phone: 07 3346 5073 email: s.baniahmadi@uq.edu.au name: Linda Mileshkin, Professor role: PRINCIPAL_INVESTIGATOR lat: -37.814 lon: 144.96332 hasResults: False

 nctId: NCT06278844 id: 3020 briefTitle: Exercise Capacity Improvement by Conduction System Pacing in heArt Failure patieNts Without Compelling CRT inDication acronym: ESCPAND overallStatus: RECRUITING date: 2023-12-12 date: 2026-09 date: 2027-12 date: 2024-02-26 date: 2024-02-26 name: University Hospital, Antwerp class: OTHER briefSummary: This randomized controlled trial aims to investigate the impact of conduction system pacing in comparison to right ventricular apical pacing on exercise capacity, as measured by peak oxygen uptake (VO2peak), in heart failure patients with indication for pacing but no compelling indication for cardiac resynchronization therapy (CRT). The mechanisms of exercise intolerance in heart failure patients influenced by conduction system pacing will be assessed. conditions: Heart Failure With Reduced Ejection Fraction conditions: Heart Failure With Preserved Ejection Fraction conditions: Heart Conduction Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 75 type: ESTIMATED name: Conduction system pacing name: Right ventricular apical pacing measure: Exercise capacity measure: Exercise capacity measure: Echocardiographic parameters (Ejection Fraction) measure: QRS width measure: Biomarker, N-terminal pro B-type natriuretic peptide levels measure: Health-related quality of life scores sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitair Ziekenhuis Antwerpen status: RECRUITING city: Edegem state: Antwerp zip: 2650 country: Belgium name: Faro Verelst role: CONTACT phone: 038213538 email: faro.verelst@uza.be lat: 51.15662 lon: 4.44504 hasResults: False

 nctId: NCT06278831 id: 2023-02645 briefTitle: Efficacy of Structured SOcial COnsultation and Support in Reducing the FINancial Burden of Radiotherapy acronym: SOCOFIN-1 overallStatus: RECRUITING date: 2023-07-08 date: 2024-05-31 date: 2024-10-15 date: 2024-02-26 date: 2024-02-26 name: University Medical Center Goettingen class: OTHER briefSummary: Objectives:

* Assess the extent of financial burden of patients undergoing radiotherapy
* Identify clinical and socio-economical factors correlated with the occurrence and extent of financial toxicity
* Design a structured social consultation to reduce financial burden induced by radiotherapy

Inclusion criteria:

1. age ≥ 18 years of age
2. indication for radiation treatment of a malignant disease
3. Karnofsky Performance score (KPS) ≥ 70%
4. Life expectancy ≥ 3 months

Exclusion criteria:

1. Inability to provide informed consent
2. Inability to attend study visits and fulfill data collection requirements
3. Simultaneous participation in other studies which could interfere with this study Primary outcome: Financial burden as expressed by the COST score, measured at baseline and 3 months after completion of radiotherapy

Secondary outcomes:

* Socio-Economic factors at baseline
* Health-related quality of life (EORTC QLQ-C30) at baseline and 3 months
* Depression (PHQ-9) at baseline and 3 months
* Coping mechanisms to address financial burden

Primary Endpoint: Influence of secondary outcomes on changes of the primary outcome (COST-Score) between baseline and 3 months.

Secondary Endpoints:

* Changes in the COST-Score over time
* Changes in PHQ-9 over time
* Changes in EORTC QLQ-C30 over time

This is an exploratory pilot study. To assess the compliance and effectiveness of the used methods all patients willing to participate in the given time period will be enrolled.

To be assessed for eligibility: n = 300 To be allocated/randomised (if applicable) to trial: n = 150 To be analysed: n = 120 conditions: Financial Toxicity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 225 type: ESTIMATED name: Questionnaire measure: Financial Toxicity measure: Factors that may influence the occurrence or extent of financial burden measure: Factors that may influence the occurrence or extent of financial burden measure: Factors that may influence the occurrence or extent of financial burden measure: Factors that may influence the occurrence or extent of financial burden sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Medical Center Göttingen status: RECRUITING city: Göttingen state: Niedersachsen zip: 37075 country: Germany name: Rami El Shafie, Prof. Dr. role: CONTACT phone: +4955164505 email: rami.elshafie@med.uni-goettingen.de lat: 51.53443 lon: 9.93228 hasResults: False

 nctId: NCT06278818 id: MNESYS-PE0000006 briefTitle: Effects of Telerehabilitation on Brain Network Connectivity overallStatus: RECRUITING date: 2023-12-07 date: 2024-06-07 date: 2026-03-01 date: 2024-02-26 date: 2024-02-26 name: University of Pavia class: OTHER name: University of Parma name: University of Bologna name: University of Rome Tor Vergata briefSummary: The current project aims at assessing the impact of various cognitive telerehabilitation approaches on patients with Mild Cognitive Impairment (MCI) associated with neurodegenerative diseases, namely Alzheimer's disease (AD) and Parkinson's disease (PD). The study focuses on non-pharmacological interventions to maintain patients' residual functionality, limit disease progression, and improve quality of life for both patients and their caregivers.

This longitudinal and multicenter study applies innovative cognitive telerehabilitation (TR) methods and evaluates their impact on functional parameters obtained with high-density electroencephalogram (HD-EEG) and resting-state functional magnetic resonance imaging (rsFMRI). The goal is to identify neurophysiological correlates of the effects of three different cognitive TR in individuals with MCI due to neurodegenerative conditions.

The study aims to:

* Identify correlations between improvement in cognitive performance and functional brain data.
* Use acquired knowledge to develop neurologically guided TR approaches for broader use.

The research will include patients diagnosed with MCI associated with neurodegenerative diseases. Primary outcome measures include changes in resting-state brain connectivity assessed through HD-EEG and rsFMRI. Secondary outcomes involve the assessment of changes in neuropsychological measures, caregiver burden, immediately after rehabilitation and after longitudinal follow-up.

The study is designed to last 30 months, with follow-up assessments at three time points. The primary outcomes will be evaluated using rsFMRI and HD-EEG instrumental acquisitions, the secondary outcomes will be evaluated using clinical assessments and neuropsychological tests. conditions: Mild Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The neurophysiologist and neuroradiologist will be blinded to the type of rehabilitation treatment (experimental group vs. control). whoMasked: OUTCOMES_ASSESSOR count: 110 type: ESTIMATED name: Cognitive Telerehabilitation name: Control Condition measure: Changes in resting-state brain networks functional connectivity after NBTC treatment measure: Changes in resting-state EEG coherence after NBTC treatment measure: Changes in resting-state EEG coherence after HomeCore treatment measure: Changes in resting-state brain networks functional connectivity after SMRT treatment measure: Changes in neuropsychological and caregiver burden measures after TR sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Mondino Foundation status: RECRUITING city: Pavia zip: 27100 country: Italy name: Cristina Tassorelli, MD role: CONTACT phone: 0382380419 phoneExt: 0039 email: cristina.tassorelli@unipv.it name: Silvia Paola P Caminiti, PhD role: CONTACT phone: 0382380419 phoneExt: 0039 email: silviapaola.caminiti@unipv.it lat: 45.19205 lon: 9.15917 hasResults: False

 nctId: NCT06278805 id: ayk22 briefTitle: Adaptation and Validation of the LUNS for Use in Turkey. overallStatus: RECRUITING date: 2024-03-01 date: 2024-12-01 date: 2025-02-01 date: 2024-02-26 date: 2024-04-11 name: Uşak University class: OTHER name: Ankara University name: Istanbul University briefSummary: According to the most up-to-date knowledge, there is no Turkish comprehensive and validated instrument to assess stroke survivors' unmet needs in the longer term. So, this study aims to translate and adapt the LUNS into Turkish and examine its psychometric properties in survivors living at home after a stroke.

Our hypothesis in this study is:

- The Turkish Longer-term Unmet Needs after Stroke Questionnaire (T-LUNS) is a valid tool for assessing the unmet needs of stroke patients in the Turkish population. conditions: Stroke conditions: Disability Physical conditions: Quality of Life studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 110 type: ESTIMATED name: The reliability and validity study of the T-LUNS measure: The Turkish Longer-term Unmet Needs after Stroke Questionnaire (T-LUNS) measure: The Stroke Impact Scale 3.0 (SIS) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Usak status: RECRUITING city: Uşak zip: 64200 country: Turkey name: Ali Y Karahan role: CONTACT phone: +905386921934 email: ali.karahan@usak.edu.tr lat: 38.67351 lon: 29.4058 hasResults: False

 nctId: NCT06278792 id: Z-2021104 briefTitle: Readily Available Urinary Sodium Analysis in Patients With Acute Decompensated Heart Failure acronym: EASY-HF overallStatus: COMPLETED date: 2022-03-07 date: 2023-07-12 date: 2024-01-05 date: 2024-02-26 date: 2024-02-26 name: Ziekenhuis Oost-Limburg class: OTHER name: Fund for Scientific Research, Flanders, Belgium briefSummary: The goal of this clinical trial is to compare physician-guided (SOC) versus nurse-led natriuresis-guided diuretic therapy in patients with acute decompensated heart failure (ADHF). The main questions it aims to answer are:

* difference in natriuresis and diuresis
* feasibility of the protocol.

Participants will be asked to gather two 24 h urine collections.

Researchers will compare SOC versus nurse-led diuretic titration to see if there is a difference in natriuresis after 48 hours. conditions: Acute Decompensated Heart Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The EASY-HF study was a single-centre, randomized, open-label study comparing standard of care (SOC) diuretic management at the treating physician's discretion with a nurse-led natriuresis-guided protocol in patients with ADHF. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: All physicians were blinded for the spot urinary sodium measurements. Additionally, while urine was collected for the first 48 h in both groups, the analysis was only performed afterwards. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 60 type: ACTUAL name: Diuretic protocol name: Standard of Care measure: Urinary sodium excretion after 48 hours measure: Urinary output after 48 hours measure: Urinary sodium excretion on daily base measure: Urinary output on daily base measure: Achievement of decongestion measure: Diuretic dose measure: User-friendliness device and protocol measure: Weight measure: Number of participants with need for heart failure rehospitalization measure: Rate of all-cause mortality measure: Length of hospital stay measure: Number of participants with severe hypotension measure: Number of participants with abnormal blood parameters sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ziekenhuis Oost-Limburg AV city: Genk state: Limburg zip: 3600 country: Belgium lat: 50.965 lon: 5.50082 hasResults: False

 nctId: NCT06278779 id: X23-0311 briefTitle: Comparative Effectiveness Study of Two Forms of Ketamine for Treatment-resistant Depression acronym: TREK overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-04 date: 2024-02-26 date: 2024-03-13 name: The George Institute class: OTHER name: The University of New South Wales briefSummary: The goal of this study is to compare the effectiveness of two formulations of ketamine - Spravato® and racemic ketamine - in people with treatment-resistant depression (TRD). The main questions it aims to answer are:

* How the two formulations compare in terms of their effectiveness in treating TRD.
* How the two formulations compare in their acceptability to patients, safety, effects on patient quality of life and function, and cost effectiveness.

Participants will be randomised to receive either Spravato® or racemic ketamine treatment and asked to complete some questionnaires to assess the effects on mood, treatment acceptability, side effects, quality of life and function, and health economic outcomes. conditions: Treatment Resistant Depression studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, prospective, parallel group, comparative effectiveness trial. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Primary outcome raters will be blinded to treatment allocation. whoMasked: OUTCOMES_ASSESSOR count: 162 type: ESTIMATED name: Esketamine group name: Racemic ketamine measure: Montgomery-Asberg Depression Rating Scale (MADRS) measure: Montgomery-Asberg Depression Rating Scale (MADRS) score measure: Response - Montgomery-Asberg Depression Rating Scale (MADRS) measure: Remission - Montgomery-Asberg Depression Rating Scale (MADRS) measure: DASS-21 measure: Clinical Global Impression-Improvement (CGI-I) measure: Clinical Global Impression-Severity (CGI-S) measure: Columbia Suicide Severity Rating Scale (C-SSRS) measure: Speed of response - Clinical Global Impression-Improvement (CGI-I) measure: Psychotomimetic symptoms measure: Suicide attempts or gestures measure: Number of Participants with urinary symptoms, as assessed using the Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS) measure: Cognitive Failure Questionnaire scores (CFQ) measure: Ketamine liking/craving score measure: Number of Participants with urinary symptoms, as assessed using the Ketamine Side Effect Tool (KSET) measure: Acceptability Questionnaire measure: All-cause dropouts measure: Recovering Quality of Life Questionnaire (REQOL-10) measure: WHO Disability Assessment Scale (WHODAS-12) measure: Patient Health Questionnaire-9 (PHQ-9) measure: Assessment of Quality of Life Questionnaire (AQoL-8D) measure: Resource Use Questionnaire (RUQ) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Royal Prince Alfred Hospital city: Camperdown state: New South Wales zip: 2050 country: Australia name: Hadley Lindsay role: CONTACT email: SLHD-RPA-KetamineClinic@health.nsw.gov.au name: Nicholas Glozier role: PRINCIPAL_INVESTIGATOR lat: -33.88965 lon: 151.17642 facility: Black Dog Institute city: Randwick state: New South Wales zip: 2031 country: Australia name: Stella Antoniou role: CONTACT email: depressionclinic@blackdog.org.au name: Adam Bayes role: PRINCIPAL_INVESTIGATOR lat: -33.91439 lon: 151.24895 facility: Ramsay Clinic Northside city: St Leonards state: New South Wales zip: 2065 country: Australia name: Mayra Ouriques role: CONTACT email: neuroinfo.nsc@ramsayhealth.com.au name: Colleen Loo role: PRINCIPAL_INVESTIGATOR lat: -33.82344 lon: 151.19836 facility: Ramsay Clinic Lakeside city: Warners Bay state: New South Wales zip: 2282 country: Australia name: Sally Sally Wilkinson role: CONTACT email: ClinicalTrialsUnit.WBP@ramsayhealth.com.au name: Natasha Cairns role: CONTACT email: ClinicalTrialsUnit.WBP@ramsayhealth.com.au name: Michael Bull role: PRINCIPAL_INVESTIGATOR lat: -32.97251 lon: 151.65268 facility: Gold Coast University Hospital city: Southport state: Queensland zip: 4215 country: Australia name: Catherine Donald role: CONTACT email: specialistmooddisorderclinic@health.qld.gov.au name: Shanthi Sarma role: PRINCIPAL_INVESTIGATOR lat: -27.96724 lon: 153.39796 facility: Ramsay Clinic Albert Road city: Melbourne state: Victoria zip: 3004 country: Australia name: Melanie Hurley role: CONTACT email: research.arc@ramsayhealth.com.au name: Malcolm Hopwood role: PRINCIPAL_INVESTIGATOR lat: -37.814 lon: 144.96332 hasResults: False

 nctId: NCT06278766 id: M24-416 briefTitle: A Study to Assess the Mass Balance of [14C] ABBV-552 in Healthy Male Participants Following Single Oral Dose Administration overallStatus: COMPLETED date: 2024-02-21 date: 2024-04-19 date: 2024-04-19 date: 2024-02-26 date: 2024-04-29 name: AbbVie class: INDUSTRY briefSummary: The purpose of this study is to evaluate mass balance, pharmacokinetics and safety of \[14C\] ABBV-552 in healthy, male volunteers following administration of a single oral dose. conditions: Healthy Volunteer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 8 type: ACTUAL name: ABBV-552 measure: Number of Participants with Adverse Events (AEs) measure: Maximum observed concentration (Cmax) of ABBV-552 measure: Time to Cmax (peak time, Tmax) of ABBV-552 measure: Terminal phase elimination rate constant (λz) of ABBV-552 measure: Terminal phase elimination half-life (t1/2) of ABBV-552 measure: Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt) of ABBV-552 measure: Area under the plasma concentration-time curve (AUC) from time 0 to infinite time (AUCinf) of ABBV-552 measure: Amount of ABBV-552 excreted in the urine over the sampling period (Aeu) measure: Percent of ABBV-552 excreted in the urine measure: Renal clearance ABBV-552 (CLr) measure: Amount of ABBV-552 excreted in the feces over the sampling period (Aef) measure: Percent radioactivity excreted in the feces sex: MALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Fortrea Clinical Research Unit Inc /ID# 262684 city: Madison state: Wisconsin zip: 53704 country: United States lat: 43.07305 lon: -89.40123 hasResults: False

 nctId: NCT06278753 id: 2025/05/02 briefTitle: Comparison of Standard Cystoscopy With Carbon Dioxide Cystoscopy overallStatus: RECRUITING date: 2021-07-01 date: 2024-03-01 date: 2024-04-01 date: 2024-02-26 date: 2024-02-26 name: Tepecik Training and Research Hospital class: OTHER briefSummary: For the evaluation of the lower urinary tract after laparoscopic hysterectomy, routine standard saline cystoscopy and carbon dioxide cystoscopy will be compared. conditions: Bladder Injury conditions: Ureter Injury conditions: Surgical Injury conditions: Complication of Surgical Procedure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: carbon dioxide cystoscopy measure: It was aimed to evaluate the effectiveness and reliability of carbon dioxide cystoscopy. measure: It was aimed to evaluate the speed and image quality of carbon dioxide cystoscopy in detecting intravesical masses. sex: FEMALE minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tepecik Training and Research Hospital status: RECRUITING city: İzmir state: Eurasia zip: 35090 country: Turkey name: Ali Turgut role: CONTACT phone: 02324696969 email: iyikliniktepecikeah@gmail.com lat: 38.41273 lon: 27.13838 hasResults: False

 nctId: NCT06278740 id: SCIUSG24 briefTitle: Upper Extremity Pathologies in Spinal Cord Injuries overallStatus: NOT_YET_RECRUITING date: 2024-02-26 date: 2025-02-26 date: 2025-03-26 date: 2024-02-26 date: 2024-02-26 name: Afyonkarahisar Health Sciences University class: OTHER briefSummary: This study aims to determine the relationship between upper extremity pathologies and demographic data, duration of manual wheelchair use, duration of injury, physical examination and musculoskeletal ultrasound measurements in patients with spinal cord injuries. conditions: Spinal Cord Injuries conditions: Upper Extremity Problem conditions: Musculoskeletal Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 174 type: ESTIMATED name: Musculoskeletal Ultrasound measure: Comparison of US findings among participants measure: Visual Analog Scale (VAS) measure: The Physical Examination of the Shoulder Scale (PESS) measure: The Quick Disability of the Arm, Shoulder, and Hand (Quick DASH) measure: American Spinal Injury Association (ASIA) Impairment Scale measure: The Spinal Cord Independence Measure (SCIM-III) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Afyonkarahisar Health Sciences University city: Afyonkarahisar zip: 03100 country: Turkey name: Mahmut Sami DOĞANLAR, MD role: CONTACT phone: +905512579828 email: mahmutdoganlar96@gmail.com name: Nuran EYVAZ, MD role: CONTACT phone: +905334262442 email: eyvaznuran@gmail.com lat: 38.75667 lon: 30.54333 hasResults: False

 nctId: NCT06278727 id: SYSKY-2023-1173-01 briefTitle: Development and Validation of the Prediction Model for Functional Mitral Regurgitation Regression in Heart Failure Patients Taking Guideline-directed Medical Therapy overallStatus: RECRUITING date: 2024-01-01 date: 2025-06-01 date: 2025-12-31 date: 2024-02-26 date: 2024-02-26 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: This observational study is to develop and validate the prediction model for functional mitral regurgitation regression in heart failure patients taking GDMT. The patients diagnosed ≥2+ functional mitral regurgitation by ultrasonic cardiogram are enrolled in this study and would be clinically followed by at least one year (clinical visit at 3 months, 6 months, and 12 months), and then by when the endpoints are reached. conditions: Mitral Regurgitation conditions: Heart Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 270 type: ESTIMATED name: angiotensin-converting enzyme inhibitors/angiotensin II receptor blocker/angiotensin receptor-neprilysin inhibitor name: The development of the prediction model measure: FMR regression rate measure: FMR regression rate measure: composite endpoint sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun-Yatsen Memorial Hospital status: RECRUITING city: Canton state: Guangdong country: China name: Maohuan Lin role: CONTACT lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06278714 id: 0012 briefTitle: Influence of an Inspiratory Muscle Fatigue Protocol on Healthy Youngs on Respiratory Muscle Strength and Heart Rate Variability overallStatus: NOT_YET_RECRUITING date: 2024-03-04 date: 2024-03-11 date: 2024-03-20 date: 2024-02-26 date: 2024-02-26 name: Sierra Varona SL class: OTHER name: Universidad Europea de Madrid 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 inspiratory muscle fatigue and maximal inspiratory pressure, diaphragmatic strength (guided by ultrasound image) and heart rate variability.

According to our hypothesis, the execution of a protocol inducing inspiratory muscle fatigue in healthy youngs could influence cardiorespiratory function.

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, heart rate variability and diaphragmatic strength (ultrasound image), will be conducted. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT 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 count: 18 type: ESTIMATED name: Inspiratory muscle training measure: Respiratory muscle strength measure: Diaphragmatic thickness and thickening fraction measure: Diaphragm movement curve measure: Heart rate variability sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06278701 id: 2024-003-01 briefTitle: The Effect of Late-evening Snacks on Patients With Primary Hepatocellular Carcinoma After Hepatectomy overallStatus: ACTIVE_NOT_RECRUITING date: 2023-11-01 date: 2025-01-31 date: 2025-07-30 date: 2024-02-26 date: 2024-02-26 name: DU Yao class: OTHER briefSummary: Late-evening snacks, in which a portion of food is moved to bedtime while the total amount of food eaten per day remains unchanged, can effectively improve the metabolic state of accelerated catabolism.

The goal of this clinical trial is to learn about the effects of late-evening snacks on health conditions of hepatocellular carcinoma patients who underwent hepatectomy, and to further explore the effects of late-evening snacks on patients' metabolic patterns. The main question it aims to answer are: • the effect of late-evening snacks on the nutritional status of hepatic resection patients with hepatocellular carcinoma;

* the effect of late-evening snacks on the recovery of liver function in liver cancer hepatectomy patients;
* the effect of late-evening snacks on the complication rate of hepatic resection patients with hepatocellular carcinoma;
* the effect of late-evening snacks on long-term quality of life of hepatic resection patients with hepatocellular carcinoma;
* the effect of late-evening snacks on the metabolic pattern of hepatic resection patients with hepatocellular carcinoma.

After learning about the 2 dietary modalities of the late-evening snacks and regular diet, patients will be placed in the different groups according to your preference. Patients who enter the test group will have additional meal 1h before bedtime every day, while patients in the control group will have normal diet. Patients will be asked to :

* eat 1h before bedtime;
* follow the doctor's instructions during their stay in the hospital;
* have follow-up examinations at 1 month, 3 months and 6 months after the operation, after which blood samples will be collected for metabolite testing. conditions: Liver Neoplasms studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study utilizes a grouping method based on patient preference. You will learn about the 2 dietary modalities, the late-evening snacks and the regular diet, and then you will be placed in the different groups according to your preference. Patients who volunteer for the 1h bedtime meal will be in the test group and those who volunteer for the regular diet will be in the control group. Dietary counseling and follow-up visits will be conducted in both groups, the difference being the presence or absence of the 1h bedtime meal pattern. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 106 type: ESTIMATED name: late-evening snacks measure: Albumin rising measure: Prealbumin rising measure: Decrease in Alanine Aminotransferase measure: Decrease in Aspartate Aminotransferase measure: Decrease in Cholinesterase measure: Decrease in Total bilirubin measure: Lower total hospitalization costs measure: Relapse-Free Survival measure: Improved quality of life sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Drum Tower Hospital, Medical School of Nanjing University city: Nanjing state: Jiangsu zip: 210008 country: China lat: 32.06167 lon: 118.77778 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-12-22 uploadDate: 2024-02-02T09:22 filename: Prot_SAP_000.pdf size: 743937 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-12-22 uploadDate: 2024-02-04T04:41 filename: ICF_001.pdf size: 292546 hasResults: False

 nctId: NCT06278688 id: 112R10438Y briefTitle: Precision Probiotic Supplementation in Individuals With Mild Cognitive Impairment overallStatus: NOT_YET_RECRUITING date: 2024-03-18 date: 2025-07-31 date: 2027-07-31 date: 2024-02-26 date: 2024-02-26 name: National Yang Ming University class: OTHER name: National Science and Technology Council name: Far Eastern Memorial Hospital briefSummary: The overarching goal of this randomized-controlled trial is to investigate the role and mechanism of the microbiota-gut-brain axis in MCI. The main questions it aims to answer are:

Aim 1: To investigate the association between gut microbiota, MCI and AD biomarkers. Investigators plan to compare gut microbiota profiles in a well-characterized cohort between individuals with MCI and cognitively normal adults using metagenomics sequencing data. Also, the relationship between gut microbiota and AD biomarkers, such as amyloid PET and plasma tau, will be explored in MCI and cognitively normal adults.

Aim 2: To determine the efficacy of precision probiotic supplementation on cognitive decline (primary outcome) and functional brain changes (secondary outcome) in individuals with MCI due to AD using a randomized, double-blind, placebo-controlled trial. Investigators plan to recruit 120 individuals with MCI due to AD, i.e., MCI with positive amyloid biomarkers. Participants will be randomized to a 12-month supplement of precision probiotics based on the individual gut probiotic profile or placebo. The primary outcome measure will be the changes in cognitive functions over 6 months (primary endpoint) and 12 months. The secondary outcome measure will be resting-state functional brain changes.

Aim 3: To investigate potential mediators underlying the effect of probiotic supplementation. The most apparent mediator will be a shift or changes in gut microbiota. Other potential mediators will be related to decreased lipopolysaccharide, proinflammatory cytokines such as tumor necrosis factor-alpha (TNF-α), interleukin (IL)-6 and IL-10, and increased brain- derived neurotrophic factor, short-chain fatty acid, etc. conditions: Mild Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 120 type: ESTIMATED name: Precision probiotics measure: The changes in attention measure: The changes in memory measure: The changes in executive function measure: The changes in global cognition at the 12th month from baseline. measure: The changes in brain imaging at the 12th month from baseline. sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06278675 id: SEOVA briefTitle: Multiple Study of Electroaccpuncture in ARDS overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2026-06-30 date: 2026-12-31 date: 2024-02-26 date: 2024-04-23 name: Nanjing University of Traditional Chinese Medicine class: OTHER briefSummary: In order to clarify the clinical efficacy of electroacupuncture on inhibiting systemic inflammatory response, improving respiratory mechanics parameters and prognosis in patients with sepsis-related ARDS. conditions: Acute Respiratory Distress Syndrome conditions: Sepsis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 264 type: ESTIMATED name: Acupuncture needles measure: Respiratory mechanics indicators 1 measure: Respiratory mechanics indicators 2 measure: Respiratory mechanics indicators 3 measure: Respiratory mechanics indicators 4 measure: Respiratory mechanics indicators 5 measure: Respiratory mechanics indicators 6 measure: Respiratory mechanics indicators 7 measure: Sedation and analgesia measure: Sedative drug use measure: Analgesic drug use measure: Inflammatory factors measure: CD4、CD8、CD4/CD8 measure: Vasoactive drugs applications measure: CRRT applications measure: ECMO applications measure: All-cause mortality to day 28 measure: All-cause mortality to day 60 measure: ICU-free days measure: Hospital-free days sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine city: Nanjing state: Jiangsu zip: 210029 country: China name: Jun Lu, Doctor role: CONTACT phone: +86 13813865758 email: lujun@njucm.edu.cn lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06278662 id: CIRCUS cmRCT briefTitle: Cohort Multiple Randomized Controlled Trial in Pediatric Asthma acronym: CIRCUS overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2034-04-01 date: 2034-04-01 date: 2024-02-26 date: 2024-02-26 name: Mattienne van der Kamp class: OTHER briefSummary: The overarching goal of this study is to optimize pediatric asthma care and to continuously evaluate variations/innovations of the care (including transformation to remote eHealth care).

Primary Objectives within cmRCT cohort:

* Provide a framework for multiple randomized (eHealth) interventions for asthmatic children
* Generate short- and long-term data on Quality of life (QoL), asthma outcomes (asthma control, lung function), quality of care, self-management capacity, healthcare use, and therapy compliance in a representative secondary care pediatric asthma cohort.

Secondary Objectives within cmRCT cohort:

* Evaluate current pediatric asthma care at the Pediatric department of Medisch Spectrum Twente, in order to explore possible improvements for the pediatric asthma care.
* Compare the short and long-term asthma outcomes between the eHealth care path and the outpatient care path.
* Compose patient risk profiles that include both personal, clinical and exposome markers and clinical asthma endpoints (for example clinical admission/exacerbations). conditions: Pediatric Asthma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The CIRCUS study has a cmRCT design to determine the effects of (eHealth) interventions in asthmatic children. Children are included in the prospective dynamic cohort during outpatient visits. Children and/or their parents are asked to sign consent for three parts of the cmRCT, of which at least consent for part 1 is needed to be eligible for participation:

1. Participating in the prospective dynamic cohort and data collection.
2. Willingness to participate in interventions.
3. Willingness to fill out additional questionnaires and/or do additional measurements if a child is randomly selected for the control group of an intervention, which uses additional outcomes. primaryPurpose: DIAGNOSTIC masking: NONE maskingDescription: The masking is dependent of the future interventions. count: 300 type: ESTIMATED name: video directly observed therapy (vDOT) measure: Asthma control measure: Pediatric Asthma Quality of Life measure: Quality of care measure: Self-management capacity measure: Healthcare use measure: Wheather data measure: Air quality measure: Pollen measure: Medication delivery sex: ALL minimumAge: 4 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06278649 id: 2023-161-Multi-site briefTitle: Relaxation and Guided Imagery as an Intervention for Asthma overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-01-01 date: 2026-01-01 date: 2024-02-26 date: 2024-02-26 name: Pace University class: OTHER name: University of Connecticut name: Touro University briefSummary: The purpose of the current study is to investigate the usefulness of a Relaxation and Guided Imagery intervention for the reduction of asthmatic symptoms in adults and children whose asthma symptoms are aggravated, or triggered by anxiety. This study will replicate the previous literature to further investigate the impact that a Relaxation and Guided Imagery intervention can have on anxiety and related asthmatic symptoms using a multiple baseline (small sample size) research design. Participants will fill out questionnaires, listen to RGI audio tapes, and provide lung functioning samples by blowing into a spirometer. conditions: Asthma conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 5 type: ESTIMATED name: Relaxation and Guided Imagery measure: Asthma measure: Asthma measure: Anxiety measure: Quality of Life sex: ALL minimumAge: 8 Years maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06278636 id: 5745 briefTitle: Laparoscopic Ultrasound Examination: Analysis of Feasibility acronym: LUXA overallStatus: RECRUITING date: 2023-07-18 date: 2024-12-30 date: 2025-01-30 date: 2024-02-26 date: 2024-02-26 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: This is a prospective cohort study to assess the feasibility of the laparoscopic ultrasound examination, directly by surgeons, during minimally invasive gynaecological surgery.

The secondary aims are to examine the learning curve for laparoscopic ultrasound examination and the performance score in obtaining high quality ultrasound images of anatomical parameters by a team of 5 gynecological laparoscopic fellows. The patients' medical history and symptoms will also be recorded to define whether these clinical data can influence the failure rate. With advanced technology, the conventional workflow can be simplified by using laparoscopic ultrasound probes directly by surgeons, to utilize the hospital resources efficiently and to reduce operating times. In this regard, we would like to demonstrate that the application of laparoscopic examination is feasible and easy to learn by surgeons. This innovative technique could open up multiple diagnostic and therapeutic opportunities for the patient, providing potential clinical information useful to the surgeon. conditions: Gynecologic Cancer conditions: Surgical Procedure, Unspecified studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Laparoscopi ultrasound examination measure: feasibility of the laparoscopic measure: the learning curve of fellow surgeons measure: the performance of fellow surgeons sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario Agostino Gemelli, IRCCS status: RECRUITING city: Rome zip: 00168 country: Italy name: Floriana Mascilini, Dr role: CONTACT name: Antonia Carla Testa, Prof role: CONTACT name: Floriana Mascilini role: PRINCIPAL_INVESTIGATOR lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06278623 id: 4935 briefTitle: Focal Muscle Vibration in Parkinson's Disease overallStatus: RECRUITING date: 2023-05-11 date: 2025-12-01 date: 2025-12-01 date: 2024-02-26 date: 2024-02-26 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Postural instability has a major impact on the mobility and daily life activities of Parkinson's disease (PD) patients as it often leads to reduced mobility, insecure stance and falls.

The aim of this study was to evaluate the effect of focal vibration on the static and dynamic balance of a group of Parkinson's disease patients with Hoehn and Yahr (HeY) stage II-III. They underwent three weeks of focal muscle vibration applied to the quadriceps, soles of the feet and trapezius muscles bilaterally in addition to conventional physiotherapy . The static and dynamic balance was assessed at baseline (T0), after 3 weeks of treatment (T1) and after 1 month from the last treatment (T2) with the Tinetti scale and stabilometry evaluations. conditions: Parkinson Disease conditions: Postural; Defect conditions: Rehabilitation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 23 type: ESTIMATED name: Focal Muscle Vibratory Energy (EVM) Treatment measure: Tinetti scale measure: NRS numeric rating scale of pain measure: Stabilometric Test measure: Mc Gill Pain questionnaire sex: ALL minimumAge: 18 Months stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Gianpaolo Ronconi status: RECRUITING city: Roma zip: 00168 country: Italy name: gianpaolo ronconi role: CONTACT phone: +393477123940 email: gronconi@yahoo.it lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06278610 id: 3612 briefTitle: Pelvic Exenteration and Laterally Extended Pelvic Resection acronym: Pre-PEX overallStatus: RECRUITING date: 2020-11-19 date: 2024-12-30 date: 2025-01-31 date: 2024-02-26 date: 2024-02-26 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Growing evidence in literature is supporting the role of ultrasound scan (US) as accurate tool in diagnosis and staging of gynecologic cancers. In particular, different studies demonstrated the accuracy of US in assessing endometrial, cervical, and ovarian cancer in the primary setting. However, the number of studies investigating the role of US in the recurrent setting is limited. Moreover, there is no evidence in literature exploring the role of US in laterally-extended pelvic recurrences from gynecologic cancer, where the Magnetic Resonance Imaging (MRI) scan is still considered the most accurate tool. conditions: Gynecologic Cancer conditions: Surgical Procedure, Unspecified studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 85 type: ESTIMATED name: PELVIC EXENTERATION measure: pelvic exenteration resection. measure: accuracy of US with the accuracy of MRI sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS status: RECRUITING city: Roma zip: 00168 country: Italy name: ANTONIA CARLA Pr TESTA role: CONTACT email: antoniacarla.testa@policlinicogemelli.it name: NICOLO' DR BIZZARRI role: CONTACT phone: 3471771680 email: nicolo.bizzarri@policlinicogemelli.it lat: 41.89193 lon: 12.51133 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2020-05-29 uploadDate: 2023-02-24T13:07 filename: Prot_000.pdf size: 598158 hasResults: False

 nctId: NCT06278597 id: GLC02-22 briefTitle: Automatic Evaluation of the Anterior Chamber Angle Width by a New Non-contact Optical Device overallStatus: RECRUITING date: 2023-09-05 date: 2024-01-20 date: 2025-01-24 date: 2024-02-26 date: 2024-02-26 name: Fondazione G.B. Bietti, IRCCS class: OTHER briefSummary: The aim of the study is to evaluate an objective, non-invasive optical device able to quantify, without eye contact, the width of the irido-corneal angle and to better identify cases of narrow angle or angle closure that may be prevented with relatively simple treatments. conditions: Glaucoma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 65 type: ESTIMATED name: NACA Estimator measure: Agreement between the automatic Narrow Anterior Chamber Angle Estimator grading of peripheral anterior chamber width with clinical grading as performed by Van Herick (VH) test at slit lamp measure: Agreement between the automatic Narrow Anterior Chamber Angle Estimator grading of peripheral anterior chamber width with clinical grading as performed by gonioscopy. measure: Reproducibility (intra-session) and repeatability (inter-session) of the peripheral anterior chamber width (PACW) evaluation by the Narrow Anterior Chamber Angle Estimator measure: Sensitivity and specificity of NACA Estimator grading of PACW in detecting primary angle closure suspects as classified by clinical gonioscopy. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Fondazione GB Bietti status: RECRUITING city: Roma zip: 00184 country: Italy name: Carmela Carnevale, MD role: CONTACT phone: +390677052834 email: carmela.carnevale@fondazionebietti.it name: Francesco Oddone, PhD role: CONTACT phone: +390677052834 email: francesco.oddone@fondazionebietti.it lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06278584 id: 2020001-00 briefTitle: iLux Treatment for Meibomian Gland Dysfunction acronym: MGD overallStatus: COMPLETED date: 2020-10-15 date: 2021-02-01 date: 2022-02-28 date: 2024-02-26 date: 2024-02-26 name: Clínica de Oftalmología de Cali S.A class: OTHER briefSummary: Summary:

Purpose: To compare the safety and efficacy of eyelid treatment with the ILux®-MGD Treatment System in one session versus five sessions of mechanical meibomian gland expression (MMGE) in patients with moderate to severe meibomian gland dysfunction (MGD).

Methods: Prospective, randomized, open-label, controlled clinical trial comparing one session of the ILux® MGD Treatment System versus five sessions of MMGE in both eyes of 130 patients aged ≥18 years with OSDI scores ≥13, total MGS of 15 in the lower lid of each eye and NI-TBUT \&lt;10 s, who were randomized 1:1 to ILux® or MMGE. conditions: Meibomian Gland Dysfunction conditions: Eyes Dry Chronic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 130 type: ACTUAL name: iLUX Treatment System measure: Effectiveness defined as changes from baseline to 1, 3, 6, 9 and 12 months in Non Invasive Tear break-up time (NI-TBUT) in seconds. measure: Effectiveness defined as changes from baseline to 1, 3, 6, 9 and 12 months in Meibomian gland scores (MGS). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clínica de Oftalmología de Cali S.A city: Cali state: Valle Del Cauca zip: 760036 country: Colombia lat: 3.43722 lon: -76.5225 hasResults: False

 nctId: NCT06278571 id: R-2018-785-100 briefTitle: Effect of Education With Mobile App on Metabolic Control in Patients With Type 2 Diabetes overallStatus: RECRUITING date: 2023-01-30 date: 2025-04-30 date: 2025-12-03 date: 2024-02-26 date: 2024-02-26 name: Coordinación de Investigación en Salud, Mexico class: OTHER_GOV briefSummary: The objective of this study is to compare the effect of education through a mobile application with medical and nutritional reinforcement on the metabolic control of Mexican patients with type 2 diabetes attending primary care clinics in Mexico.

The research question is: What is the effect of education through a mobile application with medical and nutritional reinforcement vs.

nutritional and medical reinforcement, versus an educational platform to influence the metabolic control of patients with type 2 diabetes? Multicenter clinical trial in six family medicine units of the Mexican Institute of Social Security. These selected units are: UMF 9, UMF 28, UMF 7, UMF 1, UMF 9 and UMF 10.

Patients with type 2 diabetes will be randomly assigned to the educational intervention through the educational site, (n=160 patients), two clinics will be assigned for the use of the mobile App and the educational site (n=160 patients), and two clinics will be part of the control group (n=160 patients). conditions: Female studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multicenter clinical trial primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Participants are unaware of other intervention arms whoMasked: PARTICIPANT count: 480 type: ESTIMATED name: Educational intervention with App and web site education name: Educational interventión with web site education name: Control group with nutritional therapy measure: Number of participants with glycosylated hemoglobin at control goals measure: Number of participants with iipid profile in control targets measure: Number of participants with body mass index profile in control target measure: Number of patients with changes to a healthy lifestyle measure: The proportion of patients with adequate knowledge of diabetes sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Instituto Mexicano Del Seguro Social status: RECRUITING city: Ciudad de mexico zip: 03100 country: Mexico name: LUBIA Velazquez, PhD role: CONTACT phone: 525523259424 email: lubia2002@yahoo.com.mx name: Gabriela Ortiz, Master role: CONTACT phone: 5543379062 email: lubia2002@yahoo.com.mx name: Abril V Muñoz, PhD role: SUB_INVESTIGATOR name: Jorge Escobedo, Phd role: SUB_INVESTIGATOR name: Ignacio Pineda, Master role: SUB_INVESTIGATOR lat: 19.42847 lon: -99.12766 hasResults: False

 nctId: NCT06278558 id: 2023-02-01 briefTitle: Psychological Factors Influencing Cancer Post-traumatic Growth acronym: CEMA-P overallStatus: RECRUITING date: 2023-11-10 date: 2026-11-10 date: 2027-11-10 date: 2024-02-26 date: 2024-02-26 name: Centre Hospitalier de Valenciennes class: NETWORK name: Ligue contre le cancer, France name: Centre Oscar Lambret name: Centre de Cancérologie Les Dentellières name: Clinique Teissier briefSummary: The study focuses on post-traumatic growth (positive changes linked to appreciation of life, personal strengths, social relationships...) in the context of different types of cancer and with a longitudinal approach to the care pathway. The aim of the study is to better understand whether psychological variables (emotional competence, psychological flexibility, psychological distress) and patients' care satisfaction, assessed at the start of the cancer treatment pathway, can influence their post-traumatic growth at the end of the chemotherapy protocol and 6 months later. conditions: Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 289 type: ESTIMATED name: Interviews with a psychologist/psychiatrist measure: Post-traumatic growth measure: Post-traumatic growth measure: Post-traumatic growth measure: Satisfaction of supportive care needs measure: Satisfaction of supportive care needs measure: Satisfaction of supportive care needs measure: Emotional competence measure: Emotional competence measure: Emotional competence measure: Anxiety and depression symptoms measure: Anxiety and depression symptoms measure: Anxiety and depression symptoms measure: Psychological flexibility measure: Psychological flexibility measure: Psychological flexibility sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier de Valenciennes status: RECRUITING city: Valenciennes zip: 59300 country: France name: FODIL Hanane role: CONTACT phone: 0327140665 email: fodil-h@ch-valenciennes.fr name: Anne Sophie Baudry role: PRINCIPAL_INVESTIGATOR lat: 50.35 lon: 3.53333 hasResults: False

 nctId: NCT06278545 id: MANFREDI PHRCK 2022 briefTitle: Trial Evaluating Modified FOLFIRINOX and Modified FOLFOX in the Treatment of Locally Advanced or Metastatic Small Bowel Adenocarcinoma acronym: FOLFORINOX SBA overallStatus: RECRUITING date: 2024-02-16 date: 2027-02 date: 2029-02 date: 2024-02-26 date: 2024-02-26 name: Centre Hospitalier Universitaire Dijon class: OTHER briefSummary: Randomized, non-comparative, open-label, multi-centre Phase II study to evaluate modified FOLFIRINOX and modified FOLFOX in the locally advenced or metastatic small bowel adenocarcinoma.

The primary objective is to assess the percentage of patients alive without prograssion at 8 months. conditions: Locally Advanced or Metastatic Small Bowel Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 130 type: ESTIMATED name: modified FOLFORINOX name: Modified FOLFOX measure: Assess the percentage of patients alive without progression sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chu Dijon Bourgogne status: RECRUITING city: Dijon zip: 21000 country: France name: Sylvain MANFREDI role: CONTACT phone: +33 03 80 29 37 50 email: sylvain.manfredi@chu-dijon.fr lat: 47.31667 lon: 5.01667 hasResults: False

 nctId: NCT06278532 id: NEGKOG briefTitle: Validation of the Lithuanian Version of the BNSS, CDSS, and the SCoRS overallStatus: RECRUITING date: 2023-12-11 date: 2026-12-11 date: 2026-12-11 date: 2024-02-26 date: 2024-02-26 name: Lithuanian University of Health Sciences class: OTHER briefSummary: This study aims to validate the Lithuanian version of the Brief Negative Symptoms Scale, Calgary Depression Scale for Schizophrenia, and Schizophrenia Cognition Rating Scale in a Lithuanian sample. This will be done by comparing results obtained from the Brief Negative Symptoms Scale, Calgary Depression Scale for Schizophrenia, and Schizophrenia Cognition Rating Scale with results obtained from the Positive and Negative Symptoms Scale, the Montgomery Asberg Depression Rating Scale, and the Montreal Cognitive Assessment test. conditions: Schizophrenia conditions: Negative Symptoms in Schizophrenia conditions: Depressive Symptoms Due to Primary Psychotic Disorder (Diagnosis) conditions: Cognitive Deficit studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 200 type: ESTIMATED name: Brief Negative Symptoms Scale name: The Calgary Depression Scale for Schizophrenia name: The Schizophrenia Cognition Rating Scale measure: Validated Lithuanian version of the Brief Negative Symptoms Scale. measure: Validated Lithuanian version of the Calgary Depression Scale for Schizophrenia. measure: Validated Lithuanian version of the Schizophrenia Cognition Rating Scale. measure: Correlation between negative symptoms and cognitive deficits of schizophrenia measure: Correlation between depressive symptoms and cognitive deficits of schizophrenia measure: Correlation between negative symptoms, cognitive deficits, depressive symptoms of schizophrenia and health-related quality of life sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lithuanian University of Health Sciences Hospital Kaunas Clinics status: RECRUITING city: Kaunas zip: LT-50161 country: Lithuania name: Jonas Montvidas role: CONTACT phone: +37066240919 email: jonas.montvidas@lsmu.lt name: Eimantas Zauka role: CONTACT phone: +37069220076 email: eimantas.zauka@kaunoklinikos.lt lat: 54.90272 lon: 23.90961 facility: Jonas Montvidas status: RECRUITING city: Kaunas zip: LT-53137 country: Lithuania name: Jonas Montvidas role: CONTACT phone: +37066240919 email: jonas.montvidas@lsmu.lt name: Algirdas Musneckis role: CONTACT phone: +37061378748 email: algirdas.musneckis@kaunoklinikos.lt lat: 54.90272 lon: 23.90961 hasResults: False

 nctId: NCT06278519 id: CARAMBOLE briefTitle: CARdiAc Mri and BiOLogical samplEs at the Acute Phase of a Myocardial Infarction (CARAMBOLE) acronym: CARAMBOLE overallStatus: RECRUITING date: 2024-03-01 date: 2026-09-01 date: 2026-09-01 date: 2024-02-26 date: 2024-03-12 name: Poitiers University Hospital class: OTHER name: Fédération Française de Cardiologie briefSummary: ST-Segment Elevation Myocardial infarction (STEMI) corresponding to acute occlusion of cornary artery is the most severe ischemic myocardial disease and a leading cause of mortality of heart failure worldwide. Although acute mortality from STEMI has decreased over the last decades, the prognosis remains pejorative and difficult to anticipate. The best management of STEMI patients depends of predictive factors of clinical prognosis and justifies an active research of these factors, in particular the mechanisms leading to deleterious left ventricular remodeling, myocardial inflammation, reperfusion injury including the no-reflow phenomenon which is a major determinant of heart failure. Cohorts of consecutive STEMI patients, with a comprehensive assessment of clinical, biological and imaging parameters are needed to offer the basis for new hypothese for research or interventions and to precisely evaluate the quality of care provided.

The main objective of this study is to identify new markers: clinical, biological and imaging, treatment response and prognosis after STEMI.

Secondary objectives of the CARAMBOLE cohort are to establish a comprehensive clinical databse, completed with biological samples and imaging data, that can be used in the following areas:

* Descriptive epidemiology of STEMI and myocardial reperfusion
* Evaluation of the clinical implications of the realization of a cardiac MRI at the acute phase of STEMI (regarding no-reflow, LVEF, intra cardiac thrombi)
* Treatments observatory: safety, efficacy, indication of treatments provided in real life compared to the treatments recommended, adherence to treatments, costs
* Quality of life, personal, familial, social and professional consequences of myocardial infarction
* Research of new diagnostic and prognosis biomarkers
* Research projects (e.g risk of developping cgnitive disorders in patients with STEMI as compared to the general population)

Participants will undergo:

* a cardiac MRI at the acute phase of their STEMI (5 +/- 3 days) then at 1 year follow-up
* biological samples including blood, urinary and feces samples, at the acute phase of their STEMI (from admission and up to 8 days) then at 1 year follow-up
* questionnaire assessment regarding their quality of life, cognitive status,and socio-economic conditions at the acute phase and 1 year follow-up of their STEMI. conditions: Myocardial Infarction studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 150 type: ESTIMATED name: Blood, urinary and feces collection name: Cardiac MRI name: Quality of life and cognitive status questionnaire measure: Major Adverse cardiac Events (MACE) measure: Infarct size measure: Infarct size measure: No-reflow size measure: No-reflow size measure: Cardiac enzymes rate measure: Cardiac enzymes rate measure: Cardiac enzymes rate measure: Cardiac enzymes rate measure: Inflammatory markers rate measure: Inflammatory markers rate measure: Inflammatory markers rate measure: Inflammatory markers rate measure: Gut microbiota profiling measure: Gut microbiota profiling measure: Genitourinary microbiota profiling measure: Genitourinary microbiota profiling measure: EQ-5D-3L score (European Quality of Life 5 Dimensions 3 Level version) measure: EQ-5D-3L score (European Quality of Life 5 Dimensions 3 Level version) measure: Codex test measure: Codex test sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: C.H.U. of Poitiers status: RECRUITING city: Poitiers zip: 86000 country: France name: Claire BOULETI, MD role: CONTACT phone: +33 5 49 44 43 25 email: claire.bouleti@chu-poitiers.fr lat: 46.58333 lon: 0.33333 hasResults: False

 nctId: NCT06278506 id: 4612 briefTitle: Resection or Ablation of Small Kidney Tumors acronym: RESTART overallStatus: RECRUITING date: 2024-01-31 date: 2027-12 date: 2037-12 date: 2024-02-26 date: 2024-02-26 name: Karolinska University Hospital class: OTHER briefSummary: Ablative treatments are believed to have a lower rate of complications, shorter hospital stays, and fewer interventions with benign PAD compared to partial nephrectomies in small kidney cancer lesions. The purpose of the study is to compare complications, the frequency of residual tumors, impact on kidney function, differences in quality of life, and health economic factors in a randomised study. We will also compare the oncological outcomes, including survival and recurrence of kidney cancer. conditions: Kidney Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: RCT primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: Ablation name: Surgery measure: Number of participants with surgical complications according to Clavien-Dindo grade 2-5 measure: Radiological signs of a residual tumor at the 6-month follow-up measure: Number of postoperative hospitalization days (LOS) measure: Cancer-specific survival (CSS) measure: Overall survival (OS) measure: Change in eGFR one year after treatment sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Karolinska University Hospital status: RECRUITING city: Stockholm zip: 14186 country: Sweden name: Anders Kjellman, MD, PhD role: CONTACT phone: +46736995258 email: anders.kjellman@regionstockholm.se name: Per-Olof Lundgren, MD, PhD role: CONTACT lat: 59.33258 lon: 18.0649 hasResults: False

 nctId: NCT06278493 id: AL2846-I-0002 briefTitle: A Clinical Study of AL2846 Capsule Combined With Gemzar Injection in the Treatment of Advanced Pancreatic Cancer overallStatus: COMPLETED date: 2018-08-23 date: 2021-10-25 date: 2023-05-01 date: 2024-02-26 date: 2024-02-26 name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. class: INDUSTRY briefSummary: This is a clinical study to observe the tolerance and primary efficacy of AL2846 capsules combined with Gemzar injection in patients with pancreatic cancer, and to determine the recommended dosage and administration method for subsequent clinical studies. conditions: Pancreatic Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 34 type: ACTUAL name: AL2846 capsules name: Gemzar measure: Dose limiting toxicity (DLT) measure: Maximum tolerated dose (MTD) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tianjin Medical University Cancer Hospital city: Tianjin state: Tianjin zip: 300181 country: China lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06278480 id: LNC-MECA-003 briefTitle: Clinical Trial to Evaluate the Regeneration of Articular Cartilage Through Arthroscopy After MegaCarti® Application overallStatus: ACTIVE_NOT_RECRUITING date: 2023-06-23 date: 2024-02-29 date: 2024-02-29 date: 2024-02-26 date: 2024-02-26 name: L&C Bio class: INDUSTRY briefSummary: The MegaCarti® is the decellularized allogeneic cartilage and acts as a cover after bone marrow stimulation to prevent the loss of blood clots and induces cartilage regeneration by assisting in the location of stem cells derived from bone marrow. During the 48-week confirmatory clinical trial of MegaCarti®, patients who simultaneously underwent high tibial osteotomy(HTO) were treated with a group in which MegaCarti® was implanted after microfracture and a group in which microfracture alone was performed. Cartilage regeneration is evaluated in patients with arthroscopy data at the time of fixation removal surgery. conditions: Osteoarthritis, Knee studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 40 type: ACTUAL name: MegaCarti® name: microfracture measure: Comparison of the ICRS-Cartilage Repair Assessment grade-Overall repair assessment measure: Comparison of macroscopic status of regenerated cartilage measure: Comparison of IKDC score measure: Comparison of VAS score measure: Comparison of KOOS score measure: Comparison of WOMAC score measure: Comparison of Kellgren-Lawrence grade measure: Comparison of HKA angle, Posterior Tibial slope sex: ALL minimumAge: 19 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yonsei University Health System, Gangnam Severance Hospital city: Seoul zip: 06273 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06278467 id: KonyaBeyhekimTRH2023 briefTitle: Frequency of Cognitive Dysfunction in Patients With Chronic Low Back Pain overallStatus: COMPLETED date: 2022-03-01 date: 2023-12-15 date: 2024-02-12 date: 2024-02-26 date: 2024-02-26 name: Konya Beyhekim Training and Research Hospital class: OTHER_GOV briefSummary: This study evaluates cognitive dysfunction status and related factors in patients with chronic low back pain over the age of 60. conditions: Cognitive Dysfunction conditions: Low Back Pain studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 107 type: ACTUAL name: visual pain scale (VASpain/fatigue), Beck depression index (BDI), name: Pain catastrophizing scale, sleep quality with a single Likert type question in the Pittsburgh questionnaire name: Roland Morris Disability Questionnaire, quality of life with Short Form-36 ( SF-36), name: Montreal Cognitive Assessment Scale (MOCA); Standard Mini mental test (SMMT) measure: Montreal Cognitive Assessment Scale (MOCA) measure: Standard Mini mental test (SMMT) measure: Short Form-36 ( SF-36) measure: Beck depression scale (BDI) measure: Roland Morris Disability Questionnaire measure: A single Likert type question in the Pittsburgh questionnaire (Sleep quality) measure: VAS pain and VAS fatigue measure: Pain catastrophizing scale sex: ALL minimumAge: 60 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Konya Beyhekim Training and Research Hospital city: Konya state: Selçuklu zip: 42060 country: Turkey lat: 37.87135 lon: 32.48464 facility: University of Health Sciences, Konya Beyhekim Training and Research Hospital, Department of Physical Medicine and Rehabilitation city: Konya zip: 42060 country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False

 nctId: NCT06278454 id: NrtPac-1 id: CTR20240312 type: OTHER domain: Center for Drug Evaluation, NMPA briefTitle: Safety and Efficacy of NRT6008 in Patients With Unresectable Locally Advanced Pancreatic Cancer (LAPC) overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-12 date: 2026-12 date: 2024-02-26 date: 2024-02-26 name: Chengdu New Radiomedicine Technology Co. LTD. class: INDUSTRY briefSummary: This is a single arm, open label, multi-center phase I study, including phase Ia dose escalation and phase Ib dose expansion. Safety review committee (SRC) will be formed to monitor safety and efficacy data through the study. And the independent review committee (IRC) will be formed to monitor efficacy data through the study. conditions: Unresectable Pancreatic Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 58 type: ESTIMATED name: NRT6008 Injection + Systematic chemotherapy measure: Maximum tolerated dose (MTD) or the recommended phase Ⅱ dose (RP2D) measure: Dose-limiting toxicity (DLT) measure: Adverse events (AE) and severe adverse events (SAE) measure: Objective response rate (ORR) measure: Duration of response (DOR) measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Resection rate (R0 and R1) measure: Concentration of tumor biomarkers measure: Numeric rating scale (NRS) of pain measure: Distribution of NRT6008 injection in human body and radioactivity of biological samples sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Henan Cancer Hospital city: Zhengzhou state: Henan country: China name: Suxia Luo role: CONTACT name: Suxia Luo role: PRINCIPAL_INVESTIGATOR lat: 34.75778 lon: 113.64861 facility: Second Affiliated Hospital of Soochow University city: Suzhou state: Jiangsu country: China name: Duanmin Hu role: CONTACT name: Duanmin Hu role: PRINCIPAL_INVESTIGATOR lat: 31.30408 lon: 120.59538 facility: Shanghai Changhai Hospital city: Shanghai state: Shanghai zip: +8602131162338 country: China lat: 31.22222 lon: 121.45806 facility: Chongqing University Cancer Hospital city: Chongqing country: China name: Weiqing Chen role: CONTACT name: Weiqing Chen role: PRINCIPAL_INVESTIGATOR lat: 29.56278 lon: 106.55278 facility: Tianjin Medical University General Hospital city: Tianjin country: China name: Bangmao Wang role: CONTACT name: Bangmao Wang role: PRINCIPAL_INVESTIGATOR lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06278441 id: Zila Özlem KIRBAŞ briefTitle: The Effect of White Noise and Kangaroo Care Practices on Stress Parameters in Newborns With Heel Lancing overallStatus: COMPLETED date: 2023-01-01 date: 2023-09-01 date: 2024-02-10 date: 2024-02-26 date: 2024-02-26 name: Karadeniz Technical University class: OTHER briefSummary: Aim: It is an examination of the effects of white noise and kangaroo care on some physiological parameters (pulse, saturation, crying duration) and stress markers (cortisol and glucose-regulated protein 78 (GRP78)) in heel lancing in newborns.

Methods: In this parallel-group, randomized controlled study, healthy newborns with a gestational age of ≥37 weeks, birth weight of \>2500 g, and an Apgar score of ≥8 at the 1st minute and 5th minute were included. White noise and kangaroo care were applied to newborns in the intervention groups for heel lancing.

Results: Ninety newborns were randomized into three groups (30 in each group). A statistically significant difference was determined between the median values of total crying time according to groups (p\<0.001). A statistically significant difference was determined between the median values of pulse measurements according to the interaction of group and time (p\<0.001). A statistically significant difference was determined between the median values of saturation measurements according to groups (p=0.001). A statistically significant difference was determined between the mean values of cortisol and GRP78 measurements according to the group and time interaction (p\<0.001).

Conclusion: It was concluded that white noise and kangaroo care help reduce newborns' stress in the case of heel lancing. conditions: Healthy Newborns studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is parallel-group, randomized controlled. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Due to the nature of the intervention, blinding could not be done for the participants, and the two researchers who collected the data, but the statistician and two other researchers who analyzed the results were unaware of group allocation. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ACTUAL name: Kangaroo care and White noise measure: Ninety newborns were randomized into three groups (30 in each group). sex: ALL minimumAge: 32 Hours maximumAge: 72 Hours stdAges: CHILD facility: Bayburt University city: Bayburt zip: 69100 country: Turkey lat: 40.25631 lon: 40.22289 hasResults: False

 nctId: NCT06278428 id: DEE UMC briefTitle: Genotype, Phenotype, and Disease Progression of Developmental Epileptic Encephalopathy With Onset Before 2 Years of Age overallStatus: RECRUITING date: 2023-11-01 date: 2028-11-01 date: 2028-11-01 date: 2024-02-26 date: 2024-02-28 name: Number 2 Children's Hospital, Ho Chi Minh City class: OTHER briefSummary: According to estimates by the World Health Organization in 2019, more than 50 million people around the world have epilepsy. Nearly 80% of patients with epilepsy live in developing countries. Among them, children under 2 years old are the group with the highest incidence of epilepsy, and at the same time, the most dangerous epilepsy groups are also likely to start at these ages. World medical literature on epileptic encephalopathy and early-onset development before 2 years of age records that 71% of children have severe intellectual disability and 60% of children show signs of autism spectrum disorder, of which Children with epileptic and developmental encephalopathy due to genetic causes are at higher risk of developing neurodevelopmental disorders than children with epileptic and developmental encephalopathy due to other causes. However, in Vietnam, there is no research on this topic.

The question is what are the phenotypes, genotypes, and progression after 2 years of follow-up of Vietnamese children with epileptic and developmental encephalopathy with onset before 2 years of age? conditions: Epilepsy; Seizure conditions: Child Development conditions: Gene Abnormality conditions: Early Onset Disorder studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Genotye of early-onset developmental epileptic encephalopathy measure: Phenotye of early-onset developmental epileptic encephalopathy measure: Progression of epileptic encephalopathy and early onset developmental epileptic encephalopathy sex: ALL maximumAge: 23 Months stdAges: CHILD facility: Children hospital number 2 status: RECRUITING city: Ho Chi Minh zip: 700000 country: Vietnam name: Thuy-Minh-Thu LT NGUYEN, MD role: CONTACT phone: +84983966371 email: dr.thu.nguyen.neurology@gmail.com lat: 10.82302 lon: 106.62965 hasResults: False

 nctId: NCT06278415 id: P2021/Neonat/PhyCord 1 briefTitle: Physiologically Based Cord Clamping To Improve Neonatal Outcomes After Elective Cesarean Delivery acronym: PhyCord1 overallStatus: RECRUITING date: 2024-01-21 date: 2024-08 date: 2024-09 date: 2024-02-26 date: 2024-02-28 name: Queen Fabiola Children's University Hospital class: OTHER name: The Belgian Kids Fund name: Fonds IRIS-Recherche name: Ars Statistica briefSummary: Before birth, the baby's lungs are filled with fluid and babies do not use the lungs to breathe, as the oxygen comes from the placenta. As delivery approaches, the lungs begin to absorb the fluid. After vaginal delivery, the umbilical cord is clamped and cut after a delay that allows some of the blood in the umbilical cord and placenta to flow back into the baby. Meanwhile, as the baby breathes for the first time, the lungs fill with air and more fluid is pushed out. However, it does not always work out that way. Some babies need to be delivered via cesarean section, a surgical delivery requiring incisions through the abdominal and uterine walls. After cesarean section, the mother is often unable to hold the baby close right away as a result of her own post-surgical care. Moreover, a baby born by planned cesarean section may have breathing problems because of extra fluid staying in the lungs. Thus, the baby must breathe quicker and harder to get enough oxygen enter into the lungs. Although the baby is usually getting better within one or two days, the treatment requires close monitoring, breathing help, and nutritional help as the baby is too tired to suck and swallow milk. Sometimes, the baby cannot recover well and show greater trouble breathing needing intensive care. This further separates the mother and her baby. A possible mean to help the baby to adapt better after cesarean section while staying close to the mother is to delay cord clamping when efficient breathing is established, either spontaneously or after receiving breathing help at birth. In this study, we intend to test this procedure in term infants born by planned cesarean section and see whether the technique helps the baby to better adapt after birth and to better initiate a deep bond with the mother. conditions: Transient Tachypnea of the Newborn studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Physiological based cord clamping name: Differed cord clamping measure: Rate of neonatal mortality measure: Rate of neonatal resuscitation measure: Rate of neonatal respiratory morbidity measure: Number of admission to the NICU or special care baby unit measure: Success of PBCC measure: Time to first breath/cry measure: Changes in physiological variables during neonatal transition measure: Changes in physiological variables during neonatal transition measure: Changes in physiological variables during neonatal transition measure: Changes in physiological variables during neonatal transition measure: Changes in physiological variables during neonatal transition measure: Changes in physiological variables during neonatal transition measure: Early neonatal parameters measure: Early neonatal parameters measure: Hemoglobin level measure: Bilirubin level measure: Number of neonatal adverse events measure: Maternal perioperative parameters measure: Maternal perioperative parameters measure: Maternal perioperative parameters measure: Maternal perioperative parameters measure: Number of maternal adverse events measure: Rate of maternal-infant bonding measure: Rate of maternal-infant bonding measure: Rate of maternal-infant bonding measure: Child developmental assessment measure: Parental satisfaction survey sex: ALL minimumAge: 37 Weeks maximumAge: 42 Weeks stdAges: CHILD facility: CHU Brugmann status: RECRUITING city: Brussels zip: 1020 country: Belgium name: Andrew CARLIN role: CONTACT phone: +3224773295 email: andrew.carlin@chu-brugmann.be name: Andrew CARLIN, MD role: PRINCIPAL_INVESTIGATOR lat: 50.85045 lon: 4.34878 facility: Hôpital Universitair Des Enfants Reine Fabiola status: RECRUITING city: Brussels zip: 1020 country: Belgium name: Anna AMORUSO role: CONTACT phone: +3224773250 email: anna.amoruso@hubruxelles.be name: Anna AMORUSO, MD role: PRINCIPAL_INVESTIGATOR lat: 50.85045 lon: 4.34878 hasResults: False

 nctId: NCT06278402 id: JinnahH briefTitle: Efficacy of Oral Tofacitinib in Moderate to Severe Alopecia Areata, Totalis and Universalis at Tertiary Care Hospital, Karachi. overallStatus: COMPLETED date: 2023-07-01 date: 2024-01-06 date: 2024-01-16 date: 2024-02-26 date: 2024-02-26 name: Jinnah Hospital class: OTHER briefSummary: To determine the efficacy of oral Tofacitinib in the treatment of moderate to severe alopecia areata, totalis and universalis at tertiary care hospital of Karachi, Pakistan. Efficacy of treatment in patients presenting with alopecia areata will be assessed using SALT Score on follow up at 6,12 and 24 weeks where four categories of treatment response were defined: 0 (re-growth ≤10%), 1 (11-25%), 2 (26-50%), 3 (51-75%) and 4 (re-growth \>75%). Efficacy will be considered if re-growth ≥ 2. conditions: Alopecia Areata conditions: Alopecia Totalis conditions: Alopecia Universalis studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This study includes patients with moderate to severe Alopecia Areata, totalis and universalis. The efficacy of JAK 1/3 inhibitor, Tofacitinib will be assessed by using SALT score (Severity of Alopecia Tool) at Baseline, 06 weeks, 12 weeks and 24 weeks. Oral Tofacitinib given at a dose of 5 mg twice daily after relevant investigations. The data will be analyzed in SPSS version 23. primaryPurpose: TREATMENT masking: NONE count: 30 type: ACTUAL name: Tofacitinib measure: Alopecia sex: ALL minimumAge: 15 Years maximumAge: 60 Years stdAges: CHILD stdAges: ADULT facility: Misbah Zari Qadir city: Karachi state: Sindh country: Pakistan lat: 24.8608 lon: 67.0104 hasResults: False

 nctId: NCT06278389 id: ADYY-ACC017-101 id: CTR20240167 type: REGISTRY domain: chinadrugtrials.org.cn briefTitle: Single Ascending Dose, Food Effects and Drug-Drug Interactions of ACC017 Tablets in Healthy Adult Participants overallStatus: RECRUITING date: 2024-01-24 date: 2024-04-23 date: 2024-04-23 date: 2024-02-26 date: 2024-03-05 name: Jiangsu Aidea Pharmaceutical Co., Ltd class: INDUSTRY name: Chengdu Aidea Pharmaceutical Technology Co., Ltd briefSummary: The objective of this clinical trial is to investigate the safety and tolerability of single ascending dose ACC017 tablets in Chinese healthy adult participants. This study aims to address the following major questions:

* Recommended dosage for ACC017 tablets used in phase Ib/IIa trial;
* The pharmacokinetic (PK) characteristics of single dose ACC017 tablets;
* The effect of food (FE) on the PK of ACC017 tablets;
* Drug-drug interactions (DDIs) when ACC017 tablets are co-administered with emtricitabine and tenofovir alafenamide fumarate (FTC/TAF) tablets (II). conditions: Healthy Adult Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 52 type: ESTIMATED name: ACC017 tablets name: Emtricitabine and Tenofovir Alafenamide Fumarate Tablets measure: Frequency, causality, severity, and expectedness of adverse events (AEs) measure: ACC017 PK parameter: Cmax (after a single mono-drug administration under the fasting condition) measure: ACC017 PK parameter: C24h (after a single mono-drug administration under the fasting condition) measure: ACC017 PK parameter: AUC0-t (after a single mono-drug administration under the fasting condition) measure: ACC017 PK parameter: AUC0-∞ (after a single mono-drug administration under the fasting condition) measure: ACC017 PK parameter: Tmax (after a single mono-drug administration under the fasting condition) measure: ACC017 PK parameter: t1/2 (after a single mono-drug administration under the fasting condition) measure: ACC017 PK parameter: Vz/F (after a single mono-drug administration under the fasting condition) measure: ACC017 PK parameter: CL/F (after a single mono-drug administration under the fasting condition) measure: ACC017 PK parameter: λz (after a single mono-drug administration under the fasting condition) measure: ACC017 PK parameter: AUC_%Extrap (after a single mono-drug administration under the fasting condition) measure: ACC017 PK parameter: MRT0-t (after a single mono-drug administration under the fasting condition) measure: ACC017 PK parameter: MRT0-∞ (after a single mono-drug administration under the fasting condition) measure: Vital signs: temperature measure: Vital sign: pulse measure: Vital signs: blood pressure measure: Vital signs: respiration measure: Electrocardiogram (ECG): heart rate measure: Electrocardiogram (ECG): PR interval measure: Electrocardiogram (ECG): QRS duration measure: Electrocardiogram (ECG): QTc interval measure: ACC017 PK parameter: Cmax measure: ACC017 PK parameter: C24h measure: ACC017 PK parameter: AUC0-t measure: ACC017 PK parameter: AUC0-∞ measure: ACC017 PK parameter: Tmax measure: ACC017 PK parameter: t1/2 measure: ACC017 PK parameter: Vz/F measure: ACC017 PK parameter: CL/F measure: ACC017 PK parameter: λz measure: ACC017 PK parameter: AUC_%Extrap measure: ACC017 PK parameter: MRT0-t measure: ACC017 PK parameter: MRT0-∞ sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Beijing Ditan Hospital Capital Medical University status: RECRUITING city: Beijing zip: 100015 country: China name: Fujie Zhang role: CONTACT email: treatment@chinaaids.cn name: Chaoying Hu role: CONTACT email: hucarol@126.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06278376 id: f/2023/045 briefTitle: Evaluation of Diagnoses and Clinical Outcomes in Children Undergoing MRI Scans overallStatus: ACTIVE_NOT_RECRUITING date: 2023-04-25 date: 2024-12-31 date: 2024-12-31 date: 2024-02-26 date: 2024-02-26 name: Jessa Hospital class: OTHER briefSummary: The aim of this study is to evaluate the indications and therapeutical consequences of MRI scans of (young) children undergoing risky remote anaesthesia. The investigators want to aim for a clear indication in children undergoing MRI in the future before undergoing possible unnecessary procedures and MRI scans. conditions: Magnetic Resonance Imaging studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 410 type: ACTUAL measure: Incidence measure: Therapeutical implications: diagnosis measure: Therapeutical implications: treatment measure: Clinical indications measure: Evaluation of body part measure: Evaluation of symptoms measure: Clinical outcome: adverse event measure: Clinical outcome: surgery measure: Clinical outcome: admission to hospital measure: Clinical outcome: mortality measure: Evaluation of age measure: Influence of COVID-19 pandemic sex: ALL minimumAge: 6 Months maximumAge: 16 Years stdAges: CHILD facility: Jessa hospital city: Hasselt zip: 3500 country: Belgium lat: 50.93106 lon: 5.33781 hasResults: False

 nctId: NCT06278363 id: StrokeSex_23 briefTitle: Sexual Nursing Care in Stroke Patients acronym: StrokeSex_23 overallStatus: RECRUITING date: 2023-11-01 date: 2024-06-30 date: 2025-04-30 date: 2024-02-26 date: 2024-03-28 name: IRCCS Centro Neurolesi "Bonino-Pulejo" class: OTHER briefSummary: The study aims to assess the impact of "sexual nursing care" on sexual dysfunctions in Italian stroke patients.

The method involves a randomized clinical trial with two groups: one receiving specific sexual care and the other standard care, both involving the partner. Various assessment scales are used, and four outpatient interventions are administered over six months.

Results indicate improvement in body awareness, management of sexual dysfunctions, relational dynamics, and quality of life for both patients and partners.

In conclusion, the importance of sexual health in stroke patients is highlighted as an indicator of quality of life. Targeted nursing interventions can facilitate timely diagnosis and a personalized approach to patients and partners. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: We aim to assess the effectiveness of an intervention in stroke subjects to increase awareness of sexual health, effectively manage sexual dysfunctions, reduce their frequency, and enhance psychophysical well-being. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Participant Masking: Participants are unaware of the treatment they are receiving. This helps prevent biases in reporting outcomes based on knowledge of the treatment.

Care Provider Masking: The individuals providing care, such as therapists or nurses, are also unaware of the treatment assigned to each participant. This prevents them from inadvertently influencing outcomes based on their knowledge of the treatment.

Investigator Masking: The individuals responsible for collecting and analyzing the data are blinded to the treatment allocation. This helps ensure impartiality and prevents biases in data interpretation.

Outcomes Assessor Masking: Individuals responsible for assessing the outcomes of the study, such as evaluating patient progress or interpreting test results, are blinded to the treatment group to which participants belong. This prevents biases in outcome assessment. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 113 type: ESTIMATED name: Sexual Nursing care name: Standard Nursing Care measure: Effectiveness of "sexual nursing care" intervention in enhancing sexual awareness measure: psychosocial well-being and relational dynamics of stroke patients and their partners sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Centro Neurolesi Bonino Pulejo status: RECRUITING city: Messina state: Italy/Messina zip: 98124 country: Italy name: Maria Grazia Maggio, PsyD, PhD role: CONTACT phone: +39-09060128840 email: mariagrazia.maggio@irccsme.it name: Maria Grazia Maggio, PsyD, PhD role: PRINCIPAL_INVESTIGATOR lat: 38.19394 lon: 15.55256 hasResults: False

 nctId: NCT06278350 id: D2570-201 briefTitle: Evaluate the Efficacy and Safety of D-2570 in Participants With Moderate-to-Severe Plaque Psoriasis overallStatus: RECRUITING date: 2024-02-04 date: 2024-12-31 date: 2025-03-31 date: 2024-02-26 date: 2024-02-26 name: InventisBio Co., Ltd class: INDUSTRY briefSummary: This is a randomized, double-blind, placebo-controlled, multicenter clinical trial in participants with moderate-to-severe plaque psoriasis . conditions: Plaque Psoriasis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 160 type: ESTIMATED name: D-2570 name: Placebo measure: Percentage of subjects with at least 75% improvement in PASI measure: Percentage of subjects with at least 75% improvement in PASI measure: Percentage of subjects with at least 90% improvement in PASI measure: Percentage of subjects with 100% improvement in PASI measure: Percentage improvement in PASI measure: Percentage of subjects with a PGA measure: The main PK parameters ：Time to maximum measured plasma concentration（Tmax） measure: The main PK parameters ：Peak Plasma Concentration（Cmax) measure: The main PK parameters：Area under the plasma concentration versus time curve（AUC） measure: The main PK parameters：Vz/F (apparent volume of distribution) measure: The main PK parameters： Half-life（t1/2） measure: The main PK parameters： Mean Residence Time (MRT) measure: The main PK parameters：CL/F (apparent clearance) measure: Weight and height will be combined to report BMI in kg/m^2 measure: Incidence and severity of AEs based on NCI CTCAE V5.0 measure: Incidence and severity of TEAEs based on NCI CTCAE V5.0 sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University People's Hospital status: RECRUITING city: Beijing country: China name: Jianzhong Zhang role: CONTACT phone: 13911815813 email: rmzjz@126.com name: Cheng Zhou role: CONTACT phone: 010-88325470 email: zhoucheng@live.cn lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06278337 id: C19-35 briefTitle: X-linked Moesin Associated Immunodeficiency acronym: X-MAIDReg overallStatus: RECRUITING date: 2021-08-12 date: 2026-08-12 date: 2027-01-12 date: 2024-02-26 date: 2024-02-26 name: Institut National de la Santé Et de la Recherche Médicale, France class: OTHER_GOV briefSummary: Moesin deficiency was initially described in 7 male participants aged 4 to 69 years and is characterized by lymphopenia of the 3 lineages and moderate neutropenia. Genetically, 6 out of 7 participants had the same missense mutation in the moesin gene located on the X chromosome. The 7th patient has a mutation leading to the premature introduction of a STOP codon into the protein.Clinically the 7 participants with X-linked moesin-associated immunodeficiency all presented with recurrent bacterial infections of the respiratory, gastrointestinal or urinary tracts, and some had severe varicella.Therapeutically, in the absence of a molecular diagnosis and due to his SCID-like phenotype, one patient was treated with geno-identical hematopoietic stem cell transplantation . The remaining are untreated or treated with immunoglobulin substitution and/or prophylactic antibiotics.

Since this study, the moesin gene has been integrated into DNA chips used for the molecular diagnosis of immune deficiencies in several countries. Physicians in Canada, the United States, Japan, South Africa and Europe have contacted us with a total of 16 known participants to date. Because of their very low severe, uncontrolled CMV infection and the absence of treatment recommendations, two 2 American participants were treated with allogeneic transplantation with severe post-transplant complications (1), and one of the participants died as a result of the transplant. Management of XMAID participants therefore varies widely from country to country, depending on age at diagnosis and clinical picture. It ranges from no treatment treatment (associated with recurrent infections and skin manifestations), IgIv substitution and/or antibiotic prophylaxis antibiotic prophylaxis, with low toxicity and apparent efficacy, and allogeneic transplantation, with all the risks risks involved (graft-related toxicity, graft versus host, disease, rejection, risk of infection). The Investigators therefore feel it is important to review the diagnosis, clinical presentation and management of X-MAID participants. The study the investigator propose will enable to understand the presentation of X-MAID participants, establish guidelines and provide the best treatment for each patient according to his or her clinical picture conditions: Immune Deficiency conditions: Autoimmune Diseases conditions: Infections conditions: Diagnosis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 16 type: ESTIMATED name: genetic restrospective study measure: The main objective measure: Secondary objectives1 measure: secondary objectives 2 measure: secondary objective 3 measure: secondary objectives 4 measure: secondary objective 5 sex: MALE minimumAge: 4 Years maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: National Institutes of Health status: NOT_YET_RECRUITING city: Bethesda state: Maryland zip: 20892 country: United States name: Luigi Notarangelo, Doctor role: CONTACT lat: 38.98067 lon: -77.10026 facility: Perelman School of medecine status: NOT_YET_RECRUITING city: Philadelphia state: Pennsylvania zip: 19050 country: United States name: Jennifer Heimall, Pr role: CONTACT lat: 39.95233 lon: -75.16379 facility: Brown University status: NOT_YET_RECRUITING city: Providence state: Rhode Island zip: 02912 country: United States name: Anthony Hayward role: CONTACT lat: 41.82399 lon: -71.41283 facility: Genomic Research Centre, School of Biomedical Sciences Institute of Health and Biomedical Innovation status: NOT_YET_RECRUITING city: Brisbane zip: 4001 country: Australia name: Lyn Griffith, Pr role: CONTACT lat: -27.46794 lon: 153.02809 facility: Hôpital Universitaire de la Reine Fabiola status: NOT_YET_RECRUITING city: Bruxelles zip: 1020 country: Belgium name: Catherine Heijmans, Doctor role: CONTACT lat: 50.85045 lon: 4.34878 facility: Hôpital Necker status: RECRUITING city: Paris zip: 75015 country: France name: Benedicte NEVEN role: CONTACT lat: 48.85341 lon: 2.3488 facility: CHU Rennes, CNRS UMR 629 status: RECRUITING city: Rennes zip: 35000 country: France name: Virginie Gandemer, Doctor role: CONTACT lat: 48.11198 lon: -1.67429 facility: CHU St Etienne Hôpital Nord status: NOT_YET_RECRUITING city: Saint-Étienne zip: 42270 country: France name: Jean-Louis STEPHAN, Doctor role: CONTACT lat: 45.43389 lon: 4.39 facility: Tokyo Medical and Dental University (TMDU) status: NOT_YET_RECRUITING city: Bunkyō-Ku zip: 1138510 country: Japan name: Kohsuke Imai, Pr role: CONTACT lat: 35.37517 lon: 139.92991 facility: Departments of Internal Medicine and Immunology status: NOT_YET_RECRUITING city: Rotterdam country: Netherlands name: Virgil Dalm role: CONTACT lat: 51.9225 lon: 4.47917 hasResults: False

 nctId: NCT06278324 id: C1736 id: 2023-A02286-39 type: REGISTRY domain: ANSM briefTitle: Effectiveness of a Nasal Spray on Viral Respiratory Infections overallStatus: RECRUITING date: 2024-01-26 date: 2024-05 date: 2024-07 date: 2024-02-26 date: 2024-02-26 name: CEN Biotech class: INDUSTRY name: Urgo Research, Innovation & Development briefSummary: There is no cure for cold or flu, most people recover in about within two weeks. Paracetamol may be used to reduce aches or treat fever, headache, or body aches. Antiviral solutions ranging from simple universal saline solutions to novel compounds have been proposed to provide a temporary barrier to prevent viral infection and propagation.

The nasal spray "Humer Stop Virus" is indicated in patients presented with early symptoms of viral respiratory infection. This spray forms a protective barrier in the nasal mucosa which is the main entry of the upper air respiratory system viruses. The spray traps the viruses and helps the organism to eliminate them before they multiply themselves.

This clinical investigation is conducted to assess the performance, clinical benefit and safety of this nasal spray in patients with early symptoms of acute respiratory disease whether or not infection is related to common cold, flu or COVID virus. Indeed, presence of early symptoms of acute respiratory infection does not always imply viral infectionAntigen self-tests are available to confirm viral infection with flu viruses or severe acute respiratory syndrome (SARS-CoV-2). However, influenza and other winter viruses are not systematically searched for in general population, because this is of neither collective nor individual interest. To be as pragmatic as possible, we chose to assess performance and safety of the nasal spray on intended users in real conditions. Patients with early symptoms of cold, flu or COVID, are enrolled regardless their PCR test positivity confirming viral infection at the time of enrollment. For study needs, the primary endpoint, which aims to assess the performance of the nasal spray in terms of stopping the viral infection, is assessed in a subgroup of patients with a positive PCR test with flu, COVID or common cold virus in the nasal sample collected at enrollment. conditions: Acute Respiratory Tract Infection conditions: Flu, Human conditions: COVID-19 conditions: Common Cold studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controlled Trial, parallel arms (1:1 allocation ratio), single center, with a blind assessment for primary outcome primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Blinded assessment of viral load analyses whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Nasal Spray HSV Treatment measure: Performance of nasal spray in eliminating viruses measure: Changes from baseline in viral load measure: Rate of patients cleared from viral infection measure: Rate of patients with improved viral infection measure: Rate of patients with worsening viral infection measure: Rate of patients with new viral infection measure: Changes in symptom severity measure: Duration of illness measure: Time to clinical improvement of the symptoms measure: Adverse event occurence measure: Patient opinion of nasal spray measure: Nasal spray safety sex: ALL minimumAge: 18 Years maximumAge: 84 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cen Experimental status: RECRUITING city: Dijon state: Burgundy zip: 21000 country: France name: Amandine FRY role: CONTACT phone: 0033380680513 email: amandine.fry@groupecen.com name: Carole PERRIN, MD role: PRINCIPAL_INVESTIGATOR lat: 47.31667 lon: 5.01667 hasResults: False

 nctId: NCT06278311 id: 20235761 briefTitle: Correlation of Toxins With Gastrointestinal (GI) and Overall Health overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-02 date: 2025-02 date: 2024-02-26 date: 2024-03-28 name: Vibrant America Clinical Lab class: INDUSTRY name: Los Angeles Integrative Gastroenterology and Nutrition, Inc briefSummary: The goal of this observational study is to evaluate the levels of urinary environmental toxins, heavy metals, PFAS and mycotoxins with gastrointestinal (GI) and overall health. conditions: Gastrointestinal Diseases studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 250 type: ESTIMATED measure: Determination of the Total Toxicity score measure: Determination of the Symptom score measure: Determination of the Diagnosis score measure: Determination of individual scores sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Los Angeles Integrative Gastroenterology and Nutrition, Inc city: Los Angeles state: California zip: 90067 country: United States name: Dr. Farshid S Rahbar, MD role: CONTACT phone: 310-289-8000 email: Research@laintegrativegi.com name: Dr. Farshid S Rahbar, MD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 facility: Vibrant America Clinical Lab city: Santa Clara state: California zip: 95054 country: United States name: Hari K Krishnamurthy, MS role: CONTACT phone: 866-364-0963 email: hari@vibrantsci.com name: Hari K Krishnamurthy, MS role: PRINCIPAL_INVESTIGATOR lat: 37.35411 lon: -121.95524 hasResults: False

 nctId: NCT06278298 id: REC/012/003318 briefTitle: Different Level of ECSWT in Post Mastectomy Lymphedema overallStatus: ACTIVE_NOT_RECRUITING date: 2023-03-01 date: 2024-06-01 date: 2025-01-01 date: 2024-02-26 date: 2024-02-26 name: Cairo University class: OTHER briefSummary: to investigate the effectiveness of different dosages of ECSW in the treatment of post mastectomy lymphedema volume and quality of life (Qol) conditions: Lymphedema of Upper Limb studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 45 type: ESTIMATED name: Shockwave name: CDT measure: lymphedema volume measure: skin thickness of the arm sex: FEMALE minimumAge: 30 Years maximumAge: 60 Years stdAges: ADULT facility: Cairo University city: Giza state: Dokki zip: 12612 country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06278285 id: 21-AOIP-01 briefTitle: Effect of Agonist GLP1 on Adipose Tissue in Patients Undergoing Bariatric Surgery acronym: Maigrir_OT overallStatus: RECRUITING date: 2024-03-06 date: 2025-09-01 date: 2026-03-01 date: 2024-02-26 date: 2024-03-18 name: Centre Hospitalier Universitaire de Nice class: OTHER briefSummary: Normalizing weight gain and preventing the redistribution of body fat is a major health issue, and could help prevent the onset of various symptoms of metabolic syndrome. Above all, it is important to understand the mechanisms by which these different treatments affect adipose tissue. To this end, the investigators will first study the impact of GLP-1 analogues on adipose tissue. The main objective is to show that subjects treated with a GLP-1 agonist have a significant change in their oxytocin levels compared with subjects not treated with a GLP-1 agonist. conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 40 type: ESTIMATED name: Blood GLP1 name: Blood No treated GLP1 measure: Rate of oxytocin measure: Fibrosis rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Nice - Hôpital de l'Archet status: RECRUITING city: Nice state: Alpes-maritimes zip: 06200 country: France name: Roux Christian, PhD role: CONTACT phone: +33492039220 email: roux.c@chu-nice.fr name: Iannelli Antonio, PhD role: CONTACT phone: +33492035900 email: iannelli.a@chu-nice.fr name: Iannelli Antonio, PhD role: PRINCIPAL_INVESTIGATOR lat: 43.70313 lon: 7.26608 hasResults: False

 nctId: NCT06278272 id: AIPEI briefTitle: AI Evaluation of Pancreatic Exocrine Insufficiency in CP Patients overallStatus: COMPLETED date: 2023-03-01 date: 2024-01-01 date: 2024-01-01 date: 2024-02-26 date: 2024-02-26 name: Changhai Hospital class: OTHER briefSummary: Early assessment of pancreatic exocrine insufficiency (PEI) is crucial for determining appropriate chronic pancreatitis (CP) treatment plans, thereby avoiding unnecessary suffering and further complications in patients. A total of 504 patients with CP who underwent fecal elastase-1 test and contrast-enhanced CT at Changhai Hospital between January 2018 and April 2023 were enrolled in this study. The investigators aim to establish a fully automated workflow to establish a PEI classification model based on radiomic features, semantic features and deep learning features on enhanced CT images for evaluating the severity of PEI. conditions: Chronic Pancreatitis conditions: Exocrine Pancreatic Insufficiency conditions: Machine Learning conditions: Deep Learning studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 504 type: ACTUAL measure: Classification of pancreatic exocrine insufficiency sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Changhai Hospital city: Shanghai zip: 200433 country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06278259 id: P.T.REC/012/005023 briefTitle: Telerehabilitation Program Bases Aerobic and Baduanjin Exercises in Post Stroke Elderly Patients overallStatus: RECRUITING date: 2024-02-20 date: 2025-02-28 date: 2025-09-30 date: 2024-02-26 date: 2024-03-08 name: Cairo University class: OTHER briefSummary: It is an interventional study in which 60 stroke patients estimated to enroll according to random allocation and will divided into two groups. The study group participants will involve in Telerehabilitation sessions will be based on low-impact rhythmic movements, guided by video with the Baduanjin exercise program ,the control group will receive the same aerobic exercises only conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Telerehabilitation program bases aerobic and Baduanjin exercises name: Telerehabilitation program bases aerobic exercises measure: physical function measure: Cognitive function measure: sleep quality measure: participants' satisfaction with the program sex: ALL minimumAge: 65 Years maximumAge: 75 Years stdAges: OLDER_ADULT facility: Faculty of Physical Therapy status: RECRUITING city: Cairo state: Dokki zip: 11432 country: Egypt name: marwa M elsayed, phd role: CONTACT phone: 01156033818 phoneExt: 02 email: marwadd999@gmail.com name: marwa M elsayed, ph.d role: CONTACT phone: 01156033818 phoneExt: 02 email: marwadd999@gmail.com lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06278246 id: 050/2021 briefTitle: Investigating the Muscarinic System in Schizophrenia Using Positron Emission Tomography overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2029-02 date: 2029-02 date: 2024-02-26 date: 2024-02-26 name: Centre for Addiction and Mental Health class: OTHER briefSummary: Within the schizophrenia population, there are individuals that respond to first-line antipsychotic treatments while others do not. The availability of muscarinic M4 subtype receptors (M4R) may play a role as to whether a person with schizophrenia is responsive to first-line antipsychotics or not. The goal of this observational study is to compare the availability of M4R in antipsychotic-free patients with schizophrenia and matched healthy controls. In addition, M4R availability in schizophrenia patients will be examined in relation to response to first line antipsychotics and clinical and cognitive measures. This study may help better understand antipsychotic resistance in schizophrenia and lead to the development of new treatment options, particularly for cognitive deficits and negative symptoms. conditions: Schizophrenia conditions: Schizophreniform Disorders studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 58 type: ESTIMATED name: PET Scan measure: M4 receptor expression measure: Clinical Data Statistical Analysis measure: Statistical Analysis of Cognitive Data measure: Statistical Analysis of Psychopathological Personality Traits in Health Control Group sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre for Addiction and Mental Health city: Toronto state: Ontario zip: M5T1R8 country: Canada lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06278233 id: 2023/85-70 briefTitle: Bihemispheric Transcranial Direct Current Stimulation* on Speech Fluency acronym: TDCS overallStatus: RECRUITING date: 2024-02 date: 2024-06 date: 2024-09 date: 2024-02-26 date: 2024-02-26 name: Biruni University class: OTHER briefSummary: It will be determined whether bihemispheric stimulation (anodal to the left IFG and cathodal to the right IFG) is used with fluency-facilitating conditions for 5 consecutive days in individuals with stuttering and whether there is a difference in terms of the effects seen in speech fluency compared to the sham condition. conditions: Stuttering, Adult studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In this study, a double-blind, randomized controlled research design from experimental research methods will be applied. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: One researcher not involved in any aspect of the study will randomize participants to the sham and tDCS study arms using blocked randomization. To ensure blinding, one researcher will record the administration of the tDCS and assessments, while independent speech-language pathologists will monitor the assessment recordings and score the test items. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: Transcranial direct current stimulation measure: Disfluent syllables measure: Stuttering Severity Instrument- Fourth Edition (SSI-IV) score measure: The Overall Assessment of the Speaker's Experience of Stuttering (OASES) score sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Biruni University status: RECRUITING city: Istanbul state: Zeytinburnu zip: 34015 country: Turkey name: Feyzanur Ocak, Slp role: CONTACT lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06278220 id: Corneal HOA briefTitle: Scheimpflug Versus Placido-disc System in Evaluation of Corneal Higher-Order Aberrations overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-07 date: 2027-02 date: 2024-02-26 date: 2024-02-28 name: Assiut University class: OTHER briefSummary: Aim of work:

To assess the agreement between placido-based topographer (wavelight allegro topolyzer vario) and scheimpflug -based (Oculus Pentacam ) regard measuring corneal higher order aberrations before and after LASIK. conditions: Corneal Higher-order Aberrations studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 36 type: ESTIMATED name: placido-based topographer (wavelight allegro topolyzer vario) and scheimpflug -based (Oculus Pentacam ) measure: Agreement between placido-based topographer (wavelight allegro topolyzer vario) and scheimpflug -based (pentacam) measure: Changes in high order aberrations after LASIK. sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Naglaa Moustafa city: Assiut country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False

 nctId: NCT06278207 id: 22731 briefTitle: An Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions acronym: FINEROD overallStatus: RECRUITING date: 2024-02-15 date: 2024-06-30 date: 2024-06-30 date: 2024-02-26 date: 2024-04-18 name: Bayer class: INDUSTRY briefSummary: This is an observational study, in which data from people in Japan with chronic kidney disease (CKD) together with type 2 diabetes (T2D) are studied. The participants in this study are already receiving the study treatment finerenone as part of their regular care from their doctors. In observational studies, only observations are made without specified advice or interventions. CKD is a long-term progressive decrease in the kidneys' ability to work properly. In people with T2D, the body does not make enough of a hormone called insulin, or does not use insulin well enough. The resulting high blood sugar levels can cause damage to the kidneys. CKD often occurs together with T2D or as a consequence of T2D. Finerenone works by blocking certain proteins, called mineralocorticoid receptors. By doing this, it may reduce damage to kidneys, heart and blood vessels. Finerenone was recently approved in the US and is now available for doctors to prescribe to people with CKD together with T2D. Consequently, there is a need to collect more information about how finerenone is used, its safety and how well it works under real-world conditions. The main purpose of this study is to collect and describe the characteristics of people with CKD and T2D who are receiving initiate finerenone treatment as prescribed by their doctors. To do this, the researchers will collect general information of the participants such as age or gender and data on kidney function and possible heart problems.

The researchers will also collect data on any other disease or medical condition in the participants and on other medications used while taking finerenone.

The data will come from a network of commercial electronic health records (EHRs) and national claims data in Japan. They cover the period from July 1st, 2021 until September 2023. Only already available data is collected and studied. There are no required visits or tests in this study. conditions: Chronic Kidney Disease conditions: Type 2 Diabetes Mellitus studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 2500 type: ESTIMATED name: Finerenone (BAY 94-8862) measure: Participants' characteristics at baseline in a cohort of participants with CKD and T2D who initiate finerenone. measure: Participants' comorbidities at baseline in a cohort of participants with CKD and T2D who initiate finerenone. measure: Participants' comedications at baseline in a cohort of participants with CKD and T2D who initiate finerenone. measure: Proportion of finerenone initiators with and without UACR measurements at baseline measure: Mean UACR in the subcohort with UACR measurements measure: Incidence rate of kidney failure in participants with CKD and T2D that initiate finerenone. measure: Incidence rate of a composite cardiovascular outcome in participants with CKD and T2D that initiate finerenone. measure: Drug utilization patterns in a cohort of participants with CKD and T2D that initiate finerenone. measure: Number of participants who initiate finerenone at a 10 mg dose daily measure: Proportion of participants who continue the original 10 mg dose daily at the 1, 3, 6, and 12 months mark measure: Proportion of participants who up-titrate from 10 mg daily dose to a 20 mg dose daily at the 1, 3, 6, and 12 months mark measure: Number of participants who initiate finerenone at a 20 mg dose daily measure: Proportion of participants who continue the original 20 mg dose daily at the 1, 3, 6, and 12 months mark measure: Proportion of participants who down-titrate from 20 mg daily dose to a 10 mg dose daily at the 1, 3, 6, and 12 months mark sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bayer status: RECRUITING city: Berlin zip: 13353 country: Germany lat: 52.52437 lon: 13.41053 facility: Many Locations status: COMPLETED city: Multiple Locations country: Japan hasResults: False

 nctId: NCT06278194 id: 22.11.2023.589 briefTitle: Masseter Muscle Thickness in Gasser Ganglion Radiofrequency Treatment overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-07-15 date: 2024-11-15 date: 2024-02-26 date: 2024-02-26 name: Başakşehir Çam & Sakura City Hospital class: OTHER_GOV briefSummary: Trigeminal neuralgia is common painful disorder in pain medicine clinics. Gasserian ganglion radiofrequency thermocoagulation is one of the treatment option in patients with trigeminal neuralgia in refractory cases. The most commonly involved branch in trigeminal neuralgia is the mandibular branch. Masseter muscle is innervated by mandibulary nerve branch of the trigeminal nerve.

The radiofrequency thermocoagulation therapy is used to ablate the affected trigeminal nerve branch and some of patients complain of subjective masseter weakness after this procedure.

In theoretical basis, muscles innervated by target nerve are affected from ablation procedure. In this study the primary aim is to evaluate the change of the masseter muscle thickness in patients treated by gasserian ganglion radiofrequency thermocoagulation. The results may also show possible functional effect of the procedure related with masseter muscle. conditions: Trigeminal Neuralgia conditions: Gasserian Ganglion; Lesion studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Gasserian Ganglion Radiofrequency Thermocoagulation measure: Masseter muscle thickness measure: Masseter muscle thickness measure: Masseter muscle thickness sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06278181 id: 2023/08/1545 briefTitle: Diabetes, Metabolic Syndrome and Risk of Malaria in Cameroon overallStatus: RECRUITING date: 2023-09-21 date: 2024-12-30 date: 2025-01-30 date: 2024-02-26 date: 2024-03-01 name: Karolinska Institutet class: OTHER name: University of Dschang name: European Foundation for the Study of Diabetes briefSummary: Non-communicable diseases (NCDs) such as diabetes are increasing in countries where malaria transmission is common. This study aims to investigate the relationship between NCDs and parasitic infections in Cameroon. The investigators will assess the risk of malaria, as well as other parasitic diseases, in a prospectively followed group of adults with diabetes, compared with those without diabetes. Malaria parasites and intestinal worms will be tested using blood and stool collected at four time points during a one-year follow-up. In addition, this project will investigate how natural protection against malaria is affected by diabetes and other risk factors for heart diseases. conditions: Malaria conditions: Diabetes Mellitus conditions: Metabolic Syndrome conditions: Endemic studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED measure: asymptomatic malaria measure: symptomatic malaria measure: schistosoma infection measure: strongyloides infection sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Limbe Regional Hospital status: RECRUITING city: Limbe country: Cameroon name: George Awungafac, MD role: CONTACT phone: +23779750125 email: george.awungafac@ki.se lat: 4.02356 lon: 9.20608 hasResults: False

 nctId: NCT06278168 id: CNR-IRIB-PRO-2024-002 briefTitle: Awareness Training in Children With Autism Spectrum Disorder. overallStatus: RECRUITING date: 2023-06-12 date: 2024-06-01 date: 2025-05-08 date: 2024-02-26 date: 2024-02-26 name: Istituto per la Ricerca e l'Innovazione Biomedica class: OTHER name: Messina, Italy briefSummary: The proposed protocol aims to facilitate awareness and understanding of autism spectrum disorder among children aged 8 to 14 with an IQ between 85 and 115. Conducted once a week for 60 minutes, the protocol encompasses two initial group sessions followed by 5 group meetings, introducing activities to foster self-awareness, cognitive understanding, and an inclusive environment. Subsequently, the protocol advances to 12 individual sessions focused on emotional well-being and self-awareness, integrating Oculus technology and chest sensors for heart rate monitoring. Initiating the intervention, individual family meetings are scheduled to outline intervention goals and phases. The initial group sessions focus on social bonding, cognitive understanding, and creating an accepting atmosphere among participants. Utilizing activities addressing neurodiversity awareness and technological tools like tablets, the sessions encourage discussions on individual differences and sensitivities. The subsequent individual sessions are structured to explore personal values, identify inner critical voices, and develop emotional awareness through exercises exploring emotions and physical sensations. Progressively, the intervention introduces mindfulness, guiding participants to acknowledge emotions as normal and encouraging alignment of daily actions with personal values. Following this, sessions center on building observational skills, recognizing past behaviors, and fostering strengths tied to values. Participants are encouraged to distinguish between their critical "consultant" and the value-driven "explorer," fostering personal growth and reflection. The protocol's later stages delve into identifying personal strengths linked to core values and exploring value-driven goals. Visual exercises, metaphors, and flexible self-views are emphasized, promoting adaptability and self-evolution. The protocol concludes by advocating a flexible self-view, embracing change, and connecting oneself to ever-evolving metaphors like "a cup with changing contents" or "the ever-changing sky." These sessions culminate with visual relaxation facilitated through Oculus technology while simultaneously monitoring participants' heart rates using chest sensors. This comprehensive approach integrates technological tools with emotional and cognitive exercises, providing a multifaceted framework to enhance self-awareness and promote acceptance within the context of neurodiversity. conditions: Autism conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: Awareness training with using Oculus. name: Awareness training without using Oculus measure: Wechsler Intelligence Scale for Children Fourth edition (WISC-IV) measure: Multidimensional Anxiety Scale for Children-Second Edition (MASC 2) measure: Screen for Child Anxiety Related Disorders (SCARED) sex: ALL minimumAge: 8 Years maximumAge: 14 Years stdAges: CHILD facility: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR) status: RECRUITING city: Messina zip: 98164 country: Italy name: Flavia Marino role: CONTACT phone: +393395798263 email: flavia.marino@irib.cnr.it name: Maria Valeria Maiorana role: CONTACT phone: +393285856656 email: mariavaleria.maiorana@irib.cnr.it name: Flavia Marino role: PRINCIPAL_INVESTIGATOR name: Germana Doria role: SUB_INVESTIGATOR name: Chiara Failla role: SUB_INVESTIGATOR name: Noemi Vetrano role: SUB_INVESTIGATOR name: Ileana Scarcella role: SUB_INVESTIGATOR name: Roberta Minutoli role: SUB_INVESTIGATOR name: Paola Chilà role: SUB_INVESTIGATOR name: Giovanni Pioggia role: SUB_INVESTIGATOR name: Gennaro Tartarisco role: SUB_INVESTIGATOR lat: 38.19394 lon: 15.55256 hasResults: False

 nctId: NCT06278155 id: CNR-IRIB-PRO-2024-001 briefTitle: Social Relations Training for Children With ASD overallStatus: RECRUITING date: 2023-04-17 date: 2025-01-15 date: 2025-04-28 date: 2024-02-26 date: 2024-02-26 name: Istituto per la Ricerca e l'Innovazione Biomedica class: OTHER name: Messina, Italy briefSummary: The following protocol was developed with the intention of significantly improving social skills by focusing on increasing relationship skills among children with ASD. Divided into two distinct parts, "Basic Social Relationships" and "Intermediate Social Relationships," the protocol has 4 stages for the former and 5 stages for the latter. Each phase is preparatory to the next, and in addition, a teaching procedure is implemented that adopts three prompt levels (partial, moderate and total), gradually aiming to reduce the assistance provided to encourage independent response. This gradual approach is designed to stimulate greater independence in social interactions.

The training lasts between 6 and 12 months, with one or two weekly group meetings lasting forty-five minutes each. Before the start and at the end of the protocol, participants are assessed using the Vineland scale to evaluate their adaptive behaviors.

The primary goal is to enable children with autism to develop meaningful social skills, providing them with concrete tools to interact more effectively and independently with their peers, thus improving their quality of life and social involvement. The protocol involves two distinct groups, experimental and control group.

The experimental group involves the use of a social robot that acts as a mediator in the interactions among participants. The role of the social robot is to facilitate, reinforce and support the participants' responses during the activities. The therapist coordinates with the social robot, helping to guide, reinforce and support participants' interactions.

In the control group, the therapist takes on the role of mediating interactions, helping and facilitating participants' responses. There is no involvement of a social robot; therefore,the therapist self acts directly to guide, reinforce and support the participants' social interactions. conditions: Autism conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Social relation training with social robot name: Traditional social relations training measure: Vineland-II (Vineland Adaptive Behavior Scales-II - Survey Intervention Form) sex: ALL minimumAge: 5 Years maximumAge: 10 Years stdAges: CHILD facility: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR) status: RECRUITING city: Messina zip: 98164 country: Italy name: Flavia Marino role: CONTACT phone: +393395798263 email: flavia.marino@irib.cnr.it name: Giovanni Pioggia role: CONTACT phone: +393203390892 email: giovanni.pioggia@irib.cnr.it name: Flavia Marino role: PRINCIPAL_INVESTIGATOR name: Germana Doria role: SUB_INVESTIGATOR name: Chiara Failla role: SUB_INVESTIGATOR name: Noemi Vetrano role: SUB_INVESTIGATOR name: Ileana Scarcella role: SUB_INVESTIGATOR name: Roberta Minutoli role: SUB_INVESTIGATOR name: Paola Chilà role: SUB_INVESTIGATOR name: Giovanni Pioggia role: SUB_INVESTIGATOR name: Alfio Puglisi role: SUB_INVESTIGATOR lat: 38.19394 lon: 15.55256 hasResults: False

 nctId: NCT06278142 id: ERTELEME_1 briefTitle: Web-Based Cognitive Behavior Therapy for Procrastination overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-04 date: 2024-07 date: 2024-02-26 date: 2024-02-26 name: Anadolu University class: OTHER briefSummary: The main purpose of this study is to present the development process and project flow of an internet-based self-help intervention programme to reduce the level of procrastination among university students. conditions: Mental Health Issue studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 45 type: ESTIMATED name: Internet Based Intervention - GUIDED name: Internet Based Intervention - WİTHOUT GUİDANCE measure: Tuckman Procrastination Behaviour Scale measure: Cognitive Distortions Questionnaire measure: Time Management Scale measure: Attitude Scale for Internet-Based Interventions measure: Depression Anxiety Stress Scale-21 (DASS-21) measure: Sociodemographic Information Form sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06278129 id: 4146 briefTitle: Evaluation of the Diagnostic and Prognostic Efficacy of MRI in Acute Sensorineural Hearing Loss and Ménière's Disease acronym: MRI_SSHL/MD overallStatus: RECRUITING date: 2018-06-19 date: 2021-04-23 date: 2025-12-31 date: 2024-02-26 date: 2024-02-26 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: Evaluation of the diagnostic and prognostic efficacy of nuclear magnetic resonance imaging in patients with acute sensorineural hearing loss or in patients suffering from probable or definite MD. The neuroradiological and audiological evaluation are held on in the same day in order to better clarify the radiological and clinical correlates. conditions: Sudden Sensorineural Hearing Loss conditions: Meniere Disease conditions: Ménière's Vertigo conditions: Meniere's Disease Aggravated conditions: Inner Ear Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 64 type: ESTIMATED name: Vestibular myogenic potentials measure: Evaluation of inner ear structures in MRI images sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Audiology and Neuroradiology - Milan (Italy) status: RECRUITING city: Milan zip: 20133 country: Italy name: Diego Zanetti, MD Prof role: CONTACT phone: 00390255033936 email: audiologia@policlinico.mi.it name: Federica Di Berardino, MD Prof role: PRINCIPAL_INVESTIGATOR name: Giorgio Conte, MD Prof role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06278116 id: 2024-ALIGNERSCLEANSIGN briefTitle: Comparison of Absorbance Values, Sensory Evaluations and Periodontal Effects of Five Different Products for Clean Aligners Cleansing overallStatus: RECRUITING date: 2024-03-01 date: 2024-06 date: 2024-06 date: 2024-02-26 date: 2024-03-05 name: University of Pavia class: OTHER briefSummary: The aim of the study is to evaluate the most efficient product for the cleaning of Invisalign® clear aligners (Align Technology Inc., San Jose, CA, USA) through objective and subjective assessments after the use of 5 different products. For each aligner, one product is used for 2 weeks until all of them are used, therefore 5 different aligners are required for the study. A periodontal evaluation is conducted to assess variations during the time frame of the study. conditions: Dental Malocclusion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Aligners cleansing with water name: Aligners cleansing with dish soap Svelto name: Aligners cleansing with Polident Antibacterial Denture Cleaner name: Aligners cleansing with Invisalign Cleaning Crystals name: Aligners cleansing with Geldis measure: Change in adsorbance (A) value measure: Changes in patient's perception measure: Changes in Probing Pocket Depth (PPD) values measure: Changes in Gingival Index (GI) values measure: Changes in Bleeding on probing (BOP) measure: Change in Schiff Air Index - Dental sensitivity test measure: Change of the BEWE Index Basic Erosive Wear Examination measure: Change in plaque index (PI): sex: ALL minimumAge: 14 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia status: RECRUITING city: Pavia state: Lombardy zip: 27100 country: Italy name: Andrea Scribante, DDS, PhD role: CONTACT phone: +39 0382516223 email: andrea.scribante@unipv.it lat: 45.19205 lon: 9.15917 hasResults: False

 nctId: NCT06278103 id: 2023PI113 briefTitle: Correlation Between Expression of Hormonal Receptors, Clinical Data, and Methylation Profile in Meningiomas (MethylRH-M) acronym: MethylRH-M overallStatus: ENROLLING_BY_INVITATION date: 2000-01-01 date: 2024-07-01 date: 2024-09-01 date: 2024-02-26 date: 2024-02-26 name: Central Hospital, Nancy, France class: OTHER briefSummary: This research aims to explore the relationship between hormonal receptor expression and the clinical and histopathological characteristics of meningiomas. The underlying hypothesis is that hormonal receptor expression, as well as the methylation profile of their gene promoters, are associated with specific aspects of meningiomas and patients' clinical outcomes. The main objective is to study the correlation between the immunohistochemical expression of hormonal receptors and clinicopathological data. The secondary objectif is to study the correlation between the methylation profile of hormonal receptor gene promoters and their immunohistochemical expression. conditions: Meningioma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 180 type: ESTIMATED measure: immunohistochemical expression of different hormonal receptors measure: methylation profile of the promoters of hormonal receptor genes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06278090 id: AUDC briefTitle: Impact of Ursodeoxycholic Acid Treatment on the Gallbladder Polyp Evolution acronym: GALPOL overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2026-02 date: 2026-07 date: 2024-02-26 date: 2024-02-28 name: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz class: OTHER briefSummary: The goal of this observational study is to learn about the impact of ursodeoxycholic acid treatment on the gallbladder polyp evolution in patients with gallbladder polyps that undergo follow up. The main question it aims to answer is:

• Whether ursodeoxycholic acid could decrease the gallbladder polyp size and therefore spare unnecessary follow up or surgical interventions

Participants will be managed according to the standard practice of the department they are attended:

* According to the established practice in the Department of Surgery, patients that either do not have an indication for cholecystectomy or decline the offered intervention, and are subjects for a follow up, are usually prescribed Ursodeoxycholic Acid, at 10-15 mg/kg/day for at least 6 months.
* According to the standard practice of Gastroenterology Department, patients are followed up according to the published guidelines.

Researchers will compare the groups that receive or not ursodeoxycolic acid treatment to see if the polyp size evolution differs significantly. conditions: Gallbladder Polyp studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 36 type: ESTIMATED name: Ursodeoxycholic Acid Only Product measure: Reducing gallbladder polyp size by 2mm or more measure: Modification of the expected follow up sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06278077 id: C2104 id: 2022-003565-38 type: EUDRACT_NUMBER briefTitle: Neurexan - a Clinical Trial in Short-Term Insomnia Patients overallStatus: RECRUITING date: 2023-09-04 date: 2024-12-31 date: 2024-12-31 date: 2024-02-26 date: 2024-02-26 name: Biologische Heilmittel Heel GmbH class: INDUSTRY briefSummary: This clinical study aims to understand the effects of a medication called Neurexan on sleep patterns and stress in people with short-term insomnia. The study involves comparing Neurexan to a placebo - a tablet that looks like Neurexan but lacks active ingredients. The main goal of the study is to determine if Neurexan can enhance sleep efficiency in those with short-term insomnia. Sleep efficiency, which is the proportion of time spent asleep in relation to total time in bed, including attempts to fall asleep, will be assessed through Polysomnography (PSG). PSG examines various sleep characteristics such as brain activity, muscle and heart activity, and breathing.

Participants will take either Neurexan or the placebo for 14 days. Sleep efficiency will be evaluated using PSG before and after the treatment period. Additionally, sleep quality-related factors will be investigated using PSG data, sleep diaries, and participant-completed questionnaires.

The study will also investigate Neurexan's impact on stress levels. This will be assessed using the Cold Pressor Test, which measures stress through having the participant immerse their hand into ice water, and measuring changes in blood pressure and heart rate, both indicators of stress. In addition, blood and saliva samples collected before and after treatment with Neurexan or placebo, will be analyzed for stress-related hormones such as cortisol. Patient questionnaires and Electroencephalography (EEG), a non-invasive brain activity recording, will further assess stress symptoms.

Researchers will analyze data related to sleep efficiency, sleep quality, and stress symptoms. By comparing outcomes before and after Neurexan or placebo treatment, the study aims to detect improvements in these areas. Positive results with Neurexan but not with the placebo would provide robust evidence for Neurexan's efficacy in addressing sleep and stress management issues. This study contributes valuable insights into Neurexan's potential benefits for individuals with short-term insomnia. conditions: Insomnia conditions: Stress Reaction studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, double-blind, active- and placebo-controlled confirmatory clinical trial primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: All involved personnel at the investigational site, the Sponsor (except production unit) and the CRO (except independent biostatistician for performing the randomization) will be blinded during the trial. The Investigator keeps the sealed treatment code envelopes throughout the course of the trial for the individual patients and must not break the code without a valid reason (e.g., in case of emergency). whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Neurexan name: Placebo measure: Change from baseline in Sleep Efficiency. measure: Change from baseline in sleep pattern characterized by Number of Awakenings. measure: Change from baseline in daytime performance assessed by Epworth Sleepiness Scale patient questionnaire. measure: Ecological Momentary Assessments - continuous daily stress assessment. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jena University Hospital, Department of Psychiatry & Psychotherapy status: RECRUITING city: Jena state: Thuringia zip: 07743 country: Germany name: Martin Walter, MD role: CONTACT phone: +49 (0)3641 9390101 email: Martin.Walter@med.uni-jena.de lat: 50.92878 lon: 11.5899 hasResults: False

 nctId: NCT06278064 id: BFHHZML20240006 briefTitle: Exosome-based Liquid Biopsies for Upper Gastrointestinal Cancers Diagnosis overallStatus: RECRUITING date: 2024-02-01 date: 2024-12-31 date: 2025-06-30 date: 2024-02-26 date: 2024-02-26 name: Beijing Friendship Hospital class: OTHER briefSummary: This study constitutes a case-control investigation employing a retrospective approach. Plasma samples from individuals with esophageal cancer, benign esophageal diseases, gastric cancer, benign gastric diseases, and a healthy control group were systematically collected. Advanced Data-Independent Acquisition (DIA) proteomics and single-vesicle membrane protein detection techniques were employed to quantify protein content within exosomes. Specific protein biomarkers indicative of early-stage upper gastrointestinal tumors were identified. External validation of these protein markers was conducted using Parallel Reaction Monitoring (PRM) technology on an independent validation cohort. The objective is to establish protein marker predictions for early diagnosis of upper gastrointestinal tumors and prognostication of therapeutic efficacy. conditions: Gastric Cancer conditions: Esophagus Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 562 type: ESTIMATED name: Gastric Cancer name: Esophagus Cancer measure: Plasma proteins in patients with gastric cancer measure: Plasma proteins in patients with esophagus cancer sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The Fourth Hospital of Hebei Medical University status: RECRUITING city: Shijiazhuang state: Hebei country: China name: Lianmei Zhao, Ph.D. role: CONTACT lat: 38.04139 lon: 114.47861 facility: Beijing Friendship Hospital, Capital Medical University status: RECRUITING city: Beijing country: China name: Li Min, Ph.D. role: CONTACT name: Li Min, Ph.D role: PRINCIPAL_INVESTIGATOR name: Chenjie Xu, Ph.D role: SUB_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Cancer Hospital Chinese Academy of Medical Sciences status: RECRUITING city: Beijing country: China name: Yibin Xie, Ph.D role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06278051 id: 21411 briefTitle: An Observational Study to Learn More About How Safe Treatment With Rivaroxaban is in Children in Japan With Venous Thromboembolism overallStatus: RECRUITING date: 2024-02-19 date: 2024-12-31 date: 2024-12-31 date: 2024-02-26 date: 2024-04-18 name: Bayer class: INDUSTRY name: Janssen Pharmaceutical Companies (formerly Johnson & Johnson Pharmaceutical Research & Development L.L.C.) briefSummary: This is an observational study in which only data will be collected from children with venous thromboembolism who are prescribed rivaroxaban or warfarin by their doctors.

Venous thromboembolism (VTE) is a condition in which people have problems due to the formation of blood clots in their veins.

The study drug rivaroxaban is an approved treatment for VTE in children and adults in Japan. It is a blood thinner that prevents the blood from clotting by blocking a protein responsible for blood clotting.

Warfarin is another blood thinner that is available for VTE. In this study warfarin is the reference drug.

A previous study was carried out to learn about how well rivaroxaban works and how safe it is in children with VTE. However, to better understand the safety of this drug in children, more knowledge is needed about the use of rivaroxaban in the real world.

The main purpose of this study is to learn more about the occurrence of major bleeding in children taking rivaroxaban. Major bleeding can be bleeding within the skull, bleeding inside the eye, bleeding from an organ in the digestive system, or bleeding which requires being given blood from a donor.

In addition, this study will help learn more about the following in children with VTE:

* The occurrence of major bleeding during treatment with rivaroxaban and during treatment with warfarin
* The occurrence of bleeding of importance in children being treated with rivaroxaban and in children being treated with warfarin. Bleeding of importance in children can be: bleeding from the lung, blood in the kidney, heavy menstrual bleeding
* The occurrence of major bleeding and bleeding of importance in children who are taking drugs called anti platelet agents and NSAIDs to prevent blood clots at the same time as rivaroxaban, who are taking a drug that blocks the action of a protein called 'CYP3A4' at the same time as rivaroxaban, who have reduced kidney function, who have taken rivaroxaban for a long time, or who have taken other drugs by mouth to prevent blood clots before starting rivaroxaban
* The occurrence of repeated VTE on treatment with rivaroxaban and on treatment with warfarin The children with VTE in this study are already receiving rivaroxaban or warfarin treatment as part of their regular care from their doctors.

The data will come from an electronic health records database created by a company called Medical Data Vision. The data will be collected between January 2021 and June 2024.

Researchers will look at the health information from children less than 18 years of age with VTE in Japan who are prescribed treatment with rivaroxaban or warfarin during the study period.

In this study, only available data from routine care are collected. No visits or tests are required as part of this study conditions: Venous Thromboembolism studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: Rivaroxaban granules for oral suspension name: Warfarin measure: Incidence of major bleeding in participants treated with rivaroxaban measure: Clinical characteristics and demographics of participants with pediatric VTE treated with rivaroxaban measure: Incidence of major bleeding in participants treated with warfarin measure: Incidence of bleeding important in pediatrics in participants treated with rivaroxaban and treated with warfarin as reference measure: Incidence of major bleeding and bleeding important in pediatrics in participants treated with rivaroxaban and in special target patient groups sex: ALL minimumAge: 0 Months maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Many facilities status: RECRUITING city: Multiple Locations country: Japan facility: Bayer status: RECRUITING city: Osaka zip: 530-0001 country: Japan lat: 34.69374 lon: 135.50218 hasResults: False

 nctId: NCT06278038 id: NO.0057 in 2024 Ethical Review briefTitle: Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets Versus Venlafaxine Hydrochloride Sustained-release Tablets in Patients With Major Depression Disorder overallStatus: NOT_YET_RECRUITING date: 2024-02-29 date: 2024-12-31 date: 2024-12-31 date: 2024-02-26 date: 2024-02-29 name: First Affiliated Hospital of Zhejiang University class: OTHER briefSummary: The purpose of this study is to evaluate efficacy and safety of toludesvenlafaxine hydrochloride sustained-release tablets in the treatment of major depression disorder compared to venlafaxine hydrochloride sustained-release tablets, to provide evidence-based basis for clinical rational drug use. conditions: Major Depression Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Toludesvenlafaxine hydrochloride sustained-release tablets name: Venlafaxine hydrochloride sustained-release tablets measure: Snaith-Hamilton Pleasure Scale (SHAPS) Total Score measure: Snaith-Hamilton Pleasure Scale (SHAPS) Total Score measure: Snaith-Hamilton Pleasure Scale (SHAPS) Reductive Rate measure: Dimensional Anhedonia Rating Scale (DARS) Score measure: Montgomery-Asberg Depression Rating Scale (MADRS) Score measure: 17-item Hamilton Depression Rating Scale (HAM-D17) Score measure: Sheehan Disability Scale (SDS) Score measure: Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Score measure: Treatment Emergent Symptom Scale (TESS) Score measure: Arizona Sexual Experience Scale (ASEX) Score measure: Count of red blood cell in blood measure: Count of white blood cell in blood measure: Count of platelet in blood measure: Concentration of hemoglobin in blood measure: Concentration of alanine aminotransferase in blood measure: Concentration of aspartate aminotransferase in blood measure: Concentration of gamma-glutamyltransferase in blood measure: Concentration of blood glucose in blood measure: Concentration of serum creatinine in blood measure: Concentration of urea in blood measure: Concentration of total cholesterol in blood measure: Concentration of high density lipoprotein in blood measure: Concentration of low density lipoprotein in blood measure: Concentration of triglyceride in blood measure: Concentration of protein in urine measure: Concentration of sugar in urine measure: Count of white blood cell in urine measure: Count of red blood cell in urine measure: ECG QT Interval measure: Changes in weight measure: Changes in pulse measure: Changes in both systolic and diastolic blood pressure measure: Changes in respiration rate measure: Changes in armpit temperature sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06278025 id: GO 19/833 briefTitle: Dysphagia and Deep Cervical Flexor Muscles overallStatus: COMPLETED date: 2019-09-01 date: 2024-02-01 date: 2024-02-01 date: 2024-02-26 date: 2024-03-18 name: Atılım University class: OTHER briefSummary: Cervical posture is vital for normal swallowing function. Changes in cervical posture during swallowing alter the bolus flow and swallowing kinematics through changes in gravity and oropharyngeal space. The hyoid bone does not articulate with any bone, so it requires adequate tension of the hyolaryngeal complex and proper cervical postural alignment to maintain its stabilization and position. Changes in cervical posture and stabilization can cause changes in hyoid bone position and kinematics through muscles and ligaments which may lead to decrease in hyoid elevation, loss of optimal strength of the suprahyoid and infrahyoid muscles due to disrupted length-tension relationship, and an increased risk of aspiration due to insufficient laryngeal elevation. Further, deterioration in cervical posture and decreased stabilization resulting from cervical muscle weakness or/both endurance could affect the control and strength of masticatory muscles, tongue muscles and suprahyoid - infrahyoid muscles, which are involved in swallowing function. Whereby DCF weakness gives rise to inadequate cervical stabilization, change in hyoid bone stabilization, alterations in suprahyoid and infrahyoid muscle function, and decreased laryngeal elevation may adversely affect the normal function of the swallowing related muscles. Thus, decreased cervical stabilization, which is often seen in neurological diseases, may be related to neurogenic dysphagia. Given the known changes in cervical stabilization as a consequence of neurologic injury, the additional impact on swallowing or a potentially already neurologically-disordered swallow is considered. Thus, loss of cervical stabilization may be one of the factors affecting dysphagia in patients with neurological diseases providing more information on all potential factors contributing to swallow impairment, potentially leading to more targeted and effective swallowing interventions. However, there is no study investigating the role of the DCF muscles in dysphagia. Therefore, the aim of the present study was to comparison of deep cervical flexor muscle strength and endurance in patients with and without neurogenic dysphagia. conditions: Dysphagia conditions: Neurological Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 30 type: ACTUAL name: assessment measure: dcf muscle strenght measure: dcf endurance sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Atilim University city: Ankara state: Incek zip: 06830 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06278012 id: E-59394181-604.01.02-32288 briefTitle: Development of Atılım Kinesiophobia Scale overallStatus: RECRUITING date: 2024-01-01 date: 2024-03-30 date: 2024-03-30 date: 2024-02-26 date: 2024-04-01 name: Atılım University class: OTHER briefSummary: Background:

Kinesiophobia or fear of movement, is defined as an excessive and irrational fear of physical movement to avoid painful injury, harm or re-injury. The existing scales measuring kinesiophobia are thought to have some limitations (the difficulty of patients to understand and answer the questions, the presence of questions that are not suitable for the patient's condition). These questionnaires may not have specific questions enough to assess fear of movement in different patient populations.

Aim: The aim of this study is to develop and validate the Turkish Atılım Kinesiophobia Scale.

Material/method:

In the first stage of the study, research on kinesiophobia was reviewed and a total of 38 questions were created for the scale. The questions were submitted to the opinion of 11 experts working in the physiotherapy and rehabilitation field. Then A total of 100 patients with acute and chronic musculoskeletal pain completed the Turkish Atılım Kinesiophobia Scale and Tampa Scale of Kinesiophobia. conditions: Kinesiophobia conditions: Acute Pain conditions: Chronic Pain conditions: Fear of Movement studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 150 type: ESTIMATED measure: The pilot study of the scale will be conducted with a total of 40 patients, 10 participants for each patient group. measure: item analyses and exploratory factor analysis (EFA) analysis will be performed with a sample size of 5 times the number of questions in the item pool with acute and chronic pain patients. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Atılım University status: RECRUITING city: Ankara country: Turkey name: Naime Uluğ, PhD. role: CONTACT phone: +905365434409 email: naime.ulug@atilim.edu.tr lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06277999 id: D8820C00001 briefTitle: C.Difficile Observational Study overallStatus: NOT_YET_RECRUITING date: 2024-02-28 date: 2024-10-11 date: 2024-10-11 date: 2024-02-26 date: 2024-02-26 name: AstraZeneca class: INDUSTRY briefSummary: D8820C00001 is an exploratory, non-interventional, unblinded, observational study evaluating the acceptability, feasibility and performance of methods to collect, transport and test biospecimens in participants ≥ 18 years of age with an active CDI. Participants will also be monitored for recurring episodes of diarrhea and will need to complete validated PROs and study evaluation questionnaires conditions: Clostridium Infections studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: Number of participants that completed key study activities according to protocol measure: Time intervals across stool sample collection logistics measure: Participant Experience and site staff evaluation questionnaires measure: Gather information to assess logistics, resourcing and performance of different toxin detection assays (eg. EIA, PCR, CCNA) sex: ALL minimumAge: 18 Years maximumAge: 130 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06277986 id: KY20212018-F-2 briefTitle: Early Diagnosis of Gastric Cancer Cachexia overallStatus: RECRUITING date: 2021-06-01 date: 2024-09-01 date: 2024-09-01 date: 2024-02-26 date: 2024-02-26 name: Xijing Hospital class: OTHER briefSummary: Gastric cancer is one of the most common malignancies, the morbidity and mortality of which are among the highest. In cancer patients, the incidence of cachexia is very high, and even 80% of patients will eventually develop into cachexia. However, once gastric cancer patients develop cachexia, patients are unlikely to obtain clinically significant benefits from conventional treatment. Therefore, it is important to find biomarkers for early detection of cachexia. The investigators carried out a plasma-derived exosomal microRNA(miRNA) study for early diagnosis of cachexia in gastric cancer, and the development of early diagnosis kits for gastric cancer cachexia. conditions: Cachexia studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 150 type: ESTIMATED name: cachexia measure: BMI sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fourth Military Medical University status: RECRUITING city: Xi'an state: Shaanxi country: China name: Jipeng Li role: CONTACT phone: +86-029-84771533 lat: 34.25833 lon: 108.92861 hasResults: False

 nctId: NCT06277973 id: 0007551-2 briefTitle: Feasibility Study of the Self-Care Immediate Stabilization Procedure (ISP) ® After a Traumatic Experience overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-01 date: 2025-05 date: 2024-02-26 date: 2024-03-27 name: Tel Aviv University class: OTHER briefSummary: The study aims to assess the feasibility of an online intervention platform based on the Immediate Stabilization Procedure (ISP®). This intervention targets early trauma reactions, aiming to reduce the risk of future PTSD. conditions: Post-traumatic Stress Disorder conditions: Acute Stress Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomly allocated to one of the following groups: the experiment group and the waiting list group. Each group will receive the intervention but in the waiting list group this will occur a week later:

Experiment group:

Day 1 - questionnaires (T1) Day 4 - intervention Day 7 - questionnaires (T2) Day 97 - follow up questionnaires (T3)

Waiting list group:

Day 1 - questionnaires (T0) Day 7 - questionnaires (T1) Day 11- intervention Day 14- questionnaires (T2) Day 104- follow up questionnaires (T3) The parallel element of this model lies in the first week of the study: the experiment group goes through 2 measurements with the intervention in the middle of the week, whereas the waiting list group goes through 2 measurements without the intervention. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Participants will be informed that the intervention will occur between 2 days and 14 days and that they will fill 3-4 surveys. They will not be aware that there are two groups. whoMasked: PARTICIPANT count: 200 type: ESTIMATED name: Eye Movement Desensitization and Reprocessing (EMDR) measure: PCL-5 (Posttraumatic Stress Disorder Checklist) measure: GAD-7 (General Anxiety Disorder-7) measure: SSASI (The Short Scale Anxiety Sensitivity Index) measure: BSI 18 (Brief Symptom Inventory) measure: DES-II (Dissociative Experiences Scale) measure: DERS (Difficulties in Emotion Regulation Scale) measure: NSESSS (The National Stressful Events Survey Acute Stress Disorder Short Scale) measure: SASRQ (Stanford Acute Stress Reaction Questionnaire) measure: Exposure to traumatic event during the current war measure: PDEQ (Peritraumatic Dissociative Experiences Questionnaire) measure: TIS (Tonic Immobility Scale) measure: PDI (The Peritraumatic Distress Inventory) measure: Questionnaires to test user experience of the system measure: Questionnaire for examining the experience of the intervention measure: Qualitative interview measure: Questionnaire regarding receiving emotional treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tel Aviv University city: Tel Aviv country: Israel lat: 32.08088 lon: 34.78057 hasResults: False

 nctId: NCT06277960 id: CNS2301 briefTitle: Septal Ablation for Obstructive HCM overallStatus: NOT_YET_RECRUITING date: 2024-02-29 date: 2024-06-30 date: 2024-11-30 date: 2024-02-26 date: 2024-02-26 name: SuZhou Sinus Medical Technologies Co.,Ltd class: INDUSTRY briefSummary: Hypertrophic cardiomyopathy (HCM) is a common clinical genetic-related disease, with a global incidence of 0.2%-0.5%, but only a few cases (10-20%) have been clinically diagnosed. About 70% of them are hypertrophic obstructive cardiomyopathy (HOCM), these HOCM patients have significant clinical symptoms, including progressively increasing fatigue, angina, exertional dyspnea, and syncope. Conservative medications are used to treat the vast majority of patients. Invasive therapy, which includes surgical myectomy, percutaneous transluminal septal myocardial ablation(PTSMA), percutaneous intramyocardial septal radiofrequency ablation (PIMSRA) and percutaneous endocardial septal radiofrequency ablation (PESA) is introduced to patients with refractory symptoms or drug resistance. However, surgical operations are complicated and high risk procedures with high mortality. Interventional approaches are very difficult to perform and therefore the application is limited.

Previous researches have shown that interventricular septal radiofrequency ablation could effectively reduce the left ventricular outflow tract pressure gradient (LVOTG), thereby treating obstructive hypertrophic cardiomyopathy (HOCM). This device is based on the same radiofrequency ablation energy principle, however, the catheter is introduced into the right ventricle and performs ablation treatment on the hypertrophic interventricular septum, which is potentially a lower risk route of access for septal ablation than currently attempted interventional approaches.

The purpose of this study is to evaluate the safety and efficacy of percutaneous intramyocardial septal ablation catheters in the treatment of obstructive hypertrophic cardiomyopathy. conditions: Hypertrophic Obstructive Cardiomyopathy (HOCM) studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: percutaneous intramyocardial septal radiofrequency ablation system measure: 30-day major adverse clinical events (MACE) measure: Technical success rate measure: Short Form 36 (SF-36) health survey questionnaire measure: Improvement of left ventricular outflow tract gradient (LVOTG) measure: Improvement of NYHA functional classification measure: 6-min walk distance sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sir Run Run Shaw Hospital city: Hangzhou state: Zhejiang zip: 310016 country: China name: Yaxun Sun, MD role: CONTACT phone: +86 15057173170 email: sunyaxun@zju.edu.cn lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06277947 id: SYSKY-2024-096-01 briefTitle: Administration of Hyperthermic Intraperitoneal Chemotherapy in the General Ward acronym: GARD-HIPEC overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-12 date: 2025-05 date: 2024-02-26 date: 2024-02-26 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER name: Shenshan Medical Center, Memorial Hospital of Sun Yat-sen University briefSummary: Ovarian cancer is the most lethal gynecologic malignancy. The majority of patients get diagnosed with advanced disease with peritoneal dissemination.It has been demonstrated that the addition of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) to interval debulking surgery can improve the prognosis. The National Comprehensive Cancer Network (NCCN) treatment guideline has recommended HIPEC as a first-line treatment for patients with advanced ovarian cancer. However, the guideline recommended the "Dutch model" of HIPEC, which is limited for routinely being performed in China. So we propose a HIPEC treatment modality, the bedside closed HIPEC in the general ward (C-HIPEC), which is suitable for the clinical characteristics of China. The aim of this study was to evaluate the safety of this model as a way to lay the foundation for subsequent efficacy evaluation and clinical promotion. conditions: Epithelial Ovarian Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Patients would receive C-HIPEC in the general ward after interval debulking surgery in 24 hours. primaryPurpose: TREATMENT masking: NONE count: 92 type: ESTIMATED name: China Hyperthermic Intraperitoneal Chemotherapy(C-HIPEC) measure: The incidence of adverse events of grade 3-5 measure: Time to progress (TTP) measure: The Time to the First Subsequent Therapy，TTFST measure: Quality of life, QLQ-C30 sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University city: Guangzhou country: China lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06277934 id: RGT001-075-203 briefTitle: A Study of RGT001-075 in Adult Patients With Obesity overallStatus: RECRUITING date: 2024-03-08 date: 2024-06 date: 2024-07 date: 2024-02-26 date: 2024-04-04 name: Regor Pharmaceuticals Inc. class: INDUSTRY briefSummary: This study is being conducted to evaluate RGT001-075 to help people who are above a healthy weight range to lose weight. In this study participants will either get RGT001-075 or a "dummy" medicine (placebo). Which treatment participants get is decided by chance. Participants need to take RGT001-075 or placebo once every day for 12 weeks. conditions: Obesity studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: RGT001-075 name: Placebo measure: Number of participants with Treatment-emergent Adverse Event(AE) by severity/Serious Adverse Event (SAE), with Clinical Laboratory Abnormalities, Clinically Significant Change From Baseline in Vital Signs and Abnormal Electrocardiogram(ECG) readings measure: Percent change in body weight measure: Change in body weight in kilogram measure: Percentage of participants who achieve ≥5% and ≥10% body weight reduction measure: Change in Body mass index (BMI) in kg/m^2 measure: Change in waist circumference in centimetre measure: RGT001-075 pharmacokinetics (PK): Area under the curve up to the last measured concentration(AUC0-last) measure: RGT001-075 pharmacokinetics (PK): Area under curve from time zero to time infinite(AUC0-inf) measure: RGT001-075 pharmacokinetics (PK): Maximum observed concentration (Cmax) measure: RGT001-075 pharmacokinetics (PK): Time to achieve maximum concentration(Tmax) measure: RGT001-075 pharmacokinetics (PK): Elimination half-life(t1/2) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Velocity Clinical Research status: RECRUITING city: Los Angeles state: California zip: 90057 country: United States name: David Guzman, MD role: CONTACT lat: 34.05223 lon: -118.24368 facility: Velocity Clinical Research status: RECRUITING city: Valparaiso state: Indiana zip: 46383 country: United States name: Robert Buynak, MD role: CONTACT lat: 41.47309 lon: -87.06114 facility: Velocity Clinical Research status: RECRUITING city: Omaha state: Nebraska zip: 68134 country: United States name: Frederick Raiser, MD role: CONTACT lat: 41.25626 lon: -95.94043 facility: Velocity Clinical Research status: RECRUITING city: Vestal state: New York zip: 13850 country: United States name: Eric Lorraine, MD role: CONTACT lat: 42.08507 lon: -76.05381 facility: Velocity Clinical Research status: RECRUITING city: Durham state: North Carolina zip: 27701 country: United States name: William Cromwell, MD role: CONTACT lat: 35.99403 lon: -78.89862 facility: Velocity Clinical Research status: RECRUITING city: Cleveland state: Ohio zip: 44122 country: United States name: Margaret Rhee, MD role: CONTACT lat: 41.4995 lon: -81.69541 facility: Velocity Clinical Research status: RECRUITING city: Medford state: Oregon zip: 97504 country: United States name: Sarah Smiley, MD role: CONTACT lat: 42.32652 lon: -122.87559 facility: Velocity Clinical Research status: RECRUITING city: East Greenwich state: Rhode Island zip: 02818 country: United States name: David Fried, MD role: CONTACT lat: 41.66038 lon: -71.45589 facility: Velocity Clinical Research status: RECRUITING city: Dallas state: Texas zip: 75230 country: United States name: Dan Lender, MD role: CONTACT lat: 32.78306 lon: -96.80667 facility: Velocity Clinical Research status: RECRUITING city: West Jordan state: Utah zip: 84088 country: United States name: Barbara Rizzardi, MD role: CONTACT lat: 40.60967 lon: -111.9391 hasResults: False

 nctId: NCT06277921 id: 110-2 briefTitle: Morbidity and Mortality After Esophageal and Esophagogastric Junction Cancer Surgery acronym: ESOSTAT overallStatus: NOT_YET_RECRUITING date: 2024-03-18 date: 2024-09-18 date: 2024-12-31 date: 2024-02-26 date: 2024-02-26 name: P. Herzen Moscow Oncology Research Institute class: OTHER_GOV name: National Medical Research Radiological Centre of the Ministry of Health of Russia briefSummary: Esophageal and esophagogastric junction cancer is still one of the main health care issue and esophagectomy with lymph node dissection is the only chance to be cure.

However, esophagectomy for esophageal cancer is a complex procedure which carries high risk of morbidity rate of 24% and a mortality rate of 2% to 5.6%, respectively There is a need to study the differences of 90-day postoperative morbidity and mortality in different clinics and centers of the Russian Federation. conditions: Esophageal Cancer conditions: Oesophageal Cancer conditions: Siewert Type I Adenocarcinoma of Esophagogastric Junction conditions: Siewert Type III Adenocarcinoma of Esophagogastric Junction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: Elective Surgery for gastric cancer measure: the type of complications and the incidence of it sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: A.S. Loginov Moscow Clinical Scientific Center city: Moscow country: Russian Federation lat: 55.75222 lon: 37.61556 facility: I.M. Sechenov First Moscow State Medical University city: Moscow country: Russian Federation lat: 55.75222 lon: 37.61556 facility: P.Herzen Moscow Oncological Research Institute city: Moscow country: Russian Federation name: Andrey Ryabov role: CONTACT name: Nuriddin Abdulkhakimov role: CONTACT lat: 55.75222 lon: 37.61556 facility: Petrovsky National Research Centre of Surgery city: Moscow country: Russian Federation lat: 55.75222 lon: 37.61556 facility: Vishnevsky National Medical Research Center of Surgery city: Moscow country: Russian Federation lat: 55.75222 lon: 37.61556 facility: Nizhny Novgorod Regional Clinical Oncological Dispensary city: Nizhny Novgorod country: Russian Federation lat: 56.32867 lon: 44.00205 facility: A.Tsyb Medical Radiological Research Centre city: Obninsk country: Russian Federation lat: 55.09681 lon: 36.61006 facility: National Medical Research Centre for Oncology city: Rostov-on-Don country: Russian Federation lat: 47.23135 lon: 39.72328 facility: Petrov National Medical Research Center of Oncology city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 hasResults: False

 nctId: NCT06277908 id: 110-1 briefTitle: Postoperative Morbidity and Mortality After Gastric Cancer Surgery acronym: GASTROSTAT overallStatus: NOT_YET_RECRUITING date: 2024-03-18 date: 2024-09-18 date: 2024-12-31 date: 2024-02-26 date: 2024-02-26 name: P. Herzen Moscow Oncology Research Institute class: OTHER_GOV name: National Medical Research Radiological Centre of the Ministry of Health of Russia briefSummary: Gastric cancer is still one of the main health care issue and gastrectomy with lymph node dissection is the only chance to be cure. Trials show that the postoperative course differs significantly between eastern and western centers, as well as between clinics within Russian Federation. Postoperative 30-day postoperative mortality after gastric cancer surgery ranges from 1% to 5%, and postoperative complication rates range from 10% to 40%. To improve the quality of further studies and recommendations for standardization of surgical treatment of gastric cancer and its complications, there is a need to study the differences in 90-day postoperative morbidity and mortality in different clinics and centers of the Russian Federation. conditions: Gastric Cancer conditions: Siewert Type III Adenocarcinoma of Esophagogastric Junction conditions: Stomach Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 700 type: ESTIMATED name: Elective Surgery for gastric cancer measure: the type of complications and the incidence of it sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: A.S. Loginov Moscow Clinical Scientific Center city: Moscow country: Russian Federation name: Roman Izrailov role: CONTACT name: Nikolay Semenov role: CONTACT lat: 55.75222 lon: 37.61556 facility: A.Tsyb Medical Radiological Research Centre city: Moscow country: Russian Federation lat: 55.75222 lon: 37.61556 facility: I.M. Sechenov First Moscow State Medical University city: Moscow country: Russian Federation lat: 55.75222 lon: 37.61556 facility: P.Herzen Moscow Oncological Research Institute city: Moscow country: Russian Federation name: Andrey Ryabov role: CONTACT name: Nuriddin Abdulkhakimov role: CONTACT lat: 55.75222 lon: 37.61556 facility: Petrovsky National Research Centre of Surgery city: Moscow country: Russian Federation lat: 55.75222 lon: 37.61556 facility: Vishnevsky National Medical Research Center of Surgery city: Moscow country: Russian Federation lat: 55.75222 lon: 37.61556 facility: Nizhny Novgorod Regional Clinical Oncological Dispensary city: Nizhny Novgorod country: Russian Federation lat: 56.32867 lon: 44.00205 facility: National Medical Research Centre for Oncology city: Rostov-on-Don country: Russian Federation lat: 47.23135 lon: 39.72328 facility: Petrov National Medical Research Center of Oncology city: Saint Petersburg country: Russian Federation lat: 59.93863 lon: 30.31413 hasResults: False

 nctId: NCT06277895 id: KYLL-202401-047 briefTitle: VOCs in Patients With Acute Cardiogenic Chest Pain overallStatus: RECRUITING date: 2024-01-26 date: 2024-12-31 date: 2024-12-31 date: 2024-02-26 date: 2024-02-26 name: Qilu Hospital of Shandong University class: OTHER briefSummary: The goal of this observation study is to compare VOCs in cardiogenic chest pain population/health conditions, to answer：Establishment and promotion of the application system of emergency rapid detection of expiratory Volatile Organic Compounds (VOCs) in patients with acute cardiogenic chest pain

1. VOCs levels were measured at baseline in healthy people, and markers of VOCs that could be used to identify acute cardiogenic chest pain were sought.
2. The relationship between abnormal VOCs (mainly aldehydes) and prognosis of patients and the correlation with Super-score for early warning of acute heart failure. conditions: Acute Coronary Syndrome conditions: Acute Aortic Syndrome studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 1400 type: ESTIMATED name: VOCs measure: Baseline VOCs (aldehydes) levels in healthy population measure: MACE in patients with cardiogenic chest pain sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Qilu hospital status: RECRUITING city: Jinan state: Shandong zip: 250012 country: China name: yuan bian role: CONTACT phone: 18560084775 email: 15165110975@163.com lat: 36.66833 lon: 116.99722 hasResults: False

 nctId: NCT06277882 id: Si 067/2024 briefTitle: Efficacy and Durability of Hepatitis A Vaccination in Patients With Advanced Fibrosis and Cirrhosis overallStatus: RECRUITING date: 2024-02-29 date: 2025-03-01 date: 2025-05-31 date: 2024-02-26 date: 2024-03-19 name: Mahidol University class: OTHER briefSummary: The hepatitis A virus (HAV) is a significant global public health concern. The hepatitis A virus is transmitted primarily by the faecal-oral route, leading to acute hepatitis. Symptoms include low-grade fever, anorexia, jaundice, and typically resolve without complications.

However, HAV infection in patients with chronic liver disease, especially those over 50 years old, may result in more severe outcomes, including fulminant hepatitis, with a higher mortality rate compared to the general population

HAV vaccination is a cornerstone of prevention, especially in high-risk groups. Currently, there is a recommendation to vaccinate patients with chronic liver disease against HAV infection. However, these patients often have compromised immune responses, leading to lower vaccine efficacy compared to the general population.

The goal of this randomized controlled trial is to compare the efficacy and safety of the standard 2-dose (0, 6 months) hepatitis A vaccination regimen with an intensive 3-dose (0, 1, 6 months) schedule in patients with advanced fibrosis and cirrhosis.

The main questions it aims to answer are:

* Compared the seroconversion rate of the standard 2-dose (0, 6 months) hepatitis A vaccination regimen versus the intensive 3-dose (0, 1, 6 months) hepatitis A vaccination regimen in patients with advanced fibrosis and cirrhosis.
* Compared the antibody levels against the hepatitis A virus (Anti-HAV IgG) of the standard 2-dose (0, 6 months) hepatitis A vaccination regimen versus the intensive 3-dose (0, 1, 6 months) hepatitis A vaccination regimen in patients with advanced fibrosis and cirrhosis. conditions: Cirrhosis conditions: Hep A conditions: Vaccination studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 50 type: ESTIMATED name: HAVRIX measure: Post-vaccination serological response rate measure: Post-vaccination serological response measure: Post-vaccination serological response measure: Anti-hepatitis A Virus (HAV) antibody at month 1 measure: Anti-hepatitis A Virus (HAV) antibody at month 7 measure: Anti-hepatitis A Virus (HAV) antibody at 1 year sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Medicine, Siriraj Hospital status: RECRUITING city: Bangkok Noi state: Bangkok zip: 10700 country: Thailand name: Watcharasak Chotiyaputta, Asso Prof role: CONTACT phone: 6624197281 email: watcharasak.cho@mahidol.ac.th lat: 13.76266 lon: 100.47798 hasResults: False

 nctId: NCT06277869 id: PR-22146 briefTitle: Effectiveness Trial of Thermal Jacket overallStatus: RECRUITING date: 2024-03-01 date: 2024-12-22 date: 2024-12-31 date: 2024-02-26 date: 2024-03-07 name: International Centre for Diarrhoeal Disease Research, Bangladesh class: OTHER name: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh name: Directorate General of Health Services (DGHS), Bangladesh name: Poeticgem International Ltd briefSummary: Globally, over 15 million neonates are born preterm each year. They account for approximately 30% of global neonatal deaths and 19% of total neonatal deaths in Bangladesh. They usually die because they cannot maintain normal temperature due to their weight, immature skin and underdeveloped thermal regulatory capacity of the brain.

Maintaining continuous Kangaroo Mother Care (KMC) for at least 16-20 hours/day, is sometimes not feasible for mothers or caregivers. In addition, we also have the challenge of keeping preterm or low birthweight (LBW) neonates warm during transportation.

The scientists at icddr,b, Johns Hopkins University, and George Mason University developed the thermal jacket for keeping preterm or LBW neonate warm. We have already completed the laboratory trial on mannquins and clinical safety trial among preterm or LBW neonates. Now, we propose to build on our previous work by systematically testing the effectiveness trial of the 'thermal jacket' among preterm or LBW neonates at clinical settings.

Hypothesis: Thermal jacket can increase the rate of euthermia among the preterm or LBW neonates in the selected health facilities in Bangladesh.

Objectives: The aim of this study is to test whether the thermal jacket can attain and maintain euthermia of preterm or LBW neonates in clinical settings of Bangladesh. conditions: Preterm Neonate conditions: Low Birthweight Neonate studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: Stepped wedge cluster randomised trial primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: Thermal Jacket name: Kangaroo Mother Care measure: Body temperature of preterm or low birthweight neonates maintain the euthermic range. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Lakshmipur District Hospital status: RECRUITING city: Lakshmipur state: Chattogram zip: 3700 country: Bangladesh name: Ahmed Kabir, MBBS role: CONTACT phone: 01842587456 email: laxmipur@hospital.dghs.gov.bd lat: 22.9443 lon: 90.83005 facility: Kushtia 250 Bedded General Hospital status: RECRUITING city: Kushtia state: Khulna zip: 7000 country: Bangladesh name: Md. Rafiqul Islam, MBBS role: CONTACT phone: 01829699289 email: kushtia@hospi.dghs.gov.bd lat: 23.9028 lon: 89.11943 facility: Jamalpur 250 Beded General Hospital status: NOT_YET_RECRUITING city: Jamalpur state: Mymensingh zip: 2000 country: Bangladesh name: Muhammad Mahfuzur Rahman, MBBS role: CONTACT phone: 01716267689 email: jamalpur@hospital.dghs.gov.bd lat: 24.91965 lon: 89.94812 hasResults: False

 nctId: NCT06277856 id: Aysun Eksioglu id: Ayse Akyar type: OTHER domain: Ege University briefTitle: Peer Interaction of Primiparas Sharing a Room With Multiparas With Successful Breastfeeding Experience overallStatus: RECRUITING date: 2023-09-15 date: 2024-06-15 date: 2024-09-15 date: 2024-02-26 date: 2024-02-26 name: Ege University class: OTHER briefSummary: The World Health Organization (WHO) states that peer support breastfeeding education programs are effective interventions for improving breastfeeding outcomes. In this context, the WHO's Global Strategy for Infant and Young Child Feeding recommends the implementation of "lay health worker peer counselors" and "mother-to-mother support groups" to promote and support breastfeeding. The tenth step of the Baby-Friendly Hospital Initiative also emphasizes the importance of mother-to-mother support as a successful intervention for breastfeeding. However, in our country, there have been limited studies and efforts to provide peer education and support for breastfeeding. Although various valuable studies using different educational techniques have been conducted to improve breastfeeding rates, the integration of these programs into routine clinical practice remains insufficient. This study aims to implement a peer interactive education program in postpartum rooms to bring experienced and inexperienced mothers together, as part of the hospital routine. The project will focus on the development and implementation of a peer interactive education program and will investigate its impact on the breastfeeding self-efficacy of primiparous mothers. The research follows a two-group pre-test and post-test design, is non-blind, and uses randomized controlled methodology. Initially, the hospital rooms will be rearranged to accommodate the implementation of the peer support breastfeeding education module. Researcher midwives will provide a brief training to experienced peer educator mothers who have previously breastfed.Afterwards, the peer education program will be conducted when the experienced mother and primiparous mother are together in the room. The study emphasizes improving early postpartum breastfeeding success and aims to make peer interaction a routine part of hospital practice. The feasibility of implementing peer education in hospitals will be evaluated, considering its simplicity and practicality. The impact of peer interactions on the mother's breastfeeding self-efficacy and attitudes towards breastfeeding will be assessed.

Overall, this research aims to improve breastfeeding rates by implementing peer support programs in hospital settings and evaluating the outcomes of peer interactions in terms of the mother's breastfeeding self-efficacy and attitudes towards breastfeeding. conditions: Mothers studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: In order to eliminate selection bias in the study, "block randomisation" method, one of the fixed probability randomisation methods, will be used and women who meet the inclusion criteria will be distributed to the intervention and control groups. whoMasked: INVESTIGATOR count: 128 type: ESTIMATED name: Peer interaction/control measure: breastfeeding self-efficacy measure: exclusive breastfeeding rate sex: FEMALE minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: Ege University status: RECRUITING city: Izmir zip: 35100 country: Turkey name: Ayşe Akyar, Midwife role: CONTACT phone: +905538507280 email: akyarayse_02@hotmail.com; lat: 38.41273 lon: 27.13838 hasResults: False

 nctId: NCT06277843 id: PR-21131 briefTitle: Low-Cost and Reusable Thermal Jacket for Managing Preterm or Low Birth Weight Neonates. overallStatus: COMPLETED date: 2022-06-13 date: 2022-09-01 date: 2022-09-30 date: 2024-02-26 date: 2024-02-26 name: International Centre for Diarrhoeal Disease Research, Bangladesh class: OTHER name: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh name: Directorate General of Health Services (DGHS), Bangladesh name: Poeticgem International Ltd name: University of Dhaka briefSummary: Globally, over 15 million neonates are born preterm each year. They account for approximately 30% of global neonatal deaths and 19% of total neonatal deaths in Bangladesh. They usually die because they cannot maintain normal temperature due to their weight, immature skin and underdeveloped thermal regulatory capacity of the brain.

Maintaining continuous KMC for at least 16-20 hours/day, is sometimes not feasible for mothers or caregivers. In addition, we also have the challenge of keeping preterm or LBW neonates warm during transportation.

The scientists at icddr,b, Johns Hopkins University, and George Mason University developed the re-usable thermal jacket for keeping preterm or low-birth-weight neonate warm. We propose to build on previous work by systematically testing the safety of the 'thermal jacket' among preterm or low birthweight (LBW) neonates.

Objective of this study is to conduct clinical safety trial of the thermal jacket to test whether the thermal jacket can retain euthermia of preterm or LBW neonates for 2 hours. conditions: Preterm conditions: Low Birthweight conditions: Hypothermia Neonatal studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single arm non-randomized trial primaryPurpose: TREATMENT masking: NONE count: 10 type: ACTUAL name: Thermal Jacket measure: Body temperature of preterm or low birthweight neonates and duration of time in euthermic range. sex: ALL minimumAge: 0 Hours maximumAge: 72 Hours stdAges: CHILD facility: Bangabandhu Sheikh Mujib Medical University (BSMMU) city: Dhaka zip: 1000 country: Bangladesh lat: 23.7104 lon: 90.40744 hasResults: False

 nctId: NCT06277830 id: 2023P002788 briefTitle: Physical Activity Monitoring in Myasthenia Gravis overallStatus: RECRUITING date: 2024-02-14 date: 2024-06 date: 2024-06 date: 2024-02-26 date: 2024-03-04 name: Massachusetts General Hospital class: OTHER name: BioSensics briefSummary: The goal of this observational study is to evaluate the feasibility of using wearable sensor and digital technologies to measure motor and speech function in adults with autoimmune Myasthenia Gravis (MG).

The main question\[s\] it aims to answer are:

* To measure the correlation of sensor-based measures of motor function with existing outcome measures including the MG-ADL, MGQOL15r, QMG, MGComposite, and Neuro-QOL Fatigue scales.
* To develop and validate tablet-based digital assessments of speech and facial expression and to compare with existing outcome measures.

Participants will wear a pendant sensor for 7 days and then participate in tablet-based and in-person myasthenia-specific physical examinations. This will be performed in concert with routine care in the Massachusetts General Hospital MG clinic. conditions: Myasthenia Gravis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 20 type: ESTIMATED name: Wearable sensor measure: Primary outcome measure: Exploratory outcome sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Massachusetts General Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02114 country: United States name: Carina Stafstrom, BS role: CONTACT email: cstafstrom@mgh.harvard.edu role: CONTACT phone: 617-726-5175 lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06277817 id: 2021/1916 briefTitle: The Effect of Chest Physiotherapy Methods Applied Before Aspiration on Respiratory Characteristics overallStatus: COMPLETED date: 2021-05-19 date: 2021-06-25 date: 2022-10-24 date: 2024-02-26 date: 2024-02-26 name: Inonu University class: OTHER briefSummary: Physiotherapy is one of the most frequently used supportive treatments in intensive care units due to its positive effects on critically ill patients. Chest physiotherapy (GF), which constitutes the most effective part of the physiotherapy programs applied to intensive care patients under mechanical ventilation (MV) support, consists of a series of techniques aimed at clearing airway secretions, facilitating appropriate lung ventilation by increasing lung volume and respiratory muscle strength, and improving the respiratory system and gas exchange. . Of these techniques, manually applied percussion vibration and expiratory rib cage compression (EGCC) are some of the most commonly applied GF techniques in patients on MV support. This study was conducted to evaluate the effect of chest physiotherapy techniques applied before aspiration on vital signs, blood gas values and amount of secretion in patients on mechanical ventilation support. conditions: Patient Involvement studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The randomization of this study was performed by a statistical expert independent of the study, using the computer-assisted Random Allocation Rule method, which is one of the random assignment methods (http://biostatapps.inonu.edu.tr/RAY/).78 patients to be included in the study were divided into 3 groups and assigned an equal number of patients in each group according to the results of the random assignment method. In order to assign patients to research groups impartially, the research groups determined were written on papers and group assignments were made by drawing lots. Thus, the number of individuals in the groups and the probability of each patient included in the study being in either of the experimental or control groups were equalized. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 78 type: ACTUAL name: expiratory rib cage compression name: percussion vibration measure: The effect of percussion vibration on the amount of secretion measure: Effect of expiratory rib cage compression on the amount of secretion measure: Effect of percussion vibration on blood gas parameters measure: Effect of expiratory rib cage compression on blood gas parameters measure: Perküsyon vibrasyonun yaşam bulgularına etkisi measure: Effect of expiratory rib cage compression on vital signs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tunceli State Hospital city: Tunceli zip: 62000 country: Turkey lat: 39.09921 lon: 39.54351 hasResults: False

 nctId: NCT06277804 id: LTC004-102 briefTitle: A Phase I Study of LTC004 Combin With FC in Patients With Advanced/Metastatic Malignancies Tumor overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2027-07-01 date: 2027-07-01 date: 2024-02-26 date: 2024-02-26 name: Letolab class: INDUSTRY briefSummary: This was a multicenter, open PHASE I study of LTC004 in Combination With Cyclophosphamide and Fludarabine in Patients With Advanced/Metastatic Malignancies Tumor, the study design consisting of 2 phases: Phase Ia (Phase Ia dose escalation) and Phase Ib (Phase Ib expansion). The objective of this study was to evaluate combination safety, tolerability, pharmacokinetic,pharmacodynamics characteristics, and initial efficacy in advanced malignant tumors. conditions: Adult Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: LTC004 in Combination With Cyclophosphamide and Fludarabine measure: Safety, tolerability and antitumor efficacy of Combination. measure: PK Characteristics and immunogenicity of Combination sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06277791 id: HStomatologyWuhan1 briefTitle: The Combination of Adebrelimab and TP Regimen for Neoadjuvant Therapy in Patients With Stage IVB Oral Squamous Cell Carcinoma overallStatus: RECRUITING date: 2023-08-19 date: 2024-07-31 date: 2025-07-31 date: 2024-02-26 date: 2024-02-26 name: Hospital of Stomatology, Wuhan University class: OTHER briefSummary: The goal of this \[type of study:clinical trial\] is to \[learn about\] in \[Clinical IVB stage oral squamous cell carcinoma patients\]. The main question it aims to answer are:

• \[Observing the effectiveness and safety of the combination of Adebrelimab and TP regimen in neoadjuvant therapy for clinical IVB stage oral squamous cell carcinoma patients\] Participants will \[Received treatment with Adebrelimab combined with TP regimen, followed by surgery after 2 cycles of neoadjuvant therapy. After surgery, radiotherapy and chemotherapy combined with immunotherapy were chosen based on the patient\&#39;s condition, with a total follow-up of two years.\]. conditions: Clinical IVb Stage Oral Squamous Cell Carcinomas Patients studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: Adebrelimab measure: Effective mitigation rate（EMR） measure: DFS measure: R0 resection rate measure: ORR measure: mOS sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: School of Stomatology Wuhan University status: RECRUITING city: Hubei state: Wuhan zip: 430079 country: China name: JJia Associate Professor role: CONTACT phone: +8613277924848 email: junjia@whu.edu.cn name: zili Yu role: PRINCIPAL_INVESTIGATOR hasResults: False

 nctId: NCT06277778 id: HSEARS20211117003-03 briefTitle: Effect of Combined Music and Taekwondo Training for Children With Autism Spectrum Disorder overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-06-30 date: 2026-12-31 date: 2024-02-26 date: 2024-02-26 name: The Hong Kong Polytechnic University class: OTHER briefSummary: The goal of this randomized controlled trial is to evaluate the effect of combined music and taekwondo training on the mental and physical condition of children with autism spectrum disorder. Participants will be asked to do combined music and taekwondo training or taekwondo training alone to evaluate if the combined training is better than the taekwondo training alone on mental and physical performance for children with autism spectrum disorder. conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: Taekwondo training with music therapy name: Taekwondo training alone measure: Engagement in the Training Sessions measure: Gross Motor Skills measure: Physical Activity Level measure: Enjoyment State measure: Rate of Perceived Exertion measure: Taekwondo skills performance measure: Conners' Continuous Performance Test II measure: Comprehensive Trail-Making Test (CTMT) measure: Social Responsiveness Scale, second edition (SRS-2) measure: Childhood Autism Spectrum Test measure: Strength and Difficulties Questionnaires (SDQ) measure: Clinical Global Improvement (CGI) score sex: ALL minimumAge: 7 Years maximumAge: 9 Years stdAges: CHILD hasResults: False

 nctId: NCT06277765 id: CM310-101212 briefTitle: Study of CM310 Injection in Adolescent Subjects With Atopic Dermatis overallStatus: NOT_YET_RECRUITING date: 2024-05-30 date: 2025-05-30 date: 2025-05-30 date: 2024-02-26 date: 2024-02-26 name: Keymed Biosciences Co.Ltd class: INDUSTRY briefSummary: This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, PK, PD and immunogenicity of CM310 in children patients with moderate-to-severe atopic dermatitis. conditions: Atopic Dermatitis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 180 type: ESTIMATED name: CM310 name: placebo measure: Proportion of subjects achieving EASI-75 at week 18 sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Peking University People's hospital city: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06277752 id: CIBI128A101 briefTitle: A Study to Investigate the Pharmacokinetic/Pharmacodynamic Characteristics of IBI128(A New Xanthine Oxidase Inhibitor) overallStatus: COMPLETED date: 2024-03-05 date: 2024-03-16 date: 2024-03-16 date: 2024-02-26 date: 2024-03-22 name: Innovent Biologics (Suzhou) Co. Ltd. class: INDUSTRY briefSummary: A Phase I study to evaluate the pharmacokinetic/pharmacodynamic characteristics,safety and tolerability of IBI128 after multidosing in Chinese health subjects. conditions: Gout Arthritis studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ACTUAL name: dose-5 group name: dose-1 group name: dose-2 group name: dose-4 group name: dose-3 group measure: PK parameter: Cmax measure: PK parameter: AUC measure: PK parameter: Tmax measure: PK parameter: T1/2 measure: Safety parameter: AE measure: PD parameter: serum UA (uric acid） measure: Tolerability parameter: SAE sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: The First Affiliated city: Zhengzhou state: Henan zip: 450000 country: China lat: 34.75778 lon: 113.64861 hasResults: False

 nctId: NCT06277739 id: 20220117020315695 briefTitle: Brain Effect Mechanism of Spinal Manipulative Therapy on LDH Analgesia Based on Multimodal MRI overallStatus: ACTIVE_NOT_RECRUITING date: 2022-06-01 date: 2026-09-01 date: 2026-09-01 date: 2024-02-26 date: 2024-02-28 name: Zhou Xingchen class: OTHER briefSummary: The clinical symptoms of Lumbar Disc Herniation (LDH) can be effectively ameliorated through Spinal Manipulative Therapy (SMT), which is closely linked to the brain's pain-regulating mechanisms. Magnetic Resonance Imaging (MRI) offers an objective and visual means to study how the brain orchestrates the characteristics of analgesic effects. From the perspective of multimodal MRI, the investigators applied functional MRI (fMRI) and Magnetic Resonance Spectrum (MRS) techniques to comprehensively evaluate the characteristics of the effects of SMT on the brain region of LDH from the aspects of brain structure, brain function and brain metabolism. This multimodal MRI technique provides a biological basis for the clinical application of SMT in LDH. conditions: Lumbar Disc Herniation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Spinal Manipulative Therapy name: Sham Laser Treatment measure: visual analogue scale (VAS) measure: Japanese Orthopaedic Association Scores (JOA) measure: Amplitude of Low-Frequency Fluctuation (ALFF) measure: Regional Homogeneity (ReHo) measure: Functional Connectivity (FC) measure: Magnetic Resonance Spectrum （MRS） sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Third Affiliated Hospital of Zhejiang Chinese Medical University city: Hangzhou state: Zhejiang zip: 310053 country: China lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06277726 id: IU-SBE-CGI-01 briefTitle: The Effect of Two Non-pharmacological Methods on Pain and Anxiety Experienced During Intrauterine Device Application. overallStatus: RECRUITING date: 2023-07-01 date: 2024-04 date: 2024-04 date: 2024-02-26 date: 2024-02-26 name: Inonu University class: OTHER name: The Scientific and Technological Research Council of Turkey briefSummary: The purpose of this study is to determine the effect of emotional freedom technique and music, which are effective in relieving pain and anxiety, on the pain and anxiety that occur during intrauterine device application. conditions: Intrauterine Devices studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled study with pre-test post-test group primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: In order to ensure randomization and prevent contamination between groups, data will be collected in a sequence such that emotional freedom technique is collected one week, music is collected one week, and control group data is collected one week. It will be decided by drawing lots which group's data will be collected first. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 168 type: ESTIMATED name: Emotional freedom technique group name: Music group name: Control group measure: Visual Analog Scale (VAS) measure: State Anxiety Inventory sex: FEMALE minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: Şırnak State Hospital status: RECRUITING city: Şırnak zip: 73000 country: Turkey name: Ceylan GÜZEL İNAL, Lecturer role: CONTACT phone: +095432588644 email: cylngzl@hotmail.com lat: 37.51393 lon: 42.45432 hasResults: False

 nctId: NCT06277713 id: CME2023/069 briefTitle: Preventing Exercise Resistance With Sedentary Interruptions acronym: PERSI overallStatus: RECRUITING date: 2024-02-19 date: 2024-10-30 date: 2025-07-01 date: 2024-02-26 date: 2024-03-04 name: Hasselt University class: OTHER briefSummary: The goal of this randomised cross-over trial is to learn about the interaction between sedentary behaviour throughout the day and the metabolic effect of an exercise bout on that same day in office workers with an increased risk for chronic disease.

The main question this study aims to answer is if the lipid-lowering effects of an exercise bout can be more pronounced by implementing alternations between a seated and a standing working position throughout the day.

Participants will be asked to:

* Complete three intervention periods for a duration of 2 days at their workplace,
* Attend a supervised training session (60min) at the research facility at the end of each intervention period,
* Attend three assessment days at the research facility where postprandial metabolism will be evaluated after a standardised meal test. conditions: Sedentary Behavior conditions: Lipid Metabolism Disorder conditions: Exercise studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Participants will follow three regimes of 2 days each including a sedentary control, a sedentary with exercise and a standing breaks with exercise regimen. The sequence of the regimens will be randomised. Each regimen will be followed by a minimum wash-out period of 7 days during which subjects will continue their normal lifestyle.

We will use a balanced design with 6 randomisation blocks (ABC, ACB, BAC,BCA, CAB, CBA). The randomisation will be computer-generated and allocation will be determined by a member of the research team drawing a sealed, non-translucent envelop with herein written the scheme. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The outcome assessor will be blinded to the allocation of participants as samples will be code labeled. whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Standing interruptions name: Exercise bout name: Sedentary measure: Total and incremental area under the curve of postprandial response in lipid metabolism measure: Total and incremental area under the curve of glucose and insulin postprandial responses measure: Resting metabolic rate sex: ALL minimumAge: 30 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hasselt University status: RECRUITING city: Diepenbeek state: Limburg zip: 3590 country: Belgium name: Bert Op 't Eijnde, Prof. dr. role: CONTACT phone: +3211292121 email: bert.opteijnde@uhasselt.be name: Jen Vanherle, Drs. role: CONTACT email: jen.vanherle@uhasselt.be name: Bert Op 't Eijnde, Prof. dr. role: PRINCIPAL_INVESTIGATOR name: Jen Vanherle, Drs. role: SUB_INVESTIGATOR lat: 50.90769 lon: 5.41875 hasResults: False

 nctId: NCT06277700 id: CMT001 briefTitle: Effects Of Dynamic Stabilizatıon Exercises And HVLA Manipulatıon in Low Back Paın acronym: DNSHVLA overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-03-01 date: 2024-06-01 date: 2024-02-26 date: 2024-02-26 name: SEFA HAKTAN HATIK class: OTHER briefSummary: Our aim is to contribute to the literature by comparatively examining the effects of DNS exercises and chiropractic HVLA manipulation on pain, pain-related functional impairment (disability), physical competence level, dynamic fitness level of core muscles and postural deviations in patients with chronic nonspecific low back pain. conditions: Low Back Pain conditions: Neuromuscular Subluxation of Joint studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 60 people will participate in the study and the participants will be divided into four groups. The groups will be formed as chiropractic manipulation (CM) group (n=15), dynamic neuromuscular stabilization (DNS) group (n=15), CM + DNS group (n=15) and control group (CG) (n=15). Chiropractic manipulation will be performed once in the side-lying position. An individualized exercise program will be applied to the DNS group under the supervision of a physiotherapist. Kruskal Wallis test for comparisons of quantitative variables between 4 independent groups; Mann Whitney U test with Bonferonni correction will be used in double subgroup comparisons of significant variables. Friedman test was used for comparisons of quantitative variables in 3 dependent groups. Wilcoxon test with Bonferonni correction will be used for two-way subgroup comparisons for significant variables. In all statistical analyzes in the study, results with a p value below 0.05 will be considered statistically significant. primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Chiropractic Manipulation (HVLA - high velocity low amplitude) name: Dynamic Neuromuscular Stabilization measure: Visual Analog Scale measure: Physical Adequacy Level measure: Disability Level measure: Dynamic Stabilization and Adaptibility measure: Posture sex: ALL minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT facility: Sefa Haktan Haktik city: Sinop country: Turkey lat: 42.02683 lon: 35.16253 hasResults: False

 nctId: NCT06277687 id: SYSKY-2024-023-02 briefTitle: Exploratory Study on the Application of Virtual Augmented Reality Combined With Finder in Preoperative Anterolateral Thigh Flap Perforator Positioning overallStatus: RECRUITING date: 2024-02-15 date: 2025-01-01 date: 2026-01-01 date: 2024-02-26 date: 2024-03-19 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: Oral and maxillofacial region is an important anatomical part of human body, responsible for chewing, swallowing, language, expression, breathing and other physiological functions. The tissue defects in this area not only seriously affect the physiological function, but also lead to facial deformity and aesthetic damage, affecting the quality of life of patients. The anterolateral thigh flap has become one of the main methods for defect repair due to its large tissue volume and high survival rate, and one of the key steps to ensure a high survival rate is the location of the perforator. How to find the perforator more accurately by improving the detection scheme or locating the perforator according to the anatomical structure, and guide the preparation and cutting of the flap, is the main direction of current research. This study intends to conduct a exploratory study on perforator localization of flap , and explore its effectiveness and accuracy through sensitivity and specificity.

In this study, a total of 24 patients with maxillofacial defects caused by tumors, trauma and other reasons requiring anterolateral femoral flap repair were included, and the perforator branch of femoral anterolateral flap was positioned preoperatively by Virtual augmented reality combined with perforator positioning device and color Doppler ultrasound. After the anterolateral thigh flap was prepared, the incision was closed in the donor area of the leg, and the flap was transplanted free to the maxillofacial defect area for repair. The sensitivity, specificity, positive predictive value, negative predictive value, distance difference and odds ratio of the two methods were calculated respectively, and the differences of each evaluation index between the two groups were compared, mainly to evaluate the sensitivity and specificity between the two groups. conditions: Blood Vessel Perforation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: After performing CTA examination, input the CTA data into Cinematic Anatomy reconstruction software to analyze blood vessels, muscles and other tissues are reconstructed in three dimensions. Before the operation, the Finder is used to restore the position of the thigh during CTA examination. The Hololens is used to match the reconstructed three-dimensional image with the Finder and the thigh. Before the operation, the pedicles of the descending branches of the lateral arteries and the perforating vessels are marked on the skin of the thigh to achieve the positioning and marking of the perforating branches. primaryPurpose: DIAGNOSTIC masking: NONE count: 24 type: ESTIMATED name: Virtual Augmented Reality Combined With Finder measure: Sensitivity measure: Specificity measure: positive predictive value measure: negative predictive value measure: Youden Index sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University status: RECRUITING city: Guanzhou state: Guangdong zip: 510000 country: China name: Song Fan, Doctor degree role: CONTACT phone: 020-81332477 email: fansong2@mail.sysu.edu.cn name: Song Fan, Doctor degree role: PRINCIPAL_INVESTIGATOR hasResults: False

 nctId: NCT06277674 id: ZF2023-252 briefTitle: Efficacy of Cadonilimab in Non-squamous Non-small Cell Lung Cancer Patients Resistant to EGFR-TKI overallStatus: RECRUITING date: 2023-11-02 date: 2024-12 date: 2025-06 date: 2024-02-26 date: 2024-03-08 name: Guangzhou University of Traditional Chinese Medicine class: OTHER name: Akeso Pharmaceuticals, Inc. briefSummary: This study was designed to evaluate the efficacy and safety of cadonilimab (anti PD-1 and CTLA-4 bispecific antibody) in combination with pemetrexed and anlotinib for treatment of elderly patients with T790M-negative advanced non-squamous non-small cell lung cancer following resistance to EGFR-TKI. conditions: Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Cadonilimab plus Pemetrexed and Anlotinib measure: ORR(Objective response rate) measure: Progression-free survival (PFS) measure: (Disease control rate assessed by investigators) DCR (CR+PR+SD) measure: Overall survival (OS) sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Guangdong Provincial Hospital of Traditional Chinese Medicine status: RECRUITING city: Guangzhou state: Guangdong zip: 510120 country: China name: Haibo Zhang, Prof role: CONTACT phone: 86-020-81887233 phoneExt: 34830 email: haibozh@gzucm.edu.cn lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06277661 id: 2023H0305 briefTitle: The Mom and Infant Outcomes (MOMI) Study overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-06-30 date: 2028-05-30 date: 2024-02-26 date: 2024-04-09 name: Ohio State University class: OTHER briefSummary: The investigator's long-term goal is to mitigate pregnancy-related mortality (PRM) risk by systematically delivering integrated clinical and supportive care that is effective, equitable, and scalable. The investigator's central hypothesis is that the Multi-modal Maternal Infant Perinatal Outpatient Delivery System (MOMI PODS) will mitigate postpartum (PP) risk and reduce disparities in PP risk by improving biopsychosocial profiles and facilitating access to evidence-based clinical and supportive care. To test this hypothesis, the investigators will conduct a hybrid type 1 randomized controlled trial (RCT) of MOMI PODS versus enhanced usual care (EUC, which we will term MOMI CARE) among a total sample of 384 mother-infant dyads (192/group) following pregnancy affected by a cardiometabolic and/or mental health condition. The investigators will enroll participants on PP day 1 and collect data at baseline and 6 months and 1 year PP. The investigators will collect implementation and service data across sites. conditions: Postpartum Depression conditions: Postpartum Anxiety conditions: Cardiometabolic Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 384 type: ESTIMATED name: MOMI PODS name: Enhanced Usual Care (EUC) measure: Change in Life's Essential 8 (LE8) Composite Score measure: Change in Life's Essential 8 (LE8) Composite Score measure: Change in Life's Essential 8 (LE8) Composite Score measure: Change in Patient Health Questionnaire-9 (PHQ-9) Score measure: Change in Patient Health Questionnaire-9 (PHQ-9) Score measure: Change in Patient Health Questionnaire-9 (PHQ-9) Score measure: Change in Generalized Anxiety Disorder-7 (GAD-7) Score measure: Change in Generalized Anxiety Disorder-7 (GAD-7) Score measure: Change in Generalized Anxiety Disorder-7 (GAD-7) Score sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The Ohio State University city: Columbus state: Ohio zip: 43210 country: United States name: Shannon L. Gillespie, PhD, RN role: CONTACT phone: 614-292-4589 email: gillespie.175@osu.edu name: Sandra Solove, MA role: CONTACT phone: 6142478366 email: solove.3@osu.edu lat: 39.96118 lon: -82.99879 hasResults: False

 nctId: NCT06277648 id: 18-2021 briefTitle: the Pericapsular Nerve Group (PENG) and Suprainguinal Fascia Iliaca Blocks (SIFIB) in Elderly Patients overallStatus: RECRUITING date: 2022-01-01 date: 2024-04-01 date: 2024-04-15 date: 2024-02-26 date: 2024-02-28 name: Haseki Training and Research Hospital class: OTHER briefSummary: This clinical trial aims to compare the effect of the pericapsular nerve group (PENG) and suprainguinal fascia iliaca blocks (SIFIB) on pain management in elderly patients with subtrochanteric femur fractures.

The participants will be patients determined to have proximal femoral nailing. According to randomisation, each participant will receive either PENG or SIFIB postoperatively after spinal anaesthesia. The investigator will measure postoperative pain scores, total amount of analgesic consumption and motor ability postoperatively. conditions: Collum Femoris Fracture conditions: Pericapsular Nerve Group Block conditions: Suprainguinal Fascia Iliaca Block studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: a double-blind, prospective, randomized, controlled study primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: The orthopaedic surgeon responsible for the study was blinded to the study groups. This surgeon was the sole evaluator of postoperative pain scores and total analgesia consumption. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 75 type: ESTIMATED name: PENG block name: SIFIB measure: pain scores measure: rescue analgesia sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Haseki Training and Research Hospital status: RECRUITING city: Istanbul state: Sultangazi country: Turkey name: Berna Caliskan role: CONTACT email: caliskan.b@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06277635 id: TAPAC001 briefTitle: Effect of Silymarin Against Methotrexate-induced Liver Injury in Rheumatic Diseases overallStatus: RECRUITING date: 2024-02-01 date: 2025-04 date: 2025-04 date: 2024-02-26 date: 2024-02-26 name: Phramongkutklao College of Medicine and Hospital class: OTHER briefSummary: To study the effect of silymarin against methotrexate-induced liver injury in rheumatic diseases including rheumatoid arthritis, psoriatric arthritis and psoriasis conditions: Rheumatoid Arthritis conditions: Psoriatic Arthritis conditions: Psoriasis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 72 type: ESTIMATED name: Silymarin name: Placebo measure: AST or ALT > 1X ULN ( normal AST and ALT 0-50 U/L) measure: AST or ALT > 2X ULN ( normal AST and ALT 0-50 U/L) AST or ALT > 2X ULN AST or ALT > 2X ULN measure: AST or ALT > 3X ULN ( normal AST and ALT 0-50 U/L) measure: AST or ALT > 5X ULN or >3X ULN ( normal AST and ALT 0-50 U/L) with symptom of hepatitis such as Fatique, abdominal pain, nausea, vomiting or total bilirubin > 2X with jaundice measure: Discontinuation rate of methotrexate measure: Adverse events measure: Change of DAS-28 ESR or CRP Score measure: Change of BASDAI Score measure: Change of ASDAS ESR or CRP Score measure: Change of BSA for psoriasis sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rheumatic Disease Unit, Department of Internal Medicine, Phramongkutklao Hospital and College of Medicine status: RECRUITING city: Bangkok, Thailand, 10400 state: Bangkok zip: 10400 country: Thailand name: Rattapol Pakchotanon, M.D. role: CONTACT phone: 66+23547980 email: rattapolpmk@gmail.com name: Rattapol Pakchotanon, M.D. role: SUB_INVESTIGATOR name: Supasa Niyompanichakarn, M.D. role: SUB_INVESTIGATOR lat: 13.75398 lon: 100.50144 hasResults: False

 nctId: NCT06277622 id: PekingUTH ZFCY PFUN briefTitle: A Prospective Multicenter Cohort Study About Internal Fixation Using PFUN Versus PFNA for Femoral Intertrochanteric Fracture overallStatus: RECRUITING date: 2024-01-01 date: 2025-09-30 date: 2025-12-31 date: 2024-02-26 date: 2024-02-26 name: Peking University Third Hospital class: OTHER name: Beijing Yanqing Hospital briefSummary: This prospective multicenter cohort study is to compare the post-operative implant failure rate between the patients with femoral intertrochanteric fracture (AO classification 31-A) using Proximal Femoral Universal Nail (PFUN) versus Proximal Femoral Nail Antirotation (PFNA) at 21-month follow up. The patients are divided into the PFUN group and the PFNA group according to the internal fixation they choose. The internal fixation failure rate (IFFR) and differences in fracture prognosis of the two groups will be compared. Obtain clinical data of PFUN in the Chinese population, and verify the safety and efficacy of PFUN for patients with femoral intertrochanteric fracture. conditions: Femoral Intertrochanteric Fractures studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This prospective multicenter cohort study is to compare the post-operative implant failure rate between the patients with femoral intertrochanteric fracture (AO classification 31-A) using Proximal Femoral Universal Nail (PFUN) versus Proximal Femoral Nail Antirotation (PFNA) at 21-month follow up.The patients are divided into the PFUN group and the PFNA group according to the internal fixation they choose. primaryPurpose: TREATMENT masking: NONE count: 130 type: ESTIMATED name: PFUN name: PFNA measure: Internal fixation failure rate measure: Number of Participants with Bone nonunion measure: Harris hip score measure: operation time measure: The times of intraoperative fluoroscopy measure: Number of Participants with Postoperative adverse events sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University Third Hospital status: RECRUITING city: Beijing state: Beijing zip: 100191 country: China name: Yuan Cao, MD role: CONTACT phone: +86-01082266699 email: cy6415@126.com name: Fang Zhou, MD role: CONTACT phone: +86010-82267010 email: zhouf@bjmu.edu.cn lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06277609 id: 20508A briefTitle: A Trial Investigating Lu AF28996 in Healthy Adult Participants overallStatus: RECRUITING date: 2024-02-27 date: 2024-05-18 date: 2024-05-18 date: 2024-02-26 date: 2024-03-07 name: H. Lundbeck A/S class: INDUSTRY briefSummary: The purpose of this study is to investigate repeated doses of Lu AF28996 in healthy participants and co-administered with two other compounds, and in a separate cohort following co-administration with antibiotics, to see how well the doses are tolerated and what the body does to the drug after administering it. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Lu AF28996 name: Acetylsalicylic Acid name: Mefenamic Acid name: Amoxicillin/clavulanic acid measure: Maximum Observed Concentration (Cmax) of Lu AF28996 measure: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Lu AF28996 measure: Nominal Time Corresponding to the Occurrence of Cmax sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Covance Dallas CRU status: RECRUITING city: Dallas state: Texas zip: 75247 country: United States lat: 32.78306 lon: -96.80667 hasResults: False

 nctId: NCT06277596 id: ETK00-2023-0101 briefTitle: The Effects of Progressive Clinical Pilates Exercises Applied as 2 Different Ways in Fibromyalgia overallStatus: RECRUITING date: 2024-04-10 date: 2024-07-30 date: 2024-08-30 date: 2024-02-26 date: 2024-04-16 name: Eastern Mediterranean University class: OTHER briefSummary: The aim of this study is to compare the effects of progressive clinical Pilates exercises applied as group under the supervision of a physiotherapist and home exercise programs on pain level, physical condition, functional status, psychosocial status and quality of life in individuals with fibromyalgia between the ages of 20-50. conditions: Fibromyalgia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 48 type: ESTIMATED name: Exercise measure: Visual Analog Scale ( VAS ) measure: Sociodemographic information (age) measure: Sociodemographic information (height) measure: Sociodemographic information (weight) measure: Trunk Muscle Endurance (McGill Endurance Test and Plank Test) measure: Chair Sit to stand test measure: 6 minute walk test measure: Fatigue Severity Scale measure: Pittsburgh Sleep Quality Index measure: Revised Fibromyalgia Impact Questionnaire measure: Fear-Avoidance Beliefs Questionnaire measure: Pain Self-Efficacy Questionnaire measure: Body Awareness Questionnaire measure: Cognitive Exercise Therapy Approach-Biopsyhosocial Questionnaire (BETY-BQ) measure: Short form-36 (SF-36) measure: Treatment Satisfaction Evaluation sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: Eastern Mediterranean University status: RECRUITING city: Famagusta zip: 99628 country: Cyprus name: Sevim Oksüz, Asst.Prof.Dr role: CONTACT phone: 5488351465 phoneExt: +90 email: sevim.oksuz@emu.edu.tr lat: 35.12054 lon: 33.93894 hasResults: False

 nctId: NCT06277583 id: NUS-IRB-2023-191 briefTitle: Urban Care Farming on Living Well and Productive Engagement of Older Adults overallStatus: RECRUITING date: 2023-11-28 date: 2024-12-31 date: 2025-12-31 date: 2024-02-26 date: 2024-02-26 name: National University of Singapore class: OTHER name: National Medical Research Council (NMRC), Singapore briefSummary: The goal of the randomized controlled trials is to learn about the effects of urban farming interventions on older adults' physical, mental, and social well-being of older adults aged 50 and above. The main questions the study aims to answer are Q1. Would participants who have undergone the urban care farming intervention have lower stress levels compared to those who did not undergo the intervention? Q2. Would the quality of life and biopsychosocial factors of older adults who participate in the urban farming interventions be better before the intervention and compared to those who did not participate? Q3. Would running intervention programs as such demonstrate cost-effectiveness? Participants will be enrolled in 24 weekly lessons providing hands-on urban farming techniques, including physical activity, planting, and social interactions. Researchers will compare older participants with similar demographic profile to determine if the biological, psychological, and social factors are better for the intervention group. conditions: Stress, Psychological studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Waitlist controlled trials: Participants from both the intervention and waitlist control groups will undergo the intervention 6 months apart. primaryPurpose: OTHER masking: NONE count: 200 type: ESTIMATED name: Urban care farming measure: WHO Quality of Life Scale (WHOQOL-BREF) measure: Immuno-biomarkers: IL-1RA, IL-6, IL-8 (CXCL8), IL-10, IL-13, IL-17A (CTLA-8), MIP-3 beta (CCL19), SDF-1 alpha, MMP-3, MMP-9, MCP-1 (CCL2), and TNF alpha measure: Brief sense of community scale (BSCS) measure: Fried phenotype of frailty measure: Lubben social network scale (LSNS-6) measure: Functional near-infrared spectroscopy measure: EQ5D measure: Geriatric anxiety scale (GAS-10) measure: MOCA measure: Brief resilience scale measure: De jong Gierveld loneliness scale measure: Fitbit measure: Body weight and height measure: Fasting plasma glucose, HbA1c measure: Serum Creatinine measure: Attitude towards eating healthy food measure: Waist and hip circumference measure: Blood pressure measure: Lipid panel measure: Eating fruits and vegetables behavior sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NUS status: RECRUITING city: Singapore zip: 117549 country: Singapore name: Ezra Chiam role: CONTACT phone: +6566016036 email: ezra.chiam@nus.edu.sg name: Cynthia Chen, PhD role: PRINCIPAL_INVESTIGATOR name: Choon Nam Ong, MD, PhD role: SUB_INVESTIGATOR name: Schwarz Herbert, PhD role: SUB_INVESTIGATOR name: Mary Chong, PhD role: SUB_INVESTIGATOR name: Roger Ho, PhD role: SUB_INVESTIGATOR name: Leng Leng Theng, PhD role: SUB_INVESTIGATOR lat: 1.28967 lon: 103.85007 facility: Jurong Lake Garden status: RECRUITING city: Singapore zip: 618661 country: Singapore name: Joan Hung role: CONTACT email: Joan_HUNG@nparks.gov.sg lat: 1.28967 lon: 103.85007 hasResults: False

 nctId: NCT06277570 id: 2023-487 briefTitle: Investigation of the Effect of Superimposed Neuromuscular Electrical Stimulation in Patients With Knee Osteoarthritis. overallStatus: RECRUITING date: 2023-10-31 date: 2025-03-31 date: 2025-06-30 date: 2024-02-26 date: 2024-02-26 name: Gulhane School of Medicine class: OTHER briefSummary: The aim of the study is to investigate the effects of superimposed neuromuscular electrical stimulation with active contraction on physical function, muscle and joint structure, functionality, and quality of life in patients with knee osteoarthritis. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The sample of the study will consist of participants who applied to Etlik City Physical Therapy and Rehabilitation Hospital, were diagnosed with knee osteoarthritis by the physician, and will receive routine treatment in the electrotherapy unit. Patients will be randomly assigned to groups. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 63 type: ESTIMATED name: conventional physiotherapy name: NMES name: Superimposed NMES measure: Muscle strength measure: Joint position sense measure: Muscle structure and knee joint cartilage thickness measure: Joint range of motion measure: Short Form-36 measure: Western Ontario and McMaster Universities Osteoarthritis Index Scale measure: Visual Analog Scale (VAS) measure: Balance assessment measure: Functional capacity sex: ALL minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Physiotherapy and Rehabilitation, University of Health Sciences status: RECRUITING city: Ankara state: Etlik zip: 06018 country: Turkey name: Oğuzhan METE role: CONTACT email: oguzhan.mete@sbu.edu.tr lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06277557 id: HSEARS20211229002 briefTitle: Evaluation of the Effects of Virtual Reality Learning Environment on Nursing Student Non-technical Skills Development overallStatus: COMPLETED date: 2022-01-10 date: 2023-08-31 date: 2023-08-31 date: 2024-02-26 date: 2024-02-26 name: The Hong Kong Polytechnic University class: OTHER briefSummary: The goal of this waitlist control study is to evaluate the benefits of virtual reality teaching pedagogy to developing non-technical skills in nursing students.

The main question\[s\] it aims to answer are:

1. What is the relationship between VR training programs and students' situation awareness skills development?
2. What is the relationship between VR training programs and students' communication skills development?
3. What is the relationship between VR training programs and students' satisfaction/self-confidence in learning?
4. What is the relationship between the sense of presence and satisfaction/ self-confidence in learning?
5. How does the student's learning experience after VR training programs?

Participants will attend the Virtual Reality training program. Researchers will compare the use of high-fidelity simulation to see if the non-technical skills were developed. conditions: Educational Problems studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: Waitlist-control study primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 180 type: ACTUAL name: Virtual Reality measure: Situation awareness and communication skills measure: Student's self-confidence in learning measure: Participants' sense of presence in this virtual clinical environment sex: ALL minimumAge: 18 Years maximumAge: 22 Years stdAges: ADULT facility: Timothy LAI city: Kowloon country: Hong Kong lat: 22.31667 lon: 114.18333 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2022-01-01 uploadDate: 2024-02-18T20:16 filename: Prot_SAP_000.pdf size: 840053 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2022-01-01 uploadDate: 2024-02-18T20:16 filename: ICF_001.pdf size: 720367 hasResults: False

 nctId: NCT06277544 id: M2024087 briefTitle: Analysis of Prognosis and Risk Factors of LAL Reconstruction Procedure for Patients With AF of the LAL: a Prospective Cohort Study overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-27 date: 2026-06-30 date: 2026-06-30 date: 2024-02-26 date: 2024-02-26 name: Peking University Third Hospital class: OTHER briefSummary: To compare the clinical outcomes of CAI patients with and without lateral ankle avulsion fracture after ligament repair/reconstruction, and to analyze the risk factors associated with the outcome. conditions: Avulsion Fracture of Lateral Ankle Ligament studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: lateral ankle ligament repair or reconstruction measure: Karlsson score measure: Visual Analogue Scale (VAS) measure: American Orthopaedic Foot and Ankle Society (AOFAS) measure: Tegner Scale sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Peking University Third Hospital city: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06277531 id: IRB00006761-M2024086 briefTitle: Evaluation of diagnostiC Capacity of eccDNAs as Biomarkers in Indetermined biLiary Stricture(ECCBILE) acronym: ECCBILE overallStatus: RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2027-03-01 date: 2024-02-26 date: 2024-04-03 name: Peking University Third Hospital class: OTHER name: Beijing Tsinghua Changgeng Hospital briefSummary: Biliary stricture is mainly malignant in the adults and caused by several types of fatal malignancies such as pancreatic cancer, cholangiocarcinoma, and metastatic tumor, which have poor prognosis that the overall survival of unresectable lesions is no more than 15 months. The poor outcome often relates to a lack of reliable strategies for early diagnosis, which results in most patients with malignant biliary stricture being already advanced-stage disease at presentation. Therefore, it is critical to discover novel and effective strategies for the early diagnosis of malignant biliary strictures.

Brush cytology and biopsy during endoscopic retrograde cholangiopancreatography (ERCP) are the main methods for recognizing malignant diseases of the bile duct, but their sensitivity is relatively low, 45% and 48.1%, respectively. Even when combined with other biomarkers like carbohydrate antigen 19-9 (CA19-9), their sensitivity is still less than 80%.

In the previous study, the investigators found that bcf-eccDNA has excellent diagnostic value in predicting uncertain bile duct stricture, and the sensitivity and specificity of a related eccDNA in 40 samples are 80.8% and 100%. The sensitivity and specificity of another eccDNA were 92.3% and 92.9%, respectively. However, the sample size is still relatively small, and further prospective studies are needed to evaluate its diagnostic efficacy. conditions: Biliary Stricture conditions: Bile Duct Cancer conditions: Pancreas Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 99 type: ESTIMATED measure: Patient is diagnosed with malignant disease from biliary system sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University Third Hospital status: RECRUITING city: Beijing state: Beijing zip: 1000191 country: China name: Zhuo Cheng, M.D. role: CONTACT phone: +86-18701012781 email: chengzhuo321@pku.edu.cn lat: 39.9075 lon: 116.39723 facility: Beijing Tsinghua Changgung Hospital status: RECRUITING city: Beijing state: Beijing zip: 102218 country: China name: Xiue Yan, M.D. role: CONTACT phone: +86-15811117418 email: pskyq@163.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06277518 id: Liqin Deng briefTitle: System for Postoperative Admission to ICU for Patients With Digestive System Malignancy overallStatus: ACTIVE_NOT_RECRUITING date: 2023-09-20 date: 2025-12 date: 2026-06-20 date: 2024-02-26 date: 2024-02-26 name: General Hospital of Ningxia Medical University class: OTHER briefSummary: Postoperative admission to ICU for patients with digestive system tumors is one of the most common postoperative complications of all non-cardiac surgeries. The study found that supportive treatment of critically ill patients admitted to ICU after surgery was conducive to reducing mortality, and the most common complications of postoperative ICU admission were infections, especially respiratory infections and surgical site infections. A growing body of evidence supports that ICU stays are expensive, always occupy major hospital resources, and are associated with the worst outcomes. To date, there is insufficient evidence to determine which patients with digestive system tumors benefit the most from being admitted to the ICU after surgery. Therefore, this study intends to adopt retrospective study to determine the risk factors of postoperative ICU transfer for patients with digestive system malignant tumor, and build a risk prediction model for postoperative ICU admission, so as to guide the decision of postoperative ICU transfer for patients with digestive system malignant tumor. conditions: Intensive Care Unit Syndrome studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 2000 type: ACTUAL name: Surgery for malignant tumors of the digestive system measure: admitted to ICU after surgery sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: General Hospital of Ningxia Medical University city: Yinchuan state: Ningxia zip: 750004 country: China lat: 38.46806 lon: 106.27306 hasResults: False

 nctId: NCT06277505 id: 2023(164) briefTitle: Efficacy and Safety Evaluation of Prebiotics Combined With Quadruple Probiotics in Improving Functional Constipation. overallStatus: ENROLLING_BY_INVITATION date: 2024-02-20 date: 2024-04-20 date: 2024-06-20 date: 2024-02-26 date: 2024-02-26 name: The First Affiliated Hospital of Xiamen University class: OTHER briefSummary: The purpose of this study is to analyze the intestinal microecology of patients with functional constipation before and after treatment through intestinal microecological intervention, mainly using the combination of probiotics and prebiotics. We will record the patient's stool diary, including bowel movements, stool quality, bowel time, defecation difficulty, emptying sensation, manual operation and medication. At the same time, we will use the Bristol Fecal Traits Scale (BSFS) and the Constipation Patient Self-Rating Scale (PAC-SYM) and Constipation Patient Quality of Life Scale (PAC-QOL) scores completed weekly. In addition, we will monitor indicators of inflammation (IL-1β, IL-6, TNF-alpha) and intestinal barrier function (LPS), neurotransmitter (serotonin, acetylcholine)) to assess constipation improvement in patients with functional constipation. conditions: Effect of Prebiotics and Probiotics on Functional Constipation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Take prebiotics and probiotics name: lifestyle guidance measure: Change in the number of fully autonomous bowel movements per week at the end of treatment sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: The First Affiliated Hospital of Xiamen Univisity city: Xiamen state: Fujian zip: 350000 country: China lat: 24.47979 lon: 118.08187 hasResults: False

 nctId: NCT06277492 id: GN-001 briefTitle: A First-In-Human Study of Single and Multiple Ascending Doses of Oral SUL-238 in Healthy Subjects overallStatus: RECRUITING date: 2024-02-19 date: 2025-08-09 date: 2025-11-08 date: 2024-02-26 date: 2024-02-26 name: GEN İlaç ve Sağlık Ürünleri A.Ş. class: INDUSTRY name: Sulfateq B.V. briefSummary: The goal of this randomized, double-blind, placebo-controlled, single-center study is to evaluate the safety, tolerability, pharmacokinetics of single and multiple oral doses of SUL-238 in healthy subjects (aged ≥40 years). conditions: Healthy Subjects studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 69 type: ESTIMATED name: Single ascending doses SUL-238 name: Single dose Placebo name: Single dose SUL-238 name: Multiple ascending doses SUL-238 name: Multiple doses Placebo measure: Incidence of Treatment-Emergent Adverse Events as Measured by NCI-CTCAE criteria measure: Incidence of Treatment-Emergent Adverse Events as Measured by Clinical Laboratory Measurements According to Established Clinical Normal Ranges measure: Incidence of Treatment-Emergent Adverse Events as Measured by ECG measure: Incidence of Treatment-Emergent Adverse Events as Measured by physical examination and vital signs measure: Incidence of Treatment-Emergent Adverse Events as Measured by central nervous system (CNS) and autonomic nervous system (ANS) examination. measure: PK parameter: Maximum drug concentration in plasma (Cmax) of SUL-238 after a single ascending dose (Part 1 and Part 2). measure: PK parameter: Maximum drug concentration in plasma (Cmax) of SUL-238 after multiple ascending doses (Part 3). measure: PK parameter: Area under the concentration-time curve in plasma (AUC) of SUL-238 after single ascending dose (Part 1 and Part 2). measure: PK parameter: Area under the concentration-time curve in plasma (AUC) of SUL-238 after multiple ascending doses (Part 3). measure: Renal clearance and percentage of drug excreted in urine after single and multiple ascending doses of SUL-238. measure: Percentage of drug excreted in feces after multiple ascending doses of SUL-238. measure: The cerebrospinal fluid (CSF) levels of SUL-238 sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erciyes University IKUM Center status: RECRUITING city: Kayseri zip: 38030 country: Turkey name: Zafer Sezer, MD role: CONTACT phone: +903522076666 phoneExt: 24405 email: drzafersezer@gmail.com lat: 38.73222 lon: 35.48528 hasResults: False

 nctId: NCT06277479 id: Rigshospitalet. Hematology briefTitle: Late Effects and HRQoL in Survivors of Allo-HSCT - a Cross Sectional Study overallStatus: ENROLLING_BY_INVITATION date: 2024-03 date: 2024-09 date: 2024-09 date: 2024-02-26 date: 2024-02-29 name: Rigshospitalet, Denmark class: OTHER name: Danish Cancer Society briefSummary: The cross-sectional study aims to describe the burden of late effects and survivorship-specific health-related quality of life in a nationwide cohort of patients treated with allo-HSCT in Denmark. Further, identify demographic, medical or personal factors associated with better self-reported health and quality of life. conditions: Hematological Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 1600 type: ESTIMATED measure: EORTC Quality of Life Survivorship Core questionnaire (EORTC-QOL-SURV100) measure: Health literacy Questionnaire (HLQ) measure: Modified 7-day Lee Chronic-versus-Host Disease Symptom Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mette Schaufuss Engedal city: Copenhagen zip: 2100 country: Denmark lat: 55.67594 lon: 12.56553 hasResults: False

 nctId: NCT06277466 id: XYFY2023-KL478-01 briefTitle: Effect of Mutations in T2DM Susceptibility Genes on the Expression of Susceptibility Genes in Patients With T2DM and Controls overallStatus: RECRUITING date: 2024-01-01 date: 2028-01-31 date: 2028-01-31 date: 2024-02-26 date: 2024-02-28 name: The Affiliated Hospital of Xuzhou Medical University class: OTHER briefSummary: In this study, investigators wanted to determine the effect of T2DM susceptibility gene mutations on self-expression.

Participants (T2DM patients and controls) were recruited to identify genotypes and detect the levels of T2DM susceptibility genes expression in the fresh peripheral plasma. The normal pancreatic tissues or adjacent tissues of pancreatic cancer were also collected to identify the expression differences of T2DM susceptibility genes under different genotypes. conditions: Type 2 Diabetes Mellitus conditions: Gene Polymorphisms conditions: Genetic Mutations conditions: Susceptibility, Genetic studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 300 type: ESTIMATED name: Fresh normal pancreatic tissues or adjacent tissues of pancreatic cancer were collected from controls and T2DM patients without hypoglycemic drugs name: Fresh blood samples were collected from healthy subjects and T2DM patients without hypoglycemic drugs measure: Detection of T2DM susceptibility gene expression in newly diagnosed T2DM patients measure: Detection of T2DM susceptibility gene expression in controls measure: Correlation between T2DM susceptibility gene expression and clinicopathological features measure: Baseline BMI of newly diagnosed with T2DM patients with different genotypes measure: Baseline waist hip ratio (WHR) of newly diagnosed with T2DM patients with different genotypes measure: Baseline fasting plasma glucose (FPG) of newly diagnosed with T2DM patients with different genotypes measure: Baseline HbA1c of newly diagnosed with T2DM patients with different genotypes measure: Baseline TC of newly diagnosed with T2DM patients with different genotypes measure: Baseline TG of newly diagnosed with T2DM patients with different genotypes measure: Baseline HDL-C of newly diagnosed with T2DM patients with different genotypes measure: Baseline LDL-C of newly diagnosed with T2DM patients with different genotypes measure: Baseline BMI of controls with different genotypes measure: Baseline WHR of controls with different genotypes measure: Baseline FPG of controls with different genotypes measure: Baseline HbA1c of controls with different genotypes measure: Baseline TC of controls with different genotypes measure: Baseline TG of controls with different genotypes measure: Baseline HDL-C of controls with different genotypes measure: Baseline LDL-C of controls with different genotypes sex: ALL minimumAge: 25 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: China, Jiangsu, Department of Endocrinology status: RECRUITING city: Xuzhou zip: 221006 country: China name: Hongwei Ling, MD role: CONTACT phone: 18052268607 email: linghongwei@medmail.com.cn name: Renguo Chen, MD role: PRINCIPAL_INVESTIGATOR name: Yuhan Huang, MD role: SUB_INVESTIGATOR lat: 34.18045 lon: 117.15707 hasResults: False

 nctId: NCT06277453 id: 2024KY010 briefTitle: Effect of Adjuvant Chemotherapy Cycles on Patients With Node-negative Gastric Cancer Following Neoadjuvant Chemotherapy overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-01 date: 2023-08-25 date: 2024-09-30 date: 2024-02-26 date: 2024-02-26 name: Fujian Medical University class: OTHER briefSummary: To explore the effect of adjuvant chemotherapy cycles on the prognosis of this specific patient with lymph node-negative gastric cancer following neoadjuvant chemotherapy. conditions: Locally Advanced Gastric Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 219 type: ACTUAL name: surgery measure: 3-year overall survival sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Gastric Surgery， Fujian Medical University Union Hospital city: Fuzhou state: Fujian country: China lat: 26.06139 lon: 119.30611 hasResults: False

 nctId: NCT06277440 id: NSTC 112-2314-B-341-001 briefTitle: Cognitive Training for Attention Deficit Hyperactivity Disorder and Developmental Delays overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-09-30 date: 2024-09-30 date: 2024-02-26 date: 2024-02-26 name: Taipei Medical University class: OTHER briefSummary: To explore whether children with Attention Deficit Hyperactivity Disorder and developmental delays who receive cognitive training and conventional rehabilitation can improve executive function more than traditional rehabilitation alone. A magnetoencephalographic examination will be arranged to explore how brain network activation works.

Research method: 20 preschool children with Attention Deficit Hyperactivity Disorder and developmental delays under rehabilitation therapy will be collected. They will be randomly assigned to the experimental group (receiving rehabilitation therapy and three times per week for 15 minutes, a total of 12 weeks of interactive cognitive training) and the control group (receiving rehabilitation therapy only). Therapeutic effects will be evaluated. conditions: Attention Deficit Hyperactivity Disorders conditions: Developmental Delays studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Twenty preschool children with Attention Deficit Hyperactivity Disorder and developmental delays under rehabilitation therapy will be collected. They will be randomly assigned to the experimental group (receiving rehabilitation therapy and three times per week for 15 minutes, a total of 12 weeks of interactive cognitive training) and the control group (receiving rehabilitation therapy only). Therapeutic effects will be evaluated by an investigator blinded to the group's allocation before and after 12 weeks of treatment. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Outcome measurements will be performed by a researcher who is blind to the groups' allocation. whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: cognitive training name: active control measure: Changes of executive function measure: changes of symptoms of attention deficit hyperactivity disorder measure: changes of attention measure: Changes of sensory integration measure: changes of intelligence measure: changes of functional performance measure: Changes of family impact measure: Changes of quality of life measure: Changes in performance activity in kindergarten measure: changes of brain network connectivity sex: ALL minimumAge: 4 Years maximumAge: 6 Years stdAges: CHILD facility: Shin Kong Wu Ho-Su Memorial Hospital city: Taipei zip: 111-01 country: Taiwan name: Ru-Lan Hsieh, MD role: CONTACT phone: 886-2-28332211 phoneExt: 2538 email: rulanhsieh@gmail.com name: Ru-Lan Hsieh, MD role: PRINCIPAL_INVESTIGATOR lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06277427 id: [2023]S208 briefTitle: Refractory ANCA Associated Vasculitis and Lupus Nephritis Treated With BCMA-targeting CAR-T Cells overallStatus: RECRUITING date: 2024-02-05 date: 2026-02-01 date: 2027-01-31 date: 2024-02-26 date: 2024-02-26 name: Lingli Dong class: OTHER name: Shenzhen Pregene Biopharma Co., Ltd. briefSummary: Lupus nephritis (LN) and ANCA-associated vasculitis are severe autoimmune diseases, which may lead to the death of patients, particularly when they are refractory to the conventional therapeutic agents. Based on the current knowledge, the autoantibodies against self-antigens may exert important pathological roles in the pathogenesis of both LN and ANCA-associated vasculitis, of which the origins are primarily plasmablasts and plasma cells. BCMA is the molecule expressed on memory B cells, plasmablasts and plasma cells, and therefore is an ideal target for the elimination of potential pathogenic antibody secreting cells. Chimeric antigen receptor (CAR) T cells against BCMA may provide a novel therapeutic way for the refractory LN and ANCA-associated vasculitis patients to eliminate the pathogenic autoantibody-secreting cells. In this study, the safety and efficacy of a novel CAR-T cell therapy using PRG-1801 cells, are evaluated in patients with refractory LN and ANCA-associated vasculitis. conditions: Lupus Nephritis conditions: ANCA Associated Vasculitis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: PRG-1801 （CAR-T against BCMA） measure: AE Incidence of PRG-1801 Single Infusion measure: Types and incidence of dose-limiting toxicity(DLT) after PRG-1801 cells infusion in subjects with refractory ANCA-associated vasculitis and refractory LN. measure: Therapeutic effects-For refractory ANCA-associated vasculitis(The proportion of subjects who maintained remission after cell infusion) measure: Therapeutic effects-For refractory ANCA-associated vasculitis(Changes in VDI (Vasculitis Damage Index) scores from baseline after cell infusion) measure: Therapeutic effects-For refractory ANCA-associated vasculitis (Changes in glomerular filtration rate compared to baseline after cell infusion in subjects with renal involvement.) measure: Therapeutic effects-For refractory LN (Changes in SLEDAI-2000 score from baseline after cell infusion) measure: Therapeutic effects-For refractory LN (Changes in FACIT fatigue score from baseline after cell infusion ) measure: Therapeutic effects-For refractory LN (Changes in PGA score (0-10) from baseline after cell infusion) measure: Therapeutic effects-For refractory LN (Changes in eGFR(mL/min/1.73 m2) relative to baseline after cell infusion) measure: Therapeutic effects-For refractory LN (Changes in UPCR (g/24h）relative to baseline after cell infusion） measure: Therapeutic effects-For refractory LN (The proportion of subjects who achieved overall response rate after cell infusion.） measure: Therapeutic effects-For refractory LN（The proportion of subjects who achieved complete renal response after cell infusion.） measure: PK feature evaluation (PK parameters related to CAR copy number） measure: Serum sBCMA level measure: Serum ANCA titer level (AAV) measure: Serum dsDNA level (LN) measure: Serum ANA titer level (LN) measure: Serum complement C3 levels measure: Serum complement C4 levels measure: Serum immunoglobulin quantification measure: Levels of CRP levels measure: Levels of ferritin levels measure: Levels of cytokine levels measure: Changes of peripheral blood lymphocyte subsets measure: Expression levels of BCMA on peripheral blood B cell subsets surface measure: The level of anti drug antibody (ADA) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji Hospital status: RECRUITING city: Wuhan state: Hubei zip: 430030 country: China name: Lingli Dong, MD role: CONTACT phone: 86-27-83665519 email: tjhdongll@163.com name: Cong Ye, MD role: CONTACT phone: 86-27-83665518 email: Yecong@163.com lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06277414 id: 2024ll0204001 briefTitle: a Prediction of Post-Endoscopic Retrograde Cholangiopancreatography Complication overallStatus: RECRUITING date: 2018-01-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-26 date: 2024-02-26 name: The First Affiliated Hospital of University of South China class: OTHER briefSummary: To develop effective preoperative and postoperative prediction models for postoperative complications of ERCP conditions: Endoscopic Retrograde Cholangiopancreatography studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED name: collection of laboratory test results, imaging results and symptoms measure: Number of Participants with Pancreatitis measure: Number of Acute PEC(post-ERCP-cholecystitis ) measure: Number of Participants with Cholangitis measure: Number of Participants with Perforation measure: Number of Participants with bile duct stents sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of University of South China status: RECRUITING city: Hengyang state: Hunan country: China name: Chen Guodong, PhD role: CONTACT phone: 15211450345 email: Chenguodong@usc.edu.cn lat: 26.88946 lon: 112.61888 hasResults: False

 nctId: NCT06277401 id: RCT_hypermobile_knee briefTitle: Exercise in Patients With Hypermobile Joints and Knee Pain acronym: HIPEr-Knee overallStatus: NOT_YET_RECRUITING date: 2024-02-15 date: 2025-06-01 date: 2026-06-01 date: 2024-02-26 date: 2024-02-26 name: University of Southern Denmark class: OTHER name: Independent Research Fund Denmark name: Odense Patient Data Explorative Network briefSummary: Pain associated with knee joint hypermobility is common in the adult population, but evidence on treatment is sparse. This study investigates if high-load resistance training is superior to usual care in improving activity-related pain in young patients (18-45 years) with hypermobile joints and knee pain. conditions: Hypermobility, Joint conditions: Hypermobility Syndrome conditions: Knee Discomfort studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The patients will be kept blind to treatment allocation by being provided with minimal information about the content of the two exercise interventions and the study hypotheses; the patients will be informed that the study compares two different exercise protocols that both include safe exercises to reduce knee pain and increase knee function.

An independent biostatistician blinded to group allocation will perform the primary RCT analysis. To reduce the risk of interpretation bias, blinded results from the analyses (group A compared with group B) will be presented to all authors, who will agree on two alternative written interpretations before the data manager unblinds the randomisation code. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 90 type: ESTIMATED name: Neuromuscular training for the knee name: High-load strength training for the knee measure: Visual Analogue Scale Nominated Activity measure: Knee injury and Osteoarthritis Outcome Score (KOOS) measure: Adverse events measure: Dynamic knee strength measure: Knee reposition sense measure: Single-Leg-Hop for Distance measure: Knee pain past week measure: Tampa scale of Kinesiophobia (TSK) 11 item measure: EQ-5D-5L measure: EQ VAS measure: Global perceived effect (GPE) measure: PASS measure: TF measure: Clinical important difference measure: Knee instability questions measure: Tendon stiffness measure: Quadriceps rate of torque development (RTD) measure: Patella instability measure: Quadriceps maximal voluntary isometric contraction sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Physiotherapy Clinics Region of Southern Denmark city: Odense state: Fyn zip: 5000 country: Denmark name: Behnam Liaghat, PhD role: CONTACT phone: +4526826801 email: bliaghat@health.sdu.dk lat: 55.39594 lon: 10.38831 facility: University of Southern Denmark city: Odense state: Fyn zip: 5230 country: Denmark name: Behnam Liaghat, PhD role: CONTACT phone: +4526826801 email: bliaghat@health.sdu.dk lat: 55.39594 lon: 10.38831 hasResults: False

 nctId: NCT06277388 id: GASTO-10108 briefTitle: Evaluation of Impedance Cardiography for Assessing Hemodynamic Shifts in Patients With LA-NSCLC During Treatment. overallStatus: RECRUITING date: 2021-06-05 date: 2024-06-05 date: 2024-07-01 date: 2024-02-26 date: 2024-02-28 name: Sun Yat-sen University class: OTHER briefSummary: This study aimed to investigate the role of impedance cardiography (ICG) in evaluating hemodynamic changes during the 6-minute walk test (6MWT) in patients with locally advanced non-small cell lung cancer (LA-NSCLC) who underwent combined concurrent chemoradiotherapy (CCRT) and immunotherapy. Additionally, It sought to analyze the predictive significance of cardiac parameters to both treatment toxicity and survival prognosis. conditions: Non-small Cell Lung Cancer conditions: Cardiac Toxicity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 237 type: ESTIMATED name: Impedance cardiography measure: Stroke volume（SV） sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hui Liu status: RECRUITING city: Guangzhou state: Guangdong zip: 510060 country: China name: Hui Liu, MD role: CONTACT phone: +86-020-87343031 email: liuhuisysucc@126.com lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06277375 id: 813/793 briefTitle: The Effect of Slow Stroke Back Massage on Pain and Fatigue in Women With Fibromyalgia overallStatus: ENROLLING_BY_INVITATION date: 2023-09-14 date: 2024-02-15 date: 2024-03-15 date: 2024-02-26 date: 2024-02-26 name: TC Erciyes University class: OTHER briefSummary: Fibromyalgia syndrome (FM) is defined as a non-inflammatory chronic pain syndrome with widespread pain in the musculoskeletal system, tender points (PINs) on physical examination and no specific laboratory findings. T Sampling was calculated using Power power (G Power 3.1.9.4) analysis. The effect size of the study was calculated based on the mean pain scores and standard deviations of the control and experimental groups taken from the study conducted by Field, et al. (2002). Accordingly, when 25 patients were included in each group, it was determined that the power was 85% at 5% Type I error level. The application to the experimental group will be done 3 days a week for 10 minutes for a total of 30 minutes. data will be collected with patient information form, fatigue severity scale and vas. conditions: Massage Intervention studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Massage measure: VAS measure: Fatigue sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dilek Efe Arslan city: Kayseri state: Melikgazi zip: 38280 country: Turkey lat: 38.73222 lon: 35.48528 hasResults: False

 nctId: NCT06277362 id: CLTI012023 briefTitle: Peripheral Extreme Revascularization in "No-option" Patiens With Chronic Limb Threatening Ischemia acronym: PiPER overallStatus: RECRUITING date: 2020-01-31 date: 2025-12 date: 2027-06 date: 2024-02-26 date: 2024-02-26 name: EndoCore Lab s.r.l. class: OTHER briefSummary: The objective of the study is to evaluate early safety and effectiveness of the percutaneous deep foot venous arterialization performed in clinical practice, in an unselected population of patients with "no-option" CLTI. conditions: Peripheral Arterial Disease conditions: Critical Limb-Threatening Ischemia conditions: Diabetic Foot studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Safety Composite measure: Procedural Success measure: Primary Patency measure: Secondary Patency measure: A-V fistula flow rate measure: Minor amputation rates measure: Major amputation rates measure: Re-Treatment rate measure: Wound Size measure: TpcO2 measure: WIFi class measure: Freedom from all cause death measure: Freedom from procedure-related death measure: Rutherford class sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ospedale Pederzoli status: RECRUITING city: Peschiera Del Garda state: Veneto zip: 37019 country: Italy name: Bruno Migliara, MD role: CONTACT email: bruno.migliara@gmail.com lat: 45.43912 lon: 10.68614 facility: Ospedale San Martino status: NOT_YET_RECRUITING city: Belluno zip: 32100 country: Italy name: Luca Ferretto, MD role: CONTACT name: Luca Ferretto, MD role: PRINCIPAL_INVESTIGATOR lat: 46.14262 lon: 12.2156 facility: Ospedale Bufalini status: NOT_YET_RECRUITING city: Cesena zip: 47521 country: Italy name: Gabriele Testi, MD role: CONTACT name: Gabriele Testi, MD role: PRINCIPAL_INVESTIGATOR lat: 44.1391 lon: 12.24315 facility: Ospedale di Conegliano - USLL2 status: NOT_YET_RECRUITING city: Conegliano zip: 31015 country: Italy name: Massimo Corato, MD role: CONTACT name: Massimo Corato, MD role: PRINCIPAL_INVESTIGATOR lat: 45.88805 lon: 12.30201 facility: Ospedale Cardarelli status: NOT_YET_RECRUITING city: Napoli zip: 80131 country: Italy name: Gianluca Cangiano, MD role: CONTACT name: Gianluca Cangiano, MD role: PRINCIPAL_INVESTIGATOR lat: 40.85216 lon: 14.26811 facility: Arcispedale Santa Maria Nuova status: NOT_YET_RECRUITING city: Reggio Emilia zip: 42122 country: Italy name: Antonio Fontana, MD role: CONTACT name: Antonio Fontana, MD role: PRINCIPAL_INVESTIGATOR lat: 44.69825 lon: 10.63125 facility: Ospedale Santa Chiara status: NOT_YET_RECRUITING city: Trento zip: 38123 country: Italy name: Stefano Bonvini, MD role: CONTACT name: Stenano Bonvini, MD role: PRINCIPAL_INVESTIGATOR lat: 46.06787 lon: 11.12108 hasResults: False

 nctId: NCT06277349 id: MAUV1005 briefTitle: Multifocal-toric IOL Compared to Multifocal IOL Combined With Limbal Relaxing Incisions for Correction of Moderate Astigmatism During Cataract Surgery overallStatus: COMPLETED date: 2009-03-04 date: 2011-01-04 date: 2011-01-04 date: 2024-02-26 date: 2024-03-13 name: Moorfields Eye Hospital NHS Foundation Trust class: OTHER briefSummary: The purpose of the present study is to compare the outcome of multifocal toric intraocular lens with standard multifocal lens plus incisional surgery in patients undergoing bilateral cataract surgery. conditions: Cornea conditions: Astigmatism conditions: Cataract studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised controlled trial with intra-patient comparison (bilateral study), patients are either receiving implant of a multifocal toric IOL or implant of a standard multifocal IOL combined with limbal relaxing incisions. primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 30 type: ACTUAL name: Toric multifocal IOL name: Non-toric multifocal IOL measure: Composite scoring of unaided distance and near vision (monocularly) measure: Residual astigmatism evaluation by Subjective Refraction and autorefraction (Topcon) sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2009-02-06 uploadDate: 2024-02-23T13:05 filename: Prot_000.pdf size: 169392 hasResults: False

 nctId: NCT06277336 id: 2023-01716; kt23ChristCrain3 briefTitle: Effects of Intravenous [Pyr1]Apelin-13 on Healthy Volunteers With Artificially Induced SIAD acronym: ESCAPE overallStatus: RECRUITING date: 2024-03-01 date: 2024-12 date: 2025-12 date: 2024-02-26 date: 2024-04-12 name: University Hospital, Basel, Switzerland class: OTHER briefSummary: Hyponatremia is a common electrolyte imbalance which often results from hormonal disregulation. The study aims to investigate whether the apelin hormone, which plays a role in regulating salt and water balance in the body, can be used to treat hyponatremia.

The study will involve healthy volunteers who will be given a medication that causes their bodies to retain water, thus inducing a temporary hyponatremia state. The researchers will measure the volunteers' blood and urine electrolyte levels to see how these are influenced by apelin administration. As comparison, the same measurements will be done in volunteers dosed with placebo instead of apelin.

The researchers believe that apelin may be able to help to correct hyponatremia by increasing urine output. If the study focused in the healthy volunteers population is successful, the investigators will assess the effect of apelin administration in patients with chronic hyponatremia.

The study's hypothesis is that intravenous apelin will increase urinary excretion and sodium levels in healthy participants with artificially induced hyponatremia. conditions: SIAD - Syndrome of Inappropriate Antidiuresis conditions: Hyponatremia studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 20 type: ESTIMATED name: Placebo name: Apelin Low Dose name: Apelin High Dose name: Selected Apelin Dose measure: Total urinary excretion (ml) measure: Hourly and total urinary excretion (ml) measure: Change in electrolyte free water clearance (ml/min) measure: Change in free water clearance (ml/min) measure: Change in plasma osmolality (mOsm/kg) measure: Change in plasma sodium (mmol/l) measure: Change in body weight (kg) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Basel status: RECRUITING city: Basel zip: 4031 country: Switzerland name: Mirjam Christ-Crain, Prof. Dr. role: CONTACT phone: +41 61 328 70 80 email: Mirjam.Christ-Crain@usb.ch name: Mirjam Christ-Crain, Prof. Dr. role: PRINCIPAL_INVESTIGATOR name: Sophie Monnerat, Dr. Med. role: SUB_INVESTIGATOR name: Julie Refardt, PD. Dr. Med. role: SUB_INVESTIGATOR name: Neeraj Dhaun, Dr. role: SUB_INVESTIGATOR name: Fiona A. Chapman, PhD role: SUB_INVESTIGATOR name: Anthony P. Davenport, Prof. role: SUB_INVESTIGATOR name: Janet Maguire, PhD role: SUB_INVESTIGATOR lat: 47.55839 lon: 7.57327 hasResults: False

 nctId: NCT06277323 id: Cardio briefTitle: UCLA Health Patient Cardiology Care Gaps overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-30 date: 2025-07-30 date: 2025-07-30 date: 2024-02-26 date: 2024-02-26 name: University of California, Los Angeles class: OTHER name: UCLA Health Department of Medicine briefSummary: This is a prospective randomized clinical trial evaluating how two behaviorally-informed interventions (i.e., monthly report card and storyboard interventions) impact physician behavior, with the goal of closing care gaps in preventive care and disease management.

In particular, the monthly report card intervention seeks to elevate physicians' intentions to close their patients' care gaps, while the storyboard intervention seeks to prompt action by making patients' care gaps salient. The trial investigates the separate and joint impacts of the proposed behaviorally-informed interventions on encouraging physicians to close their patients' care gaps. conditions: Health Maintenance conditions: Cardiology studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel randomized trial at the physician level. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 46 type: ACTUAL name: Monthly report card intervention name: Storyboard intervention measure: Care gap closure (patients seen) measure: Care gap closure (all patients in panel) measure: Number of care gaps closed (patients seen) measure: Number of care gaps closed (all patients in panel) measure: HCC/RAF care gap closure (all patients in panel) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UCLA Health Department of Medicine, Quality Office city: Los Angeles state: California zip: 90095 country: United States lat: 34.05223 lon: -118.24368 hasResults: False

 nctId: NCT06277310 id: 3WP in SNH briefTitle: Implementation of the 3 Wishes Project in Safety-Net Hospitals overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-19 date: 2028-04 date: 2028-08 date: 2024-02-26 date: 2024-04-02 name: University of California, Los Angeles class: OTHER name: Olive View-UCLA Education & Research Institute name: LAC+USC Medical Center briefSummary: Dignified and compassionate end-of-life (EOL) care is a cornerstone of high-quality, patient-centered care, but in safety-net hospitals EOL care is often overlooked, considered too late, or not at all. By eliciting and implementing final wishes for dying patients, the 3 Wishes Project (3WP) has demonstrated, in tertiary academic centers, that acts of compassion can improve the EOL experience and help families cope with loss. The investigators propose to implement the 3WP in safety-net hospitals where there are less resources and more diverse, disadvantaged patient populations, and hypothesize that there will be similar positive effects on the EOL experience for patients, families, and clinicians. conditions: End of Life studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a before and after stepped wedge study design primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 900 type: ESTIMATED name: 3 Wishes Project measure: Families' assessment of the quality of end-of-life, particularly in emotional and spiritual support. measure: Family anxiety and depression measure: Nurse Burnout measure: Family PTSD sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: LA General Hospital city: Los Angeles state: California zip: 90033 country: United States lat: 34.05223 lon: -118.24368 facility: Ronald Reagan UCLA Medical Center city: Los Angeles state: California zip: 90095 country: United States lat: 34.05223 lon: -118.24368 facility: Olive View Medical Center city: Sylmar state: California zip: 91342 country: United States lat: 34.30778 lon: -118.44925 facility: Harbor-UCLA city: Torrance state: California zip: 90502 country: United States lat: 33.83585 lon: -118.34063 hasResults: False

 nctId: NCT06277297 id: NP/2022/4583 briefTitle: Prognotic Role of CMR in Takotsubo Syndrome acronym: EVOLUTION overallStatus: RECRUITING date: 2022-11-09 date: 2026-11 date: 2032-11 date: 2024-02-26 date: 2024-02-28 name: University of Cagliari class: OTHER briefSummary: The primary objective of this observational registry is to develop a comprehensive clinical and imaging score (incorporating echocardiography and cardiac magnetic resonance data) that enhances risk stratification for patients with Takotsubo syndrome.

The secondary objectives of this registry are as follows:

Investigate the diagnostic value of cardiac magnetic resonance parameters in predicting in-hospital and long-term outcomes in patients with Takotsubo syndrome.

Compare the proposed risk stratification score for patients with Takotsubo syndrome with previously existing scores.

Investigate the contribution of machine learning models in predicting in-hospital and long-term outcomes compared to standard clinical scores.

The design and rationale of this registry are available at 10.1097/RTI.0000000000000709 conditions: Takotsubo Cardiomyopathy conditions: Machine Learning conditions: Magnetic Resonance Imaging studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 350 type: ESTIMATED measure: All-cause mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Cagliari status: RECRUITING city: Cagliari zip: 09100 country: Italy name: Riccardo Cau role: CONTACT phone: +393393493317 email: riccardo.cau@unica.it name: Luca Saba role: PRINCIPAL_INVESTIGATOR name: Riccardo Cau role: PRINCIPAL_INVESTIGATOR lat: 39.23054 lon: 9.11917 hasResults: False

 nctId: NCT06277284 id: MG-K10-I-002 briefTitle: Clinical Study of MG-K10 Humanized Monoclonal Antibody Injection in Healthy Adult Subjects overallStatus: ACTIVE_NOT_RECRUITING date: 2023-10-23 date: 2024-01-26 date: 2024-04 date: 2024-02-26 date: 2024-02-26 name: Shanghai Mabgeek Biotech.Co.Ltd class: OTHER_GOV name: The Second Hospital of Anhui Medical University briefSummary: Research Topics A randomized, open-label, parallel-group, phase I clinical trial comparing the pharmacokinetics of MG-K10 humanized monoclonal antibody in healthy adults conditions: Pharmacokinetics studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 60 type: ESTIMATED name: MG-K10 humanized monoclonal antibody injection (prefilled syringe) name: MG-K10 humanized monoclonal antibody injection（Penicillin bottle） measure: Pharmacokinetic: the maximum concentration (Cmax) measure: Pharmacokinetic: area under the curve of o~t measure: Pharmacokinetic: area under the curve of o~∞ measure: Safety evaluation index sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: The Second Affiliated Hospital of Anhui Medical University city: Hefei state: Anhui zip: 230061 country: China lat: 31.86389 lon: 117.28083 hasResults: False

 nctId: NCT06277271 id: 1901611-9 briefTitle: E-cigarettes as a Harm Reduction Strategy overallStatus: RECRUITING date: 2023-06-20 date: 2024-02-20 date: 2024-03-20 date: 2024-02-26 date: 2024-02-26 name: Prisma Health-Upstate class: OTHER name: Clemson University briefSummary: E-cigarettes have emerged as an effective strategy for replacing cigarettes among smokers from the general population, but there is a dearth of studies investigating their utility in replacing cigarettes among smokers with opioid use disorder (OUD). This study aims to evaluate the feasibility and acceptability of implementing a cigarette harm reduction intervention involving e-cigarettes in office-based buprenorphine clinics. conditions: Smoking studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: E-cigarette measure: Percentage of people who are eligible measure: Percentage of consented participants measure: Percentage of participants who report using the e-cigarette at least once a day measure: Percentage of participants with at least one puff of study e-cigarette measure: Percentage of daily diary completed measure: Cigarette dependence measured via the Fagerstrom test for nicotine dependence measure: Cigarette demand measured via the cigarette purchase task measure: Combustible cigarette smoking measure: Switching to e-cigarettes measure: Smoking reduction sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prisma Health status: RECRUITING city: Greenville state: South Carolina zip: 29609 country: United States name: Alain Litwin, MD role: CONTACT phone: 864-455-5648 email: alain.litwin@prismahealth.org lat: 34.85262 lon: -82.39401 hasResults: False

 nctId: NCT06277258 id: BSMMU/2022/9656 briefTitle: Patient Empowerment in the Management of Gestational Diabetes Mellitus overallStatus: RECRUITING date: 2023-01-31 date: 2024-10 date: 2024-12 date: 2024-02-26 date: 2024-02-26 name: Public Health Foundation of Bangladesh class: OTHER briefSummary: This study is a clustered randomized controlled trial assessing the outcome of "Patient Empowerment" in the management of Gestational Diabetes Mellitus by applying the patient empowering model in the intervention group and the conventional method of treatment in the control group. It will be conducted in four centres in Dhaka city of Bangladesh. The primary outcome measures will be determining the frequency of good fetomaternal and neonatal outcome through glycemic control. Target of Glycemic Status: For Pregnant Mother, Fasting, 95 mg/dL (5.3 mmol/L), Two-hour postprandial,120 mg/dL (6.7 mmol/L), For Neonate glycemic status at or above 2.5 mmol/l. Maternal outcome during pregnancy - Decrease chance of antenatal infections that is Vulvovaginitis and recurrent UTI, Decrease pre-eclampsia, Decrease Antepartum Hemorrhage and Polyhydramnios. Maternal outcome in the form of mode of safe delivery- Increase frequency of vaginal delivery, Decrease chance of obstructed labour. Maternal outcome after delivery- Decrease chance of Postpartum Hemorrhage, Decrease chance of puerperal sepsis. Fetal Outcome- Less chance of Intra uterine death and prematurity. Neonatal Outcome- Less chance of Birth injury, Birth asphyxia, Perinatal death, Good Apgar score (≥ 7) in 1st and 5th minute, Less need for NICU care and Less chance of macrosomia (≥ 4 kg) at term. Fewer proportion of patients will require insulin to manage GDM. The secondary outcomes will be patient satisfaction and the patient will be a future resource person. conditions: Diabetes Mellitus in Pregnancy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: At the end of the study, the outcome will be assessed by blinded. whoMasked: OUTCOMES_ASSESSOR count: 388 type: ESTIMATED name: Patient Empowerment model measure: Number of Participants with adverse maternal pregnancy outcome measure: Number of Participants with adverse foetal outcome measure: Number of Participants with adequate glycaemic control measure: Maternal satisfaction sex: FEMALE minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT facility: Azimpur Maternity hospital ( MCHTI) status: RECRUITING city: Dhaka zip: 1205 country: Bangladesh name: Rukhsana Parvin, MSc role: CONTACT phone: +8801303701545 email: rukhsana.nipa44@gmail.com lat: 23.7104 lon: 90.40744 facility: Shaheed Suhrawardy Medical College (ShSMC) status: RECRUITING city: Dhaka zip: 1207 country: Bangladesh name: Farhana Akter, MSc role: CONTACT phone: +8801819138421 email: isha.farhana19@gmail.com name: Fatema Ashraf, MBBS, FCPS, MS,MPH role: PRINCIPAL_INVESTIGATOR lat: 23.7104 lon: 90.40744 facility: Bangabandhu Sheikh Mujib Medical University (BSMMU) status: RECRUITING city: Dhaka zip: 1217 country: Bangladesh name: Naznin Akter, MSc role: CONTACT phone: +8801739867303 email: zshela286@gmail.com name: Tabassum Parvin, MBBS, FCPS role: PRINCIPAL_INVESTIGATOR lat: 23.7104 lon: 90.40744 hasResults: False

 nctId: NCT06277245 id: LK001303 briefTitle: A Phase 3 Study of LNK01001 Capsule in Subjects With Moderate to Severe Atopic Dermatitis. overallStatus: RECRUITING date: 2024-02-06 date: 2025-09-30 date: 2025-11-30 date: 2024-02-26 date: 2024-03-20 name: Lynk Pharmaceuticals Co., Ltd class: INDUSTRY briefSummary: This is a randomized, double-blind study comparing LNK01001 to placebo in participants with moderately to severely atopic dermatitis who were candidates for systemic therapy (ie, patients with a history of inadequate response to topical treatments, those who were using a systemic treatment, or those for whom topical treatments are otherwise medically inadvisable).

The objective of this study is to evaluate the efficacy and safety of LNK01001 in adult patients with moderate to severe AD who are candidates for systemic therapy. conditions: Atopic Dermatitis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 354 type: ESTIMATED name: LNK01001 name: Placebo measure: Eczema Area and Severity Index (EASI-75) at Week 16 measure: Investigator's Global Assessment (IGA) score of 0/1 at Week 16 measure: Worst-Itch Numeric Rating Scale (WI-NRS-4)-4 at Week 16 measure: Worst-Itch Numeric Rating Scale (WI-NRS-4)-4 at all visits other than Week 16. measure: Change from Baseline in Eczema Area and Severity Index at all visits. measure: Eczema Area and Severity Index (EASI 75) at all visits other than Week 16 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dermatological Hospital of Southern Medical University status: RECRUITING city: Guangzhou country: China name: Bing Yang, Doctor role: CONTACT phone: 020-87257353 email: yangbin101@hotmail.com lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06277232 id: HMV-2023-00504 id: 2022-05364-02 type: OTHER domain: The Swedish Ethical Review Authority briefTitle: Nutrition Care in Patients Living With Chronic Pain overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-06-30 date: 2026-10-31 date: 2024-02-26 date: 2024-03-22 name: Linkoeping University class: OTHER_GOV name: Ostergotland County Council, Sweden name: Fibromyalgia foundation briefSummary: The investigators' purpose is to develop and test the feasibility, usability, and satisfaction of the Diet4painrelief app as a platform for implementing nutrition care in a specialist pain rehabilitation clinic. The Diet4painrelief will consist of two components: a) a screening tool for nutrition status b) an individually tailored behavior change program aiming to improve the dietary habits and behaviors of patients living with chronic pain.

The study is planned to include 20 patients with complex chronic pain and non-optimal BMI (underweight or overweight/obesity) to examine the feasibility and outcomes of evidence-based Interdisciplinary Pain Rehabilitation Program (IPRP) integrated with nutrition care. The Diet4painrelief includes a screening tool to assess basic nutritional status as well as their intake of key unhealthy and healthy foods and drinks (through three 24hour-dietary recordings or food diary). Thereafter, the patients receive a personalized behavior change program for dietary optimization. The investigators will design and adapt 6 modules in the digital platform (Diet4painrelief app) based on the International Association for the Study of Pain (IASP) recommendations (6 aspects about 'nutrition and pain') and Sweden's food culture. Clinical outcomes using patient-reported data on socio-demographics, pain aspects, psychometric data, physical disability, and quality of life will be measured at three occasions: first appointment (Pre-IPRP), immediately after completing the rehabilitation program (Post-IPRP), and at a 12-month follow-up (FU-IPRP). Blood samples will be taken to identify biomarkers at the same occasions that provide objective information on metabolic and nutritional abnormalities and further to evaluate the effect of the dietary intervention on changing of pain rehabilitation outcomes. conditions: Nutrition Poor conditions: Overweight and Obesity conditions: Mobile Phone Use conditions: Pain, Chronic studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Repeated measures, single-subject withdrawal design. All subjects who enroll in the study will receive the intervention and there is no randomization. primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Nutrition care name: Dialogue and education (part of Interdisciplinary Pain Rehabilitation Program) name: activity training (part of Interdisciplinary Pain Rehabilitation Program) name: meetings (part of Interdisciplinary Pain Rehabilitation Program) name: Cognitive behavioral therapy (part of Interdisciplinary Pain Rehabilitation Program) name: Relaxation techniques (part of Interdisciplinary Pain Rehabilitation Program) name: Physical exercise (part of Interdisciplinary Pain Rehabilitation Program) measure: Pain intensity (numeric rating scale) measure: Pain interference (one aspect in Multidimensional Pain inventory) measure: Dietary habits (a lifestyle questionnaire) measure: Perceived Usability (System Usability Scale) measure: Perceived benefit (numeric rating scale) measure: Adherences/ compliances of nutritional care (numeric rating scale) measure: Difficulty sleeping (Insomnia Severity Index) measure: Emotional distress (The Hospital Anxiety and Depression Scale, HAD) measure: Impact of chronic pain (Multidimensional Pain inventory) measure: Health- related quality of life 1 (EQ-5D) measure: Health- related quality of life 2 (RAND-36) measure: Pain coping (Chronic Pain Acceptance Questionnaire, CPAQ) measure: Fear of movement (Tampa scale for Kinesiophobia) measure: Physical activity and sedentary behavior (self-estimated time, questionnaire) measure: Body fatness (physiological parameter) measure: Body weight (physiological parameter) measure: Biomarkers explored from blood samples (physiological parameters such as proteins, lipids, metabolites and micro-RNA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06277219 id: LAT010-01 briefTitle: A First-in-Human, Phase 1/2 Study of LAT010 in Patients With Advanced Solid Tumors (LIGHTSPEED-1) acronym: LIGHTSPEED-1 overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-12 date: 2027-03 date: 2024-02-26 date: 2024-02-26 name: Latticon Antibody Therapeutics, Inc class: INDUSTRY briefSummary: This is an open-label, multicenter, Phase 1/2, first-in-human (FIH), dose-escalation and cohort-expansion study of LAT010 to evaluate the safety, tolerability, immunogenicity, PK, PD, and antitumor activity in patients with advanced solid tumors. The study consists of 2 parts: Phase 1 dose-escalation and Phase 2 cohort expansion. conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: LAT010 name: LAT010 + ICI measure: Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) (Phase 1) measure: Incidence of changes in clinical laboratory values (Phase 1) measure: Incidence of dose-limiting toxicities (DLTs) (Phase 1) measure: Objective response rate (ORR) per RECIST 1.1 (Phase 2) measure: Maximum plasma concentration (Cmax) of LAT010 measure: Area under the plasma concentration-time curve (AUC) of LAT010 measure: Terminal phase half-life (t1/2) of LAT010 measure: Time to maximum concentration of LAT010 measure: Trough concentration of LAT010 measure: Volume of distribution of LAT010 measure: Clearance of LAT010 measure: ADA occurrence and titer in serum measure: Objective response rate (ORR) per RECIST 1.1 (Phase 1 ) measure: Duration of response (DOR) measure: Disease control rate (DCR) measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Incidence of AEs and SAEs measure: Epigenetic assessment of the proliferation and activation of CD4+ Treg cells, CD8+ T cells, and natural killer (NK) cells. measure: Optional flow cytometry assessment of the proliferation and activation of CD4+ Treg cells, CD8+ T cells, and NK cells. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Huntsman Cancer Institute city: Salt Lake City state: Utah zip: 84112 country: United States name: Jeana McKenney role: CONTACT phone: 801-213-8414 email: jeana.mckenney@hci.utah.edu name: Benjamin L Maughan, MD role: PRINCIPAL_INVESTIGATOR lat: 40.76078 lon: -111.89105 hasResults: False

 nctId: NCT06277206 id: FAPIPDAC02 briefTitle: A Study Using 18F-FAPI PET to Evaluate Treatment Response in Pancreatic Adenocarcinoma overallStatus: COMPLETED date: 2021-08-04 date: 2023-11-19 date: 2024-02-10 date: 2024-02-26 date: 2024-02-26 name: Zhejiang University class: OTHER briefSummary: To explore the potential utility of 18F-FAPI-04 PET/CT for pathologic response evaluation to systemic treatment in PDAC conditions: 18F-FAPI conditions: Pancreas Adenocarcinoma conditions: Systemic Treatment conditions: Pathologic Response studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 59 type: ACTUAL name: 18F-FAPI PET/CT measure: Change of Maximum standardized uptake value measure: Change of Mean standardized uptake value measure: Maximum standardized uptake value measure: Mean standardized uptake value measure: Metabolic Tumor Volume measure: Total Lesion FAP expression measure: Change of Metabolic Tumor Volume measure: Change of Total Lesion FAP expression sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: First Affiliated Hospital, Medical College of Zhejiang University city: Hangzhou state: Zhejiang zip: 310003 country: China lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06277193 id: KonyaBeyhekimTRH briefTitle: Investigation of the Relationship Between Sarcopenia and Balance, Fear of Falling and Fall Risk in Older Female Patients overallStatus: COMPLETED date: 2020-11-03 date: 2022-12-01 date: 2023-09-28 date: 2024-02-26 date: 2024-02-26 name: Konya Beyhekim Training and Research Hospital class: OTHER_GOV briefSummary: This study (study type: cross-sectional) aims to investigate the relationship of sarcopenia level with balance, fear of falling and risk of falling in the elderly female population. In the first stage, 166 participants were divided into two groups: sarcopenia and non-sarcopenia. Afterwards, they were categorized according to sarcopenia level (probable sarcopenia group, sarcopenia group, severe sarcopenia group, group without sarcopenia) and comparisons were made between these subgroups. Then, they were evaluated with various scales and tests (in terms of balance, fear of falling and risk of falling). conditions: Sarcopenia studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: CROSS_SECTIONAL count: 166 type: ACTUAL name: valuation of balance status, fear of falling and risk of falling in patients non-sarcopenia. name: Evaluation of balance status, fear of falling and risk of falling in patients with probable sarcopenia. name: Evaluation of balance status, fear of falling and risk of falling in patients with sarcopenia. name: Evaluation of balance status, fear of falling and risk of falling in patients with severe sarcopenia. measure: Sociodemographic data measure: Berg Balance Scale(BBS) measure: Falls Efficacy Scale (FES) measure: Balance and Gait Assessment Scale measure: Biochemical data measure: Co-morbidities measure: Number of drugs measure: Basic activities of daily living (Katz) measure: Instrumental activities of living (Lawton-Brody; IADL) measure: Mini-nutritional evaluation (MNA-Short form) measure: Mini-mental state assessment (MMSE) measure: Yesavage Geriatric Depression Scale Short Form (GDS-SF) measure: FRAIL fragility index measure: Short physical performance battery (SPPB) measure: Timed up and go test (TUG) measure: The Tampa Scale for Kinesiophobia (TSK) sex: FEMALE minimumAge: 65 Years stdAges: OLDER_ADULT facility: Konya Beyhekim Training and Research Hospital Physical Medicine and Rehabilitation Clinic city: Selçuklu state: Konya country: Turkey lat: 37.8842 lon: 32.49222 hasResults: False

 nctId: NCT06277180 id: TCR-FAPI for MTC Surgery briefTitle: 68Ga-TCR-FAPI PET/CT Guided Precision Surgery for MTC overallStatus: RECRUITING date: 2023-10-01 date: 2025-12-31 date: 2027-12-31 date: 2024-02-26 date: 2024-02-26 name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences class: OTHER name: Peking University name: Peking University Cancer Hospital & Institute briefSummary: This is a phase II clinical trial to evaluate the capability of 68Ga-labeled targeted covalent radiopharmaceutical (TCR) fibroblast activation protein inhibitor (FAPI) PET/CT to guide the surgical treatment of medullary thyroid carcinoma (MTC). The surgical extent of MTC is determined based on the lesion range revealed by 68Ga-TCR-FAPI PET/CT, with the main endpoint being 1-month post-surgical calcitonin level. conditions: Medullary Thyroid Cancer conditions: Prositron Emission Tomography conditions: Fibroblast Activation Protein Inhibitor conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Surgery name: Surgery measure: 1-month post-surgery calcitonin level measure: 2-year event free survival measure: Ratio of patient that change surgical plan measure: Accuracy, sensitivity, specificity of 68Ga-TCR-FAPI PET/CT in identifying MTC lesions sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College status: RECRUITING city: Beijing zip: 100021 country: China name: Shaoyan Liu, M.D. role: CONTACT phone: 0086-010-87787190 email: shaoyanliu.bj@263.net lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06277167 id: KXZY-GB05-101 briefTitle: A Phase I Study of Human Interferon Alfa 1b Inhalation Solution in Healthy Participants overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-07 date: 2024-05-21 date: 2024-05-21 date: 2024-02-26 date: 2024-02-26 name: Kexing Biopharm Co., Ltd. class: INDUSTRY name: Guoxin Pharmaceutical Technology (Beijing) Co., Ltd. name: The Third Hospital of Changsha name: Beijing SSYP Data Technology Development Co.,Ltd. name: United-Power Pharma Tech（Shanghai）Co., Ltd. briefSummary: A Randomized, Double-Blind, Placebo-Controlled Phase-I Clinical Study to Evaluate the Tolerability, Safety and PK Profiles of Human interferon alfa 1b inhalation solution in Healthy Adult Subjects after Administration of Single Ascending Doses and Multiple Ascending Doses conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 35 type: ACTUAL name: Human interferon alfa 1b inhalation solution name: Human interferon alfa 1b inhalation solution placebo name: Human interferon alfa 1b inhalation solution name: Human interferon alfa 1b inhalation solution placebo measure: TEAEs measure: (ADRs) measure: (SAE) measure: TEAEs that lead to subject discontinuation from the study measure: Cmax After a Single Dose of GB05 Drug Product measure: Tmax After a Single Dose of GB05 Drug Product measure: AUC0-t and AUC0-inf After a Single Dose of GB05 Drug Product measure: t1/2 After a Single Dose of GB05 Drug Product measure: Ke After a Single Dose of GB05 Drug Product measure: Vd After a Single Dose of GB05 Drug Product measure: MRT After a Single Dose of GB05 Drug Product measure: CL After a Single Dose of GB05 Drug Product measure: Cmax,ss After Multiple Doses of GB05 Drug Product measure: Cmin,ss After Multiple Doses of GB05 Drug Product measure: Css_av After Multiple Doses of GB05 Drug Product measure: DF After Multiple Doses of GB05 Drug Product measure: (Cmax,ss-Cmin,ss)/Cmin,ss After Multiple Doses of GB05 Drug Product measure: ADA measure: NAb sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: The Third Hospital of Changsha city: Changsha country: China lat: 28.19874 lon: 112.97087 hasResults: False

 nctId: NCT06277154 id: MASCT-I-2004 briefTitle: MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment of Advanced Soft Tissue Sarcoma overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2026-02 date: 2027-02 date: 2024-02-26 date: 2024-02-26 name: HRYZ Biotech Co. class: INDUSTRY briefSummary: This study will evaluate the safety and efficacy of MASCT-I combined with Doxorubicin and Ifosfamide for first-line treatment in patients with advanced soft tissue sarcoma. conditions: Leiomyosarcoma conditions: Liposarcoma conditions: Synovial Sarcoma conditions: Angiosarcoma conditions: Undifferentiated Pleomorphic Sarcoma conditions: Epithelioid Sarcoma conditions: Malignant Peripheral Nerve Sheath Tumors conditions: Fibrosarcoma conditions: Pleomorphic Rhabdomyosarcoma conditions: Endometrial Stromal Sarcoma conditions: Desmoplastic Small Round Cell Tumor studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 148 type: ESTIMATED name: MASCT-I name: Doxorubicin name: Ifosfamide measure: Progression-Free Survival (PFS) measure: Overall Survival (OS) measure: Objective Response Rate (ORR) measure: Disease Control Rate (DCR) measure: Duration of response (DoR) measure: Adverse events and serious adverse events measure: Adverse events and serious adverse events related to MASCT-I measure: Rate and severity of clinically-significant abnormalities in laboratory testings measure: Immune response to tumor-associated antigens sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen University Cancer Center city: Guangzhou country: China name: Xing Zhang role: CONTACT email: zhangxing@sysucc.org.cn name: Xing Zhang role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06277141 id: M230742 briefTitle: The Vitality Mammography Messaging Study acronym: VMS overallStatus: ACTIVE_NOT_RECRUITING date: 2023-09-27 date: 2024-03-31 date: 2024-03-31 date: 2024-02-26 date: 2024-03-22 name: Wits Health Consortium (Pty) Ltd class: OTHER name: Discovery Vitality briefSummary: The investigators will be conducting a randomized controlled trial amongst members of a Wellness Program to test receipt of mammogram using the Whatsapp social media platform and testing various messages. conditions: Breast Cancer Female studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial primaryPurpose: SCREENING masking: NONE count: 6665 type: ESTIMATED name: Standard message name: Radiology booking site link. name: Radiology practice telephone numbers name: Radiology site link and telephone numbers measure: Comparison of mammography screening rates using WhatsApp sex: FEMALE minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Witwatersrand city: Johannesburg state: Gauteng country: South Africa lat: -26.20227 lon: 28.04363 hasResults: False

 nctId: NCT06277128 id: WS016-Ⅱ-01 briefTitle: A Study to Evaluate the Safety and Efficacy of WS016 in Patients With Hyperkalemia. overallStatus: RECRUITING date: 2023-09-11 date: 2024-04-18 date: 2024-08-04 date: 2024-02-26 date: 2024-02-26 name: Waterstone Pharmaceutical (Wuhan) Co., LTD. class: INDUSTRY briefSummary: The goal of this clinical trial is to evaluate the efficacy of different doses of WS016(3g, 6g and 12g) orally administered three times a day for 48 hours (acute treatment phase) vs placebo in the treatment of hyperkalemia, and to evaluate the efficacy of WS016(3g, 6g and 12g) orally administered once daily for 12 days ( maintenance treatment phase) vs placebo in maintaining normokalemia in participants have returned to normokalemia after the acute treatment phase. conditions: Hyperkalemia studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 140 type: ESTIMATED name: WS016 3g name: WS016 6g name: WS016 12g name: Matching Placebo measure: Exponential rate of change in serum potassium(S-K) levels during the acute treatment phase measure: Exponential rate of change in S-K levels during the maintenance treatment phase measure: Mean change in S-K levels during the acute treatment phase measure: Proportion of participants recover from hyperkalemia measure: Time to normalization in S-K levels measure: Proportion of patients remaining normokalemic measure: Mean change in S-K levels during the maintenance treatment phase sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University People's Hospital status: RECRUITING city: Beijing state: Beijing zip: 100000 country: China name: Li Zuo role: CONTACT phone: 86+ 13910028495 email: zuoli@bjmu.edu.cn lat: 39.9075 lon: 116.39723 facility: Peking University Shougang Hospital status: RECRUITING city: Beijing state: Beijing zip: 100000 country: China name: Zhenzhong Zhu role: CONTACT phone: 86+ 13811830871 email: doczzz@sina.com lat: 39.9075 lon: 116.39723 facility: Zhongshan Hospital, Xiamen University status: RECRUITING city: Xiamen state: Fujian zip: 361000 country: China name: Tianjun Guan role: CONTACT phone: 86+ 13950199068 email: guantianjun@aliyun.com lat: 24.47979 lon: 118.08187 facility: The Affiliated Hospital of Hebei University status: RECRUITING city: Baoding state: Hebei zip: 071000 country: China name: Yan Gao role: CONTACT phone: 86+ 13613125826 email: gaoyan227@sina.com lat: 38.85111 lon: 115.49028 facility: Hebei Traditional Chinese Medicine Hospital status: RECRUITING city: Shijiazhuang state: Hebei zip: 050000 country: China name: Jinchuan Tan role: CONTACT phone: 86+ 13831187910 email: 1955981973@qq.com lat: 38.04139 lon: 114.47861 facility: The Second Hospital of Hebei Medical University status: RECRUITING city: Shijiazhuang state: Hebei zip: 050000 country: China name: Shaomei Li role: CONTACT phone: 86+ 15803210955 email: lishaomeitougao@126.com lat: 38.04139 lon: 114.47861 facility: The First Hospital of Qiqihar status: RECRUITING city: Qiqihar state: Heilongjiang zip: 161000 country: China name: Yanjun Zhao role: CONTACT phone: 86+ 13945277125 email: 18603622020@126.com lat: 47.34088 lon: 123.96045 facility: The First People's Hospital of Nanyang City status: RECRUITING city: Nanyang state: Henan zip: 473000 country: China name: Mingai Song role: CONTACT phone: 86+ 18937765862 email: ai13837706962@163.com lat: 32.99472 lon: 112.53278 facility: Puyang Oilfield General Hospital status: RECRUITING city: Puyang state: Henan zip: 457000 country: China name: Xianjun Xue role: CONTACT phone: 86+ 13839288161 email: 13839288161@163.com lat: 29.45679 lon: 119.88872 facility: Shiyan Taihe Hospital status: RECRUITING city: Shiyan state: Hubei zip: 442000 country: China name: Qinghong Zhang role: CONTACT phone: 86+ 13971930628 email: zhangqinghong9809@126.com lat: 32.6475 lon: 110.77806 facility: Wuhan No.4 Hospital status: RECRUITING city: Wuhan state: Hubei zip: 430000 country: China name: Chuanwen Xu role: CONTACT phone: 86+ 18607171819 email: chuanwenxu@sina.com lat: 30.58333 lon: 114.26667 facility: Zhuzhou Central Hospital status: RECRUITING city: Zhuzhou state: Hunan zip: 412000 country: China name: Qingfeng Peng role: CONTACT phone: 86+ 13973319588 email: 460593067@qq.com lat: 27.83333 lon: 113.15 facility: Affiliated Hospital of Inner Mongolia Medical University status: RECRUITING city: Hohhot state: Inner Mongolia zip: 010000 country: China name: Jianrong Zhao role: CONTACT phone: 86+ 13848129952 email: zjr13848129952@163.com lat: 40.81056 lon: 111.65222 facility: Sir Run Run Hospital, Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu zip: 210000 country: China name: Wenwen Li role: CONTACT phone: 86+ 13951644706 email: 546466035@qq.com lat: 32.06167 lon: 118.77778 facility: The Second Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu zip: 210000 country: China name: Junwei Yang role: CONTACT phone: 86+ 18951767513 email: jwyang@njmu.edu.cn lat: 32.06167 lon: 118.77778 facility: The Affiliated Hospital of Nantong University status: RECRUITING city: Nantong state: Jiangsu zip: 226000 country: China name: Xinzhong Huang role: CONTACT phone: 86+ 13912288751 email: huangxz421@126.com lat: 32.03028 lon: 120.87472 facility: Shenyang Central Hospital, affiliated to Shenyang Medical College status: RECRUITING city: Shenyang state: Liaoning zip: 110000 country: China name: Zhenhua Ji role: CONTACT phone: 86+ 18002477058 email: jzh642@sina.com lat: 41.79222 lon: 123.43278 facility: General Hospital of Ningxia Medical University status: RECRUITING city: Yinchuan state: Ningxia zip: 750000 country: China name: Na Tian role: CONTACT phone: 86+ 13995216063 email: 13995216063@163.com lat: 38.46806 lon: 106.27306 facility: The First People's Hospital of Tancheng County status: RECRUITING city: Linyi state: Shandong zip: 276100 country: China name: Changyou Sun role: CONTACT phone: 86+ 15168960721 email: scy6119125@126.com lat: 35.06306 lon: 118.34278 facility: Qilu Hospital of Shandong University (Qingdao) status: RECRUITING city: Qingdao state: Shandong zip: 266000 country: China name: Lanjie He role: CONTACT phone: 86+ 18561812668 email: nxhelanjie@126.com lat: 36.06488 lon: 120.38042 facility: Minhang District Central Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200000 country: China name: Xudong Xu role: CONTACT phone: 86+ 18918169003 email: xxdmzx@sina.com lat: 31.22222 lon: 121.45806 facility: Shanghai First People's Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200000 country: China name: Qiuling Fan role: CONTACT phone: 86+ 13904012680 email: cmufql@163.com lat: 31.22222 lon: 121.45806 facility: Shanghai No.5 Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200000 country: China name: Jianying Niu role: CONTACT phone: 86+ 18918168518 email: njyphd2008@163.com lat: 31.22222 lon: 121.45806 facility: Shanghai Tongji Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200000 country: China name: Chen Yu role: CONTACT phone: 86+ 13311996821 email: yuchen@tongji.edu.cn lat: 31.22222 lon: 121.45806 facility: The Second Affiliated Hospital of Tianjin Medical University status: RECRUITING city: Tianjin state: Tianjin zip: 300000 country: China name: Rong Li role: CONTACT phone: 86+ 18698061623 email: beilloa@sohu.com lat: 39.14222 lon: 117.17667 facility: Tianjin People's Hospital status: RECRUITING city: Tianjin state: Tianjin zip: 300000 country: China name: Gang Long role: CONTACT phone: 86+ 13602121007 email: longgang@hotmail.com lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06277115 id: BASEC Nr. 2020-02002 briefTitle: Acute and Long-term Effects of CPAP in OSA overallStatus: RECRUITING date: 2021-02-01 date: 2024-07 date: 2024-12 date: 2024-02-26 date: 2024-02-28 name: University of Zurich class: OTHER briefSummary: Two-phase interventional non-inferiority trial (phase 1: at least 8 weeks of CPAP; phase 2: 2 weeks of CPAP withdrawal) including 32 patients with moderate to severe OSA to compare the physiological consequences of a short-term CPAP withdrawal to the changes in previously untreated OSA. The trial has been designed as a validation of the CPAP-withdrawal model. Baseline in-laboratory sleep studies will be performed prior to CPAP initiation, after 6-8 weeks on CPAP (treatment effect) and following 2 weeks of CPAP therapy withdrawal (withdrawal effect, effect of OSA recurrence). conditions: Obstructive Sleep Apnea of Adult studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Two-phase intervention: several weeks of CPAP therapy followed by two weeks CPAP therapy withdrawal primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: Continuous positive airway pressure (CPAP) measure: Nocturnal systolic blood pressure measure: Epworth Sleepines Scale Score (ESS) measure: 48h, 24h, diurnal and nocturnal systolic and diastolic blood pressure measure: Office systolic and diastolic blood pressure measure: 48h, 24h, diurnal, nocturnal and office heart rate measure: Heart rate variability in the time and frequency domain (CV, RMSSD, pRR50, LF, HF, LF/HF) measure: Blood pressure variability (BPV, systolic and diastolic) measure: Baroreflex sensitivity (BRS) measure: Arterial stiffness measure: Measures of nocturnal hypoventilation (median and maximal transcutaneous partial pressure of CO2 = tcpCO2) measure: Measures of nocturnal hypoxaemia (mean nocturnal oxygen saturation = ¢SpO2) measure: Measures of nocturnal hypoxaemia (time spent with SpO2 below 90% = t<90) measure: Measures of nocturnal hypoxaemia (hypoxic burden) measure: Measures of OSA severity (apnoea-hypopnoea-index) measure: Measures of OSA severity (oxygen-desaturation index) measure: Sleepiness (Stanford Sleepiness Scale (SSS)) measure: Fatigue (fatigue severity scale (FSS)) measure: Disease-specific quality of life (Functional Outcomes of Sleep Questionnaire (FOSQ)) measure: Superoxide dismutase measure: Urinary catecholamines measure: Pulse rise index (>6 beats per minute) measure: Nocturnal oxymetry measures (¢SpO2, t<90, ODI-3%, ODI-4%) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Zurich status: RECRUITING city: Zurich zip: 8091 country: Switzerland name: Esther I Schwarz, MD role: CONTACT phone: 0041442553828 email: estherirene.schwarz@usz.ch name: Joël J Herzig role: CONTACT email: joel.herzig@usz.ch lat: 47.36667 lon: 8.54999 hasResults: False

 nctId: NCT06277102 id: Music pain FHF briefTitle: Effects of Music on Acute Postoperative Pain Intensity and Mobility After Fragility Hip Fracture overallStatus: RECRUITING date: 2024-01-26 date: 2024-06-01 date: 2024-06-01 date: 2024-02-26 date: 2024-02-26 name: Hospital Authority, Hong Kong class: OTHER_GOV briefSummary: Music has been proven to be beneficial in postoperative care by reducing pain. The effects of music listening to reduce pain postoperatively are well studied among cases undergoing elective orthopaedic surgery. No study has been conducted focusing on pain control among cases with fragility hip fractures in an acute ward setting with non-schedule non-elective orthopaedic operation.

In Queen Elizabeth Hospital a standardized analgesic protocol is used for all fragility hip fracture cases unless contraindicated, a suboptimal post-operative pain control is not uncommonly seen. Stepping up analgesics is usually a concern in the elderly with a higher rate of side effects, a safe and simple non-pharmacological intervention for pain control is therefore needed.

The aim of this study is to study the effectiveness of incorporating music on pain intensity and mobility with the standard postoperative rehabilitation care of fragility hip fracture in Queen Elizabeth Hospital. conditions: Hip Fractures studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 60 type: ESTIMATED name: music listening measure: Pain intensity measured by 11-point pain intensity numerical rating scale after music listening in postoperative Day 1 - 2 among subjects with fragility hip fracture measure: Modified functional ambulatory classification (MFAC) in postoperative Day 3 among subjects with fragility hip fracture measure: New mobility score (NMS) in postoperative Day 3 among subjects with fragility hip fracture sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Ward G9, Queen Elizabeth Hospital status: RECRUITING city: Hong Kong country: Hong Kong name: Kwan Yiu Jeffrey Lau role: CONTACT phone: 62017014 email: lky194a@ha.org.hk name: Kwan Yiu Jeffrey Lau role: PRINCIPAL_INVESTIGATOR lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06277089 id: Correction of EOS by casts briefTitle: Curve Correction of Early Onset Scoliosis by Mehta Serial Casts overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-09-01 date: 2024-02-26 date: 2024-02-26 name: Assiut University class: OTHER briefSummary: Assessment of the role of Mehta Serial Casts in Curve Correction of Early Onset Scoliosis conditions: Scoliosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 5 type: ESTIMATED name: Casts measure: Difference of the scoliotic cobb angle at last cast sex: ALL minimumAge: 3 Years maximumAge: 10 Years stdAges: CHILD hasResults: False

 nctId: NCT06277076 id: FMD1234 briefTitle: Accuracy of Computer- Guided Implant Surgery in Partially Edentulous Patients. overallStatus: COMPLETED date: 2023-01-28 date: 2023-05-02 date: 2023-08-15 date: 2024-02-26 date: 2024-02-26 name: Saint-Joseph University class: OTHER briefSummary: The dental implant placed freehand with a digital planing is vastly increasing. The accuracy between the planned and the placed implants still not well determined. Between a single implant and a full mouth rehabilitation, the precision is very wide. A precision scale must be settled according to each indication in order to offer the clinician a safety and a predictability for his procedures. conditions: Dental Implant conditions: Computer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 13 type: ACTUAL name: Computer Implant guided Surgery measure: Assess Accuracy of Implant Placement in Vertical Displacement (VD). measure: Assess Accuracy of Implant Placement in Horizontal Displacement (HD) measure: Assess Accuracy of Implant Placement in Error Depth (ED) measure: Assess Accuracy of Implant Placement in Error Angle (EA) measure: Evaluate Precision of the Printed Guide measure: Study Complications and Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Saint Joseph University of Beirut/Dental school city: Beirut zip: 1107 2180 country: Lebanon lat: 33.88894 lon: 35.49442 hasResults: False

 nctId: NCT06277063 id: NFEC-2024-057 briefTitle: nVNS for the Prevention and Treatment of Primary Headache overallStatus: NOT_YET_RECRUITING date: 2024-03-10 date: 2026-08-31 date: 2026-12-30 date: 2024-02-26 date: 2024-03-13 name: Nanfang Hospital, Southern Medical University class: OTHER name: BrainClos Co., LTD. name: Zhuhai Fudan Innovation Institute briefSummary: This study is a single-center, randomized, double-blind controlled study. Patients will be randomly assigned to two groups by envelope drawing. The subjects will be divided into two groups: the acute intervention group and the preventive intervention group. In each group, the subjects will be randomly divided into the experimental group and the control group by means of envelope extraction.

Children and adolescents (7-20 years old) with migraine who met the inclusion criteria will be enrolled as subjects in the experimental group, and the changes in headache scores before and after the intervention will be compared. The intervention method is as follows: ictal intervention, in which subjects will be evaluated for headache improvement after a short intervention during an acute exacerbation. By wearing a vagus stimulator, the stimulating electrode will be located in the concha region rich in vagus nerve fiber endings, and the appropriate stimulation intensity will be adjusted for stimulation. Therefore, this study will verify the effect of nVNS on the acute attack and preventive treatment of primary headache in children and adolescents. Based on the electrocardiogram and electromyography indicators during the intervention process of nVNS, an objective evaluation system for the improvement of headache by nVNS is established, and the role of stimulation parameters on the effect is further explored to realize the optimization of parameters. conditions: Primary Headache conditions: Migraine in Adolescence conditions: Migraine in Children conditions: Cluster Headache conditions: Tension Headache studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 288 type: ESTIMATED name: Transcutaneous auricular vagus nerve stimulation name: Sham transcutaneous auricular vagus nerve stimulation measure: Visual analogue scales(VAS)-actue period measure: Visual analogue scales(VAS)-prevention period measure: Heart rate variability(HRV) measure: Electromyography(EMG) sex: ALL minimumAge: 7 Years maximumAge: 20 Years stdAges: CHILD stdAges: ADULT facility: Nanfang Hospital, Southern Medical University city: Guangzhou state: Guangdong country: China name: Ji Ya-Bin, post-doc role: CONTACT phone: +8615913186246 email: yabinji@126.com lat: 23.11667 lon: 113.25 typeAbbrev: Prot_SAP_ICF hasProtocol: True hasSap: True hasIcf: True label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Study Protocol date: 2024-02-03 uploadDate: 2024-03-06T22:03 filename: Prot_SAP_ICF_002.pdf size: 158671 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form: Informed Consent Form date: 2024-02-03 uploadDate: 2024-03-06T22:01 filename: ICF_003.pdf size: 139248 hasResults: False

 nctId: NCT06277050 id: NPC-ICMB briefTitle: Maintenance Therapy With Toripalimab and Capecitabine Versus Capecitabine Alone in High-risk Nasopharyngeal Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-03-07 date: 2029-02-20 date: 2030-02-20 date: 2024-02-26 date: 2024-03-07 name: Jiangxi Provincial Cancer Hospital class: OTHER briefSummary: N3 classification, rENE positivity is a high-risk type of locally advanced nasopharyngeal carcinoma. EBV DNA remaining at detectable levels after induction chemotherapy is also a characteristic of high-risk nasopharyngeal carcinoma. Based on the available evidence, patients with high-risk nasopharyngeal carcinoma are recommended to receive oral maintenance therapy to reduce the risk of failure.

The purpose of this study was to conduct a prospective, multicenter, randomized phase III clinical trial to determine whether maintenance therapy with triprilimab combined with capecitabine is better than maintenance therapy with capecitabine alone in high-risk nasopharyngeal carcinoma (N3+, rENE+, Detectable EBV DNA after 2 cycles of induction chemotherapy). conditions: Nasopharyngeal Carcinoma conditions: High-Risk Cancer conditions: Maintenance Therapy studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 264 type: ESTIMATED name: Maintenance Therapy with Toripalimab and Capecitabine name: Maintenance Therapy with Capecitabine measure: Progression-free Survival measure: Distant Metastasis-Free Survival measure: Overall Survival measure: Loco-Regional Recurrence-Free Survival sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06277037 id: AB-729-204 briefTitle: Long-Term Follow-up Study for Subjects With CHB Previously Treated With Imdusiran (AB729) overallStatus: NOT_YET_RECRUITING date: 2024-07-15 date: 2029-08-30 date: 2029-10-30 date: 2024-02-26 date: 2024-04-01 name: Arbutus Biopharma Corporation class: INDUSTRY briefSummary: This is a long term follow-up study for chronic hepatitis B (CHB) subjects who have received imdusiran treatment in a prior clinical trial, stopped NA therapy during that trial, and remain off therapy. Subjects may enroll after completing the end of study visit (baseline visit within 12 weeks ± 1 week from the end of study \[EOS\] visit) from their imdusiran clinical trial (the "parent study"). No interventions will be performed in this study other than blood sample collections, review of current medications, and reporting of any adverse events related to study procedures or NA therapy if restarted. Study participation will be for approximately 2 years (to complete a total of at least 3 years of follow-up while off NA therapy, inclusive of parent study participation). conditions: Long Term Follow-up studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 35 type: ESTIMATED name: Non-interventional measure: To evaluate the durability of effect of imdusiran on HBV parameters measure: To evaluate the durability of effect of imdusiran on HBV parameters measure: To evaluate the durability of effect of imdusiran on HBV parameters sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Alfred Hospital city: Melbourne state: Victoria zip: 3004 country: Australia name: Stuart Roberts role: CONTACT role: CONTACT email: S.Roberts@alfred.org.au lat: -37.814 lon: 144.96332 facility: Fiona Stanley Hospital city: Murdoch zip: 6150 country: Australia name: Sam Galhenage role: CONTACT lat: -32.06987 lon: 115.83757 facility: Queen Mary Hospital city: Hong Kong country: Hong Kong lat: 22.27832 lon: 114.17469 facility: Prince of Wales Hospital city: Shatin country: Hong Kong name: Grace Wong role: CONTACT lat: 22.38333 lon: 114.18333 facility: Changhua Christian Hospital city: Changhua city zip: 600566 country: Taiwan lat: 24.07327 lon: 120.56276 facility: Chia-Yi Christian Hospital city: Chiayi City zip: 60002 country: Taiwan name: Chi-Yi Chen role: CONTACT lat: 23.47917 lon: 120.44889 facility: Kaohsiung Medical University Chung-Ho Memorial Hospital city: Kaohsiung zip: 80756 country: Taiwan name: Wan-Long Chuang role: CONTACT lat: 22.61626 lon: 120.31333 facility: E-Da Hospital city: Kaohsiung zip: 82445 country: Taiwan name: Gin-Ho Lo role: CONTACT lat: 22.61626 lon: 120.31333 facility: Taichung Veterans General Hospital city: Taichung zip: 40705 country: Taiwan name: Sheng-Shun Yang role: CONTACT lat: 24.1469 lon: 120.6839 facility: Chang Gung Medical Foundation Linkou city: Taoyuan zip: 33305 country: Taiwan name: Chao-Wei Hsu role: CONTACT lat: 24.95233 lon: 121.20193 facility: University Hospital of Wales, Cardiff city: Cardiff zip: CF144XW country: United Kingdom name: Jonathan Underwood role: CONTACT lat: 51.48 lon: -3.18 facility: Royal London Hospital city: London zip: E11FR country: United Kingdom lat: 51.50853 lon: -0.12574 facility: King's College Hospital city: London zip: SE59RS country: United Kingdom name: Kosh Agarwal role: CONTACT lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06277024 id: FUGES-32 briefTitle: A Study on the Safety and Efficacy of the Combination of Candenizumab, Lenvatinib, and SOX Regimen in the Treatment of HER2 Negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Patients overallStatus: RECRUITING date: 2023-01-01 date: 2024-12-31 date: 2027-12-31 date: 2024-02-26 date: 2024-02-26 name: Fujian Medical University class: OTHER briefSummary: Evaluate the objective response rate (ORR) of the combination of candenizumab, lenvatinib, and SOX regimen for the treatment of HER2 negative advanced gastric or gastroesophageal junction adenocarcinoma patients conditions: Overall Response Rate studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Combination of Cardonizumab with Lenvatinib and SOX regimen measure: ORR sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Gastric Surgery， Fujian Medical University Union Hospital status: RECRUITING city: Fuzhou state: Fujian country: China name: Changming Huang, MD role: CONTACT phone: +8613805069676 email: hcmlr2002@163.com lat: 26.06139 lon: 119.30611 hasResults: False

 nctId: NCT06277011 id: Meta10-19-004 briefTitle: Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of Relapsed and/or Refractory CD19-positive B Cell Hematological Malignancies Clinical Research overallStatus: RECRUITING date: 2023-02-10 date: 2025-02-01 date: 2025-05-15 date: 2024-02-26 date: 2024-02-26 name: Anhui Provincial Hospital class: OTHER_GOV name: Leman Biotech Co., Ltd briefSummary: A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory CD19-positive B cell Hematological Malignancies conditions: Acute Lymphoblastic Leukemia conditions: Non-hodgkin Lymphoma studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: Metabolically Armed CD19 CAR-T cells measure: MTD measure: Objective response rate (ORR) measure: Concentration of CAR-T cells measure: Pharmacodynamics of CAR-T cells sex: ALL minimumAge: 3 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Anhui Provincial Hospital status: RECRUITING city: Hefei state: Anhui zip: 518000 country: China name: Xingbing Wang, PhD role: CONTACT phone: +8613856007984 email: wangxingbing@ustc.edu.cn lat: 31.86389 lon: 117.28083 hasResults: False

 nctId: NCT06276998 id: LK001304 briefTitle: A Study of LNK01001 Capsule in Subjects With Active Rheumatoid Arthritis overallStatus: RECRUITING date: 2023-12-12 date: 2025-08-04 date: 2026-11-20 date: 2024-02-26 date: 2024-03-22 name: Lynk Pharmaceuticals Co., Ltd class: INDUSTRY briefSummary: Brief Summary: This is a randomized, double-blind study comparing LNK01001 to placebo in Chinese participants with moderately to severely active rheumatoid arthritis who are on a stable dose of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and have an inadequate response or Intolerance to biologic DMARDs(bDMARDs).

The study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of LNK01001 12 mg twice daily (BID) versus placebo for the treatment of signs and symptoms of participants with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of csDMARDs and had an inadequate response to or intolerance to at least 1 bDMARD.

The study objective of Period 2 (Week 24 to Week 76) is to evaluate the long-term safety, tolerability, and efficacy of LNK01001 12 mg BID in participants with RA who completed Period 1. conditions: Rheumatoid Arthritis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 430 type: ESTIMATED name: LNK01001 name: Placebo measure: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24 measure: Change from Baseline in Disease Activity Score 28 (DAS28) (CRP) at week 24 measure: Percentage of Participants with an American College of Rheumatology 50% (ACR50) Response at week 24 measure: Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at all visits. measure: Percentage of Participants with an American College of Rheumatology 70% (ACR70) Response at all visits. measure: Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at all visits. measure: Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at all visits measure: Percentage of Participants with an American College of Rheumatology 20% (ACR20) Response at all visits (except week 24). measure: Change from Baseline in the Severity of Morning Stiffness at all visits. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital status: RECRUITING city: Beijing country: China name: Xiaofeng Zeng role: CONTACT phone: 0086-010-69158793 email: xiaofeng.zeng@cstar.org.cn lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06276985 id: 977/91 briefTitle: Impact of Injectable Platelet Rich Fibrin Versus Low-intensity Pulsed Ultrasound on Different Orthodontic Tooth Movements During Clear Aligner Therapy overallStatus: ENROLLING_BY_INVITATION date: 2024-02-25 date: 2024-06-25 date: 2024-07-25 date: 2024-02-26 date: 2024-02-26 name: Al-Azhar University class: OTHER briefSummary: The aim of this prospective clinical project will be to compare the effect of platelet rich fibrin versus low- intensity pulsed ultrasound on therate of different orthodontic tooth movements during clear aligner therapy. conditions: Effect of Platelet Rich Fibrin Versus Low Intensity Pulsed Ultrasound During Clear Aligner Therapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: BASIC_SCIENCE masking: NONE count: 82 type: ESTIMATED name: low intensity pulsed ultrasound and iPRF measure: Influence of low-level laser therapy versus low-intensity pulsed ultrasound on rate of different orthodontic tooth movements by millimeter sex: ALL minimumAge: 15 Years maximumAge: 22 Years stdAges: CHILD stdAges: ADULT facility: AlAzhar university city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06276972 id: P.T.REC/012/005000 briefTitle: Relationship Between Spine Coronal Alignment and Lower Limb Biomechanical in Scoliosis overallStatus: ACTIVE_NOT_RECRUITING date: 2023-03-12 date: 2024-03-01 date: 2024-03-15 date: 2024-02-26 date: 2024-02-26 name: Delta University for Science and Technology class: OTHER name: Benha University briefSummary: To examine the relationships between spine coronal alignment and lower limb biomechanical parameters in scoliotic adolescents conditions: Scoliosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 89 type: ACTUAL name: no intervention measure: Cobb's angle measure: Coronal balance measure: length of the the tibia and femur measure: tibiofemoral angle measure: knee joint line convergence angle measure: lower limb mechanical axis; and mechanical axis deviation sex: ALL minimumAge: 10 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Delta university for science and technology city: Gamasa state: Dakahleya zip: 7731168 country: Egypt lat: 31.44112 lon: 31.53675 hasResults: False

 nctId: NCT06276959 id: WCHSIRB-D-2022-430 briefTitle: The Effectiveness of iTero Element 5D NIRI System in Early Proximal Caries Detection in Permanent Teeth overallStatus: RECRUITING date: 2023-01-01 date: 2025-03-01 date: 2025-03-01 date: 2024-02-26 date: 2024-04-12 name: West China College of Stomatology class: OTHER briefSummary: As a new emerging technology for the diagnosis of dental caries, near-infrared imaging requires further research and validation to determine its effectiveness. This study aims to compare near-infrared imaging with cone-beam computed tomography (CBCT) to validate the efficiency of near-infrared imaging in diagnosing proximal caries using large-scale clinical data through retrospective cross-sectional studies. conditions: Dental Caries studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 120 type: ESTIMATED name: intraoral scanning name: clinical oral examination name: cone-beam computed tomography measure: positive percent agreement measure: negative percent agreement measure: overall percent agreement measure: Proximal caries positive site diagnosed by CBCT measure: Proximal caries positive site diagnosed by near-infrared imaging (NIRI) measure: Proximal caries positive site diagnosed by unaided visual examination (UVE) sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: West China Hospital of Stomatology, Sichuan University status: RECRUITING city: Chengdu state: Sichuan zip: 610041 country: China name: Zhihe Zhao, Doctor role: CONTACT phone: +86 139 8188 1666 email: zhzhao@scu.edu.cn lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06276946 id: LCCC2244 briefTitle: Sparing Parotid Ducts Via MRI Sialography for Reduced Patient Reported Xerostomia overallStatus: NOT_YET_RECRUITING date: 2024-05-08 date: 2028-07 date: 2029-01 date: 2024-02-26 date: 2024-03-22 name: UNC Lineberger Comprehensive Cancer Center class: OTHER briefSummary: Radiation-induced xerostomia (dry mouth) is one of the most common and severe toxicities experienced by patients undergoing radiation treatment for head and neck cancer. Radiation-induced dry mouth is a frequently experienced symptom and persists after treatment, potentially indefinitely. Current practice does not specifically attempt to spare the parotid ducts, where stem/progenitor cells are believed to preferentially reside, and considers the entire salivary gland to have equal function. New radiation therapy planning and conducting strategies are needed to reduce this toxicity and maximize patient quality of life post-treatment.

This randomized Phase II study explores the contribution of magnetic resonance imaging (MRI) guided salivary gland duct definition to decrease patient-reported xerostomia in patients with oropharynx cancer receiving radiation therapy. The severity of xerostomia will be measured by patient-reported (PRO) symptoms, saliva secretion, saliva pH, and buffering. conditions: Oropharynx Cancer conditions: Head and Neck Cancer conditions: Xerostomia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 98 type: ESTIMATED name: standard radiotherapy name: experimental radiotherapy measure: The difference in patient-reported xerostomia 6 months measure: Saliva mass measure: Parotid duct dose constraint measure: The difference in patient-reported xerostomia 12 months measure: Xerostomia by NCI-CTCAE sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of North Carolina at Chapel Hill, Department of Radiation Oncology city: Chapel Hill state: North Carolina zip: 27599 country: United States lat: 35.9132 lon: -79.05584 hasResults: False

 nctId: NCT06276933 id: MA-NSCLC-II-039 briefTitle: A Study of Camrelizumab Combined With Chemotherapy ± Thalidomide in First-line Treatment of Patients With Advanced Non-small Cell Lung Cancer (NSCLC) overallStatus: NOT_YET_RECRUITING date: 2024-02-22 date: 2025-11-22 date: 2026-11-22 date: 2024-02-26 date: 2024-02-26 name: Tongji University class: OTHER name: Shanghai Pulmonary Hospital, Shanghai, China briefSummary: To explore and evaluate the safety and efficacy of camrelizumab combined with chemotherapy ± thalidomide in first-line treatment of advanced non-small cell lung cancer patients conditions: Lung Cancer conditions: Camrelizumab studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 104 type: ESTIMATED name: Camrelizumab + chemotherapy+Thalidomide name: Camrelizumab + chemotherapy+placebo measure: Incidence rate of any grade Reactive Cutaneous Capillary Endothelial Proliferation(RCCEP) measure: Median time to RCCEP measure: Median time to RCCEP of level 3 or above measure: Incidence rate of ≥G3 grade RCCEP measure: Overall Response Rate (ORR) measure: Progression-Free Survival (PFS) measure: Overall Survival(OS) measure: Treatment-related Adverse Events (TRAE) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06276920 id: 2024/5554(1) briefTitle: Evaluation of Joint Position Sense in Healthy Individuals overallStatus: RECRUITING date: 2024-02-07 date: 2024-02-29 date: 2024-02-29 date: 2024-02-26 date: 2024-02-26 name: Inonu University class: OTHER briefSummary: It was aimed to measure the elbow joint position sense in healthy individuals in the case of a closed kinetic chain and to compare it with the measurement made in the case of an open kinetic chain. conditions: Proprioception studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 4 type: ESTIMATED measure: Joint position sense measurement with universal goniometer in close kinetic chain measure: Joint position sense measurement with universal goniometer in open kinetic chain sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Inonu University status: RECRUITING city: Malatya zip: 12000 country: Turkey name: DILAN DEMİRTAŞ KARAOBA role: CONTACT phone: 0554112779 email: dilandemirtas92@gmail.com lat: 38.35018 lon: 38.31667 hasResults: False

 nctId: NCT06276907 id: ILBS-ACLF-16 briefTitle: An Open-label Randomized Controlled Trial Comparing the Role of Therapeutic Plasma-exchange in Ameliorating Secondary Organ Dysfunctions in Patients With ACLF and Develop Biomarkers of Treatment Response overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2027-12-31 date: 2027-12-31 date: 2024-02-26 date: 2024-02-26 name: Institute of Liver and Biliary Sciences, India class: OTHER briefSummary: Rationale: Current understanding of the pathophysiology of ACLF suggests that unresolved injury, poor infection control, and liver regeneration result in persistent systemic inflammation and cytokine storm, which subsequently lead to systemic inflammatory response syndrome (SIRS) resulting in multiple organ failures, septic shock and deaths in ACLF. Nearly 74% of ACLF patients initially diagnosed without SIRS, sepsis, or organ failure developed SIRS by day 7 which increases the onset of secondary organ failure and sepsis with high short-term mortality. The emerging use of plasma exchange has shown some potential benefits in terms of dampening systemic inflammation and improvement of outcomes in some ACLF patients. However, there is currently no randomized controlled trial exploring the potential role in ameliorating secondary organ dysfunctions in patients with ACLF is not known. Hence in the current objective, we want to study the role of plasma exchange in the management of sec. organ failure in ACLF patients in a randomized controlled trial and identify the biomarker to access the treatment response to therapy. conditions: Acute on Chronic Liver Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 190 type: ESTIMATED name: Plasma Exchange name: Standard Medical Treatment measure: The AARC grading is done by AARC score the values of which vary from 5-15 , pts are divided into 3 grades i.e AARC score 5-7- grade 1, 8-10- grade 2, and AARC 11-15 as grade 3. Improvement in 1 grade is associated with 40% improvement in 28-day survival measure: Transplant-free survival at 28-days measure: The impact of TPE on the progression or resolution of secondary organ failures at day 7, 14 and 28 measure: the development of infection at day 7 and 14 in patients who had no infection measure: Duration of ICU and hospital stay measure: The proportion of patients developing adverse events will be compared between the two groups sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Liver & Biliary Sciences city: New Delhi state: Delhi zip: 110070 country: India name: Dr Rakhi Maiwall, DM role: CONTACT phone: 01146300000 email: rakhi_2011@yahoo.co.in lat: 28.63576 lon: 77.22445 hasResults: False

 nctId: NCT06276894 id: IRB #2064530-1 briefTitle: Functional Near-Infrared Spectroscopy (fNIRS) Assessing Neural Activity During Virtual Reality Walking Intervention acronym: fNIRS overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-02-01 date: 2025-02-01 date: 2024-02-26 date: 2024-02-26 name: Craig Hospital class: OTHER briefSummary: The purpose of this study is to evaluate the safety and feasibility of using a portable neuroimaging device called functional near-infrared spectroscopy (fNIRS) to successfully analyze fNIRS data in individuals with chronic TBI during treadmill training augmented with VR. conditions: Traumatic Brain Injury studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 15 type: ESTIMATED name: Motek C-Mill™ treadmill name: training session with and without VR wearing the fNIRS cap measure: Incidence of Treatment-Related Adverse Events (e.g., Safety and Tolerability) measure: Acceptability of the intervention measure: fNIRS Data Quality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Craig Hospital city: Englewood state: Colorado zip: 80113 country: United States lat: 39.64777 lon: -104.98776 hasResults: False

 nctId: NCT06276881 id: DSC1001 id: 1R43DA054845-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R43DA054845-01 briefTitle: Visual Stimulation for Pain Relief overallStatus: COMPLETED date: 2022-06-03 date: 2022-12-28 date: 2023-05-01 date: 2024-02-26 date: 2024-04-03 date: 2024-04-03 name: Dandelion Science class: INDUSTRY name: National Institutes of Health (NIH) name: National Institute on Drug Abuse (NIDA) briefSummary: The goal of this study is to investigate a novel neuromodulatory approach utilizing visual stimulation to impact pain perception in healthy participants. conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 75 type: ACTUAL name: Visual Stimulation measure: Visual Analog Scale (VAS) Score measure: Event-related Potential (ERP) sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Dandelion Science city: Hoboken state: New Jersey zip: 07030 country: United States lat: 40.74399 lon: -74.03236 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2021-12-21 uploadDate: 2024-03-08T12:20 filename: Prot_SAP_000.pdf size: 689133 hasResults: True

 nctId: NCT06276868 id: HELEN-017 briefTitle: Darsilide Combined With AI, Trastuzumab and Patuzumab in the Neoadjuvant Treatment of HR+/HER2+ Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-07-01 date: 2029-06-01 date: 2024-02-26 date: 2024-02-26 name: Henan Cancer Hospital class: OTHER_GOV briefSummary: This study is intended to carry out a single arm, prospective, open clinical study, and use Darsilide combined with endocrine therapy, Trastuzumab and Patuzumab to treat early or locally advanced breast cancer of TPBC before surgery. It is intended to further explore the efficacy and safety of the new adjuvant treatment for TPBC patients with step-down therapy. conditions: Breast Cancer conditions: HER2-positive Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, single arm clinical study primaryPurpose: TREATMENT masking: NONE count: 66 type: ESTIMATED name: Dalcilib+letrozole+HP treatment group measure: pathologic complete response measure: Adverse event occurrence measure: objective response rate measure: Residual cancer burden measure: Event free survival measure: Disease free survival measure: Distant disease/recurrence free survival sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Henan cacer hospital city: Henan state: Henan zip: 450008 country: China hasResults: False

 nctId: NCT06276855 id: CUtülay briefTitle: Sleep Hygiene Education in Individuals With Fibromyalgia; Sleep Quality, Pain and Depression overallStatus: COMPLETED date: 2021-06-23 date: 2021-07-01 date: 2021-12-31 date: 2024-02-26 date: 2024-02-26 name: Cumhuriyet University class: OTHER briefSummary: Objective: This semi-experimental study was conducted to determine the effect of sleep hygiene education on sleep quality, pain, and depression in individuals with fibromyalgia.

Patients and methods: A sample of 70 individuals with fibromyalgia (35 experimental, 35 control) were included in the study. Data was collected using the Pittsburgh Sleep Quality Index, the Visual Analog Scale, and the Beck Depression Inventory. conditions: Fibromyalgia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Experimental group Control group primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 70 type: ACTUAL name: Sleep hygiene education measure: Demographic Information Form (DIF). measure: Pittsburgh Sleep Quality Index (PSQI). measure: Visual Analog Scale (VAS). measure: Beck Depression Inventory (BDI). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sivas Cumhuriyet University city: Sivas state: Center zip: 58140 country: Turkey lat: 39.74833 lon: 37.01611 hasResults: False

 nctId: NCT06276842 id: 12345678 briefTitle: Efficacy of Combining an Inferior Alveolar Nerve Block With a Buccal Infiltration overallStatus: COMPLETED date: 2020-04-01 date: 2020-09-30 date: 2020-09-30 date: 2024-02-26 date: 2024-02-26 name: CIMS Dental College class: OTHER briefSummary: OBJECTIVE To compare the effectiveness of using both a combined technique of an Inferior Alveolar Nerve block and buccal infiltration with that achieved by utilizing an Inferior Alveolar Nerve block alone for endodontic treatment of mandibular molars with irreversible pulpitis.

STUDY DESIGN Randomized clinical trial PLACE AND DURATION OF STUDY Operative Dentistry Department of Armed Forces Institute of Dentistry Rawalpindi, from 1st April 2020 to 31st September 2020.

MATERIAL AND METHODS A total of 120 patients were enrolled in the study. Sixty patients of group A received conventional Inferior Alveolar Nerve block and sixty patients of Group B received buccal infiltration along with conventional Inferior Alveolar Nerve block. conditions: Pulpitis studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 120 type: ACTUAL name: Inferior Alveolar Nerve Block name: Buccal Infiltration name: Inferior Alveolar Nerve Block and Buccal Infiltration measure: Comparison of Anesthesia Effectiveness Between Combined Technique (Inferior Alveolar Nerve Block and Buccal Infiltration) and Inferior Alveolar Nerve Block Alone sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Dr Ayesha Ahmed city: Multan country: Pakistan lat: 30.19679 lon: 71.47824 hasResults: False

 nctId: NCT06276829 id: 02.05.2023/291 briefTitle: Behçet and LDH/Albumin overallStatus: COMPLETED date: 2020-02-01 date: 2023-04-01 date: 2023-04-01 date: 2024-02-26 date: 2024-02-26 name: Ataturk University class: OTHER briefSummary: ABSTRACT Objective: To investigate whether the lactate dehydrogenase to albumin ratio can be used as a parameter to determine disease severity in Behçet's disease, an inflammatory disease, by comparing it to healthy controls.

Patients and Methods: In this retrospective cohort study, patients with Behçet's disease aged 18-69 years who presented to the outpatient clinic between February 2020 and April 2023 and healthy individuals of similar age and gender were enrolled. LDH, albumin levels, and LDH/albumin ratio of both groups were compared. Clinical findings and characteristics of Behçet's patients and disease severity were recorded and analyzed in relation to LDH/albumin ratio. conditions: Behcet's Disease conditions: Albumin conditions: Lactate Dehydrogenase conditions: Disease Severity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 1 type: ACTUAL name: LDH/albumin ratio measure: LDH/albumin ratio sex: ALL minimumAge: 18 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erdal Pala city: Erzurum zip: 25240 country: Turkey lat: 39.90861 lon: 41.27694 hasResults: False

 nctId: NCT06276816 id: 2022-LC14 briefTitle: Cardiac Denervation Ablation Strategy for Severe Sinus Bradycardia overallStatus: RECRUITING date: 2023-09-13 date: 2024-09-30 date: 2024-12-30 date: 2024-02-26 date: 2024-02-26 name: China National Center for Cardiovascular Diseases class: OTHER_GOV briefSummary: This is a prospective clinical observation and registration study. The investigator aimed to evaluate the efficacy and safety of cardiac denervation ablation as a treatment strategy for severe sinus bradycardia. conditions: Sinus Bradycardia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 88 type: ESTIMATED measure: Number of patients with postoperative recurrence of bradycardia symptoms measure: The result of the atropine test measure: Changes in quality of life measured by Medical Outcomes Study 36- Item Short Form Health Survey (SF-36) measure: Changes in quality of life measured by EuroQol Five Dimensions Questionnaire Visual Analogue Scale (EQ VAS) measure: Changes in minmum heart rate measure: Changes in mean heart rate measure: Changes in deceleration capacity sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: 1Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College status: RECRUITING city: Beijing country: China name: Yao Yan, MD PhD role: CONTACT phone: +86-1390-1121-319 email: ianyao@263.net.cn lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06276803 id: Adenocyte 104 briefTitle: The LINFU® U.S. Registry for the in the General Population Without Risk Factors overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2034-04-15 date: 2034-06-15 date: 2024-02-26 date: 2024-03-06 name: Adenocyte, LLC class: INDUSTRY briefSummary: Adenocyte has developed LINFU®, (Low Intensity Non-Focused Ultrasound excitation of the pancreas) as a method of identifying early, asymptomatic pancreatic cancer and its noninvasive precancerous lesions.. In this study, LINFU® will be evaluated in the general population with no risk factors and who exhibit no signs or symptoms of disease, This study will help determine if LINFU® can be used to help identify early, asymptomatic pancreatic ductal adenocarcinoma (PDAC) or their precursor lesions (PanIn-2, PanIn-3). conditions: Pancreatic Cancer conditions: Pancreatic Ductal Adenocarcinoma conditions: Pancreatic Dysplasia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: LINFU® measure: The number of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® measure: The change in size of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® will be determined long term measure: Determine the number of patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® that require medical or surgical intervention measure: Yearly survival rate of patients with early pancreatic ductal adenocarcinomas or their noninvasive precursor lesions identified with LINFU® sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06276790 id: ChengdeCentralHospital briefTitle: Objective Analysis of Caesarean Scar Pregnancy overallStatus: COMPLETED date: 2019-01-18 date: 2022-12-23 date: 2022-12-25 date: 2024-02-26 date: 2024-02-26 name: Chengde Central Hospital class: OTHER_GOV briefSummary: This study uses a systematic scoring method combined with clinical and ultrasound data to comprehensively evaluate patient conditions and explore the guiding value of the ultrasound quantitative scoring system for selecting the surgical approach for caesarean scar pregnancy. conditions: Caesarean Scar Pregnancy conditions: Ultrasound Scoring System studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 117 type: ACTUAL name: ultrasound-guided/hysteroscopic curettage name: Procedure/Surgery: laparoscopic removal of the pregnancy lesion measure: intraoperative blood loss measure: length of hospital stay measure: serum β-HCG levels sex: FEMALE minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chengde Central Hospital city: Chengde zip: 067000 country: China lat: 40.9519 lon: 117.95883 hasResults: False

 nctId: NCT06276777 id: SPRG Dentin Hypersensitivity briefTitle: The Effect of Using Desensitizers Containing S-PRG In Treatment Of Dentin Hypersensitivity Over 6 Months: A Randomized Clinical Trial acronym: S-PRG overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-11-01 date: 2024-12-01 date: 2024-02-26 date: 2024-02-26 name: Eman Omar Elfarouk class: OTHER briefSummary: The goal of this clinical trial is to compare the effect of desensitizer containing S-PRG have similar effect as sodium fluoride with functionalized tri-calcium phosphate containing desensitizer in relieving dentinal hypersensitivity in adult patients for six months follow-up. patients will be asked to report pain degree on the visual analogue scale (VAS) along the follow up periods on both groups. conditions: Dentin Hypersensitivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Participants and both assessors will be blind to the type of material used. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Tooth varnish (PRG Barrier Coat from Shofu) name: Tooth varnish (Clinpro white varnish 3M) measure: Dentin hypersensitivity reduction sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Faculty of Dentistry Cairo University city: Cairo zip: 11331 country: Egypt name: Eman Omar, bachelor role: CONTACT phone: 01156677558 email: eman.omar@dentistry.cu.edu.eg lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06276764 id: Adenocyte 103 briefTitle: The LINFU® U.S. Registry in Patients With IPMN (Intraductal Papillary Mucinous Neoplasm of the Pancreas) overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2034-03-30 date: 2034-05-01 date: 2024-02-26 date: 2024-02-26 name: Adenocyte, LLC class: INDUSTRY briefSummary: In this study, LINFU® will be evaluated in patients who have been identified with IPMN to determine if it can be used to help identify early, pancreatic ductal adenocarcinoma and its noninvasive precursor lesions (dysplasia). The study will also help determine if LINFU® results in earlier intervention, treatment and improvement in patient outcomes. conditions: IPMN, Pancreatic conditions: Pancreas Cancer conditions: Pancreatic Cyst studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: LINFU® name: Standard imaging tests measure: The number of pancreatic ductal adenocarcinomas or their precursor lesions, dysplasia, identified only with LINFU® will be compared to standard screening methods measure: The change in size of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® will be determined over a 5 year period measure: Determine the number of patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® that require medical or surgical intervention. measure: Yearly survival rate of patients with early pancreatic ductal adenocarcinomas or their noninvasive precursor lesions identified only with LINFU® sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06276751 id: E1-23-3870 ptx endtidalco2 briefTitle: The Diagnostic Value of End-Tidal CO2 in Patients Diagnosed With Pneumothorax overallStatus: COMPLETED date: 2023-08-15 date: 2024-02-06 date: 2024-02-13 date: 2024-02-26 date: 2024-02-26 name: Ankara City Hospital Bilkent class: OTHER briefSummary: Pneumothorax (PTX) is defined as the accumulation of air in the pleural space. PTX can cause a disruption in the perfusion of lung tissue in the affected area and increase intrathoracic pressure, potentially leading to obstruction of venous return and, consequently, posing a life-threatening condition. Therefore, PTX requiring urgent intervention is a significant concern in emergency departments.

End-tidal carbon dioxide (ETCO2) provides insight into carbon dioxide levels resulting from lung perfusion and serves as a respiratory parameter informing the prognosis of various critical illnesses. One of the most important factors determining lung perfusion is the effective lung area. Among the crucial issues for emergency departments are PTX cases, which typically regress following urgent intervention, leading to the establishment of an effective lung area. Hypotheses have been proposed in the literature suggesting that ETCO2 may be affected in PTX cases due to the relationship between effective lung area and ETCO2.

In this study, investigetors aimed to investigate changes in ETCO2 levels following tube thoracostomy applied to PTX cases. conditions: Pneumothorax studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 43 type: ACTUAL name: End-tidal CO2 monitor measure: ETCO2-0 measure: ΔETCO2-1 measure: ΔETCO2-2 measure: ETCO2-1 measure: ETCO2-2 sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Bilkent Şehir Hastanesi city: Ankara state: Çankaya zip: 06170 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06276738 id: Adenocyte 102 briefTitle: The LINFU® U.S. Registry in Patients With Clinical Signs and/or Symptoms of Disease overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2034-03-01 date: 2034-05-01 date: 2024-02-26 date: 2024-02-29 name: Adenocyte, LLC class: INDUSTRY briefSummary: Evaluate LINFU® in patients who exhibit signs or symptoms (i.e. jaundice, abdominal pain, weight loss, nausea and vomiting etc.) suggestive of pancreatic cancer (PDAC) or have evidence of imaging studies suggestive of PDAC. conditions: Pancreatic Cancer conditions: Jaundice conditions: Abdominal Neoplasm studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: LINFU® (Low Intensity Non-Focused Ultrasound excitation of the pancreas) measure: The number of pancreatic ductal adenocarcinomas identified only with LINFU® will be compared to standard screening methods measure: The change in size of pancreatic ductal adenocarcinomas identified only with LINFU® will be determined measure: Determine the number of patients with pancreatic ductal adenocarcinoma identified only with LINFU® that require medical or surgical intervention measure: Yearly survival rate of patients with pancreatic ductal adenocarcinomas identified only with LINFU® sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06276725 id: 23-606 briefTitle: Writing Wrongs: Expressive Writing for Microaggressions acronym: WW overallStatus: RECRUITING date: 2024-03-18 date: 2024-12-01 date: 2025-04-01 date: 2024-02-26 date: 2024-03-25 name: Auburn University class: OTHER name: Medical University of South Carolina briefSummary: Racial and ethnic based stressors, such as microaggressions, are pervasive, distressing, and result in lasting negative repercussions for minoritized students at predominantly white institutions (PWIs). These racial and ethnic based stressors are experienced in addition to the universally experienced stressors of higher education. Negative repercussions of microaggressions include increased drop out or transfer rates, distress, fatigue resulting in decreased academic performance, and depression and posttraumatic stress symptoms. Expressive writing (EW) may be a scalable intervention for addressing the negative repercussions resulting from microaggressions experienced by minoritized students at PWIs. Previous research suggests that EW for stressful life events results in benefits such as reduced depression and posttraumatic stress symptoms, improved coping strategies, and reduced activity restriction. Despite such benefits, EW was not designed to specifically address microaggressions in a minoritized student population. Informed by the ADAPT-ITT model, our research group conducted a pilot study with similar procedures. This pilot study demonstrated the acceptability of an adapted version of the EW intervention titled Writing Wrongs (WW), as well as recommended future modifications for WW. In the current study we aim to conduct a randomized-controlled trial to establish the efficacy of WW in alleviating clinical symptoms. We hypothesize that WW will improve symptoms of racial and discriminatory trauma and symptoms of depression, anxiety, and posttraumatic stress over time and compared to an assessment-only condition. We will conduct exploratory analyses to examine short-term changes in affect within and across sessions and across conditions. We will recruit minoritized students enrolled at a PWI. Participants will complete a pre-intervention assessment prior to being randomized into the two conditions. Participants in the intervention condition will engage in three sessions of WW and complete measures of clinical symptoms across multiple time points (i.e., pre-intervention, immediately after the final writing session, one week after the final session). Participants in the assessment-only condition will be administered the same measures at the same timepoints and given access to the WW after completing the study. If found to be efficacious, WW has the potential to be widely disseminated to minoritized college students who experience microaggressions. conditions: Posttraumatic Stress Disorder conditions: Discriminatory Stress conditions: Microaggression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: After consenting to participate in the study, participants will be randomized in a 1:1 manner into either the Writing Wrongs Intervention or the Assessment Control condition. All participants will complete a total of five online study sessions including a pre-intervention assessment, three intervention or assessment only sessions, and a one-week follow-up assessment . primaryPurpose: TREATMENT masking: NONE count: 70 type: ESTIMATED name: Writing Wrongs measure: Racial and Discriminatory Trauma measure: Daily Racial and Discrimination Trauma measure: Depression measure: Anxiety measure: Stress measure: Posttraumatic Stress measure: Daily Depression measure: Daily Anxiety measure: Daily Posttraumatic Stress measure: Negative Affect measure: Positive Affect measure: Acceptability of Writing Wrongs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Auburn University status: RECRUITING city: Auburn state: Alabama zip: 368849 country: United States name: Cassidy M Brydon, MS role: CONTACT phone: 954-591-5261 email: cmb0106@auburn.edu name: Tracy K Witte, PhD role: CONTACT phone: 334-844-6465 email: tracy.witte@auburn.edu lat: 32.60986 lon: -85.48078 hasResults: False

 nctId: NCT06276712 id: UNISS_PHD_Osstem_5 briefTitle: RCT Comparing KS Versus TS for Ovedenture overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-30 date: 2028-01-30 date: 2024-02-26 date: 2024-02-26 name: Università degli Studi di Sassari class: OTHER name: Dr. Dario Melodia name: Dr. Milena Pisano name: Dr. Aurea Lumbau name: Prof. Silvio Mario Meloni name: Prof. Edoardo Baldoni briefSummary: To evaluate the clinical and radiographic outcomes of KS implants used to rehabilitate edentulous mandible with dental-retained overdentures, and to compare it with same treatment on TS implants conditions: Dental Implant conditions: Dental Implant-Abutment Design conditions: Edentulous Jaw studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A multicenters, randomized controlled trial. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: A blinded (when possible) outcome assessor will evaluate all the outcomes and will take the radiogram for centralized analysis. whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: Implant placement with 3.5 mm diameter KS implants. name: Implant placement with 3.5 mm diameter TS implants. measure: Number of implant failure measure: Number of prosthesis failure measure: Number of complications measure: Rate of implant stability measure: Peri-implant marginal bone level changes measure: Patient satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06276699 id: FAHS briefTitle: Efficacy of a Combination of Conservative Treatments Compared to Isometric Exercise on Clinical Outcomes in Patients With Cervical Radiculopathy overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-05 date: 2024-06 date: 2024-02-26 date: 2024-04-16 name: University of Peradeniya class: OTHER briefSummary: This intervention study is to evaluate the efficacy of a combination of conservative treatments compared to isometric exercise on clinical outcomes in patients with cervical radiculopathy. It is a randomized, parallel, 2-arm superiority trial study. The study will be conducted at the District General Hospital in Trincomalee, where patients with cervical radiculopathy seek medical care. Patients who refer to the Department of Physical Medicine (DPM) from the Out Patients Department (OPD), orthopedic clinic and surgical clinic with a diagnosis of cervical radiculopathy or neck and arm pain (symptoms extending distal to the shoulder) will be eligible for recruitment. The study details will be explained to the subjects in the language that they best understand. Written informed consent will be obtained from the individuals who express their willingness to participate in the study, and they will sign the informed consent document accordingly. conditions: Cervical Radiculopathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 46 type: ESTIMATED name: 1.Isometric exercise 2.combined conservative treatment measure: Difference in pain intensity measured by Visual Analogue Scale (VAS) between combination of treatments and isometric exercises at 6-weeks post-baseline. measure: Difference in cervical ROM measured by Goniometry between combination of treatments and isometric exercises at 6-weeks post-baseline. measure: Difference in functional disability measured by Neck Disability Index between combination of treatments and isometric exercises at 6-weeks post-baseline sex: ALL minimumAge: 35 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06276686 id: RS211 - 332296 briefTitle: Exercise for Improving Long-course Chemoradiotherapy Efficacy in People With Locally Advanced Rectal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-01 date: 2026-02 date: 2024-02-26 date: 2024-04-24 name: University of Hull class: OTHER name: Hull University Teaching Hospitals NHS Trust briefSummary: This is a single arm feasibility study of exercise for improving long- course neoadjuvant chemoradiotherapy (NACRT) efficacy in people diagnosed with locally advanced rectal cancer. The study aims to recruit up to 30 patients from the Queen's Centre for Oncology and Haematology of Castle Hill Hospital, Cottingham, diagnosed with locally advanced rectal cancer. Consenting patients will be provided with an 11-week course of structured aerobic exercises and resistance training in the periods before, during and after their chemoradiotherapy treatment. The patients will be followed up for 6 months post long course neoadjuvant chemoradiotherapy (NACRT), with a total of 3 assessment periods. conditions: Locally Advanced Rectal Carcinoma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 30 type: ESTIMATED name: Supervised Vigorous intensity aerobic interval exercise measure: Recruitment rate measure: Attendance rate measure: withdrawal rate measure: Serum Carcinoembryonic antigen levels measure: Quality of life measure: Quality of life measure: Physical activity levels sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06276673 id: 301 briefTitle: The Influences of Single Chamber vs. Multi-chamber Blood Flow Restriction Cuffs overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-13 date: 2024-11-10 date: 2024-12-10 date: 2024-02-26 date: 2024-02-26 name: Salisbury University class: OTHER briefSummary: The purpose of this study is to investigate the use of single (SC) and multi-chamber (MC) blood flow restriction (BFR) cuff exercise on indices of arterial stiffness, muscle morphology, and participant perception. conditions: Blood Vessel Disease conditions: Muscle Edema studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Participants will undergo three treatment sessions (control (no BFR), SC BFR, and MC BFR) in a randomized order separated by one week. primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: Unable to blind due to differences in cuff size and appearance. count: 35 type: ESTIMATED name: Delfi measure: Arterial Stiffness measure: Muscle Morphology sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Salisbury University city: Salisbury state: Maryland zip: 21801 country: United States lat: 38.36067 lon: -75.59937 hasResults: False

 nctId: NCT06276660 id: STUDY23070079 briefTitle: Post-Concussion Differences Between Buffalo Concussion Treadmill Test (BCTT) and Modified Dynamic Exertion (mEXiT) Test overallStatus: RECRUITING date: 2024-03-05 date: 2024-09 date: 2024-12-31 date: 2024-02-26 date: 2024-03-06 name: University of Pittsburgh class: OTHER briefSummary: This study aims to compare symptom provocation, physiologic response, and rate of perceived (RPE) between the Buffalo Concussion Treadmill Test (BCTT) and a Modified Dynamic Exertion (mEXiT) test after sport related concussion in adolescents aged 14-17. Participants will be enrolled at their initial concussion clinical visit within 14 days of their injury, and randomly assigned to either the BCTT or mEXiT group. Participants will complete a single visit. conditions: Mild Traumatic Brain Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 60 type: ESTIMATED name: BCTT name: Dynamic ExIT measure: Physiological response to dynamic or aerobic test (HEART RATE) measure: Post Concussion Symptom Scale measure: Patient Health Questionnaire (PHQ-9) measure: Generalized Anxiety Disorder (GAD-7) measure: Vestibular Ocular Motor Screening (VOMS) measure: Clinical Profiles Screening (CP-Screen) measure: Blood Pressure sex: ALL minimumAge: 14 Years maximumAge: 17 Years stdAges: CHILD facility: UPMC/Univ of Pgh Sports Medicine Concussion Research Program status: RECRUITING city: Pittsburgh state: Pennsylvania zip: 15203 country: United States name: Cynthia Holland, MPH role: CONTACT phone: 412-904-1298 email: clh197@pitt.edu lat: 40.44062 lon: -79.99589 hasResults: False

 nctId: NCT06276647 id: 850584 id: R01MD016029 type: NIH link: https://reporter.nih.gov/quickSearch/R01MD016029 briefTitle: Improving Health Outcomes and Equity by Targeting Postpartum Mothers at Highest Risk acronym: HOME overallStatus: RECRUITING date: 2024-02-20 date: 2025-02-15 date: 2025-05-31 date: 2024-02-26 date: 2024-03-01 name: University of Pennsylvania class: OTHER name: National Institutes of Health (NIH) name: Columbia University name: National Institute on Minority Health and Health Disparities (NIMHD) briefSummary: The goal of this educational clinical trial is to identify Black women most at risk for poor outcomes following delivery, the problems they experience, and to create a system to improve quality of postpartum care for high-risk women. The main question\[s\] it aims to answer are:

* How can the investigators help postpartum Black people who have poor outcomes by decreasing the number of ED visits/readmissions for postpartum people within the first 30 days postpartum?
* How can the investigators increase the ability of participants to "obtain needed services" and ability for patients to see their provider when they need to, in the 30-day post discharge period as one of the main pathways of unnecessary ED visits?

Participants will be put into the study group or control group. The study group will receive a pamphlet postpartum with helpful information as well as a patient navigator who the participants will be able to reach out to their first 30 days postpartum. conditions: Maternal Behavior conditions: Postpartum Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 214 type: ESTIMATED name: HOME measure: Emergency Department (ED) Visits and Readmissions measure: Ability to Obtain Needed Services measure: Depressive Symptoms measure: Depressive Symptoms sex: FEMALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Hospital of the University of Pennsylvania status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Elizabeth Howell, MD MPP role: CONTACT email: elizabeth.howell1@pennmedicine.upenn.edu name: Micki Burdick, PhD role: CONTACT email: micki.burdick@pennmedicine.upenn.edu name: Elizabeth Howell, MD MPP role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06276634 id: STU00219535 id: R21HD108587 type: NIH link: https://reporter.nih.gov/quickSearch/R21HD108587 briefTitle: Intermittent Hypoxia in Persons With Multiple Sclerosis overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-01 date: 2027-01 date: 2024-02-26 date: 2024-04-09 name: Shirley Ryan AbilityLab class: OTHER name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) name: Northwestern University briefSummary: This study aims to understand the mechanisms of a novel intervention involving breathing short durations of low levels of oxygen for persons with multiple sclerosis (MS). This intervention with low levels of oxygen is called Acute Intermittent Hypoxia (AIH), the levels of oxygen experienced are similar to breathing the air on a tall mountain, for less than 1 minute at a time. Previous studies have shown that AIH is a safe and effective way to increase strength in persons with MS. Here the investigators aim to look at brain activation and ankle strength before and after AIH to gain a better understanding of how the AIH may improve strength in those persons with MS. conditions: Multiple Sclerosis conditions: Multiple Sclerosis-Relapsing-Remitting conditions: Multiple Sclerosis, Secondary Progressive studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomized, double-blind, placebo-controlled, cross-over, repeated measures study design primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 21 type: ESTIMATED name: Acute Intermittent Hypoxia name: Sham-Acute Intermittent Hypoxia measure: Ankle Plantarflexion Strength measure: Task fMRI measure: Timed 25 Feet Walk test measure: Six-Minute Walk test measure: Stride length measure: 12-Item Multiple Sclerosis walk scale (MSWS-12) measure: Resting-State fMRI sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shirley Ryan AbilityLab city: Chicago state: Illinois zip: 60611 country: United States name: Alexander Barry, MS, CCRC role: CONTACT phone: 312-238-1435 email: abarry@sralab.org name: Milap Sandhu, PT, PhD role: PRINCIPAL_INVESTIGATOR name: Molly Bright, D.Phil. role: SUB_INVESTIGATOR lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06276621 id: STUDY00003564 briefTitle: Family Bridge Program overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-05 date: 2026-05 date: 2024-02-26 date: 2024-02-26 name: Seattle Children's Hospital class: OTHER name: Children's Hospital of Philadelphia briefSummary: Pediatric healthcare inequities in the United States (US) remain persistent and pervasive. Suboptimal patient-provider communication plays an important role in creating and maintaining disparate outcomes; this is compounded by mismatches between a family's skills and resources and demands imposed by the complexity of the health system (such as health literacy and system navigation). Few interventions exist to address inequities related to communication and system navigation in the inpatient setting; given the established links between these inequities and disparate clinical outcomes, such interventions are needed. To address this gap, the study team collaborated with parents/caregivers, staff, and providers to develop and pilot-test a novel program to improve navigation ability, communication, and hospital-to-home transition for a diverse population of children and their families, The Family Bridge Program (FBP).

The FBP combines principles of effective patient navigation and communication coaching interventions into a brief and targeted inpatient program. It is designed for a broad population of low-income children of color, is not disease-specific, is not limited to English proficient families, and is less time-intensive than traditional navigation, to enable provision of support to more families. The FBP, delivered in-person by a trained lay navigator, includes: (1) hospital orientation; (2) unmet social needs screening (e.g., food insecurity); (3) parent communication and cultural preference assessment, relayed to the medical team; (4) communication coaching for parents; (5) emotional support; (6) assistance with care coordination and logistics; and (7) a phone call 2 days post-discharge. Program elements are flexibly delivered based on parent need and interest.

In pilot testing, the program was feasible to deliver, acceptable to parents and providers, and significantly improved parent-reported system navigation ability. The current R01 proposes a two-site randomized controlled trial (RCT) of the effectiveness of FBP among 728 families of low-income children of color. Enrolled families will be randomized 1:1 (stratified by site and language) to FBP or usual care plus written resources. The specific aims of this clinical trial are to (1) Test the effect of the FBP on parent-reported system navigation ability, quality of hospital-to-home transition, diagnosis comprehension, observed communication quality, perceived stress and revisits for families of low-income children of color; (2) Examine whether changes in parent-reported barriers and needs mediate program effects; and (3) Identify subgroups of parents among whom the FBP is more effective. The proposed RCT will use a rigorous design to test a feasible, innovative program to address a critical national problem. If effective, the Family Bridge Program would provide a scalable model for improving health care experiences and outcomes for families of low-income children of color, including those who prefer a language other than English for their medical care. conditions: Healthcare Inequities conditions: General Pediatric Medical Conditions conditions: Healthcare System Navigation conditions: Patient-provider Communication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 728 type: ESTIMATED name: Family Bridge Program name: Care as usual - resources only measure: System Navigation Ability measure: Pediatric Transition Experience Measure (P-TEM) measure: Diagnosis Comprehension measure: Perceived Stress Scale measure: Observed Communication: utterances in which team offers information measure: Observed Communication: utterances in which team offers supportive talk measure: Observed Communication: utterances in which parent asks questions measure: Observed Communication: utterances in which parent responds assertively measure: Observed Communication: parent talk-time measure: Observed Communication: global partnership rating measure: 30-day readmissions sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06276608 id: PED_Fe_def briefTitle: Iron Deficiency in Pediatric Heart Surgery overallStatus: RECRUITING date: 2024-02-23 date: 2024-04-20 date: 2024-06-30 date: 2024-02-26 date: 2024-02-28 name: Queen Fabiola Children's University Hospital class: OTHER briefSummary: The prevalence of iron deficiency in pediatric cardiac surgery patients is not very well known. Iron deficiency can lead to anemia, higher transfusion rates and possibly higher complication rates. In this retrospective study, the iron status of all patients undergoing pediatric cardiac surgery at our institution between January 2019 and december 2023 will be analyzed. Together with iron status, transfusion requirements as well as complications will be recorded. Iron status will be reported with descriptive statistics, patients with or without iron deficiency will be compared using non-parametric tests. conditions: Iron Deficiencies conditions: Iron Deficiency Anemia conditions: Cardiac Surgical Procedures conditions: Congenital Heart Disease in Children studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 300 type: ESTIMATED name: Iron status measure: Prevalence of preoperative iron deficiency (%) measure: Complications sex: ALL maximumAge: 16 Years stdAges: CHILD facility: H.U.B - Hôpital Universitaire des Enfants Reine Fabiola status: RECRUITING city: Brussels zip: 1020 country: Belgium name: Denis Schmartz, MD role: CONTACT phone: +3225553919 email: denis.schmartz@hubruxelles.be lat: 50.85045 lon: 4.34878 hasResults: False

 nctId: NCT06276595 id: IRB00009466 briefTitle: Telling Our Daughters Our Story acronym: TODOS overallStatus: ACTIVE_NOT_RECRUITING date: 2019-03-30 date: 2022-03-22 date: 2024-07-30 date: 2024-02-26 date: 2024-02-26 name: Johns Hopkins Bloomberg School of Public Health class: OTHER name: White Mountain Apache Tribe name: Native American Research Centers for Health briefSummary: The objective of this research study is to evaluate a culturally grounded program among American Indian (AI) female children and the children's female caregivers. This project will evaluate the impact of "Nowhi Isdza bit Nadagoldi: Telling Our Daughters Our Story (henceforth referred to as TODOS) on associated risk and protective factors for early substance use and sexual debut through a randomized controlled trial on the White Mountain Apache (WMA) reservation. The investigators will examine whether the TODOS program effectively reduces risk factors and improves protective factors associated with early substance use and sexual debut, with long term goals of reducing teen pregnancy and teen substance use. conditions: Substance Use conditions: Sexual Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 183 type: ACTUAL name: Nowhi Isdza bit Nadagoldi: Telling Our Daughters Our Story (TODOS) name: Control condition - 3 Monthly Group Activities in the Community measure: Change in child cultural knowledge score on knowledge assessment measure: Change in average score on risky behaviors assessment measure: Change in child reproductive health knowledge via a reproductive health knowledge questionnaire sex: FEMALE minimumAge: 8 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: White Mountain Apache Center for Indigenous Health city: Whiteriver state: Arizona zip: 85941 country: United States lat: 33.83699 lon: -109.96427 hasResults: False

 nctId: NCT06276582 id: 519379-2 briefTitle: Screening for Neonatal Jaundice With a Mobile Health Device: a Validation Study in Oaxaca, Mexico. overallStatus: RECRUITING date: 2023-01-17 date: 2024-05-31 date: 2024-05-31 date: 2024-02-26 date: 2024-02-26 name: Norwegian University of Science and Technology class: OTHER name: Picterus AS name: Instituto Mexicano del Seguro Social briefSummary: The performance and accuracy of the smartphone application (app) Picterus Jaundice Pro (PicterusJP) will be validated by a cross-sectional study conducted in low resource settings in Mexico. Physics-based and machine learning-based models will be used to analyze the images obtained with the app and its performance will be compared. conditions: Jaundice, Neonatal studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 150 type: ESTIMATED name: Screening for neonatal jaundice with a mobile health device measure: Enable high qualitative estimation of bilirubin levels in the blood of Mexican newborns using Picterus JP measure: Correlation between bilirubin measurements with Picterus JP and total serum bilirubin measure: Accuracy of Picterus JP to screen for neonatal jaundice sex: ALL minimumAge: 1 Day maximumAge: 14 Days stdAges: CHILD facility: Hospital General de Zona 1 status: RECRUITING city: Oaxaca zip: 68040 country: Mexico name: Rey Manuel Silva Mendez role: CONTACT phone: +529511283520 email: reymsilvam@gmail.com lat: 17.06542 lon: -96.72365 hasResults: False

 nctId: NCT06276569 id: 2023-LCYJ-MS-26 briefTitle: Efficacy and Safety of Sivelestat in Preventing Postoperative Acute Respiratory Distress Syndrome After Cardiac Surgery :a Single Centre Random Control Trial. overallStatus: NOT_YET_RECRUITING date: 2024-02-18 date: 2026-06-30 date: 2026-12-31 date: 2024-02-26 date: 2024-02-28 name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School class: OTHER briefSummary: The aim of this study is to assess the effectiveness and safety of sivelestat sodium in preventing acute respiratory distress syndrome (ARDS) following cardiac surgery, with the objective of providing evidence-based support for its clinical application. conditions: Cardiac Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 384 type: ESTIMATED name: Sivelestat name: placebo measure: Oxygenation index measure: Inflammatory index measure: Myocardial injury marker measure: Acute physiology and chronic health evaluation(APACHE II) socre measure: Murray socre measure: ICU time measure: In-hospital time measure: 30-day all-cause mortality measure: 90-day all-cause mortality sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06276556 id: ABP-671-302 briefTitle: Extension Study of ABP-671 in Participants With Gout overallStatus: ENROLLING_BY_INVITATION date: 2024-04-22 date: 2025-07-02 date: 2025-07-02 date: 2024-02-26 date: 2024-02-26 name: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: The primary objectives of this study are to assess the safety, tolerability, and efficacy of ABP-671 in lowering serum uric acid (sUA) in participants with gout who roll over from Study ABP-671-301 after they complete the double-blind 28-week Treatment Period of Part 1 (Phase 2b) or Part 2 (Phase 3). conditions: Gout studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 580 type: ESTIMATED name: ABP-671 name: Allopurinol measure: Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L) measure: Incidence of treatment-emergent adverse events (Safety and Tolerability) measure: Proportion of participants who achieve sUA levels <5.0 mg/dL (<0.300 mmol/L) sex: ALL minimumAge: 19 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alliance for Multispecialty Research city: Tempe state: Arizona zip: 85281 country: United States lat: 33.41477 lon: -111.90931 facility: Tucson Neuroscience Research, LLC city: Tucson state: Arizona zip: 85710 country: United States lat: 32.22174 lon: -110.92648 facility: Anaheim Clinical Trials (Cenexel ACT) city: Anaheim state: California zip: 92801 country: United States lat: 33.83529 lon: -117.9145 facility: Center for Clinical Trials of Sacramento city: Sacramento state: California zip: 95823 country: United States lat: 38.58157 lon: -121.4944 facility: Access Research Institute city: Brooksville state: Florida zip: 34613 country: United States lat: 28.55554 lon: -82.38991 facility: Nature Coast Clinical Reasearch city: Crystal River state: Florida zip: 34429 country: United States lat: 28.90248 lon: -82.5926 facility: JY Research Institute Inc. city: Cutler Bay state: Florida zip: 33189 country: United States lat: 25.5783 lon: -80.3377 facility: Accel Clinical Research Site city: DeLand state: Florida zip: 32720 country: United States lat: 29.02832 lon: -81.30312 facility: Jacksonville Center for Clinical Research city: Jacksonville state: Florida zip: 32216 country: United States lat: 30.33218 lon: -81.65565 facility: A & D Doctor Center city: Miami state: Florida zip: 33135 country: United States lat: 25.77427 lon: -80.19366 facility: Bioclinical Research Alliance city: Miami state: Florida zip: 33155 country: United States lat: 25.77427 lon: -80.19366 facility: Cordova Research Institute city: Miami state: Florida zip: 33155 country: United States lat: 25.77427 lon: -80.19366 facility: Century Research LLC city: Miami state: Florida zip: 33173 country: United States lat: 25.77427 lon: -80.19366 facility: ITB Research city: Miami state: Florida zip: 33173 country: United States lat: 25.77427 lon: -80.19366 facility: Combined Research Orlando Phase I-IV city: Orlando state: Florida zip: 32807 country: United States lat: 28.53834 lon: -81.37924 facility: New Horizons Research city: Palmetto Bay state: Florida zip: 33158 country: United States lat: 25.62177 lon: -80.32477 facility: Advanced Clinical Research of Atlanta city: Atlanta state: Georgia zip: 30309 country: United States lat: 33.749 lon: -84.38798 facility: Centricity Research city: Columbus state: Georgia zip: 31904 country: United States lat: 32.46098 lon: -84.98771 facility: Alliance for Multispecialty Research, LLC. city: Newton state: Kansas zip: 67114 country: United States lat: 38.04668 lon: -97.34504 facility: DelRicht Research city: New Orleans state: Louisiana zip: 70115 country: United States lat: 29.95465 lon: -90.07507 facility: AMR city: New Orleans state: Louisiana zip: 70119 country: United States lat: 29.95465 lon: -90.07507 facility: Annapolis Internal Medicine/CCT Research city: Annapolis state: Maryland zip: 21401 country: United States lat: 38.97845 lon: -76.49218 facility: DelRicht Research of Gulfport city: Gulfport state: Mississippi zip: 39501 country: United States lat: 30.36742 lon: -89.09282 facility: Quality Clinical Research, Inc city: Omaha state: Nebraska zip: 68114 country: United States lat: 41.25626 lon: -95.94043 facility: Santa Rosa Medical Center city: Las Vegas state: Nevada zip: 89119 country: United States lat: 36.17497 lon: -115.13722 facility: Inspire Santa Fe Medical Group city: Santa Fe state: New Mexico zip: 87505 country: United States lat: 35.68698 lon: -105.9378 facility: OnSite Clinical Solutions city: Salisbury state: North Carolina zip: 28144 country: United States lat: 35.67097 lon: -80.47423 facility: Altoona Center for Clinical Research city: Duncansville state: Pennsylvania zip: 16635 country: United States lat: 40.42341 lon: -78.4339 facility: ClinSearch city: Chattanooga state: Tennessee zip: 37421 country: United States lat: 35.04563 lon: -85.30968 facility: Medical Care/CCT city: Elizabethton state: Tennessee zip: 37643 country: United States lat: 36.34872 lon: -82.21069 facility: PanAmerican Clinical Research, LLC city: Brownsville state: Texas zip: 78520 country: United States lat: 25.90175 lon: -97.49748 facility: Quality Research Inc. city: San Antonio state: Texas zip: 78209 country: United States lat: 29.42412 lon: -98.49363 facility: Worldwide Clinical Trials city: San Antonio state: Texas zip: 78217 country: United States lat: 29.42412 lon: -98.49363 facility: Paratus Clinical Research Western Sydney city: Blacktown state: New South Wales zip: 2148 country: Australia lat: -33.76667 lon: 150.91667 facility: Emeritus Research Sydney city: Botany state: New South Wales zip: 2019 country: Australia lat: -33.94599 lon: 151.19591 facility: Paratus Clinical Research Central Coast city: Kanwal state: New South Wales zip: 2259 country: Australia lat: -33.253 lon: 151.4911 facility: A R Houston Medical Pty Ltd city: Kippa-Ring state: Queensland zip: 4021 country: Australia lat: -27.22586 lon: 153.0835 facility: Emeritus Research Melbourne city: Camberwell state: Victoria zip: 3124 country: Australia lat: -37.84205 lon: 145.0694 facility: Austin Health - Repatriation Hospital city: Heidelberg state: Victoria zip: 3084 country: Australia lat: -37.75 lon: 145.06667 facility: New Hospitals city: Tbilisi zip: 0114 country: Georgia lat: 41.69411 lon: 44.83368 facility: Evex Hospitals Caraps Medline city: Tbilisi zip: 0159 country: Georgia lat: 41.69411 lon: 44.83368 facility: Aversi Clini city: Tbilisi zip: 0160 country: Georgia lat: 41.69411 lon: 44.83368 facility: The First Medical Center city: Tbilisi zip: 0180 country: Georgia lat: 41.69411 lon: 44.83368 facility: Academician Vakhtang Bochorishvili Clinic city: Tbilisi zip: 0186 country: Georgia lat: 41.69411 lon: 44.83368 facility: Innova city: Tbilisi zip: 0186 country: Georgia lat: 41.69411 lon: 44.83368 facility: Clinical Research Center (CRC) city: C.p. zip: 01010 country: Guatemala facility: Clínica Médica Especializada en Medicina Interna y Reumatología (CREER) city: C.p. zip: 01010 country: Guatemala facility: Clínica Médica Especializada en Medicina Interna y Reumatología city: C.p. zip: 01010 country: Guatemala facility: Clínica Médica Especializada en Medicina Interna city: C.p. zip: 01010 country: Guatemala facility: Buddhist Dalin Tzu Chi General Hospital city: Chiayi City zip: 62247 country: Taiwan lat: 23.47917 lon: 120.44889 facility: Chang Gung Memorial Hospital CGMH city: Kaohsiung City zip: 833 country: Taiwan lat: 22.61626 lon: 120.31333 facility: Chung Shan Medical Univ. Hospital city: Taichung zip: 402367 country: Taiwan lat: 24.1469 lon: 120.6839 facility: Cheng-Shin General Hospital city: Taipei City zip: 112401 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Chang Gung Memorial Hospital LinKou city: Taoyuan zip: 333423 country: Taiwan lat: 24.95233 lon: 121.20193 hasResults: False

 nctId: NCT06276543 id: C-BSEAL-002 briefTitle: Bactiseal Catheter Safety Registry Study overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-07-31 date: 2026-12-31 date: 2024-02-26 date: 2024-04-19 name: Integra LifeSciences Corporation class: INDUSTRY briefSummary: Research Purpose:

This study aims to continuously evaluate the safety of subjects implanted with a catheter (trade name: Bactiseal) produced by Integra LifeSciences Production Corporation. Device safety will be assessed based on all the adverse events that occurred within 2 years after implanted the catheter.

Research Design:

This study is designed to be single arm, multi-center, and retrospective. A total of 200 subjects will be retrospectively enrolled. Information will be collected on adverse events, including bacterial culture and drug resistance testing when infection (if done), of subjects enrolled within 2 years after the implantation of the Bactiseal Catheter between January 01, 2019 and June 30, 2022.

The following information will be collected from subjects' medical records or hospitals' databases (if any):

1. General condition of the subjects (including previous shunting and external drainage operation)
2. Intraoperative condition and catheter implantation
3. Information on the shunt catheters
4. Adverse events of subjects within 2 years after the operation and classification of the adverse events (except anticipated adverse events listed in section 8.1.2)
5. Relevant examinations in case of postoperative infection, including bacterial culture and drug resistance testing (if done) conditions: Hydrocephalus studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 200 type: ESTIMATED name: antibiotic-impregnated catheter measure: Infection outcome measure: Safety outcome sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Children's Hospital, Capital Medical University city: Beijing state: Beijing zip: 100045 country: China name: Hailang Sun, MD role: CONTACT phone: 0086-10-59616408 email: et2007yy@163.com lat: 39.9075 lon: 116.39723 facility: Xuanwu Hospital, Capital Medical University city: Beijing state: Beijing zip: 100053 country: China name: Ning Wang, MD role: CONTACT phone: 010-83198899 lat: 39.9075 lon: 116.39723 facility: Beijing Hospital city: Beijing state: Beijing zip: 100730 country: China name: Cheng Sha, MD role: CONTACT phone: 0086-10-85132266 email: bjshacheng@163.com lat: 39.9075 lon: 116.39723 facility: Guangzhou Women and Children Medical Center city: Guangzhou state: Guangdong zip: 510623 country: China name: Fangcheng Li, MD role: CONTACT phone: 020-81886332 lat: 23.11667 lon: 113.25 facility: Guangdong Province People Hospital city: Guangzhou state: Guangdong zip: 519041 country: China name: Feng Wang, MD role: CONTACT phone: 0086 20 83827812 lat: 23.11667 lon: 113.25 facility: Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430030 country: China name: Ting Lei, MD role: CONTACT phone: 0086 27 83662688 lat: 30.58333 lon: 114.26667 facility: Shanghai Children's Medical Center affiliated to Shanghai Jiaotong University School of Medicine city: Shanghai state: Shanghai zip: 200127 country: China name: Nan Bao, MD role: CONTACT phone: 0086-21-38626161 email: baonan@scmc.com.cn lat: 31.22222 lon: 121.45806 facility: West China Hospital of Sichuan University city: Chengdu state: Sichuan zip: 610041 country: China name: Jianguo Xu, MD role: CONTACT phone: 0086 28 85422114 lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06276530 id: APHP231036 briefTitle: Impact of Surgical Approach on Adaptation of Posture-respiratory Coupling acronym: VaPosVent overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-02 date: 2025-03 date: 2024-02-26 date: 2024-02-26 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: This study aims to identify physiopathologic mechanisms related to surgical approaches during lobectomies for non-small cell lung cancer which can explain the better quality of life and the decrease of of post-operative complications in minimally invasive techniques (video-assisted thoracic surgery and robotic-assisted thoracic surgery) compared to conventional thoracotomy. conditions: Resectable Lung Non-Small Cell Carcinoma studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 50 type: ESTIMATED name: EOS imaging for musculoskeletal disorder name: Movement analysis by an optoelectronic camera. name: Stabilometric measurement by strength platform measure: Thoracic kyphosis (T1- T12 angle) and vertical alignment head-pelvis and head- C7 vertebra (angle OD-HA and OD-C7) (EOS) measure: Width of rib cage (EOS) measure: Rib cage volume (EOS) measure: " Umbrella "angle (EOS) measure: Center of Pressure displacement (Optoelectronic system) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Thoracic and Vascular Surgery Tenon University Hospital city: Paris zip: 75020 country: France name: Harry ETIENNE, M.D., PhD role: CONTACT phone: +33 6 67 96 82 89 email: h.etienne@hotmail.fr lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06276517 id: APHP220918 id: 2022-A01739-34 type: OTHER domain: IDRCB briefTitle: Hidden Impairments During Subarachnoid Haemorrhage Recovery, Description and Evolution of a Newly Described Syndrom acronym: HIDDEN overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2028-03 date: 2028-03 date: 2024-02-26 date: 2024-02-26 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Descriptive observational study in patients with spontaneous subarachnoid hemorrhage or following aneurysmal rupture to assess the presence of a post-HSA syndrome at 3 months, 6 months and 1 year, and its impact on functional outcome using the Rivermead questionnaire conditions: Intracranial Hemorrhages studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: questionnaire name: SS-QoL name: SF-36 name: CIQ-R name: BREFF name: MoCA name: IADL name: mMRS name: PCL-5 name: Brief-Cope measure: Evaluate the presence of post SAH syndrome at 3 months and its impact on return to work using the Rivermead Post-Concussion symptoms questionnaire (RPQ), and its impact on functional outcome. measure: - study the factors determining the presence of a post-HSA syndrome and an inability to return to work at 3 months, 6 months and 1 year measure: To study the prevalence of post-traumatic stress in this population measure: Study patients' coping strategies in relation to functional recovery using the Brief-Cope self-questionnaire sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06276504 id: APHP211001 id: 2023-503520-31-00 type: OTHER domain: EU CT number briefTitle: Pembrolizumab in Progressive Multifocal Leukoencephalopathy (PML) in Immunocompromised Patients Without HIV Infection acronym: PENALTY overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-04 date: 2028-04 date: 2024-02-26 date: 2024-02-26 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: This study aims to assess the efficacy and safety of pembrolizumab in immunocompromised patients with progressive multifocal leukoencephalopathy (PML). This phase II, multicenter, single-arm study includes patients with an underlying cause of immunosuppression hardly reversible, i.e. not the patients with HIV nor those receiving biologics for chronic inflammatory diseases. Patients will receive intravenous pembrolizumab (2 mg/kg, maximum 200 mg) at month 0, 1 and 2 (total of three doses). The primary endpoint will be achieving at least one negative result of JCV viral load in cerebrospinal fluid (CSF) within the M0 to M3 period. conditions: Progressive Multifocal Leukoencephalopathy studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 33 type: ESTIMATED name: Pembrolizumab, 25 mg/ml solution for intravenous (IV) injection measure: Negativation of JCV viral load in the CSF as assessed by PCR: at least one JCV PCR in the CSF negative in the Day 0 to Month 3 period measure: Negativation of JCV PCR viral load in the CSF: cumulative incidence of negative JCV viral load measures by PCR in CSF, with death as competing event measure: Evolution of the JCV viral load in the CSF (repeated measures JCV PCR in CSF) measure: Repositivation of JCV PCR: at least a positive result following at least a negative result measure: Evolution of National Institutes of Health Stroke Scale (NIHSS) score measure: Evolution of 6-item Modified Rankin Scale score (includes death as most severe state) measure: Evolution of Glasgow Outcome Scale Extended (GOS-E) score measure: Relapse or progression measure: Death (and date of death) measure: Cause specific death: death related to PML measure: Any adverse event classified by using US NCI CTCAE sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Pitié-Salpêtrière - Médecine Intensive Réanimation city: Paris zip: 75013 country: France name: Nicolas WEISS, Pr role: CONTACT phone: +33 (0)1 42 16 27 70 email: nicolas.weiss@aphp.fr lat: 48.85341 lon: 2.3488 facility: Hôpital Pitié-Salpêtrière - Service d'hématologie clinique city: Paris zip: 75013 country: France name: Damien ROOS-WEIL, Dr role: CONTACT phone: +33 (0)1 42 16 15 96 email: damien.roosweil@aphp.fr lat: 48.85341 lon: 2.3488 facility: Hôpital Pitié-Salpêtrière - Service des Maladies infectieuses et tropicales city: Paris zip: 75013 country: France name: Valérie POURCHER, Pr role: CONTACT phone: +33 (0)1 42 16 02 62 email: valerie.martinez@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06276491 id: XmAb541-01 briefTitle: Phase 1, Safety and Tolerability Study of XmAb®541 in Advanced Solid Tumors overallStatus: RECRUITING date: 2024-04-04 date: 2027-12 date: 2028-12 date: 2024-02-26 date: 2024-04-18 name: Xencor, Inc. class: INDUSTRY briefSummary: The primary purpose of this study is to determine whether the investigational drug XmAb541 is safe and well tolerated, and to determine an optimal and safe dose(s) for further study. The study will also evaluate effect of XmAb541 on tumor outcomes. conditions: Ovarian Cancer conditions: Endometrial Cancer conditions: Germ Cell Tumor conditions: Testicular Germ Cell Tumor conditions: Ovarian Germ Cell Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: Dose escalation and expansion study primaryPurpose: TREATMENT masking: NONE count: 212 type: ESTIMATED name: XmAb541 measure: Incidence of Adverse Events measure: Incidence of dose-limiting toxicities (DLTs) measure: Incidence of cytokine release syndrome (CRS) measure: Measurement of Cmax measure: Measurement of area under curve (AUC) measure: Measurement of Ctrough measure: Objective Response Rate measure: Duration of Response measure: Changes in Circulating Tumor DNA (ctDNA) sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Montefiore Einstein Comprehensive Cancer Center status: RECRUITING city: Bronx state: New York zip: 10461 country: United States lat: 40.84985 lon: -73.86641 hasResults: False

 nctId: NCT06276478 id: 2024-PEDOAI briefTitle: Positive Psychological Deconditioning of Pediatric Patients With Dental Anxiety Through Artificial Intelligence overallStatus: ENROLLING_BY_INVITATION date: 2024-03-04 date: 2024-06 date: 2024-06 date: 2024-02-26 date: 2024-03-07 name: University of Pavia class: OTHER briefSummary: Pediatric patients who will be attending dental treatment at both the Orthodontics and Pediatric Dentistry Unit, Department of Clinical, Surgical, Diagnostic, and Pediatric Sciences at the University of Pavia, Pavia, Italy and a private dental practice in Genoa, Italy, will be recruited for the study.

A cartoon version of a small molar will be drawn using the software Paint (version 22000.0, Microsoft Corporation, Redmond, Washington State, U.S.). The drawing will be animated using an AI-based software (Sketch MetaDemolab, Meta AI Research, Astor Place, New York city, New York, U.S.). A text will be created in collaboration with OpenAI (version 3.5, Open AI, San Francisco, California, U.S.) to be integrated into the video, utilizing terminology deemed most suitable for a patient with dental anxiety. The text will be transformed from written to spoken dialogue using an AI-based software (Flexclip, version 5.6.0, PearlMountain, Hong Kong, China), and then incorporated into the video.

Children will undergo the first dental visit at the baseline (T0), in which the following indexes will be assessed: Modified Dental Anxiety Scale (MDAS), Face-Leg-Activity-Cry-Consolability Scale (FLACC), Simplified Oral Hygiene Index (OHI-S), Bleeding on Probing (BOP) and the International Caries Detection and Assessment System (ICDAS). They will be randomly divided into two group:

* in the Trial group, patients will watch the the video, and then the tell-show-do technique will be used to explain the dental procedures;
* in the Control group, only the "tell-show-do" technique will be used. Variables considered will include age, gender, and the presence/absence of a parent or another companion.

At the second visit (T1), scheduled approximately after two weeks, the variables will be re-evaluated and professional debridement will be performed with a piezoelectric instrument (Satelect Acteon Newton p5 xs,Acteon Group, Mèrignac, France and Sonicflex Kavo, KaVo Dental, Biberach an der Riss, Germany) and manual scaler/curettes (Courette 9/10, 11/12 and 13/14 Gracey and Scaler lm 23, Hu Friedy, Europe). Values will be registered again, for the third time, after the professional debridement. conditions: Dental Anxiety conditions: Dental Phobia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 42 type: ESTIMATED name: AI-video name: Verbal instructions measure: Change in Modified Dental Anxiety Scale - MDAS (Humphris GM et al. 1995) measure: Change in Face, Leg, Activity, Cry, Consolability Scale - FLACC (Merkel, S. I. et al., 1997) measure: Change in Bleeding on Probing - BoP (Löe H. et al.,1967) measure: Change in Simplified Oral Hygiene Index - OHI-S (Greene JC et al, 1964) measure: International Caries Detection and Assessment System - ICDAS sex: ALL minimumAge: 4 Years maximumAge: 8 Years stdAges: CHILD facility: Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia city: Pavia state: Lombardy zip: 27100 country: Italy lat: 45.19205 lon: 9.15917 hasResults: False

 nctId: NCT06276465 id: UC-GTG-2306 id: 2023-507482-26-00 type: OTHER domain: EU-CT briefTitle: Treatment With Darolutamide +/- Radiation Therapy for Patients With a Castration Resistant Cancer and Metastases Detected by Functional Imaging acronym: PEACE8 overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2024-07-01 date: 2032-07-01 date: 2024-02-26 date: 2024-02-26 name: UNICANCER class: OTHER name: Bayer briefSummary: In earlier stages of prostate cancer, male sexual hormones (androgens) stimulate the growth of cancer cells. Castration-resistant prostate cancer (CRPC) means that the prostate cancer continued to grow despite patients are taking hormone therapy to control the disease. One of the standard treatments for these patients is so-called 'new generation' hormonal therapy. These hormone therapies include apalutamide, enzalutamide, or darolutamide. They work by blocking androgen receptors that play an important role in the growth of prostate cancer.

In the case of oligometastatic CRPC, the cancer has gone beyond the prostate and has spread to other organs in the body (metastases), but these metastases remain limited in number.

An early detection of the oligometastatic CRPC and appropriate treatment may prolong survival in these patients.

The treatment proposed as part of this research is a combination of oral darolutamide, approved in Europe to treat patients with CRPC who do not have metastasis visible on CT-scan or bone scintigraphy (but visible with positron emission tomography-scan (PET-Scan), a more precise imaging technique) with stereotactic body radiotherapy (SBRT), a new radiotherapy technique guided by very high precision medical imaging. This method makes it possible to better target cancer cells while preserving neighboring healthy organs.

The principal objective of this trial is to evaluate the efficacy of the combination of SBRT with darolutamide, compared to darolutamide. conditions: Prostatic Cancer, Castration-Resistant studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Eligible patients will be randomly allocated in a 1:1 ratio to either the:

* Control arm: ADT + darolutamide.
* Experimental arm: ADT + darolutamide + SBRT. primaryPurpose: TREATMENT masking: NONE count: 336 type: ESTIMATED name: Darolutamide 300 mg name: Stereotactic body radiation therapy name: Androgen deprivation therapy measure: Radiographic Progression-free survival (rPFS) measure: Time to treatment failure (TTF) measure: Overall survival (OS) measure: Prostate cancer-specific survival measure: Time to PSA progression measure: Biochemical response rate measure: Time to next symptomatic skeletal event (SSE) measure: Time to pain progression measure: Safety/tolerance measure: Functional Assessment of CAncer Therapy - Prostate (FACT-P) measure: Brief Pain Inventory - Short Form (BP-SFI) questionnaire sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06276452 id: 23.0434 id: U2CDA050097 type: NIH link: https://reporter.nih.gov/quickSearch/U2CDA050097 briefTitle: Supporting Resilience Among Re-entered Seniors acronym: SRRS overallStatus: RECRUITING date: 2024-03-09 date: 2024-11-30 date: 2024-11-30 date: 2024-02-26 date: 2024-03-15 name: University of Louisville class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: The first goal (Aim 1) of this clinical trial is to learn about specific strengths, challenges, and desired areas of knowledge and skill-building among older adults who re-entered their communities from a period of incarceration and to then develop a new psychoeducational intervention tailored to these older adults. The second goal (Aim 2) of this clinical trial is to test if the intervention increases chronic disease management and whether the intervention is considered appropriate and acceptable by older adults who re-entered their communities from a period of incarceration.

Aim 1 participants will:

* complete a baseline survey
* participate in a focus group

Aim 2 participants will:

* complete a baseline survey
* participate in an 8-week once weekly intervention
* complete three follow up surveys conditions: Chronic Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 8 type: ESTIMATED name: Psychoeducation measure: Chronic disease self managment sex: MALE minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: New Legacy Reentry status: RECRUITING city: Louisville state: Kentucky zip: 40203 country: United States name: Stephanie Grace Prost, PhD role: CONTACT email: stephanie.prost@louisville.edu lat: 38.25424 lon: -85.75941 hasResults: False

 nctId: NCT06276439 id: IRB23-0314 briefTitle: Intraoperative Imaging of Lymph Nodes overallStatus: RECRUITING date: 2024-02-19 date: 2025-03-30 date: 2026-02-19 date: 2024-02-26 date: 2024-02-26 name: University of Illinois at Urbana-Champaign class: OTHER name: U.S. National Science Foundation name: Ss. Cyril and Methodius University of Skopje, Macedonia briefSummary: One-third of the global population battles cancer, with surgery being the primary treatment for localized forms. Successful treatment often hinges on the thorough removal of primary tumors and pinpointing cancerous sentinel lymph nodes (SLN). Although modern surgical imaging and fluorescent probes enhance the detection of sentinel lymph nodes using near-infrared (NIR) fluorescence, their inability to precisely determine the nodes' status can result in additional surgeries, lymphedema, and a reduced quality of life for patients. Our research direction aims to harness the potential of bioinspired imaging technologies with the goal of precisely identifying SLN status and ensuring only the cancerous lymph nodes are excised during the initial procedure. To realize this objective, we're drawing inspiration from the mantis shrimp's visual system to create a single-chip multispectral camera that spans the deep ultraviolet to the near-infrared spectrum. Our pioneering sensor seamlessly combines perovskite nanocrystals, optical filters, and vertically-aligned photodetectors on a single chip, enabling concurrent imaging of external NIR fluorophores and internal UV fluorescence from tumor-specific markers. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 48 type: ESTIMATED name: Surgical removal of breast cancer and lymph nodes measure: Positive lymph node detection with custom sensors sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Clinic Hospital status: RECRUITING city: Skopje zip: 1000 country: North Macedonia name: Viktor Gruev, PhD role: CONTACT phone: +1.267.847.4020 email: vgruev@illinois.edu name: Goran Kondov, MD, PHD role: CONTACT phone: +389 70 252010 email: kondov@yahoo.com lat: 41.99646 lon: 21.43141 hasResults: False

 nctId: NCT06276426 id: 24468 briefTitle: Plants Optimizing Development Study (PODS) acronym: PODS overallStatus: RECRUITING date: 2024-03-18 date: 2026-09-30 date: 2026-09-30 date: 2024-02-26 date: 2024-04-17 name: University of Illinois at Urbana-Champaign class: OTHER name: Soy Nutrition Institute briefSummary: This study aims to conduct a randomized clinical trial to measure the effects of a 3-month daily mixed-soy food intervention vs. a control group receiving isocaloric foods on reproductive hormones, body composition, metabolic risk, fecal microbiota, and cognition among 8-11-year-old children. Additionally, this study will assess soy food intake immediately following participation in the clinical trial to determine changes in soy food acceptance in children. conditions: Healthy Children studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 96 type: ESTIMATED name: Soy foods name: Non-Soy Plant-Based Foods measure: Sex steroid excretion measure: Gut microbiota measure: Attentional Accuracy measure: Attentional Reaction Time measure: Hippocampal-dependent Relational memory measure: Body Composition measure: Metabolic Markers measure: Pubertal Staging measure: Cognitive Abilities and Academic Achievement sex: ALL minimumAge: 8 Years maximumAge: 11 Years stdAges: CHILD facility: University of Illinois status: RECRUITING city: Urbana state: Illinois zip: 61801 country: United States name: Naiman Khan, PhD, RD role: CONTACT phone: 217-300-2197 email: nakhan2@illinois.edu name: Naiman Khan, PhD, RD role: PRINCIPAL_INVESTIGATOR lat: 40.11059 lon: -88.20727 hasResults: False

 nctId: NCT06276413 id: REBRA id: REBRA type: REGISTRY domain: REBRA briefTitle: REgistRy BRAnch goRE EndopRosthEsis acronym: REBRA overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-12-31 date: 2030-12-31 date: 2024-02-26 date: 2024-02-26 name: University Hospital Padova class: OTHER briefSummary: Multicenter registry on patients treated by the new Gore thoracic branched endoprosthesis conditions: Aortic Aneurysm, Thoracic conditions: Aortic Dissection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: GORE TAG Thoracic Branch Endoprosthesis measure: early mortality measure: device stability measure: technical success measure: early major adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vascular and Endovascular Clinic - Padova University city: Padova zip: 35020 country: Italy name: Michele Piazza, Pr role: CONTACT phone: 3498644688 email: michele.piazza@unipd.it lat: 45.40797 lon: 11.88586 hasResults: False

 nctId: NCT06276400 id: 4-24-0023:1 briefTitle: LPFC Organization in Emotion-Duration Difference Estimation overallStatus: RECRUITING date: 2024-01-29 date: 2028-03-31 date: 2028-03-31 date: 2024-02-26 date: 2024-03-05 name: University of California, Santa Barbara class: OTHER briefSummary: To support optimal behavior in daily life, goals and responses following emotional events should ideally incorporate not only the valence and intensity of prior emotional episodes but also their temporal features, such as the relative duration of positive vs. negative attributes. However, how specific brain regions contribute to the integration of temporal and emotional information and promote goal-directed response remains unknown.

The goal of this study is to examine how specific brain regions track both emotional and temporal information of dynamic emotional events to inform other related brain regions to guide goal-oriented and context-appropriate actions. The investigators will scan healthy human participants using functional MRI (fMRI) while they view emotional image sequences and track the associated emotional and temporal (duration) information, and act accordingly. The investigators will employ multivariate patterns analysis and pattern similarity analysis to identify brain regions that represent (can decode) emotion, time, and their combined signals, as well as brain regions that represent the associated action goal. In addition, to infer the causal contributions of these brain regions in forming task-relevant representations (emotion, time, and action goal), the same participants will be recruited to receive transcranial magnetic stimulation (TMS) in these regions. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a basic science study in which all participants will participate in all task conditions within each experiment (repeated-measures design). primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: Participants will typically be unaware of the conditions presented, though because these involve manipulations of stimuli or task demands, they may be aware of the manipulation. This is not expected to impact the primary outcome measures (e.g., BOLD signal activation patterns). count: 50 type: ESTIMATED name: Emotion valence name: Time name: TMS Stimulation measure: Multivariate BOLD metrics measure: Behavioral response sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: University of California, Santa Barbara status: RECRUITING city: Santa Barbara state: California zip: 93106 country: United States lat: 34.42083 lon: -119.69819 hasResults: False

 nctId: NCT06276387 id: K23AT011768-01 type: NIH link: https://reporter.nih.gov/quickSearch/K23AT011768-01 id: K23AT011768 type: NIH link: https://reporter.nih.gov/quickSearch/K23AT011768 briefTitle: Defining Stress REsilience And Mindfulness Effects in Rheumatoid Arthritis acronym: DREAMER overallStatus: RECRUITING date: 2024-01-26 date: 2025-12 date: 2025-12 date: 2024-02-26 date: 2024-02-26 name: University of California, San Francisco class: OTHER name: National Center for Complementary and Integrative Health (NCCIH) briefSummary: This clinical trial will test a mindfulness program in individuals with rheumatoid arthritis (RA). The main goals of this pilot study are to:

* Assess patient satisfaction with a mindfulness course
* Identify barriers to participation in, or completion of, a mindfulness course
* Gather initial information to understand how a mindfulness course impacts RA symptoms

Participants will:

* Complete online questionnaires
* Attend two in-person study visits, involving a brief joint exam and blood draw
* Roughly half the participants will have the chance to participate in an 8-week online mindfulness course
* Roughly half the participants will be invited to participate in an online focus group following completion of the mindfulness course

Researchers will compare those in the mindfulness course with those receiving standard care in preparation for a larger future study to see how mindfulness impacts stress and inflammation in individuals with RA. conditions: Arthritis, Rheumatoid studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomly assigned to participate in a mindfulness-based stress reduction (MBSR) course or treatment as usual (TAU). Randomization will be done using a program-tracking system. primaryPurpose: OTHER masking: DOUBLE maskingDescription: Physicians completing joint exams to assess clinical disease activity, including the principal investigator, will be blinded to participant assignment. It will not be possible for participants to be blinded to treatment condition. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Mindfulness Program measure: Patient Satisfaction as Assessed by CSQ-8, Adapted for DREAMER Study measure: MBSR Course Attendance (Intervention Adherence) measure: Percent of Study Completers (Study Retention) measure: Clinical Disease Activity Index (CDAI) measure: Disease Activity Score in 28 Joints (DAS-28) measure: Modified Rheumatoid Arthritis Disease Activity Index, 5-item (RADAI-5) measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference, 4-Item Scale measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue, 4-Item Scale measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Global Mindfulness, 13-item Scale measure: Perceived Stress Scale, 10-item measure: Brief Resilience Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Osher Center for Integrative Health status: RECRUITING city: San Francisco state: California zip: 94115 country: United States lat: 37.77493 lon: -122.41942 hasResults: False

 nctId: NCT06276374 id: SMC 2023-12-107 briefTitle: Highest Efficacy of Dual Antiplatelet Therapy After Carotid Artery Stenting in High Bleeding Risk Patients overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-11-30 date: 2027-12-31 date: 2024-02-26 date: 2024-02-26 name: Woo-Keun Seo class: OTHER briefSummary: To compare the safety of dual antiplatelet therapy with aspirin and clopidogrel and single antiplatelet therapy administered from 30 days to 12 months following carotid artery stenting on clinically significant bleeding and its prevention effects on net clinical events including combined cardiovascular and cerebrovascular accidents and major bleeding events in patients with carotid artery disease who are at high bleeding risk. conditions: Carotid Artery Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 1556 type: ESTIMATED name: Patients who are scheduled to undergo carotid artery stenting measure: Clinically significant bleeding measure: Combined cardiovascular and cerebrovascular accidents sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06276361 id: ROV-QUAR-2023-01 briefTitle: Pharmacokinetics, Safety and Tolerability of Different Formulations and Dose Strengths of Quarterly Risperidone (QUAR) in Patients With Schizophrenia acronym: QUARTZ overallStatus: RECRUITING date: 2023-09-26 date: 2026-05 date: 2026-05 date: 2024-02-26 date: 2024-03-12 name: Rovi Pharmaceuticals Laboratories class: INDUSTRY briefSummary: This is a single ascending dose phase 1 study to evaluate the pharmacokinetics (PK), safety, and tolerability of a single intramuscular (IM) injection of quarterly Risperidone (QUAR) for different formulations and dose strengths in participants with schizophrenia. conditions: Schizophrenia studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Oral risperidone; QUAR F1/2, Dose 1 - Gluteal name: Oral risperidone; QUAR F1/2, Dose 2 - Gluteal name: Oral risperidone; QUAR F1/2, Dose 3 - Gluteal name: Oral risperidone; QUAR F1/2, Dose 3 - Deltoids measure: λz measure: t1/2 measure: Tmax measure: Cmax measure: Cmin measure: Clast measure: AUC0-t measure: AUCinf measure: AUCextrap measure: Vd/F measure: Cl/F sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Investigational Site status: RECRUITING city: Amman country: Jordan lat: 31.95522 lon: 35.94503 hasResults: False

 nctId: NCT06276348 id: 20226892 briefTitle: Newborn Genomic Sequencing Pilot Study overallStatus: ACTIVE_NOT_RECRUITING date: 2023-03-13 date: 2024-02-28 date: 2024-09 date: 2024-02-26 date: 2024-03-04 name: Rady Pediatric Genomics & Systems Medicine Institute class: OTHER briefSummary: The goal of this clinical trial is to test a new method for newborn screening using whole genome sequencing, called BeginNGS. Newborns who are not suspected of having genetic diseases and who are admitted to the NICU at Rady Children's Hospital, San Diego, will be enrolled. The main questions this study aims to answer are:

* What is the diagnostic yield of diagnostic whole genome sequencing (DWGS) in this population?
* What is the diagnostic sensitivity and specificity of BeginNGS and whole exome sequencing (WES) as compared to DWGS?
* What are the potential issues related to implementing DWGS in this population?

Enrolled newborns will have a blood sample taken and will receive three tests:

* DWGS
* BeginNGS
* WES conditions: Genetic Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single group, multiple interventions. All enrollees receive all interventions. primaryPurpose: SCREENING masking: NONE count: 120 type: ACTUAL name: Whole genome sequencing name: BeginNGS test name: WES measure: Proportion of enrolled infants who are diagnosed with a genetic disease by DWGS. measure: Proportion of enrolled infants who are identified with a genetic disease by BeginNGS. measure: Proportion of enrolled infants who are identified with a genetic disease by WES. measure: Proportion of enrolled infants who have a positive standard NBS test. measure: Proportion of parents approached who agree to participate in the study. measure: Parental reasons for refusal. measure: Time from sample arriving in lab to return of DWGS results. measure: Time from birth to return of DWGS results. measure: Results of confirmatory testing if BeginNGS or WES identifies a diagnostic finding not reported by DWGS. sex: ALL minimumAge: 1 Day maximumAge: 10 Days stdAges: CHILD facility: Rady Children's Hospital San Diego city: San Diego state: California zip: 92123 country: United States lat: 32.71533 lon: -117.15726 hasResults: False

 nctId: NCT06276335 id: IRAS:322440 briefTitle: Influence of Timing of Implant Placement on Early Healing Molecular Events overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2026-05-30 date: 2024-02-23 date: 2024-03-08 name: Queen Mary University of London class: OTHER name: University of Zurich briefSummary: Dental implants have been on the market for several years and they are routinely used to replace single/multiple missing teeth with a high success rate. However, there is still a limited number of studies comparing the influence of timing of implant placement on wound healing. In addition, there is no data available on the signaling pathways and the expression of healing biomarkers involved in the early stages of osseointegration after immediate implant placement (IP) or delayed implant placement (DP).

The primary objective of this study is to describe changes in the expression of inflammatory, angiogenesis and osseous biomarkers of saliva at 1, 3, 7, 15 and 30 days and of PICF at 3, 7, 15 and 30 days after immediate implant placement (IP) compared with delayed placement (DP). conditions: Dental Implant conditions: Healing Wound conditions: Biomarkers conditions: Saliva studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Immediate implant placement and guided bone regeneration (Test) name: Late implant placement and guided bone regeneration (Control) measure: Changes in the expression of inflammatory, angiogenesis and osseous biomarkers of PICF and saliva measure: Blood flow changes measure: Soft tissue volume changes measure: Peri-implant bone level measure: Full mouth plaque score (FMPS) measure: Full mouth bleeding score (FMBS) measure: Probing pocket depth (PPD) measure: Gingival recession (REC) measure: Clinical attachment level (CAL) measure: Suppuration measure: Patient satisfaction at 6 months after loading measure: Changes in the pink esthetic score (PES) measure: Changes in the white esthetic score (WES) measure: Changes in the papilla fill index (PFI) measure: Implant survival sex: ALL minimumAge: 25 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre for Oral Clinical Research city: London zip: E1 2AD country: United Kingdom name: Nikolaos Donos, DDS MS PhD role: CONTACT phone: +44(0)2078823063 email: BHNT.Clinicaloralresearchcentre@nhs.net name: Vandana Luthra, Dr role: CONTACT phone: +44(0)2078826348 email: BHNT.Clinicaloralresearchcentre@nhs.net name: Nikolaos Donos, DDS MS PhD role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06276322 id: HU-FTR-SZK-01 briefTitle: Assessment of All Spine Segments ın Individuals With Low Back Pain overallStatus: RECRUITING date: 2023-12-01 date: 2024-03-20 date: 2024-12-31 date: 2024-02-23 date: 2024-03-07 name: Hacettepe University class: OTHER briefSummary: The aim of the study is to evaluate the kinematics of all spine segments in 3 planes and compare them with asymptomatic controls using wearable technology while performing functional tasks that patients with chronic low back pain often describe as painful in their daily lives. conditions: Low Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Low back pain group and healthy group primaryPurpose: OTHER masking: NONE count: 46 type: ESTIMATED name: Low back pain group name: Healthy group measure: Evaluation of the kinematics of the all spine during walking measure: Evaluation of the kinematics of the all spine during Bending Forward and Lifting Objects measure: Evaluation of the kinematics of the all spine during Standing from Sitting measure: Evaluation of the kinematics of the all spine during Climbing Step measure: Spine Normal Joint Movement evaluation measure: Pain intensity: Visual Analog Scale measure: Oswestry Disability Index measure: Fear of movement: Tampa Kinesiophobia Scale sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Hacettepe university status: RECRUITING city: Ankara state: Altındağ zip: 06050 country: Turkey name: Sümeyye Zehra Güler, MSc role: CONTACT phone: 5079320390 phoneExt: +90 email: zhrkzlk1906@gmail.com lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06276309 id: NECC2401 briefTitle: Protein Molecular Characteristics and Prognosis of Cervical Neuroendocrine Tumors overallStatus: RECRUITING date: 2024-02-01 date: 2024-06-30 date: 2024-06-30 date: 2024-02-23 date: 2024-02-23 name: Fujian Maternity and Child Health Hospital class: OTHER briefSummary: The clinical diagnosis and treatment data of 300 cases of cervical neuroendocrine tumors were collected, including age, preoperative biopsy pathology results, postoperative histopathological results, TCT results, and colposcopy biopsy pathology results. At the same time, paraffin tissue specimens (remaining specimens after pathological diagnosis) from 100 cases of cervical neuroendocrine tumors from multiple centers across the country were collected to establish a cervical neuroendocrine tumor data follow-up database. Protein concentration and omics analysis were performed on the data results, to evaluate the molecular characteristics and prognosis of cervical neuroendocrine tumor proteins, and to preliminarily explore its clinical application value. conditions: Neuroendocrine Neoplasm conditions: China conditions: Women conditions: Cervical Cancer conditions: Cervical Lesion studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 300 type: ESTIMATED measure: mortality rate measure: Disease-free survival sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fujian Maternity and Child Health Hospital status: RECRUITING city: Fuzhou state: Fujian zip: 350001 country: China name: Binhua Dong role: CONTACT phone: +8687558732 email: dbh18-jy@126.com lat: 26.06139 lon: 119.30611 facility: Fujian Provincial Hospital status: RECRUITING city: Fuzhou state: Fujian country: China name: Dongjie Chen role: CONTACT lat: 26.06139 lon: 119.30611 facility: Ningde Mindong Hospital status: RECRUITING city: Ningde state: Fujian country: China name: Fang Xie role: CONTACT lat: 26.66167 lon: 119.52278 facility: Putian City first Hospital status: RECRUITING city: Putian state: Fujian country: China name: Yi Chen role: CONTACT lat: 25.43944 lon: 119.01028 facility: The Second Affiliated Hospital of Fujian Medical University status: RECRUITING city: Quanzhou state: Fujian country: China name: Luhong Li role: CONTACT lat: 24.91389 lon: 118.58583 facility: Zhangzhou affiliated Hospital of Fujian Medical University status: RECRUITING city: Zhangzhou state: Fujian zip: 363000 country: China name: Feifeng Shi, M.D role: CONTACT lat: 24.51333 lon: 117.65556 facility: Maternal and Child Health Hospital of Hubei Province status: RECRUITING city: Wuhan state: Hubei country: China name: Hongning Cai, M.D role: CONTACT phone: +8615926224867 lat: 30.58333 lon: 114.26667 facility: Xiangya Hospital, Central South University status: RECRUITING city: Changsha state: Hunan country: China name: Yu Zhang role: CONTACT lat: 28.19874 lon: 112.97087 facility: Jiangxi maternal and Child Health Hospital status: RECRUITING city: Nanchang state: Jiangxi country: China name: Ling Li role: CONTACT lat: 28.68396 lon: 115.85306 hasResults: False

 nctId: NCT06276296 id: 0001 briefTitle: Heart Rate Variability After Ablation overallStatus: RECRUITING date: 2023-03-01 date: 2024-08-31 date: 2024-10-01 date: 2024-02-23 date: 2024-02-23 name: Charles University, Czech Republic class: OTHER name: Vascular surgery, University hospital Královské Vinohrady, Prague briefSummary: Pulsed-field catheter ablation is a promising new treatment method for patients with atrial fibrillation. The mechanism of cell damage here is different from that of classic catheter ablation, in which the ganglion plexuses around the pulmonary veins are also damaged and thus changes in the autonomic nervous system occur. The aim of the work is to find out, using heart rate variability, whether the autonomic system is less affected during pulsed field ablation than in classic radiofrequency ablation. conditions: Atrial Fibrillation studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Holter EKG - 1 day before ablation name: Radiofrequency ablation name: Pulsed field ablation name: Holter EKG - 1 month after ablation measure: Mean RR interval (ms) measure: SDNN (ms) measure: RMSSD (ms) measure: pNN50 (%) measure: peak frequency (Hz) measure: power (ms2) measure: LF/HF ratio measure: SD1 (ms) measure: SD2 (ms) measure: SD2/SD1 measure: ApEn measure: Correlation dimension sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady status: RECRUITING city: Prague zip: 10034 country: Czechia name: Jana Vesela, Ing.,Ph.D. role: CONTACT phone: +420267162714 email: janca.zd@gmail.com name: Pavel Osmancik, MD,Ph.D. role: CONTACT phone: +420267162714 email: pavel.osmancik@fmail.com lat: 50.08804 lon: 14.42076 hasResults: False

 nctId: NCT06276283 id: DZ2022E0006 briefTitle: DZD9008 In Combination With Bevacizumab in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutation (WU-KONG29) overallStatus: RECRUITING date: 2023-02-15 date: 2025-05-31 date: 2026-02-28 date: 2024-02-23 date: 2024-02-23 name: Dizal Pharmaceuticals class: INDUSTRY briefSummary: This study tests a combination therapy (i.e., DZD9008 plus bevacizumab) in patients with advanced NSCLC harboring EGFR mutations who have progressed on or after standard of care, which aims to understand whether the combination therapy is safe, how well the combination therapy works, and how the body will process DZD9008 when used in combination with bevacizumab. conditions: Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: DZD9008 plus Bevacizumab measure: Part A: 1) Dose Limiting Toxicity (DLT); 2) Treatment-Emergent Adverse Events (TEAEs); TEAEs ≥CTCAE grade 3; and Serious Adverse Events (SAEs). Part B: 1) TEAEs; TEAEs ≥CTCAE grade 3; and SAEs. measure: Part A: 1) Tumor response per RECIST 1.1 and 2) Plasma concentration of DZD9008 and its metabolite. Part B:1) Tumor response per RECIST 1.1; 2) Intracranial tumor response per RECISIT 1.1; 3) Plasma concentration of DZD9008 and its metabolite. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Chest Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200030 country: China name: Lu, Dr role: CONTACT lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06276270 id: PT-MUC-1_05-21 briefTitle: Multi-centre, Open-label, First-in-man Study With Mucopad HA overallStatus: RECRUITING date: 2023-12-12 date: 2024-12-31 date: 2024-12-31 date: 2024-02-23 date: 2024-02-23 name: Contipro Pharma a.s. class: OTHER briefSummary: The device´s intended use is to treat defects and/or lesions of the oral mucosa, e.g. oral mucositis.To prove safety of the device in terms of clinical results. conditions: Oral Mucositis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Mucopad HA measure: Resolution of mucositis symptoms since completion of radiotherapy measure: - Pain management (VAS scale) measure: Development of xerostomy measure: Subjective evaluation on scale 1-5 of the treatment by investigator/ patient sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Masarykův onkologický ústav, Klinika radiační onkologie status: RECRUITING city: Brno state: Česká Republika zip: 56401 country: Czechia name: Tomáš Novotný role: CONTACT phone: +420543131103 email: novotny@mou.cz lat: 49.19522 lon: 16.60796 facility: FN Hradec Králové Klinika onkologie a radioterapie status: RECRUITING city: Hradec Králové state: Česká Republika zip: 56401 country: Czechia name: Milan Vošmik role: CONTACT phone: +420495832316 email: milan.vosmik@fnhk.cz lat: 50.20923 lon: 15.83277 facility: Fakultní nemocnice Ostrava, Klinika onkologická status: RECRUITING city: Ostrava state: Česká Republika zip: 56401 country: Czechia name: Jana Jackaninová role: CONTACT phone: +420597371111 email: jana.jackaninova@fno.cz lat: 49.83465 lon: 18.28204 facility: Etická komise FN Bulovka status: RECRUITING city: Praha state: Česká Republika zip: 56401 country: Czechia name: Petra Holečková role: CONTACT phone: +420266084516 email: petra.holeckova@bulovka.cz lat: 50.08804 lon: 14.42076 facility: Fakultní Thomayerova nemocnice Onkologická klinika 1.LF UK a FTN status: RECRUITING city: Praha state: Česká Republika zip: 56401 country: Czechia name: Radka Lohynská role: CONTACT phone: +420261083890 email: radka.lohynska@ftn.cz lat: 50.08804 lon: 14.42076 hasResults: False

 nctId: NCT06276257 id: 2024-7301 briefTitle: Paravertebral Block for Mastectomy With Immediate Reconstruction overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-07 date: 2025-12 date: 2024-02-23 date: 2024-02-23 name: CHU de Quebec-Universite Laval class: OTHER briefSummary: Following a mastectomy, patients may develop chronic pain, called post-mastectomy pain syndrome (PMPS). This syndrome manifests itself as complex neuropathic pain that seems linked to nerve damage suffered either during surgery, during healing or by nervous system dysfunction. However, the exact pathophysiology remains unknown. Typically, the pain is located on the ipsilateral side of the surgery and projects to the anterior thorax to the lateral thorax and may affect the proximal part of the arm. This pain persists for more than three months following the procedure and has the characteristics of neuropathic pain: burning sensation, tingling, electric shock, hyperalgesia, etc. The prevalence of PMDS varies between 2% and 78%; this disparity comes from the fact that there are no clear criteria in the literature for making the diagnosis. One of the risk factors for developing PMDS is the presence of acute pain immediately postoperatively.

The main objective of this study is to compare two analgesic modalities, namely BPV (study modality) and usual analgesia (control modality), in patients undergoing total mastectomy with immediate reconstruction under general anesthesia with the aim of to evaluate their functional pain score at 24, 48 and 72 hours following the surgical procedure. conditions: Postoperative Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Paravertebral block name: Usual analgesia measure: Evaluation of postoperative pain using the BPI measure: Total use of opioids received intraoperatively. measure: Use of non-opioid analgesia intraoperatively measure: Total dose of opioids received in the PACU measure: Time before first opioid measure: Total opioids consumed in the 48 hours following surgery measure: Chronic pain sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06276244 id: NM040-GUP19002 briefTitle: Trial Readiness and Endpoint Assessment in Congenital and Childhood Myotonic Dystrophy acronym: GUP19002 overallStatus: ACTIVE_NOT_RECRUITING date: 2020-07-08 date: 2024-04 date: 2024-04 date: 2024-02-23 date: 2024-02-23 name: Fondazione Serena Onlus - Centro Clinico NeMO Milano class: OTHER name: Bambino Gesù Hospital and Research Institute name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS name: IRCCS Istituto delle Scienze Neurologiche di Bologna name: IRCCS Fondazione Stella Maris name: IRCCS Istituto Neurologico Mondino, Pavia, Italy name: Azienda Ospedaliera Città della Salute e della Scienza di Torino name: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta name: Istituto Giannina Gaslini briefSummary: Children with congenital myotonic dystrophy (CDM) present at birth with respiratory insufficiency, talipes equinovarus, feeding difficulties and hypotonia. There is a 30% mortality rate in the first year of life. Children with childhood onset myotonic dystrophy present with symptoms later on but soon develop behavioural difficulties and learning difficulties and are at risk for autistic features and gastrointestinal symptoms. The ability to conduct a therapeutic trial in children with CDM or ChDM is directly limited by the lack of available data regarding appropriate clinical endpoints and biomarkers. Whereas there is an active Italian collaboration recruiting adults with DM1 to study muscle and multisystem aspects in this population, there is no active network in Italy involved in the pediatric population with DM1. Though the underlying mechanism is the same in adult DM1, in CDM and ChDM there are specific challenges to the pediatric population. The aim of this project is to coordinate the Italian Child Neurologist actively involved with CDM and ChDM in a common effort of standardizing protocols and procedures to be applied in the care of these patients. Specific aims are to collect functional measures and clinical information over time to define clinically meaningful endpoints and outcome measures in preparation for international therapeutic clinical trials. This project will contribute to the ongoing international study in CDM by recruiting additional patients from all over Italy and will extend the investigations to the childhood onset forms as an additional add-on pilot study in view of potential treatment options. The investigators expect that the Italian network, with Telethon support, will provide the necessary backbone for trial readiness in the pediatric population both at the national and international levels. conditions: CDM conditions: ChDM studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Physical function measure: Physical function measure: Cognitive-behavioral and Quality of Life measure: Cognitive-behavioral and Quality of Life measure: Biomarkers measure: Biomarkers sex: ALL maximumAge: 17 Years stdAges: CHILD facility: Fondazione Serena Onlus - Centro Clinico NeMO Milano city: Milan zip: 20162 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06276231 id: SalbuEase briefTitle: Nebulized Salbutamol in Acute Renal Colic overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-03-01 date: 2026-05-01 date: 2024-02-23 date: 2024-03-19 name: Oman Medical Speciality Board class: OTHER_GOV briefSummary: A Prospective, double blinded, Randomized efficacy and safety trial of Nebulized Salbutamol in acute renal colic.

Research Summary:

INTRODUCTION: Pain is a common reason for individuals to seek health care, especially emergency care. Salbutamol has an effect for smooth muscle relaxation of the ureters. The administration of Salbuatmol has been shown to be safe and effective in the treatment of asthma exacerbation, but there have been no studies evaluating the use of neublized salbutamol for the treatment of acute renal colic pain in the emergency department.

METHOD: This is a double blinded randomized clinical controlled trial. Two hundred renal colic patients presenting to the emergency department will be randomized to intervention (10 mg nebulized salbutamol) and (10 ml neublized Normal saline) case groups. Both the groups will get the standard treatment (IM diclofenac 75mg) added to the intervention. Their pain before and after intervention will be measured by Numerical Rating scale (NRS pain score). Patient and attending physician will be blinded throughout the study. The Secondry outcomes are safety, need for rescue medications and time to discharge.

AIM: The aim of this study is to compare analgesic effects of Nebulized Salbutamol versus Placebo in adult patients with renal colic.

PRIMARY OJECTIVES: Analgesic effects of Nebulized Salbutamol on the Numerical Rating scale (NRS).

SECONDARY OBJECTIVES: Adverse Events, the need of rescue pain medications and time to discharge.

PATEINT POPULATION: Adults (from age 18 to 60 years) who presents to emergency department (ED) at Armed force Hospital with acute flank pain suggestive of renal colic

INTERVENTION: Single dose of Nebulized Salbutamol 10mg.

CLINICAL MEASURMENT: Numerical pain Analog Scale will be assessed at 0,15,30, 45 and 60 minutes after intervention. Number and dosage of rescue medication, any reported events by patient or attending physician will be documented.

OUTCOME: Decrease in pain measures by NRS pain score after Nebulized Salbutamol is given, tolerability and safety evaluation. conditions: Renal Colic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 214 type: ESTIMATED name: Salbutamol name: 0.9% Normal Saline name: Diclofenac Injection measure: Pain reduction at 60 minutes measure: Adverse Event/Side Effects measure: Need of Rescue medications measure: Pain reduction rate. measure: ED revisits sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06276218 id: PSU briefTitle: Efficacy of Self - Adjustable Clavicular Brace Versus Standard Clavicular Brace for Treatment of Mid Shaft Clavicle Fracture: A Randomized Controlled Study overallStatus: RECRUITING date: 2022-02-01 date: 2024-02-15 date: 2024-02-16 date: 2024-02-23 date: 2024-02-23 name: Prince of Songkla University class: OTHER briefSummary: A randomized control trial was conducted to compare the outcomes of conservative management for closed midshaft clavicular fractures using self-adjustable clavicular brace and standard clavicular brace. conditions: Clavicle Fracture studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 68 type: ESTIMATED name: Clavicular brace measure: DASH measure: Pain, analgesic usage, radiographic outcomes, time to union, and patient satisfaction sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prince of Songkla University status: RECRUITING city: Songkla state: Hatyai zip: 90110 country: Thailand name: Thanachai Klongsangsorn role: CONTACT phone: +66991964733 email: poom_thanachai@hotmail.com lat: 7.19882 lon: 100.5951 hasResults: False

 nctId: NCT06276205 id: 1037/RC/KEMU briefTitle: Vitamin D & Levothyroxine Combination Versus Levothyroxine on Lipid Profile in Hypothyroidism acronym: ViDaLLiT overallStatus: RECRUITING date: 2024-03-01 date: 2024-09-30 date: 2024-09-30 date: 2024-02-23 date: 2024-02-23 name: King Edward Medical University class: OTHER briefSummary: The goal of this clinical trial is to study the improvement of lipid levels in hypothyroid individuals after staring treatment.

The main question it aims to answer is:

• whether adding Vitamin D to standard therapy has any additional benefits

Participants will be given Vitamin D in replacement doses according to their pre-existing Vitamin D level in addition to levothyroxine.

Researchers will compare them with another group receiving only levothyroxine to see how much lipids improve in them conditions: Hypothyroidism Primary conditions: Lipid Disorder conditions: Dyslipidemias studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Vitamin D name: Levothyroxin measure: Decline in Total Cholesterol measure: Decline in LDL sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: King Edward Medical University status: RECRUITING city: Lahore state: Punjab zip: 54000 country: Pakistan name: AP Endocrinology role: CONTACT phone: +923004683473 email: sidrah.lodhi@gmail.com lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06276192 id: 2023-01882-01 briefTitle: Digital Physiotherapy Treatment for Patients With Subacromial Pain Compared to Usual Physiotherapy in Primary Care acronym: diSAID overallStatus: NOT_YET_RECRUITING date: 2024-02-26 date: 2026-03-26 date: 2028-03-26 date: 2024-02-23 date: 2024-02-23 name: Region Östergötland class: OTHER name: Linkoeping University briefSummary: The goal of this clinical trial is to test a digital treatment for patients with subacromial pain using the digital Shoulder Aid (diSAID) strategy. The participants in this study will be randomly assigned to digital treatment (diSAID) or to receive the treatment that is currently available in primary care, i.e. continue according to usual practice.

The main question this clinical trial aims to answer are:

- Can the diSAID improve shoulder function and reduce pain for patients with subacromial pain in primary care? conditions: Subacromial Pain Syndrome conditions: Shoulder Pain conditions: Rotator Cuff Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Non-Inferiority Randomised Controlled Trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Digital Physiotherapy (diSAID) name: Traditional Physiotherapy measure: Mean change in shoulder function and pain after 12 weeks using The Shoulder Pain and Disability Index (SPADI) measure: Mean change in shoulder pain intensity at rest, arm activity and at night measured by numeric rating scale (NRS) measure: Mean change in pain Self-Efficacy measure: Mean change of self-reported rating of improvement measure: Mean change of health-related quality of life measure: Patients treatment expectancies measure: Patients self-reported rating of pain sensitivity measure: Costs and cost-effectiveness direct and indirect measure: Impact on the environment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anna Petersson city: Linköping zip: SE 58191 country: Sweden name: Anna Petersson, PhD student role: CONTACT phone: +46101031053 email: anna.h.petersson@regionostergotland.se name: Teresa Holmgren, PhD role: CONTACT phone: +46101034158 email: Teresa.Holmgren@regionostergotland.se name: Hanna Björnsson Hallgren, Associate Prof role: PRINCIPAL_INVESTIGATOR name: Jenny Samuelsson, PhD role: SUB_INVESTIGATOR lat: 58.41086 lon: 15.62157 hasResults: False

 nctId: NCT06276179 id: KFSIRB200-97 briefTitle: Epidural Oxycodone for Pain Management for Lower Limb Amputation overallStatus: RECRUITING date: 2024-02-24 date: 2024-08-01 date: 2024-08-01 date: 2024-02-23 date: 2024-02-28 name: Kafrelsheikh University class: OTHER briefSummary: The aim of this study is to evaluate the effect of epidural oxycodone for pain management after lower limb amputation. conditions: Epidural conditions: Oxycodone conditions: Pain conditions: Lower Limb Amputation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Oxycodone name: Bupivacaine measure: Acute postoperative pain scores measure: Time to the first request for the rescue analgesia measure: Postoperative morphine consumption measure: Incidence of phantom limb pain measure: Adverse effects sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kafrelsheikh University status: RECRUITING city: Kafr Ash Shaykh state: Kafrelsheikh zip: 33516 country: Egypt name: Gamal H Shams, MD role: CONTACT phone: 00201095927971 email: gamal.shams2@gmail.com name: Ahmed A Ghareeb, MD role: PRINCIPAL_INVESTIGATOR name: Mohamed H Osman, MD role: PRINCIPAL_INVESTIGATOR name: Heba F Dawood, MD role: PRINCIPAL_INVESTIGATOR name: Mohamed M Kotb, MD role: PRINCIPAL_INVESTIGATOR lat: 31.11174 lon: 30.93991 hasResults: False

 nctId: NCT06276166 id: 72374215 briefTitle: Trajectory of Frailty and Cognitive Dysfunction in Older Adults overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2026-06-30 date: 2026-12-31 date: 2024-02-23 date: 2024-03-07 name: Zheng Li class: OTHER briefSummary: To explore the heterogeneity of the development trend of frailty and cognitive function of older adults. conditions: Frailty conditions: Cognitive Dysfunction conditions: Community-dwelling Older Adults studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 934 type: ESTIMATED name: No intervention measure: Frailty measure: Cognitive function measure: Health status and life style measure: Activities of daily life (ADLs) measure: Anxiety measure: Apathy measure: Perceived social support measure: Social network sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06276153 id: CRGGCext briefTitle: Construction of Multicenter Retrospective Registry Cohort Database for Gallbladder Cancer acronym: CRGGCext overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2027-02-28 date: 2029-02-28 date: 2024-02-23 date: 2024-02-28 name: RenJi Hospital class: OTHER briefSummary: The aim of the study is to establishing a standardized clinical information database for patients with malignant tumors of gallbaldder. Based on the database, real-world clinical research on the diagnosis and treatment of biliary tract tumors is about to be carried out, and a high-standard cohort research foundation is laid for precision therapy. conditions: Biliary Tract Diseases conditions: Gallbladder Cancer conditions: Gallbladder Neoplasms studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 5000 type: ESTIMATED name: no interventions measure: overall survival measure: progression-free survival sex: ALL minimumAge: 18 Years maximumAge: 74 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06276140 id: 4/23/2-4661/2-9 briefTitle: Iron-deficiency Anaemia and Its Impact on Recovery After Colorectal Cancer Surgery acronym: ID-COLO overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-01 date: 2026-01 date: 2024-02-23 date: 2024-02-28 name: Oncology Institute of Vojvodina class: OTHER_GOV name: University of Bern briefSummary: The aim of this prospective, observational cohort study is to assess the impact of iron deficiency anaemia on the incidence of perioperative complications and the quality of recovery after surgery in patients undergoing colorectal cancer surgery. The main questions the study aims to answer are:

* whether the presence of preoperative iron deficiency anaemia leads to a poorer quality of postoperative recovery in patients undergoing colorectal cancer surgery
* whether different combinations of complete blood count parameters (red blood cell indices) could be suitable diagnostic tools for the detection of iron deficiency in the latent stage (without laboratory-confirmed anaemia) in colorectal cancer patients.

Blood samples for laboratory analyses will be collected from each study patient admitted to the surgical ward one day prior to elective surgery and on the first postoperative day during the stay in the intensive care unit. The pre-operative laboratory analyses include a complete blood count and serum iron status parameters (iron concentration, ferritin concentration, TIBC, UIBC and TSAT). Laboratory parameters analysed on the first postoperative day include complete blood count, serum concentration of electrolytes (Na, K, Ca, Cl, Mg), serum concentration of urea and creatinine, parameters of haemostasis (aPTT, PT, INR), serum concentration of C-reactive protein and procalcitonin.

Data about overall morbidity, intraoperative complications, quality of postoperative recovery, red blood cell transfusion rate, all-cause infection rate, antibiotic usage, as well as length of hospital stay will be collected.

The researchers will compare the group of patients with iron deficiency anaemia, the group of patients with iron deficiency in the latent stage and the control group to determine whether patients with iron deficiency have a higher incidence of perioperative complications and impaired recovery after surgery. The researchers will investigate whether iron deficiency can be detected at an early stage, when anaemia is not yet present, by calculating various red blood cell indices. conditions: Iron Deficiencies conditions: Iron Deficiency Anaemia conditions: Postoperative Complications conditions: Colorectal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Laboratory analyses for the detection of iron deficiency anaemia measure: Overall morbidity measure: Prevalence of absolute iron deficiency, functional iron deficiency and iron deficiency anaemia in the study population measure: Red blood cell transfusion rate measure: All-cause infection rate measure: Days of antibiotic use measure: Number of different antibiotics administered measure: Length of Intensive care unit-stay measure: Length of hospital-stay measure: Intraoperative complications measure: Quality of postoperative recovery measure: Reoperation measure: Estimated total iron-deficit measure: Serum ferritin level measure: Values of different erythrocyte indices sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06276127 id: MERC301123 briefTitle: Oral Bisoprolol Vs IV Diltiazem in Atrial Fibrillation or Flutter With Rapid Ventricular Rate. acronym: BisoAF overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-06 date: 2024-02-23 date: 2024-03-05 name: Oman Medical Speciality Board class: OTHER_GOV briefSummary: INTRODUCTION: The study focuses on comparing the effectiveness of oral Bisoprolol, a beta-1 adrenergic receptor blocker, against intravenous Diltiazem, a calcium channel blocker, in treating rapid atrial fibrillation or flutter with rapid ventricular response in an emergency setting. This research aims to fill the gap in empirical evidence regarding the use of oral Bisoprolol for these conditions, potentially offering a convenient, evidence-based alternative for patient management in emergency departments where established protocols are lacking.

METHOD: This study is a randomized controlled trial targeting patients who present to the emergency room with symptomatic atrial fibrillation or flutter and rapid ventricular response requiring intervention. Participants will be split into two groups and undergo continuous monitoring of vital signs and regular electrocardiograms to ensure safety and document any adverse effects. The primary focus is on patient safety while evaluating the efficacy of the treatments.

AIM: Evaluate the efficacy and safety of oral bisoprolol in treating atrial fibrillation or atrial flutter with rapid ventricular response in an emergency department setting.

PRIMARY OJECTIVES: The primary efficacy outcome will be evaluated by achieving a HR\<110 beats per minute or a decrease ≥20% of baseline HR at 60 minutes. The primary safety outcome measures are HR \< 60 bpm and SBP \< 95 mm Hg.

SECONDARY OBJECTIVES: The use of Rescue medication, proportion of patients who required hospitalization, worsening of heart failure or pulmonary oedema, side effect of medication ( dizziness, headaches, gastrointestinal symptoms)

PATEINT POPULATION: Adults (18 and older) presenting to the emergency department at Sultan Qaboos University Hospital with symptomatic atrial fibrillation or atrial flutter with rapid ventricular response requiring treatment.

INTERVENTION: A single oral dose of 5 mg Bisoprolol (maximum dose of 5 mg) or a single intravenous dose of Diltiazem at 0.25 mg/kg (to a maximum dose of 30 mg).

CLINICAL MEASURMENT: Heart rate recorded every 15 minutes up to the 90-minute mark, with a 12-lead ECG performed every 30 minutes.

OUTCOME: For therapy to be considered effective, patients must achieve a ventricular rate ≤110/min or experience a drop-in ventricular rate of at least 20% at 60 minutes. conditions: Atrial Fibrillation With Rapid Ventricular Response conditions: Atrial Flutter With Rapid Ventricular Response studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: * Study Design: Double-blind, randomized controlled trial.
* Participants: Patients with atrial fibrillation/flutter and rapid ventricular rate.
* Treatment Arms: Oral Bisoprolol vs. Intravenous Diltiazem.
* Randomization: Subjects randomly assigned to either treatment group.
* Primary Endpoint: Reduction of heart rate to a target level within a specific timeframe.
* Secondary Outcomes: Adverse effects, hospital admission rates, additional rate control needs.
* Objective: Compare effectiveness and safety of oral Bisoprolol to intravenous Diltiazem.
* Monitoring: Continuous observation of vital signs and electrocardiograms for safety. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: While the treating physician, nurse, and the patient will not be blinded to the treatment, the investigator collecting data and the statistician analysing it will remain blinded to treatment allocations. This ensures unbiased data collection and analysis. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Oral Bisoprolol name: Intravenous Diltiazem measure: Efficacy Outcome Evaluated by Achieving the Target Heart Rate Reduction measure: Safety Outcome Evaluated by the Presence of serious adverse event measure: The use of Rescue medication measure: Proportion of patients who required hospitalization measure: ED revisit measure: Number of Participants Experiencing Treatment-Related Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sultan Qaboos University Hospital city: Muscat state: Al-khod zip: 38 country: Oman name: Fatin k Al omairi, MD role: CONTACT phone: 71308058 phoneExt: +968 email: r2220@resident.omsb.org name: Awatif Al-Alalawi, MD role: PRINCIPAL_INVESTIGATOR name: Usama Alkhalasi, MD role: SUB_INVESTIGATOR name: Mohamed Al Rawahi, MD role: SUB_INVESTIGATOR name: Adil Al Riyami, MD role: SUB_INVESTIGATOR name: Said Al Hadhrami, MD role: SUB_INVESTIGATOR name: Hatim Al Lawati, MD role: SUB_INVESTIGATOR lat: 23.58413 lon: 58.40778 hasResults: False

 nctId: NCT06276114 id: 07 briefTitle: IVL vs ELCA for Stent Underexpantsion (IVL-ELCA DRAGON) acronym: DRAGON overallStatus: COMPLETED date: 2020-08-01 date: 2023-10-31 date: 2023-10-31 date: 2024-02-23 date: 2024-02-23 name: Medical University of Silesia class: OTHER briefSummary: The IVL- ELCA DRAGON Registry is a multicenter study that enrolled consecutive patients with stent underexpansion treated with IVL ora ELCA in high-volume PCI centers.

The primary efficacy endpoint was device success (technical success with a final stent expansion ≥ 80%). Thirty days device-oriented composite endpoint (DOCE: cardiac death, target lesion revascularization, or target vessel myocardial infarction) was the secondary endpoint. conditions: Coronary Artery Calcification conditions: Intravascular Lithotripsy conditions: Excimer Laser-coronary Atherectomy conditions: Stent Restenosis conditions: Stent Occlusion studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 121 type: ACTUAL name: Stent Underexpansion measure: The primary efficacy endpoint was device success measure: Device-oriented composite endpoint (DOCE) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Unit of Structural Interventional Cardiology, Department of Clinical and Experimental Medicine, Careggi University Hospital city: Florence country: Italy lat: 43.77925 lon: 11.24626 facility: Fabrizio D'Ascenzo city: Turin country: Italy lat: 45.07049 lon: 7.68682 facility: Department of Invasive Cardiology, Medical University of Bialystok, The Medical University of Bialystok Clinical Hospital city: Białystok country: Poland lat: 53.13333 lon: 23.16433 facility: First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland city: Gdańsk country: Poland lat: 54.35205 lon: 18.64637 facility: Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland city: Katowice zip: 40-635 country: Poland lat: 50.25841 lon: 19.02754 facility: Jacek Legutko city: Kraków country: Poland lat: 50.06143 lon: 19.93658 facility: Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland city: Kraków country: Poland lat: 50.06143 lon: 19.93658 facility: 1st Military Hospital in Lublin, Lublin, Poland city: Lubin country: Poland lat: 51.40089 lon: 16.20149 facility: Department of Cardiology, Copper Health Centre (MCZ) city: Lubin country: Poland lat: 51.40089 lon: 16.20149 facility: Clinical Department of Interventional Cardiology, Medical University of Lublin city: Lublin country: Poland lat: 51.25 lon: 22.56667 facility: Department of Cardiology, University Hospital, Institute of Medical Sciences city: Opole country: Poland lat: 50.67211 lon: 17.92533 facility: Department of Cardiology, Poznan University of Medical Sciences city: Poznań country: Poland lat: 52.40692 lon: 16.92993 facility: Department of Cardiology, The Ministry of Internal Affairs and Administration Hospital, Rzeszow city: Rzeszów country: Poland lat: 50.04132 lon: 21.99901 facility: 1st Department of Cardiology, Medical University of Warsaw city: Warsaw country: Poland lat: 52.22977 lon: 21.01178 facility: Department of Cardiology and Internal Diseases, Military Institute of Medicine city: Warsaw country: Poland lat: 52.22977 lon: 21.01178 facility: Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Warsaw, Poland city: Warszawa country: Poland lat: 52.22977 lon: 21.01178 facility: Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration city: Warszawa country: Poland lat: 52.22977 lon: 21.01178 facility: Department of Invasive Cardiology, Wejherowo city: Wejherowo country: Poland lat: 54.60568 lon: 18.23559 facility: Centre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical University city: Wrocław country: Poland lat: 51.1 lon: 17.03333 facility: Third Department of Cardiology, Medical University of Katowice city: Zabrze country: Poland lat: 50.32492 lon: 18.78576 hasResults: False

 nctId: NCT06276101 id: NEWISH-HPV-101 briefTitle: NWRD08 DNA Plasmid for HPV-16 and/or HPV-18 Related Cervical HSIL overallStatus: RECRUITING date: 2024-01-25 date: 2024-12-30 date: 2025-07-30 date: 2024-02-23 date: 2024-02-23 name: Newish Technology (Beijing) Co., Ltd. class: INDUSTRY briefSummary: This is a single-arm, open label, multi-center Phase 1 clinical study to evaluate the safety and tolerability of HPV-16 and HPV-18-targeted DNA plasmid vaccine (NWRD08) in patients HPV-16 and/or HPV-18 related cervical HSIL. conditions: High-grade Squamous Intraepithelial Lesion (HSIL) studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 9 type: ESTIMATED name: NWRD08 administered by electroporation measure: Safety measure: Dose-limiting toxicity (DLT) measure: Immunogenicity measure: Histopathology outcome and HPV Viral clearance measure: The recommended phase II dose (RP2D) sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Peking Union Medical College Hospital status: RECRUITING city: Beijing state: Beijing zip: 100730 country: China name: Fang Jiang, M.D. role: CONTACT phone: 86-010-69155635 email: 13671170943@163.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06276088 id: NFEC-2024-067 briefTitle: Plasma and Tissue SAA1 Levels in Cancer Patients to Predict Hyperprogression of Immunotherapy overallStatus: RECRUITING date: 2024-02-18 date: 2025-12-31 date: 2026-10-31 date: 2024-02-23 date: 2024-03-15 name: Nanfang Hospital, Southern Medical University class: OTHER briefSummary: Immune checkpoint inhibitors have ushered in a new era of cancer treatment, bringing significant survival benefits to patients. However, some patients have accelerated tumor growth in the early stage of immunotherapy, called hyperprogression. The quality of life of patients with hyperprogression is seriously reduced, and there is no effective treatment at present, and the prognosis is extremely poor. Therefore, early identification of high-risk groups of hyperprogression is the key to prevent hyperprogression. However, there are no effective biomarkers to predict hyperprogression. By sequencing, proteomics and metabolomics analysis of clinical tissue and blood samples, we found that the level of SAA1 was significantly increased in patients with hyperprogression, and SAA1 was an effective marker for predicting hyperprogression in pan-cancer. We planned to conduct a multicenter, prospective cohort study to verify the reliability of SAA1 as a marker for predicting hyperprogression of immunotherapy in pan-cancer patients. conditions: Immunotherapy conditions: Hyperprogression conditions: Biomarker studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 374 type: ESTIMATED measure: Incidence of hyperprogression measure: Event-free survival measure: Progression-free survival measure: Overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanfang hospital, Southern medical university status: RECRUITING city: Guangzhou state: Guangdong zip: 510515 country: China name: Jian Guan, M.D. role: CONTACT phone: 86+13632102247 email: guanjian5461@163.com name: Jian Guan, M.D. role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 facility: Fujian Provinical Hospital status: NOT_YET_RECRUITING city: Fuzhou country: China name: Yongmei Dai role: CONTACT lat: 26.06139 lon: 119.30611 facility: Huizhou Central People's Hospital status: NOT_YET_RECRUITING city: Huizhou country: China name: Yunming Tian role: CONTACT lat: 23.11147 lon: 114.41523 facility: Jieyang people's hospital status: NOT_YET_RECRUITING city: Jieyang country: China name: Peibao Lai role: CONTACT lat: 23.5418 lon: 116.36581 facility: Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou status: NOT_YET_RECRUITING city: Meizhou country: China name: Jianda Sun role: CONTACT lat: 24.2886 lon: 116.11767 hasResults: False

 nctId: NCT06276075 id: 10/KRN/2020 briefTitle: The Impact of Erigo®Pro Therapy and Motor Imagery on the Balance of Stroke Patients. overallStatus: COMPLETED date: 2022-12-15 date: 2023-05-10 date: 2023-09-10 date: 2024-02-23 date: 2024-02-23 name: Anna Olczak class: OTHER briefSummary: The aim of the study is to examine the impact of motor imagery, Erigo®Pro tilt table intervention, and classic rehabilitation on the balance of people after a stroke. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 66 type: ACTUAL name: Conventional rehabilitation, the Erigo®Pro table, motor imagery measure: Trunk Control Test measure: Berg Balance Scale measure: RiabloTM device measure: RiabloTM device measure: Luna EMG measure: Luna EMG sex: ALL minimumAge: 38 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Military Institute of Medicine city: Warsaw state: Masovian District zip: 04-141 country: Poland lat: 52.22977 lon: 21.01178 hasResults: False

 nctId: NCT06276062 id: Titanium nail usage briefTitle: Uses of Titanium Nail in Pediatric Fractures overallStatus: RECRUITING date: 2023-09-01 date: 2024-09 date: 2024-10 date: 2024-02-23 date: 2024-02-28 name: Sohag University class: OTHER briefSummary: The aim of this study is to investigate the short term functional and radiological outcomes of using double short titanium elastic nails as treatment of pediatric distal radius fractures. conditions: Trauma Injury of Upper Extremity Forearm Multiple conditions: Fracture of Distal End of Radius studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Distal radius fracture fixation in pediatrics. measure: Comparison between usage of titanium nail and old methods sex: ALL minimumAge: 4 Years maximumAge: 16 Years stdAges: CHILD facility: Sohag university status: RECRUITING city: Sohag country: Egypt lat: 26.55695 lon: 31.69478 hasResults: False

 nctId: NCT06276049 id: DGETRRP2023-54 briefTitle: ChatGPT Helping Advance Training for Medical Students: A Study on Self-Directed Learning Enhancement acronym: CHAT-MS overallStatus: ACTIVE_NOT_RECRUITING date: 2023-11-25 date: 2024-01-06 date: 2024-03-02 date: 2024-02-23 date: 2024-02-23 name: Wang Shalong class: OTHER name: Central South University briefSummary: The goal of this clinical trial is to evaluate the effect of LearnGuide, a custom GPT developed with ChatGPT for supporting self-directed learning (SDL) in medical students. The main questions it aims to answer are:

How does LearnGuide influence SDL skills among medical students? Can LearnGuide improve critical thinking and learning flow as measured by Cornell Critical Thinking Test (CCTT) Level Z score and Global Flow Score (GFS)?

Participants will:

Undergo a two-hour introduction to LearnGuide. Engage in 12 weeks of SDL task-based training with LearnGuide\&amp;#39;s support.

If there is a comparison group: Researchers will compare the group utilizing LearnGuide for SDL and the group without this tool to see if there is a significant difference in SDL skills, critical thinking, and learning flow experiences. conditions: Self-Directed Learning conditions: Artificial Intelligence conditions: Medical Education studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 103 type: ACTUAL name: custom GPT supported self-directed learning measure: Self-Directed Learning Scale measure: Cornell Critical Thinking Test (CCTT) Level Z measure: Flow Short Scale sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Geriatirc Surgery city: Changsha state: Hunan zip: 410011 country: China lat: 28.19874 lon: 112.97087 hasResults: False

 nctId: NCT06276036 id: CAPID briefTitle: Autoimmune Cytopenias as a Sign of Primary Immunodeficiency. overallStatus: ACTIVE_NOT_RECRUITING date: 2019-07-23 date: 2024-12-01 date: 2025-06-01 date: 2024-02-23 date: 2024-03-29 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: Autoimmune cytopenias resistant to treatment are among the most common clinical manifestations observed in patients with congenital alterations of the immune system, such as primary immunodeficiencies (PI). The exact contribution of immune system alterations to the pathogenesis of autoimmune cytopenias has not yet been fully elucidated. Moreover, conventionally employed therapeutic strategies often fail, leading to increased healthcare costs, high morbidity, and even mortality. Therefore, there is a need to establish clinical guidelines for diagnosis and to identify early biomarkers capable of identifying individuals responsive to therapy. Thus, a systematic approach to the study of such pathologies will allow for the identification of early biomarkers and facilitate the development of targeted therapeutic strategies conditions: Cytopenia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 53 type: ACTUAL name: Identification of specific markers measure: Identification of specific markers sex: ALL minimumAge: 1 Year maximumAge: 17 Years stdAges: CHILD facility: University of South Florida city: Tampa state: Florida zip: 33620 country: United States lat: 27.94752 lon: -82.45843 facility: Ghent University Hospital city: Ghent country: Belgium lat: 51.05 lon: 3.71667 facility: Clinica Pediatrica - Università di Catania city: Catania country: Italy lat: 37.49223 lon: 15.07041 facility: Meyer Children's Hospital IRCCS city: Florence country: Italy lat: 43.77925 lon: 11.24626 facility: IRCCS Istituto Giannina Gaslini city: Genova country: Italy lat: 44.40478 lon: 8.94438 facility: Azienda Ospedaliero Universitaria Pisana city: Pisa country: Italy lat: 43.70853 lon: 10.4036 hasResults: False

 nctId: NCT06276023 id: 2023P003638 id: 1R01AG078204-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01AG078204-01 briefTitle: Supporting Our Caregivers In ADRD Learning (SOCIAL) acronym: SOCIAL overallStatus: RECRUITING date: 2024-03-22 date: 2025-03-15 date: 2025-04-01 date: 2024-02-23 date: 2024-03-25 name: Massachusetts General Hospital class: OTHER name: National Institute on Aging (NIA) name: University of California, San Francisco briefSummary: Building on limitations of prior research, the investigators developed the Mindful and Self-Compassionate Care Program (MASC) to help caregivers of persons with Alzheimer Disease and Related Dementias (ADRD) manage stress associated with the general caregiver experience including stress stemming from managing challenging patient behaviors. MASC teaches: (1) mindfulness skills; (2) compassion and self-compassion skills; and (3) behavioral management skills. MASC also provides psychoeducation and group-based training and skill practice to facilitate skill uptake and integration within the caregiver experience and tasks.

The main aim is to: Demonstrate feasibility, acceptability, credibility, fidelity, preliminary efficacy and evidence for proposed mechanism of MASC through a pilot randomized controlled trial.

Relevant stakeholders (caregivers of persons with ADRD) will participate in the intervention. conditions: Alzheimer's Disease and Related Dementias conditions: Quality of Life conditions: Caregiver Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: MASC is an intervention that includes evidence-based skills of: 1) mindfulness; 2) compassion toward others and self; 3) behavioral management skills. MASC comprises 6 sessions delivered in a group format over secure live video with Zoom. Each session includes psychoeducation on program skills, skill practice, strategies to incorporate the skill into the caregiver experience, and strategies for sustained practice. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 80 type: ESTIMATED name: Mindful and Self-Compassionate Care Program (MASC) name: Health Education Program (HEP) measure: Feasibility of Recruitment measure: Feasibility of Randomization measure: Feasibility of Assessment Measures measure: Feasibility of Quantitative Measures measure: Adherence to treatment measure: Patient's Global Impression of Change (PGIC) measure: Perceptions of Questionnaire Battery measure: Adherence to Home Practice measure: Perceptions of Email and Text Reminders measure: Credibility and Expectancy measure: Modified Perception of Global Improvement measure: Satisfaction with the Intervention measure: Therapist Fidelity measure: Symptoms of Depression measure: Mindfulness measure: Perceived Stress Scale measure: Symptoms of Anxiety measure: The Self-Compassion Scale measure: Compassion measure: Caregiver self-efficacy measure: Loneliness measure: Social Support measure: Well-being measure: Distress Due to Patient Challenges Behaviors measure: Dyadic Relationship Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Massachusetts General Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02114-2524 country: United States name: Michelle StPaul, MS role: CONTACT email: mstpaul2@mgh.harvard.edu lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06276010 id: 2023-102 briefTitle: Use of Nafamostat Mesilate for Anticoagulation in Patients With ECMO overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2026-12-31 date: 2024-02-23 date: 2024-02-26 name: Xiaotong Hou class: OTHER briefSummary: The purpose of this study is to evaluate the effectiveness and safety of nafamostat mesilate compared with unfractionated heparin for anticoagulation in patients with ECMO after cardiac surgery. conditions: Extracorporeal Membrane Oxygenation Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 80 type: ESTIMATED name: nafamostat mesilate name: unfractionated heparin group measure: Incidence of thrombotic complications measure: Incidence of severe bleeding complications measure: Infusion volume of blood products measure: ACT qualified rate measure: Hospitalization mortality measure: The incidence of oxygenator dysfunction measure: Heparin-induced thrombocytopenia measure: Time to reach the target anticoagulant level for the first time sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Anzhen Hospital city: Beijing state: Beijing zip: 100029 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06275997 id: GAIN briefTitle: GAIN Project: Gastric Cancer and Artificial Intelligence acronym: GAIN overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2028-03 date: 2024-02-23 date: 2024-02-23 name: Istituto Clinico Humanitas class: OTHER briefSummary: Our GAIN project comprises four core work packages (WPs): WP1. Nation-level randomized controlled trial; WP2. Development of an innovative AI tool; WP3. Novel microsimulation modelling; WP4. Patient inclusion.

The nation-level multi-center tandem randomized controlled trial (WP1) will contribute to a better understanding of how the real-time AI algorithm can reduce miss rate of early gastric cancer and dysplasia during gastroscopy. Moreover, the innovation project will contribute to development of a novel AI tool (WP2) that can stratify the risk of gastric cancer by identifying in vivo precancerous conditions. Furthermore, a microsimulation modelling will allow us to predict how the use of AI can prevent gastric cancer and affect cost and patients' burdens. The assessment of the balance between benefits and harms is quite crucial especially for this type of medical device because the value of innovative tools is sometimes overestimated due to stakeholders' enthusiasm (WP3). Finally, we will take care of patients' perspective throughout the study project by including patient organization in both WP1, 2, and 3 (WP4). conditions: Gastric Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel/Crossover Study Model; Patients will be randomized 1:1:1:1 primaryPurpose: PREVENTION masking: NONE count: 6600 type: ESTIMATED name: Integration of Artificial Intelligence (AI) assistance to screening gastroscopy measure: Miss rate reduction measure: Change number of Detections measure: patient satisfaction sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06275984 id: PI23/00288 id: 4R23/440 type: OTHER domain: IDIAP Jordi Gol briefTitle: Effectiveness of Online Training in Cardiopulmonary Resuscitation Maneuvers for a Network of Volunteers. acronym: EFORCP overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2026-12 date: 2024-02-23 date: 2024-04-15 name: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina class: OTHER name: Hospital Universitari Joan XXIII de Tarragona. briefSummary: Background: Cardiorespiratory arrest (CPA) occurs when there is a cessation of cardiac mechanical activity, typically diagnosed by the absence of consciousness, pulse, and breathing. Actions taken in response to CPA include recognizing the condition and promptly notifying emergency medical services, initiating Cardiopulmonary Resuscitation (CPR) maneuvers, and employing an Automated External Defibrillator (AED). Survival rates are directly influenced by the time elapsed between CPA onset and the initiation of CPR maneuvers, as well as the quality of these interventions

Hypotheses: Online education in CPR maneuvers is an effective and efficient tool for training individuals from the general population on how to respond to cardiac arrests

Objectives: The primary aim of this study is to assess the efficacy of online CPR and AED training within the general population of the province of Tarragona. Specific objectives include: 1) evaluating participants' theoretical and practical CPR skills in the short and medium term following online training, and 2) exploring the experiences of individuals who have completed the online training and simulation sessions using qualitative methodology.

Methodology:This study will unfold in several phases: 1) Online CPR-AED training and assessment of theoretical knowledge acquisition; 2) Evaluation of acquired practical CPR skills (know-how) within a simulation environment, conducted on a subset of the population completing phase 1;3)Analysis of the experiences of a subset of individuals who have participated in the preceding two phases, employing qualitative methodology

Variables and determinations:The primary response variable for phase 1 will be the difference in scores obtained from the online questionnaire between the final (post-training) and initial (pre-training) assessments.

In phase 2, the main variable will be the pass/fail categorization of scores in the simulation. This evaluation will be conducted by two members of the Advanced Clinical Simulation Unit at Joan XXII Hospital using a predefined checklist. Throughout the various phases of the study, socio-demographic data and course performance data will be taken into account

Expected results: The research team for this study aims to ascertain the efficacy and effectiveness of online CPR-AED training within the general population. Furthermore, the study aims to provide evidence regarding the optimal duration and frequency for repeating such training.

Applicability and Relevance: This proposal advocates for a significant and innovative project, given the dearth of literature on this topic. While there are existing indications and studies on CPR-AED training among specific populations such as students and healthcare professionals, the presented proposal seeks to broaden the scope of training to encompass the general population. conditions: Cardiorespiratory Arrest conditions: Cardiopulmonary Arrest With Successful Resuscitation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 156 type: ESTIMATED name: online CPR-AED training measure: Difference between pre and post training scores in ad hoc designed scale measure: Percentage of participants that reach or exceed 10 out of 12 on the checklist measure: Odds ratios (with 95% CI) for adjustment variables measure: Scores on the standard satisfaction questionnaire commonly used by the Catalan Health Institute to evaluate training activities sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IDIAP Jordi Gol city: Barcelona zip: 08007 country: Spain name: Ester Granado_Font, PhD role: CONTACT phone: 977778715 phoneExt: 405 email: egranado.tgn.ics@gencat.cat name: Ester Granado-Font, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06275971 id: KBSMC 2022-07-006 briefTitle: Effectiveness of Continuous Glucose Monitoring System Among Cardiac Surgery Patients overallStatus: RECRUITING date: 2022-11-24 date: 2024-06-30 date: 2024-08-31 date: 2024-02-23 date: 2024-02-23 name: Kangbuk Samsung Hospital class: OTHER name: DexCom, Inc. briefSummary: The aim of this study is to assess the level of glycemic control and the incidence of surgery-related complications in cardiac patients post-surgery when Continuous Glucose Monitoring (CGM) is utilized, as compared to traditional methods of arterial/venous blood sampling and Point-of-Care Testing (POCT) for glucose monitoring. conditions: Cardiac Disease conditions: PreDiabetes conditions: Diabetes Mellitus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Treatment group: glycemic control using CGM Control group: glycemic control using arterial/venous blood sampling and POCT glucose primaryPurpose: TREATMENT masking: NONE count: 68 type: ESTIMATED name: Dexcom G6 name: SMBG or venous/arterial blood glucose measure: Time within the target range of 100-180 mg/dL measure: Time within the target range of 100-140 mg/dL measure: Time within the target range of 70-180 mg/dL measure: Time to reach <70 mg/dL measure: Time to reach <54 mg/dL measure: Time to reach >180 mg/dL measure: Time to reach >250 mg/dL measure: Standard Deviation (SD) measure: Coefficient of variation (CV) measure: Mean glucose measure: Glucose management indicator (GMI) measure: Number of days of ICU hospitalization measure: Number of days hospitalized after surgery measure: Number of participants with pneumonia occurrence after surgery measure: Number of participants with wound infection occurrence after surgery measure: Number of participants who underwent CRRT implementation after surgery measure: Number of participants with Atrial fibrillation occurrence after surgery measure: Number of participants with symptomatic CVA (ischemic and hemorrhagic) occurrence after surgery measure: Changes in concentration of serum CRP level after surgery measure: Mortality within 30 days of surgery sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kangbuk Samsung Hospital status: RECRUITING city: Seoul zip: 03181 country: Korea, Republic of name: Sun Joon Moon, MD role: CONTACT lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06275958 id: 2023-506115-17 id: 2023-506115-17 type: EUDRACT_NUMBER briefTitle: DOSAGE Study: Upfront Dose-Reduced Chemotherapy in Older Patients With Metastatic Colorectal Cancer acronym: DOSAGE overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2028-06 date: 2028-12 date: 2024-02-23 date: 2024-02-23 name: Leiden University Medical Center class: OTHER name: Dutch Colorectal Cancer Group name: Stichting Darmkanker briefSummary: The goal of this phase III, open-label, non-inferiority randomized controlled clinical trial is compare upfront dose-reduced chemotherapy with the standard dose chemotherapy in older patients ( ≥70 years) with metastasized colorectal cancer, with regard to progression-free survival (PFS). The choice between monotherapy (a fluoropyrimidine) and doublet chemotherapy (a fluoropyrimidine with oxaliplatin) will be made for each individual patient based on expected risk of chemotherapy toxicity (according to the G8 screening). Patients classified as low risk of toxicity will be randomized between doublet chemotherapy in either full-dose, or with an upfront dose-reduction of 25%. Patients classified as high risk will be randomized between monotherapy in either full-dose or upfront dose-reduction.

Primary outcome is PFS. Secondary endpoints include grade ≥3 toxicity, QoL, physical functioning, overall survival, number of treatment cycles, dose reductions, hospital admissions, cumulative received dosage and cost-effectiveness. conditions: Older Patients conditions: Colorectal Cancer conditions: Metastatic Cancer conditions: Candidates for Palliative Chemotherapy studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A phase III, open-label, non-inferiority, randomized controlled clinical trial comparing dose-reduced chemotherapy versus standard dose chemotherapy in older adults with metastasized colorectal cancer primaryPurpose: TREATMENT masking: NONE count: 587 type: ESTIMATED name: Doublet Chemotherapy, Standard Dose (100%) name: Doublet Chemotherapy, Dose-reduced (75%) name: Monotherapy, Standard Dose (100%) name: Monotherapy, Dose-reduced (75%) measure: Progression-Free Survival measure: Quality of Life Questionnaire measure: Quality of Life Questionnaire measure: Physical functioning Questionnaire measure: Physical functioning Questionnaire measure: Grade 3-5 chemotherapy-related toxicity measure: Overall Survival measure: Number of completed treatment cycles measure: Dose reductions during treatment measure: Dose delay during treatment measure: Unplanned hospitalizations measure: Cumulative received dosage measure: Cost-effectiveness sex: ALL minimumAge: 70 Years stdAges: OLDER_ADULT facility: Jeroen Bosch Ziekenhuis city: 's-Hertogenbosch country: Netherlands lat: 51.69917 lon: 5.30417 facility: Noordwest Ziekenhuisgroep city: Alkmaar country: Netherlands lat: 52.63167 lon: 4.74861 facility: Ziekenhuis Amstelland city: Amstelveen country: Netherlands lat: 52.30083 lon: 4.86389 facility: Amsterdam UMC city: Amsterdam country: Netherlands lat: 52.37403 lon: 4.88969 facility: Rijnstate city: Arnhem country: Netherlands lat: 51.98 lon: 5.91111 facility: Wilhelmina Ziekenhuis city: Assen country: Netherlands lat: 52.99667 lon: 6.5625 facility: Rode Kruis Ziekenhuis city: Beverwijk country: Netherlands lat: 52.48333 lon: 4.65694 facility: Haaglanden Medisch Centrum city: Den Haag country: Netherlands lat: 52.07667 lon: 4.29861 facility: Hagaziekenhuis city: Den Haag country: Netherlands lat: 52.07667 lon: 4.29861 facility: Slingeland Ziekenhuis city: Doetinchem country: Netherlands lat: 51.965 lon: 6.28889 facility: Ziekenhuis Gelderse Vallei city: Ede country: Netherlands lat: 52.03333 lon: 5.65833 facility: Catharina Ziekenhuis city: Eindhoven country: Netherlands lat: 51.44083 lon: 5.47778 facility: Treant city: Emmen country: Netherlands lat: 52.77917 lon: 6.90694 facility: Admiraal de Ruyter Ziekenhuis city: Goes country: Netherlands lat: 51.50417 lon: 3.88889 facility: Beatrixziekenhuis city: Gorinchem country: Netherlands lat: 51.83652 lon: 4.97243 facility: Groene Hart Ziekenhuis city: Gouda country: Netherlands lat: 52.01667 lon: 4.70833 facility: Saxenburgh city: Hardenberg country: Netherlands lat: 52.57583 lon: 6.61944 facility: St. Jansdal Ziekenhuis city: Harderwijk country: Netherlands lat: 52.34167 lon: 5.62083 facility: Elkerliek Ziekenhuis city: Helmond country: Netherlands lat: 51.48167 lon: 5.66111 facility: Tergooi MC city: Hilversum country: Netherlands lat: 52.22333 lon: 5.17639 facility: Medisch Centrum Leeuwarden city: Leeuwarden country: Netherlands lat: 53.20139 lon: 5.80859 facility: Leiden University Medical Center city: Leiden country: Netherlands lat: 52.15833 lon: 4.49306 facility: Alrijne Ziekenhuis city: Leiderdorp country: Netherlands lat: 52.15833 lon: 4.52917 facility: Canisius Wilhelmina Ziekenhuis city: Nijmegen country: Netherlands lat: 51.8425 lon: 5.85278 facility: Laurentius Ziekenhuis city: Roermond country: Netherlands lat: 51.19417 lon: 5.9875 facility: Bravis ziekenhuis city: Roosendaal country: Netherlands lat: 51.53083 lon: 4.46528 facility: Ikazia Ziekenhuis city: Rotterdam country: Netherlands lat: 51.9225 lon: 4.47917 facility: Maasstad Ziekenhuis city: Rotterdam country: Netherlands lat: 51.9225 lon: 4.47917 facility: Ommelander Ziekenhuis city: Scheemda country: Netherlands lat: 53.17333 lon: 6.97222 facility: ZorgSaam Zorggroep Zeeuws-Vlaanderen city: Terneuzen country: Netherlands lat: 51.33583 lon: 3.82778 facility: Bernhoven city: Uden country: Netherlands lat: 51.66083 lon: 5.61944 facility: Diakonessenhuis city: Utrecht country: Netherlands lat: 52.09083 lon: 5.12222 facility: St Antonius city: Utrecht country: Netherlands lat: 52.09083 lon: 5.12222 facility: VieCuri Medisch Centrum city: Venlo country: Netherlands lat: 51.37 lon: 6.16806 facility: Streekziekenhuis Koninging Beatrix city: Winterswijk country: Netherlands lat: 51.9725 lon: 6.71944 facility: Zaans Medisch Centrum city: Zaandam country: Netherlands lat: 52.43854 lon: 4.82643 hasResults: False

 nctId: NCT06275945 id: 1010073 briefTitle: Feasibility Study of A VoRo UrologIc ScaffolD (ARID) acronym: ARID overallStatus: RECRUITING date: 2023-04-03 date: 2026-07-30 date: 2026-10-30 date: 2024-02-23 date: 2024-02-23 name: Levee Medical, Inc. class: INDUSTRY name: RQMplus briefSummary: The objective of this study is to evaluate the safety and performance of the Voro Urologic Scaffold as a prophylactic treatment for post-prostatectomy stress urinary incontinence.

The study is a prospective, multicenter, single arm study. Up to 40 subjects will be treated at up to 3 investigational sites in Panama. Subjects will be followed up post-treatment at catheter removal, 6 weeks post prostatectomy, 3 months, 6 months, 12 months and 2 years. conditions: Stress Urinary Incontinence conditions: Radical Prostatectomy studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, non-randomized first-in-man study primaryPurpose: PREVENTION masking: NONE count: 40 type: ESTIMATED name: Voro Urologic Scaffold measure: The change in pad weight of 24-hour pad weight test from baseline to post procedure 6-month and 12-month follow-ups. measure: The change in pad weight of 1-hour pad weight test from baseline to post procedure 6-month and 12-month follow-ups. measure: The changes in the standing cough test (SCT) from baseline to post procedure 6-month and 12-month follow-ups. sex: MALE minimumAge: 45 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Hospital status: RECRUITING city: Panama City state: Punta Pacifica country: Panama name: Natalia Vega role: CONTACT email: nvega@candmresearch.org name: Margelis Munoz role: CONTACT phone: 507-6499-9304 email: mmunoz@candmresearch.org name: Gustavo Espino, MD role: PRINCIPAL_INVESTIGATOR lat: 8.9936 lon: -79.51973 hasResults: False

 nctId: NCT06275932 id: TermoNeo/2023 briefTitle: Management of Healthy Newborn's Body Temperature at Birth overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-05-31 date: 2024-02-23 date: 2024-02-23 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: At birth, the newborn begins a process of adaptation to extrauterine life. One of the phases of this stabilization process is the maintenance of body temperature; indeed, the newborn passes from a warm environment (mother's womb) of around 37°C to an environment with a temperature lower (delivery room) and, therefore, must implement a series of physiological processes to be able to maintain body temperature constant and within ideal ranges through a balance between production and heat loss.

Hypothermia at birth could cause risks or comorbidities such as an increased risk of infant mortality, hypoglycemia, sepsis, metabolic acidosis, respiratory distress syndrome (RDS) and intraventricular hemorrhage (IVH).

One of the factors that affects heat loss in the delivery room is the relationship between surface area, volume and body mass of the newborn. The decrease in body temperature is directly related to gestational age and weight at birth; indeed, this problem is much more present in premature and/or low weight newborns at birth. Even if a full-term newborn has a more developed thermoregulation center than a preterm newborn, this does not mean that this type of newborns is not at risk heat dispersion.

To date, the strategies that are implemented for the physiological newborn are documented in the literature are, in addition to the heat chain described by the World Health Organization (WHO), the implementation of skin-to-skin contact (skin to skin) mother-newborn.

Some studies demonstrating the beneficial effect of this procedure on maintenance of the newborn's body temperature.

The aim of this study is to evaluate two healthcare interventions to prevent heat loss of healthy newborns at birth. conditions: Newborn, Infant conditions: Body Temperature conditions: Delivery Room studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 776 type: ESTIMATED name: Interventional group name: Standard of care group measure: Newborn's body temperature at the end of skin-to-skin contact measure: Newborns' proportion with a body temperature < 36.5°C when arriving at the nursery measure: Newborns' proportion with temperature below 36.0°C at the end of skin-to-skin contact and at arrival in the nursery measure: Newborns' proportion with moderate hypothermia (temperature 36.0 - 36.4°C) at the end of skin-to-skin contact and at arrival in the nursery measure: Newborns' proportion with hyperthermia (temperature > 37.5°C) at the end of skin-to-skin contact and at arrival in the nursery measure: Newborns' average temperature one hour after arriving at the nursery measure: Duration of nursery stay measure: Duration of skin-to-skin contact measure: Newborns' proportion exclusively breastfed at discharge measure: Type of breastfeeding at discharge measure: Newborns' proportion with hypoglycemia during hospitalization measure: Newborns' proportion affected by respiratory distress syndrome measure: Newborns' proportion transferred to the Neonatal Intensive Care Unit (NICU) measure: Newborns' weight loss at discharge measure: Mortality before discharge from hospital sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico city: Milan zip: 20122 country: Italy name: Gabriele Sorrentino, pedRN role: CONTACT phone: +393496060149 email: gabriele.sorrentino@policlinico.mi.it name: Gabriele Sorrentino, pedRN role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06275919 id: IOV-BT-1-2023 MIRAGE briefTitle: Regorafenib for Recurrent Grade 2 and 3 Meningioma (MIRAGE Trial) acronym: MIRAGE overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-12 date: 2027-03 date: 2024-02-23 date: 2024-03-15 name: Istituto Oncologico Veneto IRCCS class: OTHER name: Bayer briefSummary: The focus of this study will be to investigate whether Regorafenib demonstrates antitumor activity against recurrent grade II or III meningiomas.

Small trials and case series suggest clinical relevant activity of several VEGF inhibitors such as sunitinib, bevacizumab and valatinib reporting a 6m-PFS rate of 42-64%. Indeed, VEGF and VEGF receptors (VEGFR) are regularly overexpressed in meningiomas and can correlate with outcome.

Regorafenib inhibits angiogenic receptor tyrosine kinases (RTKs) and is highly selective for VEGFR1/2/3; moreover Regorafenib inhibits PDGFRB, FGFR1 and oncogenic intracellular signalling cascades involving c-RAF/RAF1 and BRAF highly expressed in meningiomas.

Noteworthy, Regorafenib showed antitumor activity in vitro and in vivo in a recent study; indeed, Regorafenib showed significant inhibition of meningioma cell motility and invasion and in vivo, mice with orthotopic meningioma xenografts showed a reduced volume of signal enhancement in MRI following Regorafenib therapy; this translated in a significantly increased overall survival time (p\<0.05) for Regorafenib treated mice.

Moreover, Regorafenib showed good efficacy in different cancer types, such as colorectal cancer, GIST, hepatocellular carcinoma and glioblastoma (REGOMA trial) , maintainingmaintaining a good quality of life. conditions: Meningioma, Malignant studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 104 type: ESTIMATED name: Regorafenib 40 MG Oral Tablet name: Local Standard of Care measure: Progression free survival (PFS) measure: Overall survival (OS) measure: Objective response rate (ORR) measure: Patient Reported Outcomes (PROs) measure: Patient Reported Outcomes (PROs) measure: Toxicity during treatment measure: Disease control rate (DCR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRST Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" city: Meldola state: Forlì-Cesena country: Italy name: Lorena Gurrieri, MD role: CONTACT email: lorena.gurrieri@irst.emr.it name: Lorena Gurrieri, MD role: PRINCIPAL_INVESTIGATOR lat: 44.12775 lon: 12.0626 facility: Humanitas Cancer Center city: Rozzano state: Milano country: Italy name: Matteo Simonelli, MD role: CONTACT email: matteo.simonelli@hunimed.eu name: Matteo Simonelli, MD role: PRINCIPAL_INVESTIGATOR lat: 45.38193 lon: 9.1559 facility: Ospedale San Paolo city: Bari country: Italy name: Valeria Internò, MD role: CONTACT email: valeria.interno@libero.it name: Valeria Internò, MD role: PRINCIPAL_INVESTIGATOR lat: 41.11148 lon: 16.8554 facility: Ospedale Bellaria - AUSL Bologna city: Bologna country: Italy name: Enrico Franceschi, MD role: CONTACT email: e.franceschi@isnb.it name: Enrico Franceschi, MD role: PRINCIPAL_INVESTIGATOR lat: 44.49381 lon: 11.33875 facility: Azienda Ospedaliero Universitaria Careggi city: Firenze country: Italy name: Isacco Desideri, MD role: CONTACT email: isacco.desideri@unifi.it name: Isacco Desideri, MD role: PRINCIPAL_INVESTIGATOR lat: 43.77925 lon: 11.24626 facility: Policlinico San Martino city: Genova country: Italy name: Elisa Bennicelli, MD role: CONTACT email: elisa.bennicelli@hsanmartino.it name: Elisa Bennicelli, MD role: PRINCIPAL_INVESTIGATOR lat: 44.40478 lon: 8.94438 facility: Spedali Riuniti city: Livorno country: Italy name: Anna Luisa Di Stefano, MD role: CONTACT email: annaluisa.distefano@uslnordovest.toscana.it name: Anna Luisa Di Stefano, MD role: PRINCIPAL_INVESTIGATOR lat: 43.54427 lon: 10.32615 facility: Azienda Ospedaliero Universitaria G. Martino city: Messina country: Italy name: Nicola Silvestris, MD role: CONTACT email: n.silvestris@unime.it name: Nicola Silvestris, MD role: PRINCIPAL_INVESTIGATOR lat: 38.19394 lon: 15.55256 facility: Fondazione IRCCS Istituto Neurologico Carlo Besta city: Milano country: Italy name: Paola Gaviani, MD role: CONTACT email: paola.gaviani@istituto-besta.it name: Paola Gaviani, MD role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 facility: IRCCS Ospedale San Raffaele city: Milano country: Italy name: Giulia Berzero, MD role: CONTACT email: berzero.giulia@hsr.it name: Giulia Berzero, MD role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 facility: Ospedale del Mare city: Napoli country: Italy name: Bruno Daniele, MD role: CONTACT email: b.daniele@libero.it name: Bruno Daniele, MD role: PRINCIPAL_INVESTIGATOR lat: 40.85216 lon: 14.26811 facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS city: Roma country: Italy name: Silvia Chiesa, MD role: CONTACT email: silvia.chiesa@policlinicogemelli.it name: Silvia Chiesa, MD role: PRINCIPAL_INVESTIGATOR lat: 41.89193 lon: 12.51133 facility: IRCCS Istituto Tumori Regina Elena city: Roma country: Italy name: Veronica Villani, MD role: CONTACT email: veronica.villani@ifo.it name: Veronica Villani, MD role: PRINCIPAL_INVESTIGATOR lat: 41.89193 lon: 12.51133 facility: Policlinico Umberto I - Università Sapienza Roma city: Roma country: Italy name: Giuseppe Minniti, MD role: CONTACT email: giuseppe.minniti@uniroma1.it name: Giuseppe Minniti, MD role: PRINCIPAL_INVESTIGATOR lat: 41.89193 lon: 12.51133 facility: A.O.U. Città della Salute e della Scienza di Torino city: Torino country: Italy name: Roberta Rudà, MD role: CONTACT email: roberta.ruda@unito.it name: Roberta Rudà, MD role: PRINCIPAL_INVESTIGATOR lat: 45.07049 lon: 7.68682 hasResults: False

 nctId: NCT06275906 id: NAFLD-POS5 briefTitle: Influence of a Mediterranean Diet Combined With a Physical Activity Intervention, on NAFLD and Inflammation Parameters. acronym: NAFLD-POS5 overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2025-04-08 date: 2026-04-08 date: 2024-02-23 date: 2024-02-23 name: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis class: OTHER name: Russo Francesco name: Cozzolongo Raffaele name: Shahini Endrit name: Zappimbulso Marianna name: Giannuzzi Vito name: De Nucci Sara name: Rinaldi Roberta name: Sila Annamaria name: Tatoli Rossella name: Cerabino Nicole name: Donghia Rossella name: Franco Isabella name: Bianco Antonella name: Curci Ritanna name: Bagnato Claudia Beatrice name: Sciarra Sabrina name: Prospero Laura name: Serino Grazia name: Scalavino Viviana name: Piccinno Emanuele name: Pesole Pasqua Letizia name: Coletta Sergio name: Stabile Dolores name: Riezzo Giuseppe name: Ancona Anna name: D'Attoma Benedetta name: Ignazzi Antonia briefSummary: The study in question is an interventional study with nutritional intervention.

The aim of the study is to evaluate whether the adoption of two different models of Mediterranean Diet, based on the different percentage of carbohydrates and lipids, associated with a program of moderate intensity aerobic physical exercise, in patients with obesity and NAFLD can exercise, after only 3 months, effects on:

* specific aspects associated with NAFLD, such as the degree of hepatic steatosis and fibrosis;
* circulating levels of molecules correlated with the degree of generalized and hepatic inflammation and the blood concentrations of metabolic and cardiovascular risk factors associated with abdominal obesity;
* intestinal barrier;
* body composition;
* intestinal microbiota;
* symptoms of IBS (irritable bowel syndrome) in patients with NAFLD. conditions: NAFLD conditions: Obesity conditions: IBS studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study evaluates the effects of two different Mediterranean Diet models, based on different percentages of macronutrients, on NAFLD and Metabolic Risk.

The Mediterranean Diet is associated with a program of moderate intensity aerobic physical exercise (walking) carried out 3 times a week for 3 months. primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Mediterranean diet and moderate intensity physical exercise (outdoor walking). measure: The effect of intervention on CAP value measure: The effect of intervention on FLI value measure: The effect of intervention on routine blood chemistry parameters, relating to NAFLD and fibrosis, nutritional status, inflammatory status and metabolic and cardiovascular risk measure: The effect of the intervention on the integrity of the intestinal barrier measure: The effect of the intervention on the Gastrointestinal Symptoms measure: The effect of the intervention on the Body Composition sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Irccs Saverio de Bellis city: Castellana Grotte state: Bari zip: 70013 country: Italy lat: 40.88643 lon: 17.16549 hasResults: False

 nctId: NCT06275893 id: ACM01 briefTitle: IC14 (Atibuclimab) in Arrhythmogenic Cardiomyopathy overallStatus: RECRUITING date: 2024-03-29 date: 2025-02-01 date: 2025-08-01 date: 2024-02-23 date: 2024-04-02 name: Implicit Bioscience class: INDUSTRY briefSummary: The goal of this clinical trial is to test IC14 (atibuclimab) in patients with arrhythmogenic cardiomyopathy (ACM) and who have an implantable cardoverter/defibrillator in place. ACM is also called arrhythmogenic right ventricular dysplasia (ARV) or arrhythmogenic right ventricular cardiomyopathy (ARVC). The main questions the study aims to answer are the effect of treatment on blood markers of inflammation, safety, and pharmacokinetics. There will also be measurements of myocardial imaging of C-C chemokine receptor type 2 (CCR2+) immune cells (optional), monitoring of cardiac arrhythmias using the patient's pre-existing intracardiac cardioverter/defibrillator (ICD) and a Holter monitor, electrocardiogram (ECG), echocardiogram (ECHO), and blood tests. Results will be compared to baseline; there is no inactive placebo treatment group.

Participants will be asked to undergo screening and baseline testing, then receive 4 intravenous infusions with blood measurements before and after the infusion (including 24, 48, and 72 hours and 7, 14, and 28 days). Participants will be offered specialized scanning of the heart muscle, and will be asked to provide recordings from their ICD, undergo Holter monitoring twice, and have electrocardiograms (ECG), echocardiograms (ECHO) and blood tests. conditions: Arrhythmogenic Right Ventricular Dysplasia conditions: Arrhythmogenic Left Ventricular Cardiomyopathy conditions: Arrhythmogenic Right Ventricular Cardiomyopathy 1 conditions: Arrhythmogenic Cardiomyopathy studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Open-label treatment with IC14. Participant outcomes will be compared to baseline. Pharmacokinetics will be measured. primaryPurpose: TREATMENT masking: NONE count: 5 type: ESTIMATED name: IC14 measure: Safety: Treatment-emergent adverse events and serious adverse events measure: Safety: Incidence of anti-drug antibodies measure: Inflammatory biomarker C-reactive protein measure: CCR2+ Myocardial Imaging (optional) measure: Ventricular tachycardia measure: Ventricular premature contractions measure: Sustained and non-sustained ventricular tachycardia measure: Treated ventricular tachycardia measure: Atrial premature contractions measure: New York Heart Association (NYHA) Functional Class measure: Implantable cardioverter/defibrillator (ICD) discharges measure: Quality-of-Life Score determined by the Kansas City Cardiomyopathy Questionnaire measure: Disease biomarker Troponin I measure: Disease biomarker N-terminal B-type natriuretic peptide (NT-pro-BNP) measure: Inflammatory biomarker interleukin (IL)1-beta measure: Pharmacokinetics: Serum IC14 concentration versus time curve measure: Pharmacokinetics: Peak serum IC14 concentration measure: Pharmacokinetics: Half life measure: Pharmacodynamics: Receptor Occupancy measure: Pharmacodynamics: Effective Concentration 95% sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Washington University School of Medicine status: RECRUITING city: Saint Louis state: Missouri zip: 63110 country: United States name: Philip S. Cuculich, MD role: PRINCIPAL_INVESTIGATOR lat: 38.62727 lon: -90.19789 hasResults: False

 nctId: NCT06275880 id: F-2023-3201-066 briefTitle: Intraarticular Collagen in Patients With Gonarthrosis overallStatus: COMPLETED date: 2023-04-01 date: 2023-07-30 date: 2024-01-10 date: 2024-02-23 date: 2024-02-23 name: Instituto Mexicano del Seguro Social class: OTHER_GOV briefSummary: The objective of this clinical trial is to verify the effectiveness of polyvinyl pyrrolidone collagen in all patients with symptomatic gonarthrosis grades II-IV in patients over 40 years of age. The main objectives that this study aims to answer are the following:

1. - Document the effectiveness of intra-articular polyvinylpyrrolidone collagen in the treatment of symptomatic gonarthrosis.
2. - Compare the intensity of pain, the degree of stiffness and functionality of the joint, prior to application and one month after the therapeutic intervention.
3. - Identify demographic, clinical and therapeutic factors that influence the effectiveness of intra-articular PVP collagen in the treatment of symptomatic gonarthrosis.

Patients diagnosed with symptomatic gonarthrosis Grade II-IV, referred to the Physical Medicine and Rehabilitation service within 3 months, will be selected. Two study groups will be assigned: GROUP those who received intra-articular infiltration of PVP Collagen, GROUP B: patients who received conservative treatment. Through rehabilitation with a home program for one month, in both cases, ENA and the WOMAC scale will be evaluated at the beginning of the study and after 4 weeks. conditions: Gonarthrosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 130 type: ACTUAL name: Intra-articular infiltration of PVP Collagen name: Rehabilitation measure: Western Ontario and McMaster Universities Osteoarthritis Index - Pain measure: Western Ontario and McMaster Universities Osteoarthritis Index - stiffness measure: Western Ontario and McMaster Universities Osteoarthritis Index - functionality measure: Number Analog Scale for pain sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital General Regional No. 1 Lic. Ignacio García Téllez city: Mérida state: Yucatán zip: 97155 country: Mexico lat: 20.97537 lon: -89.61696 hasResults: False

 nctId: NCT06275867 id: SOPRIMA//T023635 briefTitle: Improved Access to Quality Care and Healthcare Use overallStatus: RECRUITING date: 2024-01-20 date: 2024-06-10 date: 2024-08-30 date: 2024-02-23 date: 2024-02-23 name: London School of Economics and Political Science class: OTHER name: University of Witwatersrand, South Africa briefSummary: This study is an individual-level randomised controlled trial which looks at the effect of providing free access to higher quality providers in urban South Africa. The study will recruit about 1,500 individuals with a child aged 5 or under. They will be randomly allocate to a control group (CONTROL) with the default free access to government facilities or one of the two treatment groups where they will have free access to private providers located either relatively close (CONVENIENT) by or relatively far (INCONVENIENT). The primary outcomes be overuse and underuse of healthcare services for children under 5 conditions: Health Care Utilization conditions: Health Knowledge, Attitudes, Practice conditions: Health, Subjective studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: CARE_PROVIDER count: 1500 type: ESTIMATED name: Free high-quality care name: Close distance name: Far distance measure: Underuse measure: Overuse measure: Illness duration measure: Out-of-pocket expenditures measure: Health knowledge sex: ALL minimumAge: 2 Months maximumAge: 6 Years stdAges: CHILD facility: HDSS Soweto clusters status: RECRUITING city: Soweto state: Gauteng country: South Africa name: Nomalanga Boyce role: CONTACT email: nomalanga.boyce@wits-vida.org lat: -26.26781 lon: 27.85849 hasResults: False

 nctId: NCT06275854 id: 22265 briefTitle: YASU Research Registry: For Young Adults With Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2030-05-01 date: 2030-05-01 date: 2024-02-23 date: 2024-02-23 name: Young Adult Survivors United class: OTHER name: Staunton Farm Foundation name: Elsie H. Hillman Foundation briefSummary: The goal of this observational research registry is to learn about health, wellbeing, and needs of survivors of young adult cancer (diagnosed between the ages of 18 and 39). The main question\[s\] it aims to understand are:

* What are the levels of depression, anxiety, social support, and financial distress
* Determine effectiveness of YASU programming by measuring changes over time

With this registry, the investigators also plan to identify survivors who may be eligible for participation in future research studies pertaining to young adult cancer.

Participants will be asked to complete electronic surveys every 6 to 12 months during participation in the registry. conditions: Cancer conditions: Leukemia conditions: Sarcoma conditions: Germ Cell Cancer conditions: Lymphoma conditions: Colorectal Cancer conditions: Melanoma conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 5000 type: ESTIMATED measure: Anxiety measure: Depressive symptoms measure: Social Support measure: Financial Toxicity measure: Needs Assessment measure: Name, address, email, phone number sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06275841 id: C4891035 briefTitle: A Study to Learn If the Study Medicine Esomeprazole Changes How the Body Processes the Other Study Medicine Vepdegestrant overallStatus: RECRUITING date: 2024-02-23 date: 2024-05-03 date: 2024-05-24 date: 2024-02-23 date: 2024-03-22 name: Pfizer class: INDUSTRY name: Arvinas Estrogen Receptor, Inc. briefSummary: The purpose of the study is to investigate the effect of multiple doses of a proton-pump inhibitor (PPI) esomeprazole on the PK of vepdegestrant under fed conditions in healthy adult participants.

All participants in this study will receive one dose of vepdegestrant alone by mouth in Period 1. In Period 2, everyone will receive esomeprazole by mouth once a day for multiple days. Participants will also receive one dose of vepdegestrant by mouth. The levels of vepdegestrant in Period 1 will be compared to the levels of vepdegestrant in Period 2 to determine if the PPI affects how vepdegestrant is processed differently in healthy adults. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 12 type: ESTIMATED name: vepdegestrant name: esomeprazole measure: Maximum observed plasma concentration (Cmax) of vepdegestrant when vepdegestrant is administered alone measure: Maxium observed plasma concentration of vepdegestrant when vepdegestrant is administered with esomeprazole measure: Area under the curve from time zero to extrapolated infinite time (AUCinf) when vepdegestrant is administered alone measure: Area under the curve from time zero to extrapolated infinite time (AUCinf) when vepdegestrant is administered with esomeprazole measure: number of participants with treatment-emergent adverse events (AEs) and serious adverse events (SAEs) measure: Number of participants with clinical laboratory abnormalities measure: Number of participants with electrocardiogram (ECG) abnormalities measure: Number of participans with clinically significant change from baseline in vital signs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pfizer Clinical Research Unit - New Haven status: RECRUITING city: New Haven state: Connecticut zip: 06511 country: United States lat: 41.30815 lon: -72.92816 hasResults: False

 nctId: NCT06275828 id: PoliceGeneralHospiral briefTitle: The Effect of Perioperative and Postoperative Music Reduces Pain Perception After Anterior Cruciate Ligament Reconstruction overallStatus: ACTIVE_NOT_RECRUITING date: 2022-12-15 date: 2023-07-31 date: 2024-02-20 date: 2024-02-23 date: 2024-02-23 name: Police General Hospital, Thailand class: OTHER briefSummary: study the effect of music therapy in pre-operative and post operative period and measure the out come by the visual analog scale (pain score) and analgesic drug use such as morphine and the anxiety score conditions: Anterior Cruciate Ligament Tear studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 46 type: ACTUAL name: slow beat mesic listening by headphone measure: visual analog scale measure: analgesic drug use measure: Amsterdam Preoperative Anxiety and Information Scale sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Police General Hospital city: Bangkok state: Pathuwam zip: 10330 country: Thailand lat: 13.75398 lon: 100.50144 hasResults: False

 nctId: NCT06275815 id: R01DC020958 type: NIH link: https://reporter.nih.gov/quickSearch/R01DC020958 briefTitle: Promoting Caregiver Implementation of an Effective Early Learning Intervention overallStatus: RECRUITING date: 2024-04-10 date: 2028-07-31 date: 2028-07-31 date: 2024-02-23 date: 2024-04-12 name: Ohio State University class: OTHER name: Nationwide Children's Hospital briefSummary: The goal of this study is to examine the impact of a caregiver-implemented shared reading program, Sit Together and Read (STAR), on children ages 4 to 5 with developmental language disorder. The main questions it aims to answer are:

* how much STAR impacts children's literacy skills in the short-term and long-term--up to two-years after completing STAR.
* how do caregiver supports in the form of small monetary rewards or encouraging texts help caregivers to implement STAR at its intended frequency of sessions per week.

Caregiver participants will be assigned to either a control group or one of three STAR groups. Children's skills related to literacy and learning will be assessed before the intervention starts, at the end of the intervention, and every six months post-intervention for two years.

Researchers will determine the short term and long term impacts of STAR compared to the control group. Researchers will compare the three STAR conditions to see if the rewards or encouragement helped parents to follow through with completing more STAR sessions. conditions: Developmental Language Disorder conditions: Reading; Difficult studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 320 type: ESTIMATED name: Sit Together and Read (STAR) name: Monetary Reward name: Text Encouragement measure: Preschool Word and Print Awareness (PWPA) measure: Phonological Awareness Literacy Screening (PALS): Alphabet Knowledge and Name Writing measure: The Reading House (THR) measure: Woodcock Johnson Test of Achievement- IV (WJ-IV): Word Attack and Letter-Word Identification measure: Woodcock Johnson Test of Achievement- IV (WJ-IV): Spelling, Passage Comprehension sex: ALL minimumAge: 48 Months maximumAge: 66 Months stdAges: CHILD facility: Schoenbaum Family Center; Crane Center for Early Childhood Research and Policy status: RECRUITING city: Columbus state: Ohio zip: 43201 country: United States name: Jennifer M Bostic, MA role: CONTACT phone: 614-292-5715 email: bostic.18@osu.edu name: Laura M Justice, PhD role: PRINCIPAL_INVESTIGATOR name: Rebecca Dore, PhD role: SUB_INVESTIGATOR name: Hui Jiang, PhD role: SUB_INVESTIGATOR lat: 39.96118 lon: -82.99879 facility: Nationwide Children's Hospital status: RECRUITING city: Columbus state: Ohio zip: 43205 country: United States name: Jamie B Boster, PhD role: CONTACT phone: 614-722-8756 email: jamie.boster@nationwidechildrens.org name: Jamie B Boster, PhD, CCC-SLP role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False

 nctId: NCT06275802 id: 22-5.1T/2 briefTitle: The Effect of Nutrition Education Interventions for Adolescents overallStatus: RECRUITING date: 2022-06-06 date: 2023-12-30 date: 2024-06-30 date: 2024-02-23 date: 2024-02-23 name: Ege University class: OTHER briefSummary: The aim of this study is to determine the effect of nutrition education on nutritional literacy, nutritional status, eating habits and eating behavior in high school students. The research will be conducted in six high schools, three of which are intervention schools and three of which are control schools It is planned that a total of 1000 students will be included in the study from the intervention school and 1000 students from the control school. At the beginning of the study (June 2022), an introductory form (sociodemographic characteristics, body image (Stunkart scale), dietary habits, knowledge about weight status) was applied to all students. Adolescent Nutrition Literacy Scale (ANLS), Instrument of Nutrition Literacy, Mediterranean Diet Quality Index (KID-MED), Eating Attitudes Test 26 (EAT-26), International Physical Activity Questionnaire Short Form (IPAQ) were applied, anthropometric measurements and three-day food consumption records were taken. During the study, nutrition initiatives consisting of 8 modules will be made to the intervention schools. Control schools will not be interfered with during this period.At the end of the study, the procedures applied at the beginning will be repeated. conditions: Nutrition, Healthy conditions: Nutrition Disorders in Adolescence conditions: Eating Habit conditions: Eating Behavior conditions: Body Image studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 1000 type: ESTIMATED name: Nutrition Education name: nutritional status, eating habits measure: nutrition literacy measure: Mediterranean Diet Quality Index (KID-MED) measure: Eating Attitudes Test 26 (EAT-26) measure: weight and height measurement measure: waist circumference measurement measure: Food Consumption Record measure: International Physical Activity Questionnaire (IPAQ- Short Form) sex: ALL maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Menemen District Directorate of National Education status: RECRUITING city: İzmir country: Turkey name: Sibel ÖZER role: CONTACT phone: (0232) 832 26 29 lat: 38.41273 lon: 27.13838 hasResults: False

 nctId: NCT06275789 id: 2023-268 briefTitle: Mix of Demineralized Freeze-Dried Bone Allograft and Deproteinized Bovine Bone Mineral: a Possible Solution for Alveolar Ridge Preservation? overallStatus: RECRUITING date: 2024-01-26 date: 2025-06 date: 2025-06 date: 2024-02-23 date: 2024-04-09 name: Nova Southeastern University class: OTHER name: Geistlich Pharma AG name: ZimVie briefSummary: The purpose of the study is to compare a new grafting material for alveolar ridge preservation to a commonly used and well studied material. Alveolar ridge dimensions as well as histology will be compared. conditions: Alveolar Ridge Preservation conditions: Dental Extraction conditions: Bone Graft studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Alveolar ridge preservation measure: changes in horizontal dimensions of the alveolar ridge measure: changes in vertical dimensions of the alveolar ridge measure: vital bone percentage measure: thickness of the buccal plate in mm and its influence on the ridge dimension measure: the thickness of the lingual plate in mm and its influence on the ridge dimension measure: the thickness of the overlying buccal soft tissue in mm and its influence on the ridge dimension measure: the position of extraction site (maxilla vs. mandible) and its influence on the ridge dimension measure: # of cigarettes and its influence on the ridge dimension measure: oral hygiene using the plaque index and its influence on the ridge dimension sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nova Southeastern University status: RECRUITING city: Fort Lauderdale state: Florida zip: 33328 country: United States name: Saynur Vardar-Sengul, DDS, PhD role: CONTACT phone: 954-262-1815 email: svardarsengul@nova.edu lat: 26.12231 lon: -80.14338 hasResults: False

 nctId: NCT06275776 id: OC-2022-005 briefTitle: HIP-STITCH (Wound Recovery After THA) overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2028-03-01 date: 2028-05-01 date: 2024-02-23 date: 2024-03-05 name: Reinier Haga Orthopedisch Centrum class: OTHER briefSummary: This prospective randomised trial will investigate the effect of four different suturing techniques (Monocryl, Vicryl Rapide with Indermil skin glue, Dermabond Prineo, and Stryker Zip) on the amount of aberrant wound recovery within 14 days after total hip arthroplasty at the RHOC in Zoetermeer, The Netherlands.

This will be done by assessing photographs of the plaster and photographs of the operation wound with a self-developed classification model. The photographs of the plaster will be taken by the test subject at home at 3 days and 11 days postoperatively.

The photographs of the operation wound will be taken by a member of the research team, and the doctor's assistant, respectively, during a visit to the outpatient clinic at 7 days and 14 days postoperatively.

Hypothesis: Monocryl sutures give the highest amount of aberrant wound recovery within fourteen days after primary THA. conditions: Wound Healing Disturbance of studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Test subjects are randomised into one of four study arms. Each study arm corresponds with one of the suturing techniques that are going to be used to close the superficial skin after Total Hip Arthroplasty. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: No one in this study can reasonably be blinded for the suturing technique during the duration of the study, since the suturing techniques differ substantially in shape, appearance and size. The only blinding in this study is the blinding of the outcome assessor to data of the test subjects. The assessor will only see the photographs of the wound/plaster, and the moment on which the photograph was taken. Additional information on the test subject, such as age, comorbidities, et cetera, will be withheld from the assessor. whoMasked: OUTCOMES_ASSESSOR count: 236 type: ESTIMATED name: Ethicon Monocryl Smooth Suture name: Ethicon Vicryl Rapide Braided Suture name: Flexifuze Indermil Topical Skin Adhesive name: Dermabond Prineo Skin Closure System name: Stryker Zip Skin Closure System measure: Number of Participants with Aberrant Wound Recovery measure: Number of Participants with Superficial or Deep Wound Infection measure: Patient reported outcome measure: Satisfaction scores suturing method (Questionnaire) measure: Costs measure: Patient reported outcome measure: Score of Self-removal of the suturing technique (Questionnaire) measure: Patient reported outcome measure: Number of Participants with Other postoperative symptoms measure: Number and Type of Complications measure: Number of Visits to a Healthcare Professional sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Reinier Haga Orthopedisch Centrum city: Zoetermeer state: Zuid Holland zip: 2725NA country: Netherlands name: Brechtje Hesseling, Msc role: CONTACT phone: 003179-2065595 email: onderzoek@rhoc.nl name: Nina MC Mathijssen, Dr. role: CONTACT phone: 003179-2065595 email: onderzoek@rhoc.nl lat: 52.0575 lon: 4.49306 hasResults: False

 nctId: NCT06275763 id: 2020/ABM/01/00037 briefTitle: Optimal Medical Treatment of Difficult-to-treat Hypertension acronym: OPTIMAL-HT overallStatus: RECRUITING date: 2023-10-20 date: 2025-12-01 date: 2025-12-31 date: 2024-02-23 date: 2024-02-23 name: National Institute of Cardiology, Warsaw, Poland class: OTHER briefSummary: The purpose of this study is to evaluate best medical management to achieve the BP goals of ESC/ESH (120-129 / 70-79 mmHg) in HT patients who are \<65 years old and ineffectively treated (BP ≥ 130/80 mg) with 3 or more antihypertensive drugs conditions: Hypertension studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 2500 type: ESTIMATED name: Phase C: Eplerenone name: Phase C: Spironolactone name: Phase C: Torasemide name: Phase B: Triplixam / Elestar HCT name: Phase A: Confirmation of uncontrolled hypertension measure: Patients with uncontrolled BP on ABPM measure: Patients with controlled BP after 12 weeks on triple SPC measure: Systolic BP reduction on 4th antihypertensive drug measure: Percentage of patients with BP controlled confirmed by HBPM measure: Consistency of the rate of uncontrolled BP measure: Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by OBPM measure: Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by HBPM measure: Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by ABPM measure: Percentage of patients requiring an increase in the dose measure: Consistency of the rate of uncontrolled BP measure: The magnitude of the decrease in SBP and DBP on OBPM, ABPM and HBPM after 12 weeks measure: The magnitude of changes in HBPM and ABPM derived indices after 12 weeks measure: Phase C measure: Changes of SBP on ABPM (24h mean) after 12 weeks of treatment measure: Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by OBPM measure: Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by HBPM measure: Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by ABPM measure: Phase C continuation measure: Phase C continuation measure: Changes in HBPM and ABPM derived indices after 12 weeks - comparison of treatment groups measure: Changes of SBP on ABPM (24h mean) after 24 weeks of treatment compared against spironolactone measure: Changes of SBP on ABPM (24h mean) after 24 weeks of treatment compared against baseline measure: Percentage of patients with controlled BP after 24 weeks of treatment, confirmed by OBPM - comparison between groups measure: Percentage of patients with controlled BP after 24 weeks of treatment, confirmed by HBPM - comparison between groups measure: Percentage of patients with controlled BP after 24 weeks of treatment, confirmed by ABPM - comparison between groups measure: Consistency of the rate of controlled BP between ABPM, HBPM and OBPM after 24 weeks measure: Changes in SBP and DBP on OBPM, ABPM and HBPM after 24 weeks of treatment - comparison between groups measure: Changes in HBPM and ABPM derived indices after 24 weeks of treatment - - comparison between groups measure: Percentage of patients requiring an increase in the dose of drugs used after 6 and 12 weeks - comparison between groups sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Institute of Cardiology status: RECRUITING city: Warsaw state: Mazowieckie zip: 04628 country: Poland name: Agata Skutnik role: CONTACT email: askutnik@ikard.pl lat: 52.22977 lon: 21.01178 hasResults: False

 nctId: NCT06275750 id: CEI 175/23 briefTitle: Non-surgical Spinal Decompression in Patients With Chronic Low Back Pain overallStatus: COMPLETED date: 2023-08-21 date: 2023-11-29 date: 2024-01-11 date: 2024-02-23 date: 2024-02-23 name: Hospital Civil de Guadalajara class: OTHER briefSummary: The goal of this quasi-experimental trial was to evaluate the effects of non-surgical spinal decompression on disability and pain in patients with chronic low back pain and sciatica throughout a two-month follow-up, and to analyze the relationship between demographic factors and clinical outcomes after a program of non-surgical spinal decompression.

The main questions it aims to answer were:

* Non-surgical spinal decompression is effective to reduce pain intensity and self-reported disability in patients with chronic low back pain and sciatica?
* Age, level of education and work activities are related with clinical outcome in patients treated with non-surgical spinal decompression?

Participants underwent eight sessions, three per week, with the BTL-6000 spinal decompression system. The study did not have a comparison group. conditions: Low Back Pain conditions: Sciatica conditions: Lumbar Disc Herniation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 39 type: ACTUAL name: Spinal decompression with BTL-6000 spinal decompression system (BTL Industries Ltd.) measure: Self-reported disability measure: Pain intensity sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Hospital Civil de Guadalajara Fray Antonio Alcalde city: Guadalajara state: Jalisco zip: 44280 country: Mexico lat: 20.66682 lon: -103.39182 hasResults: False

 nctId: NCT06275737 id: POP-UP G-128 briefTitle: POP-UP: a Single-arm, Two-cohort Study: Trimodal Prehab for Upper GI and Pancreatic Cancer acronym: POP-UP overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2027-03 date: 2027-03 date: 2024-02-23 date: 2024-02-23 name: GERCOR - Multidisciplinary Oncology Cooperative Group class: OTHER briefSummary: This is a multicenter, two-cohort, open-label, single-arm feasibility study. The primary objective is to assess the feasibility of the 8-week trimodal prehabilitation program alongside perioperative triplet chemotherapy in eligible patients with localized pancreatic ductal adenocarcinoma (PDAC) or oesogastric cancer (OGC) . conditions: Pancreatic Ductal Adenocarcinoma conditions: Esophageal Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Two-cohort, open-label, single-arm feasibility study primaryPurpose: OTHER masking: NONE count: 72 type: ESTIMATED name: Prehabilitation program measure: Rate of patients with successful completion of an 8-week trimodal prehabilitation program measure: Success rate (as defined above) for Adapted Physical Activity (APA), nutritional, and psychological interventions measured separately. measure: Health-related quality of life (HRQoL) assessment measure: Rate of patients who start and complete post-habilitation Adapted Physical Activity (APA) sessions measure: Nutritional status assessment measure: Physical/functional test assessment measure: Number of patients with reduced chemotherapy tolerance measure: Number of patients with chemotherapy dose modification measure: Rate of patients who complete the strategy measure: Number of patients with Granulocyte-colony stimulating factor (G-CSF) prescription and grade ≥ 2 neutropenia measure: Rate of patients with exocrine pancreatic insufficiency and the dose of pancreatic enzyme consumption measure: Rate of surgical complications measure: Overall survival (OS) assessment measure: Disease-free survival (DFS) assessment measure: Adherence to Adapted Physical Activity (APA) program assessment measure: Physical activity behavior changes assessment measure: Nurse coordination sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06275724 id: CKJX839A11401 briefTitle: Specified Drug-use Survey of Leqvio for s.c. Injection. overallStatus: RECRUITING date: 2024-03-04 date: 2027-12-31 date: 2027-12-31 date: 2024-02-23 date: 2024-04-26 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: The objective of this study is to evaluate the long-term safety of Leqvio in patients with familial hypercholesterolaemia or hypercholesterolaemia in post-marketing clinical practice conditions: Familial Hypercholesterolaemia conditions: Hypercholesterolaemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 560 type: ESTIMATED name: inclisiran measure: Number of patients with adverse events measure: Numbers of patients with serious adverse events, adverse events by severity, and adverse drug reactions measure: Number of patients with adverse events leading to discontinuation of treatment with the product measure: Percent change from baseline in LDL-C levels sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Novartis Investigative Site status: RECRUITING city: Handa state: Aichi zip: 475-0817 country: Japan lat: 34.88333 lon: 136.93333 facility: Novartis Investigative Site status: RECRUITING city: Ichinomiya state: Aichi zip: 491-8551 country: Japan lat: 35.3 lon: 136.8 facility: Novartis Investigative Site status: RECRUITING city: Komaki state: Aichi zip: 485-8520 country: Japan lat: 35.28333 lon: 136.91667 facility: Novartis Investigative Site status: RECRUITING city: Nagoya state: Aichi zip: 454-0933 country: Japan lat: 35.18147 lon: 136.90641 facility: Novartis Investigative Site status: RECRUITING city: Nagoya state: Aichi zip: 461-0045 country: Japan lat: 35.18147 lon: 136.90641 facility: Novartis Investigative Site status: RECRUITING city: Toyoake city state: Aichi zip: 470 1192 country: Japan lat: 35.038 lon: 136.99931 facility: Novartis Investigative Site status: RECRUITING city: Matsuyama state: Ehime zip: 791-8016 country: Japan lat: 33.83916 lon: 132.76574 facility: Novartis Investigative Site status: RECRUITING city: Fukuoka-city state: Fukuoka zip: 811-0213 country: Japan lat: 33.6 lon: 130.41667 facility: Novartis Investigative Site status: RECRUITING city: Kitakyushu state: Fukuoka zip: 800-0031 country: Japan lat: 33.85181 lon: 130.85034 facility: Novartis Investigative Site status: RECRUITING city: Shirakawa state: Fukushima zip: 961-0005 country: Japan facility: Novartis Investigative Site status: RECRUITING city: Kure-city state: Hiroshima zip: 737-0023 country: Japan lat: 34.23222 lon: 132.56658 facility: Novartis Investigative Site status: RECRUITING city: Asahikawa state: Hokkaido zip: 078-8214 country: Japan lat: 43.77063 lon: 142.36489 facility: Novartis Investigative Site status: RECRUITING city: Sapporo state: Hokkaido zip: 004-0052 country: Japan lat: 43.06667 lon: 141.35 facility: Novartis Investigative Site status: RECRUITING city: Sapporo state: Hokkaido zip: 065-0027 country: Japan lat: 43.06667 lon: 141.35 facility: Novartis Investigative Site status: RECRUITING city: Amagasaki state: Hyogo zip: 660-8511 country: Japan lat: 34.71667 lon: 135.41667 facility: Novartis Investigative Site status: RECRUITING city: Himeji state: Hyogo zip: 670-8560 country: Japan lat: 34.81667 lon: 134.7 facility: Novartis Investigative Site status: RECRUITING city: Kobe state: Hyogo zip: 654-0026 country: Japan lat: 34.6913 lon: 135.183 facility: Novartis Investigative Site status: RECRUITING city: Takarazuka-city state: Hyogo zip: 665-0873 country: Japan lat: 34.79936 lon: 135.35697 facility: Novartis Investigative Site status: RECRUITING city: Moriya-city state: Ibaraki zip: 302-0102 country: Japan lat: 35.93333 lon: 140.0 facility: Novartis Investigative Site status: RECRUITING city: Kanazawa-city state: Ishikawa zip: 920-8641 country: Japan lat: 36.6 lon: 136.61667 facility: Novartis Investigative Site status: RECRUITING city: Fujisawa state: Kanagawa zip: 252-0802 country: Japan lat: 35.34926 lon: 139.47666 facility: Novartis Investigative Site status: RECRUITING city: Yokohama state: Kanagawa zip: 235-0016 country: Japan lat: 35.43333 lon: 139.65 facility: Novartis Investigative Site status: RECRUITING city: Yokosuka state: Kanagawa zip: 238-8567 country: Japan lat: 35.28361 lon: 139.66722 facility: Novartis Investigative Site status: RECRUITING city: Yokosuka state: Kanagawa zip: 240-0101 country: Japan lat: 35.28361 lon: 139.66722 facility: Novartis Investigative Site status: RECRUITING city: Kumamoto-city state: Kumamoto zip: 861-4193 country: Japan lat: 32.80589 lon: 130.69182 facility: Novartis Investigative Site status: RECRUITING city: Yatsushiro-city state: Kumamoto zip: 866-8533 country: Japan lat: 32.55723 lon: 130.65285 facility: Novartis Investigative Site status: RECRUITING city: Kyotanabe state: Kyoto zip: 610-0334 country: Japan lat: 34.8045 lon: 135.76681 facility: Novartis Investigative Site status: RECRUITING city: Kyoto-city state: Kyoto zip: 602-8566 country: Japan lat: 35.02107 lon: 135.75385 facility: Novartis Investigative Site status: RECRUITING city: Kyoto-city state: Kyoto zip: 607-8062 country: Japan lat: 35.02107 lon: 135.75385 facility: Novartis Investigative Site status: RECRUITING city: Omura state: Nagasaki zip: 856-8562 country: Japan lat: 32.92139 lon: 129.95389 facility: Novartis Investigative Site status: RECRUITING city: Ikoma state: Nara zip: 636-0802 country: Japan lat: 34.68333 lon: 135.7 facility: Novartis Investigative Site status: RECRUITING city: Kashihara state: Nara zip: 634-0045 country: Japan lat: 34.50896 lon: 135.7929 facility: Novartis Investigative Site status: RECRUITING city: Nagaoka-city state: Niigata zip: 940-8621 country: Japan lat: 37.45 lon: 138.85 facility: Novartis Investigative Site status: RECRUITING city: Oita-city state: Oita zip: 870-0263 country: Japan lat: 33.23333 lon: 131.6 facility: Novartis Investigative Site status: RECRUITING city: Kurashiki state: Okayama zip: 713-8121 country: Japan lat: 34.58333 lon: 133.76667 facility: Novartis Investigative Site status: RECRUITING city: Okayama-city state: Okayama zip: 700-8558 country: Japan lat: 34.65 lon: 133.93333 facility: Novartis Investigative Site status: RECRUITING city: Urasoe state: Okinawa zip: 901-2102 country: Japan lat: 26.25902 lon: 127.73012 facility: Novartis Investigative Site status: RECRUITING city: Uruma state: Okinawa zip: 904-2293 country: Japan lat: 26.37609 lon: 127.85908 facility: Novartis Investigative Site status: RECRUITING city: Izumisano-city state: Osaka zip: 598-8577 country: Japan lat: 34.41663 lon: 135.31667 facility: Novartis Investigative Site status: RECRUITING city: Moriguchi state: Osaka zip: 570-8507 country: Japan lat: 34.73333 lon: 135.56667 facility: Novartis Investigative Site status: RECRUITING city: Osaka-city state: Osaka zip: 540-0006 country: Japan lat: 34.69374 lon: 135.50218 facility: Novartis Investigative Site status: RECRUITING city: Osaka-city state: Osaka zip: 543-0035 country: Japan lat: 34.69374 lon: 135.50218 facility: Novartis Investigative Site status: RECRUITING city: Osaka-city state: Osaka zip: 543-8555 country: Japan lat: 34.69374 lon: 135.50218 facility: Novartis Investigative Site status: RECRUITING city: Takatsuki-city state: Osaka zip: 569-0852 country: Japan lat: 34.84833 lon: 135.61678 facility: Novartis Investigative Site status: RECRUITING city: Takatsuki-city state: Osaka zip: 569-8686 country: Japan lat: 34.84833 lon: 135.61678 facility: Novartis Investigative Site status: RECRUITING city: Takatsuki state: Osaka zip: 569-1121 country: Japan lat: 34.84833 lon: 135.61678 facility: Novartis Investigative Site status: RECRUITING city: Toyonaka state: Osaka zip: 560-0083 country: Japan lat: 34.78244 lon: 135.46932 facility: Novartis Investigative Site status: RECRUITING city: Asaka state: Saitama zip: 351-0021 country: Japan lat: 35.80472 lon: 139.60194 facility: Novartis Investigative Site status: RECRUITING city: Gyoda state: Saitama zip: 361-0056 country: Japan lat: 36.14074 lon: 139.46011 facility: Novartis Investigative Site status: RECRUITING city: Tokorozawa state: Saitama zip: 359-1142 country: Japan lat: 35.79916 lon: 139.46903 facility: Novartis Investigative Site status: RECRUITING city: Nagahama state: Shiga zip: 526-8580 country: Japan lat: 35.38333 lon: 136.26667 facility: Novartis Investigative Site status: RECRUITING city: Hachioji-city state: Tokyo zip: 192-0918 country: Japan lat: 35.65583 lon: 139.32389 facility: Novartis Investigative Site status: RECRUITING city: Machida state: Tokyo zip: 194-0021 country: Japan lat: 35.54028 lon: 139.45083 facility: Novartis Investigative Site status: RECRUITING city: Nerima-ku state: Tokyo zip: 176-8530 country: Japan facility: Novartis Investigative Site status: RECRUITING city: Shinjuku state: Tokyo zip: 160-8488 country: Japan lat: 35.2946 lon: 139.57059 facility: Novartis Investigative Site status: RECRUITING city: Toshima-ku state: Tokyo zip: 171-0014 country: Japan facility: Novartis Investigative Site status: RECRUITING city: Takaoka state: Toyama zip: 939-1104 country: Japan lat: 36.75 lon: 137.01667 facility: Novartis Investigative Site status: RECRUITING city: Hashimoto state: Wakayama zip: 648-0005 country: Japan lat: 34.31667 lon: 135.61667 facility: Novartis Investigative Site status: RECRUITING city: Sakata-city state: Yamagata zip: 998-8501 country: Japan lat: 38.91667 lon: 139.855 facility: Novartis Investigative Site status: RECRUITING city: Fukuoka zip: 815-0082 country: Japan lat: 33.6 lon: 130.41667 facility: Novartis Investigative Site status: RECRUITING city: Gifu zip: 500-8384 country: Japan lat: 35.42291 lon: 136.76039 facility: Novartis Investigative Site status: RECRUITING city: Kagoshima zip: 892-0853 country: Japan lat: 31.56667 lon: 130.55 facility: Novartis Investigative Site status: RECRUITING city: Nagasaki zip: 852-8055 country: Japan lat: 32.75 lon: 129.88333 facility: Novartis Investigative Site status: RECRUITING city: Oita zip: 870-1133 country: Japan lat: 33.23333 lon: 131.6 facility: Novartis Investigative Site status: RECRUITING city: Oita zip: 879-7761 country: Japan lat: 33.23333 lon: 131.6 facility: Novartis Investigative Site status: RECRUITING city: Osaka zip: 545-8586 country: Japan lat: 34.69374 lon: 135.50218 hasResults: False

 nctId: NCT06275711 id: 223K003 briefTitle: The Effect of Therapeutic Communication Methods on the Psychological State of Children overallStatus: COMPLETED date: 2023-11-30 date: 2023-12-06 date: 2023-12-06 date: 2024-02-23 date: 2024-02-23 name: Gazi University class: OTHER name: The Scientific and Technological Research Council of Turkey briefSummary: Earthquake is a disaster that causes physical, psychological, social, economic and cultural losses for individuals and affects/interrupts all age groups and normal life. Children are a group that is more affected by the earthquake than other members of the society and are exposed to its long-term effects. Children who have experienced earthquakes and continue to stay in the earthquake zone experience physical, economic, and social problems. In addition, the emotional and psychological development of these children is negatively affected.

Due to the earthquake that occurred on 6 February 2023 affecting 11 provinces in our country, the needs in the field vary. After the acute period (first 1 month), children need psychological support. Problems that cannot be solved in the early period may cause health and behavioural problems in children in later ages and adulthood. In this context, approaching children with appropriate therapeutic communication methods positively affects their psychological well-being and directly affected physical resilience by enabling them to express their emotions.

The aim of the study was to evaluate the effect of therapeutic communication programme on state and trait anxiety levels, psychological resilience, mental health and well-being of children aged 8-12 years affected by the earthquake.

Hypotheses H1. After the therapeutic communication programme, children's State Anxiety Scale scores decrease.

H2. After the therapeutic communication programme, children's Continuance Anxiety Scale scores decrease.

H3. After the therapeutic communication programme, children's Me and My Emotions Scale scores decrease.

H4. After the therapeutic communication programme, children's scores on the Child and Adolescent Psychological Resilience Scale increase. conditions: Psychological studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Pre-test post-test quasi-experimental study primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 65 type: ACTUAL name: Therapeutic communication methods measure: State Anxiety Scale on Children measure: Trait Anxiety Scale on Children measure: Me and My Feelings Scale on Children measure: Child and Youth Resilience Measure sex: ALL minimumAge: 8 Years maximumAge: 12 Years stdAges: CHILD facility: K-1 Container City city: Adıyaman state: Altınsehir zip: 02040 country: Turkey lat: 37.76441 lon: 38.27629 hasResults: False

 nctId: NCT06275698 id: RD2023-14 HONEY-POT id: 323188 type: OTHER domain: IRAS id: 56974 type: OTHER_GRANT domain: CPMS briefTitle: HONEY for the Treatment of POst-Tonsillectomy Pain acronym: HONEY-POT overallStatus: RECRUITING date: 2023-09-04 date: 2025-09-04 date: 2025-09-04 date: 2024-02-23 date: 2024-02-23 name: East and North Hertfordshire NHS Trust class: OTHER_GOV name: Manuka Doctor UK Ltd name: National Institute for Health Research, United Kingdom briefSummary: Double-blind, randomised, placebo controlled, single-site trial in adults to compare the effect of Manuka honey with standard of care compared to placebo with standard of care on post-tonsillectomy pain and postoperative outcomes.

Main aim is to investigate a potential improvement in post-tonsillectomy pain control, with a low cost and freely available alternative to conventional analgesics. Recent systematic review and multidisciplinary consensus suggest a potential role for the inclusion of honey for this purpose. Clinical efficacy over placebo remains to be conclusively demonstrated in robust clinical trials. conditions: Post Surgical Pain conditions: Analgesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intervention arm - Manuka honey, to be taken per-oral 15ml TDS for 14 days post-tonsillectomy.

Placebo - sugar-based syrup, thickened with sodium alginate and with honey flavouring, to be taken per-oral 15ml TDS for 14 days post-tonsillectomy. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Intervention (Manuka honey) and placebo will be supplied in identical opaque jars with identical labels apart from individual unique ID numbers to facilitate un-blinding in the case of adverse events.

Neither the patient nor the researcher collecting data will be aware of which arm the patient has been enrolled onto. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Manuka honey MGO 1000 name: Sugar-based syrup, thickened with sodium alginate and flavoured with honey flavouring measure: VAS pain scores measure: Number and frequency of concurrent analgesia usage measure: Rate of readmission to hospital measure: Rate of secondary haemorrhage measure: Rate of infection requiring antibiotics treatment measure: Speed of return to work sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lister Hospital status: RECRUITING city: Stevenage zip: SG1 4AB country: United Kingdom name: Toral Odedra role: CONTACT phone: 07918 360 060 email: toral.odedra@nhs.net lat: 51.90224 lon: -0.20256 hasResults: False

 nctId: NCT06275685 id: CIP-0001510 briefTitle: Forecasting Seizures Using Intelligent Wearable Technology for Health Tracking acronym: Foresight overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-06 date: 2026-06 date: 2024-02-23 date: 2024-02-23 name: Empatica, Inc. class: INDUSTRY briefSummary: The goal of this interventional study is to develop a personalized seizure risk forecast tool in people with epilepsy.

The main questions it aims to answer are:

* can we develop a future seizure probabilities tool that is more accurate than chance based on the pattern and frequency of previous generalized tonic-clonic seizure (GTCS) events, as well as changes in physiological and behavioral variables.
* does this tool improve the lives of people with epilepsy?

Researchers will compare a group that does not have access to the forecast tool to a group that does and see if it is accurate and if people with it report that it improved their quality of life. conditions: Epilepsy; Seizure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 3000 type: ESTIMATED name: SeizureWise algorithm name: Multi-day Visualizations measure: Sensitivity of SeizureWise measure: Change in QoL and psychological health indicators using the Quality of life in epilepsy (QOLIE-10-P) measure: Qualitative assessment of multi-day visualizations measure: Stress level with visualizations using the brief epilepsy anxiety survey instrument (brEASI-8) measure: Modifiable behavior change measure: Accuracy of SeizureWise low-likelihood forecast measure: Accuracy of SeizureWise high-likelihood forecast sex: ALL minimumAge: 6 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06275672 id: TREAT INTERACT briefTitle: Implementing an Education- and Health System Task-shifting Approach for Child Mental Health Promotion in Uganda acronym: TREAT overallStatus: RECRUITING date: 2023-08-01 date: 2025-05 date: 2025-12 date: 2024-02-23 date: 2024-02-23 name: Norwegian Center for Violence and Traumatic Stress Studies class: OTHER name: Makerere University name: University of Bergen name: Norwegian Institute of Public Health name: Norwegian University of Science and Technology briefSummary: This study will adapt a school version (mhGAP-IGs) of the World Health Organization´s (WHO) "Mental Health Gap Action Programme Intervention Guide" (mhGAP). Both teachers and health workers will receive training in mhGAP, and systems for collaboration between the school and health sector as well as other relevant stakeholders will be developed and integrated. The project is conducted in close collaboration with key stakeholders from the Ministry, the health and education sector, the police, and religious leaders. The aim is to increase mental health literacy among school staff, facilitate a healthy school environment, and increase detection of mental health needs among primary school aged children. conditions: Mental Health Issue conditions: Stigma, Social conditions: Child Development conditions: Child Abuse studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Stepped-wedge cluster randomized trial to randomize 18 schools into six cohorts of three schools incrementally. primaryPurpose: PREVENTION masking: NONE count: 180 type: ESTIMATED name: Adapted version of the mhGAP-IG measure: Reach questionnaire, developed by the project group measure: The Program Sustainability tool (Finch et al., 2013) measure: Service measure on access to mental health care, developed by the project group measure: Attitudes about Child Mental Health (Perceived Discrimination-Devaluation (Link et al., 1987) questionnaire measure: The dimensions of discipline inventory, school (DDI; Strauss & Faucher, 2007) measure: Treatment at home, developed by the project group, by inspiration from our siste project "TREAT C-AUD") measure: The Implementation Quality Questionnaire (Bogen, 2020) measure: Fidelity Scale, developed by the project group measure: General Health Questionnaire (GHQ; Goldberg, 1970) measure: Attitudes on Gender Norms (Waszak et al., 2000) questionnaire measure: Help-seeking behaviour, developed by the project group after inspiration from Yifeng et al., 2022 measure: Pediatric Symptom Checklist (PSC-17; Jellinek et al., 1998) measure: Teacher Support Scale (TSS; Metheny, McWhirter, & O'Neil, 2008) measure: Teacher violence scale (Piskin et al, 2014) measure: The dimensions of discipline inventory, home (DDI; Strauss & Faucher, 2007) measure: The Implementation Leadership Scale (Aarons, Ehrhart, et al., 2014) measure: Organizational Readiness for Implementing Change (Shea et al., 2014) measure: Teacher concerns about child mental health, developed by the project group, after inspiration from Yifeng et al., 2022 measure: Provider Report of Sustainment Scale (PRESS) (Moullin et al., 2021) (PRESS): development and validation (PRESS; Moullin et al., 2021) measure: Mental health knowledge (Evans-Lacko et al., measure: AUDIT scale (WHO) measure: Child alcohol use, developed by the project group measure: Child mental health - Pediatric symptoms (Jelinek et al.) measure: Perceived teacher support and its influence on adolescent career development (Metheny et al., 2008) measure: Sexual violence, developed by the project group measure: Dimensions of discipline inventory (DDI; Straus and Fauchier, 2007) sex: ALL minimumAge: 5 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Nowegian Center for Violence and Traumatic Stress Studies status: RECRUITING city: Oslo zip: 0655 country: Norway name: Ane-Marthe Skar, PhD role: CONTACT phone: 97661591 email: amskar@gmail.com lat: 59.91273 lon: 10.74609 hasResults: False

 nctId: NCT06275659 id: CT-100-D-003 briefTitle: An Exploratory Study to Evaluate a Digital Intervention to Disrupt Scratching in Atopic Dermatitis and Psoriasis overallStatus: ACTIVE_NOT_RECRUITING date: 2023-12-04 date: 2024-02-23 date: 2024-03-18 date: 2024-02-23 date: 2024-03-08 name: Click Therapeutics, Inc. class: INDUSTRY briefSummary: CT-100 is a platform that provides interactive, software based therapeutic components that may be used as part of a treatment in future software-based prescription digital therapeutics. One class of CT-100 components are Digital Neuro-activation and Modulation (DiNaMo TM) components.

DiNaMo components target key neural systems (including but not limited to systems related to sensory-, perceptual-, affective-, pain-, attention-, cognitive control, social- and self- processing) to optimally improve a participant's health. conditions: Psoriasis conditions: Atopic Dermatitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 120 type: ACTUAL name: CT-100-004-A name: CT-100-004-B measure: Change in Peak Pruritus Numerical Rating Scale measure: Change in Dermatology Life Quality Index measure: Change in Quality of Life symptoms measure: Time in App measure: Experience with Study App measure: Improved global rating of change measure: Frequency of Adverse Events measure: Severity of Adverse Events measure: Frequency of Serious Adverse Events measure: Severity of Serious Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Click Therapeutics city: New York state: New York zip: 10013 country: United States lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06275646 id: Adeel2 briefTitle: Comparison Of Outcome Of Different Layers in Hypospadias Surgery overallStatus: COMPLETED date: 2022-01-01 date: 2022-12-31 date: 2023-04-01 date: 2024-02-23 date: 2024-02-23 name: Children Hospital and Institute of Child Health, Lahore class: OTHER briefSummary: To compare the outcome of applying autologous platelet-rich plasma membrane layer and dartos fascial flap versus only dartos fascial flap in mid and distal penile hypospadias surgery. A total of 220 patients fulfilling the selection criteria were admitted after taking informed consent. Cases were randomly divided into groups A and B using a random generator of the Excel program. In group A, dartos flap and PRP sheet layer were applied and in group B, only a preputial dartos fascial flap was applied conditions: Hypospadias studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized control trial primaryPurpose: TREATMENT masking: NONE count: 220 type: ACTUAL name: PRP layer name: dartos flap measure: wound infectiom measure: frequency of glans dehiscence measure: frequency of meatal stenosis sex: MALE minimumAge: 6 Months maximumAge: 12 Years stdAges: CHILD facility: The Children Hospital city: Lahore state: Punjab zip: 42000 country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06275633 id: H-18055648 briefTitle: Behavioural Profiling of Disease-related Cognitive and Motor Impairment in PD overallStatus: COMPLETED date: 2019-03-19 date: 2021-12-03 date: 2023-07-30 date: 2024-02-23 date: 2024-02-23 name: University Hospital Bispebjerg and Frederiksberg class: OTHER briefSummary: In this project, patients with Parkinson's Disease (PD) will be characterized by measuring cognitive and motor function and relation to effect of Levodopa.

Participants will be patients with Parkinson's Disease and healthy controls. It will be investigated if there is a difference between patients with a good measured Levodopa response and with a poor measured response. conditions: Parkinson Disease conditions: Medication conditions: UPDRS conditions: Motor Function conditions: Cognitive Impairment conditions: Depression conditions: Impulsive conditions: Levodopa studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a prospective patient with Parkinson's Disease cohort. After acute levodopa challenge test patients with Parkinson's Disease are divided due to measured levodopa response and their self-rated medicine effect. primaryPurpose: DIAGNOSTIC masking: NONE maskingDescription: There will be a blinded assessment of videos of participants with Parkinson's Disease ON and OFF medication count: 68 type: ACTUAL name: Levodopa measure: Motor improvement measure: Cognitive function measure: Cognitive function measure: Depressive symptoms measure: Impulsivity sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Bispebjerg and Frederiksberg city: Copenhagen state: Region Hovedstaden zip: 2400 country: Denmark lat: 55.67594 lon: 12.56553 hasResults: False

 nctId: NCT06275620 id: AGTC-RPGR-001 DAWN briefTitle: A Study Comparing Two Doses of AGTC-501 in Male Participants With X-linked Retinitis Pigmentosa Caused by RPGR Mutations (DAWN) overallStatus: ENROLLING_BY_INVITATION date: 2023-11-14 date: 2025-07 date: 2029-08 date: 2024-02-23 date: 2024-03-21 name: Beacon Therapeutics class: INDUSTRY briefSummary: This Phase 2 study is a non-randomized, open-label, study of the safety of AGTC-501 in participants with XLRP who have previously been treated with a full-length AAV vector-based gene therapy targeting RPGR protein. conditions: X-Linked Retinitis Pigmentosa studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: AGTC-501 (high dose and standard corticosteroid regimen) name: AGTC-501 (low dose and standard corticosteroid regimen) name: AGTC-501 (high dose and modified corticosteroid regimen) measure: The primary safety outcome is the number and proportion of participants experiencing Grade 3 or higher local (ocular) or non-ocular treatment-emergent adverse events, including treatment-emergent serious adverse events (SAEs). measure: Change from baseline in mean sensitivity across the whole grid, as measured by MAIA microperimetry measure: Response, as measured by MAIA microperimetry, where response is defined as a greater than or equal to 7 dB visual sensitivity improvement from baseline in at least 7 loci. measure: Change from baseline in BCVA using Early-Treatment Diabetic Retinopathy Study (ETDRS) visual acuity measure: Change from baseline in LLVA using ETDRS visual acuity measure: Change from baseline in Ora-VNC mobility test score sex: MALE minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of Florida city: Jacksonville state: Florida zip: 32209 country: United States lat: 30.33218 lon: -81.65565 facility: Bascom Palmer Eye Institute city: Miami state: Florida zip: 33136 country: United States lat: 25.77427 lon: -80.19366 facility: Boston Children's Hospital city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 facility: Cincinnati Eye Institute city: Cincinnati state: Ohio zip: 45242 country: United States lat: 39.12713 lon: -84.51435 facility: Cleveland Clinic city: Cleveland state: Ohio zip: 44195 country: United States lat: 41.4995 lon: -81.69541 facility: Casey Eye Institute city: Portland state: Oregon zip: 97239 country: United States lat: 45.52345 lon: -122.67621 facility: Retina Foundation of the Southwest city: Dallas state: Texas zip: 75231 country: United States lat: 32.78306 lon: -96.80667 hasResults: False

 nctId: NCT06275607 id: FY23-24-93 briefTitle: Maladaptive Anger Treatment overallStatus: RECRUITING date: 2024-02-07 date: 2025-12-31 date: 2025-12-31 date: 2024-02-23 date: 2024-02-23 name: The University of Texas at San Antonio class: OTHER briefSummary: From a psychoevolutionary perspective, anger is a universal emotion that can serve the function of making us aware of wrongdoing and motivating us to undo/correct the wrongdoing. However, it is well recognized in clinical psychology that anger can be maladaptive, often causing distress and impairment in various areas of day-to-day life; untreated maladaptive anger has been found to raise the risk of certain physical health problems e.g., hypertension and coronary heart disease. At the very extreme, rage has been implicated in aggression and violence. Not surprisingly, there has been a widespread quest for anger treatments or what is popularly called "anger management". One treatment approach that has received increasing empirical support is Cognitive Behavioral Affective Therapy (CBAT), which has been applied to patients with chemical dependence and individuals with chronic pain. To extend this programmatic line of research, the proposed research aims to evaluate the efficacy of CBAT in reducing multiple (psychometric and self-monitored) measures of anger within a community sample. conditions: Anger conditions: Intermittent Explosive Disorder conditions: Emotional Distress conditions: Aggression conditions: Violence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Cognitive Behavioral Affective Therapy name: Emotional Discussion measure: Anger Parameters Scale (APS) measure: Anger Parameters Scale (APS) measure: Anger Parameters Scale (APS) measure: Anger Expressions Scale (AES) measure: Anger Expressions Scale (AES) measure: Anger Expressions Scale (AES) measure: Self-Monitored Anger (Anger Log) measure: Self-Monitored Anger (Anger Log) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Texas at San Antonio status: RECRUITING city: San Antonio state: Texas zip: 78249 country: United States name: Ephrem Fernandez, Ph.D. role: CONTACT email: ephrem.fernandez@utsa.edu name: Brandon S Perez, M.S. role: CONTACT email: brandon.perez3@utsa.edu name: Ephrem Fernandez, Ph.D. role: PRINCIPAL_INVESTIGATOR name: Brandon S Perez, M.S. role: SUB_INVESTIGATOR lat: 29.42412 lon: -98.49363 hasResults: False

 nctId: NCT06275594 id: YUMC2023-12-017 briefTitle: Trial Evaluating the Efficacy of Remimazolam in Endobronchial Ultrasound Guided Transbronchial Needle Aspiration acronym: REST overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-02-01 date: 2025-02-01 date: 2024-02-23 date: 2024-02-23 name: Yeungnam University Hospital class: OTHER briefSummary: Study to evaluate the efficacy and safety of remimazolam in patients undergoing endobronchial ultrasound-guided transbronchial needle aspiration

Primary Outcome Evaluate and compare the success of the procedure in patients undergoing EBUS-TBNA (Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration) when administered with remimazolam in the experimental group, versus Real world midazolam (Control Group 1), and On label midazolam (Control Group 2).

Secondary Outcome In patients undergoing EBUS-TBNA, compare the following aspects when administered with remimazolam in the experimental group versus Real world midazolam (Control Group 1) and On label midazolam (Control Group 2): Procedure start time, Time taken to achieve full alertness, Need for flumazenil administration, Total dose of fentanyl used, Scale of coughing/discomfort/convenience, Changes in vital signs, Complications related to the procedure. conditions: Midazolam conditions: Remimazolam studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 330 type: ESTIMATED name: Byfavo name: Midazolam measure: Procedural success during EBUS-TBNA (composite outcome) measure: Time to start of procedure after administration of the first dose of study medication measure: Time taken to achieve full alertness after the procedure measure: Requirement for flumazenil dosage during the procedure measure: Total fentanyl dose measure: Scale of coughing/discomfort/inconvenience measure: Changes in blood pressure measure: Changes of heart rate measure: Changes in respiration rate measure: Complications related to the procedure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yeungnam University Hospital city: Daegu state: Namgu zip: 42415 country: Korea, Republic of name: June Hong Ahn, M.D. PhD role: CONTACT phone: 821028562008 email: fireajh@gmail.com lat: 35.87028 lon: 128.59111 hasResults: False

 nctId: NCT06275581 id: CR15_15 (EM-11-050055) briefTitle: Clinical Evaluation of the Performance of a Newly Developed Glass Ionomer Restorative for Posterior Restorations in an Adult Population overallStatus: TERMINATED date: 2017-06-14 date: 2021-03-24 date: 2021-10-01 date: 2024-02-23 date: 2024-02-23 name: Universidad Europea de Madrid class: OTHER name: 3M briefSummary: STUDY DESIGN Post market clinical follow-up; pilot study, prospective, controlled, randomized, split-mouth, blinded evaluation INTRODUCTION AND PURPOSE OF STUDY Continuous advancements in the field of glass ionomers have led to an increasing range of permanent indications, especially with regards to stress bearing Class II restorations. As a further development in the 3M glass ionomer category, Ketac Universal can be used for the abovementioned indication in a simplified procedure without the need for cavity conditioning or restoration coating. All products used in this study are CE marked thus can be used for routine clinical treatment.

STUDY OBJECTIVES Objective of the study is to evaluate the clinical survival and quality parameters of Class II Ketac Universal restorations compared to intra-individual (split-mouth) Class II Ketac Molar Quick control restorations over time STUDY ENDPOINTS

Primary Endpoint:

1. Evaluation of restoration survival over time based on the glass ionomer restoration criteria (simplified FDI criteria as proposed by Mathilde Peters et al.)

Secondary Endpoints:

1. Evaluation of restoration quality based on the glass ionomer restoration criteria (simplified FDI criteria)
2. Evaluation of restoration wear based on comparison of digital impressions

Safety Endpoint:

1. Evaluation of potential adverse events NULL HYPOTHESIS There is no statistically significant difference between both glass ionomers

* regarding overall survival
* regarding restoration quality parameters TEST GROUP Ketac Universal Aplicap Glass Ionomer Restorative (3M) CONTROL GROUP Ketac Molar Quick Aplicap Glass Ionomer Restorative (3M)
* regarding restoration wear METHODS AND MATERIALS A total of 39 subjects were enrolled and treated. The study was originally planned with 80 patients. Due to slow recruitment, it was decided to decrease the number of patients.

Treatment:

After signing informed consent, test and control product were randomly assigned to the two study teeth (randomization letter). Restoration extension (e.g. mod) and reason for restoration placement (e.g. secondary caries, tooth fracture) were recorded in the CRF. Two teeth per subject were included. Each product was used strictly according to respective Instructions for Use without using the optional protective coating. Restorations were placed in combination with sectional matrix system (Palodent system) and according to best practice (especially with regards to moisture control). Finishing and polishing was done with the Sof-Lex system. Areas in close proximity to the pulp were covered with local application of a calcium hydroxide material in both study materials. Study teeth were excluded from study if pulp exposure had occurred or if only a repair restoration was required instead of a full Class II restoration.

Evaluation periods:

All subjects were evaluated by two independent evaluators according to Performance Criteria for Posterior Glass Ionomer Restorations (simplified FDI criteria)

* at baseline at day of restoration placement or up to 1 month after restoration placement
* after 6 months (± 1 months)
* after 1 year (± 1 months)
* after 2 years (± 1 months) In addition, photos (at least occlusal view) were taken of every study tooth prior to restoration placement and at every evaluation.

In order to further assess the wear of both restorative materials, full arch digital impressions (both upper and lower jaw) were taken at baseline evaluation and at every following evaluation using 3M True Definition Scanner. STL files were digitally compared to those taken at baseline. conditions: Tooth Wear conditions: Glass Ionomer Cements studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Blinded evaluation whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 39 type: ACTUAL name: Ketac Universal Aplicap Glass Ionomer Restorative (3M) (test group) name: Ketac Molar Quick Aplicap Glass Ionomer Restorative (control group) measure: Restoration survival over time based on the glass ionomer restoration criteria measure: Evaluation of restoration quality based on the glass ionomer restoration criteria measure: Evaluation of restoration wear based on comparison of digital impressions measure: Safety Endpoint: The safety endpoint is the incidence of Adverse Events. sex: ALL minimumAge: 18 Years maximumAge: 66 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dental Health Clinic at Universidad Europea de Madrid (UEM) Department of Prosthodontics city: Madrid zip: 28045 country: Spain lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06275568 id: HSC-SPH-23-0655 briefTitle: Accelerating Healthcare Engagement in Healthy Food Interventions - Food Rx in High Risk Pregnant Mothers With About Fresh and Texas Children's Health Plan overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-11-15 date: 2024-11-15 date: 2024-02-23 date: 2024-02-23 name: The University of Texas Health Science Center, Houston class: OTHER briefSummary: The purpose of the study is to assess if the Fresh Connect food prescription (Fresh Connect Food Rx) program that provides consistent access to healthy fresh produce through purchases at the grocery store plus nutrition education impacts gestational weight gain, other pregnancy and birth outcomes, and food and nutrition security in low-income, ethnically diverse, at-risk women residing in Houston, Texas. Enrollment of participants will begin in pregnancy at the time of the first prenatal visit (as long as the first visit occurs before the end of the first trimester); each participant will be followed until 60 days post-partum (up to 11 months follow-up per participant). conditions: Nutrition in High-Risk Pregnancy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 620 type: ESTIMATED name: Usual Care Fresh Connect cardholder engagement name: Enhanced engagement communication measure: Absolute gestational weight gain (GWG) in pounds measure: Absolute gestational weight gain (GWG) in pounds measure: Absolute gestational weight gain (GWG) in pounds measure: Excess gestational weight gain (EGWG) in pounds measure: Excess gestational weight gain (EGWG) in pounds measure: Excess gestational weight gain (EGWG) in pounds measure: Number of participants diagnosed with pregnancy-induced hypertension measure: Number of participants diagnosed with gestational diabetes measure: Number of participants with pre-term birth (<37 weeks) measure: Infant birth weight sex: FEMALE minimumAge: 18 Years maximumAge: 44 Years stdAges: ADULT facility: The University of Texas Health Science Center at Houston city: Houston state: Texas zip: 77030 country: United States name: Shreela Sharma, PhD role: CONTACT phone: 713-500-9344 email: Shreela.V.Sharma@uth.tmc.edu name: Naomi Tice, MPH role: CONTACT phone: (713) 500-9000 email: Naomi.Tice@uth.tmc.edu lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06275555 id: 2023-101 briefTitle: Use of Bivalirudin for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-12-31 date: 2024-02-23 date: 2024-02-26 name: Xiaotong Hou class: OTHER briefSummary: The purpose of this study was to evaluate the efficacy and safety of bivalirudin in anticoagulation therapy in patients with extracorporeal membrane oxygenation (ECMO) compared with unfractionated heparin. conditions: Extracorporeal Membrane Oxygenation Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 154 type: ESTIMATED name: bivalirudin name: unfractionated heparin measure: thrombotic complications measure: bleeding complications measure: Hospitalization mortality measure: Loop replacement measure: Infusion volume of blood products measure: Acute renal failure measure: Heparin-induced thrombocytopenia measure: the time of reaching the target anticoagulant level for the first time measure: Percentage of time during ECMO within the target anticoagulant level sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Anzhen Hospital city: Beijing state: Beijing zip: 100029 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06275542 id: USurabaya briefTitle: Ability to Maintain Saturation Levels Without Oxygen Supplementation as a Extubation Criteria Without TOF Monitoring Equipment overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-01 date: 2026-01-01 date: 2024-02-23 date: 2024-02-23 name: University of Surabaya class: OTHER name: Department of Anesthesiology and Intensive Therapy, Faculty of Medicine, Universitas Gadjah Mada name: Sardjito General Hospital, Yogyakarta briefSummary: Patients undergoing general anesthesia will have an endotracheal tube inserted. Adequate muscle strength recovery in the recovery room is crucial to ensure before extubation. One of the criteria we use to determine the recovery of muscle strength post-use of muscle relaxants in conditions without specific monitoring devices is the ability to maintain body oxygen levels without oxygen assistance for 3 minutes. This study aims to determine the muscle strength value in the recovery room using extubation strategies without muscle strength monitoring compared to extubation strategies with muscle strength monitoring. conditions: Anesthesia Intubation Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study was conducted through a randomized clinical trial with blinding of observers. Two parallel groups were selected to compare the incidence of paralysis in the recovery room. The research samples were collected using non-probability sampling method through consecutive enrollment over a specific period. This study consisted of 3 comparisons distinguished based on the type of volatile anesthetic gas maintenance and neuromuscular blockade agent, namely:

* Comparison 1: The volatile anesthetic gas used was sevoflurane and the muscular blockade agent used was rocuronium.
* Comparison 2: The volatile anesthetic gas used was isoflurane and the muscular blockade agent used was rocuronium.
* Comparison 3: The volatile anesthetic gas used was sevoflurane and the muscular blockade agent used was atracurium. primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Upon arrival in the recovery room, all subjects were fitted with SpO2, EKG, NIBP monitors, and the TOF monitoring device. TOF values were measured by a second researcher who was unaware of the type of intervention. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 240 type: ESTIMATED name: Train of four monitoring device intraoperative name: Neostigmine name: Air chalenge prior to extubation name: Train of Four monitoring device in recovery room measure: Residual paralysis in recovery room measure: Adverse events sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06275529 id: 27.12.2023.685 briefTitle: Evaluation of Transforaminal Epidural Steroid Injection in Radicular Low Back Pain According to MSU Classification overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-06-15 date: 2024-08-15 date: 2024-02-23 date: 2024-02-23 name: Başakşehir Çam & Sakura City Hospital class: OTHER_GOV briefSummary: Low back pain is a common disease in all ages and it effects seriously quality of life. Medical treatment,interventional methods and surgery are the treatment options. Transforaminal epidural steroid injections (TFSI) is one of the interventional method for radiculopathy with low back pain. Michigan State University(MSU) classification is a MRI based disc herniation classification. It helps to classified disc herniation in types, places and sizes.

The aim of this study to evaluate the pain and oswestry disability index in patients who have radiculopathy with low back pain, undergone TFSI according to MSU classification. conditions: Radiculopathy Lumbar conditions: Low Back Pain conditions: Disc Herniation conditions: Injections, Epidural studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 160 type: ESTIMATED name: Transforaminal Epidural Steroid Injection measure: Change of the pain severity score measure: Change of the disability score sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06275516 id: 2024-208 briefTitle: Safety and Efficacy of Multisensory Stimulation Virtual Reality for Stroke Patients. overallStatus: NOT_YET_RECRUITING date: 2024-02-20 date: 2024-06-20 date: 2024-09-20 date: 2024-02-23 date: 2024-02-23 name: First Affiliated Hospital of Chongqing Medical University class: OTHER briefSummary: This was a single-blind randomized controlled trial of multisensory stimulation virtual reality to improve motor and cognitive dysfunction in stroke patients. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: multi-sensory stimulation immersive VR+ treadmill training name: treadmill training measure: Fugl-Meyer scale measure: Berg balance scale measure: three-dimensional gait detection measure: Fall incidents measure: Dizzy incidents sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06275503 id: STROKESTOP III briefTitle: STROKESTOP III - Optimized Method for Atrial Fibrillation Screening overallStatus: NOT_YET_RECRUITING date: 2024-02-20 date: 2025-02-28 date: 2026-06-30 date: 2024-02-23 date: 2024-02-23 name: Danderyd Hospital class: OTHER name: Karolinska Institutet name: Landstinget i Värmland briefSummary: Atrial fibrillation is the most common sustained cardiac arrhythmia affecting more than 3% of the adult population. The symptoms of atrial fibrillation can range from asymptomatic to debilitating. It can be permanent in its nature, but also paroxysmal with only short bursts of atrial fibrillation randomly occurring and can therefore remain unnoticed. Atrial fibrillation increases the risk of stroke five fold if left untreated.

Screening for atrial fibrillation in elderly populations above age 65 years can result in detection of new atrial fibrillation cases ranging from 0,5% new AF with a single time-point ECG, up to 30% AF if an implantable loop recorder is inserted for 3 years.

Currently opportunistic screening using pulse palpation, or a single time-point ECG is recommended by the European Society of Cardiology guidelines. Systematic screening in individuals aged 75 or above, or at a high stroke risk should be considered.

Overall, participation in systematic atrial fibrillation screening trials has been shown to be relatively low with almost 50% non-participants. Participants are generally healthier, with higher socioeconomic status, hence the ones who would potentially benefit the most remain absent.

Opportunistic screening has shown promising results with higher participation rates and the possibility of better outreach. There is a lack of data from randomized trials on the difference in participation rates in systematic and opportunistic screening approaches when screening with prolonged ECG monitoring. conditions: Atrial Fibrillation conditions: Atrial Fibrillation New Onset studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Cluster randomized trial primaryPurpose: SCREENING masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 2200 type: ESTIMATED name: Screening invitation mode measure: Participation in screening measure: AF detection in opportunistic compared to systematic screening measure: OAC treatment after AF detection measure: Compliance to OAC treatment 1 year after initiation measure: Health economy measure: Composite endpoint of stroke, death and severe bleeding measure: Reminder strategy effect on participation measure: Comparison of automatic ECG analysis (using AI) for detection of AF in a (by AI algorithm classified) high- compared to a low-risk group measure: Application of the FIND-AF algorithm sex: ALL minimumAge: 75 Years maximumAge: 76 Years stdAges: OLDER_ADULT facility: Karolinska Institutet, Dept Med H city: Stockholm zip: 141 86 country: Sweden name: Emma Svennberg, MD PhD role: CONTACT phone: +46739584822 email: emma.svennberg@regionstockholm.se name: MD PhD role: CONTACT lat: 59.33258 lon: 18.0649 facility: Region Värmland city: Värmland country: Sweden name: Fredrik Carlstedt role: CONTACT lat: 60.83333 lon: 16.5 hasResults: False

 nctId: NCT06275490 id: 181123PER6_3_1 briefTitle: Post Extraction Changes Following Ridge Preservation Using Partially Demineralized Dentin Block Versus L- PRF Block overallStatus: RECRUITING date: 2024-01-01 date: 2024-05-01 date: 2024-11-15 date: 2024-02-23 date: 2024-02-23 name: Cairo University class: OTHER briefSummary: * The aim is to evaluate post extraction hard tissue changes following ridge preservation using partially demineralized dentin block versus L-PRF block in intact socket in the esthetic zone.
* The main question: In patients with un restorable tooth, Will ridge preservation using partially demineralized dentin block be more effective than L-PRF block in managing the post extraction hard tissue alterations?
* After enrolment, periodontal and radiographic examination and patients with badly un-restorative tooth in the esthetic zone will be identified. These patients will undergo to mesio-distal distance between adjacent teeth, corono-apical height of bone, presence of labial undercut, dehiscence, or fenestration and Relation to adjacent teeth measurements using trans gingival probing technique, and preapical radiograph or CBCT .
* In both groups, the desired tooth will be extracted under local anesthesia using peritomies and surgical forceps.
* In intervention group: the teeth will be cleaned and dried, and then the dentin will be ground to obtain particles of a certain size then partially demineralize dentin will obtained by using a tooth transformer machine. At the same time, blood samples are collected and processed to obtain fibrin membranes rich in platelets and leukocytes. This tissue is then mixed with partially demineralized dentin to create a solid mass called a "dentin block". During the process of preserving the alveolar bumps after extraction, this solid mass "dentin mass" is placed inside the dental pockets and covered with fibrin membranes rich in platelets and white blood cells, then 5/0 proline suture are used to fix the fibrin membranes and dentin mass in place. After the recovery period "4-6 months", a biopsy is taken for some cases from the site of the operation for histological evaluation during implant placement.
* In control group: the same steps as the first group will be used, but by replacing the partially demineralized dental graft with a xenograft.
* Outcomes: Radiographic vertical buccal bone changes, vertical Palatal bone changes, horizontal bone changes, Percentage of new vital bone formation, Percentage of residual bone graft, Implant Primary Stability. The results directly postoperative and 4-6 months postoperatively. conditions: Socket Preservation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A Randomized Controlled Pilot Trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Partially Demineralized Dentin Block name: L-PRF block measure: Radiographic vertical bone changes measure: Radiographic horizontal bone changes measure: Percentage of new vital bone formation and residual graft measure: Implant Primary Stability sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Faculty of dentistry Cairo University status: RECRUITING city: Cairo state: Elmanil zip: 4240101 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06275477 id: 29BRC23.0029 briefTitle: 68Gallium-FAPI PET/CT Imaging in Chronic Inflammatory and Fibrotic Diseases acronym: PARADISE overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-21 date: 2026-04-21 date: 2024-02-23 date: 2024-02-23 name: University Hospital, Brest class: OTHER briefSummary: This single-center pilot study is designed to explore the preliminary utility of the \[68Ga\] Ga-FAPI imaging agent in positron emission tomography (PET) combined with computed tomography (CT) for a range of chronic inflammatory and fibrosing diseases. The study focuses on the potential of \[68Ga\] Ga-FAPI, a novel radiotracer targeting Fibroblast Activation Protein (FAP), to improve diagnostic accuracy in various medical conditions. Thirteen distinct clinical situations have been selected for this investigation, including rheumatoid arthritis, liver fibrosis, and systemic lupus, among others. This approach aims to ascertain the value of further clinical development in each area and refine the use of this imaging modality in routine care for both initial evaluation and ongoing monitoring of these diseases. conditions: Inflammatory Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a single-center, descriptive and analytical pilot study, which will be implemented in 13 distinct and independent populations of patients with chronic inflammatory and/or fibrosing disease. primaryPurpose: DIAGNOSTIC masking: NONE count: 390 type: ESTIMATED name: 68Ga-FAPI46 measure: PET uptake intensity measure: [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Biomarkers correlation measure: [68Ga]Ga-FAPI PET/CT - Biomarkers correlation measure: [68Ga]Ga-FAPI PET/CT - Biomarkers correlation measure: [68Ga]Ga-FAPI PET/CT - Biomarkers correlation measure: [68Ga]Ga-FAPI PET/CT - Biomarkers correlation measure: [68Ga]Ga-FAPI PET/CT - Biomarkers correlation measure: [68Ga]Ga-FAPI PET/CT - Functional parameters correlation measure: [68Ga]Ga-FAPI PET/CT - Functional parameters correlation measure: [68Ga]Ga-FAPI PET/CT - Functional parameters correlation measure: [68Ga]Ga-FAPI PET/CT - Functional parameters correlation measure: [68Ga]Ga-FAPI PET/CT - Functional parameters correlation measure: [68Ga]Ga-FAPI PET/CT - Functional parameters correlation measure: [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation measure: [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation measure: [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation measure: [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation measure: [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation measure: [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation measure: [68Ga] Ga-FAPI PET/CT parameters evolution measure: [68Ga] Ga-FAPI PET/CT parameters evolution measure: [68Ga] Ga-FAPI PET/CT / [18F] F-FDG PET/CT comparison measure: [68Ga] Ga-FAPI PET/CT kinetic measure: [68Ga] Ga-FAPI PET/CT kinetic measure: [68Ga] Ga-FAPI PET/CT kinetic sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06275464 id: BT-600-101 briefTitle: BT-600 Single and Multiple Ascending Oral Doses in Healthy Adult Subjects overallStatus: RECRUITING date: 2024-01-11 date: 2024-04 date: 2024-06 date: 2024-02-23 date: 2024-02-23 name: Biora Therapeutics, Inc. class: INDUSTRY briefSummary: This is a randomized, double-blind, placebo-controlled Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of BT-600 when administered in single and multiple ascending doses to healthy participants. The study will enroll up to 48 participants, with participation lasting 2-3 weeks in addition to up to 28 days (about 4 weeks) for screening.

The purposes of this study are to learn about the safety and tolerability of single and multiple rising oral doses of BT-600, assess the blood and tissue levels of tofacitinib released from BT-600, and assess the body's effects to the study drug following oral doses of BT-600 in blood and tissue in healthy adult participants.

BT-600 is a swallowable drug/device combination product designed to deliver a liquid formulation of tofacitinib to the colon and dispense the study drug throughout the colon. BT-600 consists of two components, the drug part containing a reservoir, which will be filled with liquid tofacitinib, and the drive part. The drive part contains the hardware and software that identifies the colon region and then dispenses the drug to the specific region. The device which contains the drug is referred to as the NaviCap™ device. The NaviCap device is approximately the size of a fish oil pill, is made of plastic material known to be safe for ingestion and has rounded ends for ease of swallowing. Liquid tofacitinib in the reservoir is automatically released when the BT-600 localization technology determines that it has reached the colon. BT-600 passes through the colon and the NaviCap device is excreted via a bowel movement. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 48 type: ESTIMATED name: BT-600 name: BT-600 Placebo measure: Adverse Events measure: Pharmacokinetic (PK) Assessments sex: ALL minimumAge: 19 Years maximumAge: 50 Years stdAges: ADULT facility: Celerion status: RECRUITING city: Lincoln state: Nebraska zip: 68502 country: United States lat: 40.8 lon: -96.66696 hasResults: False

 nctId: NCT06275451 id: EssaiClinique_QUALI-RES briefTitle: Qualitative Study of Emotional Regulation in Schizophrenia acronym: QUALI-RES overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-01 date: 2026-01 date: 2024-02-23 date: 2024-02-28 name: University Hospital, Grenoble class: OTHER briefSummary: The main aim of this study is to investigate emotional regulation in individuals with schizophrenia using a qualitative methodology (semi-structured interview) and, therefore, from the person's point of view.

Given the qualitative nature of the methodology used in this study, the investigators have no specific hypothesis. The investigators have a general hypothesis suggesting that the patients' discourse will enable us to highlight the emotional regulation difficulties described in the literature. conditions: Schizophrenia conditions: Schizophrenia Schizoaffective studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 40 type: ESTIMATED name: Semi-structured interview measure: Emotional regulation in schizophrenia measure: Factors influencing emotional regulation in schizophrenia measure: Improved emotional regulation in schizophrenia measure: Stages of emotional regulation in schizophrenia sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06275438 id: 81829502.903/39 briefTitle: Comparison of Oxytocin Receptor Immunoreactivity in Placentas Obtained From Women Having Cesarean and Natural Birth overallStatus: COMPLETED date: 2018-08-25 date: 2019-07-01 date: 2019-12-01 date: 2024-02-23 date: 2024-02-23 name: Kafkas University class: OTHER briefSummary: Our study examines the effects of oxytocin hormone receptors. mechanisms of placental tissue cells and therefore intrauterine development. It was conducted to investigate the effects on newborn babies apgar score, fontanel openings, birth weights, etc. By collecting data, normal and They were compared between cesarean births by statistical analysis. normal in this regard Based on the hypothesis that there is a difference between labor and cesarean delivery, this study has been made.OXTR primary antibody was used for immunohistochemical examination. There was no significant difference between the groups in terms of histological examination. In the study, it was found that OXTR immunoreactivity was strong in decidual cells and stromal cells in villi. A stronger OXTR immunoreactivity was detected in villous stroma of placenta of the natural birth group compared to the cesarean birth group. Reaction was not observed in syncytotrophoblast cells and syncytial nodes in both groups, but strong immunoreaction was observed fetal endothelial cells and fetal capillaries in both groups. conditions: Healthy Mothers Who Have Had Both Vaginal and Cesarean Deliveries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: "Our study was conducted on the placentas of 40 women admitted to the obstetrics clinics of Kars Harakani State Hospital and Kafkas University Training and Research Hospital, after obtaining necessary permissions. Out of 40 placentas, 5 were excluded due to blood incompatibility, 2 were excluded due to subsequent diagnosis of chronic conditions (thyroid disorder, Behçet's disease), and 1 was excluded due to the presence of an accessory placenta, resulting in a total of 32 placentas included in the study. Among these, 16 were from women who had undergone normal vaginal delivery (control group), and 16 were from women who had undergone cesarean section (case group). Tissue samples obtained from the placentas were subjected to histological and immunohistochemical methods to obtain various findings primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 32 type: ACTUAL name: The delivery being performed via cesarean section surgery rather than natural childbirth measure: Oksitosin Receptor Immunoreactivity measure: Pearson correlation analysis sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Kafkas Universty city: Kars state: Merkez zip: 36100 country: Turkey lat: 40.59825 lon: 43.08548 hasResults: False

 nctId: NCT06275425 id: 4-2023-0429 briefTitle: Comparison of the Coughing Frequency of Remimazolam Total Intravenous Anesthesia Versus Inhalational Anesthesia overallStatus: COMPLETED date: 2023-06-25 date: 2023-11-29 date: 2023-11-29 date: 2024-02-23 date: 2024-02-23 name: Yonsei University class: OTHER briefSummary: This study is a randomized controlled trial. Adult patients undergoing thyroidectomy under general anesthesia at Severance Hospital and Yonsei Cancer Center are included in tis study. For intervention group, patients receive anesthesia with total intravenous remimazolam, while for control group, patients receive anesthesia with inhalation anesthetic.

The primary end point of the study is to determine whether coughing during endotracheal tube extubation is less when anesthesia is maintained with intravenous remimazolam compared to inhalation anesthetics. The secondary end points are cough score (graded into 4 levels), frequency of reoperation due to postoperative bleeding, These include the frequency of hypertension during the extubation process and whether additional painkillers are used in the recovery room. conditions: Thyroid Neoplasm conditions: Cough studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: a single-blinded randomized controlled trial primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 106 type: ACTUAL name: Total intravenous anesthesia with Byfavo name: Inhalation anesthesia with Sevoflurane measure: Proportion of patients not coughing during postoperative extubation measure: Cough score sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, College of Medicine, Yonsei University, city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06275412 id: IRB-23-04-5675 id: 5R01MD018583-02 type: NIH link: https://reporter.nih.gov/quickSearch/5R01MD018583-02 briefTitle: Family Intervention for Black Teens With Type 1 Diabetes acronym: 3Ms overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2028-03 date: 2028-03 date: 2024-02-23 date: 2024-02-23 name: Wayne State University class: OTHER name: National Institute on Minority Health and Health Disparities (NIMHD) briefSummary: The purpose of this study is to conduct a multicenter, randomized effectiveness trial of The 3Ms 2.0 compared to an educational control condition for improving adolescent glycemic control and diabetes-related family relationships and reducing primary caregiver diabetes-related distress among Black adolescents with type 1 diabetes (T1D) and their primary caregivers. The proposed study would develop and test The 3Ms 2.0 adapted intervention when delivered using a mobile health approach (accessed via parents' cell phone). The intervention will also include new family intervention content (videoclips and text messages). conditions: Type 1 Diabetes conditions: Family Relations studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: CARE_PROVIDER count: 216 type: ESTIMATED name: The 3Ms 2.0 Intervention name: Educational Attention Control (EAC) measure: Glycemic Control measure: Caregiver Diabetes Distress measure: Diabetes-Specific Family Conflict measure: Diabetes-Specific Parental Monitoring measure: Diabetes-Specific Family Support measure: Illness Management measure: Intervention Satisfaction sex: ALL minimumAge: 10 Years maximumAge: 14 Years stdAges: CHILD facility: Children's National Hospital city: Washington state: District of Columbia zip: 20010 country: United States name: Angelica Eddington, Ph.D., ABPP role: CONTACT phone: 202-476-2342 email: aeddington@childrensnational.org name: Angelica Eddington, Ph.D., ABPP role: SUB_INVESTIGATOR lat: 38.89511 lon: -77.03637 facility: LeBonheur Children's Hospital city: Memphis state: Tennessee zip: 38103 country: United States name: Kristoffer S Berlin, Ph.D. role: CONTACT email: ksberlin@memphis.edu name: Kathryn Sumpter, MD role: SUB_INVESTIGATOR name: Kristoffer S Berlin, Ph.D. role: SUB_INVESTIGATOR lat: 35.14953 lon: -90.04898 facility: University of Tennessee Health Science Center-Memphis city: Memphis state: Tennessee zip: 38163 country: United States name: Kristoffer S Berlin, Ph.D. role: CONTACT email: ksberlin@memphis.edu name: Kathryn Sumpter, MD role: SUB_INVESTIGATOR name: Kristoffer S Berlin, Ph.D. role: SUB_INVESTIGATOR lat: 35.14953 lon: -90.04898 hasResults: False

 nctId: NCT06275399 id: INTERFORCE briefTitle: Comprehensive Assessment of Morphometric, Functional, Biomechanical and Biological Interactions Between Atherosclerotic Plaque and Platelets Within the Stenosed Coronary Artery acronym: INTERFORCE overallStatus: RECRUITING date: 2023-07-21 date: 2025-07-21 date: 2026-07-21 date: 2024-02-23 date: 2024-02-23 name: Medical University of Warsaw class: OTHER name: National Science Centre, Poland name: University College, London name: Queen Mary University of London briefSummary: The main objective of the present study is to verify, in vivo, whether shear forces computed solely based on coronary angiography and computational fluid dynamics (CFD) techniques are associated with the biomarkers indicating the prothrombotic tendency of circulating blood in situ - distally and proximally to the coronary stenosis. The study will prospectively assess the relationship between i) the value and distribution of shear rate and shear stress (SS) estimated using three-dimensional angiography and CFD techniques, and ii) atherosclerotic plaque characteristics as assessed by optical coherence tomography (OCT), iii) functional parameters of diseased vessels assessed by vessel fractional flow reserve (vFFR), and iv) in situ platelet activation, as expressed by platelet-derived microvesicles (pMVs) and small extracellular vesicles (sEVs), platelet aggregometry and other serum prothrombotic or inflammatory biomarkers sampled within the coronary artery. conditions: Chronic Coronary Syndrome conditions: Atherosclerosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 105 type: ESTIMATED name: OCT examination name: Blood sampling name: Assessment of vFFR and shear stress parameters measure: Correlation between the mean shear rate and shear stress values at the lesion's site and the concentration of pMVs and sEVs sampled in the distal segment of the artery. measure: Correlation between the shear stress measurements at the site of the lesion and the concentration of inflammatory biomarkers in the distal segment of the artery measure: Correlation between the shear stress measurements at the site of the lesion and the platelet reactivity parameters in the distal segment of the artery measure: Correlation between the shear rate and shear stress values at the site of the lesion and the gradient (delta) concentration of the pMVs and sEVs measure: Correlation between the shear rate and shear stress values at the site of the lesion and the gradient (delta) concentration of inflammatory biomarkers measure: Correlation between the shear rate and shear stress values at the site of the lesion and the gradient (delta) of platelet reactivity measure: Concentrations of inflammatory biomarkers categorized by the atherosclerotic plaque morphology and the mean value of shear stress affecting the endothelium at the stenosis site and as well as according to the vessel measure: Platelet reactivity levels categorized by the atherosclerotic plaque morphology and the mean value of shear stress affecting the endothelium at the stenosis site and as well as according to the vessel measure: Concentrations of pMVs and sEVs categorized by the atherosclerotic plaque morphology and the mean value of shear stress affecting the endothelium at the stenosis site and as well as according to the vessel measure: Platelet reactivity levels in blood sampled from the stenosed vs. the non-stenosed coronary artery measure: Concentrations of analyzed pMVs and sEVs in blood sampled from the stenosed vs. the non-stenosed coronary artery measure: Concentrations of analyzed inflammatory biomarkers in blood sampled from the stenosed vs. the non-stenosed coronary artery measure: Correlation between vFFR delta pressure and the delta platelet reactivity in stenosed artery compared to these gradients in a non-stenosed artery in the same patient measure: Correlation between vFFR delta pressure and the delta concentration of the pMVs and sEVs in stenosed artery compared to these gradients in a non-stenosed artery in the same patient measure: Correlation between vFFR delta pressure and the delta concentration of the inflammatory biomarkers in stenosed artery compared to these gradients in a non-stenosed artery in the same patient sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of Warsaw status: RECRUITING city: Warsaw state: Mazowieckie zip: 02-097 country: Poland name: Mariusz Tomaniak, MD, PhD, Assoc. Prof. role: CONTACT email: mariusz.tomaniak@wum.edu.pl name: Adrian Bednarek role: CONTACT email: adikbednarek@gmail.com name: Mariusz Tomaniak, MD, PhD, Assoc. Prof. role: PRINCIPAL_INVESTIGATOR lat: 52.22977 lon: 21.01178 hasResults: False

 nctId: NCT06275386 id: 2.31/II/24 briefTitle: Drug-Coated Balloon in Native Chronic Total Occlusion Percutaneous Coronary Intervention acronym: IMAGINATION overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-09-01 date: 2025-09-01 date: 2024-02-23 date: 2024-02-23 name: National Institute of Cardiology, Warsaw, Poland class: OTHER briefSummary: The IMAGINATION trial is an investigator-initiated, prospective, single-center study of symptomatic patients with a native chronic total occlusion (CTO) undergoing intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) with a drug-coated balloon (DCB). Post-PCI IVUS and fractional flow reserve (FFR) at baseline and at 6-months follow-up will be performed. In addition, patients included in the coronary computed tomography angiography (CCTA) substudy will undergo photon-counting CCTA at 12-months follow-up. The aim of this study is to evaluate the efficacy and safety of DCB-only approach in native coronary CTO. conditions: Coronary Artery Disease conditions: Total Occlusion of Coronary Artery studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Paclitaxel Drug-coated balloon measure: In-segment late lumen loss measure: Angiographic outcomes assessed directly post-PCI measure: HQ-IVUS outcomes assessed directly post-PCI measure: Physiologic outcomes assessed directly post-PCI measure: Angiographic outcomes at 6-months follow-up measure: HQ-IVUS outcomes at 6-months follow-up measure: Physiologic outcomes at 6-months follow-up measure: Computed tomographic outcomes at 12-months follow-up (CCTA substudy) measure: Clinical outcomes at 12-months follow-up sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Institute of Cardiology city: Warsaw state: Mazowieckie zip: 04-628 country: Poland name: Agnieszka Zdziennicka role: CONTACT email: azdziennicka@ikard.pl lat: 52.22977 lon: 21.01178 hasResults: False

 nctId: NCT06275373 id: 20-10974 briefTitle: The Effect of Teprotumumab on Thyroid Eye Disease and Thyroid Dysfunction acronym: Teprotumumab overallStatus: RECRUITING date: 2021-05-12 date: 2026-05-12 date: 2027-12-12 date: 2024-02-23 date: 2024-02-23 name: Walter Reed National Military Medical Center class: FED briefSummary: This protocol studies the clinical outcome of patients with active thyroid disease with visually significant signs and symptoms of proptosis, pain, diplopiam lid/orbital edema, or lid/orbital erythema recommended for treatment with teprotumumab infusion (Tepezza®). Patients recommended for treatment will be evaluated by an oculoplastic surgeon (Dr. Eva Chou) and endocrinologist (Dr. Thanh Hoang). conditions: Thyroid Eye Disease conditions: Graves Ophthalmopathy conditions: Graves Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: Teprotumumab Injection [Tepezza] measure: Ophthalmological Clinical Activity Score (CAS) scoring measure: Thyroid stimulating immunoglobulin measure: HLA subtypes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Walter Reed National Military Medical Center status: RECRUITING city: Bethesda state: Maryland zip: 20889 country: United States name: Thanh D Hoang, DO role: CONTACT phone: 301-295-5165 phoneExt: 6220 email: thanh.d.hoang.mil@health.mil name: Iris E Morris, PhD role: CONTACT phone: 3013194599 email: iris.e.morris3.civ@health.mil lat: 38.98067 lon: -77.10026 hasResults: False

 nctId: NCT06275360 id: SPLP-002-23F briefTitle: Repositioning Immunotherapy in VetArans With Lung Cancer acronym: RIVAL overallStatus: RECRUITING date: 2024-03-01 date: 2027-02-28 date: 2030-03-31 date: 2024-02-23 date: 2024-03-12 name: VA Office of Research and Development class: FED briefSummary: This study is a multicenter Phase II single arm trial to assess the safety and efficacy of chemotherapy and immunotherapy followed by radiotherapy in patients with unresectable Stage III NSCLC. conditions: Non-Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Carboplatin, paclitaxel, and nivolumab for three cycles followed by radiotherapy followed by nivolumab (for squamous cell lung cancer) OR Carboplatin, pemetrexed, and nivolumab for three cycles followed by radiotherapy followed by nivolumab (for lung adenocarcinoma) primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Nivolumab measure: Progression-free survival measure: Treatment Tolerance measure: Adverse Events measure: Best overall response rate (BOR) measure: Overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA status: NOT_YET_RECRUITING city: West Los Angeles state: California zip: 90073-1003 country: United States name: Daniel Shin, MD role: CONTACT phone: 310-478-3711 email: Daniel.Shin@va.gov name: Michelle Treadwell role: CONTACT phone: 3104783711 phoneExt: 45003 email: Michelle.Treadwell@va.gov lat: 34.0464 lon: -118.44813 facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT status: RECRUITING city: West Haven state: Connecticut zip: 06516-2770 country: United States name: Michal Rose, MD role: CONTACT phone: 203-932-5711 phoneExt: 2832 email: Michal.Rose@va.gov name: Alicia Roy role: CONTACT phone: 2039325711 phoneExt: 3006 email: Alicia.Roy@va.gov lat: 41.27065 lon: -72.94705 facility: VA Ann Arbor Healthcare System, Ann Arbor, MI status: RECRUITING city: Ann Arbor state: Michigan zip: 48105-2303 country: United States name: Brittany M Pannecouk, BS role: CONTACT phone: 734-845-3966 email: brittany.pannecouk@va.gov name: Laura A Randolph, BA role: CONTACT phone: (734) 845-5091 email: Laura.Randolph@va.gov name: Michael D Green role: PRINCIPAL_INVESTIGATOR name: Nithya Ramnath, MD role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 facility: Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE status: NOT_YET_RECRUITING city: Omaha state: Nebraska zip: 68105-1850 country: United States name: Apar Kishor P Ganti, MD role: CONTACT phone: 402-346-8800 phoneExt: 3846 email: Aparkishor.Ganti@va.gov name: Anna Kellogg role: CONTACT phone: 4029954143 email: Anna.Kellogg@va.gov lat: 41.25626 lon: -95.94043 facility: Durham VA Medical Center, Durham, NC status: NOT_YET_RECRUITING city: Durham state: North Carolina zip: 27705-3875 country: United States name: Michael Kelley, MD role: CONTACT phone: 919-286-0411 phoneExt: 172199 email: Michael.Kelley6@va.gov name: Maya Robinson role: CONTACT phone: 9192866926 email: Maya.Robinson@va.gov lat: 35.99403 lon: -78.89862 facility: Louis Stokes VA Medical Center, Cleveland, OH status: NOT_YET_RECRUITING city: Cleveland state: Ohio zip: 44106-1702 country: United States name: Charles Nock, MD role: CONTACT phone: 216-791-3800 phoneExt: 64825 email: Charles.Nock@va.gov name: Margaret Titkin role: CONTACT phone: 2167913800 phoneExt: 36241 email: MargaretTiktin@va.gov lat: 41.4995 lon: -81.69541 facility: Hunter Holmes McGuire VA Medical Center, Richmond, VA status: NOT_YET_RECRUITING city: Richmond state: Virginia zip: 23249-0001 country: United States name: Bhaumik Patel, MD role: CONTACT phone: 804-675-5446 email: Bhaumik.Patel@va.gov lat: 37.55376 lon: -77.46026 hasResults: False

 nctId: NCT06275347 id: 19CI 30 087 041 id: 1/1142021 type: OTHER domain: Comite del Centro de alta especialidad del Estado de Veracruz briefTitle: Very Low Calorie Ketogenic Low-fat Diet (VLCKLFD) acronym: Zelé2021 overallStatus: COMPLETED date: 2021-01-15 date: 2021-12-30 date: 2023-05-25 date: 2024-02-23 date: 2024-02-23 name: Universidad Veracruzana class: OTHER briefSummary: This study aimed to assess the efficacy and safety of the Zélé program, a controlled ketogenic diet, for weight loss and maintenance. It involved a randomized clinical trial with participants aged 18-60, BMI between 30-34.9 kg/m², and no severe health issues conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A Randomized Clinical Trial was conducted in patients with obesity type I patients primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Eligible patients were assigned to a one of the four VIME Weight Loss and Wellness Center for management and follow up according to their preference, a sequential number in inclusion order was given, with all the patients coded with a 4-digit number. This code was sent to the people in the food production plant where the patients were randomized in a double blinded study, with a 2:1 allocation for low-fat, normo-protein, controlled ketogenic diet (Zélé method) or low calories diet whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 88 type: ACTUAL name: Low-fat normoprotein Controlled Ketogenic Diet. name: Hypocaloric Balanced Diet measure: Evaluate the efficacy of this nutritional intervention measure: Volume of total body tissue corresponding to muscle measure: Percentage of body weight made up of adipose tissue measure: Visceral Fat measure: Bone mass measure: Total body water measure: Waist circumference measure: Hip circumference measure: Muscular strenght measure: Weight measure: Height measure: BMI Body index mass measure: Hemoglobin measure: Hematocrit measure: Leukocytes measure: Fasting Blood Glucose measure: Glycated hemoglobin (HbA1c) measure: Insulin measure: Creatinine measure: Urea measure: Uric acid measure: Sodium measure: Potassium measure: Calcium measure: Phosphorus measure: Magnesium measure: Albumin measure: Direct bilirubin measure: Indirect bilirubin measure: Total bilirubin measure: Alanine aminotransferase measure: Aspartate Amino Transferase measure: Total cholesterol measure: Triglycerides measure: High Density Lipoproteins measure: Low Density lipoproteins measure: Protein C Reactive measure: Thyroid stimulating hormone measure: Triiodothyronine measure: Thyroxine measure: Cholecalciferol measure: Gasometric variables, Partial pressure of oxygen (PaO2) measure: HCO3 (Bicarbonate ion plasma concentration) measure: Arterial pH measure: Lactic acid measure: Adherence to this nutritional intervention measure: Satisfaction survey sex: ALL minimumAge: 18 Years maximumAge: 61 Years stdAges: ADULT facility: Francisco J Nachón García city: Ciudad de Mexico country: Mexico lat: 19.42847 lon: -99.12766 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2021-04-23 uploadDate: 2024-02-16T19:37 filename: Prot_SAP_000.pdf size: 549651 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2021-04-23 uploadDate: 2024-01-14T23:04 filename: ICF_001.pdf size: 249137 hasResults: False

 nctId: NCT06275334 id: 9133 briefTitle: Dinutuximab Beta at the HUS and the Toulouse Oncopole acronym: DNB overallStatus: RECRUITING date: 2023-11-28 date: 2024-11 date: 2024-11-28 date: 2024-02-23 date: 2024-02-23 name: University Hospital, Strasbourg, France class: OTHER briefSummary: In this study the investigators wish to describe the cohort of pediatric patients suffering from neuroblastoma and treated with Dinutuximab and to compare the costs and quality of life between the two French centers, the University Hospital of Strasbourg (HUS) and the Oncopole of Toulouse. conditions: Neuroblastoma studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 40 type: ESTIMATED measure: Comparison of two methods of treating a pediatric pathology in two French health establishments, the HUS and the Oncopole of Toulouse. sex: ALL minimumAge: 2 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: Service de Pharmacie - Stérilisation - CHU de Strasbourg - France status: RECRUITING city: Strasbourg zip: 67091 country: France name: Anne EL AATMANI, Pharm, PhD role: CONTACT phone: 33 3 88 12 78 06 email: Anne.ELAATMANI@chru-strasbourg.fr name: Emilie BERTHON, Pharm, PhD role: CONTACT phone: 33 3 88 12 78 06 email: emilieberthon@orange.fr name: Anne EL AATMANI, Pharm, PhD role: PRINCIPAL_INVESTIGATOR name: Emilie BERTHON, PhamD, PhD role: PRINCIPAL_INVESTIGATOR name: Sophie PERRIAT, PhamD, PhD role: PRINCIPAL_INVESTIGATOR lat: 48.58392 lon: 7.74553 hasResults: False

 nctId: NCT06275321 id: Elena Garcia Roca briefTitle: Physical Exercise Benefits for Cancer Patients overallStatus: RECRUITING date: 2021-11-05 date: 2024-07-27 date: 2025-07-30 date: 2024-02-23 date: 2024-02-23 name: Universitat Jaume I class: OTHER briefSummary: The purpose of the study was to analyze the effect of a synchronous-supervised online home-based group during a 6-month exercise program on physical fitness, body composition and adherence compared to an exercise recommendation group of patients undergoing breast cancer treatment without supervision. conditions: Cancer, Breast conditions: Sports Physical Therapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: A prospective ramonized clinical trial with two groups primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Synchronous-supervised online home-based group name: Exercise recommendation group measure: Cardiorrespiratory fitness measure: Strength - Chair Stand (repetitions) measure: Flexibility measure: Incidence of treatments on quality of live assessed by EORTIC QLQ-C30 measure: Adherence measure: Rating of perceived exertion measure: Strength - Hand Grip (Kilograms) measure: Strength - Squat Jump (height in centimeters) sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jaume I University status: RECRUITING city: Castellón De La Plana state: Castellón zip: 12071 country: Spain name: Elena Garcia Roca, MSc role: CONTACT phone: +34 629112367 email: garciroc@uji.es name: Eladio J Collado-Boira, PhD role: CONTACT phone: +34 606133368 email: colladoe@uji.es lat: 39.98567 lon: -0.04935 hasResults: False

 nctId: NCT06275308 id: STUDY21100163 briefTitle: Effect of Raised End-Tidal pCo2 on Choroidal Volume overallStatus: RECRUITING date: 2023-02-27 date: 2025-02-27 date: 2025-02-27 date: 2024-02-23 date: 2024-02-23 name: University of Pittsburgh class: OTHER briefSummary: This study is to investigate the relationship between arterial carbon dioxide (CO2) concentration and vitreous pressure on the choroidal volume by integrated intraoperative OCT imaging under eye exams under anesthesia. conditions: Intraocular Pressure studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a descriptive case series. primaryPurpose: BASIC_SCIENCE masking: NONE count: 20 type: ESTIMATED name: Ventilation manipulation measure: Intraocular Pressure (IOP) (mmHg) measure: Choroidal thickness ( microns) sex: ALL maximumAge: 8 Years stdAges: CHILD facility: University of Pittsburgh Medical Center status: RECRUITING city: Pittsburgh state: Pennsylvania zip: 15224 country: United States name: Amy Monroe, MPH, MBA role: CONTACT email: monroeal@upmc.edu name: Kanwal Nischal, MD,FRCOphth role: PRINCIPAL_INVESTIGATOR name: Lieu Tran, MD role: SUB_INVESTIGATOR lat: 40.44062 lon: -79.99589 hasResults: False

 nctId: NCT06275295 id: ZRJY2021-BJ08-03-01-01 briefTitle: A Retrospective Study of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-12-24 date: 2024-12-31 date: 2024-02-23 date: 2024-02-23 name: China-Japan Friendship Hospital class: OTHER briefSummary: The goal of this observational study is to learn about the diagnostic effectiveness, safety, and influencing factors of transbronchial cryobiopsy（TBLC） in progressive pulmonary fibrosis. conditions: Pulmonary Fibrosis conditions: Transbronchial Cryobiopsy studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 300 type: ESTIMATED measure: The diagnostic rate of MDD2 based on TBLC measure: The diagnostic rate of MDD1 sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06275282 id: HUM00235849 briefTitle: Regenerative Peripheral Nerve Interfaces for the Control of Above-knee Prostheses overallStatus: RECRUITING date: 2024-03-01 date: 2027-06-30 date: 2027-09-30 date: 2024-02-23 date: 2024-03-25 name: University of Michigan class: OTHER name: United States Department of Defense briefSummary: Individuals with an above-knee lower limb amputation are known to walk more slowly, expend more energy, have a greater risk of falling, and have reduced quality of life compared to individuals without amputation and those with below knee amputation. One of the driving factors behind these deficits is the lack of active function provided by above-knee prostheses with prosthetic knees and ankles. While many prosthetic devices have been developed for functional restoration after major lower extremity amputation, there remains no stable interface to facilitate reliable, long-term volitional control of an advanced robotic limb capable moving multiple joints. Moreover, there is no existing interface that provides useful sensory feedback that in turn enhances the functional capabilities of the prosthesis. To achieve both greater signal specificity and long-term signal stability, we have developed a biologic interface known as the Regenerative Peripheral Nerve Interface (RPNI). An RPNI consists of a peripheral nerve that is implanted into a free muscle graft that would otherwise go unused in the residual limb. As the nerve grows, it reinnervates the free muscle graft which undergoes a predictable sequence of revascularization and regeneration.

The main questions it aims to answer are:

1. Can the amplitude, movement specificity and stability of sciatic nerve RPNI electromyography (EMG) signals be detected up to one year post RPNI surgery?
2. Do RPNIs contain information to enable control of a physical motorized prosthetic leg with multiple degrees of freedom?
3. Does stimulation of sciatic nerve RPNIs provides meaningful sensory feedback?

Consenting participants with unilateral transfemoral amputation (TFA) will:

1. Undergo RPNI surgery and electrode implantation in the residual limb.
2. Attend regular follow-up visits following surgery to assess the health and signal strength of the RPNIs and their ability to use a prescribed prosthesis between 3- and 12-months following implantation.
3. Undergo explantation of electrodes following the conclusion of data collection. conditions: Amputation conditions: Prostheses and Implants studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 3 type: ESTIMATED name: Intramuscular electrodes measure: Intensity of pain in residual and phantom limbs measure: Neuropathic Pain in residual limb measure: Health-Related Quality of Life measure: Amplitude and signal-to-noise ratio for each RPNI measure: Classification accuracy for movements of the phantom limb measure: Threshold for sensation after electrical stimulation of RPNI sex: ALL minimumAge: 22 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Michigan status: RECRUITING city: Ann Arbor state: Michigan zip: 48109 country: United States name: Deanna Gates, PhD role: CONTACT phone: 723-647-2698 email: gatesd@umich.edu name: Deanna Gates, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 hasResults: False

 nctId: NCT06275269 id: ZRJY2021-BJ08-04-02 briefTitle: Endoscopic Mucosal Injection Versus Ultrasound-Guided Injection of Triamcinolone to Treat Subglottic Stenosis overallStatus: NOT_YET_RECRUITING date: 2024-03-10 date: 2024-10-31 date: 2024-12-31 date: 2024-02-23 date: 2024-02-23 name: China-Japan Friendship Hospital class: OTHER briefSummary: This study employs a multicenter, randomized controlled trial method, where patients meeting the inclusion criteria for subglottic stenosis are randomly divided into two groups. These groups are respectively undergoing translaryngeal endoscopic mucosal injection and ultrasound-guided injection of triamcinolone treatment. The comparison will focus on various indicators such as therapeutic effect, incidence of adverse reactions, treatment costs, and hospital resource utilization between the two groups. The safety and effectiveness will be compared to determine the relative merits of the two treatment methods. conditions: Subglottic Stenosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Ultrasound-Guided name: Translaryngeal Endoscopic Mucosal Injection measure: Incidence of Short-Term Postoperative Complications measure: Overall medical expenses incurred by patients sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06275256 id: HS26226 briefTitle: Outcomes of MIST for BPH: A Single-Institution Prospective Study overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-03 date: 2024-02-23 date: 2024-02-23 name: University of Manitoba class: OTHER briefSummary: The investigators wish to perform a prospective study at the Men's Health Clinic in Winnipeg, Manitoba to accomplish two goals: 1) Prospectively describe 1 year outcomes for MIST therapies performed at the clinic 2) perform a head to head comparison of Rezum water vapor therapy vs the iTind device in respect to symptom score improvement, uroflow parameters and side effect profile. conditions: Benign Prostatic Hyperplasia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Rezum name: iTind measure: Symptom Scores measure: Uroflow measure: Uroflow measure: Symptom Scores measure: Symptom Scores measure: Symptom Scores measure: Pain Scale sex: MALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Men's Health Clinic city: Winnipeg state: Manitoba zip: R3K 1M3 country: Canada name: Premal Patel, MD role: CONTACT phone: 204-221-4476 email: ppatel5@hsc.mb.ca name: Harliv Dhillon, BSc role: CONTACT phone: 2049904153 email: harlivmhc@gmail.com lat: 49.8844 lon: -97.14704 hasResults: False

 nctId: NCT06275243 id: ETICA-ULE-021-2022 briefTitle: Polymorphism of ApoE in Alzheimer's Disease: Genetic Study in Castile and Leon (Spain) overallStatus: ACTIVE_NOT_RECRUITING date: 2022-07-06 date: 2023-03-13 date: 2024-03-22 date: 2024-02-23 date: 2024-02-23 name: Universidad de León class: OTHER name: Consejo General de Colegios Oficiales de Enfermería España briefSummary: The general objective of this randomized and longitudinal clinical study was to estimate the frequencies of ApoE variants both in the user population of the "Messengers of Peace" Residences and the "Associations of Relatives of Alzheimer's Patients" in Castile y Leon, since, due to its geographical location at the crossroads, it has received multiple genetic contributions from both northern Europe, the Mediterranean area and northern Africa.

The main questions it aims to answer are:

* What are the allelic frequencies of ApoE variants in the population of individuals with Alzheimer's disease in Castile and Leon?
* Is there a correlation between the ApoE4 variant and the lipid profile in the blood of individuals with Alzheimer's disease in this region? conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: It is a longitudinal randomised clinical study, in which two study groups were used. A group of cases diagnosed with Alzheimer's disease and a control group of healthy individuals without Alzheimer's disease. primaryPurpose: DIAGNOSTIC masking: NONE count: 511 type: ACTUAL name: Kit Buccal swab collection & stabilization de Canvax® name: Cholesterol levels according to ApoE Genotype name: Assessing cardiovascular risk factors in all participants measure: Distribution of ApoE variants in the Alzheimer's disease population diagnosed in Castile and Leon. measure: Cardiovascular factors in individuals with Alzheimer's disease and healthy subjects. measure: ApoE genotypes and cholesterol levels in the Alzheimer's disease population diagnosed in Castile and Leon. sex: ALL minimumAge: 60 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of León city: León zip: 240071 country: Spain lat: 42.60003 lon: -5.57032 hasResults: False

 nctId: NCT06275230 id: ZRJY2021-BJ08-02-07 briefTitle: Establishment of Human Lung Stem Cell Proliferation System and Organoid Construction in COPD overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2025-12-31 date: 2025-12-31 date: 2024-02-23 date: 2024-02-23 name: China-Japan Friendship Hospital class: OTHER briefSummary: The goal of this study is to proliferate human lung stem cell in vitro in order to establish a lung organoid derived from patients with COPD. The main question it aims to answer are:

* Can human lung stem cell proliferate in vitro.
* Can a lung organoid derived from patients with COPD be established. Participants will be sampled during pulmonary bronchoscope for organoid establishment. conditions: Chronic Obstructive Pulmonary Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 30 type: ESTIMATED measure: Number of Patients completed bronchoscope. sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06275217 id: HMRF17182481 briefTitle: Mindful Yoga for Postpartum Depression overallStatus: RECRUITING date: 2021-01-08 date: 2025-07-15 date: 2025-12-31 date: 2024-02-23 date: 2024-02-23 name: The Hong Kong Polytechnic University class: OTHER briefSummary: This is a parallel-group randomized controlled trial. A total of 198 postpartum women with depressive symptoms (EPDS scores≥8 at baseline) will be recruited and randomized into two groups: 10-week mindful yoga intervention and 10-week psychoeducation program. Clinical assessment of depression, self-report questionnaires and salivary cortisol tests will be performed at baseline, after 10-week intervention, and at 6-month and 12-month follow-ups. The investigators expected that the mindful yoga intervention will reduce depression after 10 weeks compared to psychoeducation. The mindful yoga intervention will further reduce anxiety, stress, improve quality of life and sleep, and steepen diurnal cortisol slopes. These effects will be maintained for at least six months. conditions: Mood Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 198 type: ESTIMATED name: Mindfulness-based yoga program name: Psychoeducation measure: Edinburgh Postnatal Depression Scale measure: Depression Anxiety Stress Scale-Depression measure: Depression Anxiety Stress Scale-Anxiety measure: Depression Anxiety Stress Scale-Stress measure: Pittsburgh Sleep Quality Index measure: 36 Item-Short Form Health Survey Questionnaire measure: Five Facet Mindfulness Questionnaire measure: Pregnancy Symptom Inventory measure: Cortisol concentration level measure: Physical fitness measure: Balance sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: The Hong Kong Polytechnic University status: RECRUITING city: Hong Kong country: Hong Kong name: Jessie JX Lin, PhD role: CONTACT email: jx-jessie.lin@polyu.edu.hk lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06275204 id: 101101252 id: 101101252 type: OTHER_GRANT domain: EU4H-2022-PJ-01 briefTitle: H. Pylori Screen-and-treat Study in a Population of Young Adults overallStatus: RECRUITING date: 2024-03-04 date: 2026-10-01 date: 2026-12-01 date: 2024-02-23 date: 2024-03-05 name: University of Latvia class: OTHER name: Clinical Hospital Center Rijeka name: Clinical Hospital Centre Zagreb name: Beacon Hospital name: Wroclaw Medical University name: Iuliu Hatieganu University of Medicine and Pharmacy name: National Institute of Public Health, Slovenia briefSummary: Gastric cancer remains a major challenge to public health on a global scale. H. pylori related cancer burden contributes to the largest proportion of cancer cases attributable to infections in Europe. Considering its absolute burden and persisting disparities, in addition to the substantial prevalence of H. pylori infection worldwide that is treatable, gastric cancer is a logical target for urgent action for prevention. Population-based H. pylori test-and-treat has therefore been proposed as a strategy for gastric cancer prevention. To fill the gaps in knowledge about gastric cancer prevention through H. pylori screening and eradication in younger adults, a study of a population-based H. pylori test-and-treat strategy in Ireland, Croatia, Latvia, Poland, Romania and Slovenia.

Main goals of this study are to assess future program processes, feasibility, acceptability and effectiveness. In total of 6,800 adults aged 30-34 will be tested for H. pylori infection. They will be randomly selected to represent the chosen population and invited to participate in the study based on informed consent. Confirmed infections will be treated by available combined therapy in line with treatment guidelines and the success of eradication will be retested during a control check-up.

Patients who will provide their consent to participate will undertake an interview about the risk factors in early childhood and their habits regarding alcohol consumption and use of tobacco. Compliance to testing and treatment, treatment results, adverse effects and reasons for dropping out will be additionally monitored. Gathered data will be analysed in alignment with our research questions. The investigators will disseminate reports and present the results to both the general public and the scientific community in order to foster future developments in gastric cancer prevention. conditions: Gastric Cancer conditions: H Pylori Infection conditions: H Pylori Eradication conditions: H-pylori studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 6800 type: ESTIMATED name: Bismuth-based quadruple therapy name: Levofloxacin-based quadruple therapy name: Standard triple therapy name: Levofloxacin-based triple measure: Healthcare workers' assessment of feasibility and acceptability of the proposed practical implementation of a screening program measure: Eradication rate of infection with H. pylori measure: Description of the adverse events profile measure: Participation rate of subjects selected for the program sex: ALL minimumAge: 30 Years maximumAge: 34 Years stdAges: ADULT facility: University Hospital Centre Zagreb status: RECRUITING city: Zagreb state: Grad Zagreb zip: 10000 country: Croatia name: Masa Cavlina Sevo, MD role: CONTACT phone: 00385995900847 email: masa.cavlina@gmail.com name: Mirjana Kalauz, Asst. Prof. role: CONTACT phone: 0038598519088 email: mirjanakalauz1@gmail.com name: Mirjana Kalauz, Asst. Prof. role: PRINCIPAL_INVESTIGATOR name: Pave Markos, MD, PhD role: SUB_INVESTIGATOR name: Tihomir Bradic, MD role: SUB_INVESTIGATOR name: Masa Cavlina Sevo, MD role: SUB_INVESTIGATOR lat: 45.81444 lon: 15.97798 facility: Clinical Hospital Center Rijeka status: RECRUITING city: Rijeka zip: 51000 country: Croatia name: Sandra Milic, MD role: CONTACT phone: 0038551658122 email: smilic05@gmail.com lat: 45.32674 lon: 14.44239 facility: Beacon Hospital status: RECRUITING city: Dublin zip: D18 AK68 country: Ireland name: Charlene Deane, MB Bch BAO, MSc role: CONTACT phone: 00353879114305 email: charlene.deane@beaconhospital.ie name: Ruth Pilkington, MB BcH BAO role: CONTACT phone: 0035312937521 email: ruth.pilkington@beaconhospital.ie name: Colm O Morain, MD, MB BcH BAO, FRCPI role: PRINCIPAL_INVESTIGATOR name: Orlaith Kelly, PHD, MB BcH role: SUB_INVESTIGATOR name: Charlene Deane, MB Bch BAO, MSc, MRCP role: SUB_INVESTIGATOR lat: 53.33306 lon: -6.24889 facility: Clinical and Preventive Medicine of the University of Latvia status: NOT_YET_RECRUITING city: Riga zip: LV1079 country: Latvia name: Marcis Leja, MD, PhD role: CONTACT phone: 371+29497500 email: marcis.leja@lu.lv name: Marcis Leja, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Danute Razuka Ebela, MD, PhD role: SUB_INVESTIGATOR name: Linda Mezmale, MD role: SUB_INVESTIGATOR lat: 56.946 lon: 24.10589 facility: Wroclaw Medical University status: RECRUITING city: Wroclaw zip: 50-367 country: Poland name: Katarzyna Malinowska role: CONTACT phone: 00487178417 99 email: k.malinowska@umw.edu.pl name: Elzbieta Olejnik role: CONTACT phone: 00717841666 email: elzbieta.olejnik@umw.edu.pl name: Katarzyna Neubauer, MD, PhD, Assoc. Prof. role: PRINCIPAL_INVESTIGATOR name: Radoslaw Kempinski, MD, PhD role: SUB_INVESTIGATOR lat: 51.1 lon: 17.03333 facility: Iuliu Hatieganu University of Medicine and Pharmacy status: RECRUITING city: Cluj-Napoca state: Cluj County zip: 400003 country: Romania name: Dan Lucian Dumitrascu, Prof role: CONTACT phone: 0040722756475 email: ddumitrascu@umfcluj.ro name: Radu Farcas, MD, PhD student role: CONTACT phone: 0040757554422 email: radufr@gmail.com name: Radu Farcas, MD, PhD student role: SUB_INVESTIGATOR lat: 46.76667 lon: 23.6 facility: National Institute of Public Health, Slovenia status: RECRUITING city: Ljubljana zip: 1000 country: Slovenia name: Mitja Oblak, MSc role: CONTACT phone: 0038612441541 email: Mitja.Oblak@nijz.si name: Tatjana Kofol, MD role: CONTACT phone: 0038612441484 email: Tatjana.Kofol@nijz.si name: Bojan Tepeš, prof., MD role: PRINCIPAL_INVESTIGATOR lat: 46.05108 lon: 14.50513 hasResults: False

 nctId: NCT06275191 id: 80758 id: 1UG3DE032621-01 type: NIH link: https://reporter.nih.gov/quickSearch/1UG3DE032621-01 id: 4UH3DE032621-02 type: NIH link: https://reporter.nih.gov/quickSearch/4UH3DE032621-02 briefTitle: Alternatives to Dental Opioid Prescribing After Tooth Extraction acronym: ADOPT overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-01 date: 2028-12 date: 2024-02-23 date: 2024-03-06 name: Douglas Oyler class: OTHER name: National Institute of Dental and Craniofacial Research (NIDCR) briefSummary: The goal of this clinical trial is to test a three-item intervention in oral surgeons who remove teeth. The main questions it aims to answer are:

* Can the intervention reduce opioid prescriptions to adolescents and young adults after tooth removal?
* Do oral surgeons' beliefs about the intervention and opioid prescribing change?
* Do patients that report using opioids after tooth removal have different experiences than patients that do not?

Oral surgeon participants will:

* Attend a 1-hour education session with a trained pharmacist
* Receive patient instructions and blister packs of pain medicine to give to patients
* Complete 2 surveys about feasibility and appropriateness

Patient participants will complete a survey about pain and medication use after having a tooth removed.

Researchers will compare the intervention to usual care to see if it reduces opioid prescribing. conditions: Analgesics, Opioid conditions: Acute Pain conditions: Tooth Extraction conditions: Adolescent conditions: Acetaminophen conditions: Ibuprofen studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Stepped wedge cluster randomized trial primaryPurpose: OTHER masking: DOUBLE maskingDescription: Blinding to the intervention is not possible in this study, as the intervention requires provider engagement. Provider participants and any clinic personnel will be blinded to the allocation sequence, and those not yet receiving the intervention will not be aware of the time at which they will have the intervention implemented. The study biostatistician will be aware of the allocation sequence.

At the beginning of each period, the study biostatistician will inform the research coordinator, project manager, academic detailing pharmacist, and PIs which cluster will be transitioning to the intervention condition next. This information will be used to facilitate scheduling academic detailing visits and coordinate blister pack and patient instructions material assembly. The clinic will be informed of their allocation during Visit 4 to facilitate scheduling academic detailing visits. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 38159 type: ESTIMATED name: Multicomponent intervention name: Usual care measure: Odds of post-extraction opioid prescription to adolescent/young adults after tooth extraction measure: (Change in) intervention feasibility measure: (Change in) intervention appropriateness measure: (Change in) opioid prescribing feasibility measure: (Change in) opioid prescribing appropriateness measure: Self-reported pain measure: Self-reported pain interference measure: Self-reported pain satisfaction sex: ALL minimumAge: 12 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: University of Kentucky city: Lexington state: Kentucky zip: 40536 country: United States name: Jennifer Dolly Prothro, MPH role: CONTACT email: jenniferdolly@uky.edu name: Enif Dominguez, DDS role: SUB_INVESTIGATOR name: Patricia R Freeman, PhD role: SUB_INVESTIGATOR name: Hannah K Knudsen, PhD role: SUB_INVESTIGATOR name: Craig S Miller, DDS role: SUB_INVESTIGATOR name: Sharon L Walsh, PhD role: SUB_INVESTIGATOR name: Philip M Westgate, PhD role: SUB_INVESTIGATOR lat: 37.98869 lon: -84.47772 hasResults: False

 nctId: NCT06275178 id: ZRJY2021-BJ08-02-04 briefTitle: Medical Thoracoscopy for Diagnosing Unexplained Pleural Effusion: a National Multicenter Retrospective Study overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-12-24 date: 2024-12-31 date: 2024-02-23 date: 2024-02-23 name: China-Japan Friendship Hospital class: OTHER briefSummary: This study is a national multicenter retrospective study. Patients with unexplained pleural effusion who underwent thoracoscopic or video-assisted thoracoscopic biopsy for patients in recent 10 years were retrospectively collected from multiple centers to understand the proportion and final etiological composition of pleural effusion in China. conditions: Pleural Effusion conditions: Pleural Effusion, Malignant conditions: Fibrinous Pleuritis studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 5000 type: ESTIMATED name: Medical thoracoscopy measure: The proportion of fibrinous pleurisy in Chinese population sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06275165 id: 202301754B0 briefTitle: The Effects of Acupressure on Improving Postoperative Gastrointestinal Symptom Distress in Esophageal Cancer Patients overallStatus: RECRUITING date: 2024-03-27 date: 2025-07-18 date: 2025-07-18 date: 2024-02-23 date: 2024-03-29 name: CHEN, CHIA-CHEN class: OTHER briefSummary: This study is a quasi-experimental design clinical trial with the primary objective of comparing the health status of patients with esophageal cancer. Participants were divided into an experimental group and a control group. Patients in the experimental group received routine care and acupressure for 5 consecutive days starting from the day after entering the ward after esophageal cancer surgery, in the control group, participants received routine care, and Participants were assessed on the Gastrointestinal Symptom Distress Scale at the end of the intervention. The aim of this study was to verify the effectiveness of acupressure in improving of gastrointestinal symptoms distress after esophageal cancer surgery. conditions: Esophageal Cancer conditions: Gastrointestinal Dysfunction studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants were divided into an experimental group and a control group. experimental group: received acupressure for 5 days in addition to regular care.

control group: received regular postoperative care. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: acupressure measure: Change from Baseline in gastrointestinal symptom distress Scale at study day 5(end day) sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chang Gung Memotial Hospital status: RECRUITING city: Taoyuan country: Taiwan name: Chia-Chen Chen role: CONTACT phone: +886-3-3281200 phoneExt: 3005 email: mymychen73@gmail.com lat: 24.95233 lon: 121.20193 hasResults: False

 nctId: NCT06275152 id: HDRIC-01 briefTitle: The Protective Effect of Remote Ischemic Conditioning on Residual Renal Function in Hemodialysis Patients (RIC-HD) acronym: RIC-HD overallStatus: ENROLLING_BY_INVITATION date: 2024-02-20 date: 2026-01-19 date: 2026-01-19 date: 2024-02-23 date: 2024-02-26 name: Yuanjun Yang class: OTHER briefSummary: Hemodialysis (HD) is the main renal replacement therapy for patients with end-stage renal disease. However, factors such as hemodynamic instability can lead to gradual loss of residual renal function (RRF) in HD patients. The loss of RRF not only affects the adequacy of dialysis and complications control but also impacts the patients' quality of life and survival. Unfortunately, there are currently no effective methods to protect RRF. The purpose of this study is to validate the protective effect of remote ischemic conditioning (RIC) on RRF in HD patients. This will provide evidence for the application of RIC in protecting RRF in HD patients. conditions: End-stage Renal Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized controlled pilot study primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: Only Research Assistant will be unblinded. Participant, clinical team, PI, etc. will all be blinded to the randomization group. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Remote ischemic conditioning name: Sham Remote Ischemic Conditioning measure: time to anuria measure: residual renal function (RRF) measure: Change in the renal cerebral oxygen saturation measure: serum creatinine measure: serum urea nitrogen measure: C-reactive protein (CRP) measure: Interleukin-6 measure: TFF3 measure: KIM-1 measure: IP-10 measure: hemoglobin measure: systolic pressure measure: diastolic pressure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chinese PLA General Hospital city: Beijing state: Beijing zip: 100853 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06275139 id: 2023-GSP-GG-9 briefTitle: Integrated Assessment of Cervicocerebral Vessels to Improve the Brain Injury for CAGB Patients (IACV Study) overallStatus: RECRUITING date: 2023-01-01 date: 2024-06-30 date: 2024-12-31 date: 2024-02-23 date: 2024-02-23 name: China National Center for Cardiovascular Diseases class: OTHER_GOV briefSummary: The goal of this study is to establish a prospective study to focus on the high-risk stroke population who require coronary artery bypass graft surgery. It will divide the eligible patients into 1:1 group by simple randomization method. The control group adopt the traditional diagnosis and treatment mode, and only head CT plain scan and carotid artery ultrasound shall be performed. If necessary, relevant disciplines would be consulted but no integrated assessment of cervicocerebral vessels be arranged. The final treatment plan would be decided by the surgeon alone. The experimental group adopt the multidisciplinary collaboration and integrated evaluation mode. In addition to routine diagnosis and treatment as above-mentioned, integrated assessment of cervicocerebral vessels shall be performed, including transcranial color-coded doppler, cerebral perfusion with multislice CT, and cognitive function assessment. Based on the above results, surgical plans will be formulated jointly by multiple disciplines including neurologists, vascular surgeons, ICU physicians and cardiac surgeons. Researchers will compare the two groups to investigate whether integrated assessment of cervicocerebral vessels can reduce the incidence of brain injury compared with conventional diagnosis and treatment mode. conditions: Coronary Disease conditions: Coronary Artery Bypass conditions: Strokes Thrombotic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Integrated assessment of cervicocerebral vessels shall be performed, including transcranial color-coded doppler, cerebral perfusion with multislice CT, and cognitive function assessment. primaryPurpose: PREVENTION masking: NONE count: 348 type: ESTIMATED name: Integrated Assessment of Cervicocerebral Vessels measure: The incidence of neurological complications measure: The incidence of major adverse cardiac events measure: Neurological scale scores sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fuwai Hospital; National Cardiovascular Center; Peking Union Medical College & Chinese Academy of Medical Sciences status: RECRUITING city: Beijing state: Beijing zip: 100037 country: China name: Huanmei Liu, MD role: CONTACT email: ncrc@fuwai.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06275126 id: 23-08026433 id: R01CA256877-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/R01CA256877-01A1 briefTitle: Optimizing Surgical Decisions in Young Adults With Breast Cancer acronym: CONSYDER overallStatus: RECRUITING date: 2024-03-13 date: 2026-09 date: 2027-05 date: 2024-02-23 date: 2024-04-10 name: Weill Medical College of Cornell University class: OTHER name: National Institutes of Health (NIH) name: National Cancer Institute (NCI) briefSummary: The goal of this study is to understand and improve the breast surgical decision-making process for young women newly diagnosed with breast cancer. As part of this study, the investigators will evaluate the impact and use a web-based tool called CONSYDER that is designed to provide useful information to young breast cancer patients. It is also meant to improve communication between young women and their surgeons with the purpose of helping patients make appropriate surgical decisions.

Participants will complete surveys within 1 week of the surgical consult and 6 months after surgery. Patients who receive neoadjuvant chemotherapy will also be surveyed after the completion of neoadjuvant treatment but prior to surgery. Some patients will be invited for an interview after their surgery as part of the evaluation. A subset of patients/surgeons will also have their surgical consultation audio-recorded. conditions: Breast Cancer Stage 0 conditions: Breast Cancer Stage I conditions: Breast Cancer Stage II conditions: Breast Cancer Stage III studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The study is a pragmatic, Type II hybrid effectiveness-implementation, stepped-wedge design that will incorporate a mixed-methods approach to test the efficacy and evaluate the implementation of the CONSYDER intervention primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 800 type: ESTIMATED name: CONSYDER decision aid measure: Pre-surgical decisional conflict as measured by the Decisional Conflict Scale (DCS) measure: Use of CONSYDER pre-consult measure: Knowledge as measured by adapted Breast Cancer Surgery Decision Quality Instrument (BCS -DQI) measure: Treatment goals and preferences as measured by adapted Breast Cancer Surgery Decision Quality Instrument (BCS-DQI) measure: Anxiety, as measured with the 8-item Patient Reported Outcomes Measurement Information System (PROMIS) - Anxiety - Short Form measure: Self-efficacy in communication as measured by the Perceived Efficacy in Patient-Physician Interactions scale (PEPPI). measure: Decisional regret as measured by the Decision Regret Scale (DRS) measure: Receipt of contralateral prophylactic mastectomy measure: Fidelity of implementation of CONSYDER via patient portal email measure: Use of CONSYDER post-consult measure: Frequency of CONSYDER use pre-consult measure: Frequency of CONSYDER use post-consult sex: FEMALE minimumAge: 18 Years maximumAge: 44 Years stdAges: ADULT facility: Yale Cancer Center status: RECRUITING city: New Haven state: Connecticut zip: 06510 country: United States name: Rachel Greenup, MD, MPH role: CONTACT phone: 203-737-2966 email: rachel.greenup@yale.edu name: Rachel Greenup, MD, MPH role: PRINCIPAL_INVESTIGATOR lat: 41.30815 lon: -72.92816 facility: Dana-Farber Cancer Institute status: RECRUITING city: Boston state: Massachusetts zip: 02215 country: United States name: Ann Partridge, MD, MPH role: CONTACT phone: 617-632-3800 email: ann_partridge@dfci.harvard.edu name: Ann Partridge, MD, MPH role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Weill Cornell Medicine status: RECRUITING city: New York state: New York zip: 10065 country: United States name: Shoshana Rosenberg, ScD, MPH role: CONTACT phone: 646-962-8041 email: shr4009@med.cornell.edu name: Darima Dorzhieva role: CONTACT phone: 646-962-8666 email: dad4011@med.cornell.edu name: Shoshana Rosenberg, ScD, MPH role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: Duke Cancer Institute status: RECRUITING city: Durham state: North Carolina zip: 27710 country: United States name: Jennifer Plichta, MD, MS role: CONTACT phone: 919-681-9156 email: jennifer.plichta@duke.edu name: Jennifer Plichta, MD, MS role: PRINCIPAL_INVESTIGATOR lat: 35.99403 lon: -78.89862 hasResults: False

 nctId: NCT06275113 id: K25 briefTitle: BRING-UP Prevention overallStatus: RECRUITING date: 2023-09-15 date: 2026-06-30 date: 2026-06-30 date: 2024-02-23 date: 2024-02-23 name: Heart Care Foundation class: OTHER briefSummary: The aim of this observational study is to assess in patients with a documented athero-thrombotic event: coronary artery disease (CAD), cerebrovascular disease (CVD), peripheral artery disease (PAD):

* the level of adherence to guideline recommendations with the assumption to improve the rate of patients at goal for cholesterol levels.
* the level of adherence to guideline recommendations and the rate of patients at goal for the other relevant and modifiable risk factors for cardiovascular event recurrence. conditions: Ischemic Heart Disease conditions: Cerebrovascular Disorders conditions: Peripheral Arterial Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 6000 type: ESTIMATED measure: Adherence to guideline for cholesterol level measure: Adherence to guideline for other risk factors measure: Patients' outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ospedale Barone Lombardo - Cardiologia E Utic status: NOT_YET_RECRUITING city: Canicatti' state: AG zip: 92024 country: Italy name: LUCIANO SUTERA SARDO, MD role: CONTACT lat: 37.35842 lon: 13.84786 facility: Ospedale San Giacomo D'Altopasso - Uoc Cardiologia status: RECRUITING city: Licata state: AG zip: 92027 country: Italy name: SALVATORE MONTALTO, MD role: CONTACT lat: 37.10267 lon: 13.93972 facility: Ospedale Santo Spirito - Sc Cardiologia status: RECRUITING city: Casale Monferrato state: AL zip: 15033 country: Italy name: FEDERICO NARDI, MD role: CONTACT lat: 45.13338 lon: 8.4525 facility: Ospedale San Giacomo - Sc Cardiologia status: RECRUITING city: Novi Ligure state: AL zip: 15067 country: Italy name: MARIA E ROVERE, MD role: CONTACT lat: 44.76246 lon: 8.787 facility: Ospedali Riuniti - Clinica Di Cardiologia E Aritmologia status: NOT_YET_RECRUITING city: Ancona state: AN zip: 60122 country: Italy name: PAOLO COMPAGNUCCI, MD role: CONTACT lat: 43.5942 lon: 13.50337 facility: Ospedali Riuniti - Sod Cardiologia Ospedaliera E Utic status: NOT_YET_RECRUITING city: Ancona state: AN zip: 60122 country: Italy name: GIAN PIERO PERNA, MD role: CONTACT lat: 43.5942 lon: 13.50337 facility: Casa Di Cura Villa Serena - U.O. Cardiologia Riabilitativa status: RECRUITING city: Jesi state: AN zip: 60035 country: Italy name: NICOLA RUSSO, MD role: CONTACT lat: 43.52142 lon: 13.24368 facility: Ospedale Madonna Del Soccorso - Uoc Cardiologia Indirizzo Riabilitativo status: RECRUITING city: San Benedetto Del Tronto state: AP zip: 63074 country: Italy name: MICHELA MOLISANA, MD role: CONTACT lat: 42.9568 lon: 13.87676 facility: Ospedale San Donato - U.O.C Cardiologia status: RECRUITING city: Arezzo state: AR zip: 52100 country: Italy name: MATTEO ROCCO RECCIA, MD role: CONTACT lat: 43.46276 lon: 11.88068 facility: Ospedale Valdichiana Santa Margherita - Uosd Cardiologia S.O. Cortona status: RECRUITING city: Cortona state: AR zip: 52044 country: Italy name: SIMONA D'ORAZIO, MD role: CONTACT lat: 43.27467 lon: 11.98533 facility: Aorn San Giuseppe Moscati - U.O. Cardiologia/Utic 'D. Rotiroti' status: RECRUITING city: Avellino state: AV zip: 83100 country: Italy name: EMILIO DI LORENZO, MD role: CONTACT lat: 40.91494 lon: 14.79103 facility: Ospedale Miulli - U.O.C. Cardiologia - Utic status: RECRUITING city: Acquaviva Delle Fonti state: BA zip: 70021 country: Italy name: NICOLA VITULANO, MD role: CONTACT lat: 40.89704 lon: 16.8433 facility: Ospedale Della Murgia - Fabio Perinei - S.C. Cardiologia-Utic status: RECRUITING city: Altamura state: BA zip: 70022 country: Italy name: PIETRO SCICCHITANO, MD role: CONTACT lat: 40.82664 lon: 16.54952 facility: Ospedale San Paolo - Cardiologia-Utic status: RECRUITING city: Bari state: BA zip: 70123 country: Italy name: PASQUALE CALDAROLA, MD role: CONTACT lat: 41.11148 lon: 16.8554 facility: Ics Maugeri Spa Societa' Benefit Irccs Bari - Cardiologia Riabilitativa status: RECRUITING city: Bari state: BA zip: 70124 country: Italy name: ANDREA PASSANTINO, MD role: CONTACT lat: 41.11148 lon: 16.8554 facility: Mater Dei Hospital - Riabilitazione Cardiologica status: RECRUITING city: Bari state: BA zip: 70124 country: Italy name: ROCCO LAGIOIA, MD role: CONTACT lat: 41.11148 lon: 16.8554 facility: Ospedale Umberto I - U.O.C. Cardiologia status: RECRUITING city: Corato state: BA zip: 70033 country: Italy name: ILARIA L NALIN, MD role: CONTACT lat: 41.15171 lon: 16.41143 facility: Ospedale San Giacomo - Uoc Cardiologia status: RECRUITING city: Monopoli state: BA zip: 70043 country: Italy name: ONOFRIO ROSSI, MD role: CONTACT lat: 40.94918 lon: 17.29717 facility: Ospedale Degli Infermi - Sc Di Cardiologia status: RECRUITING city: Ponderano state: BI zip: 13875 country: Italy name: ANDREA ROGNONI, MD role: CONTACT lat: 45.53846 lon: 8.05592 facility: Presidio Ospedaliero "Santa Maria Del Prato" - U.O.C. Di Cardiologia-Utic status: RECRUITING city: Feltre state: BL zip: 32032 country: Italy name: CHRISTIAN PIERGENTILI, MD role: CONTACT lat: 46.02085 lon: 11.90031 facility: Ospedale Di Bentivoglio - U.O. Cardiologia Pianura status: RECRUITING city: Bentivoglio state: BO zip: 40010 country: Italy name: GIANFRANCO TORTORICI, MD role: CONTACT lat: 44.6369 lon: 11.41737 facility: Ospedale Maggiore - U.O.C. Di Cardiologia status: RECRUITING city: Bologna state: BO zip: 40133 country: Italy name: GIANMARCO IANNOPOLLO, MD role: CONTACT lat: 44.49381 lon: 11.33875 facility: Ospedale Bellaria - U.O. Di Cardiologia status: RECRUITING city: Bologna state: BO zip: 40139 country: Italy name: STEFANO URBINATI, MD role: CONTACT lat: 44.49381 lon: 11.33875 facility: Ospedale Perrino - U.O.C. Di Cardiologia status: RECRUITING city: Brindisi state: BR zip: 72100 country: Italy name: GIAN PAOLO GIORDA, MD role: CONTACT lat: 40.63215 lon: 17.93607 facility: Casa Di Cura San Camillo - U.O. Cardiologia status: RECRUITING city: Brescia state: BS zip: 25123 country: Italy name: MARCO CAPRETTI, MD role: CONTACT lat: 45.53558 lon: 10.21472 facility: Ospedale Di Desenzano Del Garda - Divisione Di Cardiologia - U.C.C. status: RECRUITING city: Desenzano Del Garda state: BS zip: 25015 country: Italy name: GIOSUE' MASCIOLI, MD role: CONTACT lat: 45.47127 lon: 10.53559 facility: Ospedale Civile 'La Memoria' - U.O. Di Cardiologia status: RECRUITING city: Gavardo state: BS zip: 25085 country: Italy name: MARCO TRIGGIANI, MD role: CONTACT lat: 45.58939 lon: 10.44257 facility: Istituti Clinici Scientifici Maugeri Irccs Sede Di Lumezzane - U.O. Di Cardiologia Riabilitativa status: RECRUITING city: Lumezzane state: BS zip: 25065 country: Italy name: FRANCESCA RIVADOSSI, MD role: CONTACT lat: 45.64789 lon: 10.26487 facility: Ospedale Monsignor Angelo R. Di Miccoli - Uoc Cardiologia/Utic status: NOT_YET_RECRUITING city: Barletta state: BT zip: 76121 country: Italy name: FRANCESCO BARTOLOMUCCI, MD role: CONTACT lat: 41.31429 lon: 16.28165 facility: Ospedale Centrale Bolzano - Cardiologia E Prove Funzionali status: RECRUITING city: Bolzano state: BZ zip: 39100 country: Italy name: PRISCILLA MILEWSKI, MD role: CONTACT lat: 46.49067 lon: 11.33982 facility: Arnas G. Brotzu - Cardiologia Con Utic status: NOT_YET_RECRUITING city: Cagliari state: CA zip: 09134 country: Italy name: MARCO CORDA, MD role: CONTACT lat: 39.23054 lon: 9.11917 facility: Arnas G. Brotzu - S.S.D. Cardioriabilitazione status: RECRUITING city: Cagliari state: CA zip: 09134 country: Italy name: ANDREA BIANCO, MD role: CONTACT lat: 39.23054 lon: 9.11917 facility: A.O.U. Cagliari Policlinico Monserrato - Sc Cardiologia Utic Emodinamica status: NOT_YET_RECRUITING city: Monserrato state: CA zip: 09124 country: Italy name: ROBERTA MONTISCI, MD role: CONTACT lat: 39.25642 lon: 9.1444 facility: Azienda Ospedaliera S. Anna E S. Sebastiano - U.O. Cardiologia D'Emergenza Con Utic status: RECRUITING city: Caserta state: CE zip: 81100 country: Italy name: PAOLO CALABRO', MD role: CONTACT lat: 41.07262 lon: 14.33231 facility: Villa Delle Magnolie - Riabilitazione Cardiologica status: RECRUITING city: Castel Morrone state: CE zip: 81020 country: Italy name: FRANCESO PERONE, MD role: CONTACT lat: 41.12102 lon: 14.35473 facility: Casa Di Cura San Michele - Uo Cardiologia status: RECRUITING city: Maddaloni state: CE zip: 81024 country: Italy name: MARCO PEPE, MD role: CONTACT lat: 41.03578 lon: 14.3823 facility: Ospedale San Giuseppe E Melorio - U.O.C. Cardiologia Utic status: RECRUITING city: Santa Maria Capua Vetere state: CE zip: 81055 country: Italy name: PIETRO IODICE, MD role: CONTACT lat: 41.08156 lon: 14.25342 facility: Ospedale Policlinico Ss. Annunziata - Uoc Cardiologia-Utic status: NOT_YET_RECRUITING city: Chieti state: CH zip: 66013 country: Italy name: MARCO ZIMARINO, MD role: CONTACT lat: 42.34827 lon: 14.16494 facility: Santa Barbara Hospital - Cardiologia status: RECRUITING city: Gela state: CL zip: 93012 country: Italy name: GIUSEPPE LA ROSA, MD role: CONTACT lat: 37.07381 lon: 14.24038 facility: Azienda Ospedaliera Santa Croce E Carle - Sc Cardiologia status: RECRUITING city: Cuneo state: CN zip: 12100 country: Italy name: FRANCESCA GIORDANA, MD role: CONTACT lat: 44.39071 lon: 7.54828 facility: Ospedale Regina Montis Regalis - U.O. Cardiologia-Utic status: RECRUITING city: Mondovì state: CN zip: 12084 country: Italy name: MAURO FEOLA, MD role: CONTACT lat: 44.39603 lon: 7.81764 facility: Ospedale Maggiore Ss. Annunziata - Sc Cardiologia status: RECRUITING city: Savigliano state: CN zip: 12038 country: Italy name: MICHELE DE BENEDICTIS, MD role: CONTACT lat: 44.64808 lon: 7.65677 facility: Ospedale Oglio Po - U.O. Di Cardiologia-Utic status: RECRUITING city: Casalmaggiore state: CR zip: 26041 country: Italy name: CARLO PISCICELLI, MD role: CONTACT lat: 44.98981 lon: 10.42055 facility: Ospedale Annunziata - Uoc Cardiologia Interventistica status: RECRUITING city: Cosenza state: CS zip: 87100 country: Italy name: FRANCESCO GRECO, MD role: CONTACT lat: 39.2989 lon: 16.25307 facility: Ospedale Spoke Paola- Cetraro Po Paola - Utic Cardiologia status: RECRUITING city: Paola state: CS zip: 87027 country: Italy name: MARIA T MANES, MD role: CONTACT lat: 39.36313 lon: 16.03691 facility: Policlinico Di Catania Presidio San Marco - Cardiologia Utic status: NOT_YET_RECRUITING city: Catania state: CT zip: 95100 country: Italy name: ALESSIO G LA MANNA, MD role: CONTACT lat: 37.49223 lon: 15.07041 facility: P.O. Garibaldi-Nesima - Arnas Garibaldi - U.O.C. Di Cardiologia Con Utic status: RECRUITING city: Catania state: CT zip: 95122 country: Italy name: MICHELE M GULIZIA, MD role: CONTACT lat: 37.49223 lon: 15.07041 facility: P.O. "Materdomini" - A.O.U. "Renato Dulbecco" - Ssd Cardiologia Riabilitativa status: RECRUITING city: Catanzaro state: CZ zip: 88100 country: Italy name: DOMENICO ZUCCO, MD role: CONTACT lat: 38.88247 lon: 16.60086 facility: Ospedale G.B. Morgagni - L. Pierantoni - U.O. Cardiologia status: RECRUITING city: Forli' state: FC zip: 47121 country: Italy name: DANIELA SPARTA', MD role: CONTACT lat: 44.22177 lon: 12.04144 facility: Arcispedale Sant'Anna - U.O. Cardiologia status: RECRUITING city: Ferrara state: FE zip: 44124 country: Italy name: GABRIELE GUARDIGLI, MD role: CONTACT lat: 44.83804 lon: 11.62057 facility: Policlinico Riuniti - S.C. Di Cardiologia Universitaria-Utic status: RECRUITING city: Foggia state: FG zip: 71100 country: Italy name: NATALE D BRUNETTI, MD role: CONTACT lat: 41.45845 lon: 15.55188 facility: San Francesco Hospital - U.O.C. Cardiologia status: RECRUITING city: Foggia state: FG zip: 71122 country: Italy name: ALDO RUSSO, MD role: CONTACT lat: 41.45845 lon: 15.55188 facility: Ospedale Casa Sollievo Della Sofferenza - Cardiologia - Utic - Riabil Cardiologica status: RECRUITING city: San Giovanni Rotondo state: FG zip: 71013 country: Italy name: GIUSEPPE DI STOLFO, MD role: CONTACT lat: 41.70643 lon: 15.7277 facility: Aou Careggi - Riabilitazione Cardiologica status: RECRUITING city: Firenze state: FI zip: 50134 country: Italy name: COSTANZA BURGISSER, MD role: CONTACT lat: 43.77925 lon: 11.24626 facility: E.O. Ospedali Galliera - S. C. Cardiologia E U.T.I.C. status: RECRUITING city: Genova state: GE zip: 16128 country: Italy name: MARIA MOLFESE, MD role: CONTACT lat: 44.40478 lon: 8.94438 facility: Ospedale San Giovanni Di Dio - Sc Cardiologia (Gorizia-Monfalcone) status: RECRUITING city: Gorizia state: GO zip: 34170 country: Italy name: GERARDINA LARDIERI, MD role: CONTACT lat: 45.94088 lon: 13.62167 facility: Ospedale Civile San Polo - Sc Cardiologia (Gorizia-Monfalcone) status: NOT_YET_RECRUITING city: Monfalcone state: GO zip: 34074 country: Italy name: GERARDINA LARDIERI, MD role: CONTACT lat: 45.80463 lon: 13.53292 facility: Presidio Ospedaliero - U.O. Cardiologia status: RECRUITING city: Sanremo state: IM zip: 18038 country: Italy name: FABIO FERRARI, MD role: CONTACT lat: 43.81725 lon: 7.7772 facility: Ospedale Alessandro Manzoni - S.C. Di Cardiologia status: RECRUITING city: Lecco state: LC zip: 23900 country: Italy name: ROBERTO SPOLADORE, MD role: CONTACT lat: 45.85589 lon: 9.39704 facility: Presidio Ospedaliero F. Ferrari - Ssd Cardiologia - Utic status: RECRUITING city: Casarano state: LE zip: 73042 country: Italy name: DONATO MELISSANO, MD role: CONTACT lat: 40.01131 lon: 18.16237 facility: Ospedale San Giuseppe Da Copertino - U.O. Di Cardiologia status: NOT_YET_RECRUITING city: Copertino state: LE zip: 73043 country: Italy name: ALESSANDRO CALCAGNILE, MD role: CONTACT lat: 40.26821 lon: 18.0543 facility: Ospedale Vito Fazzi - Uoc Cardiologia-Utic Ed Emodinamica status: RECRUITING city: Lecce state: LE zip: 73100 country: Italy name: STEFANIA MARAZIA, MD role: CONTACT lat: 40.35481 lon: 18.17244 facility: Ospedale Ignazio Veris Delli Ponti - Uoc Cardiologia-Utic "E. Vilei" status: RECRUITING city: Scorrano state: LE zip: 73020 country: Italy name: COSIMO A GRECO, MD role: CONTACT lat: 40.09018 lon: 18.29993 facility: Ospedali Riuniti - U.O.C. Cardiologia E Utic status: RECRUITING city: Livorno state: LI zip: 57124 country: Italy name: FRANCESCO BELLINI, MD role: CONTACT lat: 43.54427 lon: 10.32615 facility: Istituto 'Marco Pasquali' Icot - Riabilitazione Cardiologica status: RECRUITING city: Latina state: LT zip: 04100 country: Italy name: ANTONIO GROSSI, MD role: CONTACT lat: 41.46614 lon: 12.9043 facility: Nuovo Ospedale Versilia - Sc Cardiologia status: RECRUITING city: Camaiore state: LU zip: 55041 country: Italy name: GIANCARLO CASOLO, MD role: CONTACT lat: 43.94265 lon: 10.29754 facility: Ospedale Giovanni Paolo Ii - Uosd Utic status: NOT_YET_RECRUITING city: Policoro state: Matera zip: 75025 country: Italy name: ANDREA ANDRIANI, MD role: CONTACT lat: 40.2128 lon: 16.67795 facility: Ospedale Pio Xi - U.O.C. Di Cardiologia status: RECRUITING city: Desio state: MB zip: 20832 country: Italy name: FELICE ACHILLI, MD role: CONTACT lat: 45.61831 lon: 9.20249 facility: Fondazione Irccs San Gerardo Dei Tintori - Ospedale San Gerardo - U.O.C. Cardiologia status: RECRUITING city: Monza state: MB zip: 20900 country: Italy name: LAURA F VALAGUSSA, MD role: CONTACT lat: 45.58005 lon: 9.27246 facility: Ospedale Di Seregno - Riabilitazione Specialistica Cardiologica status: RECRUITING city: Seregno state: MB zip: 20831 country: Italy name: ELISABETTA SCANZIANI, MD role: CONTACT lat: 45.65002 lon: 9.20548 facility: Nuovo Ospedale Di Vimercate - S.C. Cardiologia E Utic status: RECRUITING city: Vimercate state: MB zip: 20871 country: Italy name: DANIELA GRASSELLI, MD role: CONTACT lat: 45.61545 lon: 9.36801 facility: Ospedale Generale Provinciale - U.O. Cardiologia status: RECRUITING city: Macerata state: MC zip: 62100 country: Italy name: MICAELA CAPPONI, MD role: CONTACT lat: 43.29789 lon: 13.45293 facility: Iomi Istituto Ortopedico F. Scalabrino - Uo Cardiologia status: RECRUITING city: Messina state: ME zip: 98015 country: Italy name: ROBERTO CARUSO, MD role: CONTACT lat: 38.19394 lon: 15.55256 facility: Irccs Centro Neurolesi Bonino Pulejo - P.O Piemonte - Cardiologia E Utic status: RECRUITING city: Messina state: ME zip: 98124 country: Italy name: ANTONIO DUCA, MD role: CONTACT lat: 38.19394 lon: 15.55256 facility: Azienda Ospedaliera Papardo - U.O. Cardiologia Con Utic - Emodinamica status: RECRUITING city: Messina state: ME zip: 98158 country: Italy name: VITO PIPITONE, MD role: CONTACT lat: 38.19394 lon: 15.55256 facility: Ospedale Di Cernusco Sul Naviglio - U. O. Di Cardiologia E Ucc status: NOT_YET_RECRUITING city: Cernusco Sul Naviglio state: MI zip: 20063 country: Italy name: SERGIO SALA, MD role: CONTACT lat: 45.52526 lon: 9.33297 facility: Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico - Uoc Malattie Cardiovascolari status: RECRUITING city: Milano state: MI zip: 20122 country: Italy name: STEFANO CARUGO, MD role: CONTACT lat: 45.46427 lon: 9.18951 facility: Centro Cardiologico Monzino Irccs - Terapia Intensiva Cardiologica (Utic) status: RECRUITING city: Milano state: MI zip: 20138 country: Italy name: FILIPPO TOMBARA, MD role: CONTACT lat: 45.46427 lon: 9.18951 facility: Istituti Clinici Scientifici Maugeri Irccs Sede Di Milano - Riabilitazione Cardiologica status: RECRUITING city: Milano state: MI zip: 20138 country: Italy name: MAURIZIO BUSSOTTI, MD role: CONTACT lat: 45.46427 lon: 9.18951 facility: Istituti Clinici Scientifici Maugeri Irccs Sede Di Milano - Uo Cure Subacute status: RECRUITING city: Milano state: MI zip: 20138 country: Italy name: MARCO FROLDI, MD role: CONTACT lat: 45.46427 lon: 9.18951 facility: Irccs Santa Maria Nascente Fond. Don Gnocchi - Cardiologia Riabilitativa status: RECRUITING city: Milano state: MI zip: 20148 country: Italy name: ANDREA A MORASCHI, MD role: CONTACT lat: 45.46427 lon: 9.18951 facility: ASST SANTI PAOLO E CARLO - PO San Carlo - CARDIOLOGIA-UCC status: RECRUITING city: Milano state: MI zip: 20153 country: Italy name: MARTA RESCALDANI, MD role: CONTACT lat: 45.46427 lon: 9.18951 facility: Irccs Ospedale Galeazzi - Sant'Ambrogio - Cardiologia Universitaria Ed Imaging Cardiaco status: RECRUITING city: Milano state: MI zip: 20157 country: Italy name: EDOARDO CONTE, MD role: CONTACT lat: 45.46427 lon: 9.18951 facility: Asst Ospedale Metropolitano Niguarda - Diagnosi E Cure Terr. Malattie Cardiache status: RECRUITING city: Milano state: MI zip: 20159 country: Italy name: GIULIANA G MOMBELLI, MD role: CONTACT lat: 45.46427 lon: 9.18951 facility: Asst Ospedale Metropolitano Niguarda - Cardiologia 1 - Emodinamica status: RECRUITING city: Milano state: MI zip: 20162 country: Italy name: LAURA GARATTI, MD role: CONTACT lat: 45.46427 lon: 9.18951 facility: Asst Ospedale Metropolitano Niguarda - Cardiologia 4 - Diagnostica E Riabilitativa status: RECRUITING city: Milano state: MI zip: 20162 country: Italy name: ALESSANDRO MALOBERTI, MD role: CONTACT lat: 45.46427 lon: 9.18951 facility: Presidio Ospedaliero Di Passirana - Cardiologia Riabilitativa status: RECRUITING city: RHO state: MI zip: 20017 country: Italy name: ANNA FRISINGHELLI, MD role: CONTACT lat: 45.53245 lon: 9.0402 facility: Irccs Policlinico San Donato - Cardiologia Riabilitativa status: RECRUITING city: San Donato Milanese state: MI zip: 20097 country: Italy name: MASSIMO PIEPOLI, MD role: CONTACT lat: 45.41047 lon: 9.26838 facility: Irccs Policlinico Multimedica - Uo Di Cardiologia status: RECRUITING city: Sesto San Giovanni state: MI zip: 20099 country: Italy name: LUCA P ALBERTI, MD role: CONTACT lat: 45.53329 lon: 9.22585 facility: Ospedale Citta' Di Sesto San Giovanni - Sc Cardiologia-Ucc Asst Nord Milano (Bassini-Ssg) status: RECRUITING city: Sesto San Giovanni state: MI zip: 20099 country: Italy name: CAMILLA FACCHINI, MD role: CONTACT lat: 45.53329 lon: 9.22585 facility: Ospedale Santa Maria Bianca - U.O. Di Cardiologia status: RECRUITING city: Mirandola state: MO zip: 41037 country: Italy name: GIULIA NANNI, MD role: CONTACT lat: 44.88515 lon: 11.06902 facility: Ospedale Civile Di Baggiovara - U.O. Di Cardiologia status: RECRUITING city: Modena state: MO zip: 41126 country: Italy name: STEFANIA SANSONI, MD role: CONTACT lat: 44.64783 lon: 10.92539 facility: Ospedale Di Sassuolo - Cardiologia status: RECRUITING city: Sassuolo state: MO zip: 41049 country: Italy name: WALTER SACCO, MD role: CONTACT lat: 44.5432 lon: 10.7848 facility: Ospedale San Giovanni Di Dio - Uo Cardiologia - Utic status: RECRUITING city: Frattamaggiore state: Napoli zip: 80027 country: Italy name: FRANCESCO PIEMONTE, MD role: CONTACT lat: 40.9414 lon: 14.27588 facility: Fondazione G. Giglio - U.O. Di Cardiologia status: RECRUITING city: Cefalu' state: PA zip: 90015 country: Italy name: DONATELLA ARMATA, MD role: CONTACT lat: 38.03856 lon: 14.02285 facility: Ospedale Buccheri La Ferla Fatebenefratelli - Ssd Riabilitazione Cardiovascolare status: RECRUITING city: Palermo state: PA zip: 90123 country: Italy name: FILIPPO M SARULLO, MD role: CONTACT lat: 38.13205 lon: 13.33561 facility: Aou Policlinico P. Giaccone - U.O.C. Cardiologia status: RECRUITING city: Palermo state: PA zip: 90127 country: Italy name: GIUSEPPINA NOVO, MD role: CONTACT lat: 38.13205 lon: 13.33561 facility: Arnas P.O. Civico E Benfratelli - Uoc Utic status: RECRUITING city: Palermo state: PA zip: 90127 country: Italy name: IGNAZIO M SMECCA, MD role: CONTACT lat: 38.13205 lon: 13.33561 facility: Maria Eleonora Hospital - Cardiologia status: RECRUITING city: Palermo state: PA zip: 90135 country: Italy name: VINCENZO PERNICE, MD role: CONTACT lat: 38.13205 lon: 13.33561 facility: Aor Villa Sofia-Cervello P.O. Cervello - U.O. Cardiologia - Cervello status: RECRUITING city: Palermo state: PA zip: 90146 country: Italy name: VINCENZO POLIZZI, MD role: CONTACT lat: 38.13205 lon: 13.33561 facility: Aor Villa Sofia-Cervello Po Villa Sofia - Uoc Cardiologia E Utic E Emodinamica -Villa Sofia status: RECRUITING city: Palermo state: PA zip: 90146 country: Italy name: CARLO CICERONE, MD role: CONTACT lat: 38.13205 lon: 13.33561 facility: Ospedale Unico Della Val Tidone - Cardiologia E Riabilitazione status: RECRUITING city: Castel San Giovanni state: PC zip: 29015 country: Italy name: MARIATERESA DI DIO, MD role: CONTACT lat: 45.06014 lon: 9.43784 facility: Ospedale Civile 'Guglielmo Da Saliceto' - Uoc Cardiologia E Utic status: RECRUITING city: Piacenza state: PC zip: 29100 country: Italy name: DANIELA ASCHIERI, MD role: CONTACT lat: 45.05242 lon: 9.69342 facility: Ospedale Di Cittadella - U.O. Cardiologia status: RECRUITING city: Cittadella state: PD zip: 35013 country: Italy name: GAETANO POVOLO, MD role: CONTACT lat: 45.64523 lon: 11.78453 facility: Ospedale Civile Dello Spirito Santo - Cardiologia Con Utic status: RECRUITING city: Pescara state: PE zip: 65124 country: Italy name: DOMENICO DI CLEMENTE, MD role: CONTACT lat: 42.4584 lon: 14.20283 facility: Presidio Ospedaliero Citta' Di Castello - U.O. Cardiologia/Utic status: RECRUITING city: Citta' Di Castello state: PG zip: 06012 country: Italy name: ANDREA CHIOCCHINI, MD role: CONTACT lat: 43.46556 lon: 12.2375 facility: Ospedale Gubbio-Gualdo Tadino - U.O. Di Utic E Cardiologia status: RECRUITING city: Gubbio state: PG zip: 06024 country: Italy name: DEBORAH COSMI, MD role: CONTACT lat: 43.34996 lon: 12.57309 facility: Azienda Ospedaliera Di Perugia - S.C. Cardiologia status: RECRUITING city: Perugia state: PG zip: 06129 country: Italy name: FRANCESCO NOTARISTEFANO, MD role: CONTACT lat: 43.1122 lon: 12.38878 facility: Ospedale Ss. Cosma E Damiano - Sos Cardiologia status: RECRUITING city: Pescia state: Pistoia zip: 51017 country: Italy name: GAIA C MAGNAGHI, MD role: CONTACT lat: 43.8871 lon: 10.68849 facility: Ospedale Ss. Cosma E Damiano - Sos Riabilitazione Cardiologica status: RECRUITING city: Pescia state: Pistoia zip: 51017 country: Italy name: DUCCIO ROSSINI, MD role: CONTACT lat: 43.8871 lon: 10.68849 facility: Ftgm - Stabilimento Di Pisa - Cardiologia E Medicina Cardiovascolare status: RECRUITING city: Pisa state: PI zip: 56124 country: Italy name: MICHELE EMDIN, MD role: CONTACT lat: 43.70853 lon: 10.4036 facility: Auxilium Vitae Volterra - Riabilitazione Cardiologica status: RECRUITING city: Volterra state: PI zip: 56048 country: Italy name: NICOLA SCELZA, MD role: CONTACT lat: 43.40251 lon: 10.86152 facility: Presidio Ospedaliero Per La Salute Di Sacile - Cardiologia Preventiva E Riabilitativa status: RECRUITING city: Sacile state: PN zip: 33077 country: Italy name: ELISA LEIBALLI, MD role: CONTACT lat: 45.95412 lon: 12.50274 facility: Ospedale Di S. Vito Al Tagliamento - Ssd Cardiologia San Vito - Spilimbergo status: RECRUITING city: San Vito Al Tagliamento state: PN zip: 33078 country: Italy name: DANIELA PAVAN, MD role: CONTACT lat: 45.9168 lon: 12.85945 facility: Ospedale Civile - U.O.C. Cardiologia - Utic status: RECRUITING city: Fidenza state: PR zip: 43036 country: Italy name: GIOVANNI TORTORELLA, MD role: CONTACT lat: 44.86694 lon: 10.06039 facility: Istituto Don Gnocchi - U.O. Prevenzione E Riabilitazione Cardiovascolare status: RECRUITING city: Parma state: PR zip: 43100 country: Italy name: UMBERTO CAMAIORA, MD role: CONTACT lat: 44.79935 lon: 10.32618 facility: Presidio Ospedaliero San Salvatore - Cardiologia E Utic status: RECRUITING city: Pesaro state: PU zip: 61121 country: Italy name: SIMONE MAFFEI, MD role: CONTACT lat: 43.90921 lon: 12.9164 facility: Istituti Clinici Scientifici Maugeri Irccs Sede Di Pavia - U.O. Di Riabilitazione Cardiologica status: RECRUITING city: Pavia state: PV zip: 27100 country: Italy name: GIOVANNI FORNI, MD role: CONTACT lat: 45.19205 lon: 9.15917 facility: Ospedale Civile - U.O. Di Cardiologia status: RECRUITING city: Voghera state: PV zip: 27058 country: Italy name: TIZIANA SPEZZANO, MD role: CONTACT lat: 44.99151 lon: 9.01175 facility: Ospedale Civile - Uo Servizio Cardiologia status: RECRUITING city: Lugo state: RA zip: 48022 country: Italy name: GIULIA RICCI LUCCHI, MD role: CONTACT lat: 44.42137 lon: 11.91094 facility: Ospedale Civile Santa Maria Delle Croci - Uoc Cardiologia status: RECRUITING city: Ravenna state: RA zip: 48121 country: Italy name: ANDREA RUBBOLI, MD role: CONTACT lat: 44.41344 lon: 12.20121 facility: Ospedale Civile Di Guastalla - Sos Cardiologia E Riabilitazione Card Area Nord status: RECRUITING city: Guastalla state: RE zip: 42016 country: Italy name: ALESSANDRO NAVAZIO, MD role: CONTACT lat: 44.91172 lon: 10.66186 facility: Ospedale E. Franchini - S.O.S. Cardiologia status: RECRUITING city: Montecchio Emilia state: RE zip: 42027 country: Italy name: ELISABETTA CATELLANI, MD role: CONTACT lat: 44.69937 lon: 10.45211 facility: Po Santa Maria Nuova - Ausl Re Irccs - Soc Cardiologia Ospedaliera status: RECRUITING city: Reggio Emilia state: RE zip: 42100 country: Italy name: ALESSANDRO NAVAZIO, MD role: CONTACT lat: 44.69825 lon: 10.63125 facility: Ospedale Riccardo Guzzardi - U.O.C. Di Cardiologia-Utic status: RECRUITING city: Vittoria state: RG zip: 97019 country: Italy name: GIUSEPPE DI STABILE, MD role: CONTACT lat: 36.95151 lon: 14.52788 facility: P.O. San Camillo de Lellis - U.O.C. Cardiologia status: RECRUITING city: Rieti state: RI zip: 02100 country: Italy name: AMIR KOL, MD role: CONTACT lat: 42.40476 lon: 12.85735 facility: Ospedali Riuniti Anzio-Nettuno - U.O.C. Di Cardiologia - Utic status: RECRUITING city: Anzio state: RM zip: 00042 country: Italy name: NATALE DI BELARDINO, MD role: CONTACT lat: 41.45263 lon: 12.62157 facility: Ospedale Dei Castelli - U.O.C. Di Cardiologia E Utic status: RECRUITING city: Ariccia state: RM zip: 00072 country: Italy name: FRANCESCO MONTI, MD role: CONTACT lat: 41.72063 lon: 12.6723 facility: Ospedale Civile San Paolo - U.O.C. Cardiologia - Utic status: RECRUITING city: Civitavecchia state: RM zip: 00053 country: Italy name: SIMONE CALCAGNO, MD role: CONTACT lat: 42.09325 lon: 11.79674 facility: Ospedale L. Parodi Delfino - U.O.C. Di Cardiologia - Utic status: NOT_YET_RECRUITING city: Colleferro state: RM zip: 00034 country: Italy name: ROBERTA IPPEDICO, MD role: CONTACT lat: 41.72722 lon: 13.00481 facility: Icr Villa Delle Querce - Riabilitazione Cardiorespiratoria status: NOT_YET_RECRUITING city: Nemi state: RM zip: 00040 country: Italy name: MICHELE AZZARITO, MD role: CONTACT lat: 41.72185 lon: 12.71809 facility: P.O. San Filippo Neri - Asl Roma 1 - Cardiologia Clinica E Riabilitativa status: RECRUITING city: Roma state: RM zip: 00135 country: Italy name: FURIO COLIVICCHI, MD role: CONTACT lat: 41.89193 lon: 12.51133 facility: Inmi Lazzaro Spallanzani Irccs - Servizio Di Cardiologia Del Dipartimento Clinico status: RECRUITING city: Roma state: RM zip: 00149 country: Italy name: MARIA C GATTO, MD role: CONTACT lat: 41.89193 lon: 12.51133 facility: Ospedale San Camillo - Uoc Cardiologia status: RECRUITING city: Roma state: RM zip: 00152 country: Italy name: LEONARDO DE LUCA, MD role: CONTACT lat: 41.89193 lon: 12.51133 facility: Ospedale Sandro Pertini - Uoc Cardiologia status: RECRUITING city: Roma state: RM zip: 00157 country: Italy name: ANTONINO GRANATELLI, MD role: CONTACT lat: 41.89193 lon: 12.51133 facility: Ospedale Sandro Pertini - Uosd Cardiologia D'Urgenza status: RECRUITING city: Roma state: RM zip: 00157 country: Italy name: STEFANIA CHERUBINI, MD role: CONTACT lat: 41.89193 lon: 12.51133 facility: Fondazione Policlinico Universitario A. Gemelli Irccs - Uosd Cardiologia D'Urgenza status: NOT_YET_RECRUITING city: Roma state: RM zip: 00168 country: Italy name: GIOVANNA LIUZZO, MD role: CONTACT lat: 41.89193 lon: 12.51133 facility: Policlinico Casilino - U.O.C. Cardiologia status: RECRUITING city: Roma state: RM zip: 00169 country: Italy name: LEONARDO CALO', MD role: CONTACT lat: 41.89193 lon: 12.51133 facility: Osp. Fatebenefratelli Isola Tiberina - Uoc Cardiologia Diagnostica Interventistica-Utic status: NOT_YET_RECRUITING city: Roma state: RM zip: 00188 country: Italy name: MATTEO RUZZOLINI, MD role: CONTACT lat: 41.89193 lon: 12.51133 facility: Ospedale Sant'Andrea Di Roma - U.O.C. Cardiologia status: RECRUITING city: Roma state: RM zip: 00189 country: Italy name: EMANUELE BARBATO, MD role: CONTACT lat: 41.89193 lon: 12.51133 facility: Ospedale Santo Spirito - Uoc Cardiologia status: RECRUITING city: Roma state: RM zip: 00193 country: Italy name: MARINA DELFINI, MD role: CONTACT lat: 41.89193 lon: 12.51133 facility: Ospedale San Giovanni Evangelista - U.O.C. Di Cardiologia - Utic status: RECRUITING city: Tivoli state: RM zip: 00019 country: Italy name: ALFREDO POSTERARO, MD role: CONTACT lat: 41.95952 lon: 12.8016 facility: Ospedale Infermi - U.O. Cardiologia status: NOT_YET_RECRUITING city: Rimini state: RN zip: 47900 country: Italy name: ANDREA GARDI, MD role: CONTACT lat: 44.05755 lon: 12.56528 facility: Ospedale Maria Ss. Addolorata - U.O. Di Cardiologia Utic status: RECRUITING city: Eboli state: SA zip: 84025 country: Italy name: EDUARDO CAPUANO, MD role: CONTACT lat: 40.61747 lon: 15.05693 facility: Presidio Ospedaliero Umberto I - Uoc Cardiologia - Utic status: RECRUITING city: Nocera Inferiore state: SA zip: 84014 country: Italy name: MARIO PACILEO, MD role: CONTACT lat: 40.7454 lon: 14.64542 facility: Presidio Ospedaliero Luigi Curto - Uo Cardiologia-Utic status: RECRUITING city: Polla state: SA zip: 84035 country: Italy name: SILVIO SAPONARA, MD role: CONTACT lat: 40.51433 lon: 15.49715 facility: Aou S. Giovanni Di Dio-Ruggi D'Aragona - Cardiologia Intensiva Ospedaliera status: RECRUITING city: Salerno state: SA zip: 84131 country: Italy name: MICHELE R DI MURO, MD role: CONTACT lat: 40.67545 lon: 14.79328 facility: Aou S. Giovanni Di Dio-Ruggi D'Aragona - Ssd Utic status: RECRUITING city: Salerno state: SA zip: 84131 country: Italy name: AMELIA RAVERA, MD role: CONTACT lat: 40.67545 lon: 14.79328 facility: Aou S. Giovanni Di Dio-Ruggi D'Aragona - Uoc Clinica Cardiologica status: RECRUITING city: Salerno state: SA zip: 84131 country: Italy name: MICHELE CICCARELLI, MD role: CONTACT lat: 40.67545 lon: 14.79328 facility: Ospedale Villa Malta - Cardiologia E Utic status: RECRUITING city: Sarno state: SA zip: 84087 country: Italy name: MARIA C RUSSO, MD role: CONTACT lat: 40.80748 lon: 14.62151 facility: Ospedale San Luca - U.O. Utic - Cardiologia status: RECRUITING city: Vallo Della Lucania state: SA zip: 84078 country: Italy name: ANTONIO ALOIA, MD role: CONTACT lat: 40.22786 lon: 15.26635 facility: Aou Senese Ospedale S. Maria Alle Scotte - Cardiologia status: RECRUITING city: Siena state: SI zip: 53100 country: Italy name: SERAFINA VALENTE, MD role: CONTACT lat: 43.31822 lon: 11.33064 facility: Ospedale San Bartolomeo - Sc Riabilitazione Cardiologica status: RECRUITING city: Sarzana state: SP zip: 19038 country: Italy name: DANIELE BERTOLI, MD role: CONTACT lat: 44.11178 lon: 9.9622 facility: P.O. Lentini - Uosd Di Cardiologia Con Utic status: RECRUITING city: Lentini state: SR zip: 96016 country: Italy name: VINCENZO CRISCI, MD role: CONTACT lat: 37.28556 lon: 14.99737 facility: Ospedale Ss. Annunziata - Cardiologia Clinica Ed Interventistica status: RECRUITING city: Sassari state: SS zip: 07100 country: Italy name: GAVINO CASU, MD role: CONTACT lat: 40.72586 lon: 8.55552 facility: Po Ponente - Ospedale Santa Corona - Sc Cardiologia Ponente status: RECRUITING city: Pietra Ligure state: SV zip: 17027 country: Italy name: CHIARA BERNELLI, MD role: CONTACT lat: 44.1492 lon: 8.28206 facility: Casa Di Cura Villa Verde - Cardiologia status: RECRUITING city: Taranto state: TA zip: 74100 country: Italy name: ANNA N JOHN, MD role: CONTACT lat: 40.46435 lon: 17.24707 facility: Osp. San Pancrazio-Santo Stefano - Riabilitazione Cardiologica status: RECRUITING city: Arco state: TN zip: 38062 country: Italy name: GIOVANNI CIOFFI, MD role: CONTACT lat: 45.91772 lon: 10.88672 facility: Ospedale Santa Chiara - Divisione Di Cardiologia status: RECRUITING city: Trento state: TN zip: 38122 country: Italy name: FILIPPO ZILIO, MD role: CONTACT lat: 46.06787 lon: 11.12108 facility: Por Cirie' Lanzo Presidio Cirie' - S.C. Cardiologia status: RECRUITING city: Ciriè state: TO zip: 10073 country: Italy name: Michele Capriolo, MD role: CONTACT lat: 45.23486 lon: 7.60125 facility: Aou San Luigi Gonzaga - S.C.D.O. Cardiologia status: RECRUITING city: Orbassano state: TO zip: 10043 country: Italy name: Carloalberto Biolù, MD role: CONTACT lat: 45.00547 lon: 7.53813 facility: Casa Di Cura Villa Serena - Riabilitazione Cardiorespiratoria status: RECRUITING city: Piossasco state: TO zip: 10045 country: Italy name: ALEX MICANTI, MD role: CONTACT lat: 44.98802 lon: 7.4601 facility: Ospedale Degli Infermi - Sc Cardiologia status: RECRUITING city: Rivoli state: TO zip: 10098 country: Italy name: EMANUELE TIZZANI, MD role: CONTACT lat: 45.07073 lon: 7.51465 facility: Ospedale San Giovanni Bosco - Sc Cardiologia status: RECRUITING city: Torino state: TO zip: 10154 country: Italy name: MAURIZIO BERTAINA, MD role: CONTACT lat: 45.07049 lon: 7.68682 facility: Casa Di Cura Pineta Del Carso - U.O. Riabilitazione Cardiologica status: RECRUITING city: Aurisina state: TS zip: 34011 country: Italy name: LARA GOMBAC, MD role: CONTACT lat: 45.74968 lon: 13.67345 facility: Asugi Trieste - Sc Patologie Cardiovascolari status: RECRUITING city: Trieste state: TS zip: 34125 country: Italy name: LUISA MATTEI, MD role: CONTACT lat: 45.64953 lon: 13.77679 facility: Pou "Santa Maria Della Misericordia" - S.O.C. Cardiologia status: RECRUITING city: Udine state: UD zip: 33100 country: Italy name: MARIZA DE BIASIO, MD role: CONTACT lat: 46.0693 lon: 13.23715 facility: Ospedale Multimedica Castellanza - Cardiologia status: RECRUITING city: Castellanza state: VA zip: 21053 country: Italy name: ANNA PICOZZI, MD role: CONTACT lat: 45.61079 lon: 8.89616 facility: Presidio Ospedaliero Di Saronno - U.O.C. Di Cardiologia status: RECRUITING city: Saronno state: VA zip: 21047 country: Italy name: DANIELE NASSIACOS, MD role: CONTACT lat: 45.62513 lon: 9.03517 facility: Ospedale Di Circolo Galmarini - Cardiologia status: NOT_YET_RECRUITING city: Tradate state: VA zip: 21049 country: Italy name: MASSIMO BIGNOTTI, MD role: CONTACT lat: 45.70843 lon: 8.90763 facility: Ospedale Sant'Andrea - Sc Cardiologia status: RECRUITING city: Vercelli state: VC zip: 13100 country: Italy name: MARIA BERTOLAZZI, MD role: CONTACT lat: 45.32163 lon: 8.41989 facility: Ospedale Dell'Angelo - U.O.C. Cardiologia status: RECRUITING city: Mestre state: VE zip: 30171 country: Italy name: SAKIS THEMISTOCLAKIS, MD role: CONTACT lat: 45.49167 lon: 12.24538 facility: Policlinico San Marco - Riabilitazione Cardiologica status: RECRUITING city: Mestre state: VE zip: 30173 country: Italy name: FRANCO DEL PICCOLO, MD role: CONTACT lat: 45.49167 lon: 12.24538 facility: Ospedale P.F. Calvi - Uos Di Cardiologia Riabilitativa status: RECRUITING city: Noale state: VE zip: 30033 country: Italy name: VALENTINA PESCATORE, MD role: CONTACT lat: 45.54596 lon: 12.06445 facility: Ospedale Civile - U.O.C. Di Cardiologia status: NOT_YET_RECRUITING city: San Dona' Di Piave state: VE zip: 30027 country: Italy name: LEONARDO DI ASCENZO, MD role: CONTACT lat: 45.63019 lon: 12.5681 facility: Ospedale Civile - U.O.C. Di Cardiologia status: RECRUITING city: Arzignano state: VI zip: 36071 country: Italy name: CLAUDIO BILATO, MD role: CONTACT lat: 45.52027 lon: 11.33446 facility: Ospedale Alto Vicentino - U.O.C. Cardiologia - Ucic status: RECRUITING city: Santorso state: VI zip: 36014 country: Italy name: GIOVANNI MORANI, MD role: CONTACT lat: 45.73383 lon: 11.38785 facility: Ospedale Civile San Bortolo - U.O.C. Cardiologia status: RECRUITING city: Vicenza state: VI zip: 36100 country: Italy name: VALENTINA SIVIERO, MD role: CONTACT lat: 45.54672 lon: 11.5475 facility: Irccs Ospedale Sacro Cuore Don Calabria - U.O. Di Cardiologia status: RECRUITING city: Negrar state: VR zip: 37024 country: Italy name: GIULIO MOLON, MD role: CONTACT lat: 45.52918 lon: 10.93899 facility: Ospedale G. Fracastoro - U.O.C. Di Cardiologia status: RECRUITING city: San Bonifacio state: VR zip: 37047 country: Italy name: MAURIZIO ANSELMI, MD role: CONTACT lat: 45.39595 lon: 11.27352 facility: Aoui Di Verona - U.O. Cardiologia status: RECRUITING city: Verona state: VR zip: 37126 country: Italy name: MARIA G GASPARI, MD role: CONTACT lat: 45.4299 lon: 10.98444 facility: Ospedale Belcolle - Uoc Cardiologia Ed Emodinamica status: RECRUITING city: Viterbo state: VT zip: 01100 country: Italy name: LUIGI SOMMARIVA, MD role: CONTACT lat: 42.41937 lon: 12.1056 facility: Ospedale Ss. Trinita' - S.C. Di Cardiologia status: RECRUITING city: Borgomanero zip: 28021 country: Italy name: PIERFRANCO S DELLAVESA, MD role: CONTACT lat: 45.69873 lon: 8.4623 facility: Istituti Clinici Scientifici Maugeri Irccs Sede Di Veruno - Uo Cardiologia Riabilitativa status: RECRUITING city: Gattico zip: 28013 country: Italy name: MASSIMO PISTONO, MD role: CONTACT lat: 45.70717 lon: 8.52003 facility: Presidio Ospedaliero San Giugliano - U.O. Cardiologia - Utic status: RECRUITING city: Giugliano in Campania zip: 80014 country: Italy name: GIOVANNI NAPOLITANO, MD role: CONTACT lat: 40.92849 lon: 14.20197 facility: Ospedale Madonna Delle Grazie - Ssd Utic status: NOT_YET_RECRUITING city: Matera zip: 75100 country: Italy name: MICHELE A CLEMENTE, MD role: CONTACT lat: 40.66599 lon: 16.60463 facility: Ospedale Buon Consiglio Fatebenefratelli - U.O.Complessa Di Cardiologia E Utic status: RECRUITING city: Napoli zip: 80123 country: Italy name: GAETANO M RUOCCO, MD role: CONTACT lat: 40.85216 lon: 14.26811 facility: Aorn Cardarelli - U.O. Cardiologia Con Utic status: RECRUITING city: Napoli zip: 80131 country: Italy name: CIRO MAURO, MD role: CONTACT lat: 40.85216 lon: 14.26811 facility: Aorn Ospedale Dei Colli - P.O. Monaldi - Uosd Malattie Cardiologiche Congenite Adulti-Guch status: RECRUITING city: Napoli zip: 80131 country: Italy name: BERARDO SARUBBI, MD role: CONTACT lat: 40.85216 lon: 14.26811 facility: Ospedale Dei Pellegrini - Uoc Cardiologia-Utic status: NOT_YET_RECRUITING city: Napoli zip: 80134 country: Italy name: GIUSEPPE BRUZZESE, MD role: CONTACT lat: 40.85216 lon: 14.26811 facility: Ospedale S. Giovanni Bosco - Sc Cardiologia - Utic status: RECRUITING city: Napoli zip: 80134 country: Italy name: PAOLO TAMMARO, MD role: CONTACT lat: 40.85216 lon: 14.26811 facility: Ospedale Del Mare - U.O. Cardiologia Con Utic-Emodinamica status: RECRUITING city: Napoli zip: 80147 country: Italy name: BERNARDINO TUCCILLO, MD role: CONTACT lat: 40.85216 lon: 14.26811 facility: Aou Maggiore Della Carita' - Scdo Cardiologia Ii status: RECRUITING city: Novara zip: 28100 country: Italy name: LIDIA ROSSI, MD role: CONTACT lat: 45.44694 lon: 8.62118 facility: Clinica San Gaudenzio - Uoa Cardiologia status: RECRUITING city: Novara zip: 28100 country: Italy name: NADIA PODIMANI, MD role: CONTACT lat: 45.44694 lon: 8.62118 facility: Ospedale Santa Maria Delle Grazie - U.O. Cardiologia - Utic Con Emodinamica status: NOT_YET_RECRUITING city: Pozzuoli zip: 80078 country: Italy name: GIANLUIGI TAGLIAMONTE, MD role: CONTACT lat: 40.84394 lon: 14.0952 facility: Ospedale Mauriziano Umberto I - Sc Cardiologia status: RECRUITING city: Torino zip: 10128 country: Italy name: Giuseppe Musumeci, MD role: CONTACT lat: 45.07049 lon: 7.68682 hasResults: False

 nctId: NCT06275100 id: HUTH briefTitle: PREhabilitation in Patients Awaiting Acute Inpatient Cardiac SurgEry acronym: (PREP-ACE) overallStatus: RECRUITING date: 2024-04-03 date: 2024-12 date: 2025-06 date: 2024-02-23 date: 2024-04-09 name: University of Hull class: OTHER briefSummary: This is a single centre, single arm pilot feasibility study to determine the feasibility and practicality of prehabilitation in acute inpatients waiting for cardiac surgery. We will be looking into participant eligibility, acceptability, recruitment rates, completion rates and barriers to implementing a prehabilitation programme. Secondary outcomes include safety (incidence of adverse events directly related to the study), improvement in 6 minutes walk test (6MWT), hand grip strength, quality of life, and spirometry. At the end of the trial, we will be seeking the feedback of the participants to help us improve the design further. conditions: Cardiac Disease conditions: Aortic Valve Disease conditions: Coronary Artery Disease conditions: Endocarditis conditions: Valve Heart Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single arm pilot feasibility study in acute inpatients waiting for cardiac surgery. Intervention is a prehabilitation program primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 20 type: ESTIMATED name: Prehabilitation measure: Feasibility of prehabilitation in acute inpatients waiting for cardiac surgery measure: Efficacy of prehabilitation measure: Efficacy of prehabilitation measure: Efficacy of prehabilitation measure: Efficacy of prehabilitation measure: Efficacy of prehabilitation measure: Complication rate measure: Safety of Prehabilitation in acute inpatients waiting for surgery sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hull University Teaching Hospital status: RECRUITING city: Hull zip: HU1 3DR country: United Kingdom lat: 53.7446 lon: -0.33525 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-11-06 uploadDate: 2024-02-15T17:59 filename: Prot_000.pdf size: 146015 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-11-06 uploadDate: 2024-02-15T18:01 filename: ICF_001.pdf size: 107547 hasResults: False

 nctId: NCT06275087 id: situm1phd briefTitle: Differences in Speed of Recovery From Anesthesia for Intraoral Surgery acronym: PSIOS overallStatus: RECRUITING date: 2024-04-10 date: 2026-03 date: 2026-07 date: 2024-02-23 date: 2024-04-22 name: Clinical Hospital Centre Zagreb class: OTHER briefSummary: The goal of this clinical trial is to compare two groups of patients going in general anesthesia for intraoral surgery, the first group TIVA with propofol and the second group inhalational with sevoflurane. The main questions it aims to answer are to asses speed and quality of recovery from general anesthesia.

Participants will fill out a questionnaire to evaluate the quality of recovery from anesthesia using the QoR-40 1h, 24h, and 30 days after waking up from anesthesia in comparison to the results of the same questionnaire before surgery. Also, the investigators will perform a hand grip and bite strength test on the patients after waking up from anesthesia in the operating room, after 1 hour in the recovery room, and after 24 hours compared to preoperative values.

The investigators will compare TIVA and Volatile groups to see if there are any differences in recovery seed, muscle strength recovery, postoperative nausea and vomiting, and shivering between groups. conditions: Intraoral Tumor studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 42 type: ESTIMATED name: Propofol name: Sevoflurane measure: "Quality of recovery from anesthesia" QoR-40 questionnaire measure: bite strength and hand grip strength measure: Postoperative nausea and vomiting measure: Postoperative shivering sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Centre Zagreb status: RECRUITING city: Zagreb zip: 10000 country: Croatia name: Ivan Šitum role: CONTACT phone: 0915143620 email: ivsitum@gmail.com name: Ivan Šitum role: PRINCIPAL_INVESTIGATOR lat: 45.81444 lon: 15.97798 hasResults: False

 nctId: NCT06275074 id: 23-007716 briefTitle: Dry Needling and Therapeutic Exercise on Sleep in Individuals With Chronic Neck Pain and Sleep Disturbance overallStatus: RECRUITING date: 2024-03-14 date: 2024-09-01 date: 2025-03-01 date: 2024-02-23 date: 2024-04-05 name: Mayo Clinic class: OTHER briefSummary: Feasibility study investigating the effects of dry needling on individuals with chronic neck pain and sleep disturbance. conditions: Neck Pain conditions: Sleep Disturbance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE maskingDescription: Outcome assessors will be blinded to group assignment of participants. whoMasked: OUTCOMES_ASSESSOR count: 28 type: ESTIMATED name: Dry Needling name: Therapeutic Exercise measure: Participant retention rate measure: Participant intervention adherence measure: Number of adverse responses to treatment measure: Sleep Duration measure: Sleep Quality measure: Disability Level measure: Pain Level sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic - Motion Analysis Lab status: RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Ray Lunasin role: CONTACT phone: 507-538-0839 email: lunasin.ray@mayo.edu lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06275061 id: KY-2020-021 briefTitle: Chinese Obesity and MEtabolic Surgery Database (COMES Database) acronym: COMES overallStatus: RECRUITING date: 2020-05-01 date: 2030-12-31 date: 2040-12-31 date: 2024-02-23 date: 2024-02-23 name: Jinan University Guangzhou class: OTHER name: Chinese Obesity and Metabolic Surgery Collaborative briefSummary: The purpose of the Chinese Obesity and MEtabolic Surgery Database (COMES Database) is to collect data and examine the long-term effects of metabolic and bariatric surgery on obesity and metabolic disorders in the Chinese population. conditions: Obesity conditions: Metabolic Surgery conditions: Bariatric Surgery conditions: Weight Loss studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000000 type: ESTIMATED name: Metabolic and Bariatric Surgery measure: Excess weight loss effect of metabolic and bariatric surgery after 1 year measure: Excess weight loss effect of metabolic and bariatric surgery in long-term follow-ups measure: Excess weight loss effect of metabolic and bariatric surgery in long-term follow-ups measure: Excess weight loss effect of metabolic and bariatric surgery in long-term follow-ups measure: Glycemic control effect of metabolic and bariatric surgery after 1 year measure: Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups measure: Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups measure: Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups measure: Glycemic control effect of metabolic and bariatric surgery after 1 year measure: Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups measure: Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups measure: Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups measure: Glycemic control effect of metabolic and bariatric surgery after 1 year measure: Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups measure: Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups measure: Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups measure: Glycemic control effect of metabolic and bariatric surgery after 1 year measure: Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups measure: Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups measure: Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups measure: Adverse events rate of metabolic and bariatric surgery sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Jinan University status: RECRUITING city: Guangzhou state: Guangdong zip: 510630 country: China name: Wah Yang, MD role: CONTACT phone: +8615920373823 email: yangwah@qq.com lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06275048 id: STUDY00006302 briefTitle: The Influence of Oral Contraceptives During Disuse overallStatus: RECRUITING date: 2024-01-26 date: 2024-12 date: 2025-05 date: 2024-02-23 date: 2024-02-23 name: University of Central Florida class: OTHER briefSummary: Studies across various sports and physical activities have consistently shown that females incur more injuries compared to their male counterparts, but the underlying reasons for this disparity remain poorly understood. While differences in hormone levels between males and females have been speculated to play a role, very little rigorous research has been conducted to directly examine potential connections between sex hormones and injury risk. Specifically, females have been shown to be at greater risk for hand and wrist injuries. The higher injury incidence begins at puberty and persists across the lifespan, suggesting a link to hormonal factors. However, significant gaps remain in understanding the relationships between the menstrual cycle, exogenous hormones from birth control, and risk factors for sports-related injury in females. The purpose of this study is to examine changes in muscle strength and neuromuscular activation among females using monophasic oral contraceptives, females not using oral contraceptives, and males during one week of wrist/hand immobilization. conditions: Oral Contraceptives conditions: Rehabilitation conditions: Menstrual Cycle conditions: Physical Therapy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 60 type: ESTIMATED name: Wrist/hand immobilization measure: Grip Strength measure: Muscle activation sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: University of Central Florida status: RECRUITING city: Orlando state: Florida zip: 32816 country: United States name: Matt S Stock, Ph.D. role: CONTACT phone: 407-823-0364 email: matt.stock@ucf.edu name: Matt S Stock, Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 28.53834 lon: -81.37924 hasResults: False

 nctId: NCT06275035 id: 4235 briefTitle: Evaluation of Memantine in the Preservation of Memory and Neurocognition Following CSI acronym: MEMENTO overallStatus: RECRUITING date: 2024-02-22 date: 2026-01 date: 2031-01 date: 2024-02-23 date: 2024-03-01 name: Tata Memorial Centre class: OTHER briefSummary: The goal of this clinical trial is to evaluate the role of memantine in preservation of memory and neurocognition in patients undergoing craniospinal irradiation. Participants will be randomised into two arms and the interventional arm will receive memantine along with the standard treatment. Researchers will compare the neurocognitive tests of participants in both the arms to see if memantine leads to significant preservation of memory and cognition post radiation therapy. conditions: Neurocognitive Dysfunction studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 101 type: ESTIMATED name: Memantine Oral Tablet measure: Cognitive-deterioration-free survival at 2 years measure: Full-Scale Intelligence Quotient (FSIQ) in children measure: Overall survival (OS) measure: Academic performance by scholastic performance and grades measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of Memantine measure: Progression-Free Survival (PFS) measure: Full-Scale Intelligence Quotient (FSIQ) in adults measure: Full Scale Intelligence Quotient change in subgroups measure: Radiological features of cognitive decline on Magnetic Resonance Imaging measure: Neuroinflammatory markers correlation with neurocognitive decline and survival sex: ALL minimumAge: 5 Years maximumAge: 39 Years stdAges: CHILD stdAges: ADULT facility: Tata Memorial Hospital status: RECRUITING city: Mumbai state: Maharashtra zip: 400012 country: India name: Dr Tejpal Gupta, MD role: CONTACT phone: 022-24177000 phoneExt: 6015 email: tejpalgupta@rediffmail.com lat: 19.07283 lon: 72.88261 hasResults: False

 nctId: NCT06275022 id: NanjingCH011665 briefTitle: A Prospective Study on the Treatment of cLM Based on ICG Imaging overallStatus: RECRUITING date: 2023-01-01 date: 2025-12-31 date: 2026-06-30 date: 2024-02-23 date: 2024-02-23 name: Nanjing Children's Hospital class: OTHER briefSummary: The goal of this prospective randomized controlled study is to explore the role of indocyanine green-fluorescence imaging in management of cystic lymphatic malformation.. To clarify the application value of indocyanine green-fluorescence imaging in both diagnosis and treatment of cystic lymphatic malformation (cLM) in children, is helpful for exploring pathogenesis of cLM, and providing a clearer scientific basis for subsequent surgical intervention. It also provides alternative for the future diagnosis and treatment of cLM.

Participants will receive indocyanine green-fluorescence imaging before operation, while the patients in control group will receive traditional operation.

Researchers will compare difference in curative effect between two groups. conditions: Lymphatic Malformation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 110 type: ESTIMATED name: Inflow occlusion with perforation of septation and sclerotherapy name: Perforation of septation and sclerotherapy name: Indocyanine green-guided partial resection and sclerotherapy name: Partial resection and sclerotherapy measure: Cure rate measure: Effective rate measure: Treatment frequency measure: Likert score measure: Wound infection measure: Delayed healing measure: Pigmentation sex: ALL minimumAge: 30 Days maximumAge: 16 Years stdAges: CHILD facility: Children's hospital of Nanjing medical university status: RECRUITING city: Nanjing state: Jiangsu zip: 210008 country: China name: Tao Han, Dr. role: CONTACT phone: +86 186 5190 3495 email: dr.hantao@njmu.edu.cn lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06275009 id: 2023-1990 briefTitle: Chinese Occupational Population Cohort of Lifestyle and Physical Fitness (LiFitChina) acronym: LiFitChina overallStatus: RECRUITING date: 2023-12-11 date: 2026-12-11 date: 2026-12-11 date: 2024-02-23 date: 2024-02-28 name: China National Center for Cardiovascular Diseases class: OTHER_GOV briefSummary: The incidence and prevalence of metabolic risk factors such as obesity, hypertension, diabetes, and dyslipidemia, as well as cardiovascular diseases (CVD), are continuously rising among the occupational population in China, primarily comprising the middle-aged and young adults. Unhealthy lifestyles and declining physical fitness are independent risk factors affecting cardiovascular health. Additionally, the level of physical fitness is influenced by postnatal lifestyles. Lifestyle factors related to cardiovascular health in the occupational population encompass various aspects, including smoking, physical activity, diet, sleep, psychological stress, etc. These factors may interact or have a synergistic effect, necessitating a comprehensive assessment.

This project proposes a prospective cohort study design to establish a monitoring cohort for lifestyle and physical fitness among the occupational population. The study will track and follow individuals with or without any CVD metabolic risk factors, collecting information on general status, lifestyle, physical fitness, and health examination data. Exposure factors such as lifestyle and physical fitness will be measured annually, and the occurrence of CVD-related health outcomes will be observed. The aim is to develop a comprehensive evaluation index for cardiovascular health lifestyle, analyze the direct and indirect impacts of lifestyle and physical fitness on the occurrence and development of CVD, and explore potential mediating and moderating effects of physical fitness in the association between lifestyle and cardiovascular health. conditions: Lifestyle conditions: Physical Fitness conditions: Cardiovascular Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 18512 type: ESTIMATED measure: the composite end point of new major adverse cardiovascular events measure: new incidence of each major adverse cardiovascular events measure: new incidence of cancer measure: new incidence of all-cause death measure: level of systolic pressure measure: level of diastolic pressure measure: level of blood lipid measure: level of BMI measure: level of maximal oxygen uptake (VO2max) measure: level of metabolic equivalents (METs) sex: ALL minimumAge: 18 Years maximumAge: 59 Years stdAges: ADULT facility: Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College status: RECRUITING city: Beijing state: Beijing country: China name: Xue Feng, MD PhD role: CONTACT phone: +86-15601378512 email: 29611290@qq.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06274996 id: 2024ZSLYEC-063 briefTitle: Efficacy and Safety Analysis of Upadacitinib in Inflammatory Bowel Disease overallStatus: COMPLETED date: 2021-01-01 date: 2023-12-31 date: 2023-12-31 date: 2024-02-23 date: 2024-02-23 name: Sixth Affiliated Hospital, Sun Yat-sen University class: OTHER briefSummary: This study focuses on evaluating Upadacitinib, a new oral medication that inhibits specific enzymes involved in inflammation, for treating inflammatory bowel disease (IBD), which includes conditions such as Crohn\&#39;s Disease and Ulcerative Colitis. The goal is to determine how effective and safe this drug is for patients in China, where data is currently lacking.IBD significantly affects individuals\&#39; quality of life and imposes a high burden on society and healthcare systems. Current treatments don\&#39;t work for everyone, and some patients may need surgery. Upadacitinib has shown promise in other countries for treating IBD and related conditions and has been approved by the US FDA for such use.

Our study is retrospective and multicenter, meaning it will look back at patient records from multiple hospitals to analyze the outcomes of those who have received Upadacitinib. Investigators aim to enroll patients treated between January 2020 and December 2023, focusing on adults who have taken Upadacitinib for at least 8 weeks.For patients, families, and healthcare providers, this research could mean a potential new treatment option for IBD. Understanding Upadacitinib\&#39;s efficacy and safety could lead to better management of the disease, possibly reducing the need for surgery and improving the quality of life for those affected by IBD. The ultimate goal is to provide more personalized and effective treatment strategies for IBD patients in China. conditions: Inflammatory Bowel Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 81 type: ACTUAL name: Upadacitinib measure: Steroid-Free Clinical Remission measure: Clinical Response measure: Endoscopic Remission measure: Mucosal Healing measure: Radiological remission measure: Radiological response sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: the Sixth Affiliated Hospital of Sun Yat-Sen University city: Guangzhou state: Guangdong zip: 510655 country: China lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06274983 id: SCH-2629 briefTitle: DMD- Interactive Virtual Reality Study acronym: DMD-IVR overallStatus: ACTIVE_NOT_RECRUITING date: 2023-04-20 date: 2024-02-29 date: 2024-02-29 date: 2024-02-23 date: 2024-02-26 name: Sheffield Children's NHS Foundation Trust class: OTHER name: National Institute for Health Research, United Kingdom name: Sheffield Hallam University name: UCL Great Ormond Street Institute of Child Health name: Leeds General Infirmary briefSummary: This study will help determine if an Interactive Virtual Reality system can improve the physiotherapy of young patients with Duchenne muscular dystrophy (DMD). conditions: Duchenne Muscular Dystrophy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 14 type: ACTUAL name: IVR platform trial measure: Compliance: Ratings of frequency of the DMD-IVR device use for the participant's to complete recommended physiotherapy exercises. measure: Compliance: Ratings of duration of the DMD-IVR device use for the participant's to complete recommended physiotherapy exercises. measure: Post-trial qualitative interviews on perceptions, acceptability, usability and effectiveness of DMD-IVR device in the context of the family's overall burden of care measure: DMD-IVR Effectiveness standard functional assessments: North Star Ambulatory Assessment (NSAA) measure: DMD-IVR effectiveness measures with a Timed test 4 stair climb measure: DMD-IVR effectiveness measured joint range of movement using Goniometer (Standard BASELINE® 12-inch) sex: ALL minimumAge: 5 Years maximumAge: 10 Years stdAges: CHILD facility: Sheffield Childrens NHS FT city: Sheffield state: South Yorkshire zip: S10 2TH country: United Kingdom lat: 53.38297 lon: -1.4659 hasResults: False

 nctId: NCT06274970 id: 2022-143-Mch-EXP-50 briefTitle: PaThERAS: ERAS Protocols in Thyroid & Parathyroid Surgery acronym: PaThERAS overallStatus: RECRUITING date: 2023-01-25 date: 2024-09-25 date: 2024-09-25 date: 2024-02-23 date: 2024-02-23 name: Sanjay Gandhi Postgraduate Institute of Medical Sciences class: OTHER_GOV briefSummary: Enhanced recovery after surgery protocols are evidence-based multidisciplinary programs implemented in the perioperative setting to improve postoperative recovery and attenuate the surgical stress response. They have been used with success after many different types of surgery to improve perioperative patient outcomes. However, evidence on their effectiveness in thyroid and parathyroid surgery remains sparse. Goal of PaThERAS study is to investigate the clinical benefits and cost-effectiveness of enhanced recovery protocols for the perioperative management in patients undergoing total thyroidectomy for large goiters/ cancers and parathyroidectomy for symptomatic hyperparathyroidism in non-day-care setting. conditions: Thyroid Diseases conditions: Parathyroid Diseases conditions: ERAS studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 110 type: ESTIMATED name: Enhanced recovery protocols name: Conventional Protocols measure: To compare the rate of hypocalcemia in patients undergoing thyroid and parathyroid surgery implementing Enhanced recovery after surgery protocols vs Conventional peri operative protocols measure: To compare length of hospital stay in patients undergoing thyroid and parathyroid surgery in days measure: To compare hospital costs in patients undergoing thyroid and parathyroid surgery implementing Enhanced recovery after surgery protocols vs Conventional peri operative protocols measure: To compare postoperative complication rates in patients undergoing thyroid and parathyroid surgery implementing Enhanced recovery after surgery protocols vs Conventional peri operative protocols measure: To compare readmission rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sanjay Gandhi Post Graduate Institute of Medical Sciences status: RECRUITING city: Lucknow state: Uttar Pradesh zip: 226014 country: India name: Gaurav Agarwal role: CONTACT phone: 8004904646 email: gauravbsi@gmail.com name: Rinelle Mascarenhas role: CONTACT phone: 8004904653 email: rmasky@hotmail.com name: Gaurav Agarwal, MS role: PRINCIPAL_INVESTIGATOR name: Rinelle Mascarenhas, DNB General Surgery role: SUB_INVESTIGATOR lat: 26.83928 lon: 80.92313 hasResults: False

 nctId: NCT06274957 id: SaglikBilimleriUN briefTitle: The Effect of Airway and Chest Wall Oscillation on Respiratory Functions in COPD Patients in Acute Exacerbation overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-05-07 date: 2024-06-01 date: 2024-02-23 date: 2024-04-17 name: Saglik Bilimleri Universitesi class: OTHER name: Gulhane Training and Research Hospital briefSummary: Chronic obstructive pulmonary disease (COPD); It is a common, treatable and preventable disease characterized by progressive and irreversible airflow limitation and has systemic effects with respiratory system involvement. Increased respiratory workload, decreased work . conditions: COPD Exacerbation Acute studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 27 type: ESTIMATED name: CONTROL name: PEP DEVICE name: HFCWO DEVICE measure: COPD assessment test measure: Clinical COPD Questionnaire measure: mMRC dyspnea scale measure: Richard-Campbell Sleep Questionnaire measure: 30 second sit and stand measure: BODE index measure: chest circumference measurements measure: Modified Borg Scale measure: muscle strenght test sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Health Sciences city: Istanbul zip: 34353 country: Turkey name: ZUHAL KUNDURACILAR PROF DR role: CONTACT phone: +90 530 219 5286 email: zuhal.kunduracilar@sbu.edu.tr name: GAMZE KOYUTÜRK PT, PhD(c) role: CONTACT phone: +90 5065798671 email: gamzealtinkaynak@gmail.com name: GAMZE KOYUTÜRK PT, PhD (C) role: PRINCIPAL_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06274944 id: PEDS-2023-31694 briefTitle: Nasogastric/Orogastric Tube Placement Confirmation in Neonates Utilizing Self-contained pH Device, a Feasibility Study overallStatus: RECRUITING date: 2024-02-12 date: 2025-01-31 date: 2025-01-31 date: 2024-02-23 date: 2024-03-04 name: University of Minnesota class: OTHER briefSummary: This study is looking at using a self-contained pH device that will assist in confirming placement of a nasogastric or orogastric tube placed in the stomach of hospitalized infants. conditions: Premature Birth studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: nasogastric tube placement pH confirmation device measure: PH reading comparison sex: ALL maximumAge: 2 Years stdAges: CHILD facility: University of Minnesota status: RECRUITING city: Minneapolis state: Minnesota zip: 55414 country: United States name: Brittany Faanes role: CONTACT lat: 44.97997 lon: -93.26384 hasResults: False

 nctId: NCT06274931 id: 373 briefTitle: Analysis of the Pulmonary Microbiome overallStatus: RECRUITING date: 2024-02-01 date: 2024-02-20 date: 2024-06-20 date: 2024-02-23 date: 2024-02-23 name: University Magna Graecia class: OTHER briefSummary: The purpose of the protocol is to study the pulmonary microbiome in patients who develop pneumonia. conditions: Pneumonia conditions: Microbial Colonization conditions: Microbial Disease studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Bronchoscopy measure: Assessment of Lung Microbiome in Acute Respiratory Failure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hosp[ital status: RECRUITING city: Catanzaro zip: 88100 country: Italy name: Andrea Bruni role: CONTACT phone: 3401414553 email: andreabruni@unicz.it lat: 38.88247 lon: 16.60086 hasResults: False

 nctId: NCT06274918 id: 202111418 briefTitle: Reducing ESKAPE Transmission in the Operating Room overallStatus: RECRUITING date: 2023-02-01 date: 2024-06-01 date: 2024-12-01 date: 2024-02-23 date: 2024-02-23 name: University of Iowa class: OTHER name: RDB Bioinformatics, LLC name: Georgia-Pacific briefSummary: This study is designed to examine the impact of a personalized, body worn alcohol dispenser on the epidemiology of ESKAPE transmission in the anesthesia work area for patients undergoing surgery requiring general anesthesia. conditions: Surgical Procedure, Unspecified studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Personalized Body-Worn Alcohol Dispenser measure: ESKAPE transmission events with and without the body worn device measure: The epidemiology of ESKAPE transmission events measure: The epidemiology of ESKAPE transmission events measure: The epidemiology of ESKAPE transmission events measure: The epidemiology of ESKAPE transmission events measure: The epidemiology of ESKAPE transmission events measure: 90-Day Healthcare-Associated Infections sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Iowa status: RECRUITING city: Iowa City state: Iowa zip: 52242 country: United States name: Randy W Loftus, MD role: CONTACT lat: 41.66113 lon: -91.53017 hasResults: False

 nctId: NCT06274905 id: 160123 briefTitle: Topical Anaesthesia in Cutaneous Head and Neck Surgery overallStatus: COMPLETED date: 2023-02-20 date: 2023-07-07 date: 2023-07-07 date: 2024-02-23 date: 2024-02-23 name: University Hospital Waterford class: OTHER briefSummary: This study aims to assess if EMLA or ethyl chloride spray are effective in reducing the pain associated with local anaesthetic administration in cutaneous surgery of the head and neck compared to a placebo and control group through a randomized control trial study design. conditions: Pain, Acute conditions: Head and Neck Cancer conditions: Cutaneous Tumor studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Single blinding (for participants) only for patients receiving EMLA or EMLA placebo. whoMasked: PARTICIPANT count: 124 type: ACTUAL name: EMLA name: Ethyl chloride name: Aqueous cream BP measure: Pain score measure: Patient satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Waterford city: Waterford zip: X91 ER8E country: Ireland lat: 52.25833 lon: -7.11194 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2022-12-20 uploadDate: 2024-02-06T12:37 filename: Prot_SAP_000.pdf size: 417714 hasResults: False

 nctId: NCT06274892 id: 23-5818 briefTitle: Remote Monitoring of Patient Reported Outcomes to Improve the Efficacy of the Acute Phase Radiotherapy Review Process acronym: PROMOTE overallStatus: RECRUITING date: 2024-04-01 date: 2024-08-31 date: 2024-11-30 date: 2024-02-23 date: 2024-04-17 name: University Health Network, Toronto class: OTHER briefSummary: Radiation therapy (RT) is a key component in the treatment of breast and prostate cancer. However, patients may experience significant side effects. Patients can accurately self-report side effects from RT and these patient-reported outcomes (PROs) can direct communication between patient and healthcare provider (HCP), and facilitate joint decision making.

Patients state that using mobile phone applications (apps) to collect PROs (mPROs) is easily incorporated into their daily routines, allowing them to engage at a time and pace that suits them. When mPRO collection is combined with remote symptom monitoring by HCPs, these systems result in improvements in symptom control and quality of life.

Currently, patients receiving RT are seen by a Radiation Oncologist once per week during RT and once every few months after RT has finished. Recent evaluations indicate that patients and physicians consider the number of visits to be too frequent during RT, and too infrequent immediately after RT. This research will use weekly mPROs (remotely monitored by RT HCP) to determine if a patient needs (or wants) to be seen by a RT HCP during and/or immediately after RT.

Using mPROs to optimize RT patient assessment processes will ensure patients are seen if and when required. For a patient, this could result in reduced time and costs at the hospital. For the physician, resources could be re-allocated to improve access to RT services. Using mPROs after RT has the potential for earlier treatment of side effects, which has been linked to improved survival and quality of life. conditions: Prostate Cancer conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 124 type: ESTIMATED name: Remote monitoring PROs measure: Remote monitoring efficiency measure: Remote monitoring efficacy measure: Remote monitoring value measure: Remote monitoring comprehensiveness measure: Influencing factors (patient) measure: Influencing factors (disease) measure: Influencing factors (treatment) measure: Influencing factors (toxicity) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Princess Margaret Cancer Centre status: RECRUITING city: Toronto state: Ontario zip: M5G 2J9 country: Canada name: Tara Rosewall role: CONTACT phone: 4162098269 email: tara.rosewall@rmp.uhn.ca name: Winnie Li role: CONTACT phone: 4169462000 email: winnie.li@uhn.ca lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06274879 id: 1938 Ablatio-bilica id: SNCPT type: OTHER domain: Portal for clinical trials in Switzerland briefTitle: Safety of Biliary Intraductal Radiofrequency Ablation in Patients With Unresectable Extrahepatic Biliary Tract Cancer acronym: Ablatio overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2026-04-30 date: 2024-02-23 date: 2024-02-23 name: Insel Gruppe AG, University Hospital Bern class: OTHER name: Swiss Cancer League briefSummary: The goal of this clinical trial is to provide evidence for the general tolerability of radiofrequency ablation (bRFA) in patients with unresectable bile duct cancer undergoing systemic palliative treatment consisting of chemotherapy (gemcitabine and cisplatin) plus durvalumab (immune-checkpoint-inhibitor, ICI). The main question it aims to answer is whether it is safe to combine chemotherapy (gemcitabine and cisplatin) and immunotherapy (durvalumab) - CICI therapy.

Participants will be assigned to either the control group or the experimental group. In the control group, the standard of care consists of endoscopy with stent placement in the bile duct and CICI, whereas in the experimental group, bRFA will be performed in addition to the standard of care. Participants will be followed up for 6 months, during the follow-up, the stage of the tumor, blood examination, the duration of the stent from the insertion until its failure, adverse events and quality of life will be examined.

Researchers will compare the standard of care alone to the experimental group to see if the additional bRFA procedure causes higher or no difference in adverse events rate. conditions: Bile Duct Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Gemcitabin, Cisplatin and Durvalumab name: Biliary Radiofrequency Ablation name: Endoscopic Retrograde Cholangio-Pancreatography with stenting measure: Any grade 3 or 4 adverse events (AE) leading to chemo-immune checkpoint inhibitor-therapy (CICI) discontinuation up to six months after enrolment. measure: Endoscopic complications as measured by the Adverse events GastRointestEstinal Endoscopy (AGREE) criteria specifically developed for endoscopic interventions measure: Progression-free survival, which is defined as the time till the progression of disease or death, whatever comes first, from the time of enrolment to the end of follow-up. measure: Death from any cause from the time of enrolment to the end of follow-up (overall survival). measure: Development of disease-specific quality-of-life as measured by the EORTC QLQ-BIL21 before every CICI cycle plus at 3 and 6 months from the start of the CICI treatment measure: Change in health-related quality-of-life at baseline, 3 and 6 months from the start of the CICI treatment as measured by the EORTC QLQ-C30 measure: Stent patency at month 3 visit and end of study visit measure: Number of courses of CICI applied measure: Total dose of CICI applied measure: Details of adverse events measure: Prognostic significance of response to intraductal biliary RFA by genetic tumor characterization using next-generation sequencing measure: Overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Inselspital Bern University Hospital city: Bern state: Be zip: 3010 country: Switzerland name: Reiner Prof. Dr. med. Wiest role: CONTACT phone: +41 31 632 59 41 email: reiner.wiest@insel.ch name: Martin Prof. Dr. med. Berger role: CONTACT phone: +41 31 632 41 14 email: martin.berger@insel.ch name: Reiner Prof. Dr. med. Wiest role: PRINCIPAL_INVESTIGATOR name: Martin Prof. Dr. med. Berger role: SUB_INVESTIGATOR lat: 46.94809 lon: 7.44744 hasResults: False

 nctId: NCT06274866 id: dsahinoglu briefTitle: Effects Of A Home Based Exercise Program Following Total Hip Arthroplasty overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-10 date: 2023-04-30 date: 2024-06-30 date: 2024-02-23 date: 2024-02-23 name: Halic University class: OTHER briefSummary: The aim of this study is to examine the effects of home-based exercise on pain-related factors, postural control and early functional parameters in individuals undergoing total hip arthroplasty. Forty-four individuals with hip osteoarthritis were included in current study. Individuals were randomized as study group (n=23) and control group (n=21) by drawing lots. Individuals in the study group were followed up with a personalized home-based exercise program for 6 weeks. Individuals in the control group were followed up with an exercise training brochure. The exercise program of the individuals in the study group was checked at two-week intervals and adjustments were made in the exercise program. All individuals were evaluated before the operation, 2 weeks after the operation, and 12 weeks after the operation, and their data were recorded. Range of motion was measured with an inclinometer, muscle strength was measured with a hand dynamometer, joint position sense was measured with a target angle test, pain was measured with a visual pain scale, leg length was measured with a tape measure, and finally, the Q angle was measured with a goniometer. In addition to these,Tampa kinesiophobia scale, Oxford hip score and international physical activity scale were used. Timed up-and-go test was used to evaluate functional performance. Foursquare step test was used to evaluate balance, and finally, tetrax posturography device was used to evaluate postural control. conditions: PHYSİOTHERAPY studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomize controlled two groups primaryPurpose: TREATMENT masking: NONE maskingDescription: no blinding count: 48 type: ACTUAL name: exercise program name: control group measure: OXFORD HİP SCORE measure: TAMPA SCALE FOR KINESİOPHOBİA measure: İNTERNATİONAL PHYSİCAL ACTİVİTY QUESTİONAİRE (SHORT FORM) measure: JOİNT POSİTİON SENSE ERROR TEST measure: FOUR SQUARE STEP TEST measure: THE TİMED UP and GO TEST measure: Assessment of Hip Muscle Strength measure: Assessment of Hip Joint Range of Motion measure: Assessment of Postural Control measure: MEASURİNG LEG LENGTH DİSCREPANCY measure: Q ANGLE sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yeditepe Hospital city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06274853 id: 170327-0001 id: 6830/0003 type: OTHER domain: ICON plc briefTitle: GS-441524 for COVID-19 SAD, FE, and MAD Study in Healthy Subjects overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-12 date: 2024-12 date: 2024-02-23 date: 2024-02-23 name: National Center for Advancing Translational Sciences (NCATS) class: NIH name: Leidos Biomedical Research, Inc. name: ICON Government and Public Health Solutions, Inc briefSummary: The goal of this clinical trial is to evaluate the safety, tolerability, and pharmacokinetics of GS-441524 in healthy subjects. The main questions to answer are: 1) What dosage of GS-441524 is required for adequate therapeutic plasma levels? 2) Does fed or fasted state produce variability in plasma levels? 3) How is GS-441524 eliminated from the body.

Participants will receive varying levels of GS-441524 or placebo to evaluate AEs and plasma levels. conditions: COVID-19 studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: GS-441524 name: Placebo measure: Treatment-emergent adverse events (TEAEs) measure: Blood Pressure in mm/Hg measure: Pulse in beats/min measure: Respiratory Rate in breaths per minute measure: Body Temperature in degrees measure: Electrocardiogram (ECG) as measured by PR interval measure: Electrocardiogram (ECG) as measured by QT interval measure: Electrocardiogram (ECG) as measured by QT corrected (Fridericia's) measure: Plasma PK Parameter C-Max measure: Plasma PK Parameter t-max measure: Plasma PK Parameter t-lag measure: Plasma PK Parameter AUC 0-last measure: Plasma PK Parameter AUC 0-inf measure: Plasma PK Parameter t 1/2 measure: Plasma PK Parameter CL/F measure: Plasma PK Parameter Vz/F measure: Urine PK Parameter Ae urine measure: Urine PK Parameter Fe urine measure: Urine PK Parameter CL R measure: Plasma PK Parameter C trough measure: Plasma PK Parameter AUC 0-tau measure: Plasma PK Parameter CL/F ss measure: Plasma PK Parameter Vz/F ss measure: Plasma PK Parameter R ac sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06274840 id: CAR-CF briefTitle: COVID-19 Antibody Responses In Cystic Fibrosis acronym: CAR-CF overallStatus: RECRUITING date: 2022-08-08 date: 2024-05 date: 2024-05 date: 2024-02-23 date: 2024-02-23 name: Pilar Azevedo class: OTHER name: Queen's University, Belfast name: European Cystic Fibrosis Society - Clinical Trial Network name: Cystic Fibrosis Foundation name: Medical University Innsbruck briefSummary: Coronavirus disease 2019 (COVID-19) which is caused by the virus SARS-CoV-2 has resulted in an ongoing global pandemic. It is unclear whether the relatively low number of reported cases of COVID-19 in people with CF (pwCF) is due to enhanced infection prevention practices or whether pwCF have protective genetic/immune factors. This study aims to prospectively assess the proportion of pwCF, including both adults and children with CF who have evidence of SARS-CoV-2 antibodies over a two-year period. This study will also examine whether pwCF who have antibodies for SARS-CoV-2 have a different clinical presentation and what impact this has on their CF disease. The proposed study will recruit pwCF from paediatric and adult CF centres in Europe. Serological testing to detect antibodies will be performed on blood samples taken at month 0, 6, 12, 18 and 24 with additional time-points if bloodwork is available via normal clinical care. Clinical data on, lung function, CF-related medical history, pulmonary exacerbations, antibiotic use, and microbiology and vaccination receipt, will be collected during routine clinical assessments.

Associations will be examined between socio-demographic and clinical variables and serologic testing. The effects of SARS-CoV-2 infection on clinical outcomes and analyse end-points will be examined to explore any age-related or gender-based differences, as well as subgroup analysis of outcomes in lung-transplant recipients and pwCF receiving CFTR modulator therapies. As pwCF receive COVID-19 vaccination a comparison of the development and progression of anti-SARS-CoV-2 antibodies in pwCF following natural infection and vaccination SARS-CoV-2 over time will be performed. conditions: COVID-19 conditions: Cystic Fibrosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED measure: SARS-COV-2 seroprevalence measure: Association of SARS-CoV-2 seropositivity, clinical symptoms and clinical outcomes in pwCF measure: Longitudinal comparison of the detection measure: Serum proteomic and genomic responses of pwCF sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: CHLN status: RECRUITING city: Lisboa zip: 1800-268 country: Portugal name: Celeste Barreto role: CONTACT name: Ana Lopes role: CONTACT name: Celeste Barreto, MD role: PRINCIPAL_INVESTIGATOR lat: 38.71667 lon: -9.13333 hasResults: False

 nctId: NCT06274827 id: GO 22- 881 briefTitle: Electromyographic Analysis of Scapular Muscles During Closed Kinetic Chain Exercises overallStatus: COMPLETED date: 2022-09-25 date: 2023-04-30 date: 2023-06-20 date: 2024-02-23 date: 2024-02-26 name: Hacettepe University class: OTHER briefSummary: In shoulder rehabilitation, the inclusion of kinetic chain exercises is advocated in order to provide the necessary energy transfer to produce optimal force with minimal energy consumption. Closed kinetic chain (CKC) exercises are defined as exercises in which the distal segment is stabilized by encountering significant resistance while the proximal segment moves. In contrast, open kinetic chain (OKC) exercises allow the distal segment to move freely without any resistance. Recently, the importance of closed kinetic chain (CKC) exercises has increased in enhancing shoulder joint neuromuscular control by improving dynamic shoulder stability and joint position sense.

The most current shoulder rehabilitation protocols include exercises for restoration of scapular muscle imbalances.There exist studies investigating the levels of scapular muscle activation during CKC exercises. Researchers have shown that most CKC exercises especially push-ups and plank variations with the shoulder in the 90° position, generally provide high SA activity and an optimal UT/SA ratio.In the literature, there is limited information on how the level of shoulder elevation affects scapular muscle activity and ratio during closed kinetic chain exercises in the prone position. To effectively prescribe CKC exercises commonly used in rehabilitation and athletic programs, a clear understanding of shoulder elevation changes muscle activity during these exercises is required.

Our hypothesis is that glenohumeral joint elevation status will alter scapular muscle activation and activation rates. conditions: Shoulder Pain conditions: Shoulder Injuries conditions: Activation, Patient studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All participants will complete each stage in a randomized order. primaryPurpose: BASIC_SCIENCE masking: NONE count: 22 type: ACTUAL name: Superficial Electromyography measure: Muscle activation recorded with surface electromyography (sEMG) during CKC sex: MALE minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Hacettepe University city: Ankara zip: 06430 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06274814 id: AP23.501.038 briefTitle: U/S Guided Rhomboid Intercostal Block Combined With Sub-Serratus Plane Block vs Type 2 Pectoral Nerve Block overallStatus: RECRUITING date: 2023-06-01 date: 2024-04-01 date: 2024-05-01 date: 2024-02-23 date: 2024-03-13 name: National Cancer Institute, Egypt class: OTHER briefSummary: The aim of this study is to compare between U/S Guided Rhomboid Intercostal Block Combined with Sub-Serratus Plane Block vs type 2 Pectoral Nerve Block in Analgesia for Breast Cancer Surgery by measuring intraoperative hemodynamics, postoperative pain scores and morphine consumption in the first 24 h postoperative. conditions: Breast Neoplasm Female conditions: Analgesics studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 69 type: ESTIMATED name: U/S guided Rhomboid intercostal block (RIB) name: U/S guided RIB combined with the sub-serratus plane block (RISS) measure: Total morphine consumption measure: Visual Analog scale score postoperative measure: Intraoperative fentanyl consumption measure: Heart rate intraoperative measure: Timing of first rescue analgesia sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National cancer Insititute status: RECRUITING city: Cairo zip: 11796 country: Egypt name: attef, lecturer role: CONTACT phone: +20225328286 email: irb@nci.cu.edu.eg name: ahmed soliman role: PRINCIPAL_INVESTIGATOR lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06274801 id: GB002-3102 id: 2023-506334-75 type: EUDRACT_NUMBER briefTitle: Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT) overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-12 date: 2026-12 date: 2024-02-23 date: 2024-02-23 name: GB002, Inc. class: INDUSTRY briefSummary: This open-label extension study will evaluate the long-term safety, tolerability and efficacy of orally inhaled seralutinib in subjects who have completed a previous seralutinib study conditions: Pulmonary Arterial Hypertension studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: Seralutinib name: Gereic Dry Powder Inhaler measure: Incidence of treatment-emergent adverse events (TEAEs) measure: Changes in distance achieved on the Six-Minute Walk Test (6MWT) measure: Changes in NT-proBNP sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Kansas Medical Center city: Kansas City state: Kansas zip: 66160 country: United States lat: 39.11417 lon: -94.62746 facility: Pulmonary Associates of Richmond, Inc. city: Richmond state: Virginia zip: 23230 country: United States lat: 37.55376 lon: -77.46026 hasResults: False

 nctId: NCT06274788 id: OMEG-054-CP4 briefTitle: Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-03-01 date: 2027-03-01 date: 2024-02-23 date: 2024-03-12 name: Fresenius Kabi class: INDUSTRY briefSummary: This study will demonstrate safety in pediatric patients with Parenteral Nutrition-Associated Cholestasis treated with Omegaven®, which is indicated as a source of calories and fatty acids in this patient population conditions: Parenteral Nutrition Associated Liver Disease (PNALD) conditions: Essential Fatty Acid Deficiency conditions: Malnutrition conditions: Pediatric ALL studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 40 type: ESTIMATED name: Omegaven® (fish oil triglycerides) Injectable Emulsion measure: Incidence of essential fatty acid deficiency (EFAD) measure: Incidence of clinical EFAD measure: Time from treatment start to EFAD diagnosis measure: Incidence of adverse events (AEs)/serious adverse events (SAEs) measure: Routine laboratory tests: Direct or conjugated bilirubin measure: Routine laboratory tests: triglycerides measure: Fatty acid profiles: α-linolenic acid measure: Fatty acid profiles: linoleic acid measure: Fatty acid profiles: arachidonic acid measure: Fatty acid profiles: mead acid measure: Fatty acid profiles: oleic acid measure: Fatty acid profiles: docosahexaenoic acid (DHA) measure: Fatty acid profiles: eicosapentaenoic acid (EPA) measure: Anthropometric measures: body weight measure: Anthropometric measures: body height/length measure: Anthropometric measures: head circumference sex: ALL minimumAge: 1 Day maximumAge: 17 Years stdAges: CHILD hasResults: False

 nctId: NCT06274775 id: 23-12026811 briefTitle: Effect of an Educational Nail Biopsy Video on Pre-operative Anxiety, Health Literacy, and Patient Satisfaction overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-07 date: 2025-07 date: 2024-02-23 date: 2024-04-12 name: Weill Medical College of Cornell University class: OTHER briefSummary: The investigators are interested in studying the effect of an animated video depicting a nail biopsy procedure on the anxiety, health literacy, and satisfaction of participants recommended to undergo a nail biopsy procedure. The investigators hypothesize that the animated video will reduce preoperative anxiety, increase health literacy, and increase patient satisfaction in relation to nail biopsy procedures. conditions: Anxiety conditions: Literacy conditions: Satisfaction, Patient studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Educational Video measure: Anxiety, as measured by the State Trait Anxiety Inventory measure: Anxiety, as measured by the Amsterdam Preoperative Anxiety and Information Scale measure: Need for information, as measured by the Amsterdam Preoperative Anxiety and Information Scale measure: Health literacy, as measured by 4 domains of The Health Literacy Questionnaire measure: Patient satisfaction, as measured by a patient satisfaction survey measure: Quality of video intervention for intervention participants, as measured by a qualitative feedback survey sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Weill Cornell Medicine city: New York state: New York zip: 10065 country: United States name: Shari R. Lipner, MD, PhD role: CONTACT email: shl9032@med.cornell.edu name: Rachel C Hill, BS role: CONTACT phone: 5024170984 email: shl9032@med.cornell.edu lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06274762 id: MARU-SBF-ROKÇ-01 briefTitle: Visually Impaired Women Model-based Cancer Education and Breast Self-examination overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-03-31 date: 2025-03-31 date: 2024-02-23 date: 2024-02-23 name: Marmara University class: OTHER briefSummary: The aim of our study was to raise awareness among visually impaired women, who are in the vulnerable group, about breast cancer, which ranks first among female cancers, and to teach breast self-examination. conditions: Breast Cancer Awareness and BSE in Visually Impaired Women studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: There is an experimental group of 45 visually impaired women aged 20-69 and a control group of 45. Randomization was not possible. Blinding could not be done. primaryPurpose: PREVENTION masking: NONE count: 90 type: ESTIMATED name: Training and BSE application on a model measure: Champion health belief model scale sex: FEMALE minimumAge: 20 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Marmara University city: Istanbul country: Turkey name: Marmara University role: CONTACT email: sevalsaray.demir@gmail.com name: Seval Saraydemir Kıromeroglu role: PRINCIPAL_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06274749 id: 10001930 id: 001930-AG briefTitle: Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial overallStatus: RECRUITING date: 2024-05-01 date: 2027-03-31 date: 2027-03-31 date: 2024-02-23 date: 2024-04-26 name: National Institute on Aging (NIA) class: NIH briefSummary: Background:

As people age, the cells in the pancreas that produce insulin begin to release less of this hormone, and levels of blood glucose (sugar) rise. This can lead to illnesses such as diabetes. Urolithin A (UA) is a natural nutritional supplement that may improve how the body controls blood glucose.

Objective:

To learn if UA improves levels of insulin and other hormones that help control blood glucose.

Eligibility:

People aged 55 years and older with a body mass index of 27 or higher.

Design:

Participants will have 6 clinic visits over 8 weeks.

Participants will be screened. They will have a physical exam with blood and urine tests and a test of their heart function.

UA gelcaps are taken by mouth every morning at home. Half of participants will take UA. The other half will take a placebo. The placebo looks like the study drug but does not contain any medicine. Participants will not know which they are taking.

Participants will have tests during the study including:

Oral glucose tolerance: Participants will drink a sweet liquid. Blood will be drawn at intervals over the next 3 hours.

Continuous glucose monitor: A sensor with a needle that goes just under the skin will be placed on the upper arm. Participants will wear this sensor throughout the study.

Exercise. Participants will walk on a treadmill while their heart rate, hearth rhythm, and blood pressure are monitored. They will walk in a hallway at normal and fast paces.

Imaging scans of the thigh; scans of the brain are optional.... conditions: Healthy Volunteer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 180 type: ESTIMATED name: Urolithin A name: Placebo measure: To determine if urolithin A supplementation will influence insulin secretion in response to oral glucose at 4 and 8 weeks after supplementation. measure: To determine if UA supplementation will increase incretin secretion in response to oral glucose at 4 and 8 weeks after the supplementation. measure: To determine if UA supplementation will enhance mitochondria respiration, based on p31 spectroscopy by thigh MRI/MRS at baseline and 8 weeks after supplementation. measure: To determine if UA will increase brain oxidative metabolism, based on brain MRS at baseline and 8 weeks after supplementation. measure: To determine if UA supplementation will alter gut microbiome composition. sex: ALL minimumAge: 55 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Institute of Aging, Clinical Research Unit status: RECRUITING city: Baltimore state: Maryland zip: 21224 country: United States name: Josephine Egan, M.D. role: CONTACT phone: 410-558-8414 email: eganj@mail.nih.gov lat: 39.29038 lon: -76.61219 hasResults: False

 nctId: NCT06274736 id: CLINP-001012 briefTitle: Safety and Performance of Motiva® Sizers overallStatus: RECRUITING date: 2023-04-10 date: 2027-04-10 date: 2027-07-10 date: 2024-02-23 date: 2024-02-23 name: Establishment Labs class: INDUSTRY briefSummary: The Motiva® Sizer clinical study is a four-year, multicenter, post-marketing, and cohort study, designed to confirm the safety and performance of Motiva® Sizer in breast augmentation or reconstruction procedures.

The research will include 330 women, divided into two groups of 165 participants each (150 breast augmentation participants and 15 reconstruction participants). The Motiva® Sizer exposed group will consist of women who will undergo breast augmentation or reconstruction surgery with the use of Motiva® Sizer during the procedure, and a non-exposed group will consist of women who will undergo breast augmentation or reconstruction surgery without the use of Motiva® Sizer. This study will be conducted in Costa Rica.

The main goal is to evaluate the safety and the performance of the Motiva® Sizer. To this end, the results of both groups will be compared in terms of surgical complications, surgeon's, and participant's satisfaction level as well as reoperation rates.

After the augmentation or reconstruction surgery, participants will be scheduled for the following follow-up visits, (1) between 3 and 7 postoperative days, (2) between 3 and 6 postoperative weeks, (3) at 3 and (4) 6 postoperative months, and (5, 6 and 7) annually thereafter for a period of three consecutive years. In case any participant has an adverse event due to the procedure, and if required by the physician, an additional visit will be made to assess her, and this information as well as that of the scheduled visits should be recorded in the electronic data collection notebook. conditions: Breast Implant; Complications conditions: Breast Implantation; Methods, Safety and Performance conditions: Mammaplasty conditions: Breast Reconstruction conditions: Breast Augmentation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 330 type: ESTIMATED name: Motiva Sizer measure: Motiva Sizers Safety (complications) measure: Motiva Sizers Performance (satisfaction) measure: Motiva Sizers Safety (reoperations) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Establishment Labs status: RECRUITING city: Coyol state: Alajuela zip: 20102 country: Costa Rica lat: 10.00126 lon: -84.26124 hasResults: False

 nctId: NCT06274723 id: STUDY00001220 id: 1K99CA281094-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1K99CA281094-01A1 briefTitle: Responses to E-cigarette Message Source and Presentation overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-23 date: 2024-02-23 name: University of Massachusetts, Worcester class: OTHER name: National Cancer Institute (NCI) briefSummary: The goal of this clinical trial is to use crowdsourcing to test the effects of a message source (expert and peer) and message presentation types (one-sided and two-sided) to identify the optimal message type for young adults who vape and do not vape. conditions: Vaping studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 800 type: ESTIMATED name: Expert name: Peer name: 1 Sided name: 2 Sided measure: Message acceptance measure: Harm perceptions measure: Psychological reactance measure: Message liking measure: Source trust measure: Attitudes measure: Behavioral intentions to vape or try vaping sex: ALL minimumAge: 18 Years maximumAge: 24 Years stdAges: ADULT typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2024-01-17 uploadDate: 2024-01-31T10:44 filename: SAP_000.pdf size: 176839 hasResults: False

 nctId: NCT06274710 id: 23-5554 briefTitle: ODYSSEE Kidney Health Trial acronym: ODYSSEE-KH overallStatus: RECRUITING date: 2023-12-13 date: 2026-04-13 date: 2026-04-13 date: 2024-02-23 date: 2024-02-23 name: University Health Network, Toronto class: OTHER name: Sunnybrook Health Sciences Centre name: Scarborough General Hospital name: The Ottawa Hospital briefSummary: INTRODUCTION

Severe CKD is defined as a risk of greater than 10% for progressing to RRT \[home hemodialysis (HHD), home peritoneal dialysis (HPD), and transplantation\] within 2 years. There is a need to improve access to CKD self-care counselling and RRT education for patients with severe CKD. Trials of CKD self-care education have achieved therapeutic benefits with moderate to high patient-provider contact. There is high potential for a trial of digital counselling for CKD self-care and RRT education to enhance patient health and quality of life.

HYPOTHESES

The primary hypothesis is that ODYSSEE-KH versus usual care (UC) will significantly increase the incidence of home RRT, measured by a composite index of HHD, HPD, and preemptive kidney transplant at trial completion (median = 19 months; range: 12 to 27 months).

The secondary hypothesis is that ODYSSEE-KH for CKD self-care and RRT education improves Home RRT, RRT preparation, annual hospitalization rate, engagement with CKD self-care resources at months 6 and 12 and trial completion and scores on outcome measures.

RECRUITMENT

Patients diagnosed with CKD who are 18 years of age or older were recruited from University Health Network (UHN), Sunnybrook Hospital, Scarborough Health Network, and The Ottawa Hospital.

DESIGN

ODYSSEE-KH is a double-arm, parallel-group, randomized controlled trial that has assessments at baseline, months 6 and 12, and trial completion (median = 19 months; range: 12 to 27 months). This is a single-blind design with research personnel masked.

ODYSSEE-KH combines automated digital counselling of CKD self-care with renal replacement therapy (RRT) education. UC enhances the standard of usual care by providing patients with conventional digital CKD education. Over 27 months, patients will be emailed on a weekly basis with a digital link to log on to their respective program using a password-protected, personal account.

ANALYSIS

Separate GLMs will evaluate if Digital Counselling versus UC is independently associated with outcomes at months 6 and 12 and trial completion (median = 19; range: 12 to 27 months). Dependent variables include the KDQOL-SF, SF-36, EUROIA, PHQ-9, GAD-7, MIDLS, ESSI, PWB, BMPN, AI, as well as a modified SEMCD-6. Multivariable models will adjust for baseline assessments of each outcome and potential baseline covariates (noted above). In all GLMs, significant interactions will be followed by subgroup analyses with Bonferroni post hoc tests. conditions: Chronic Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 344 type: ESTIMATED name: ODYSSEE-KH measure: Incidence of home RRT measure: Improvement of Home RRT measure: Improvement of RRT preparation with planned dialysis access measure: Incidence of annual hospitalization rate measure: Engagement with RRT education and CKD self-care counselling resources measure: Self-reported engagement in activities for living well measure: Self-reported assessment for health-related quality of life due to kidney disease measure: Self-reported assessment of people's aspirations and goals measure: Self-reported measure of overall health (e.g. pain, mental health, physical, role and social functioning) measure: Self-reported depression measure: Self-reported perceived social support measure: Self-reported psychological wellbeing measure: Self-reported anxiety measure: Self-reported feeling of value to self and others measure: Self-reported measure of psychological wellbeing and happiness measure: Self-reported measure of overall life experience measure: Self-reported measure of well-being measure: Self-reported readiness for change (motivation) measure: Self-reported confidence in doing life activities sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Health Network status: RECRUITING city: Toronto state: Ontario zip: M2N 7A2 country: Canada name: Robert P Nolan, PhD role: CONTACT phone: (416) 340-4800 phoneExt: 6400 email: rob.nolan@uhnresearch.ca name: Karly Gunson, HBA, BHSc role: CONTACT phone: (416) 340-4800 phoneExt: 6400 email: karly.gunson2@uhn.ca lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06274697 id: RECHMPL22_0391 id: 2023-A01784-41 type: REGISTRY domain: ID-RCB briefTitle: Validation of a Magnetic Sensor in Arterial Flow Recording, Compared With the Reference Method, at Various Peripheral Arterial Sites acronym: COMADO overallStatus: RECRUITING date: 2024-04-02 date: 2025-04 date: 2025-04 date: 2024-02-23 date: 2024-04-11 name: University Hospital, Montpellier class: OTHER name: phymedexp briefSummary: The measurement of magnetic fields emitted by cardiac activity has already been studied in magneto-cardiography. To date, however, this technology has never been evaluated in the peripheral circulation.

The magnetic susceptibility of iron in the circulating blood and the ionic currents in the blood stream generate a very weak induced magnetic current, which can be detected by the micro-sensor of the prototype investigators wish to study.

Proving the validity of this prototype would make it a new diagnostic and even prognostic tool, non-invasive, less costly and more accessible than Doppler for screening peripheral arterial disease. conditions: Lower Extremity Artery Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 70 type: ESTIMATED name: Evaluation by magnetic sensor measure: Correlation of the two curve amplitudes (y) versus time (x) between the signal recording obtained by the CapMagic prototype on the radial artery and the pulsed echo-Doppler recording on the radial artery measure: Correlations of the two curve amplitudes (y) versus time (x) between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording, measured on the plantar artery on one side and on the pulpal artery on the other measure: Correlation of the Pulsatility index (or Gosling Pulsatility index) between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording measure: Correlation of the Systolic rise time (SRT) between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording measure: Correlation of the Systolic peak between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording measure: Correlation of the Type of flow according to Saint-Bonnet classification between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording measure: Correlation of Presence of critical ischemia measured by the CapMagic prototype and the pulsed echo-Doppler recording sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Center status: RECRUITING city: Montpellier country: France name: Gudrun BOGE, MD role: CONTACT phone: 467336279 phoneExt: 33 email: g-boge@chu-montpellier.fr name: Gudrun BOGE role: PRINCIPAL_INVESTIGATOR lat: 43.61092 lon: 3.87723 hasResults: False

 nctId: NCT06274684 id: 2023-01100 briefTitle: Feasibility of Virtual Reality Assistance in Prostate Biopsy Under Local Anesthesia. overallStatus: NOT_YET_RECRUITING date: 2024-02-19 date: 2025-05-01 date: 2025-07-01 date: 2024-02-23 date: 2024-02-28 name: University Hospital, Geneva class: OTHER briefSummary: The goal of this clinical trial is to test the impact of Virtual Reality (VR) assistance for anxiety management of patients undergoing prostate biopsies in local anaesthesia.

The main question it aims to answer:

- Is there a significant decrease on anxiety level thanks to VR-assistance?

Participants will be equipped with VR headset providing an immersive visual experience accompanied with a hypnoses oriented audio during the entire procedure.

Researchers will compare standardised anxiety scores with a control group. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Use of Virtual Reality Assistance during prostate biopsies measure: Anxiety level measure: Anxiety level of the surgeon measure: Biopsies complications sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06274671 id: 23-24-09 briefTitle: Glymphatic MRI in Clinically Isolated Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-05-15 date: 2025-05-15 date: 2024-02-23 date: 2024-02-23 name: University of Exeter class: OTHER briefSummary: The brain possesses a system to get rid of unwanted substances, named Glymphatic System (GS). When this system is faulty, these accumulate, there is local inflammation, and progressive death of the cells. This occurs in neurological diseases including Parkinson's, or Alzheimer's. Inflammation and progressive death of the cells are also present in another neurological disorder, named Multiple Sclerosis (MS).

Doctors think that GS dysfunction plays a role in MS too. In this research therefore, the aim is to study whether it drives inflammation, and disease progression in MS patients.

The researchers have developed a new way to find signs of alteration of the GS using a scan named Magnetic Resonance Imaging (MRI) and will use it in a pilot study on patients with a condition named Clinically Isolated Syndrome (CIS), which often represents the very beginning of MS. It would therefore be demonstrated that the GS is a new mechanism of disease in CIS, which may associate with the symptoms, or the alterations in the levels of some substances in the blood suggestive of brain cells damage.

Should this study be successful, this would provide preliminary evidence to perform a larger research study to assess if GS dysfunction drives the progression of MS. conditions: Clinically Isolated Syndrome studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 30 type: ESTIMATED name: Magnetic Resonance Imaging measure: To determine that patients with CIS display alterations of the glymphatic system visible in vivo by Structural MRI measure: To determine that patients with CIS display alterations of the glymphatic system visible in vivo by microstructural MRI measure: To determine that patients with CIS display alterations of the glymphatic system visible in vivo by diffusion-weighted MRI measure: To determine that patients with CIS display alterations of the glymphatic system visible in vivo by perfusion-MRI measure: To determine that patients with CIS display alterations of the glymphatic system visible in vivo by ALS-MRI measure: To correlate in vivo measures of altered glymphatic system with MRI measures of structural integrity in CIS measure: To correlate in vivo measures of altered glymphatic system with MRI measures of disease activity in CIS measure: To correlate in vivo measures of altered glymphatic system with MRI measures of enlarged Wirchow-Robin spaces in CIS measure: To correlate in vivo measures of altered glymphatic system with MRI measures of microstructural altertions in CIS measure: To correlate in vivo measures of altered glymphatic system with MRI measures of brain perfusion in CIS measure: To correlate in vivo measures of altered glymphatic system in CIS with clinical measures of disease severity measure: To correlate in vivo measures of altered glymphatic system in CIS with fluid biomarkers of axonal injury in CIS measure: To correlate in vivo measures of altered glymphatic system in CIS with fluid biomarkers of astrocytis integrity in CIS measure: To correlate in vivo measures of altered glymphatic system in CIS with fluid biomarkers of glymphatic activity in CIS sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Exeter city: Exeter country: United Kingdom name: Edoardo R de Natale, MD role: CONTACT email: e.de-natale@exeter.ac.uk lat: 50.7236 lon: -3.52751 hasResults: False

 nctId: NCT06274658 id: STUDY00006517 briefTitle: The Effects of an Acute High-intensity Exercise on Heart and Brain Function in People With Spinal Cord Injury overallStatus: RECRUITING date: 2024-02-14 date: 2025-06-30 date: 2025-08-31 date: 2024-02-23 date: 2024-02-23 name: State University of New York at Buffalo class: OTHER briefSummary: The heart and brain are regulated by the autonomic nervous system. Control of these organs can be disrupted in people with spinal cord injury (SCI). This may affect their ability to regulate blood pressure during daily activities and process the high-level information. Previous studies show that high-intensity exercise induces better outcomes on heart and information processing ability in non-injured people compared to moderate-intensity exercise. However, it is unknown the effects of high-intensity exercise on heart and brain function in people with SCI. Therefore, this study aims to examine the effects of a single bout of high-intensity interval training on heart and brain function in this people with SCI compared to age- and sex-matched non-injured controls. conditions: Autonomic Nervous System Disease conditions: Spinal Cord Injuries conditions: Cognition studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: High-intensity interval exercise measure: Low frequency of systolic blood pressure variability measure: High frequency of heart rate variability measure: Blood pressure measure: Heart rate measure: Cerebral blood flow velocity measure: Symbol Digit Matched Test score measure: California Verbal Learning Test score measure: Color-Word Stroop Test score measure: Controlled Word Association Task score sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University at Buffalo, South Campus status: RECRUITING city: Buffalo state: New York zip: 14214 country: United States name: Wenjie Ji role: CONTACT phone: 716-907-2508 phoneExt: 1 email: wji4@buffalo.edu lat: 42.88645 lon: -78.87837 hasResults: False

 nctId: NCT06274645 id: IVUS CHIP China Registry briefTitle: IVUS CHIP China Registry overallStatus: RECRUITING date: 2024-03-12 date: 2026-07 date: 2028-02 date: 2024-02-23 date: 2024-04-26 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: The goal of this observational study is to learn about in patients with complex coronary lesions undergoing PCI. The main question\[s\] it aims to answer are: the clinical efficacy and safety of an IVUS-guided approach in patients with complex coronary lesions undergoing PCI, as well as clinical outcomes up to 2 years. Participants will be treated with IVUS-guided PCI. conditions: Complex Higher Risk Indicated Patients Undergoing PCI studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2020 type: ESTIMATED name: The OptiCross High Definition (60 MHz) and OptiCross (40MHz) Intravascular Ultrasound (IVUS) catheter from Boston Scientific measure: Time-to-first-event analysis of these three event including cardiac death, target vessel myocardial infarction will be primarily used for clinical endpoints. measure: Time-to-first-event analysis will be primarily used for clinical endpoints. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan Zhongshan Hospital status: RECRUITING city: Shanghai country: China name: Chenguang Li, Doctor role: CONTACT email: li.chenguang@zs-hospital.sh.cn lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06274632 id: 2023P001913 briefTitle: ADELANTE: A Randomized Controlled Trial to Improve Engagement in Care for Latinos With HIV overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-02-28 date: 2027-02-28 date: 2024-02-23 date: 2024-04-03 name: Massachusetts General Hospital class: OTHER name: Baylor College of Medicine name: University of Miami briefSummary: The goal of this study is to test the effectiveness of ADELANTE on viral suppression among Latinos with HIV and viral non-suppression. Participants will receive ADELANTE (5-session, community health worker-delivered, problem-solving intervention) or enhanced care condition (ECC, 5 reminder phone calls). We will evaluate the overall effectiveness of ADELANTE compared with ECC on rates of viral suppression and emergency room visits and hospitalizations. Our hypothesis is that ADELANTE participants will achieve higher rates of viral suppression and will have lower rates of emergency room visits and hospitalizations compared with ECC at 12 months post-randomization. conditions: HIV/AIDS studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 250 type: ESTIMATED name: ADELANTE measure: 12-month viral suppression measure: Number of Emergency department visits measure: Number of Hospitalizations measure: 6-month viral suppression measure: Retention in care sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Miami city: Miami state: Florida zip: 33146 country: United States name: Allan Rodriguez, MD role: CONTACT phone: 305-243-3711 email: arodriguez2@miami.edu lat: 25.77427 lon: -80.19366 facility: Baylor College of Medicine city: Houston state: Texas zip: 77030 country: United States name: Thomas P Giordano, MD role: CONTACT phone: 713-798-8918 email: tpg@bcm.edu lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06274619 id: 23HH8541 id: MISP 59717 type: OTHER_GRANT domain: MSD id: 57276 type: REGISTRY domain: CPMS id: 324970 type: OTHER domain: IRAS briefTitle: Novel Mucosal Correlates Of RSV Protection In Older Adults acronym: CHIRP01 overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-02 date: 2026-02 date: 2024-02-23 date: 2024-03-07 name: Imperial College London class: OTHER briefSummary: Respiratory syncytial virus (RSV) is one of the most common causes of chest infection worldwide. Despite this, it remains an underappreciated health problem, with the first effective RSV vaccines only approved by the FDA in May 2023 and unlikely to be widely available for some time. Although RSV infection is most frequent in young children, most deaths occur in older adults, particularly in those with underlying heart and lung disease. This is believed to be due in part to the ageing immune system's reduced ability to protect against infection and symptomatic disease.

However, little is known about the way human immune responses to RSV infection in older individuals differ from those of younger people. Further understanding of the mechanisms underlying immunity and potential impairments in these higher-risk people are therefore necessary. This project aims to study the factors that influence whether or not older people develop symptomatic RSV disease in healthy older volunteers after being given an RSV-induced common cold. Samples will be taken from the blood and nose in order to identify changes in the immune system associated with susceptibility or protection in older adults. Participants will be carefully screened to ensure there are no underlying health problems that might make them more at risk of severe disease and will be monitored closely throughout the course of infection. It is anticipated that differences in immune markers in the nose and/or blood of healthy older people will predict whether or not such individuals become infected or develop symptoms. By analysing the networks of genes that are switched on and off, the aim is to identify the pathways in the immune system responsible for these differences, to ultimately develop improved diagnostic tests, vaccines and treatments. conditions: Respiratory Tract Infections studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 20 type: ESTIMATED name: RSV A Memphis 37 measure: Number of solicited and unsolicited adverse events (AEs) measure: Infection rate measure: Nasal Viral Load measure: Antibody levels by serum neutralisation assay measure: Antibody levels by ELISA sex: ALL minimumAge: 65 Years maximumAge: 75 Years stdAges: OLDER_ADULT facility: Imperial College London city: London zip: W12 0NN country: United Kingdom name: Polly Fox role: CONTACT email: polly.fox@imperial.ac.uk name: Christopher Chiu role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06274606 id: HSR230106 briefTitle: Exercise Training Study Before Bariatric Surgery acronym: BaSE overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-01-01 date: 2025-03-15 date: 2024-02-23 date: 2024-02-23 name: University of Virginia class: OTHER briefSummary: The goal of this clinical trial is to figure out if 8 weeks of walking exercise before bariatric surgery improves risk factors for diabetes and other markers of health. This is important as it may help reduce complications after surgery, improve health markers and increase physical activity levels after surgery (which is an important marker of maintaining bariatric weight loss). The main question that this study is trying to answer is whether walking improves a risk factor for type 2 diabetes called insulin sensitivity (how well your body is able to use glucose).

Adults planning to have bariatric surgery will be recruited from the Charlottesville VA area. Before they have their surgery, participants will be randomly assigned (like flipping a coin) to a group that participates in 8 weeks of walking on a treadmill (2-3 times a week) or a group that does their normal care before bariatric surgery.

Researchers will compare the effects of walking before bariatric surgery on:

* Insulin sensitivity (diabetes risk factor)
* Health of blood vessels
* Rate of complications after surgery
* Weight
* Body Fat
* Fitness level conditions: Bariatric Surgery Candidate studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In accordance with a parallel study design, 30 pre-bariatric-surgery patients will be randomized in a 1:1 ratio to either undergo 8-weeks of pre-operative standard of care or 8-weeks of pre-operative standard of care plus moderate exercise prior to undergoing bariatric-surgery. Randomization scheme: The randomization will be generated utilizing a permuted block randomization scheme in which 5 blocks of 6 treatment assignments (3 per treatment) will be generated via a computer algorithm. The 6 treatment assignments of each block will be listed in random sequential order and the treatment assignments will be assigned according to the random sequential order. The randomization will be generated by our biostatistician. primaryPurpose: SUPPORTIVE_CARE masking: NONE maskingDescription: Randomization will be completely random and will only be known by biostatistician and study coordinator in department but not on study to retain true randomization unaffected by study team. count: 30 type: ESTIMATED name: Exercise Group measure: Insulin sensitivity measure: Surgical outcomes - readmission within 30 days of surgery measure: Surgical outcomes - IV treatment as an outpatient measure: Surgical outcomes - emergency department visits measure: Surgical outcomes - time of surgery measure: Surgical outcomes - length of stay after surgery completion measure: Flow-mediated dilation (FMD) measure: Pulse-wave analysis (PWA) measure: Pulse-wave velocity (PWV) measure: Body fat measure: Lean body mass measure: Bone mineral density measure: Visceral adiposity measure: Weight measure: Blood Lipids measure: Plasma glucose measure: Plasma insulin measure: Hemoglobin A1c measure: Cardiorespiratory fitness measure: Quality of life (SF-36) sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: University of Virginia city: Charlottesville state: Virginia zip: 22902 country: United States name: Damon L Swift, PhD role: CONTACT phone: 434-924-1436 email: dls3s@virginia.edu name: Emily E Grammer, MS role: CONTACT phone: 8508968401 email: erk9nk@virginia.edu lat: 38.02931 lon: -78.47668 hasResults: False

 nctId: NCT06274593 id: AP_JBD_MJ_003 briefTitle: Study of OCT Peripapillary Angiography in Patients With Advanced Glaucoma acronym: OGA overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-09 date: 2024-02-23 date: 2024-02-23 name: Nantes University Hospital class: OTHER briefSummary: Glaucoma is a chronic disease of the optic nerve, characterized by progressive loss of nerve cells in the retina, leading to progressive loss of peripheral and central vision. There are in fact several types of glaucoma, which is the world's second leading cause of blindness after cataracts, and the leading cause of irreversible blindness.

To date, to our knowledge, there is no work analyzing the progression of angiographic OCT in patients with glaucoma.

The main aim of this study is to compare the 3-year progression rate of 3 examinations in advanced glaucoma patients: one functional (visual field) and two anatomical (OCTa and OCTrnfl). conditions: Glaucoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: OCT measure: Compare the progression of vascular density (VD) in advanced glaucoma patients. measure: Compare the progression of peripapillary retinal nerve fiber (RNFL) thickness) in advanced glaucoma patients. measure: Compare the progression of visual field in advanced glaucoma patients. measure: CV-OCTrnfl correlation study and CV-OCTa correlation study on measurements made at inclusion and on measurements made during follow-up sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jean-Baptiste Ducloyer city: Nantes zip: 44093 country: France name: Jean-Baptiste Ducloyer, MD role: CONTACT email: jeanbaptiste.ducloyer@chu-nantes.fr lat: 47.21725 lon: -1.55336 hasResults: False

 nctId: NCT06274580 id: 5916 briefTitle: Endovascular vs Conservative Treatment in Patients With Chronic Subdural Hematomas and Mild Symptoms overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2026-03-01 date: 2024-02-23 date: 2024-02-23 name: Ospedale Policlinico San Martino class: OTHER briefSummary: Embotrial-1 is an Italian multicenter prospective randomized clinical trial with open-label treatment and blinded outcome assessment (PROBE) to assess the superiority of MMA embolization compared to conservative treatment. The intervention group is MMA embolization and comparator control group is the conservative management with best medical treatment. Patients are randomized 1:1. conditions: Subdural Hematoma, Chronic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: embolization of the middle meningeal artery measure: Rate of incomplete hematoma resolution or surgical rescue measure: treatment complication measure: treatment successful sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06274567 id: 2024P000348 briefTitle: Intermittent Theta Burst Stimulation (iTBS) for Emotion Regulation in Bipolar Disorder overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2028-08-31 date: 2029-03-31 date: 2024-02-23 date: 2024-02-23 name: Massachusetts General Hospital class: OTHER name: University of Pennsylvania briefSummary: The objective of this study protocol is to test whether intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) to the inferior parietal lobule (IPL) can strengthen functional connectivity with a key region in emotion regulation (ER) neurocircuitry (anterior insula, AI) and improve performance on ER-related tasks in patients with bipolar disorder. Individual IPL sites for stimulation will be identified through baseline, pre-TMS functional magnetic resonance imaging (fMRI) scans. Patient-specific IPL subregions showing positive functional connectivity with the anterior insula and falling within the patient-specific frontoparietal control network will be used as individualized target sites for TMS stimulation. Patients will be randomized to receive 24 sessions of active versus sham iTBS to patient-specific IPL targets (6 sessions/day, 4 days, 43,200 pulses total). Post-iTBS resting-state and task-based fMRI scans will be acquired 3 days after the final day of iTBS administration (Day 4) following identical procedures as baseline. Effects of iTBS-TMS on ER will be evaluated by comparing pre-TMS versus post-TMS functional connectivity and behavior during performance on ER tasks. conditions: Bipolar Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized allocation primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: We will use an active/placebo TMS coil. TMS operator and participant will be blinded to active versus sham. Investigator will be blinded to participant condition assignment. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 136 type: ESTIMATED name: Transcranial Magnetic Stimulation (TMS) name: Sham (placebo) TMS measure: Correlated functional magnetic resonance imaging (fMRI) time series (functional connectivity) measure: Affective Multisource Interference Task measure: Balloon Analogue Risk Task sex: ALL minimumAge: 24 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Martinos Center for Biomedical Imaging city: Charlestown state: Massachusetts zip: 02129 country: United States lat: 42.37787 lon: -71.062 hasResults: False

 nctId: NCT06274554 id: 23-11026746 briefTitle: Testing the Role for Anti-fungal Therapy in Improving the Response to Medicine for Crohn's Disease overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2028-12 date: 2029-12 date: 2024-02-23 date: 2024-02-23 name: Weill Medical College of Cornell University class: OTHER name: The Leona M. and Harry B. Helmsley Charitable Trust briefSummary: The goal of this clinical trial is to learn about the effects of fluconazole in patients who plan to or are undergoing standard of care treatment with an IL-23 therapy for their Crohn's disease.

The main question it aims to assess is will patient response to IL-23 therapies improve when simultaneously treated with fluconazole. conditions: Crohn's Disease conditions: Inflammatory Bowel Diseases studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Double-blinded study whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 120 type: ESTIMATED name: Fluconazole name: Placebo name: IL-23 Therapy measure: Proportion of subjects achieving clinical response measure: Proportion of subjects achieving clinical remission measure: Proportion of patients achieving endoscopic response or remission sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Weill Cornell Medicine city: New York state: New York zip: 10065 country: United States name: Grace Xiang, BS role: CONTACT phone: 646-697-0985 email: grx4001@med.cornell.edu name: Randy Longman, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Dana Lukin, MD, PhD role: SUB_INVESTIGATOR name: Ellen Scherl, MD role: SUB_INVESTIGATOR name: Iliyan Iliev, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06274541 id: CTRIAL-IE 18-01 briefTitle: Upfront Systematic Tumour BRCA Testing in Patients With High Grade Serous or Endometrioid Ovarian, Fallopian Tube or Primary Peritoneal Cancer (HGSEC): The t-BRCA Study overallStatus: ACTIVE_NOT_RECRUITING date: 2019-03-22 date: 2025-11 date: 2025-11 date: 2024-02-23 date: 2024-02-23 name: Cancer Trials Ireland class: NETWORK briefSummary: A pilot study to evaluate the feasibility of a NGS-based tumour BRCA1/2 mutation testing pathway initiated in the oncology clinic for patients with HGSEC, either at primary diagnosis or first relapse, whereby only patients with a positive germline BRCA1/2 mutation test will be referred to clinical genetics. conditions: Serous Ovarian Tumor conditions: Endometrioid Carcinoma Ovary conditions: Fallopian Tube Cancer conditions: Primary Peritoneal Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ACTUAL name: Somatic and Germline BRCA1/2 Testing measure: Feasibility of an upfront BRCA1/2 mutation testing pathway in HGSEC in terms of clinicians' experience. measure: Feasibility of an upfront BRCA1/2 mutation testing pathway in HGSEC in terms of patients' experience. measure: The impact on patient management by determining changes in patient treatment (use of a PARP inhibitor or enrolment in BRCA-targeted clinical trials). measure: The impact on patient management by use of clinical genetics counselling sessions. measure: The economic impact of implementing an upfront tumour BRCA1/2 mutation testing pathway in the oncology clinic for HGSEC on the Irish healthcare system, using a health economic analysis (decision analysis model) measure: The proportion of germline and somatic BRCA1 and BRCA2 mutations among patients with HGSEC in Ireland measure: Patient and disease characteristics (age, stage, degree of surgical cytoreduction, platinum sensitivity) associated with BRCA1/2 mutated HGSEC compared to BRCA1/2 wild type disease. measure: Differences in treatment patterns between BRCA1/2 mutated and BRCA1/2 wild type HGSEC by examining number of systemic therapies used. measure: Differences in treatment patterns between BRCA1/2 mutated and BRCA1/2 wild type HGSEC by examining use of PARP inhibitor therapy. measure: Differences in treatment patterns between BRCA1/2 mutated and BRCA1/2 wild type HGSEC by examining enrolment in clinical trials measure: Identification of clinical outcomes (response platinum free interval (PFI)) associated with BRCA1/2-mutated HGSEC, as compared to BRCA1/2 wild type disease. measure: Identification of clinical outcomes (progression free survival (PFS)) associated with BRCA1/2-mutated HGSEC, as compared to BRCA1/2 wild type disease. measure: Identification of clinical outcomes (overall survival (OS)) associated with BRCA1/2-mutated HGSEC, as compared to BRCA1/2 wild type disease. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mater Misericordiae University Hospital / Mater Private Hospital city: Dublin state: Leinster country: Ireland lat: 53.33306 lon: -6.24889 facility: St James's Hospital city: Dublin state: Leinster country: Ireland lat: 53.33306 lon: -6.24889 facility: Bon Secours city: Cork state: Munster country: Ireland lat: 51.89797 lon: -8.47061 facility: Cork University Hospital city: Cork state: Munster country: Ireland lat: 51.89797 lon: -8.47061 facility: University Hospital Limerick city: Limerick state: Munster country: Ireland lat: 52.66472 lon: -8.62306 hasResults: False

 nctId: NCT06274528 id: 202301150 briefTitle: DORA and LP in Alzheimer's Disease Biomarkers overallStatus: RECRUITING date: 2024-03-11 date: 2029-03-11 date: 2029-03-11 date: 2024-02-23 date: 2024-03-29 name: Washington University School of Medicine class: OTHER briefSummary: The purpose of this study is to see if the sleep aid, lemborexant, can decrease the amount of amyloid-beta and tau in the fluid around the brain known as cerebrospinal fluid (CSF). Amyloid-beta and tau are proteins involved in the disease process leading to Alzheimer's disease. conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Pharmacist whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 201 type: ESTIMATED name: Lemborexant 10 mg name: Lemborexant 20mg name: Placebo measure: Changes CSF pT181/T181 ratio of lemborexant 10 and 20 mg compared to Placebo measure: Number of participants with treatment-related adverse events measure: Measure the blood concentration of lemborexant 10 mg and 20 mg and determine the dose-response relationship with CSF pT181/T181 measure: Measure changes on blood plasma amyloid-beta isoforms (Aβ38, Aβ40, Aβ42) measure: Measure changes of CSF amyloid beta isoforms (Aβ38, Aβ40, Aβ42) measure: Measure changes of blood plasma p-tau/tau forms (T181, pT181, S202, pS202, pS202/S202, T217, pT217, pT217/T217). measure: Measure changes of cerebrospinal fluid p-tau/tau forms (T181, pT181, S202, pS202, pS202/S202, T217, pT217, pT217/T217). measure: Measure changes of cerebrospinal TREM2 (exploratory) measure: Measure changes of cerebrospinal NPTX2 (exploratory) measure: Measure changes of cerebrospinal NfL (exploratory) measure: Measure changes of blood plasma NfL (exploratory) sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Washington University in St. Louis, School of Medicine status: RECRUITING city: Saint Louis state: Missouri zip: 63110 country: United States name: Cristina Toedebusch, BS role: CONTACT phone: 314-747-0646 email: toedebuschc@wustl.edu name: Chloe Meehan, BS, MA role: CONTACT phone: 314-273-0878 email: cmeehan@wustl.edu name: Brendan P. Lucey, M.D. role: PRINCIPAL_INVESTIGATOR name: J. Philip Miller, Ph.D. role: SUB_INVESTIGATOR name: Jason Hassenstab, Ph.D. role: SUB_INVESTIGATOR name: David Carr, M.D. role: SUB_INVESTIGATOR lat: 38.62727 lon: -90.19789 hasResults: False

 nctId: NCT06274515 id: WO44977 briefTitle: A Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies acronym: REMERGE overallStatus: RECRUITING date: 2024-04-02 date: 2027-01-28 date: 2027-01-28 date: 2024-02-23 date: 2024-04-08 name: Hoffmann-La Roche class: INDUSTRY briefSummary: This study will evaluate mechanisms of resistance to anti-breast cancer therapies in tumor and blood samples from participants with human epidermal growth factor receptor (HER2) positive, hormone receptor (HR) positive or triple negative breast cancer. conditions: Breast Cancer studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 320 type: ESTIMATED name: Tumor Tissue and Blood Draw measure: Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohorts H1 and H2) measure: Changes from baseline in HER2 gene copy number measured at the time of disease progression/recurrence (Cohorts H1 and H2) measure: Changes from baseline in estrogen receptor (ER) protein levels measured at the time of disease progression/recurrence (Cohorts H1 and H2) measure: Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohort H3) measure: Changes from baseline in HER2 gene copy number measured at the time of disease progression/recurrence (Cohort H3) measure: Changes from baseline in ER protein levels measured at the time of disease progression/recurrence (Cohort H3) measure: Changes from baseline in genes related to CDK4/6 resistance (incl. cell cycle alterations and tyrosine kinase receptors, Cohort R1) measure: Changes from baseline in genes related to endocrine resistance (incl. cell cycle alterations and tyrosine kinase receptors, Cohort R1) measure: Changes from baseline in tumor immune microenvironment (PD-L1 and TILs, Cohort T1) measure: Changes from baseline in immune phenotype (PD-L1 and TILs, Cohort T1) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: KEM/Evang. Kliniken Essen Mitte gGmbH; Klinik für Internistische Onkologie / Hämatologie status: RECRUITING city: Essen zip: 45136 country: Germany lat: 51.45657 lon: 7.01228 facility: I.R.S.T Srl IRCCS; Oncologia Medica status: RECRUITING city: Meldola state: Emilia-Romagna zip: 47014 country: Italy lat: 44.12775 lon: 12.0626 facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS status: RECRUITING city: Rome state: Lazio zip: 00168 country: Italy lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06274502 id: deep learning briefTitle: Automated Detection and Diagnosis of Pathological DRGs in PHN Patients Using Deep Learning and Magnetic Resonance overallStatus: COMPLETED date: 2023-10-01 date: 2024-01-31 date: 2024-01-31 date: 2024-02-23 date: 2024-03-06 name: Huazhong University of Science and Technology class: OTHER briefSummary: Here, this study aimed to develop an automated system for detecting and diagnosing lesion DRGs in PHN patients based on deep learning. This study retrospectively analyzed the DRG images of all patients with postherpetic neuralgia who underwent magnetic resonance neuroimaging examinations in our radiology department from January 2021 to February 2022. After image post-processing, the You Only Look Once (YOLO) version 8 was selected as the target algorithm model. Model performance was evaluated using metrics such as precision, recall, Average Precision, mean average precision and F1 score. conditions: Deep Learning studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 41 type: ACTUAL name: YOLOv8 measure: Develop an automated system for detecting and diagnosing lesion DRGs in PHN patients based on deep learning sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430030 country: China lat: 30.58333 lon: 114.26667 facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology city: Wuhan country: China lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06274489 id: GSN000500 briefTitle: A Study to Evaluate Setanaxib in Patients With Alport Syndrome overallStatus: RECRUITING date: 2023-11-27 date: 2025-01-27 date: 2025-01-27 date: 2024-02-23 date: 2024-04-05 name: Calliditas Therapeutics AB class: INDUSTRY briefSummary: The purpose of the study is to learn about the safety and tolerability of setanaxib in subjects with Alport syndrome, when added to their standard of care treatment. The study will assess how safe setanaxib is when compared to placebo. Study participants will be asked if they are experiencing any side effects at each study visit. In addition, tests in blood, urine and other examinations will be used to look at the safety of setanaxib. The study will also measure how well setanaxib works in comparison to a placebo, by measuring urine protein and certain markers in the blood and urine. The concentration of setanaxib in the blood will also be measured throughout the course of the study.

Setanaxib is planned for use together with the current standard of care to hopefully provide additional therapeutic benefits by preserving kidney function.

The study will be conducted at multiple research sites in the UK, Spain, and Czech Republic. Eligible participants will be randomly assigned to receive either setanaxib or placebo. Setanaxib dose level will depend on age and all participants will receive their standard of care in addition to setanaxib or placebo. The study consists of a Screening period of up to 4 weeks, a 24-week Treatment period and a 4- week Follow-up period. conditions: Alport Syndrome studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 18 type: ESTIMATED name: Setanaxib name: Placebo measure: Percentage of patients with Serious Adverse Events (SAEs) measure: Percentage of patients with treatment-emergent Adverse Events of Special Interest (AESIs) measure: The ratio of urine protein to creatinine ratio (UPCR) analysed in 24-hour urine sample measure: Percentage of patients with a 25% reduction in UPCR analysed in 24-hour urine sample measure: Pre-dose and post-dose plasma concentrations of setanaxib and GKT138184 measured as the area under the concentration-time curve over 24 hours at steady state (AUC0-24-ss) measure: Pre-dose and post-dose plasma concentrations of setanaxib and GKT138184 measured as the minimum plasma concentration at steady state (Cmin-ss) measure: Pre-dose and post-dose plasma concentrations of setanaxib and GKT138184 measured as the maximum plasma concentration at steady state (Cmax-ss) measure: Percentage of patients with clinically significant changes in heart rate measure: Percentage of patients with clinically significant changes blood pressure measure: Percentage of patients with clinically significant changes in 12-lead electrocardiogram (ECG) measure: Percentage of patients with clinically significant changes in physical examination measure: Percentage of patients with clinically significant changes in hematology, serum chemistry, urinalysis, and thyroid function measure: Percentage of patients with clinically significant changes in hearing audiometric testing (bone- and air-conduction) sex: ALL minimumAge: 12 Years maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: Fakultni Nemocnice Hradec Kralove status: RECRUITING city: Hradec Králové country: Czechia name: Roman Safranek role: CONTACT lat: 50.20923 lon: 15.83277 facility: Fakultni Nemocnice Olomouc status: RECRUITING city: Olomouc country: Czechia name: Karel Krejci role: CONTACT lat: 49.59552 lon: 17.25175 facility: Institut Klinicke a Experimentalni Mediciny status: RECRUITING city: Praha country: Czechia name: Ondrej Viklicky role: CONTACT lat: 50.08804 lon: 14.42076 facility: Vseobecna Fakultni Nemocnice v Praze status: RECRUITING city: Praha country: Czechia name: Vladimir Tesar role: CONTACT lat: 50.08804 lon: 14.42076 facility: Hospital Clinic Barcelona status: RECRUITING city: Barcelona state: L'eixample zip: 08036 country: Spain name: Marc Xipell Font role: CONTACT lat: 41.38879 lon: 2.15899 facility: Hospital Universitario 12 de Octubre status: RECRUITING city: Madrid state: Usera zip: 28041 country: Spain name: Enrique Morales role: CONTACT lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Vall d'Hebron status: RECRUITING city: Barcelona country: Spain name: Irene Agraz Pamplona role: CONTACT lat: 41.38879 lon: 2.15899 facility: Hospital Universitario Reina Sofia status: RECRUITING city: Córdoba zip: 14004 country: Spain name: Cristina Rabasco role: CONTACT lat: 37.89155 lon: -4.77275 facility: Hospital Universitario Virgen de las Nieves status: RECRUITING city: Granada zip: 18014 country: Spain name: Rafael Jose Esteban de la Rosa role: CONTACT lat: 37.18817 lon: -3.60667 facility: Royal Free London NHS Foundation Trust status: RECRUITING city: London zip: NW3 2QG country: United Kingdom name: Daniel Gale role: CONTACT lat: 51.50853 lon: -0.12574 facility: Great Ormond Street Hospital for Children status: NOT_YET_RECRUITING city: London zip: WC1N 3JH country: United Kingdom name: Zainab Arslan role: CONTACT lat: 51.50853 lon: -0.12574 facility: Royal Manchester Children's Hospital status: RECRUITING city: Manchester zip: M13 9WL country: United Kingdom name: Rachel Lennon role: CONTACT lat: 53.48095 lon: -2.23743 facility: Nottingham City Hospital status: RECRUITING city: Nottingham country: United Kingdom name: Matthew Hall role: CONTACT lat: 52.9536 lon: -1.15047 hasResults: False

 nctId: NCT06274476 id: 2020/9/9 briefTitle: Prosthetic Rehabilitation of Thin Wiry Ridge by Ridge Splitting and Simultaneous Implants Placement acronym: implant overallStatus: COMPLETED date: 2018-09-09 date: 2019-12-09 date: 2020-01-01 date: 2024-02-23 date: 2024-02-23 name: Cairo University class: OTHER briefSummary: evaluates the success of prosthetic rehabilitation of thin wiry ridge and implants placed simultaneously in splitted ridge both clinically and radiographically. conditions: Atrophic Maxillary Ridge and Mandibular Ridge studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: maxillary and mandibular atrophic ridge primaryPurpose: OTHER masking: DOUBLE maskingDescription: double whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 21 type: ACTUAL name: implant placement measure: implant success sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Mohamed yahia Sharaf city: Zagazig state: Sharkia zip: 44715 country: Egypt lat: 30.58768 lon: 31.502 hasResults: False

 nctId: NCT06274463 id: 2023-11-035 briefTitle: A Personalized Trunk Stability Exercise Program Study With Brain Disease Patients overallStatus: NOT_YET_RECRUITING date: 2024-02-21 date: 2024-12-31 date: 2024-12-31 date: 2024-02-23 date: 2024-02-23 name: Bundang CHA Hospital class: OTHER briefSummary: To investigate the effect on improving trunk stability and satisfaction with the program when a customized trunk stabilization exercise program personalized to the subject's functional level is applied to patients with brain disease. conditions: Brain Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Exercise therapy including a trunk stabilization exercise program measure: Trunk Impairment Scale measure: Berg Balance Scale measure: Joint angle measure: Joint moment measure: Joint power sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06274450 id: C2202112 briefTitle: A Clinical Study on the Improvement of Skin and Living Conditions After Drinking Rosa Roxburghii and Pomegranate Drinks overallStatus: COMPLETED date: 2022-07-06 date: 2022-09-02 date: 2022-09-02 date: 2024-02-23 date: 2024-02-23 name: Botanee Group Co., Ltd. class: INDUSTRY briefSummary: The main objective of the study is to observe changes in the subjects' skin condition and life status after 8 weeks of drinking rosa roxburghii and pomegranate drinks.

This is a single-center, randomized, single-blind, controlled, 8-week (56-day) clinical study conducted in Chinese healthy women aged 25-45 years old who were offered a rosa roxburghii and pomegranate drink. conditions: Skin Laxity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 70 type: ACTUAL name: skin care product name: Drinks with active ingredients Rosa Roxburghii and Pomegranate measure: Changes in the skin hydration measure: Changes in the skin glossiness measure: Changes in the skin firmness measure: Changes in the skin elasticity measure: Changes in the individual type angle measure: Changes in the melanin content measure: Changes in the proportion of crow's feet area measure: Changes in the proportion of fine lines under the eye measure: Changes in the CIE RGB of skin tone measure: Changes in the grade of Pigmentation measure: Skin condition Assessment after 4-week application measure: Skin condition Assessment after 8-week application measure: Changes in the satisfaction with the quality of life sex: FEMALE minimumAge: 25 Years maximumAge: 45 Years stdAges: ADULT facility: Shanghai China-norm Quality Technical Service Co ，Ltd city: Shanghai state: Shanghai zip: 200072 country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06274437 id: BND-35-001 briefTitle: A Study of BND-35 in Participants With Advanced Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-09 date: 2027-11 date: 2024-02-23 date: 2024-02-23 name: Biond Biologics class: INDUSTRY briefSummary: This is an open-label, multicenter, dose escalation and dose optimization study designed to evaluate safety, tolerability and preliminary anti-tumor activity of BND-35 administered alone and in combination with nivolumab or with cetuximab. The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy. The study will be comprised of two parts - a dose escalation phase (Part 1) and a dose optimization (Part 2). Part 1 is comprised of three sub-parts: BND-35 administered alone (Sub-Part 1A), BND-35 administered in combination with nivolumab (Sub-Part 1B), and BND-35 administered in combination with cetuximab (Sub-Part 1C). Part 2 is composed of two sub-parts: a dose optimization part where up to two doses of BND-35 per indication are administered in combination with nivolumab or with cetuximab. conditions: Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 280 type: ESTIMATED name: BND-35 name: Nivolumab name: Cetuximab measure: Part 1: Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) measure: Part 1: Proportion of patients who discontinued study treatment due to TEAEs measure: Part 1: Incidence of TEAEs dose limiting toxicities (DLT) measure: Part 2: Objective Response Rate (ORR) per RECIST v1.1 measure: Part 2: Incidence of TEAEs and SAEs measure: Part 1: Objective Response Rate (ORR) per RECIST v1.1 measure: Part 1: Maximum observed plasma concentration (Cmax) measure: Part 1: Serum concentration at the end of the dosing interval (Ctrough) measure: Part 1: Time of maximum observed serum concentration (Tmax) measure: Part 1: Terminal elimination half-life (T1/2) measure: Part 1: Area under the plasma concentration-time curve (AUC) measure: Part 1: Incidence of anti-drug antibodies (ADA) measure: Part 2: Progression Free Survival (PFS) measure: Part 2: PFS rate measure: Part 2: Duration of Response measure: Part 2: Maximum observed plasma concentration (Cmax) measure: Part 2: Serum concentration at the end of the dosing interval (Ctrough) measure: Part 2: Time of maximum observed serum concentration (Tmax) measure: Part 2: Terminal elimination half-life (T1/2) measure: Part 2: Area under the plasma concentration-time curve (AUC) measure: Part 2: Incidence of anti-drug antibodies (ADA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rambam Health Care Campus city: Haifa zip: 3109601 country: Israel name: Ruth Perets role: CONTACT role: CONTACT phone: +97247776234 email: ru_perets@rambam.health.gov.il lat: 32.81841 lon: 34.9885 facility: Hadassah University Medical Center city: Jerusalem zip: 91120 country: Israel name: Jonathan Cohen role: CONTACT role: CONTACT phone: +97226776781 email: cohenjon@hadassah.org.il lat: 31.76904 lon: 35.21633 facility: Rabin Medical Center city: Petah Tikva zip: 49100 country: Israel name: Solomon Shtemer role: CONTACT role: CONTACT phone: +97239378110 email: shtemers@clalit.org.il lat: 32.08707 lon: 34.88747 facility: Sheba Medical Center city: Ramat Gan zip: 52621 country: Israel name: Gal Strauss role: CONTACT phone: +97235304498 email: gal.strauss@sheba.health.gov.il lat: 32.08227 lon: 34.81065 facility: Tel Aviv Sourasky Medical Center city: Tel Aviv zip: 6423906 country: Israel name: Ravit Geva role: CONTACT phone: +97236973193 email: ravitg@tlvmc.gov.il lat: 32.08088 lon: 34.78057 hasResults: False

 nctId: NCT06274424 id: HUS/211/2016 and HUS/2699/2018 briefTitle: Hair Cortisol and Symptoms in Children With Psychopathology During CBT overallStatus: COMPLETED date: 2016-07-01 date: 2019-10-01 date: 2019-10-01 date: 2024-02-23 date: 2024-02-29 name: Helsinki University Central Hospital class: OTHER briefSummary: This study aims to examine the relationship between hair cortisol concentration and behavior and sleep disturbance symptoms in children with psychiatric disorders. It also investigates potential changes in hair cortisol and symptomatology after group-based cognitive behavior therapy. Furthermore, the study explores the effects of any alterations in hair cortisol concentration levels on potential behavior and sleep disturbance symptom change over the course of the study. conditions: Child Behavior Problem studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ACTUAL name: The Friends Program measure: Hair Cortisol Concentration measure: Parent- and teacher rated internalizing and externalizing symptoms measure: Child-rated internalizing symptoms measure: Parent-rated sleep disturbance symptoms sex: ALL minimumAge: 6 Years maximumAge: 13 Years stdAges: CHILD hasResults: False

 nctId: NCT06274411 id: KS2024014 briefTitle: Standby Cannulated ECMO for High-Risk Percutaneous Coronary Intervention acronym: ESCORT overallStatus: RECRUITING date: 2024-03-01 date: 2025-12-31 date: 2026-03-01 date: 2024-02-23 date: 2024-02-23 name: Beijing Anzhen Hospital class: OTHER briefSummary: The goal of this multicenter, randomized trial is to compare standby cannulated ECMO versus prophylactic ECMO in patients undergoing high-risk percutaneous coronary intervention (PCI). The main question it aims to answer is :

• If standby cannulated ECMO as compared with prophylactic ECMO will improve the outcomes in patients undergoing high-risk PCI conditions: ECMO conditions: High-risk PCI studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 176 type: ESTIMATED name: Standby cannulated ECMO name: Prophylactic ECMO measure: Composite rate of 8 major adverse events measure: Platelet drop measure: Duration of ECMO support measure: Length of hospital stay measure: Hemoglobin drop measure: Serum interleukin-6 concentration sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Anzhen Hospital status: RECRUITING city: Beijing state: Beijing zip: 100029 country: China name: Liangshan Wang, MD role: CONTACT phone: 86-13811363372 email: wangliangshanbam@sina.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06274398 id: RITE Study briefTitle: Rectal Insert TAF/EVG Pre-Exposure Prophylaxis (RITE PrEP) Study acronym: RITE PrEP overallStatus: RECRUITING date: 2024-01-16 date: 2024-10-31 date: 2024-12-31 date: 2024-02-23 date: 2024-02-23 name: Eastern Virginia Medical School class: OTHER name: CONRAD name: Emory University name: Centers for Disease Control and Prevention briefSummary: This is a double-blind, placebo-controlled, randomized two-phase study to evaluate the safety and pharmacokinetics (PK) of two TAF/EVG inserts administered rectally for 3 consecutive days, then every other day for 14 days. conditions: Safety Issues studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, Placebo-controlled, Double-blind primaryPurpose: OTHER masking: QUADRUPLE maskingDescription: Double-blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: TAF/EVG rectal insert name: Matching placebo rectal insert measure: Frequency and intensity of Adverse Events measure: Pharmacokinetics (PK) (maximum concentration (Cmax)) in blood measure: PK (Cmax) in rectal secretions measure: PK (Cmax) in rectal mucosal tissue measure: PK (Cmax) in cervicovaginal secretions measure: PK (Cmax) in cerviocovaginal mucosal tissues measure: Cytokine Profiles measure: Microbiome Profiles sex: ALL minimumAge: 18 Years maximumAge: 59 Years stdAges: ADULT facility: Emory Clinic status: RECRUITING city: Atlanta state: Georgia zip: 30322 country: United States name: Cassie Grimsley Ackerley, MD, MSc role: CONTACT email: cassie.marie.grimsley.ackerley@emory.edu lat: 33.749 lon: -84.38798 hasResults: False

 nctId: NCT06274385 id: 2311010178 briefTitle: The Effects of an Acute Dose of a Betalain-rich Concentrate on Repeated-sprint Cycling Performance and Recovery. acronym: BET_RSE overallStatus: RECRUITING date: 2024-02 date: 2024-06 date: 2024-06 date: 2024-02-23 date: 2024-02-23 name: Drexel University class: OTHER briefSummary: Betalains have well-known antioxidant and anti-inflammatory properties. Recent investigations examining the effects of a betalain-rich concentrate (BRC) on exercise and recovery performance show promise of BRC as an ergogenic aid. To date, no study has examined the effects of a single dose of a BRC on supramaximal performance and recovery. Therefore, the purpose of this study is to examine the effects of an acute dose of BRC on repeated-sprint cycling performance and recovery. conditions: Nutraceuticals studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 10 type: ESTIMATED name: Betalain-rich concentrate (AltRed) name: Placebo measure: Repeated Sprint Performance measure: Neuromuscular Fatigue sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Drexel University - Health Sciences Building status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19102 country: United States name: Arun Ramakrishnan, PhD role: CONTACT phone: 215-553-7018 email: ar88@drexel.edu lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06274372 id: FCV,V-2202 briefTitle: The Effect of Flow-controlled Ventilation on Hemodynamic and Respiratory Parameters in Laparoscopic Surgeries overallStatus: ACTIVE_NOT_RECRUITING date: 2023-08-07 date: 2024-08-06 date: 2024-08-06 date: 2024-02-23 date: 2024-03-06 name: Derince Training and Research Hospital class: OTHER briefSummary: It is aimed to investigate the effect of flow controlled ventilation on intraoperative respiratory parameters and hemodynamic parameters in laparoscopic operations. conditions: Laparoscopic Surgeries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: flow controlled ventilation name: volume controlled ventilation measure: effects of flow controlled ventilation on heamodynamic parameters measure: effectcs of flow controlled ventiletion on respiratory parameters measure: effects of flow controlled ventilation on heamodynamic parameters measure: effects of flow controlled ventilation on heamodynamic parameters measure: effectcs of flow controlled ventiletion on respiratory parameters measure: respiratory related complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kocaeli Derince Training and Research Hospital city: Derince state: Kocaeli zip: 41900 country: Turkey hasResults: False

 nctId: NCT06274359 id: 21-3985 briefTitle: Digital Storytelling to Reduce Pediatric Influenza Vaccination Disparities overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-03-31 date: 2027-08-31 date: 2024-02-23 date: 2024-02-23 name: Denver Health and Hospital Authority class: OTHER briefSummary: While the COVID-19 pandemic has highlighted health disparities, Black children have unduly suffered and died from seasonal influenza for decades. Through sustained partnership with Black community stakeholders, novel community-engaged research methods, and an innovative intervention approach, this proposal will explore, develop, and test a Digital Storytelling intervention to reduce influenza vaccination disparities in Black children aged 6 months to 5 years. This project will advance our understanding of engagement methods and interventions that improve health equity and serve as a model for future work to address vaccination disparities, ensuring all individuals have the chance to fulfill their potential free of preventable diseases. conditions: Influenza studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Caregivers will be assigned randomly to receive a series of digital stories by text message or to receive usual care. primaryPurpose: PREVENTION masking: SINGLE whoMasked: INVESTIGATOR count: 200 type: ESTIMATED name: Digital storytelling measure: Child influenza vaccination status at influenza season's end (defined as March 31, 2025 for season 1 and March 31, 2026 for season 2 if a 2nd season of recruitment is necessary) measure: Intervention Feasibility measure: Intervention Acceptability measure: Intervention Appropriateness sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Denver Health Eastside Clinic city: Denver state: Colorado zip: 80205 country: United States lat: 39.73915 lon: -104.9847 facility: Denver Health Park Hill Clinic city: Denver state: Colorado zip: 80207 country: United States lat: 39.73915 lon: -104.9847 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-01-26 uploadDate: 2024-01-30T11:52 filename: ICF_000.pdf size: 298169 hasResults: False

 nctId: NCT06274346 id: ahmedU briefTitle: Effect of Retro Walking Versus Isometric Multi-angular Exercises on Pain and Functional Performance in Knee Osteoarthritis in Geriatric Population overallStatus: COMPLETED date: 2023-06-01 date: 2023-11-10 date: 2023-11-30 date: 2024-02-23 date: 2024-02-23 name: Delta University for Science and Technology class: OTHER briefSummary: Osteoarthritis is a leading musculoskeletal cause of disability in elderly persons all over the world and a major cause of physical limitations and reduced quality of life (1). Its onset is around 40 years of age and it is estimated that over 80% of people over 55 have evidence of radiographic changes in the knee due to osteoarthritis. It has been estimated that the incidence has increased by the increase in life expectancy and it has been identified as a frequent cause for health services demand in patients over 65(2).

The common clinical manifestations of knee OA include pain, stiffness, joint enlargement, crepitus, muscle weakness, deformity, impaired proprioception, reduced joint motion, and disability(3).

Patients with knee Osteoarthritis seems to develop their own gait pattern and try to unload the affected structures during gait. More over patients with less severe knee osteoarthritis develop a gait pattern that differs from patients with severe osteoarthritis and control group of patients (4).

Isometric exercises are types of strength training in which the joint angle and muscle length do not change during contraction, and therefore this approach can be advantageous in the early stages of knee rehabilitation in cases where the range of motion is restricted due to pain (13). No physical work is performed during isometric exercise. Intensity and duration combination reflects the energy consumption of an isometric contraction (14). In addition, muscle strength increases in isometric exercise are specific to the angle applied. It was also concluded that isometric exercise performed at different angles should be especially considered as an alternative strength training since it induces the most noticeable and fastest increase in muscle moment (15). A study was conducted to investigate the effects of isometric quadriceps exercise on muscle strength, pain, and function in knee osteoarthritis, it was concluded that isometric quadriceps exercise program showed beneficial effects on quadriceps muscle strength, pain, and functional disability in patients with osteoarthritis of the knee (16).

Another study was conducted to assess the effectiveness of Isometric exercise and counseling on level of pain among patients with Knee osteoarthritis, the authors concluded that Isometric exercise and counseling program has significantly reduced pain, stiffness and improved physical function and the authors recommended that Isometric exercise and counselling should be adopted as a routine care in the hospitals treating patients with knee osteoarthritis (17) Thus, we hypothesized that a less intensive walking program such as retro walking program could provide an additional benefit more than those experienced by forward walking program in the previous studies. Therefore, the primary aim of the present study was to compare the effect of retro walking versus isometric multiangular exercises group on knee pain and function in geriatric people.

Materials and Methods

This randomized controlled experimental trial was carried out at the outpatient clinic of faculty of physical therapy, Delta University for science and technology from June 2023 to November 2023. The aims of the study and the study protocol were explained for each patient before participation in the study. All patients signed an approved informed consent form for participation in this study. Before starting the treatment program, a complete history and physical examination will be taken for all patients.

Subjects:

Sixty male and female geriatric patients had chronic knee osteoarthritis were chosen the outpatient clinic of faculty of physical therapy, Delta University for science and technology. In each case, the diagnosis of knee OA was based on the criteria specified by the American College of Rheumatology.

We recorded the height, weight, and medical history, and lower extremity dominance, level of education, occupation and duration of complaints of each patient. All were evaluated at the beginning of the treatment (week 0), at the endpoint of the treatment (week 4) conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients were randomly assigned into two groups through computer software. We put sixty patients on the software program and the program assigned them randomly. s exercise, straight leg raise, prone knee bending, side lying hip abduction, prone hip extension with 5 seconds hold and a rest interval of 2 seconds for 10 repetitions for each exercise for a period of 4 weeks, 3 days per week was given. Second group was treated by retrowalking exercises in addition to physical therapy interventions including short wave diathermy and strengthening exercise such as static quadriceps exercise, dynamic quadriceps exercise, straight leg raise, prone knee bending, side lying hip abduction, prone hip extension with 5 seconds hold and a rest interval of 2 seconds for 10 repetitions for each exercise for a period of 4 weeks, 3 days per week was given., which were given 3 times/week for 4 consecutive weeks. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Sixty male and female geriatric patients had chronic knee osteoarthritis were chosen the outpatient clinic of faculty of physical therapy, Delta University for science and technology. education, occupation and duration of complaints of each patient. All were evaluated at the beginning of the treatment (week 0), at the endpoint of the treatment (week 4). whoMasked: PARTICIPANT count: 60 type: ACTUAL name: Multiangular Isometric exercise measure: Pain intensity measure: Functional assessment: sex: ALL minimumAge: 60 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Delta University For Science and Technology city: Gamasa state: Almansourah zip: 38733 country: Egypt lat: 31.44112 lon: 31.53675 hasResults: False

 nctId: NCT06274333 id: RC.18.1.2024 briefTitle: Adding Dexmedetomidine or Tramadol to Paracetamol- An Effort to Attenuate Catheter Related Bladder Discomfort overallStatus: RECRUITING date: 2024-02-28 date: 2024-05-30 date: 2024-05-30 date: 2024-02-23 date: 2024-03-15 name: Al-Azhar University class: OTHER name: Benha University briefSummary: The insertion of a urinary catheter in a patient undergoing a surgical procedure, especially urinary interventions, may lead to catheter-related bladder discomfort (CRBD) with varying degrees of severity during the postoperative period. Paracetamol is a drug with proven efficacy for the management of mild and moderate postoperative pain. Tramadol is a centrally acting, synthetic opioid analgesic with weak opioid agonist properties. It inhibits the detrusor activity by inhibition of type-1 muscarinic (M1) and type-3 muscarinic (M3) receptors. Dexmedetomidine, a highly selective α2-adrenergic receptor agonist, with analgesic, sedative, anxiolysis, sympatholytic, and sedative properties, is a very useful associated agent for general anesthesia. conditions: Percutaneous Nephrolithotripsy (PCNL) studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Dexmedetomidine 0.5 mic/kg name: Tramadol 1mg/kg name: Paracetamol 10mg/kg measure: The incidence of catheter-related bladder discomfort (CRBD) measure: Postoperative pain measure: Meperidine requirement measure: Patient satisfaction measure: Surgeon satisfaction sex: MALE minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: Neveen Kohaf status: RECRUITING city: Cairo zip: 11865 country: Egypt name: Neveen Kohaf, Ph.D role: CONTACT phone: +201069482380 email: nevenabdo@azhar.edu.eg name: Hany Bauiomy, M.D role: PRINCIPAL_INVESTIGATOR name: Ahmed M. Abosakaya, M.D role: PRINCIPAL_INVESTIGATOR lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06274320 id: LRP22002 LIPIKAR UREA 30% briefTitle: Effect of Lipikar Urea 30% Before Actinic Keratoses Treatment overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10 date: 2024-10 date: 2024-02-23 date: 2024-02-28 name: Cosmetique Active International class: INDUSTRY briefSummary: This study is conducted in one center in Germany, in adult subjects having actinic keratoses (grade I or II) lesions on the scalp and meeting specific inclusion/exclusion criteria. The purpose of the study is to evaluate a holistic management (efficacy, tolerability and lesion cosmetic outcomes) of Tolak® treatment. conditions: Actinic Keratoses studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Group A: holistic approach name: Group B: Tolak® Standard of use measure: Change in lesion response rate measure: Percentage change sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CentroDerm GmbH city: Wuppertal country: Germany lat: 51.27027 lon: 7.16755 hasResults: False

 nctId: NCT06274307 id: IRB-21-10-4045 briefTitle: Efficacy of Transversus Abdominis Plane Block overallStatus: RECRUITING date: 2023-06-22 date: 2024-07-01 date: 2024-09-01 date: 2024-02-23 date: 2024-02-23 name: Justin Hruska class: OTHER briefSummary: This study aims to assess the efficacy of Transversus Abdominus Plane (TAP) blocks, a well-established anesthetic technique, to decrease the amount of post-operative pain in patients who undergo minimally invasive gynecologic surgeries. During minimally invasive gynecologic surgeries, the abdomen is inflated with pressurized air for visualization purposes and released at the end of the surgery. Traditionally, TAP blocks are performed by injecting long-acting local anesthetic agents under ultrasound guidance into the abdominal wall after abdominal surgery after the air has been emptied from the abdomen for additional anesthetic coverage post-operatively. This study proposes a novel approach: that performing TAP blocks while the abdomen is still insufflated will result in better post-operative pain outcomes as compared to the traditional method. conditions: Anesthesia, Local studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The treatment group (Group 1) will have a transversus abdominis plane (TAP) block performed with an insufflated abdomen in the operating room. The control group (Group 2) will receive the traditionally performed standard of care TAP block performed in the post-anesthesia care unit primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The patient will be unaware of their grouping allotment. The outcomes assessor will be unaware of the patient grouping allotment. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Transversus abdominis plane block measure: Time to perform TAP Block measure: TAP block attempts measure: Pain Score Visual Analog Scale (VAS) 0 Hours Post Surgery measure: Pain Score Visual Analog Scale (VAS) 1 Hours Post Surgery measure: Pain Score Visual Analog Scale (VAS) 2 Hours Post Surgery measure: Pain Score Visual Analog Scale (VAS) 4 Hours Post Surgery measure: Pain Score Visual Analog Scale (VAS) 24 Hours Post Surgery measure: Postoperative Opioid Consumption measure: Ease of performing TAP Block-anatomical plane visualization measure: Ease of performing TAP Block-performance efficacy measure: Patient satisfaction sex: FEMALE minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Detroit Medical Center Detroit Receiving Hospital status: RECRUITING city: Detroit state: Michigan zip: 48201 country: United States name: George M McKelvey, PhD role: CONTACT phone: 313-598-6036 email: gmckelve@dmc.org name: Justin Hruska, M.D. role: PRINCIPAL_INVESTIGATOR lat: 42.33143 lon: -83.04575 facility: Detroit Medical Center, Harper University Hospital status: RECRUITING city: Detroit state: Michigan zip: 48201 country: United States name: George M McKelvey, PhD role: CONTACT phone: 313-598-6036 email: gmckelve@dmc.org name: Justin Hruska, MD role: PRINCIPAL_INVESTIGATOR lat: 42.33143 lon: -83.04575 hasResults: False

 nctId: NCT06274294 id: 2023/12 briefTitle: Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous as Induction Therapy in Patients With Active CD or UC acronym: PASSPORT overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-01 date: 2025-01 date: 2024-02-23 date: 2024-02-23 name: CMC Ambroise Paré class: OTHER name: Paris IBD Center name: Celltrion HealthCare France briefSummary: The goal of this clinical trial is to compare induction treatment with CT-P13 SC to induction treatment with CT-P13 IV in terms of pharmacokinetics in adult patients with inflammatory bowel disease (IBD) who have been diagnosed for at least 3 months and for whom the physician has decided to initiate treatment with infliximab CT-P13 as part of the standard of care.

The main aim of this study is to demonstrate that induction treatment with CT-P13 SC is non-inferior to CT-P13 IV in terms of pharmacokinetics at Week 6. conditions: Inflammatory Bowel Diseases studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The full sample size comprises 130 patients, with 65 patients allocated to each arm. The arms are defined as follows:

* Experimental Arm: Patients receive CT-P13 SC at weeks 0, 1, 2, 3, 4, and 6, followed by subcutaneous administration every two weeks until week 24.
* Control Arm: Patients receive CT-P13 IV at weeks 0 and 2, followed by subcutaneous administration every two weeks until week 24. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 130 type: ESTIMATED name: CT-P13 measure: Ratio SC/IV measure: Ctrough at week 24 (non-inferiority) measure: AUC at week 24 measure: Clinical response at week 6 and week 24 measure: IBD disability index at week 6 measure: Fecal calprotectin at week 24 measure: Clinical remission at week 6 and week 24 measure: Presence of antibodies to infliximab at Week 6 and Week 24 measure: Concentration of C-reactive protein up to week 6 (the samples are collected at weeks 0, 6 and 24) measure: Adverse events, including injection site reactions and hypersensitivity reactions measure: TSQM collected at Week 6 and Week 24 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06274281 id: TOMs_FMD briefTitle: Digital Telerehabilitation in Functional Motor Disorders overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-02-01 date: 2026-02-01 date: 2024-02-23 date: 2024-02-23 name: Universita di Verona class: OTHER briefSummary: Functional motor disorders (FMDs) are a broad spectrum of functional neurological disorders, including abnormal gait/balance disorders. Patients experience high degrees of disability and distress, equivalent to those suffering from degenerative neurological diseases. Rehabilitation is essential in their management. However, the current systems of rehabilitation delivery face two main challenges. Patients are not receiving the amount and kind of evidence-based rehabilitation they need due to the lack of rehabilitation professionals and experts in the field. The rehabilitation setting is not adequate for the long-term management and monitoring of these patients. Digital medicine is a new field that means "using digital tools to upgrade the practice of medicine to one that is high-definition and far more individualized." It can upgrade rehabilitation practice, addressing the existing critical components towards marked efficiency and productivity. Digital telerehabilitation will increase the accessibility to personalized rehabilitation by expert professionals placing tools to monitor the patient's health by themselves.

The increasing development and availability of portable and wearable technologies are rapidly expanding the field of technology-based objective measures (TOMs) in neurological disorders. However, substantial challenges remain in (1) recognizing TOMs relevant to patients and clinicians to provide accurate, objective, and real-time assessment of gait and activity in a real-world setting and (2) their integration into telerehabilitation systems towards a digital rehabilitation transition.

This feasibility study provides preliminary data on the integration of a real-time gait and activity analysis by wearable devices in the real world with a digital platform to improve the diagnosis, monitoring, and rehabilitation of patients with FMDs. conditions: Functional Movement Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is an experimental single-blind randomized-controlled trial (RCT) with 2-parallel arms comparing the effects between the experimental group (EG) and control group (CG). After screening, a simple randomization list will be generated by a physician using an automated randomization system (alloca-tion ratio 1:1) to assign eligible patients to either the EG or the CG. Group allocation will be kept concealed. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The outcome assessor will be blinded to the type of intervention performed by the patient. whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Digital Telerehabilitation name: Usual care measure: number of patients who accept/refuse the treatment, physiotherapy compliance and falls or event near falling occurred during rehabilitation measure: Budget issues related to TOMs measure: Time spent to train patients measure: Change in the Simplified Functional Movement Disorders Rating Scale (S-FMDRS) score measure: Multidimensional Fatigue Inventory Scale (MFI-20) score measure: Change in the Brief Pain Inventory (BPI) score measure: Change in the Beck Depression Inventory (BDI-II) score measure: Change in the Beck Anxiety Inventory (BAI) score measure: Change in the 12-item Short-Form Health Survey (SF-12) score measure: The EuroQol-5D (EQ-5D) measure: iMTA Productivity Cost Questionnaire measure: Change in the Clinical Global Impression (CGI) score measure: Gait outcome: Gait speed measure: Gait outcome: Stride length measure: Gait outcome: Cadence measure: Balance outcome: CoP trajectory measure: Balance outcomes: Sway area sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona city: Verona zip: 37131 country: Italy lat: 45.4299 lon: 10.98444 facility: USD Parkinson's Disease and Movement Disorders Unit city: Verona zip: 37134 country: Italy lat: 45.4299 lon: 10.98444 hasResults: False

 nctId: NCT06274268 id: CHMS23006 briefTitle: Effect of Sarcopenia on the Occurrence of Toxicity Related to Anti-cancer Treatments acronym: SARC-ONCO overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-05-01 date: 2028-05-01 date: 2024-02-23 date: 2024-02-23 name: Centre Hospitalier Metropole Savoie class: OTHER name: Université Savoie Mont Blanc briefSummary: The goal of this clinical trial is to learn about the effect of sarcopenic status on the occurrence of treatment-related toxicity during the first course of anti-cancer treatment in several types of cancers.

The main question it aims to answer is :

Is sarcopenia a predictive marker for the occurrence of toxicity in the initial phase of cancer treatment?

The evaluation will focus on the body composition of the participants, assessed by impedancemetry, and on their muscular performance by standardized physical tests. conditions: Sarcopenia conditions: Oncology conditions: Physical Inactivity conditions: Toxicity Due to Chemotherapy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective cohort study primaryPurpose: DIAGNOSTIC masking: NONE count: 700 type: ESTIMATED name: Sarcopenia diagnostic test measure: Event-free survival according to sarcopenic statut measure: Event-free survival according to the link between: 1/ the dose/lean mass ratio and 2/ body composition and the occurrence of adverse events linked to treatment. measure: Progression free-survival measure: Overall survival measure: Objective response rate at 6 and 12 months measure: Number of patients classified as sarcopenic by BIA method and CT method. measure: Exploratory: Event-free survival during PACLITAXEL protocol measure: Exploratory: Level of spontaneous activity measurement by accelerometry (m.s-2). measure: Exploratory: RCB-based objective response rate at 6 and 12 months sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06274255 id: BalikesirU briefTitle: Serum Magnesium Level and Pediatric Migraine acronym: Migraine overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-04-10 date: 2024-05-15 date: 2024-02-23 date: 2024-02-23 name: Mersin University class: OTHER briefSummary: Aim: The purpose of this study is to compare serum magnesium levels between patients with migraine and a control group and to examine the relationship between the frequency and duration of attacks in patients with migraine and mean serum magnesium levels.

Material-Method: Patients diagnosed presenting to the Balıkesir University Medical Faculty pediatric neurology clinic between 01.09.2019 and 01.04.2023 and diagnosed with migraine were enrolled retrospectively. Patients diagnosed with migraine were included as the study group and healthy children presenting to the pediatric neurology clinic in the same period as the control group. The demographic characteristics (age, sex, and body mass index) of the patient group and their clinical (attack durations and frequencies, symptoms during attacks, and treatments) and laboratory (hemoglobin, hematocrit, platelet, glucose, calcium, magnesium, vitamin D, folate and ferritin levels) characteristics were recorded. conditions: Migraine, Magnesium, Pediatric studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED measure: Serum Magnesium Level and Pediatric Migraine measure: Serum Magnesium Level and Pediatric Migraine sex: ALL minimumAge: 72 Months maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Hilal Aydın city: Balıkesir state: Türkiye zip: 33343 country: Turkey name: Hilal Aydın, assoc. Dr. role: CONTACT phone: +902666121461 email: drhilalaydin@gmail.com name: Hilal Aydın, assoc. Dr. role: CONTACT phone: +905072607541 email: drhilalaydin@gmail.com lat: 39.64917 lon: 27.88611 facility: Aysen Orman city: Mersin state: Türkiye zip: 33343 country: Turkey lat: 36.79526 lon: 34.61792 facility: MersinU city: Mersin state: Türkiye zip: 33343 country: Turkey name: Aysen Orman role: CONTACT email: ormanaysen709@gmail.com name: Aysen Orman role: CONTACT phone: 3242410000 phoneExt: 2646 email: ormanaysen709@gmail.com lat: 36.79526 lon: 34.61792 facility: Aysen Orman city: Mersin state: Türkiye zip: 38000 country: Turkey name: Aysen Orman, assoc. Dr. role: CONTACT phone: +903242410000 phoneExt: +903242410000 email: ormanaysen709@gmail.com name: Aysen Orman, assoc. Dr. role: PRINCIPAL_INVESTIGATOR lat: 36.79526 lon: 34.61792 hasResults: False

 nctId: NCT06274242 id: MU-CIRB 2022/300.0711 briefTitle: Mixed Natural Prebiotic-Fibers Impact on Stool Frequency and Fecal Microbiota in Constipated Thai Adults overallStatus: ACTIVE_NOT_RECRUITING date: 2023-03-10 date: 2023-07-22 date: 2024-04-19 date: 2024-02-23 date: 2024-02-23 name: Mahidol University class: OTHER briefSummary: Mixed Natural Prebiotic-Fibers Impact on Stool Frequency and Fecal Microbiota in Constipated Thai Adults: A Randomized Clinical Trial. conditions: Constipation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 98 type: ACTUAL name: Haruna name: Placebo Powder measure: Change in Stool Frequency measure: Change in Fecal Microbiota measure: Change in Stool consistency sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Mahidol University city: Nakhon Pathom zip: 73170 country: Thailand lat: 13.8196 lon: 100.04427 hasResults: False

 nctId: NCT06274229 id: EA4/252/23 briefTitle: DivAirCity Social Health Survey acronym: DivAirCitySH overallStatus: RECRUITING date: 2024-02-20 date: 2024-12-31 date: 2025-12-31 date: 2024-02-23 date: 2024-02-23 name: Charite University, Berlin, Germany class: OTHER name: Universitat Politècnica de València name: Universitatea din Bucuresti name: University of Aarhus name: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy name: European Commission briefSummary: To reduce stress among urban residents, the consortium members of the European Council Horizon 2020 research program DivAirCity install different stress reducing, noise reducing and air quality improving means in the five cities of the consortium. This study measures physiological and psychological stress and health factors before and after the implementation of the project (at intervention sites) and compares the change (improvement) to the change in comparable places where no means were installed (control site). conditions: Psychological Stress conditions: Psychological Well-Being conditions: Pollution; Exposure studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Air pollution and noise reducing installations measure: WHO-5 Well-being Scale measure: Kessler K6 psychological distress measure: ASKU questionnaire measure: Questionnaire for General Physiological Health measure: Questionnaire about feelings of safety and security at the site sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Charité -- Universitaetsmedizin Berlin status: RECRUITING city: Berlin zip: 14109 country: Germany name: Farid I Kandil, PhD role: CONTACT phone: +491605631744 email: farid-ihab.kandil@charite.de lat: 52.52437 lon: 13.41053 hasResults: False

 nctId: NCT06274216 id: 4381021ABOS briefTitle: The Effect of Vitamin D Supplementation on Dental Implant Osseointegration: A Randomized Controlled Trial overallStatus: COMPLETED date: 2021-09-01 date: 2022-03-30 date: 2022-04-01 date: 2024-02-23 date: 2024-02-23 name: Ziauddin University class: OTHER briefSummary: Dental implantation is a new technique for the single or more missing tooth replacement. Dental professionals might utilize the findings of this investigation to generate local data and learn more about how vitamin D affects bone metabolism and implant osseo-integration. The long-term success of dental implants would also be enhanced and preserved with the right medical use of vitamin D conditions: Osseointegration Failure of Dental Implant studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The research commences through a self-administered questionnaire such as age, gender, weight, height, BMI, smoking habits, sun exposure, and employment status.

Prior to implant surgery, each participant undergoes a blood test to assess their vitamin D levels.

Detailed records are maintained concerning the anatomical position (molar, pre-molar, canine, and incisor) and implant site (maxilla and mandible) for every participant.

Group Formation: The participant pool is stratified into two distinct groups - Group A and Group B. This categorization is essential for implementing and comparing different interventions within the study. Group A undergoes a specific intervention wherein they receive a daily oral dose of 5000 IU of vitamin D3 for a duration of 12 weeks. In contrast, Group B receives a placebo.

Following the intervention period, the implants are allowed to cure adequately primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Groups A and B were created out of all patients who had signed up. Patients in group A received 5000 IU of vitamin D3 orally every day for 12 weeks , whereas patients in group B received a placebo. Patients were blinded to the study medication. The implants were then allowed to cure adequately and submerged for a further three months. Patients were summoned back three months later to un-cover the implant.

The both groups were compared for the difference of osseo-integration at 3 months, as well as difference of osseo-integration were compared with respect to implant site (maxilla and mandible).

Additionally, change in vitamin D levels were also assessed pre-operatively and post-operatively at 3 months. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 100 type: ACTUAL name: Vitamin D3 name: Vitamin E 400 measure: Osseo-integration is measured by evaluating the ISQ value (Implant Stability Quotient, ranging from 1-100) measure: Evaluation of Mean Change in Serum Vitamin D Levels in Dental Implant Patients with and without Vitamin D Supplementation at a Tertiary Care Hospital sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Afifa Razi city: Karachi state: Sindh zip: 74700 country: Pakistan lat: 24.8608 lon: 67.0104 hasResults: False

 nctId: NCT06274203 id: 10584-2/5-2023 briefTitle: High Dose Vitamin D Supplementation in Children With Sickle Cell Disease overallStatus: COMPLETED date: 2023-05-03 date: 2024-01-30 date: 2024-02-10 date: 2024-02-23 date: 2024-02-23 name: Zagazig University class: OTHER_GOV briefSummary: Suboptimal vitamin D status is well reported in sickle cell disease (SCD) patients and associated with a negative impact on health-related quality of life (HRQL). The investigators enrolled 42 SCD patients and 42 healthy controls, subjects within each group received monthly oral vitamin D3 dose according to the baseline status of vitamin D as follows: sufficient: 100,000 IU, insufficient: 150,000 IU, and deficient: 200,000 IU. The investigators assessed safety and efficacy on normalization of vitamin D level, bone mineral density (BMD), hand grip strength (HGS), and HRQL. conditions: Sickle Cell Disease conditions: Vitamin D Deficiency conditions: Health Related Quality of Life conditions: Hand Grip Strength conditions: Bone Mineral Density studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 75 type: ACTUAL name: Vitamin D3 measure: Serum 25(OH)D level measure: Bone mineral density (BMD) measure: Maximum handgrip strength (HGS) measure: Health related quality of life (HRQL) measure: Serum concentrations of C reactive protein (CRP) measure: Serum concentrations of Erythrocyte sedimentation rate (ESR) measure: Safety reporting of any adverse events measure: Safety measurements of serum Ca measure: childhood health assessment measure: Safety measurements of serum 25(OH)D levels sex: ALL maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Zagazig university city: Zagazig state: Sharkia zip: 44519 country: Egypt lat: 30.58768 lon: 31.502 hasResults: False

 nctId: NCT06274190 id: S68746 briefTitle: Personalized Care Pathways for Bowel Symptoms in Rectal Cancer patients_development of E-diary acronym: Treatable overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2025-10 date: 2026-03 date: 2024-02-23 date: 2024-04-08 name: KU Leuven class: OTHER name: Universitaire Ziekenhuizen KU Leuven briefSummary: Colorectal cancer is the 2nd and 3rd most common cancer in respectively women and men, of which about 40% is located in the rectum. The gold standard treatment for rectal cancer (RC) is a low anterior resection, combined with chemoradiotherapy. However, this treatment will negatively impact different aspects of bowel function and the patients' quality of life. These bowel symptoms often remain prevalent, even at 12 months after RC treatment. Most assessment tools are however not capable of capturing the full range or therapeutic-related evolution of these bowel symptoms. Consequently, the aim is to develop a validated bowel diary for diagnosing and evaluation of all bowel symptoms. conditions: Rectal Cancer conditions: LARS - Low Anterior Resection Syndrome studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 118 type: ESTIMATED name: bowel e-diary measure: Selection of items for the newly developed bowel diary measure: Assessment of content validity of the newly developed bowel diary in a post-Delphi patient focus group consisting of 8-12 participants measure: The usability of the newly developed e-diary, assessed with the System Usability Scale (SUS) in patients after rectal surgery for rectal cancer measure: The usability of the newly developed e-diary will be evaluated through conversations with patients who have undergone rectal surgery for rectal cancer, after these patients have used the e-diary for seven consecutive days measure: Construct validity of the newly developed bowel e-diary measure: Criterion validity of the newly developed bowel e-diary measure: Test-retest reliability of the newly developed bowel e-diary measure: Responsiveness of the newly developed bowel e-diary in patients after rectal surgery for rectal cancer. The newly validated e-diary is the primary outcome. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06274177 id: BTL-785_CTUS1400 briefTitle: Evaluation of the BTL-785F Device for Submental Fat Reduction and Neck Rejuvenation overallStatus: ACTIVE_NOT_RECRUITING date: 2023-07-26 date: 2024-04-01 date: 2024-04-01 date: 2024-02-23 date: 2024-02-23 name: BTL Industries Ltd. class: INDUSTRY briefSummary: This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive reduction of submental fat and skin laxity treatment. conditions: Fat Burn studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 37 type: ACTUAL name: BTL-785-7 measure: Submental fat thickness reduction measure: Incidence of Treatment-related Adverse Events measure: Change on the Clinician Reported - Submental Fat Rating Scale score measure: Satisfaction Assessed by the Satisfaction Questionnaire measure: Change in the submental-cervical angle measure: Comfort Assessed by Therapy Comfort Questionnaire sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Precision Skin LLC city: Davie state: Florida zip: 33328 country: United States lat: 26.06287 lon: -80.2331 facility: Chicago Cosmetic and Dermatologic Research city: Chicago state: Illinois zip: 60654 country: United States lat: 41.85003 lon: -87.65005 facility: New Jersey Plastic Surgery (NJPS) city: Montclair state: New Jersey zip: 07042 country: United States lat: 40.82593 lon: -74.20903 facility: Gentile Facial Plastic and Aesthetic Laser Center city: Youngstown state: Ohio zip: 44512 country: United States lat: 41.09978 lon: -80.64952 hasResults: False

 nctId: NCT06274164 id: H-54820 / RAI1 briefTitle: Clinical and Molecular Biomarker Studies in RAI1 (Retinoic Acid-Induced 1) -Related Disorders overallStatus: RECRUITING date: 2024-03-13 date: 2027-03 date: 2027-03 date: 2024-02-23 date: 2024-04-01 name: Baylor College of Medicine class: OTHER name: Doris Duke Charitable Foundation briefSummary: Currently, there is no clinically available genetic-based treatment for RAI1 (Retinoic Acid-Induced 1) -related disorders other than symptomatic management and there are no established clinical or molecular biomarkers that could be used as measures for the efficacy of therapy in future treatment studies. Biomarkers are measures of what is happening inside the body, shown by the results of laboratory, imaging or other tests.

Biomarkers can help doctors and scientists diagnose diseases and health conditions, monitor responses to treatment and see how a person's disease or health condition changes over time.

The goal of this observational and laboratory study is to develop clinical, neurophysiology and molecular biomarkers in RAI1-related disorders. The main question\[s\] it aims to answer are:

* to characterize the disease features more precisely and analyze the differentiating and overlapping features of RAI1-related disorders (Smith-Magenis syndrome and Potocki-Lupski Syndrome)
* to identify clinical, neurophysiology, and laboratory biomarkers that differentiate RAI1-related disorders one from another.

Participants will have to complete:

* a clinical examination
* a blood draw
* a skin biopsy (optional)
* a sleep study

Researchers will compare patients' blood to control group's blood for biomarker studies. conditions: RAI1 Gene 17P11.2 Deletion+Duplication studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 90 type: ESTIMATED name: Electroencephalography/Polysomnography (EEG/PSG) name: Skin Biopsy name: Blood draw measure: Rate of neurological clinical finding measure: Rate of electroencephalogram (EEG) and/or sleep abnormalities measure: Concentration of downstream molecular pathway interactors of RAI1 sex: ALL minimumAge: 1 Month maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Texas Children's Hospital status: RECRUITING city: Houston state: Texas zip: 77030 country: United States name: Davut Pehlivan, MD role: CONTACT phone: 713-798-6970 email: pehlivan@bcm.edu lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06274151 id: H-22038917 briefTitle: Optimal Treatment of Acute Skeletal Muscle Injury overallStatus: NOT_YET_RECRUITING date: 2024-02-15 date: 2025-07-31 date: 2029-12-31 date: 2024-02-23 date: 2024-02-23 name: Bispebjerg Hospital class: OTHER briefSummary: Acute muscle strain injuries occur both during sports, in leisure time activities and during manual occupation and represent a major clinical challenge and has societal economic costs. The recovery time is long and a substantial injury recurrence is observed. Despite current best evidence rehabilitation with early mechanical loading, a significant loss of muscle mass, fatty infiltration and formation of scar tissue is reported.

Animal models and human in vitro experiments suggest that inflammation is vital in the early period after an injury, however an inhibition of inflammatory processes is beneficial for healing.

We investigate here whether a pharmacological inhibition of inflammatory pathways in the 2nd week following a muscle strain injury will provide a better clinical outcome and an advantageous cellular profile than rehabilitative training alone would. conditions: Muscle Strain, Multiple Sites conditions: Inflammation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Naproxen 500 Mg name: Rehabilitation name: Placebo measure: Effect of anti-inflammatory medicine on cellular profile in skeletal muscle measure: Functional outcome performance measure: Functional outcome re-injury rate measure: Functional outcome Patient Related Outcome Measures (PROM) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06274138 id: HAPTONOMY briefTitle: The Enchanting Symphony of Haptonomy's Impact on Attachment and Spousal Harmony for Women Conceiving Through Infertility Treatment overallStatus: ENROLLING_BY_INVITATION date: 2024-03-15 date: 2024-03-30 date: 2025-03-15 date: 2024-02-23 date: 2024-03-05 name: Baskent University class: OTHER briefSummary: Pregnancies resulting from infertility treatment are considered normal and 'low-risk' in some countries, they often entail significant stress. Prenatal attachment may be experienced differently by parents conceiving through fertility interventions. The rising prevalence of fertility treatments is associated with increased risks such as preterm birth, low birth weight, and perinatal mortality for pregnancies achieved through infertility treatments. Beyond medical implications, post-infertility treatment pregnancies can induce high levels of anxiety and a perception of pregnancy as risky, affecting individuals psychologically. The transition to parenthood after infertility treatment can be psychologically challenging.

Healthy prenatal attachment in expectant mothers fosters the development of a healthy role as both mother and father. Maternal bonding is closely tied to a woman's mental health during the prenatal period and her commitment to her baby. Similarly, prenatal bonding with the father sheds light on the emotional connection developing between the father and the unborn child. Active participation in prenatal experiences, such as attending ultrasound appointments or discussing parenting plans, contributes to a stronger sense of attachment for fathers and establishes a positive foundation for future bonding. Supportive partner relationships during pregnancy enhance paternal bonding and emphasize the importance of a collaborative approach to prenatal care for both parents. The prenatal period is critical for fathers to establish an early emotional connection with their unborn children, laying a positive groundwork for postnatal bonding.

Various interventions aim to enhance communication between parents and augment prenatal attachment. One such practice is haptonomy-haptotherapy. Haptotherapy focuses on restoring emotional connections, especially with one's own body. It helps individuals recognize their emotional capacities and allows them to experience these capacities through insightful conversations, therapeutic touch, and skill exercises. In the context of pregnancy, haptonomy involves physical contact between the pregnant woman, her partner, and the unborn baby. Advocates of haptonomy believe that this touch-based communication can strengthen the bond between parents and the baby, promote a sense of security, and positively influence the pregnancy experience.

Haptonomy is thought to contribute positively to the psychological well-being of women during pregnancy, birth, and the postpartum period, potentially preventing mental health issues and enhancing the health of both mother and baby. It is emphasized that haptonomy is a distinct practice focused on enhancing communication between parents and the baby. Existing literature suggests that haptonomy can increase emotional bonding during the prenatal period and may be effective for parents showing low attachment. Studies indicate that touch communication develops from the second month, involving vibrations for communicating with the fetus, ultimately increasing bonding through haptonomy. Furthermore, haptonomy is reported to enhance both spousal and parental attachment, as demonstrated in a study emphasizing increased attachment for fathers with their partners and children.

Despite documented benefits of haptonomy in various patient groups, from cancer patients undergoing chemotherapy to pregnant women and those with chronic pain, limited research exists on haptotherapy for pregnant women. This study aims to investigate the impact of partner-administered haptonomy on prenatal attachment and marital adjustment in pregnant women. Conducted through a randomized controlled experimental design, the study seeks to provide evidence by enhancing prenatal attachments in both mothers and fathers.

Research Hypotheses:

H0-1: The application of haptonomy by partners has an effect on maternal attachment in pregnant women.

H1-1: The application of haptonomy by partners does not have an effect on maternal attachment in pregnant women.

H0-2: The application of haptonomy by partners has no effect on paternal attachment in pregnant women.

H1-2: The application of haptonomy by partners has an effect on paternal attachment in pregnant women.

H0-3: The application of haptonomy by partners has no effect on marital adjustment in pregnant women.

H1-3: The application of haptonomy by partners has an effect on marital adjustment in pregnant women. conditions: Infertility studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 76 type: ESTIMATED name: haptonomy measure: Marital adjustment score measure: Prenatal attachment score measure: Father attachment score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Başkent University city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06274125 id: AslıDemircioglu1 briefTitle: Evaluation of Kidney Damage Using NGAL Measurements overallStatus: RECRUITING date: 2023-10-01 date: 2024-03 date: 2024-04 date: 2024-02-23 date: 2024-02-23 name: Ankara City Hospital Bilkent class: OTHER briefSummary: The main objective of this study is to evaluate whether blood NGAL measurement provides superiority over sCr and BUN tests in early diagnosis for assessing renal function in patients undergoing robotic urological surgery. conditions: Prostatectomy conditions: Neutrophil Gelatinase-Associated Lipocalin conditions: Kidney Function Tests studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 55 type: ESTIMATED name: Robotic-Assisted Laparoscopic Radical Prostatectomy measure: The main objective of this study is to evaluate whether blood NGAL measurement has superiority over sCr and BUN tests in terms of early diagnosis for assessing kidney function in patients undergoing robotic urologic surgery. measure: The relationship between demographic parameters such as age, BMI, comorbidities, and ASA classification will be evaluated in relation to the development of AKI. measure: The evaluation of the relationship between intraabdominal pressure and the development of AKI. measure: The relationship between intraoperative mean arterial pressure (MAP) and NGAL (Neutrophil Gelatinase-Associated Lipocalin) values. sex: MALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Bilkent City Hospital status: RECRUITING city: Ankara state: Çankaya zip: 06530 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06274112 id: 1K23MH135222 briefTitle: Using TMS to Understand Neural Processes of Social Motivation overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2029-09 date: 2029-09 date: 2024-02-23 date: 2024-02-23 name: Auburn University class: OTHER briefSummary: The purpose of this study is to use transcranial magnetic stimulation (TMS) to better understand the neural circuits associated with social motivation.

Participant includes four study visits each that range from 1.5 - 3.0 hours in duration over approximately a one month period. The first study visit involves answering survey questions, a clinical interview, and computer tasks. The second study visit involves a magnetic resonance imaging (MRI) scan, computer tasks, and a brief TMS protocol. The second and third study visits involve a full session of TMS followed by an MRI scan and computer tasks.

Adults in the Auburn/Apelika area who avoid social situations, experience symptoms of depression or social anxiety, and are between 25 years old and 50 years old are eligible to participate. conditions: Social Avoidant Behavior conditions: Major Depressive Disorder conditions: Social Anxiety Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: All participants will receive each dose of TMS in a counterbalanced order (AB or BA) primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: TMS measure: Social motivation measure: Neural circuit function sex: ALL minimumAge: 25 Years maximumAge: 50 Years stdAges: ADULT hasResults: False

 nctId: NCT06274099 id: TDK-2023-12649 briefTitle: The Effect of the Care Given to Hemodialysis Patients on Comfort Level and Complaints overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-03 date: 2024-12 date: 2024-02-23 date: 2024-02-23 name: Reva Balci Akpinar class: OTHER name: Atatürk University briefSummary: Kolcaba's comfort theory is a theory used by nurses to increase the comfort of patients. There are limited studies determining that nursing care provided according to this theory contributes to the increase in patients' comfort levels in various patient groups. This study will be carried out in the hemodialysis center of a public hospital located in the city center of Bingöl. Patients in the intervention group receiving hemodialysis treatment will be given nursing care by the researcher for 12 sessions during the sessions in which the patient receives hemodialysis treatment. In order to provide nursing care, nursing diagnoses suitable for the patient group will be determined in advance and the care the patient needs will be given according to these diagnoses.. If necessary, the researcher will add additional diagnoses to the preliminary diagnosis form and provide care.

In this research, the individual nursing care needs of the researcher patient will be determined. Individualized caregiving is unique to this study. Individually provided care is expected to increase patient comfort and satisfaction. Increased comfort will help the patient cope more easily with the disease and hemodialysis treatment symptoms. In addition, the results of individual care provided can guide nurses in their care behaviors. By adding this research to the literature, the groundwork will be laid for studies that will provide individual care to patients. It is expected that the results of this research will guide the planning of the research and the provision of individualized care in all patient groups, especially patients receiving hemodialysis treatment. conditions: Hemodialysis Complication conditions: Nurse's Role studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: pretest posttest randomized controlled trial primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: nursing care measure: General Comfort Scale measure: Dialysis Symptom Index sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ataturk University city: Erzurum state: Diğerleri zip: 25200 country: Turkey name: REVA BALCI AKPINAR, PROF. DR role: CONTACT phone: +904422312214 email: reva@atauni.edu.tr name: RUKIYE DEMİR DIKMEN role: SUB_INVESTIGATOR lat: 39.90861 lon: 41.27694 facility: Ataturk University city: Erzurum state: Diğerleri zip: 25200 country: Turkey name: REVA BALCI AKPINAR, PROF. DR role: CONTACT phone: +904422312214 email: reva@atauni.edu.tr lat: 39.90861 lon: 41.27694 hasResults: False

 nctId: NCT06274086 id: S2022-2027-0001 briefTitle: Two-session Catheter-directed Sclerotherapy Using Ethanol for Endometrioma overallStatus: COMPLETED date: 2020-06-01 date: 2023-03-31 date: 2023-03-31 date: 2024-02-23 date: 2024-02-23 name: Asan Medical Center class: OTHER briefSummary: The goal of this clinical trial is to evaluate the safety and clinical outcomes of two-session catheter-directed sclerotherapy (CDS) with 96% ethanol in patients with endometrioma. The main question it aims to answer is:

• Is two-session CDS with 96% ethanol safe and effective for treating endometrioma?

Participants will:

* Receive the first session CDS for endometrioma
* Carry the catheter overnight and be monitored in the patient ward
* Receive the second session CDS the next day conditions: Sclerotherapy conditions: Endometrioma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 22 type: ACTUAL name: Two-session catheter-directed sclerotherapy measure: Recurrence sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Asan Medical Center city: Seoul zip: 05505 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06274073 id: E2-22-2566 briefTitle: Double-dorsal Versus Single-volar Digital Block overallStatus: COMPLETED date: 2022-10-12 date: 2023-07-12 date: 2023-09-12 date: 2024-02-23 date: 2024-02-23 name: Ankara City Hospital Bilkent class: OTHER briefSummary: The aim of this study is to compare the traditional dorsal double injection digital block with the palmar single injection technique in the suturing of acute traumatic hand finger lacerations in terms of injection pain score (NRS), anesthesia onset time, and success of anesthesia.

It is understood that single injection digital block and double injection digital block techniques do not have significant advantages over each other in terms of pain levels and procedure times.

However, the need for rescue anesthesia was evaluated to be lower in the single injection digital block technique. This difference is especially due to measurements in the volar region incisions.

According to the results of this study, we think that choosing the single injection digital block technique for volar region incisions is a more rational approach, especially in terms of the data of the need for rescue anesthesia. conditions: Laceration of Skin conditions: Anesthesia, Local conditions: Pain conditions: Nerve Block studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two parallel groups (two digital block techniques) primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 160 type: ACTUAL name: Dorsal digital block name: Palmar digital block measure: Anesthesia pain score measure: Anesthesia onset time sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara City Hospital Emergency Medicine Department city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06274060 id: 135399 id: R01MH121161 type: NIH link: https://reporter.nih.gov/quickSearch/R01MH121161 id: IRB00012628 type: OTHER domain: JHSPH IRB briefTitle: Project Phakama: Testing Support Strategies to Empower Young Women on PrEP in South Africa overallStatus: RECRUITING date: 2024-04-16 date: 2025-04 date: 2025-04 date: 2024-02-23 date: 2024-04-19 name: Johns Hopkins Bloomberg School of Public Health class: OTHER name: TB/HIV Care name: Unity Health Toronto name: National Institute of Mental Health (NIMH) briefSummary: The goal of this trial is to understand which strategies work best to support pre-exposure prophylaxis (PrEP) use among female sex workers (FSW) and adolescent girls and youth women (AGYW) in uMgungundlovu, KwaZulu-Natal, South Africa. Participants will be randomly assigned to receive a combination of up to four support strategies encourage the participants in continuing to use PrEP. The four strategies being tested are: case management, food vouchers, peer support buddies, and community-based PrEP pick-up points. The intention of this trial is to determine which PrEP support strategy or bundle(s) of strategies best promote(s) long-term PrEP use, so that these services can be scaled up to other districts in South Africa. conditions: Pre-exposure Prophylaxis conditions: HIV Infections studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: This fractional factorial design includes four strategies resulting in 16 trial arms/conditions. The design compares results in arms with and without each of the strategies, but is not fully powered to test every combination of strategies.Thus, each strategy will be received by half of the participants, though the combinations of strategies will vary. primaryPurpose: PREVENTION masking: NONE count: 304 type: ESTIMATED name: Case management name: Food vouchers name: PrEP support buddy name: Community-based PrEP pickup points measure: PrEP persistence at 7 months after PrEP initiation measure: PrEP adherence at 7 months after PrEP initiation among all trial participants measure: PrEP persistence at 1 month after PrEP initiation measure: PrEP persistence at 4 months after PrEP initiation measure: PrEP persistence at 13 months after PrEP initiation measure: PrEP adherence at 7 months after PrEP initiation among trial participants who provided dried blood spot samples sex: FEMALE minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: TB HIV Care status: RECRUITING city: Pietermaritzburg state: KwaZulu Natal zip: 3200 country: South Africa name: Chitra Singh, MSocSci role: CONTACT phone: +27721516828 email: chitra.singh@tbhivcare.org name: Joel Steingo, MBChB, MPH role: CONTACT phone: +27833009377 email: joel@tbhivcare.org name: Harry Hausler, MD, PhD, MPH role: PRINCIPAL_INVESTIGATOR name: Mfezi Mcingana, BA role: SUB_INVESTIGATOR name: Jenny Mcloughlin, RN role: SUB_INVESTIGATOR name: Joel Steingo, MBChB, MPH role: SUB_INVESTIGATOR lat: -29.61679 lon: 30.39278 hasResults: False

 nctId: NCT06274047 id: 2023-0409 id: NCI-2024-01553 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: PROSTATE-IQ: Parallel RandOmized STudy of Personalized Apalutamide Treatment and Evaluation to Improve Quality of Life in Post-Operative Radiation With Androgen Axis Suppression. A Phase III Multi-center Study for Men With Detectable PSA After Prostatectomy for Prostate Cancer. overallStatus: NOT_YET_RECRUITING date: 2024-08-31 date: 2027-06-30 date: 2029-06-30 date: 2024-02-23 date: 2024-03-28 name: M.D. Anderson Cancer Center class: OTHER name: Janssen Scientific Affairs, LLC briefSummary: 1. Personalize treatment for prostate cancer based on how aggressive the disease is and
2. Learn if apalutamide-based treatment can help to reduce fatigue and other side effects of treatment in participants who are being treated with radiation therapy for prostate cancer, as compared to standard therapy. conditions: Androgen Axis Suppression conditions: Prostatectomy conditions: Prostate Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Apalutamide name: Androgen Deprivation Therapy measure: Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Karen Hoffman, MD role: CONTACT phone: 713-563-2339 email: khoffman1@mdanderson.org name: Karen Hoffman, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06274034 id: 23-006870 id: NCI-2024-01019 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 23-006870 type: OTHER domain: Mayo Clinic Institutional Review Board briefTitle: MUSE-S Headband System for Improving Anxiety and Insomnia Among Breast Cancer Survivors overallStatus: RECRUITING date: 2024-01-08 date: 2025-01-31 date: 2025-01-31 date: 2024-02-23 date: 2024-02-23 name: Mayo Clinic class: OTHER briefSummary: This early phase I trial evaluates the feasibility and impact of a meditation headband system (MUSE-S) for breast cancer survivors. Anxiety and insomnia are among the most common distresses in breast cancer survivors during and after chemotherapy, in part due to the side effects of chemotherapy, fear of cancer coming back, progression of the cancer, and uncertainty of the future. These distresses impair patients' well-being and quality of life (QOL) in general, and their cancer treatment adherence and effectiveness in particular. Meditation has been demonstrated to be an effective management tool of stress and anxiety and is given the highest level of evidence (grade A) in the systematic review-based guidelines by the Society of Integrative Medicine. The portable, interactive, electroencephalographic (EEG) Muse headband guided meditation has been shown to improve fatigue, QOL, and stress in newly diagnosed breast cancer patients. The MUSE-S Headband System may decrease anxiety and insomnia among breast cancer survivors. conditions: Breast Carcinoma studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 40 type: ESTIMATED name: Electronic Health Record Review name: Medical Device Usage and Evaluation name: Meditation Therapy name: Survey Administration measure: Frequency of use of meditation measure: Feasibility of a wearable electroencephalographic (EEG) headband (Muse™ S Headband) measure: Impact of interactive meditation and sleep support through the Muse-S™ system sex: FEMALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester status: RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Stacy D. D'Andre, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06274021 id: UMMC-IRB-2023-125 briefTitle: Neuromodulation to Reduce Muscle Stiffness Following Spinal Cord Injury overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-31 date: 2025-12-31 date: 2024-02-23 date: 2024-03-25 name: University of Mississippi Medical Center class: OTHER name: Methodist Rehabilitation Center name: The Craig H. Neilsen Foundation briefSummary: People with spinal cord injuries may experience muscle tightness or uncontrollable spasms. This study is being conducted to investigate whether transcutaneous spinal stimulation can improve these symptoms. Transcutaneous spinal stimulation is a non-surgical intervention by applying electrical currents using skin electrodes over the lower back and belly.

The investigators want to see how well the intervention of transcutaneous spinal stimulation performs by testing different levels of stimulation pulse rates. Also, transcutaneous spinal stimulation is compared to muscle relaxants such as baclofen and tizanidine, commonly given to people with spinal cord injuries, to reduce muscle stiffness and spasms. By doing this, the investigators hope to discover if transcutaneous spinal stimulation similarly reduces muscle spasms and stiffness or if combining both methods works best. This could help improve treatment options for people with spinal cord injuries in the future. conditions: Spinal Cord Injuries conditions: Spinal Cord Injury conditions: Spinal Cord Injury Cervical conditions: Spinal Cord Injury Thoracic studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: This study employs a crossover design, wherein each participant is systematically administered a sequence of five distinct interventions randomly. This approach ensures that every participant receives each intervention in a unique sequence. The design facilitates within-subject comparisons by minimizing inter-individual variability, as each participant effectively serves as their own control across the study phases. The random assignment of intervention sequences aims to balance potential carryover effects and period effects. primaryPurpose: OTHER masking: NONE maskingDescription: The participants and assessors are kept unaware of which intervention is being administered. For this, the study drugs are designed to be visually identical for all participants, and the intervention and sham stimulation configuration is set without the assessor being present in the room. count: 16 type: ESTIMATED name: Transcutaneous spinal stimulation at 100 Hz name: Transcutaneous spinal stimulation at 50 Hz name: Transcutaneous spinal stimulation at 50 Hz and single dose of baclofen name: Transcutaneous spinal stimulation at 50 Hz and single dose of tizanidine name: Sham transcutaneous spinal stimulation measure: Change from baseline of posterior root reflexes (PRRs) recruitment curves. measure: Change from baseline of flexion withdrawal reflex (FWR) response amplitude. measure: Change from baseline of stretch reflex (SR) response amplitude. measure: Change from baseline in muscle stiffness as measured by the Modified Ashworth Scale (MAS), measure: Change from baseline in spasms as measured by the Spinal Cord Assessment Tool for Spastic Reflexes (SCATS). measure: Change from baseline of posterior root reflexes (PRRs) recruitment curves. measure: Change from baseline of flexion withdrawal reflex (FWR) response amplitude. measure: Change from baseline of stretch reflex (SR) response amplitude. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Methodist Rehabilitation Center city: Jackson state: Mississippi zip: 39216 country: United States name: Dobrivoje S Stokic, MD, DSc role: CONTACT phone: 601-364-3314 email: dstokic@mmrcrehab.org lat: 32.29876 lon: -90.18481 facility: University of Mississippi Medical Center city: Jackson state: Mississippi zip: 39216 country: United States name: Matthias J Krenn, PhD role: CONTACT phone: 601-364-3413 email: mkrenn@umc.edu lat: 32.29876 lon: -90.18481 hasResults: False

 nctId: NCT06274008 id: 230110 briefTitle: Exparel vs. ACB With Bupivacaine for ACL Reconstruction overallStatus: RECRUITING date: 2023-10-12 date: 2024-10-30 date: 2024-12-31 date: 2024-02-23 date: 2024-02-23 name: Children's Hospital of Orange County class: OTHER briefSummary: Opioid misuse and addiction among children and adolescents is an increasingly concerning problem. Post-surgical opioid prescriptions for commonly performed surgeries such as anterior cruciate ligament reconstruction (ACLR) increase opioid exposure in young athletes. The purpose of the current study is to determine if extended-release Bupivacaine Liposome Injectable Suspension (Exparel) is effective in decreasing at home narcotic consumption compared to standard Bupivacaine Adductor Canal Block for Anterior Cruciate Ligament (ACL) reconstruction/reconstruction for the surgical treatment of adolescents with ACL tears and concomitant pathology i.e. meniscus / cartilage injury/tear. conditions: ACL Tear conditions: Opioid Misuse conditions: Pain conditions: Anxiety studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 96 type: ESTIMATED name: Exparel measure: At-home narcotic consumption by the patients as measured by the medication form completed by parents post discharge measure: Postoperative pain level of child measure: Functional disability of child measure: Parent and child anxiety measure: Child pain sex: ALL minimumAge: 7 Years maximumAge: 17 Years stdAges: CHILD facility: CHOC Children's Hospital status: RECRUITING city: Orange state: California zip: 92868 country: United States name: Haydee Cortes role: CONTACT phone: 714-456-2837 email: haydee.cortes@choc.org name: Kiran Athreya role: CONTACT phone: 9493064857 email: kiran.athreya@choc.org name: John Schlechter, DO role: PRINCIPAL_INVESTIGATOR name: Zeev N. Kain, MD role: SUB_INVESTIGATOR lat: 33.78779 lon: -117.85311 hasResults: False

 nctId: NCT06273995 id: H-54233 briefTitle: Telehealth Behavioral Activation for Teens overallStatus: RECRUITING date: 2024-03-01 date: 2029-03-01 date: 2029-12-01 date: 2024-02-23 date: 2024-03-19 name: Baylor College of Medicine class: OTHER name: University of Texas briefSummary: Behavioral activation is one such empirically supported intervention. Derived from cognitive-behavioral therapy, a well-established treatment for depression, behavioral activation uses psychoeducation and skill-building to increase an individual's engagement in valued and enjoyable activities (e.g., socializing with family and friends, exercising, participating in a hobby) in order to improve depressive symptoms. Research has shown that behavioral activation is an effective intervention for depressed youth. Additionally, it has been shown as a promising intervention that can be conducted in a brief, virtual format and can be effectively implemented by both trained clinicians and trained, non-licensed interventionists. This project will provide Behavioral Activation for youth (12-17) experiencing depression or suicidal ideation who are currently enrolled in the Youth Depression Suicide Network study in Texas. conditions: Depression conditions: Suicide and Self-harm conditions: Depression in Adolescence conditions: Depression Mild conditions: Depression Moderate conditions: Depression Severe studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single group, open-label behavioral activation primaryPurpose: TREATMENT masking: NONE count: 250 type: ESTIMATED name: Behavioral Activation measure: Patient Health Questionnaire 9-modified for adolescents (PHQ-A) measure: Behavioral Activation for Depression-Short Form (BAD-SF) measure: Dimensional Anhedonia Rating Scale (DARS) measure: Strengths and Difficulties Questionnaire (SDQ) measure: Duke Social Support Index (DSSI) sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Baylor College of Medicine status: RECRUITING city: Houston state: Texas zip: 77030 country: United States name: Eric Storch, Ph.D. role: CONTACT phone: 713-798-3080 email: eric.storch@bcm.edu lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06273982 id: 1R01MH131698 type: NIH link: https://reporter.nih.gov/quickSearch/1R01MH131698 briefTitle: Behavioral Telehealth in Low-resource Primary Care Settings for Anxiety and Depression in Youth acronym: STEP-UP overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2028-05-31 date: 2028-05-31 date: 2024-02-23 date: 2024-02-23 name: San Diego State University class: OTHER name: Kaiser Permanente name: OCHIN, Inc. briefSummary: The goal of this clinical trial is to test a brief, behavioral telehealth treatment program (STEP-UP) for depression and anxiety in youths (age 8-16 years old). Youths and families will be recruited through participating community health centers and will be randomly assigned to either: (a) receive STEP-UP care from providers at their health center or (b) be referred to care from local community mental health clinicians. Youth and families will be interviewed before treatment starts, 16 weeks later, and 24 weeks later to assess how youth are feeling. The main question the study aims to answer is whether STEP-UP improves youths functioning in daily life, anxiety symptoms, and depression symptoms. Researchers will compare STEP-UP to referral to community treatment-as-usual mental health services to see if STEP-UP is more effective. conditions: Depression, Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 220 type: ESTIMATED name: STEP-UP (transdiagnostic behavioral therapy for pediatric anxiety and depression) name: ARC (assisted referral to community care) measure: Children's Global Assessment Scale (CGAS) measure: Pediatric Anxiety Rating Scale (PARS) measure: Children's Depression Rating Scale -- Revised (CDRS-R) sex: ALL minimumAge: 8 Years maximumAge: 16 Years stdAges: CHILD hasResults: False

 nctId: NCT06273969 id: PK20240105- 001 briefTitle: Ultrasonographic Evaluation of Osteopathic Manipulation for Thoracic Outlet Syndrome acronym: TOS overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-04-24 date: 2024-04-24 date: 2024-02-23 date: 2024-02-23 name: A.T. Still University of Health Sciences class: OTHER briefSummary: The purpose of the study is to develop a protocol to assess blood flow in the upper limb vasculature before and after osteopathic manipulative treatment (OMT) using Pulsed-wave Doppler ultrasonography (US). We will assess the subclavian artery and vein at two locations (above and below the clavicle) and the brachial artery and vein (within the axilla) to determine the reproducibility of the blood flow findings at each location and the impact of OMT on the blood flow. Additionally we will qualitatively assess morphological changes of the brachial plexus before and after OMT with US. conditions: Thoracic Outlet Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Twelve consented male and/or female volunteers between the ages of 18 and 65 with intermittent tingling and/or numbness in one or both hands that has occurred with two weeks of the start date of the study will be evaluated using pulsed-wave doppler ultrasonography (US) and then treated with osteopathic manipulative treatment (OMT).

US examination of the thoracic outlet will be performed using a Mindray-6 ultrasound machine and will include 4 views/positions with the subject in a seated position.

The following intervention will consist of four osteopathic manipulation techniques (OMT) being performed that target the somatic dysfunctions associated with TOS. These techniques include: 1) Direct Thoracic Inlet Myofascial Release (TIMFR); 2) Direct Muscle Energy for the Scalene Muscles; 3) Direct Muscle Energy for the Pectoralis Muscles; and 4) Supraclavicular Fascial Release. primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Osteopathic Manipulative Treatment (OMT) measure: Blood flow changes in the upper extremity. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06273956 id: bleeding scores in ItP briefTitle: Explore the Relationship Between Platelet Count and Bleeding Score in ITP overallStatus: RECRUITING date: 2022-04-10 date: 2025-10-10 date: 2025-12-30 date: 2024-02-23 date: 2024-02-23 name: Assiut University class: OTHER briefSummary: Assessment of bleeding scores in immune thrombocytopenia purpuria to explore the relationship between platelet count and bleeding score in immune thrombocytopenia purpura (ITP) and compare the clinical practicability of bleeding grading systems with adult patients with ITP. conditions: ITP - Immune Thrombocytopenia studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED measure: explore the relationship between platelet count and bleeding assessment systems (ITP Bleeding Assessment Tool (ITP -BAT) and ITP Bleeding Scale (IBLS) in Patients with ITP to measure severity of bleeding sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Aml Sayed Hamed status: RECRUITING city: Assiut country: Egypt name: Rania Mohammed Mahmoud Hafez, professor role: CONTACT phone: +201000019198 email: raniahafez@aun.edu.eg name: Yousreyia Abdel Rahman Ahmed, professor role: CONTACT phone: +201223971307 email: dr_yousryeia@yahoo.com lat: 27.18096 lon: 31.18368 hasResults: False

 nctId: NCT06273943 id: ANRS 0410s CABOPrEP id: 2024-510678-25 type: EUDRACT_NUMBER briefTitle: Impact of Long-acting Injectable Cabotegravir for HIV PrEP in MSM in France. acronym: CABOPrEP overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-10-30 date: 2026-10-30 date: 2024-02-23 date: 2024-02-23 name: ANRS, Emerging Infectious Diseases class: OTHER_GOV briefSummary: The purpose of this study is to evaluate if offering long-acting injectable cabotegravir (CAB-LA) as an additional HIV prevention choice among oral PrEP-experienced men who have sex with men (MSM) in France can significantly increase the sustained PrEP use over time and the PrEP coverage of at-risk sexual risk behaviors. conditions: Prevention studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomly assigned in a 1:1 ratio to remain on their current oral PrEP regimen with daily and/or on-demand TDF/FTC (Control arm) or to switch to a CAB-LA based PrEP (Intervention arm). primaryPurpose: PREVENTION masking: NONE count: 322 type: ESTIMATED name: Cabotegravir Tablets, for oral use. name: Cabotegravir Extended-Release Injectable Suspension, for intramuscular use. name: Tenofovir disoproxil/Emtricitabine 300mg/200mg fixed-dose combination tablets, for oral use name: Rectal Biopsies measure: Number of protocol visits completed with a documented PrEP prescription aligned with the randomization arm. measure: Number of protocol visits completed with a documented PrEP prescription aligned with the randomization arm. measure: Number of participants with missing follow-up visits, temporary PrEP discontinuation, permanent PrEP discontinuation, switching to another PrEP regimen, study discontinuation, lost to follow-up. measure: Number of participants whose last condomless anal sexual intercourse was not covered by PrEP. measure: Number of condomless anal sexual intercourse in the month prior to each study visit. measure: Number of sexual partners in the last 3 months. measure: Mean PrEP satisfaction score based on study arm. measure: Number of participants with syphilis, chlamydiae, and/or gonorrhea infection. measure: Number of participants with Grade 2 or higher clinical or laboratory drug-related adverse events at any time during the study. measure: Change from baseline in body weight (kg). measure: Change from baseline in lipids measure: Change from baseline in the insulin resistance index (HOMA-IR). measure: Number and severity of injection site reaction. measure: Cabotegravir concentration in plasma and tenofovir diphosphate and emtricitabine triphosphate concentration in dried blood spots. measure: Number of participants with new HIV infection. measure: Number of participants who used psychoactive drugs in the last 3 months measure: Score of quality of life measured by the EuroQol-5D questionnaire measure: Depression score assessed with the Center for Epidemiologic Studies Depression Scale (CES-D). measure: Self-esteem score assessed with the Rosenberg scale. measure: Number and nature of uses of community peer support and therapeutic patient education. sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Hôtel Dieu city: Paris state: Ile De France zip: 75004 country: France lat: 48.85341 lon: 2.3488 facility: Hôpital Lariboisière city: Paris state: Ile De France zip: 75010 country: France lat: 48.85341 lon: 2.3488 facility: Hôpital Saint Louis city: Paris state: Ile De France zip: 75010 country: France lat: 48.85341 lon: 2.3488 facility: Hôpital Saint Antoine city: Paris state: Ile De France zip: 75012 country: France lat: 48.85341 lon: 2.3488 facility: Hôpital La Pitié Salpêtrière city: Paris state: Ile De France zip: 75013 country: France lat: 48.85341 lon: 2.3488 facility: Hôpital Necker city: Paris state: Ile De France zip: 75015 country: France lat: 48.85341 lon: 2.3488 facility: Hôpital Bichat city: Paris state: Ile De France zip: 75018 country: France lat: 48.85341 lon: 2.3488 facility: Hôpital Tenon city: Paris state: Ile De France zip: 75020 country: France lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06273930 id: AFID briefTitle: Reduction of Dentine Hypersensitivity After Use of Different Dentifrices acronym: Dentrifices overallStatus: RECRUITING date: 2024-02-01 date: 2024-10-15 date: 2024-10-30 date: 2024-02-23 date: 2024-02-23 name: Armed Forces Institute of Dentistry, Pakistan class: OTHER briefSummary: To assess the impact of the use of 5% Calcium Sodium Phosphosilicate or 8% Arginine dentifrices on dentinal hypersensitivity following non-surgical periodontal therapy in patients with periodontitis. conditions: Sensitivity, Tooth studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 87 type: ESTIMATED name: 5% CALCIUM SODIUM PHOSPHOSILICATE name: 8% Arginine measure: To assess the impact on Dentinal hypersensitivity following the use of 5% CSPS or 8% Arginine following non-surgical periodontal therapy in patients with Periodontitis by VAS. measure: To assess the impact on Dentinal hypersensitivity following the use of 5% CSPS or 8% Arginine following non-surgical periodontal therapy in patients with Periodontitis by Schiff scale. sex: ALL minimumAge: 30 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AFID status: RECRUITING city: Rawalpindi country: Pakistan name: Muhammad J Iqbal role: CONTACT lat: 33.6007 lon: 73.0679 hasResults: False

 nctId: NCT06273917 id: FY23_Pilot2_Dresden briefTitle: Deprescribing Potentially Inappropriate Medications in the Emergency Department for Persons Living With Dementia acronym: IMPACT overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-10-01 date: 2025-01-01 date: 2024-02-23 date: 2024-02-23 name: National Institute on Aging (NIA) class: NIH name: Brown University briefSummary: Aim 1: To demonstrate the feasibility by determining proportion of completed medication reconciliation, Central Nervous System active Potentially Inappropriate Medication (CNS PIM) use among patients with Alzheimer's Disease and Related Dementias (ADRD) and Mild Cognitive Impairment (MCI) in the emergency department (ED), and communication between ED clinical pharmacists and outpatient prescribers.

Aim 2: To demonstrate the feasibility of collecting the primary and secondary outcomes for a subsequent study. The future primary outcome will be reduction in CNS PIMs 90 days after an ED visit. Secondary outcomes will include outpatient follow-up, repeat ED visits, and hospitalizations during the 90 days following an ED visit.

Aim 3: To demonstrate the acceptability of the PRIDE intervention to outpatient clinicians using the Acceptability of Intervention Measure and qualitative analysis of responses. conditions: Dementia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 290 type: ESTIMATED name: PRIDE measure: Pharmacist communication of deprescribing recommendation measure: Medication reconciliation measure: Medication supply of CNS PIMs measure: Outpatient follow up measure: Repeat Emergency Department visits sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northwestern Memorial Hospital city: Chicago state: Illinois zip: 60611 country: United States name: Scott Dresden, Dr. role: CONTACT phone: 312-926-6494 email: sdresden@nm.org name: Anuva Fellner role: CONTACT phone: 312-926-8816 email: anuva.fellner@nm.org lat: 41.85003 lon: -87.65005 facility: Northwestern Medicine Lake Forest Hospital city: Lake Forest state: Illinois zip: 60045 country: United States name: Timothy Loftus role: CONTACT phone: 312-926-6612 email: timothy.loftus@northwestern.edu lat: 42.25863 lon: -87.84063 facility: Northwestern Medicine Palos Hospital city: Palos Heights state: Illinois zip: 60463 country: United States name: JiHun Lee, DO role: CONTACT phone: 708-923-5811 email: jihun.lee@nm.org lat: 41.66809 lon: -87.79644 hasResults: False

 nctId: NCT06273904 id: Pro00132631 briefTitle: Modulating Escape Using Focused Ultrasound overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-09 date: 2025-12 date: 2024-02-23 date: 2024-02-23 name: Medical University of South Carolina class: OTHER briefSummary: This is a study to find out if a cutting-edge technology called transcranial focused ultrasound (tFUS) can be used to treat how people with anxiety or related concerns cope with emotional situations. tFUS is a brain stimulation technology that causes temporary changes in the activity of deep brain areas without a need for any surgery or other permanent or invasive procedures.

This study is recruiting participants who recently started treatment for anxiety or a related concern to come in for 3 visits at the Medical University of South Carolina. At the first visit, participants will do interviews and surveys asking about anxiety and related concerns, and they do tasks where they respond to emotional pictures while brain activity is measured using magnetic resonance imaging (MRI). At the next two visits, participants again do a task where they see and react to emotional images, and this time the task is done once before and again once after receiving tFUS that either actively causes temporary changes (lasting for about an hour) in a targeted brain area or is not active (no changes elicited). At each tFUS visit, responses are measured with sensors worn on the hand, arms, face, and head (these visits do not involve MRI).

Each visit in this study is expected to last between 2 - 3 hours. This study is not a treatment study, but it could help improve treatment in the future. Participants in this study are paid for their time. conditions: Anxiety Disorders studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 40 type: ESTIMATED name: Active transcranial focused ultrasound (tFUS) name: Sham transcranial focused ultrasound (tFUS) measure: Change in Fear-Potentiated Startle Reflex measure: Change in speed to initiate avoidance behavior measure: Change in Electroencephalography (EEG)-Assessed Contingent Negative Variation During Escape/ Avoidance Preparation measure: Change in Electroencephalography (EEG)-Assessed N200 During Implicit Approach/ Avoid Bias Assessment measure: Change in Electroencephalography (EEG)-Assessed Theta-Band Power During Behavioral Tasks measure: Change in High-Frequency Heart Rate Variability/ Respiratory Sinus Arrhythmia measure: Change in Task-Based Heart Rate (Beats per Minute) Changes measure: Change in Task-Based Galvanic Skin Conductance measure: Change in State Anxiety During Session measure: Task-Related Regional Brain Activation sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of South Carolina city: Charleston state: South Carolina zip: 29425 country: United States lat: 32.77657 lon: -79.93092 hasResults: False

 nctId: NCT06273891 id: INOVA-2023-58 briefTitle: Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes acronym: PRACET overallStatus: RECRUITING date: 2024-03-08 date: 2025-08-01 date: 2025-10-01 date: 2024-02-23 date: 2024-03-15 name: Inova Fairfax Hospital class: OTHER briefSummary: The goal of this study is to help identify the best antibiotic treatment for pregnant people when their water breaks prematurely (a condition abbreviated as PPROM). Current practice is to attempt to maintain the pregnancy until at least 34 weeks gestational age, when the risks of prematurity to the baby are lessened. Research shows that antibiotics help the pregnancy last longer, but there have been limited studies about which combination works best. Currently, both azithromycin and erythromycin are accepted antibiotic treatments, in addition to ampicillin and amoxicillin. Participants diagnosed with PPROM will be randomized to receive ampicillin and amoxicillin plus either azithromycin or erythromycin, in addition to the care they would normally receive. Studying these two drugs will help decide the best care for future patients with PPROM. conditions: Premature Rupture of Membrane studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 140 type: ESTIMATED name: Erythromycin name: Azithromycin measure: Latency period sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Inova Fairfax Medical Campus status: RECRUITING city: Falls Church state: Virginia zip: 22042 country: United States name: Ellen M Murrin, DO role: CONTACT phone: 703-776-6040 email: ellen.murrin@inova.org name: Antonio Saad, MD, MBA role: PRINCIPAL_INVESTIGATOR name: Ellen M Murrin, DO role: PRINCIPAL_INVESTIGATOR lat: 38.88233 lon: -77.17109 hasResults: False

 nctId: NCT06273878 id: RS1439/20 briefTitle: From Fetal-maternal Interface Immune Tolerance to Endometrial Cancer Immune Escape: Potential Targets for Immunotherapy overallStatus: RECRUITING date: 2023-01-15 date: 2025-01-15 date: 2025-01-15 date: 2024-02-23 date: 2024-02-23 name: Regina Elena Cancer Institute class: OTHER name: Università degli Studi dell'Insubria briefSummary: Non-interventional retro-prospective study on Endometrial tissue samples taken from surgically treated patients. conditions: Endometrial Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 80 type: ESTIMATED measure: Validate the differential expression of LOX-1 and NALP3 receptors. measure: Characterize phenotypic alterations. measure: Evaluate the predictive and/or prognostic value. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Institute - IFO - status: RECRUITING city: Rome state: RM zip: 00144 country: Italy name: Benito Chiofalo, Doctor role: CONTACT phone: ND email: benito.chiofalo@ifo.gov.it name: Valentina Bruno, Doctor role: CONTACT phone: ND email: valentina.bruno@ifo.gov.it lat: 41.89193 lon: 12.51133 facility: "Regina Elena" National Cancer Institute status: RECRUITING city: Rome zip: 00144 country: Italy name: Benito Chiofalo, Doctor role: CONTACT phone: ND email: benito.chiofalo@ifo.it name: Valentina Bruno, Doctor role: CONTACT phone: ND email: valentina.bruno@ifo.gov.it lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06273865 id: HEMSTOL77 briefTitle: Version Testing of EnzySystem Version A for Hemophilia A overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-10-15 date: 2024-12-15 date: 2024-02-23 date: 2024-02-23 name: Radboud University Medical Center class: OTHER name: Enzyre B.V. briefSummary: Background of the study:

To measure blood clotting, blood is taken from a vein. This blood is processed in the laboratory and then tested. A new device has been developed that requires only a very small volume of blood (5-10 drops of blood) to perform the laboratory tests. The long-term goal is that this device can be used by a doctor or at home to quickly measure blood clotting. In this research we want to compare this new system with the standard methods - measurement in the laboratory - and evaluate whether the correct value is determined.

Objective of the study:

The primary objective of this study is to demonstrate that the EnzySystem HemA version A can record thrombin generation TG and quantify FVIII activity levels within a time frame of 60 min in fresh whole blood samples of healthy volunteers and patients with hemophilia A in the Enzyre laboratory (for healthy volunteers) and the Radboudumc (for patients with hemophilia A).

Study design:

This is a cross-sectional observational study. All participants are asked to fill a questionnaire prior to blood collection. The blood of healthy volunteers will be collected in an office of Enzyre BV, the blood of patients will be collected in the Radboudumc. Blood collection, by venepuncture, will be conducted by a Radboudumc research nurse or physician of the research team in both locations. In total, four blood tubes with citrate as anticoagulant will be drawn (a total of around 11 mL).

Study population:

The study population consists of 20 healthy volunteers: evenly distributed between male and female; ages spread over the range from 20 to 70 years old; recruited by Enzyre via advertisement. 20 Patients: 5 severe hemophilia A; 5 moderate hemophilia A; 10 mild hemophilia A; recruited from the Hemophilia Treatment Center (HTC) Nijmegen-Eindhoven-Maastricht (NEM) (location Radboudumc).

Primary study parameters/outcome of the study:

Demonstrate that the EnzySystem HemA version A can record TG and quantitative FVIII activity levels within a time frame of 60 min in fresh blood samples of healthy volunteers and patients with hemophilia A.

Secondary study parameters/outcome of the study (if applicable):

Secondary study parameters are composed whether the measured values comply with the desired assay specificity and accuracy.

Outcomes are analysed for equivalence compared to one-stage FVIII assay, FVIII chromogenic assay, thrombin generation via the Nijmegen Hemostasis Assay, and possibly via the Technoclone assay.

Is it possible to measure FVIII activity with the EnzySystem HemA version A in fresh blood samples of healthy volunteers and patients with hemophilia A, compared to the gold standard with;

* Precision in the normal range (60-140%): min. 30%
* Precision in the low range (3-10%): min. 50%
* Limit of Detection range min. 100 % FVIII activity
* Limit of Detection low range min. 3 % FVIII activity Is it possible to measure TG with the EnzySystem HemA version A in fresh blood samples of healthy volunteers and patients with hemophilia A, compared to the gold standard with;
* Precision in the normal range (60-140%) of control samples: min. 30%
* Precision in patient with hemophilia A: min. 50%
* Limit of Detection, high range \> 400 nM thrombin activity
* Limit of Detection measured with Plasma, low range \< 50 nM thrombin

Other study parameters All samples will also be tested for other hemostasis specific parameters as these parameters may affect a proper measurement of both FVIII activity and Thrombin Generation. The following parameters will be measured in plasma obtained from the whole blood vacutainers. Moreover, left over samples (plasma) will eventually be used to develop other coagulation related parameters.

* von Willebrand Factor antigen levels
* von Willebrand Factor ristocetin activity levels
* Prothrombin Fragment 1+2 levels
* ADAMTS13 activity
* FVIII antigen levels
* blood group conditions: Hemophilia A studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 40 type: ESTIMATED name: Several assays measure: Time between venipuncture and EnzySystem assay results measure: Validity of EnzySystem FVIII activity results measure: Validity of EnzySystem thrombin generation results sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Radboud university medical center city: Nijmegen zip: 6525 GA country: Netherlands lat: 51.8425 lon: 5.85278 hasResults: False

 nctId: NCT06273852 id: PBL-0405-01 briefTitle: A Study of the Intratumoral Microdose Administration of PBA-0405 in Patients With Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-03 date: 2024-02-23 date: 2024-02-29 name: Pure Biologics S.A. class: INDUSTRY name: Presage Biosciences briefSummary: This is a multi-center, single arm, open-label, localized pharmacodynamic biomarker Phase 0 trial designed to study the biological effects within the tumor microenvironment of PBA-0405 when administered intratumorally in microdose quantities via the CIVO device. conditions: Head and Neck Squamous Cell Carcinoma conditions: Soft Tissue Sarcoma Adult conditions: Triple Negative Breast Cancer studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is an exploratory clinical trial to evaluate intratumoral mechanistic effects of novel and approved agents on intact human tumors. This substudy is not blinded. primaryPurpose: BASIC_SCIENCE masking: NONE count: 15 type: ESTIMATED name: PBA-0405 measure: Quantification of Cell Death and Immune Cell Biomarkers by immuno-histochemistry (IHC) and In-Situ Hybridization (ISH) measure: Number of Patients with Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06273839 id: B3461114 briefTitle: A Study to Learn How Different Forms of Study Medicine Tafamidis Are Taken Up Into The Blood in Healthy Adults overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-27 date: 2024-05-27 date: 2024-05-27 date: 2024-02-23 date: 2024-04-02 name: Pfizer class: INDUSTRY briefSummary: The purpose of this clinical trial is to compare the amount of tafamidis in the blood of healthy adult participants after taking three different forms of tafamidis by mouth. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: NONE count: 12 type: ACTUAL name: Tafamidis 61 mg free acid tablet (Test 1) name: Tafamidis 70 mg free acid tablet (Test 1) name: Tafamidis 61 mg free acid capsule (Reference) measure: Area under the concentration-time curve (AUCinf) measure: Maximum observed plasma concentration (Cmax) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pfizer Clinical Research Unit - Brussels city: Brussels state: Bruxelles-capitale, Région DE zip: B-1070 country: Belgium lat: 50.85045 lon: 4.34878 hasResults: False

 nctId: NCT06273826 id: 01 briefTitle: "Colorectal Leakage App" for Early Detection of Anastomotic Leakage After Colorectal Surgeries overallStatus: RECRUITING date: 2024-01-19 date: 2025-01 date: 2025-05 date: 2024-02-23 date: 2024-02-23 name: National Research Oncology and Transplantology Center, Kazakhstan class: OTHER briefSummary: The aim of this prospective observational study is to evaluate the effectiveness of the mobile application "Colorectal Leakage App" in the early diagnosis of anastomotic leakage after colorectal surgeries at the National Research Oncology Center in Astana, Kazakhstan.

Main Questions:

1. Development, validation, and implementation of the mobile application "Colorectal Leakage App," based on the Dutch Leakage Score.
2. Evaluate the diagnostic effectiveness of the application in detecting anastomotic leakage after colorectal surgeries.
3. Determine the frequency of anastomotic leakage after colorectal surgeries performed in the colorectal surgery sector of the National Research Oncology Center in the Astana city.

Participants in the study, individuals aged 18 and above undergoing colorectal surgeries, will be monitored by the mobile application "Colorectal Leakage App" in the postoperative period for early identification of anastomotic leakage. conditions: Anastomotic Leak Large Intestine conditions: Anastomotic Leak Rectum studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: "Colorectal Leakage App" measure: Diagnostic effectiveness of "Colorectal Leakage App". measure: Frequency of anastomotic leakage after colorectal surgeries. measure: Mortality within 30 days measure: Delay in the diagnosis of anastomotic leakage measure: Duration of hospital stay. measure: Number of days in the ICU. measure: Number of days between surgery and detection of AL. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Research Oncology Center status: RECRUITING city: Astana zip: 010000 country: Kazakhstan name: Saule Khamzina, MD role: CONTACT phone: +77757172961 email: khamzina.saule88@gmail.com lat: 51.1801 lon: 71.44598 hasResults: False

 nctId: NCT06273813 id: NOV-1776-CL-101 briefTitle: Treatment of Topical Ketorolac Gel in Acute Gouty Flare overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-12 date: 2024-12 date: 2024-02-23 date: 2024-02-23 name: Novilla Pharmaceuticals class: INDUSTRY briefSummary: This study will be a phase 1, open-label, bioavailability, safety and PK study of topically applied transcutaneous ketorolac tromethamine gel 12.5% (/w) (NOV-1776) versus intravenous administration of approved ketorolac tromethamine injection, USP (15mg/mL) comparator in healthy volunteers, including an evaluation of safety, tolerability, and efficacy in gout participants with flare-up. conditions: Acute Gouty Arthritis conditions: Acute Pain conditions: Gout Flare studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: All cohost 1 subjects receive single ketorolac tromethamine injection, followed by escalating doses of ketorolac tromethamine gel Cohort 2 and 3 subjects receive doses of ketorolac tromethamine gel for 5 days primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Ketorolac Tromethamine 15 MG/ML name: Ketorolac Tromethamine measure: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 measure: Area Under the Plasma Concentration Versus Time Curve (AUC) of topical ketorolac tromethamine sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Paratus Clinical, city: Blacktown zip: 2148 country: Australia name: Rahul Rahul role: CONTACT phone: +61 1300 742 326 email: info@paratusclinical.com name: Rahul Rahul role: PRINCIPAL_INVESTIGATOR lat: -33.76667 lon: 150.91667 facility: Linear Clinical Research Ltd city: Nedlands zip: 6009 country: Australia name: Jasmine Williams role: CONTACT phone: +61 8 6382 5100 lat: -31.98184 lon: 115.8073 hasResults: False

 nctId: NCT06273800 id: M23CMC briefTitle: Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients acronym: Chemosense overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2035-07-15 date: 2036-07-15 date: 2024-02-23 date: 2024-03-29 name: The Netherlands Cancer Institute class: OTHER briefSummary: This study is a prospective, multicenter study in which a serum sample will be collected at the day of starting neo adjuvant treatment in breast cancer patients conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: collection of serum sample blood at first day of neo adjuvant treatment primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: Blood sample measure: pCR rate measure: Radiological reduction on tumor size measure: Pathological reduction on tumor size measure: Residual cancer burden (RCB) measure: Distant recurrence free interval (DRFI) measure: Recurrence-free interval (RFI) measure: Overall survival (OS) sex: FEMALE minimumAge: 18 Years maximumAge: 59 Years stdAges: ADULT facility: Antoni van Leeuwenhoek city: Amsterdam state: Noord-Holland zip: 1066CX country: Netherlands name: Laura Bornes, PhD role: CONTACT name: Veerle Geurts, PhD role: CONTACT name: Marleen Kok, MD role: PRINCIPAL_INVESTIGATOR lat: 52.37403 lon: 4.88969 hasResults: False

 nctId: NCT06273787 id: Mitu briefTitle: Effect of Diaphragmatic Release in Sleep Quality During Pregnancy overallStatus: RECRUITING date: 2023-11-01 date: 2024-02-29 date: 2024-03-17 date: 2024-02-23 date: 2024-02-23 name: MTI University class: OTHER briefSummary: Sleep disordered breathing (SDB) is very common during pregnancy, and is most likely explained by hormonal, physiological and physical changes. Maternal obesity, one of the major risk factors for SDB, together with physiological changes in pregnancy may predispose women to develop SDB. SDB has been associated with poor maternal and fetal outcomes. Thus, early identification, diagnosis and treatment of SDB are important in pregnancy. conditions: SLEEP APNEA PREGNANCY studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment group a : Diaphragmatic Release in addition to positioning instruction group b: positioning instruction primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 44 type: ESTIMATED name: diaphragmatic release measure: pittshurgh sleep quality index measure: diaphragmatic excursion assessment sex: FEMALE minimumAge: 30 Years maximumAge: 40 Years stdAges: ADULT facility: MTI status: RECRUITING city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06273774 id: 8189-020 id: MK-8189-020 type: OTHER domain: Merck briefTitle: A Study of MK-8189 in Participants With Bipolar I Disorder (MK-8189-020) overallStatus: RECRUITING date: 2024-04-08 date: 2024-09-10 date: 2024-09-10 date: 2024-02-23 date: 2024-04-23 name: Merck Sharp & Dohme LLC class: INDUSTRY briefSummary: The goal of this study is to evaluate the safety and tolerability of MK-8189 in participants with stable bipolar I disorder. There will be no hypothesis testing in this study. conditions: Bipolar I Disorder studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 32 type: ESTIMATED name: MK-8189 name: Placebo measure: Number of Participants Who Experience One or More Adverse Events (AEs) measure: Number of Participants Who Discontinue Study Treatment Due to an AE sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Hassman Research Institute Marlton Site ( Site 0006) status: RECRUITING city: Marlton state: New Jersey zip: 08053 country: United States name: Study Coordinator role: CONTACT phone: 267-981-8911 lat: 39.89122 lon: -74.92183 hasResults: False

 nctId: NCT06273761 id: UW 23-550 briefTitle: Evaluation of Medication Management Service overallStatus: RECRUITING date: 2024-02-06 date: 2026-08-01 date: 2027-05-01 date: 2024-02-23 date: 2024-02-23 name: The University of Hong Kong class: OTHER name: Hong Kong Jockey Club Charities Trust name: Hong Kong Sheng Kung Hui Welfare Council name: Hong Kong Young Women's Christian Association name: Haven of Hope Hospital name: Pok Oi Hospital name: St. James Settlement name: Aberdeen Kai-fong Welfare Association name: Health In Action name: Lok Sin Tong Benevolent Society, Kowloon briefSummary: Medication management services (MMS) is a pharmacist-led service of optimizing the medication use and health outcomes, by promoting medication safety and enhancing the ability in self-management of health and diseases of patients and their caregivers. Yet, only limited evidence on the implementation of MMS service in Hong Kong is available. The goal of this clinical trial is to evaluate the cost effectiveness and effects of implementing MMS in community pharmacies owned by 8 non-government organizations (NGOs) in Hong Kong on humanistic and clinical outcomes in patients with hypertension and/or type II diabetes mellitus. The clinical trial aims to look into the following aspects:

* To evaluate the perception and satisfaction of patients on MMS service
* To investigate whether MMS could improve patients' adherence to their medication regimen, health-related quality of life, health outcomes and health service utilization, as well as their ability to understand and cope with their illness and drug-related problems
* To identify and categorize the types of drug-related problems identified during MMS
* To evaluate the cost-effectiveness of implementing MMS in community pharmacies

MMS services will be rolled out in a total of 8 NGO community pharmacies progressively (2 pharmacies per phase) in 4 successive phases. Participants will complete the questionnaires at the following time points throughout the trial, namely 1) during recruitment, 2) baseline (1 month before MMS), 3) 3 months after MMS begins, 4) 12 months after MMS begins, and 5) 24 months after MMS begins. Researchers will compare the results of questionnaires conducted at different time points to identify the potential changes in the effects of MMS. Furthermore, researchers will link up the electronic health records of the participants and identify the potential changes in the health outcomes and health service utilizations after receiving MMS. conditions: Medication Adherence conditions: Medication Safety conditions: Diabetes Mellitus, Type 2 conditions: Hypertension conditions: Polypharmacy conditions: High Risk Medications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 640 type: ESTIMATED name: Medication Management Service (MMS) measure: Medication adherence measure: Additional health service utilization measure: Patient perception and satisfaction measure: Patient perceived sensitivity to medicines measure: Social impact measure: Health-related quality of life measure: Drug-related problems measure: Change in costs measure: Change in effectiveness measure: Incremental cost effectiveness ratio (ICER) measure: Beliefs in medicines sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aberdeen Kai-Fong Welfare Association A-Lively Community Pharmacy status: RECRUITING city: Hong Kong country: Hong Kong name: Kam Kit Mak role: CONTACT phone: 3550 5460 email: kennethmak.kk@aka.org.hk lat: 22.27832 lon: 114.17469 facility: Health In Action Community Pharmacy status: RECRUITING city: Hong Kong country: Hong Kong name: Ka Shing Mak role: CONTACT phone: 3612 9515 email: simonmak@hia.org.hk lat: 22.27832 lon: 114.17469 facility: Hong Kong Sheng Kung Hui Welfare Council Community Pharmacy status: RECRUITING city: Hong Kong country: Hong Kong name: Sze Yin Lee role: CONTACT phone: 2116 0382 email: wtspharm@skhwc.org.hk lat: 22.27832 lon: 114.17469 facility: PHARM+ Haven of Hope Community Pharmacy status: RECRUITING city: Hong Kong country: Hong Kong name: Mei Lun Bruce Tsui role: CONTACT phone: 2156 2280 email: compharm@hohcs.org.hk lat: 22.27832 lon: 114.17469 facility: PHARM+ Pok Oi Hospital Community Pharmacy status: RECRUITING city: Hong Kong country: Hong Kong name: Kwok leung Li role: CONTACT phone: 59506880 email: ylcppharm1@pokoi.org.hk name: Anson Tsz Kin Leung role: CONTACT email: ylcppharic@pokoi.org.hk lat: 22.27832 lon: 114.17469 facility: PHARM+ St. James' Settlement Community Pharmacy status: RECRUITING city: Hong Kong country: Hong Kong name: Kit Sze Chan role: CONTACT phone: 2835 4320 email: ks.chan@sjs.org.hk lat: 22.27832 lon: 114.17469 facility: PHARM+ The Lok Sin Tong Community Pharmacy status: RECRUITING city: Hong Kong country: Hong Kong name: William Ho Ching Yuen role: CONTACT phone: 21872780 email: tpcp@loksintong.org lat: 22.27832 lon: 114.17469 facility: PHARM+ YWCA Community Pharmacy status: RECRUITING city: Hong Kong country: Hong Kong name: Sui Hong Ho role: CONTACT phone: 2511 6020 email: jackyho@ywca.org.hk lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06273748 id: RChildUV briefTitle: RChildUV:Study on Non-infectious Chronic Uveitis in Pediatric Age overallStatus: RECRUITING date: 2022-02-10 date: 2032-02-01 date: 2032-05-02 date: 2024-02-23 date: 2024-03-08 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: Uveitis is an inflammatory disease of the uvea, one of the highly vascularized fundamental structures of the eye. It is a rare condition in children, with an incidence in the pediatric population ranging from 2% to 14% of all uveitis cases. The diagnosis and management of patients with uveitis rely on a multidisciplinary approach involving an ophthalmologist, a rheumatologist, and an infectious disease specialist to establish the correct diagnosis and assess the involvement of other organs. In Italy, there is no national or regional registry for non-infectious chronic uveitis as per the Prime Ministerial Decree (DPCM) of March 3, 2017 (Identification of surveillance systems and registries for mortality, tumors, and other diseases). However, many clinical centers adopt data recording systems to evaluate the quality of care and to study diseases and outcomes. The Universitary Hospital Meyer Institute Research Hospital (IRCCS) is a national referral center for managing these pediatric cases of non-infectious chronic uveitis, estimated to constitute 95% of all pediatric uveitis cases conditions: Uveitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 290 type: ESTIMATED measure: Describe a population of paediatric patients with chronic non-infectious uveitis measure: Describe a population of paediatric patients with chronic non-infectious uveitis measure: Identify any differences between the different forms of uveitis in terms of characteristics and outcomes measure: Identify risk factors for a more severe course measure: Frequency achievement of response for each drug according to the definition of response measure: Time to archieve the response after drug initiation measure: Achievement of inactive disease on therapy according to the definition of MIWGUC measure: Time to achieve inactive disease on therapy according to the definition of MIWGUC measure: Presence and percentages of flares on therapy after achievement of remission on therapy measure: Time to the first flare on therapy measure: Time to flare after drug withdrawal sex: ALL minimumAge: 1 Year maximumAge: 16 Years stdAges: CHILD facility: Cincinnati Children's Hospital Medical Center status: RECRUITING city: Cincinnati state: Ohio zip: 45207 country: United States name: Sheila Angels-Han role: CONTACT lat: 39.12713 lon: -84.51435 facility: - ATTIKON General Hospital status: RECRUITING city: Athens zip: 12462 country: Greece name: Lampros Fotis role: CONTACT lat: 37.97945 lon: 23.71622 facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Florence state: Firenze country: Italy name: Gabriele Simonini role: CONTACT email: gabriele.simonini@meyer.it lat: 43.77925 lon: 11.24626 facility: Ospedale Spedali Civili di Brescia status: NOT_YET_RECRUITING city: Brescia country: Italy name: Marco Cattalini role: CONTACT lat: 45.53558 lon: 10.21472 facility: IRCCS materno infantile Burlo Garofolo status: RECRUITING city: Trieste country: Italy name: Serena Pastore role: CONTACT lat: 45.64953 lon: 13.77679 hasResults: False

 nctId: NCT06273735 id: 2019-PS-33b id: PV7350 type: OTHER domain: Martini-Klinik briefTitle: Prospective Trial: Myocardial Injury After Noncardiac Surgery (MINS) Following Radical Prostatectomy overallStatus: RECRUITING date: 2023-08-14 date: 2024-03 date: 2026-10 date: 2024-02-22 date: 2024-02-22 name: Martini-Klinik am UKE GmbH class: OTHER name: Universitätsklinikum Hamburg-Eppendorf briefSummary: The aim of this study is to prospectively analyse the rate of MINS in the standardised radical prostatectomy patient clientele at the Martini-Clinic and to identify risk factors. Pre- and postoperative troponin levels are determined (1st and 2nd postoperative day). The patient's height, weight, age and cardiovascular risk factors (including determination of the Revised Cardiac Risk Index) are recorded in the medical history as well as previous medical and interventional cardiological therapy. Furthermore, the prostate carcinoma-associated tumour and surgical parameters are determined. Clinically significant cardiovascular events during the inpatient stay are also described. Finally, a description of the rate of events, a check for correlation with the Revised Cardiac Risk Index and an identification of risk factors are carried out. conditions: Myocardial Injury studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Pre- and postoperative determination of troponin as part of the study and 24-month FU survey measure: rate of MINS in standardised open and robot-assisted radical prostatectomy sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Martini-Klinik am UKE GmbH status: RECRUITING city: Hamburg zip: 20246 country: Germany name: Markus Graefen, Professor role: CONTACT phone: +4904741051300 email: graefen@uke.de name: Anke Renter role: CONTACT phone: +49407410533115 email: renter@uke.de lat: 53.57532 lon: 10.01534 hasResults: False

 nctId: NCT06273722 id: 2024-0059 briefTitle: D-OCT for Detection and Subtyping of BCC: a Diagnostic Cohort Study overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-07-01 date: 2024-12-31 date: 2024-02-22 date: 2024-02-22 name: Maastricht University Medical Center class: OTHER briefSummary: The current gold standard for diagnosing basal cell carcinoma (BCC) is the histopathological examination of biopsy specimen. However, non-invasive imaging modalities such as optical coherence tomography (OCT) may replace biopsy if BCC presence and its subtype can be established with high confidence. Subtype differentiation is crucial; while superficial BCCs (sBCC) can be treated topically, nodular (nBCC) and infiltrative BCCs (iBCC) require excision. Dynamic OCT (D-OCT) is a functionality integrated within the OCT device, enabling the visualization of vascular structures through speckle variance.

Descriptive studies have unveiled vascular shapes and patterns associated with BCC and its respective subtypes. These findings suggest that D-OCT could contribute to the accuracy of BCC detection and subtyping. Yet comparative clinical studies between OCT and D-OCT are lacking. In the proposed diagnostic cohort study, we aim to assess whether D-OCT assessment is superior to OCT in terms of accuracy for BCC detection and subtyping. conditions: Basal Cell Carcinoma conditions: Optical Coherence Tomography studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 424 type: ESTIMATED name: Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner measure: Diagnostic accuracy for BCC detection on D-OCT assessment measure: Diagnostic accuracy for BCC subtyping on D-OCT assessment measure: Diagnostic value of vascular structures and patterns sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06273709 id: 2023-3698 briefTitle: Remote Assessment of OCT Scans for BCC Detection overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-07-01 date: 2024-12-31 date: 2024-02-22 date: 2024-02-22 name: Maastricht University Medical Center class: OTHER briefSummary: Basal cell carcinoma (BCC) is the most common form of cancer and entails approximately 80% of all cutaneous malignancies. This locally destructive neoplasm is commonly diagnosed by punch biopsy which is considered painful, causes procedural scarring and carries a small risk of infection and re-bleeding associated with invasive procedures. Moreover, awaiting the results of the subsequent histopathological examination causes treatment delay and can be stressful for the patient. The drawbacks of biopsy could be overcome by optical coherence tomography (OCT), a non-invasive diagnostic modality that may replace biopsy in up to 66% of patients. However, OCT assessors are scarce which hinders the implementation of OCT. This problem may be addressed by teledermatology in which remote OCT assessment by an assessor facilitates simultaneous assessment for multiple clinics. Remote OCT assessment withholds the OCT assessor from visually inspecting the lesion. But the effect of visual inspection on the diagnostic accuracy remains unknown and the question arises whether visual inspection is necessary for accurate OCT assessment. In this diagnostic case-control study we will determine whether distant OCT assessment without visual information on the lesion is non-inferior to distant OCT assessment with clinical and dermoscopic photographs (CDP-OCT). conditions: Basal Cell Carcinoma studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner measure: Diagnostic accuracy of high-confidence BCC diagnosis with and without clinical/dermoscopic photographs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06273696 id: 2019-519 id: NU2GGH001927 type: OTHER_GRANT domain: Centers for Disease Control and Prevention briefTitle: Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania overallStatus: COMPLETED date: 2019-05-01 date: 2019-06-11 date: 2019-07-30 date: 2024-02-22 date: 2024-02-22 name: IntraHealth International class: OTHER name: Ministry of Health, Tanzania name: President Office Regional Administration and Local Government, Tanzania name: Centers for Disease Control and Prevention name: Jhpiego name: World Health Organization briefSummary: The goal of this observational study was to evaluate the safety and acceptability of the ShangRing device for male circumcision among men in Shinyanga, Tanzania. The main question aims to answer both provider acceptability (practicality of device use and placement and removal times) and client acceptability (comfort during placement and removal, experience while wearing the ring, and penile appearance after healing). Participants voluntarily underwent male circumcision using the ShangRing device and before being discharged, were interviewed about their experience. Participants were also interviewed at device removal day (day 7), during a follow-up phone call (day 10), a sample were selected to participate in in-depth interviews (day28), and finally all men were asked to return for a follow-up visit (day 49). conditions: Penile Infection conditions: Penile Haematoma conditions: Penile Bleeding conditions: Deformity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 575 type: ACTUAL name: ShangRing measure: Number of Adverse Events measure: Number of Clients with Adverse Events measure: Descriptions of Adverse Events measure: Provider Training measure: Client Follow-up Visit Rate measure: Client Preference for ShangRing Over Surgical Circumcision measure: Client Recommendation Rate measure: Cosmetic Result Acceptability measure: Client Experience While Performing Routine Activities measure: Client Discomfort measure: Provider Ease of Application measure: Provider Preference measure: Provider Recommendation measure: Description of Procedures measure: Healing rate sex: MALE minimumAge: 13 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Kahama District Hospital city: Shinyanga country: Tanzania lat: -3.66393 lon: 33.42118 facility: Ushetu Health Centre city: Shinyanga country: Tanzania lat: -3.66393 lon: 33.42118 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2018-10-22 uploadDate: 2024-02-14T09:36 filename: Prot_000.pdf size: 2701616 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2018-07-01 uploadDate: 2023-01-18T15:12 filename: ICF_001.pdf size: 173615 hasResults: False

 nctId: NCT06273683 id: INOVA-2023-145 briefTitle: Comparison of Two Salpingectomy Techniques for Sterilization at the Time of Cesarean Delivery overallStatus: RECRUITING date: 2024-03-11 date: 2024-12 date: 2024-12 date: 2024-02-22 date: 2024-03-20 name: Inova Health Care Services class: OTHER briefSummary: One in three women of reproductive age utilize tubal sterilization for contraception, and sterilization is often requested at time of cesarean delivery. Complete salpingectomy for the purpose of permanent sterilization at the time of cesarean birth is increasingly being performed worldwide.

A preferred complete salpingectomy technique for the purpose of sterilization at the time of cesarean delivery has not emerged in current practice. The objective is to compare short-term clinical outcomes and cost of salpingectomy using a hand-held bipolar energy instrument with those of traditional suture ligation. This retrospective cohort study will be conducted from 2017-2023 at a single tertiary care hospital. The investigators hypothesize that bipolar energy instrument use will not significantly improve clinical outcomes. conditions: Permanent Sterilization conditions: Pregnancy Related studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 900 type: ESTIMATED name: Hand-held bipolar energy instrument name: Traditional suture ligation measure: Change in Hemoglobin levels on postoperative day one measure: Completion rate of sterilization measure: Total procedure estimated blood loss measure: Adjacent organ damage measure: Need for blood transfusion measure: Total operative time measure: ICU admission measure: Length of hospital stay measure: Hospital readmission postoperatively measure: Reoperation rates measure: Pain score measure: Surgical site infection measure: Cost sex: FEMALE minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Inova Fairfax Medical campus status: RECRUITING city: Falls Church state: Virginia zip: 22042 country: United States name: Jean W Thermolice, MD role: CONTACT phone: 703-531-3000 email: jean.thermolice@inova.org name: Bianca Nguyen, MD role: CONTACT email: bianca.nguyen@inova.org name: Sofia Girald-Berlingeri, MD role: SUB_INVESTIGATOR name: Bianca Nguyen, MD role: SUB_INVESTIGATOR name: Catherine Kim, MD role: SUB_INVESTIGATOR name: Miranda Newell, MS role: SUB_INVESTIGATOR name: Renee Brenner, BS role: SUB_INVESTIGATOR lat: 38.88233 lon: -77.17109 hasResults: False

 nctId: NCT06273670 id: 04-2023-200279 briefTitle: Postpartum Initiation of Long-acting Reversible Contraceptives: Knowledge Attitude and Practice Study (KAP) acronym: KAP overallStatus: RECRUITING date: 2023-06-15 date: 2024-12 date: 2025-10 date: 2024-02-22 date: 2024-02-22 name: Assiut University class: OTHER briefSummary: Comparing Knowledge, attitude and Practice of clients and service providers about the regular (6 weeks) versus earlier initiation of LARC, through a structured questionnaire prepared in English and translated to local language i.e. Arabic. conditions: Contraception studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 600 type: ESTIMATED name: screening and data collection measure: Clients' knowledge measure: Clients' attitude measure: Clients' practice measure: Providers' knowledge measure: Providers' attitude measure: Providers' practice sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Assiut University status: RECRUITING city: Assiut zip: 71515 country: Egypt name: mahmoud abdelaleem, Doctorate role: CONTACT phone: +201018880201 email: mahmaleem2000@yahoo.co.uk lat: 27.18096 lon: 31.18368 hasResults: False

 nctId: NCT06273657 id: Apokus-002 briefTitle: Effects of Medisinstart for Type 2 Diabetes overallStatus: RECRUITING date: 2024-02-07 date: 2026-02 date: 2026-02 date: 2024-02-22 date: 2024-02-22 name: Apokus AS class: OTHER name: Norwegian Pharmacy Association briefSummary: Medisinstart is a counseling service in pharmacies where patients who start taking a new medicine receive two follow-up appointments with a pharmacist. The aim of the service is to promote correct medication use and increase patient adherence. The effect of Medisinstart has previously been studied among patients starting a new cardiovascular drug. The aim of the project is to map the effects of Medisinstart among patients starting a new medication for type 2 diabetes. Knowledge about the effects of Medisinstart is important in order to maximize the benefits of the service for patients and society. The project is being conducted as a randomized controlled trial among adult patients starting a new medication for type 2 diabetes. The intervention group receives Medisinstart, while the control group only receives prescription dispensing as normal. Data collection includes HbA1c analysis in blood samples and responses to questionnaires. HbA1c is an established measure of glycemic control. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 500 type: ESTIMATED name: Medisinstart measure: HbA1c measure: HbA1c measure: Self-reported adherence measure: Self-reported adherence measure: Frequency of medication-related problems measure: Patients' beliefs about their medicines measure: Diabetes Self-Management measure: Diabetes Treatment Satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Apotek 1 Andslimoen status: RECRUITING city: Bardufoss zip: 9325 country: Norway lat: 69.06448 lon: 18.51521 facility: Apotek 1 Brandbu status: RECRUITING city: Brandbu zip: 2760 country: Norway lat: 60.42214 lon: 10.50428 facility: Apotek 1 Brummundal status: RECRUITING city: Brumunddal zip: 2380 country: Norway lat: 60.88095 lon: 10.93948 facility: Sykehusapoteket i Drammen status: RECRUITING city: Drammen zip: 3004 country: Norway lat: 59.74389 lon: 10.20449 facility: Vitusapotek Gjøvik status: RECRUITING city: Gjøvik zip: 2806 country: Norway lat: 60.79574 lon: 10.69155 facility: Vitusapotek Jessheim status: RECRUITING city: Jessheim zip: 2050 country: Norway lat: 60.14151 lon: 11.17515 facility: Boots apotek Kløfta status: RECRUITING city: Kløfta zip: 2040 country: Norway lat: 60.07407 lon: 11.13805 facility: Vitusapotek Leksvik status: RECRUITING city: Leksvik zip: 7120 country: Norway lat: 63.67274 lon: 10.6232 facility: Apotek 1 Lena status: RECRUITING city: Lena zip: 2850 country: Norway lat: 60.67391 lon: 10.81317 facility: Boots apotek Loddefjord status: RECRUITING city: Loddefjord zip: 5171 country: Norway lat: 60.36879 lon: 5.22607 facility: Sykehusapoteket i Oslo, Aker status: RECRUITING city: Oslo zip: 0586 country: Norway lat: 59.91273 lon: 10.74609 facility: Vitusapotek Røa status: RECRUITING city: Oslo zip: 0751 country: Norway lat: 59.91273 lon: 10.74609 facility: Ryfylke apotek status: RECRUITING city: Rennesøy zip: 4150 country: Norway facility: Vitusapotek Jekta status: RECRUITING city: Tromsø zip: 9015 country: Norway lat: 69.6489 lon: 18.95508 facility: Sykehusapoteket i Trondheim status: RECRUITING city: Trondheim zip: 7030 country: Norway lat: 63.43049 lon: 10.39506 facility: Vitusapotek Ulefoss status: RECRUITING city: Ulefoss zip: 3830 country: Norway lat: 59.28245 lon: 9.26548 facility: Apotek 1 Veakrossen status: RECRUITING city: Veavåg zip: 4276 country: Norway facility: Vitusapotek Åfjord status: RECRUITING city: Åfjord zip: 7170 country: Norway lat: 63.96113 lon: 10.22408 facility: Boots apotek Linnea status: RECRUITING city: Øystese zip: 5610 country: Norway lat: 60.38825 lon: 6.19251 hasResults: False

 nctId: NCT06273644 id: HNF1719-24 briefTitle: Clinical Research on Acute Intermittent Porphyria and the Use of Carbohydrate-Rich Diet as a Treatment overallStatus: RECRUITING date: 2024-01-27 date: 2027-10-31 date: 2037-12-31 date: 2024-02-22 date: 2024-02-22 name: Nordlandssykehuset HF class: OTHER name: University of Oslo name: Nord University name: UiT The Arctic University of Norway name: Norwegian University of Science and Technology name: The University of Texas Medical Branch, Galveston briefSummary: The main aim of this clinical trial is to learn about the effect of carbohydrate-rich diet as a treatment for AIP (acute intermittent porphyria).

Aim: Investigate the diet's impact on tissue and serum glucose, plasma insulin, cytokine levels, amino acids, and gut microbiota in AIP, and their correlation with PBG (Porphobilinogen).

Aim: Assess the diet's effect on AIP symptoms and health status in AIP. Aim: Measure the effect of a high-carbohydrate diet on mitochondrial activity in AIP Aim: Map and detect potential mutations in mitochondrial genomic DNA in AIP Aim: Discover new markers in AIP through RNA sequencing and machine learning.

Participants will follow two diet plans, a 4-week intervention with 60-65 E% carbohydrates and a 4 week intervention with 40-45 E% carbohydrates. conditions: Porphyria, Acute Intermittent studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The study is a crossover study involving 50 individuals with AIP. The study design was chosen to determine whether the treatment has an effect compared to baseline analyses and whether the sequence of treatment has an effect, as well as whether one of the interventions is more effective than the other. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Blinding is attempted by labeling the provided diet plans as A and B. The physician recording outcome variables and the researcher performing statistical analysis are blinded to the given diet. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Carbohydrates measure: Change in Urine Porphobilinogen/creatinine measure: Urine Porphobilinogen/creatinine concentration, percentage change of repeated measurements measure: Number of Hospitalizations,sick leaves, and doctor visits due to AIP measure: Health status measure: Plasma Glucose level measure: Interstitial fluid glucose level measure: Number of hypoglycemic events measure: Amino acid profile measure: Plasma insulin, glucose, c-peptide measure: HOMA score measure: HbA1c measure: Cytokines in plasma measure: Intestinal microbiota composition measure: Physical activity measure: Blood pressure measure: Body composition, metabolic age measure: Mitochondrial oxygen consumption rate measure: ALAS1mRNA measure: Urine-ALA/creatinine & urine-porphyrins measure: Mitochondrial function-related genes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nordland Hospital Trust status: RECRUITING city: Bodø state: Nordland zip: 8092 country: Norway name: Elin Storjord, MD PhD role: CONTACT phone: +4797072484 email: elin.storjord@nordlandssykehuset.no name: Hilde Thunhaug, IC nurse role: CONTACT phone: +47 95057864 email: hilde.thunhaug@nordlandssykehuset.no name: Elin Storjord, MD PhD role: PRINCIPAL_INVESTIGATOR name: Amy Dickey, MD role: SUB_INVESTIGATOR name: Bjørn Steen Skålhegg, PhD, Prof. role: SUB_INVESTIGATOR name: Bård O. Karlsen, PhD role: SUB_INVESTIGATOR name: Elin Røst, Master role: SUB_INVESTIGATOR name: Erik Knutsen, PhD role: SUB_INVESTIGATOR name: Hilde Thunhaug, Bachelor role: SUB_INVESTIGATOR name: Jonas Aakre Wik, PhD role: SUB_INVESTIGATOR name: Andersen Karl, MD, Prof. role: SUB_INVESTIGATOR name: Pettersen Kristin, Bachelor role: SUB_INVESTIGATOR name: Marlene B. Karlsen, Master role: SUB_INVESTIGATOR name: Nina Lorentsen, Master role: SUB_INVESTIGATOR name: Ole-Lars Brekke, MD,PhD,Prof role: SUB_INVESTIGATOR name: Randolf Hardersen, MD, PhD role: SUB_INVESTIGATOR name: Rita Laastad, Bachelor role: SUB_INVESTIGATOR name: Steinar Daae Johansen, PhD, Dean role: SUB_INVESTIGATOR name: Tor Erik Jørgensen, PhD role: SUB_INVESTIGATOR name: Vegar Rangul, PhD role: SUB_INVESTIGATOR name: Åse Emblem, PhD role: SUB_INVESTIGATOR name: Fredrik Ellefsrud, MD role: SUB_INVESTIGATOR name: Tor Claudi, MD role: SUB_INVESTIGATOR lat: 67.28 lon: 14.40501 hasResults: False

 nctId: NCT06273631 id: 2022-SR-481 briefTitle: Effect of Changes in Carbohydrate Intake on Glucose Control in Patients With Type 1 Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2025-12-31 date: 2024-02-22 date: 2024-02-22 name: Yang Tao class: OTHER briefSummary: The blood glucose fluctuates greatly in T1DM patients, especially in the middle and late stages of the disease, and carbohydrate (CHO) is the main determinant of postprandial glucose response (PGR). Based on the previous investigation to understand how nutritional habits affect blood glucose control, we will conduct dietary intervention studies in T1DM patients to explore whether the adjustment of dietary pattern is beneficial to blood glucose control, and further explore the relevant mechanism through the detection of related metabolic indicators. conditions: Type 1 Diabetes conditions: Diet Intervention conditions: Glucose Control studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 78 type: ESTIMATED name: multiple-diverse carbohydrate diet name: middle carbohydrate diet measure: Change of time in range (TIR) measure: Change of coefficient of variation of blood glucose（CV） measure: Change of mean amplitude of glycemic excursions（MAGE） measure: Change in large amplitude of glycemic excursions (LAGE) from baseline measure: Change in GA（glycosylated albumin）from baseline measure: Change in HbA1c from baseline measure: Change in 1,5-anhydroglucitol (1,5-AG) from baseline measure: Change in time above range(TAR) from baseline measure: Change in time below range(TBR) from baseline measure: Change in total insulin dose from baseline measure: Change in blood lipids from baseline measure: Change in body weight from baseline measure: Change in Incidence of hypoglycemic events from baseline measure: Change in gut microbiota from baseline measure: Change in metabolomics from baseline measure: Change in autoimmunity from baseline sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06273618 id: iLO-ML-23396 briefTitle: iLookOut Micro-learning to Improve Knowledge Retention overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-02 date: 2027-02 date: 2024-02-22 date: 2024-03-25 name: Milton S. Hershey Medical Center class: OTHER briefSummary: This project investigates whether a multi-faceted strategy involving iLookOut's evidence-based Core Training plus an innovative follow-up Micro-Learning can promote knowledge retention and change behavior among early childhood professionals (ECPs) with regard to child abuse and its reporting. Additionally, this study will evaluate if non-ECPs experience similar improvements and retention of knowledge and changes in behavior as do ECPs. conditions: Knowledge conditions: Attitudes conditions: Practice studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Early Childhood Professionals (ECPs) will be randomized to 1 of 4 groups, which will differ in terms of when they receive access to Micro-Learning. Non-ECPs will constitute a separate group, which will receive access to Micro-Learning immediately upon completing the Core Training. primaryPurpose: OTHER masking: NONE count: 12000 type: ESTIMATED name: Micro-Learning measure: Change in knowledge about child maltreatment and its reporting as assessed by validated iLookOut knowledge test measure: Change in behavior regarding child maltreatment and its reporting as measured by self-report questionnaire measure: Comparison of early childhood professionals vs. non-early childhood professionals sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Penn State College of Medicine city: Hershey state: Pennsylvania zip: 17033 country: United States lat: 40.28592 lon: -76.65025 hasResults: False

 nctId: NCT06273605 id: 102828 briefTitle: The Egg Up Trial - Testing a New Treatment Pathway for Infants With Newly Diagnosed Egg Allergy overallStatus: RECRUITING date: 2024-04-09 date: 2025-08-30 date: 2025-08-30 date: 2024-02-22 date: 2024-04-17 name: Murdoch Childrens Research Institute class: OTHER briefSummary: The goal of this study is to test the safety and feasibility of a change in management approach for infants with newly diagnosed egg allergy. Infants with newly diagnosed egg allergy will have egg introduced via a gradual and graded home based approach known as an "egg ladder" supervised by a dietitian. The main questions this study aims to answer are how safe and feasible are home-based dietitian-led "egg ladders" as a treatment pathway to achieve tolerance of egg for newly diagnosed infants with egg allergy. conditions: Food Allergy conditions: Food Allergy in Infants studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Egg Ladder measure: Number and severity of adverse events related to baked egg ingestion (step 1) while following the home-based egg ladder protocol as collected via parent questionnaire and medical history. measure: Number and severity of adverse events related to ingestion of well cooked egg as an ingredient (step 2) while following the home-based egg ladder protocol as collected via parent questionnaire and medical history. measure: Number and severity of adverse events related ingestion of well cooked whole egg (step 3) while following the home-based egg ladder protocol as collected via parent questionnaire and medical history. measure: Number and severity of adverse events related to ingestion of lightly cooked whole egg (step 4) while following the home-based egg ladder protocol as collected via parent questionnaire and medical history. measure: Number and severity of adverse events related to raw egg ingestion (step 5) while following the home-based egg ladder protocol as collected via parent questionnaire and medical history. measure: Feasibility of the home-based, egg ladder protocol to achieve egg allergy resolution 12 months from egg allergy diagnosis measure: Change from baseline (diagnosis) in parent reported Quality of Life scores using the Food Allergy Quality of Life Questionnaire (FAQLQ-PF) to study completion (12 months from diagnosis) measure: Change from baseline (diagnosis) in parental anxiety scores measured using the Impairment Measure for Parental Food Allergy - Associated Anxiety and Coping Tool (IMPAACT) to study completion (12 months from diagnosis) measure: Heath care costs sex: ALL minimumAge: 4 Months maximumAge: 12 Months stdAges: CHILD facility: Murdoch Children's Research Institute (MCRI) status: RECRUITING city: Melbourne state: Victoria zip: 3052 country: Australia name: Vicki McWilliam, PhD role: CONTACT phone: 0418588953 email: vicki.mcwilliam@rch.org.au name: Kirsten Perrett, MD, PhD role: CONTACT email: kirsten.perrett@rch.org.au lat: -37.814 lon: 144.96332 hasResults: False

 nctId: NCT06273592 id: 2023-15558 briefTitle: The Impact of a Plant-based Meat Meal Versus an Animal Meat Meal on Erectile Function in Healthy Men. acronym: Erection 2 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-02-22 date: 2024-02-22 name: Montefiore Medical Center class: OTHER name: Beyond Meat briefSummary: The goal of this study is to determine whether erectile function is differentially impacted by a single plant-based meat meal versus a single animal meat meal in healthy men with normal erectile function. conditions: Erectile Dysfunction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomized crossover design primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Outcomes assessor will be blinded to randomization group and order of testing. whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Animal-based meal name: Plant-based meat meal measure: Percent of time with ≥70% erection during overnight sleep after 1 meal measure: Erection events per hour during overnight sleep after 1 meal measure: Tumescence events per hour during overnight sleep after 1 meal. measure: Heart rate measure: Blood pressure sex: MALE minimumAge: 18 Years maximumAge: 32 Years stdAges: ADULT hasResults: False

 nctId: NCT06273579 id: 2010-270, NEU-09-042-Trial 5 briefTitle: Efficiency of Verbal Intelligent Tutor Instruction in Neurosurgical Simulation overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-10 date: 2024-12 date: 2024-02-22 date: 2024-03-05 name: McGill University class: OTHER briefSummary: At the Neurosurgical Simulation and Artificial Intelligence Learning Centre, we seek to provide surgical trainees with innovative technologies that allow them to improve their surgical technical skills in risk-free environments, potentially improving patient operative outcomes. The Intelligent Continuous Expertise Monitoring System (ICEMS), a deep learning application that assesses and trains neurosurgical technical skill and provides continuous intraoperative feedback, is one such technology that may improve surgical education.

In this randomized controlled trial, medical students from four Quebec universities will be blinded and randomized to one of three groups (one control and two experimental). Group 1 (control) will be provided with verbal AI tutor feedback based on the ICEMS error detection. Group 2 will be tutored by a human instructor who will receive ICEMS error data and deliver verbal instruction identical to that which the AI tutor delivers. Group 3 will be tutored by a human instructor who will be provided with ICEMS data but may deliver feedback as they feel is appropriate to correct the error.

The aim of this study is to determine how the method of delivery of verbal surgical error instruction influences trainee response to instruction and overall surgical performance. Evaluating trainee responses to AI instructor verbal feedback as compared to feedback from human instructors will allow for further development, testing, and optimization of the ICEMS and other AI tutoring systems. conditions: Surgical Education studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controlled Trial primaryPurpose: HEALTH_SERVICES_RESEARCH masking: DOUBLE maskingDescription: Double (Participant, Expert Instructor)

Both study participants and expert instructors are unaware of the intervention (varying the method of delivery of verbal error instruction). Moreover, when rating performance in the realistic scenario using the OSATS, experts are unaware of which group any given trainee is part of. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 78 type: ESTIMATED name: Experimental Group - Verbal expert instructor feedback in AI's words name: Experimental Group - Verbal expert instructor feedback in expert's own words measure: Response to instruction measure: Average Intelligent Continuous Expertise Monitoring System (ICEMS) expertise score measure: Objective Structured Assessment of Technical Skills (OSATS) global rating measure: Difference in the strength of emotions elicited measure: Difference in cognitive load sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Neurosurgical Simulation and Artificial Intelligence Learning Centre city: Montréal state: Quebec zip: H2X 4B3 country: Canada name: Rolando F Del Maestro, MD, PhD role: CONTACT phone: (519) 708-0346 email: rolando.del_maestro@mcgill.ca name: Bianca Giglio, BSc role: CONTACT phone: (514) 802-1608 email: bianca.giglio@mail.mcgill.ca lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06273566 id: 20230202 briefTitle: French Validation of the AdT-Physio Scale acronym: Trans-AdT overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2025-07-31 date: 2024-02-22 date: 2024-03-19 name: Pole Sante Grace de Dieu class: OTHER briefSummary: The goal of this observational study is to translate and validate the Adt-Physio scale in French, and to validate on a large number of patients the French translation of the Adt-Physio scale as a tool for evaluating adherence and perception of the intervention of a physiotherapist in patients with cystic fibrosis.

participants will have to answer the French trans-AdT scale, the Brief Cope and GSES questionnaire. conditions: Cystic Fibrosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 121 type: ESTIMATED name: Questionnaire measure: AdT-Physio scale (Adherence to Treatment of Physiotherapy scale) sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: PSLA GDD city: Caen zip: 14000 country: France lat: 49.18585 lon: -0.35912 hasResults: False

 nctId: NCT06273553 id: RG002-A1201 briefTitle: A Study in Subjects With Human Papillomavirus 16 or 18 Associated Cervical Intraepithelial Neoplasia Grade 2 or 3 overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-10 date: 2027-12 date: 2024-02-22 date: 2024-02-22 name: RinuaGene Biotechnology Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study is to to evaluate the safety, tolerability, immunogenicity, and efficacy of RG002 Injection in subjects with HPV16/18 associated Cervical Intraepithelial Neoplasia Grade 2 or 3(CIN2/3). conditions: Human Papillomavirus Associated Intraepithelial Neoplasia conditions: Cervical Intraepithelial Neoplasia Grade 2/3 conditions: Human Papillomavirus Type 16 Infection conditions: Human Papillomavirus Type 18 Infection studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 39 type: ESTIMATED name: RG002 injection measure: Part A: Safety and Tolerability of RG002 Injection, measured by the incidence of adverse events measure: Part A: Maximum tolerated dose (MTD) and/or RP2D of RG002 Injection measure: Part B: Primary efficacy of RG002 Injection, measured by the proportion of subjects with histopathological regression measure: Part A: Preliminary efficacy of RG002 Injection,measured by proportion of subjects with histopathological regression measure: Part A: Preliminary efficacy of RG002 Injection,measured by proportion of subjects with clearance of HPV16/18 measure: Part A: Preliminary efficacy of RG002 Injection,measured by proportion of subjects with histopathological regression and clearance of HPV16/18 measure: Part A and B: Immunogenicity of RG002 Injection,measured by the level of cellular immune response measure: Part A and B: Immunogenicity of RG002 Injection,measured by the proportion of T lymphocytes measure: Part A and B: Immunogenicity of RG002 Injection,measured by the expression of cytokines in serum measure: Part A and B: Immunogenicity of RG002 Injection,measured by the serum levels of anti-HPV16 and anti-HPV18 IgG antibodies. measure: Part A and B: Exposure level of RG002 Injection, measured by mRNA measure: Part A and B: Exposure level of RG002 Injection, measured by cationic lipids measure: Part A and B: Anti-drug antibody (ADA) to polyethylene glycol (PEG) of RG002 injection, measured by the serum titer of anti-PEG IgG and anti-PEG IgM measure: Part B: Secondary efficacy, measured by proportion of subjects with histopathological regression measure: Part B: Secondary efficacy, measured by proportion of subjects with clearance of HPV16/18 measure: Part B: Secondary efficacy, measured by proportion of subjects with histopathological regression and clearance of HPV16/18 measure: Part B: Safety and tolerability of RG002 Injection, measured by the incidence of adverse events measure: Part B: Optionally assess the biomarker of RG002 Injection, measured by the level of potential biomarkers and the level of infiltrating T cells and myeloid cells in the lesions. sex: FEMALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06273540 id: STA-P7-C001 briefTitle: Phase1, STP7 Cocaine Drug-Drug Interaction Study overallStatus: RECRUITING date: 2024-04-15 date: 2024-09-30 date: 2024-09-30 date: 2024-02-22 date: 2024-04-19 name: Stalicla SA class: INDUSTRY name: National Institute on Drug Abuse (NIDA) briefSummary: This is a double-blind, placebo-controlled, parallel group study to compare the effects of STP7 (mavoglurant) vs placebo control on i.v. cocaine's physiological and subjective effects in non-treatment seeking, cocaine-experienced males or females participants between 18 and 59 years of age.

The primary objective of this study is to determine if there are clinically meaningful interactions between oral STP7 (mavoglurant) treatment concurrent with 20 and 40 mg i.v. cocaine infusions by measuring adverse events and cardiovascular responses including heart rate, blood pressure, and electrocardiogram (including corrected QT interval).

The secondary objectives are:

* To evaluate whether administration of STP7 (mavoglurant) alters the pharmacokinetics of cocaine and/or its major metabolite, benzoylecgonine.
* To determine the pharmacokinetic of STP7 (mavoglurant) administered at a dose of 200 mg twice a day.
* To evaluate whether STP7 (mavoglurant) treatment alters the subjective effects of cocaine measured by Visual Analog Scales (VAS) and Brief Substance Craving Scale (BSCS). conditions: Cocaine Use Disorder studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: STP7 (mavoglurant) or Placebo measure: Incidence of Treatment-Emergent Adverse Events. measure: Heart Rate response following the STP7 treatment with the cocaine infusion. measure: Heart Rate response following the STP7 treatment with the cocaine infusion. measure: Blood Pressure (diastolic) response following the STP7 treatment with the cocaine infusion . measure: Blood Pressure (diastolic) response following the STP7 treatment with the cocaine infusion. measure: Blood Pressure (systolic) response following the STP7 treatment with the cocaine infusion. measure: Blood Pressure (systolic) response following the STP7 treatment with the cocaine infusion. measure: ECG changes (HR) following the STP7 treatment with the cocaine infusion. measure: ECG changes (RR) following the STP7 treatment with the cocaine infusion. measure: ECG changes (PR) following the STP7 treatment with the cocaine infusion. measure: ECG changes (QRS) following the STP7 treatment with the cocaine infusion. measure: ECG changes (QT) following the STP7 treatment with the cocaine infusion. measure: ECG changes (HR) following the STP7 treatment with the cocaine infusion. measure: ECG changes (RR) following the STP7 treatment with the cocaine infusion. measure: ECG changes (PR) following the STP7 treatment with the cocaine infusion. measure: ECG changes (QRS) following the STP7 treatment with the cocaine infusion. measure: ECG changes (QT) following the STP7 treatment with the cocaine infusion. measure: Pharmacokinetics: Maximum Plasma Concentration [Cmax] of cocaine. measure: Pharmacokinetics: Maximum Plasma Concentration [Cmax] of benzoylecgonine. measure: Pharmacokinetics: Maximum Plasma Concentration [Cmax] of STP7. measure: Pharmacokinetics: Maximum Plasma Concentration [Cmax] of STP7. measure: Pharmacokinetics: time to maximum plasma concentration [Tmax] of cocaine. measure: Pharmacokinetics: time to maximum plasma concentration [Tmax] of benzoylecgonine. measure: Pharmacokinetics: time to maximum plasma concentration [Tmax] of STP7. measure: Pharmacokinetics: time to maximum plasma concentration [Tmax] of STP7. measure: Pharmacokinetics: area under the concentration-time curve from time 0 to time t of cocaine. measure: Pharmacokinetics: area under the concentration-time curve from time 0 to time t of benzoylecgonine. measure: Pharmacokinetics: area under the concentration-time curve from time 0 to time of STP7. measure: Pharmacokinetics: area under the concentration-time curve from time 0 to time of STP7. measure: Pharmacokinetics: area under the concentration-time curve from time 0 to 12 hours post-dose of cocaine. measure: Pharmacokinetics: area under the concentration-time curve from time 0 to 12 hours post-dose of benzoylecgonine. measure: Pharmacokinetics: area under the concentration-time curve from time 0 to 12 hours post-dose of STP7. measure: Pharmacokinetics: area under the concentration-time curve from time 0 to 12 hours post-dose of STP7. measure: Pharmacokinetics: area under the concentration-time curve from time 0 to time infinity post-dose of cocaine. measure: Pharmacokinetics: area under the concentration-time curve from time 0 to time infinity post-dose of benzoylecgonine. measure: Pharmacokinetics: area under the concentration-time curve from time 0 to time infinity post-dose of STP7. measure: Pharmacokinetics: area under the concentration-time curve from time 0 to time infinity post-dose of STP7. measure: Pharmacokinetics: trough plasma concentration (Ctrough) of cocaine. measure: Pharmacokinetics: trough plasma concentration (Ctrough) of benzoylecgonine. measure: Pharmacokinetics: trough plasma concentration (Ctrough) of STP7. measure: Pharmacokinetics: trough plasma concentration (Ctrough) of STP7. measure: Pharmacokinetics: terminal rate constant of cocaine. measure: Pharmacokinetics: terminal rate constant of benzoylecgonine. measure: Pharmacokinetics: terminal rate constant of STP7. measure: Pharmacokinetics: terminal rate constant of STP7. measure: Pharmacokinetics: half-life of cocaine. measure: Pharmacokinetics: half-life of benzoylecgonine. measure: Pharmacokinetics: half-life of STP7. measure: Pharmacokinetics: half-life of STP7. measure: Pharmacokinetics: clearance of cocaine. measure: Pharmacokinetics: clearance of benzoylecgonine. measure: Pharmacokinetics: clearance of STP7. measure: Pharmacokinetics: clearance of STP7. measure: Pharmacokinetics: Clearance from plasma after oral administration of cocaine. measure: Pharmacokinetics: Clearance of benzoylecgonine from plasma after oral administration (CL/F) of cocaine. measure: Pharmacokinetics: Clearance from plasma after oral administration (CL/F) of STP7. measure: Pharmacokinetics: Clearance from plasma after oral administration (CL/F) of STP7. measure: Visual evaluation of the STP7 on the subjective effects of cocaine at screening measure: Visual evaluation of the STP7 on the subjective effects of cocaine at baseline and during treatment measure: Craving evaluation of the STP7 on the subjective effects of cocaine. sex: ALL minimumAge: 18 Years maximumAge: 59 Years stdAges: ADULT facility: Altasciences Clinical Kansas status: RECRUITING city: Overland Park state: Kansas zip: 66212 country: United States name: Debra Kelsh, MD role: CONTACT lat: 38.98223 lon: -94.67079 hasResults: False

 nctId: NCT06273527 id: 808681 briefTitle: Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol (R33) overallStatus: NOT_YET_RECRUITING date: 2024-11 date: 2027-06 date: 2027-06 date: 2024-02-22 date: 2024-02-22 name: University of California, San Diego class: OTHER briefSummary: The proposed project aims to test the cognitive and neural effects of a cognitive training in a sample of individuals seeking treatment for anxiety, depression, or traumatic stress symptoms. Participants will be randomly assigned to one of two groups. Group 1 will receive a computer-based program that is designed as a cognitive training intervention and Group 2 will receive a similar computer-based exercise that researchers think will be less effective in training thinking skills (also known as a control or sham condition). Participants will be compared on cognitive performance and brain response during cognitive tasks from baseline to post-treatment. conditions: Anxiety Disorders conditions: Depression conditions: Post Traumatic Stress Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 128 type: ESTIMATED name: COGENT name: Sham Program measure: Change in cognitive performance measure: Reading Span Blood Oxygen Level Dependent (BOLD) Response measure: Neuropsychological Performance measure: Repetitive Negative Thinking (RNT) measure: Disability measure: Suicide Cognitions measure: Mood and Emotions measure: Self-reported attention measure: Anxiety Symptoms measure: Symptoms of Depression measure: PTSD Symptoms sex: ALL minimumAge: 21 Years maximumAge: 55 Years stdAges: ADULT facility: UC San Diego city: San Diego state: California zip: 92037 country: United States name: Edith Jimenez role: CONTACT phone: 858-822-1470 email: e7jimenez@health.ucsd.edu name: Nathalie Dugas role: CONTACT phone: 858-534-2148 email: ndugas@health.ucsd.edu lat: 32.71533 lon: -117.15726 hasResults: False

 nctId: NCT06273514 id: TECAR and DN intervention briefTitle: Comparison the Effects of TECAR With Dry Needling in the Treatment of Myofascial Trigger Points overallStatus: COMPLETED date: 2020-12-01 date: 2022-12-31 date: 2022-12-31 date: 2024-02-22 date: 2024-02-22 name: Medical University of Silesia class: OTHER briefSummary: The aim of the study is to assess the effectiveness of dry needling (DN) and capacitive and resistive transfer of energy (TECAR) therapy in the treatment of myofascial trigger points (MTrPs) as well comparison of their efficacy.

Research hypothesis:

Capacitive and resistive energy transfer therapy is comparable to dry needling therapy for the treatment of myofascial trigger points.

It is estimated that the presence of trigger points is the main cause of pain in 30-85% of patients visiting primary health care facilities and pain management clinics. The presence of trigger points may significantly affect the patient's functional status and daily functioning. Recently, diagnostic criteria and methods of treating trigger points have evolved significantly. However, the usefulness of different imaging methods in the diagnosis of trigger points has not yet been established. Despite numerous studies, the long-term effectiveness of the dry needling method is still unknown. Furthermore, there is no available research on the short- and long-term effectiveness of capacitive and resistive energy transfer therapy in the treatment of trigger points.

Therefore, the objectives of the work were:

Determination and comparison of the short- and long-term effects of capacitive and resistive energy transfer therapy and the dry needling technique of myofascial trigger points located in the upper trapezius muscle (UT) on the strength, neck range of motion and pain intensity within this muscle.

The study is planned to include a group of 26 men aged 25 to 45 who suffer from pain caused by the presence of myofascial trigger points in the upper trapezius muscle. The subjects will be divided into two groups of equal number of people. The first group will undergo therapy using the dry needling technique, while the second group will undergo capacitive and resistive energy transfer therapy.

In order to determine the immediate effects of capacitive and resistive energy transfer therapy and dry needling techniques, measurements of muscle strength, the intensity of pain in the upper trapezius muscle and neck range of motion will be performed before and after each therapeutic session (2 session in 2 weeks are planed). In turn, to determine the long-term effects of capacitive and resistive energy transfer therapy and dry needling, the next above-mentioned measurements will be performed four weeks after the end of first therapy. conditions: Myofascial Pain Syndrome of Neck conditions: Myofascial Trigger Point Syndrome conditions: Myofascial Trigger Point Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 22 type: ACTUAL name: TECAR name: Dry needling measure: Pain - Pressure pain threshold (PPT) measure: Pain - numerical rating scale (NRS) measure: Muscle strength measure: Cervical spine range of motion (ROM) sex: MALE minimumAge: 25 Years maximumAge: 45 Years stdAges: ADULT facility: Medical fit city: Ruda Śląska state: Śląsk zip: 41-717 country: Poland lat: 50.2584 lon: 18.85632 hasResults: False

 nctId: NCT06273501 id: D-NR 2022-02876-01 briefTitle: MRI and Magnetometer-guided Sentinel Lymph Node Detection in Vulvar Cancer acronym: POSVUC overallStatus: ENROLLING_BY_INVITATION date: 2022-03-24 date: 2024-12-01 date: 2024-12-31 date: 2024-02-22 date: 2024-02-22 name: Sahlgrenska University Hospital, Sweden class: OTHER briefSummary: The aim of the feasibility study is to evaluate whether SPIO-MRI and a magnetometer could be a potential substitute to the routine dual technique in pre-and intraoperative SLN localization. Secondary, to explore if SPIO-MRI could predict lymph node status in comparison to histopathological analysis. conditions: Vulvar Cancer conditions: Lymph Node Metastasis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 20 type: ESTIMATED name: Magtrace measure: Sentinel lymph node identification sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Obstetrics and gynecology city: Gothenburg zip: 41345 country: Sweden lat: 57.70716 lon: 11.96679 hasResults: False

 nctId: NCT06273488 id: EXZL20240002 briefTitle: The Role of Auricular Point Diagnosis and Treatment in ERAS During TKA overallStatus: RECRUITING date: 2024-03-23 date: 2024-11-01 date: 2024-12-01 date: 2024-02-22 date: 2024-04-08 name: Peking Union Medical College class: OTHER briefSummary: To further improve the surgical outcomes of patients undergoing total knee arthroplasty (TKA). This study aims to use ear acupoint therapy to address the following clinical issues: 1 The degree of postoperative inflammation and edema in the patient; 2. Patient pain; 3. Patient functional recovery. 4. Surgical scar repair for patients; 5. Patient perioperative anxiety and postoperative satisfaction. Exploring the safety and effectiveness of ear acupoint therapy in the postoperative application of TKA, leveraging the advantages of suitable traditional Chinese medicine techniques in simplicity, convenience, effectiveness, and cost-effectiveness, and further improving the ERAS Chinese and Western medicine collaborative plan for TKA. conditions: Auriculotherapy conditions: Arthroplasty, Replacement, Knee conditions: Enhanced Recovery After Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 86 type: ESTIMATED name: Auriculotherapy measure: Range of motion(ROM) measure: Visual Analogue Pain Scale (VAS) measure: Self-Assessment Survey for Anxiety（SAS） measure: Acupoint electrical measurement value(AE) measure: Vancouver Scar Assessment Scale（VSS） measure: Dosage of painkillers measure: Hospital stay measure: HSS knee joint scoring measure: Thigh circumference(knee joint circumference) measure: Kine siphobia (TSK) score measure: C-reactive protein (CRP) measure: Erythrocyte Sedimentation Rate(ESR) measure: Postoperative satisfaction measure: Expenses during hospitalization measure: Demand rate and satisfaction rate of auricular point diagnosis and treatment measure: Adverse events related to auricular acupuncture diagnosis and treatment measure: Affected limb drainage volume measure: Preoperative Anxiety Scale (PAS-7) score measure: Total number of pain pump uses (presses) sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital status: RECRUITING city: Beijing state: Beijing zip: 100000 country: China name: qindong Mi role: CONTACT phone: 8615871784551 email: mqd2022ky@163.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06273475 id: OUH RoboRehab briefTitle: Robot-Assisted Training Versus Standard Training in Ischemic Stroke overallStatus: RECRUITING date: 2024-05-01 date: 2025-03-01 date: 2027-02-01 date: 2024-02-22 date: 2024-04-18 name: Odense University Hospital class: OTHER name: University of Southern Denmark name: Rigshospitalet, Denmark name: Herlev and Gentofte Hospital name: Stanford University name: Sygehus Lillebaelt name: Danish Association of the Physically Disabled briefSummary: The aim of this randomised controlled trial (RCT) nested in a prospective cohort, is to investigate the superior effect of late-phase robot-assisted versus standard training on motor function, physical function, fatigue, and quality of life in a moderately-to-severely impaired chronic stroke population following subacute rehabilitation.

The main hypothesis of the study is:

Robot-assisted training has a superior effect on motor function (Fugl-Meyer Lower Extremity Assessment; primary outcome), physical function, fatigue, and quality of life in moderately-to-severely impaired chronic stroke-affected individuals in comparison to standard training. conditions: Stroke conditions: Ischemic Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multicentre randomised (1:1) parallel-group intervention study with assessor-blinding. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Data will be analysed by the PhD student blinded towards group allocation. The test leader responsible for RCT outcome assessment will be blinded towards group allocation. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Robot-assisted Training name: Standard Training measure: Fugl-Meyer Lower Extremity Assessment of Motor Function measure: Modified Rankin Scale Score (between-group change) measure: Functional Ambulation Category (between-group change) measure: Berg Balance Scale (between-group change) measure: Barthel-100 Index (between-group change) measure: Global Rating of Change (between-group change) measure: International Physical Activity Questionnaire - Short Form (between-group change) measure: Fatigue Severity Scale 7 (between-group change) measure: EQ-5D-5L Quality of Life (between-group change) measure: Hand-grip strength (between-group change) measure: Gait speed (between-group change) measure: Contractile Muscle Power (between-group change) measure: Modified Sit-to-Stand Test (between-group change) measure: Blood Biomarkers (between-group change) measure: Modified Ashworth Scale (between-group change). measure: Oxford Cognitive Screen (between-group change) measure: Montreal Cognitive Assessment (between-group change) measure: Major Depression Inventory (between-group change) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rigshospitalet and Herlev Gentofte Hospital status: NOT_YET_RECRUITING city: Copenhagen country: Denmark name: Jon Skovgaard Jensen, Ph.d.-student role: CONTACT email: jskovgaard@health.sdu.dk name: Christina Rostrup Kruuse, Professor, MD, PhD, DMSc role: PRINCIPAL_INVESTIGATOR lat: 55.67594 lon: 12.56553 facility: Odense University Hospital status: RECRUITING city: Odense country: Denmark name: Jon Skovgaard Jensen, Ph.d.-student role: CONTACT email: jskovgaard@health.sdu.dk name: Anders Holsgaard-Larsen, Professor role: PRINCIPAL_INVESTIGATOR lat: 55.39594 lon: 10.38831 hasResults: False

 nctId: NCT06273462 id: NMCSD.2024.0006 briefTitle: Palmitoylethanolamide for Chronic Inflammatory Pain Conditions overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-05-30 date: 2024-02-22 date: 2024-02-22 name: Navy Medical Center San Diego class: FED briefSummary: The goal of this clinical trial is to evaluate if a supplement called palmitoylethanolamide (PEA) is effective in reducing the pain in patients with chronic inflammatory pain conditions. The main question the trial aims to answer is if PEA works better at treating a patients pain and improving their function better than a placebo.

Participants will be divided into two equal groups and asked to take either PEA or a placebo for 8 weeks. conditions: Chronic Pain studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective Randomize Double Blind Placebo Controlled study comparing the supplement palmitoylethanolamide (PEA) to a visually identical placebo primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Double Blinded, patients will receive visually identical capsules from research pharmacist with study label indicating PEA vs Placebo whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Palmitoylethanolamide 600mg twice a day name: placebo measure: Pain Level measure: Pain interference and function measure: Pain Catastrophizing Scale (PCS) measure: Patient Reported Outcome Measurement Information System (PROMIS) (Pain interference, Social satisfaction; Physical function) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Naval Medical Center San Diego city: San Diego state: California zip: 92118 country: United States name: Naval Medical Center Institutional Review Board role: CONTACT phone: 619-532-9927 email: kristina.m.umali.civ@health.mil name: Brian McLean COL, USA MC, MD role: PRINCIPAL_INVESTIGATOR lat: 32.71533 lon: -117.15726 hasResults: False

 nctId: NCT06273449 id: 385/2023 briefTitle: A Smart Digital Workflow Towards High Precision and Through-Put Production for Removable Partial Dentures overallStatus: RECRUITING date: 2022-12-29 date: 2024-08-30 date: 2024-08-30 date: 2024-02-22 date: 2024-02-22 name: National Dental Centre, Singapore class: OTHER name: National Medical Research Council (NMRC), Singapore briefSummary: Tooth loss is a major chronic problem in dentistry and edentulous elderly endures poorer quality of life worldwide. Removable partial dentures (RPDs) are the most widely accepted and cost-effective treatment for patients to restore oral functions. RPDs contain three components including the metal framework, denture base and acrylic teeth. Conventionally, RPD fabrication involves tedious clinical and dental laboratory procedures and is time consuming, labour-intensive, and often imprecise, therefore incapable of meeting the growing demands of RPD by an ageing population. The challenges to achieve a high quality and high-throughput RPD service lie in three aspects: 1) accuracy in capturing oral profile; 2) immediate oral information analysis and device design, and 3) automation in production. conditions: Partial-edentulism studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: 1. Conventional: The Standard of Care (SOC) workflow, which will act as a baseline compared to the other 2 groups.
2. Partial digital workflow: Adopts the same teeth profile capture method, where a physical impression of teeth profile is taken from the subject. However, instead of using physical wax pattern on the stone model for design, the stone model is scanned and, on the scan, the design is performed digitally. For fabrication of RPD, instead of using lost wax casting, the digital design is used for additive manufacturing.
3. SmartRPD digital workflow Adopts a different teeth profile capture method by using the intraoral scanner to digitally scan and save the subject's teeth profile. From the intraoral scan, a digital model of the subject's teeth profile is created but on the digital model instead, the design of RPD is digitally performed. The digital design is used for additive manufacturing. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 141 type: ESTIMATED name: Group 3 - 3D Printed Removable Partial Denture name: Group 2 - 3D Printed Removable Partial Denture measure: Evaluation of Precision in Fabricated Metal Frameworks Across Three Workflows measure: Comparison of Patient Satisfaction with RPD Prostheses Fabricated Using Three Workflows measure: Comparison of Fabrication Cost and Time Across Three Workflows sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Dental Centre Singapore status: RECRUITING city: Singapore zip: 168938 country: Singapore name: Hazel Goh Si Ying role: CONTACT phone: 63248754 email: goh.si.ying@ndcs.com.sg name: Zi Ying Phang role: PRINCIPAL_INVESTIGATOR name: Khim Hean Teoh role: SUB_INVESTIGATOR name: Janice Tan Zhi Hui role: SUB_INVESTIGATOR lat: 1.28967 lon: 103.85007 hasResults: False

 nctId: NCT06273436 id: Pro00130902 briefTitle: Healing, Equity, Advocacy and Respect for Mamas acronym: HEAR4Mamas overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2028-11-30 date: 2028-11-30 date: 2024-02-22 date: 2024-04-22 name: Medical University of South Carolina class: OTHER name: Patient-Centered Outcomes Research Institute briefSummary: The goal of the proposed research is to test the comparative effectiveness of AIM safety bundles for post-partum women delivered in-person vs. via text/phone to improve early detection of and timely care for complications during the first six weeks postpartum for women experiencing significant health disparities. conditions: Postpartum Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 2894 type: ESTIMATED name: H.E.A.R. for Mamas measure: Emergency Department (ED) visits within six weeks postpartum measure: Patient Reported Outcomes (PROs) measure: Social Determinants of Health (SDoH), Patient Activation, Shared Decision Making measure: Patient Activation measure: Shared Decision Making sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06273423 id: OULA for Postpartum Depression briefTitle: Feasibility Evaluation of a Dance Fitness Program overallStatus: NOT_YET_RECRUITING date: 2024-10 date: 2025-05 date: 2025-06 date: 2024-02-22 date: 2024-02-22 name: Montana State University class: OTHER briefSummary: The objective of this pilot project is to assess the feasibility, acceptability, and mental health impact of OULA for women with postpartum depression (PPD). conditions: Postpartum Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 40 type: ESTIMATED name: OULA, Mind-body Physical Activity measure: Feasibility and acceptability measure: Changes in postpartum depression measure: Changes in postpartum anxiety sex: FEMALE minimumAge: 20 Years maximumAge: 39 Years stdAges: ADULT hasResults: False

 nctId: NCT06273410 id: 0453-6/2022 briefTitle: Clinical Performance of An Alkasite Based Restorative Material With And Without Adhesive overallStatus: COMPLETED date: 2022-10-13 date: 2023-11-28 date: 2023-11-28 date: 2024-02-22 date: 2024-02-22 name: Hams Hamed Abdelrahman class: OTHER briefSummary: Despite significant advances in composite materials, they are still perceived as technique-sensitive and exhibit failure related to excessive wear and polymerization shrinkage. Cention N is a recently introduced alkasite restorative that contains special reactive fillers. Its application in restorative dentistry may be significant, promoting remineralization of carious lesions \& reduction of polymerization shrinkage. The study will aim to compare the clinical performance of Cention N (with and without adhesive) and composite resin (Filtek Bulk Fill) in class I restorations using FDI criteria. Thirty-six class I cavities will be selected and equally allocated into 3 groups: Group I (n=12): (Cention N with adhesive), Group II (n=12): (Cention N without adhesive) \& Group III (n=12): composite resin (Filtek Bulk Fill) in class I cavities. Patients will be followed up at 1 week 3, 6, and 12 months and evaluated using the FDI criteria. Postoperative sensitivity, staining, and recurrent caries will be evaluated in this clinical trial. conditions: Dental Restoration Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 36 type: ACTUAL name: Cention N name: Cention N + Adhesive name: Bulk Fill Composite measure: Change in pain sensitivity measure: Change in occurrence of recurrent caries measure: Change in occurrence of marginal stains sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Alexandria Faculty of Dentistry city: Alexandria country: Egypt lat: 31.21564 lon: 29.95527 hasResults: False

 nctId: NCT06273397 id: ACME-AHF briefTitle: Acetazolamide or Metolazone in Acute Heart Failure acronym: ACME-AHF overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-03-01 date: 2027-05-01 date: 2024-02-22 date: 2024-03-18 name: Clinica Alemana de Santiago class: OTHER briefSummary: Impact of Acute Heart Failure:

According to the World Health Organization (WHO), approximately 26 million people suffer from Heart Failure (HF), with a mortality rate of up to 50% within five years of diagnosis. Acute Heart Failure (AHF) exacerbations, leading to hospitalization, are common and represent the primary cause of hospital admissions in those over 65. Effective decongestion during hospitalization is crucial, as failure to achieve it doubles the risk of rehospitalization and mortality, incurring significant healthcare costs.

Use of Diuretics in Acute Heart Failure:

Diuretics, particularly loop diuretics like furosemide, are a cornerstone in managing AHF by inducing natriuresis and achieving decongestion. Clinical experience supports their use, though limited clinical trials exist. Pharmacological concepts guide their administration, emphasizing intravenous delivery in high doses and adjusting subsequent doses based on decongestive efficacy. Additionally, sequential tubular blockade with other diuretics like metolazone and acetazolamide is explored to enhance decongestion.

Use of Metolazone and Acetazolamide:

Sequential tubular blockade, using metolazone and acetazolamide in conjunction with furosemide, aims to achieve rapid and effective decongestion. While metolazone targets the distal tubule, inhibiting sodium-chloride channels, acetazolamide affects proximal tubular function. Studies like ADVOR (acetazolamide) and CLOROTIC (thiazide-like diuretic) demonstrate the potential benefits of combining these diuretics for quicker decongestion but with potential risks (in the case of Hydrochlorothiazide).

Outcomes Measured by Major Studies:

Recent studies assessing decongestion in AHF reveal a lack of uniformity in outcome selection. The primary focus should be on reducing rehospitalizations and post-discharge mortality by achieving effective decongestion. The ADVOR study, using a simple congestion score based on clinical and imaging criteria, underscores the importance of reaching a congestion score of 0 or 1 promptly.

Congestion Monitoring:

Monitoring diuretic treatment solely based on clinical aspects may not capture subclinical congestion, necessitating biochemical and imaging parameters. The ACME-AHF trial proposes a diagnostic score integrating clinical and imaging aspects to evaluate congestion status. Secondary outcomes include cumulative diuresis, weight loss, diuretic efficiency, and natriuresis, with a focus on natriuresis as a reliable physiological parameter for decongestion.

Aim of the study:

The ACME-AHF trial is designed to compare the efficacy and safety of two diuretic combination strategies: acetazolamide with furosemide and metolazone with furosemide. The primary objective is to relieve congestion, assessed using a congestion score, within the first three days of treatment during an hospitalization for acute heart failure. conditions: Heart Failure Acute conditions: Decompensated Heart Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is an Open, Multicenter, Prospective, and Randomized study with three treatment arms. The outcomes to be assessed in the initial phase will be at 4 days post-randomization, followed by evaluation at 90 days after hospital discharge. primaryPurpose: TREATMENT masking: NONE count: 1050 type: ESTIMATED name: Acetazolamide 250 MG name: Metolazone 2.5 MG name: Furosemide Injection measure: Treatment success measure: Mortality measure: Worsening Heart Failure measure: Cumulative 24-hour Natriuresis measure: Cumulative weight loss measure: Subclinical congestion measure: Change in Hematocrit value measure: Change in NT-proBNP concentration measure: Change in CA125 value measure: Any adverse event measure: Changes in pH value measure: Change in plasma electrolyte values sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06273384 id: Si 062/2023 briefTitle: Diagnostic Performance of CIM for Helicobacter Pylori Infection in Patients With Peptic Ulcer Bleeding acronym: CIM overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-09-30 date: 2024-12-31 date: 2024-02-22 date: 2024-02-22 name: Mahidol University class: OTHER briefSummary: The goal of this cross-sectional study is to evaluate the efficacy of current infection marker (CIM) method for H. pylori detection. The main questions it aims to answer are:

* To evaluate the efficacy of CIM method for H. pylori detection compared to rapid urease test(RUT), histopathology, polymerase chain reaction (PCR), and urea breath test (UBT) in patients who presented with upper gastrointestinal hemorrhage from peptic ulcer, and their sensitivity, specificity, accuracy, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio, and negative likelihood ratio.
* To evaluate the advantages of CIM method for H. pylori detection comparing to RUT, histopathology, PCR, and UBT in patients who presented with upper gastrointestinal hemorrhage from peptic ulcer as net reclassification index (NRI).
* To study the associated factors in false negative value of H. pylori detection methods with CIM, RUT, histopathology, PCR, and UBT. conditions: Helicobacter Pylori Infection conditions: Peptic Ulcer Hemorrhage studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 135 type: ESTIMATED measure: The efficacy of CIM method for H. pylori detection measure: The advantages of CIM method for H. pylori detection sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Medicine Siriraj Hospital, Mahidol University city: Bangkok Noi state: Bangkok zip: 10700 country: Thailand lat: 13.76266 lon: 100.47798 hasResults: False

 nctId: NCT06273371 id: DELISA2023 briefTitle: Tolerance and Growth Outcomes in Children Diagnosed With Cow's Milk Protein Allergy and Prescribed an Extensively Hydrolyzed Casein Formula (Damira 2000©) in Spain acronym: DELISA overallStatus: COMPLETED date: 2023-12-12 date: 2023-12-21 date: 2023-12-21 date: 2024-02-22 date: 2024-02-22 name: Lactalis class: INDUSTRY briefSummary: Damira 2000© is a 100% extensive casein hydrolysate (eHCF). It is formulated to help reverse growth retardation as a result of cow's milk proteins allergy (CMPA), to be well tolerated and to help improve symptoms.Damira 2000 is indicated for allergy/intolerance to cow's milk proteins, atopic dermatitis secondary to CMPA, intestinal malabsorption processes and prevention of allergy/intolerance to cow's milk proteins.The study aimed at evaluating the tolerance of Damira 2000 in a cohort of children with CMPA. conditions: Cow's Milk Protein Allergy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 61 type: ACTUAL name: Damira 2000 Infant formula measure: Tolerance measure: Weight measure: Height measure: Weight for height and BMI measure: Head circumference sex: ALL minimumAge: 0 Months maximumAge: 12 Months stdAges: CHILD facility: Hospital Quirónsalud de Córdoba city: Córdoba state: Andalucia country: Spain lat: 37.89155 lon: -4.77275 facility: H. Virgen del Rocío city: Sevilla state: Andalucia country: Spain lat: 37.38283 lon: -5.97317 facility: H. Virgen Macarena city: Sevilla state: Andalucia country: Spain lat: 37.38283 lon: -5.97317 facility: Instituto Hispalense de pediatría city: Sevilla state: Andalucia country: Spain lat: 37.38283 lon: -5.97317 facility: Hospital Materno infantil de Ourense city: Orense state: Galicia country: Spain lat: 42.33669 lon: -7.86407 facility: H. Clínico de Santiago city: Santiago De Compostela state: Galicia country: Spain lat: 42.88052 lon: -8.54569 facility: Clínica privada Dr. Romera city: Madrid country: Spain lat: 40.4165 lon: -3.70256 facility: Fundación Jiménez Día city: Madrid country: Spain lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06273358 id: Study Sleep Quality briefTitle: Preoperative Sleep Quality and Postoperative Delirium overallStatus: COMPLETED date: 2023-08-01 date: 2023-12-18 date: 2024-01-27 date: 2024-02-22 date: 2024-02-22 name: Konya City Hospital class: OTHER briefSummary: Background: Delirium is a neurocognitive illness that has lately been connected to sleep difficulties. It is a stressful condition. is still not fully understood. A poor sleep burden and its progress were investigated in this study to determine their correlations with the risk of delirium following surgical procedures.

Methods: Between August 1st and December 5th, 2023, 124 patients undergoing non-cardiac general anesthesia (mean age 63.68 ± 8.81 years \[SD\]; range 46-82 years) reported on their sleep characteristics. PSQI, 1- sleep duration, 2- sleep disturbance, 3- sleep latency, 4- daytime dysfunction resulting from sleepiness, 5- sleep efficiency, 6- overall sleep quality, and 7- usage of sleep medications were among these sleep characteristics. Seven component scores, ranging from 0 (no difficulty) to 3 (extreme difficulty), are obtained while assessing the PSQI. The global score ranges from 0 to 21 and is calculated by adding the component scores. Higher scores indicate poorer sleep quality. A three-day median follow-up time was used to analyze hospitalization records to gather data on new-onset delirium (n = 26). Approximately 124 people on average, with a mean. conditions: PREOPERATIVE SLEEP QUALITY ON POSTOPERATIVE DELIRIUM studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ACTUAL measure: Sleep quality and delirium index measure: Preop. and postop. sleep quality index measure: Sleep quality and QR 15 score sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yasin Tire city: Konya state: Meram zip: 42140 country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False

 nctId: NCT06273345 id: IOV-PR-1-2022-OLIGOS briefTitle: OLIGOS: Impact of Treatment on Primary Tumour in Patients With Newly Diagnosed Oligometastatic Neoplasia of the Prostate acronym: OLIGOS overallStatus: RECRUITING date: 2023-01-23 date: 2025-01 date: 2025-01 date: 2024-02-22 date: 2024-02-22 name: Istituto Oncologico Veneto IRCCS class: OTHER briefSummary: The proposed study consists of a multicentre prospective observational study involving patients with oligometastatic prostatic neoplasia defined according to CHAARTED criteria.

The aim of the study is the creation of a registry including patients with newly diagnosed OMPCa, belonging to the main urological centres in the Triveneto region, in order to evaluate the oncological outcomes and the impact on the quality of life of local treatment of the primary neoplasm (surgical or radiotherapy) in addition to systemic hormonal treatment (ADT as monotherapy or in combination with Docetaxel/androgen receptor signal inhibitors (ARTA)).

The above criteria define 'high metastatic volume' disease with the following parameters

* ≥ 4 bone metastases, including at least one outside the spine and pelvis
* Presence of visceral metastases Consequently, patients included in the study should not have the above-mentioned characteristics. conditions: Oligometastatic Prostate Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED measure: Overall survival (OS) measure: Cancer-specific survival measure: CRPCa development measure: Radiological progression-free survival measure: Quality of life assessment measure: Quality of life assessment measure: Complications sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ospedale di Bressanone status: NOT_YET_RECRUITING city: Bressanone state: Bolzano country: Italy name: Michael Aigner, MD role: CONTACT email: michael.aigner@sabes.it name: Michael Aigner, MD role: PRINCIPAL_INVESTIGATOR lat: 46.71503 lon: 11.65598 facility: Casa di Cura Abano Terme status: RECRUITING city: Abano Terme state: Padova country: Italy name: Daniele Romagnoli, MD role: CONTACT email: dromagnolo@casacura.it name: Daniele Romagnoli, MD role: PRINCIPAL_INVESTIGATOR lat: 45.35753 lon: 11.78725 facility: Ospedale di Dolo status: RECRUITING city: Dolo state: Venezia country: Italy name: Gianna Pace, MD role: CONTACT email: gianna.pace@aulss3.veneto.it name: Gianna Pace, MD role: PRINCIPAL_INVESTIGATOR lat: 45.42528 lon: 12.08429 facility: Ospedale di Bassano Del Grappa status: RECRUITING city: Bassano Del Grappa state: Vicenza country: Italy name: Antonio Celia, MD role: CONTACT email: antonio.celia@aulss7.veneto.it name: Antonio Celia, MD role: PRINCIPAL_INVESTIGATOR lat: 45.76656 lon: 11.72739 facility: Ospedale dell'Angelo - Mestre status: RECRUITING city: Mestre country: Italy name: Francesco Gerardo Mandato, MD role: CONTACT email: francesco.mandato@aulss3.veneto.it name: Francesco Gerardo Mandato, MD role: PRINCIPAL_INVESTIGATOR lat: 45.49167 lon: 12.24538 facility: Istituto Oncologico Veneto IRCCS status: RECRUITING city: Padova zip: 35128 country: Italy name: Angelo Porreca, MD role: CONTACT phone: 0423 421321 phoneExt: +39 email: angelo.porreca@iov.veneto.it name: Gian Luca De Salvo, MD role: CONTACT phone: 049 8215710 phoneExt: +39 email: gianluca.desalvo@iov.veneto.it name: Angelo Porreca, MD role: PRINCIPAL_INVESTIGATOR lat: 45.40797 lon: 11.88586 facility: Azienda Ospedale Università Padova status: NOT_YET_RECRUITING city: Padova country: Italy name: Fabio Zattoni, MD role: CONTACT email: fabio.zattoni@unipd.it name: Fabio Zattoni, MD role: PRINCIPAL_INVESTIGATOR lat: 45.40797 lon: 11.88586 facility: Ospedale MAter Salutis - Legnago status: NOT_YET_RECRUITING city: Padova country: Italy name: Pierpaolo Curti, MD role: CONTACT phone: 0442 622387 phoneExt: +39 email: pierpaolo.curti@aulss9.veneto.it name: Pierpaolo Curti, MD role: PRINCIPAL_INVESTIGATOR lat: 45.40797 lon: 11.88586 facility: Ospedali Riuniti Padova Sud status: RECRUITING city: Padova country: Italy name: Nicola Zanovello, MD role: CONTACT email: nicola.zanovello@aulss6.veneto.it name: Nicola Zanovello, MD role: PRINCIPAL_INVESTIGATOR lat: 45.40797 lon: 11.88586 facility: Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) status: NOT_YET_RECRUITING city: Trieste country: Italy name: Carlo Trombetta, MD role: CONTACT email: trombcar@units.it name: Carlo Trombetta, MD role: PRINCIPAL_INVESTIGATOR lat: 45.64953 lon: 13.77679 facility: Presidio Ospedaliero Universitario Santa Maria della Misericorida (ASU FC) status: NOT_YET_RECRUITING city: Udine country: Italy name: Gianluca Giannarini, MD role: CONTACT email: gianluca.giannarini@asufc.sanita.fvg.it name: Gianluca Giannarini, MD role: PRINCIPAL_INVESTIGATOR lat: 46.0693 lon: 13.23715 facility: Azienda Ospedaliera Universitaria Integrata - Verona status: RECRUITING city: Verona country: Italy name: Alessandro Antonelli, MD role: CONTACT phone: 0458127702/03 phoneExt: +39 email: alessandro.antonelli@aovr.veneto.it name: Alessandro Antonelli, MD role: PRINCIPAL_INVESTIGATOR lat: 45.4299 lon: 10.98444 hasResults: False

 nctId: NCT06273332 id: AI surgery protocol briefTitle: Assessment of the Artifical Intelligence Assisted Registration Versus Conventional Point Based Registration on Cone Beam-computed Tomography (CBCT) With Heavy Metal Artifacts overallStatus: ACTIVE_NOT_RECRUITING date: 2023-12-20 date: 2024-01-20 date: 2024-02-25 date: 2024-02-22 date: 2024-02-22 name: Ain Shams University class: OTHER briefSummary: Our study investigates the accuracy and duration needed for 3D model registration using artifical intelligence (AI) assistance compared to conventional point-based registration. Manual segmentation of all cone beam computed tomography (CBCT) scans will be performed before the registration procedure. conditions: Registration Accuracy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 16 type: ESTIMATED name: AI-assisted registration name: Point-based registration measure: Registration accuracy measure: Duration for registration sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Private maxillofacial digital lab city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06273319 id: 010656 briefTitle: The Effect of Oxygen Application With Double Nasal Cannula on Respiratory Complications overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-05-01 date: 2024-06-01 date: 2024-02-22 date: 2024-02-22 name: Inonu University class: OTHER briefSummary: To compare desaturation and respiratory complications by applying oxygen therapy with double nasal cannula to patients who are planned to undergo gastrointestinal endoscopy. conditions: Gastric Disease conditions: Gastric Distress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: 2 whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: OXYGEN THERAPY measure: Determination of the amount of oxygen to prevent the peripheral oxygen saturation of the patients from falling below 95% sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Inonu universitesi city: Malatya zip: 44050 country: Turkey lat: 38.35018 lon: 38.31667 hasResults: False

 nctId: NCT06273306 id: HULP.PI-4519 id: PI22/00777 type: OTHER_GRANT domain: Fondo de investigaciones sanitarias.Instituto de Salud Carlos III briefTitle: Towards Telemonitoring in Immune-Mediated Inflammatory Diseases: Implementation of a Mixed Attention Model (IMIDOC) acronym: IMIDOC overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-12-31 date: 2026-12-31 date: 2024-02-22 date: 2024-02-22 name: Instituto de Investigación Hospital Universitario La Paz class: OTHER briefSummary: The main objective is to evaluate the implementation of a hybrid care model called the mixed attention model (MAM) in clinical practice and to evaluate whether its implementation improves clinical outcomes compared to conventional follow-up.

This is a multicenter prospective observational study involving 360 patients with rheumatoid arthritis (RA) and Spondylarthritis (SpA) from five Spanish Hospitals. Patients will be followed-up by the MAM protocol, which is a care model that incorporates the use of digital tool consisting of a mobile application (App) that patients can use at home and that professionals can review asynchronously to detect incidents and to follow their patients; clinical evolution between face-to-face visits. Another group of patients, whose follow-up will be conducted in accordance with a traditional face-to-face care model, will be assessed as the control group. Sociodemographic characteristics, treatments, laboratory parameters, assessment of tender and swollen joints, visual analogue scale for pain and electronic patient reported outcome reports (ePROs) will be collected for all subjects. In the MAM group, these items will be self-assessed both by the mobile App and during face-to-face visits with rheumatologist, who will do the same for patients included in the traditional care model. Patients will be able to report any incidence related to their disease or treatment through the mobile App. conditions: Telemedicine conditions: Telehealth conditions: eHealth conditions: Rheumatic Diseases conditions: Arthritis, Rheumatoid conditions: Spondylarthritis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 360 type: ESTIMATED name: IMIDOC measure: To assess the primary objective, composite endpoints that consider the viability, adherence and degree of satisfaction of the MAM are included measure: To identify features associated with adherence to follow-up through the MAM. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06273293 id: EPIC35-PROMETEUS briefTitle: Postprocedural Contrast Mediated FFR Plus Intracoronary Infusion of Nitroglycerin in Multivessel Patients (PROMETEUS TRIAL) overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2025-01-20 date: 2026-01-20 date: 2024-02-22 date: 2024-03-13 name: Fundación EPIC class: OTHER briefSummary: the use of pressure wires is the standar of care to evaluate angiographically intermediate coronary lesions, however, limitations in the management of these type of lesions continue to be a challenge for the interventional cardiologist. The use of FFR has some limitations such as the use of adenosine due to its cost, adverse effects (e.g. transient atrioventricular block, angina, headache, etc.), time consuming and some relative contraindications for its use. In this sense, in recent years new rest indices (iFR, RFR, dPR) and hyperemic indices without adenosine (cFFR-NTG, Pd/Pa-NTG or cFFR) have been developed, demonstrating an improvement in terms of outcomes with its use, so they can also be used as a tool to guide us to plan our strategy. These new indices, particularly the cFFR-NTG, are simpler, at least as safe and have an excellent correlation with the FFR with adenosine in the assessment of intermediate coronary lesions.

In recent years, functional assessment after intervention has also been increasingly implemented, which, like intracoronary imaging, can make us change our attitude and correlate with the prognosis. The lower implementation of this practice, especially in multivessel patients, may result from having to lose the position of the wire to check equalization, difficulty in crossing the wire, wear/breakage of the material after diagnosis (2-3 vessels), use more time and contrast, etc. These problems could be reduced, at least partially, with the use of the workhorse coronary guidewire pressure microcatheter to measure post-PCI functional assessment. Although the usefulness of post-PCI FFR has been demonstrated, there is no clearly established cut-off value (0.84-0.96) and it seems that in reality the values are a continuum of risk so that the higher the value, the better the prognosis . Furthermore, other simpler indices such as rest or hyperemic indices without adenosine have not been correlated with FFR in post-PCI.

The purpose of this study is to evaluate the correlation between cFFR-NTG and other indices taking FFR as a reference in multivessel patients after undergoing intervention. Establish cut-off points and correlate it with adverse cardiovascular events (MACE) in a 1-year clinical follow-up. conditions: Coronary Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 150 type: ESTIMATED name: Fractional Flow Reserve measure: Agreement between cFFR+NTG and FFR measure: SAFETY: MACE measure: Agreement between Pd/Pa or dPR and FFR measure: Cut-off point for cFFR+NTG post-ICP measure: Evaluate the change in strategy that the measurement of FFR values ≤0.90 post-PCI measure: Cardiac death measure: Cardiovascular death measure: Acute myocardial infarction of the lesion treated/functionally evaluated measure: Acute myocardial infarction from any lesion measure: Need for revascularization of the lesion treated/functionally evaluated measure: Need for revascularization of any lesion sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06273280 id: Z-2023025 briefTitle: Renal-based Optimization of QUADruple Therapy in Patients With Heart Failure With Reduced Ejection Fraction. acronym: ReQUAD-HF overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-14 date: 2025-12 date: 2026-03 date: 2024-02-22 date: 2024-02-28 name: Ziekenhuis Oost-Limburg class: OTHER name: King Baudouin Foundation briefSummary: The goal of this clinical trial is to evaluate guideline-directed medical therapy (GDMT) up-titration in patients with heart failure with reduced ejection fraction.The main question it aims to answer is the improvement in prescription rate and dose uptitration of quadruple GDMT in patients with HFrEF, assessed by a weighed composite score.

Participants will be randomized towards control (standard of care, SOC) or intervention group.

Researchers will compare SOC with protocol-based up-titration to see if the protocolized optimization improves prescription rate of GDMT. conditions: Heart Failure conditions: Heart Failure With Reduced Ejection Fraction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a prospective, randomized-controlled trial. Due to the design, the study is open-label, but the endpoint assessment is blinded. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Due to the study design, the study is open-label. In order to reduce bias, a study nurse (blinded for allocation arm) will see or call the patient to register the heart failure medication and dose of loop diuretics at three months and optionally 12months (open-label, endpoint-blinded). whoMasked: OUTCOMES_ASSESSOR count: 345 type: ESTIMATED name: SOC name: Protocolized up-titration measure: Weighed composite score of maximal guideline-directed medical therapy measure: All-cause mortality and heart failure hospitalizations measure: Change in NTproBNP measure: Change in renal function measure: All-cause mortality measure: Number of patients with heart failure hospitalizations measure: Change in prescription rate per GDMT class measure: Incidence of predefined safety endpoints sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ziekenhuis Oost-Limburg AV city: Genk state: Limburg zip: 3600 country: Belgium lat: 50.965 lon: 5.50082 hasResults: False

 nctId: NCT06273267 id: APHP231232 briefTitle: Initiating Pediatric Palliative Care in ACT Group 4 acronym: StartSPP overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-08 date: 2024-08 date: 2024-02-22 date: 2024-02-22 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Due to the wide range of diagnoses encountered in pediatric palliative care, the Association for Children's Palliative Care (ACT) and the Royal College of Paediatrics and Child Health (RCPCH) have developed a classification of life-limiting illnesses, based on support models.

This classification includes four groups. ACT 4 category is made up of children with a serious incurable non-progressive neurological disease (for example: anoxic ischemia, cerebral palsy, traumatic or infectious brain injuries).

Although data relating to specific ACT groups are scarce, experience from clinical practice suggests that the needs and use of Pediatric palliative care resources are different across the four categories.

The specific history of ACT-4 patients suggests that pediatric palliative care may be required early on in the history of the disease but effective intervention varies greatly from one patient to another. Tthis study aims to better understand the optimal timing for introducing a PPC team into the care pathway for these children. The study also aims to describe the care trajectory over the first year of PPC intervention. conditions: Encephalopathy conditions: Cerebral Palsy conditions: Cerebral Malformation conditions: Traumatic Head Injury studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 150 type: ESTIMATED name: Collection of data from the patient's medical file measure: Description of first pediatric palliative care intervention measure: Description of the patient situation measure: Timing of pediatric palliative care intervention sex: ALL maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: Hôpital Necker-Enfants Malades city: Paris zip: 75015 country: France name: Ashley RIDLEY, M.D. role: CONTACT phone: 1 42 19 27 28 phoneExt: +33 email: ashley.ridley@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06273254 id: SCVL-TFZ-1009 briefTitle: A Bioequivalence Study of Sacubitril/Valsartan Film-coated Tablets Under Fasting Conditions overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-05 date: 2024-09 date: 2024-02-22 date: 2024-02-22 name: Viatris Inc. class: INDUSTRY briefSummary: Primary objective is to is to evaluate the bioequivalence of two formulations conditions: Bioequivalence Study studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 48 type: ESTIMATED name: Sacubitril and Valsartan Tablets 49mg/51mg name: Entresto® (Sacubitril and Valsartan Tablets 49mg/51mg) measure: Cmax measure: AUC measure: tmax measure: t1/2 measure: λz measure: AUC0-t/AUC0-∞ measure: residual area sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Medica Innova Co Ltd city: Bangkok zip: 10310 country: Thailand name: Ariya Khunvichai, Ph.D role: CONTACT phone: 666 2428 7178 email: ariya@medicainnova.com name: Suvimol Niyomnaitham, Assist. Prof., M.D., Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 13.75398 lon: 100.50144 hasResults: False

 nctId: NCT06273241 id: IPHA-2024-009 briefTitle: Impact of Food Intake on Berberine Kinetics acronym: BERKI-3 overallStatus: NOT_YET_RECRUITING date: 2024-03-04 date: 2024-09-30 date: 2024-09-30 date: 2024-02-22 date: 2024-02-22 name: University Medicine Greifswald class: OTHER briefSummary: The influence of genetic variants of the CYP2D6 enzyme and the Organic Cation Transporter 1 on the kinetics of berberine (BERKI-1) has recently been studied. A significant sex difference was observed. These results lead to the BERKI-2 study, investigating the influence of the female hormonal cycle on berberine kinetics. In this study, women took a single berberine dose once in the first and once in the second half of their menstrual cycle, men served as a control group ingesting a single berberine dose. Contrary to our expectations, the previously observed sex difference could not be confirmed.

In both BERKI-1 and 2 studies, the plasma concentration curve exhibited two peaks. The first after about 2-3 h, and the second after approximately 5 h of berberine intake. All participants took a single dose of Berberine under fasting conditions in the morning and 4 h after berberine intake, they ate a meal. Shortly after meal intake, the plasma concentration curve peaked again BERKI-3 will investigate the impact of food intake on berberine bioavailability and the kinetic properties. Given the suspected influence of berberine on glycemic control, we will also measure insulin and glucose after the meal at noon.

As in BERKI-1 and 2, time dependent blood and urine samples will be collected after a single berberine dose. One By measuring berberine metabolites by Liquid Chromatography and Mass-spec One dose will be taken in the fasted condition and the other two after a light or high caloric meal, respectively.

24 heathy volunteers with an equal ratio of man and women will be enrolled. conditions: Pharmacokinetic Study in Healthy Volunteers studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This is an unblinded, randomized, prospective study comparing berberine intake in fasted condition and after a high or low caloric meal in a cross-over design. primaryPurpose: TREATMENT masking: NONE maskingDescription: This study will be an open label study. Participants will be selected from an existing database of our Institute. count: 24 type: ESTIMATED name: food intake measure: Berberine plasma concentration fasted vs fed measure: Berberine plasma concentrations light vs heavy meal measure: Blood glucose concentrations measure: Blood insulin concentrations sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: University Medicine Greifswald, Institute of Pharmacology city: Greifswald state: Mecklenburg-Vorpommern zip: 17487 country: Germany name: Stefan Engeli, Prof. role: CONTACT phone: +49 3834865633 email: stefan.engeli@med.uni-greifswald.de name: Christin Jeschke role: CONTACT phone: +491746471584 email: Christin.Jeschke@med.uni-greifswald.de name: Stefan Engeli, Prof. role: PRINCIPAL_INVESTIGATOR lat: 54.09311 lon: 13.38786 hasResults: False

 nctId: NCT06273228 id: STUDY00000788 briefTitle: Parenting Young Children in Pediatrics overallStatus: RECRUITING date: 2023-09-27 date: 2024-10-01 date: 2024-10-01 date: 2024-02-22 date: 2024-02-22 name: University of Oregon class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: Research suggests that one in eight children in the U.S. currently lives with a parent with a substance use disorder. Parents who misuse substances are at increased risk of using harsh and other negative parenting practices with their young children, who are more likely to face challenges with emotional and behavioral regulation and subsequently misuse substances themselves. There is thus an urgent need for evidence-based interventions to promote positive parenting skills in parents who misuse substances. Interventions must be convenient, non-stigmatizing, and accessible to parents with problematic substance use, who frequently face barriers to engaging with healthcare systems. Pediatric primary care is an ideal setting to offer a brief intervention for maladaptive parenting behaviors associated with parental substance use, as the vast majority of children under 5 access pediatric primary care at least annually and parents generally report high levels of trust in their child's pediatrician.

The Family Check-Up (FCU) Online app, which was created specifically to promote positive parenting skills in parents with past or current substance misuse, is ideal for delivery to parents with pre-school age children in a pediatric primary care setting as it is brief, convenient, and delivered in a self-directed format that parents favor. The main objective of this pilot study is to test the feasibility and acceptability of the FCU-Online, a brief, app-based parenting intervention, for parents reporting lifetime problematic substance use in a pediatric primary care setting.

In this study, investigators will partner with pediatric primary care providers to recruit parent participants, then evaluate feasibility and acceptability by systematically assessing parents' engagement with the FCU Online app. Engagement data from the app includes time spent in app overall and in each module, activities completed, and which modules were accessed. Investigators will also administer a consumer satisfaction survey, which will ask parents to report on their perceptions of the app (e.g., helpfulness, useability, and effects on parenting). To assess engagement in telehealth coaching sessions, investigators will use the following variables: number of telehealth sessions completed, length of session, content of sessions, and coaches' ratings of participant engagement in the session and barriers to using the app. Coaches will also rate participant engagement on a 3-point scale from "low" to "high." Lastly, investigators will conduct qualitative interviews with a sub-sample of participants to solicit additional feedback on the acceptability of the FCU Online, focusing particularly on the perception of acceptability within an integrated primary care context and stigma associated with endorsing substance use in this setting.

A second aim of this study is to assess pediatric healthcare providers' perceptions and attitudes regarding the fit of the FCU Online with their practice settings as well as potential barriers to implementation. Through semi-structured focus groups and qualitative interviews with pediatric healthcare providers, investigators will assess provider- and practice-level factors that may facilitate or impede the implementation of the FCU Online in pediatric primary care settings. conditions: Parenting conditions: Parent-Child Relations conditions: Substance Use Disorders conditions: Stress conditions: Depression conditions: Anxiety conditions: Parenting Self-efficacy conditions: Pediatrics studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Parents will be recruited in pediatric primary care settings and will be assessed at baseline and at a 3-month follow-up. Parents will receive the intervention between baseline and follow-up. Nine parents will be randomly selected for an additional follow-up interview. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 36 type: ESTIMATED name: Family Check-Up Online measure: change from baseline in parenting skills measure: change from baseline in parenting efficacy measure: change from baseline in parent executive functioning measure: change from baseline in child social-emotional behavior measure: change from baseline in family conflict measure: change from baseline in parental substance use measure: change from baseline in parental depression measure: change from baseline in parental anxiety measure: change from baseline in parental stress measure: change from baseline in parental impact of negative life events sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Prevention Science Institute, University of Oregon status: RECRUITING city: Eugene state: Oregon zip: 97403 country: United States name: Katherine Hails, PhD role: CONTACT phone: 610-457-8627 email: khails@uoregon.edu name: Elizabeth Stormshak, PhD role: CONTACT phone: 541-912-3792 email: bstorm@uoregon.edu name: Katherine Hails, PhD role: PRINCIPAL_INVESTIGATOR lat: 44.05207 lon: -123.08675 hasResults: False

 nctId: NCT06273215 id: DCTC-IIR202217 briefTitle: Evaluation of the Pharmacokinetics of Microdose Midazolam, Dabigatran, Pitavastatin, Atorvastatin and Rosuvastatin in Diabetic Patients overallStatus: RECRUITING date: 2023-03-05 date: 2025-12-31 date: 2025-12-31 date: 2024-02-22 date: 2024-02-22 name: Peking University Third Hospital class: OTHER briefSummary: 1.To explore the functional changes of P-gp, CYP3A4, OATP1B and BCRP in Diabetic patients (including the non-obese T2DM, obese T2DM, elderly T2DM, and T1DM). conditions: Diabetes studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 48 type: ESTIMATED name: The combinations of 10 µg midazolam, 375 µg dabigatran etexilate, 10 µg pitavastatin, 50 µg rosuvastatin, and 100 µg atorvastatin were administered to diabetic patients on an empty stomach. measure: Pharmacokinetics of study drug measure: Concentration of endogenous markers of CYP3A and OATP measure: Genotype of OATP and BCRP sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University Third Hospital status: RECRUITING city: Beijing state: Beijing zip: 100191 country: China name: Yafen Li role: CONTACT phone: 18222566785 email: liyafen314159@163.com name: Dongyang Liu role: PRINCIPAL_INVESTIGATOR name: Tianpei Hong role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06273202 id: 6257 briefTitle: Ultrasound Monitoring of Muscle Thickness in Premature Patients acronym: NeoMassage overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-07 date: 2025-01 date: 2024-02-22 date: 2024-02-22 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: The goal of this interventional study is to investigate through musculoskeletal ultrasonography how the thickness and muscle trophism in infants aged 28 to 35 weeks undergoing infant massage compared with a group of infants with similar characteristics not subjected to treatment.

The main questions it aims to answer are:

* To assess by musculoskeletal ultrasound the impact of infant massage on muscle thickness muscle. Specifically, changes in muscle thickness and trophism of the quadriceps femoris.
* Potential effects on spontaneous motility and stature-ponderal growth of infants. In addition, the discomfort and behavioral status of the infant before and after massage will be investigated infant.

Patients included in the study will be randomized according to a random sequence with a 1:1 ratio into theexperimental group (GS) or the control group (GC). Patients in the GS will perform therapy with infant massage in addition to the usual rehabilitation therapies as specified by the program individual habilitative, to which patients in the control group will be subjected exclusively control.

Infant massage will be performed three times a day (10 minutes per session) until they reach the 35th week of post-conceptional age (35+6) by the two departmental physical therapists (ADP and ADV).

Ultrasound will be performed at the time of randomization (T0) and then 1 time per week until the 35th week by two operators (SN and VA); at the same time, the circumference of the thigh subjected to ultrasound examination. A 12Hz linear ultrasound probe will be used, applied perpendicular to the skin. The infant will be placed supine, with the thigh extended, in a neutral position; excessive compression will be avoided by applying a generous amount of gel. At the midpoint of the thigh, the thickness of the quadriceps muscle will be calculated by measuring the distance between the cortex of the femur and the most superficial muscle fascia. The average of at least 2 measurements will be then calculated. The Heckmatt scale will be used to assess the echogenicity of muscle and bone. In addition, at time T0 and at week 35 the following data will be collected: weeks gestational age, weight at birth and at the end of treatment, rectal temperature, blood gas parameters if present. conditions: Prematurity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 24 type: ESTIMATED name: Infant Massage measure: Quadriceps femuri thickness measure: Quadriceps femuri trophism measure: To valuate the discomfort/behavioral status of the infant. measure: To valuate the potential effects on spontaneous motility. measure: To evaluate differences in ponderal growth. sex: ALL minimumAge: 28 Weeks maximumAge: 35 Weeks stdAges: CHILD hasResults: False

 nctId: NCT06273189 id: 2017/558 briefTitle: Ultrasonic Bone Scalpel in BSSO overallStatus: COMPLETED date: 2018-12-15 date: 2020-12-15 date: 2021-12-15 date: 2024-02-22 date: 2024-02-22 name: TC Erciyes University class: OTHER briefSummary: The conventional saw compared with the piezo surgery in BSSO to evaluate cutting time, surgery duration, amount of bleeding. The purpose of this study was to answers following clinical questions: Is ultrasonic bonescalpel effective osteotomy like conventional bur in BSSO? and 2) Does it reduce operative parameter like bleeding, duration, lingual split pattern? 3) Does it reduce postoperative morbidity after BSSO. conditions: Maxillofacial Abnormalities studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: double blind primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: Conventional name: Bone Scalpel measure: Cutting Time measure: neurosensory disturbance measure: The length of the procedure measure: The splitting time measure: The pattern of the split measure: postoperative edema sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Selin Çelebi city: Kayseri state: Melikgazi zip: 38039 country: Turkey lat: 38.73222 lon: 35.48528 hasResults: False

 nctId: NCT06273176 id: MEC-2020-0812 briefTitle: The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma acronym: RECMAP overallStatus: RECRUITING date: 2023-01-01 date: 2027-01-01 date: 2028-01-01 date: 2024-02-22 date: 2024-02-22 name: Erasmus Medical Center class: OTHER name: Haaglanden Medical Centre name: Universitaire Ziekenhuizen KU Leuven name: University Hospital Heidelberg name: Technical University of Munich name: Insel Gruppe AG, University Hospital Bern name: Massachusetts General Hospital name: University of California, San Francisco briefSummary: Resection of glioblastoma in or near functional brain tissue is challenging because of the proximity of important structures to the tumor site. To pursue maximal resection in a safe manner, mapping methods have been developed to test for motor and language function during the operation. Previous evidence suggests that these techniques are beneficial for maximum safe resection in newly diagnosed grade 2-4 astrocytoma, grade 2-3 oligodendroglioma, and recently, glioblastoma. However, their effects in recurrent glioblastoma are still poorly understood. The aim of this study, therefore, is to compare the effects of awake mapping and asleep mapping with no mapping in resections for recurrent glioblastoma.

This study is an international, multicenter, prospective 3-arm cohort study of observational nature. Recurrent glioblastoma patients will be operated with mapping or no mapping techniques with a 1:1 ratio. Primary endpoints are: 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months, and 6 months after surgery and 2) residual tumor volume of the contrast-enhancing and non-contrast-enhancing part as assessed by a neuroradiologist on postoperative contrast MRI scans. Secondary endpoints are: 1) overall survival (OS), 2) progression-free survival (PFS), 4) health-related quality of life (HRQoL) at 6 weeks, 3 months, and 6 months after surgery, and 4) frequency and severity of Serious Adverse Events (SAEs) in each arm. Estimated total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.

The study will be carried out by the centers affiliated with the European and North American Consortium and Registry for Intraoperative Mapping (ENCRAM). conditions: Glioblastoma, IDH-wildtype conditions: Glioblastoma conditions: Glioblastoma Multiforme of Brain conditions: Astrocytoma, Malignant conditions: Brain Neoplasms conditions: Brain Neoplasms, Adult, Malignant conditions: Brain Neoplasms, Adult conditions: Recurrent Adult Brain Tumor conditions: Recurrent Glioblastoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 225 type: ESTIMATED name: Awake mapping under local anesthesia name: Asleep mapping under general anesthesia name: Resection under general anesthesia without mapping measure: Residual volume measure: Neurological morbidity at 6 weeks measure: Overall survival measure: Progression-free survival measure: Onco-functional outcome (OFO) measure: Serious Adverse Events measure: Neurological morbidity at 3 months measure: Neurological morbidity at 6 months measure: Overall functioning at 6 weeks measure: Overall functioning at 3 months measure: Overall functioning at 6 months measure: Quality of life at 6 weeks (EORTC QLQ C30) measure: Quality of life at 3 months (EORTC QLQ C30) measure: Quality of life at 6 months (EORTC QLQ C30) measure: Quality of life at 6 weeks (EORTC QLQ BN20) measure: Quality of life at 3 months (EORTC QLQ BN20) measure: Quality of life at 6 months (EORTC QLQ BN20) measure: Quality of life at 6 weeks (EQ-5D) measure: Quality of life at 3 months (EQ-5D) measure: Quality of life at 6 months (EQ-5D) sex: ALL maximumAge: 90 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, San Francisco status: RECRUITING city: San Francisco state: California zip: 94143 country: United States name: Mitchel Berger, MD PhD role: CONTACT lat: 37.77493 lon: -122.41942 facility: Massachusetts General Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02114 country: United States name: Brian Nahed, MD PhD role: CONTACT lat: 42.35843 lon: -71.05977 facility: University Hospital Leuven status: RECRUITING city: Leuven country: Belgium name: Steven De Vleeschouwer, MD PhD role: CONTACT lat: 50.87959 lon: 4.70093 facility: Universitätsklinikum Heidelberg status: RECRUITING city: Heidelberg country: Germany name: Christine Jungk, MD PhD role: CONTACT name: Sandro Krieg, MD PhD role: CONTACT lat: 49.40768 lon: 8.69079 facility: Technical University Munich status: NOT_YET_RECRUITING city: Munich country: Germany name: Arthur Wagner, MD role: CONTACT lat: 48.13743 lon: 11.57549 facility: Erasmus Medical Center status: RECRUITING city: Rotterdam state: Zuid-Holland zip: 3015 GD country: Netherlands name: Jasper Gerritsen, MD PhD role: CONTACT lat: 51.9225 lon: 4.47917 facility: Haaglanden Medical Center status: RECRUITING city: The Hague country: Netherlands name: Marike Broekman, MD PhD role: CONTACT lat: 52.07667 lon: 4.29861 facility: Inselspital Universitätsspital Bern status: NOT_YET_RECRUITING city: Bern country: Switzerland name: Philippe Schucht, MD PhD role: CONTACT lat: 46.94809 lon: 7.44744 hasResults: False

 nctId: NCT06273163 id: STU-2023-1168 briefTitle: Identifying Strategies to Curtail Weight Regain After GLP-1 Receptor Agonist Treatment Cessation overallStatus: RECRUITING date: 2024-03-05 date: 2024-12-31 date: 2024-12-31 date: 2024-02-22 date: 2024-03-08 name: University of Texas Southwestern Medical Center class: OTHER name: UT Southwestern Nutrition Obesity Research Center briefSummary: Longitudinal studies show there is a steep increase in weight regain in the first 3-4 months after stopping GLP-1 receptor agonist medications (GLP-1s) and most patients regain most of their weight within a year. Insurers now question the utility of GLP-1s for weight loss as they are hesitant to cover these costs long-term (\~$833 per person per month). Some patients would also prefer not to take these medications in perpetuity and are likely to struggle with lifelong adherence. These challenges present an opportunity to test alternative interventions, such as meal replacements and behavioral treatments, to support weight maintenance after successful weight loss with GLP-1s. This regimen would allow patients to benefit from significant weight loss in the first year of taking GLP-1s and use more cost effective and sustainable strategies for long-term maintenance. conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized repeated measures between-subjects design primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE maskingDescription: Complete masking is not feasible given the nature of the interventions - the program coordinator and participants will know if the participant receives home delivered medically tailored meals, a smart device application subscription, or usual care. The care provider will not be told the participants group assignment, but the participant may reveal it themselves in discussions with the provider. whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Medically tailored meals name: Noom® name: Usual care measure: Intervention Adherence measure: Intervention Satisfaction measure: Percent weight loss maintained measure: Diet quality measure: Incremental cost effective ratio (ICER) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UT Southwestern Medical Center status: RECRUITING city: Dallas state: Texas zip: 75390 country: United States name: Carolyn Haskins, MS role: CONTACT email: niche@utsouthwestern.edu name: Jessica ‪ Turcios, BS role: CONTACT email: niche@utsouthwestern.edu name: Kelseanna Hollis-Hansen, PhD, MPH role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 hasResults: False

 nctId: NCT06273150 id: 142048 briefTitle: Dentatorubral-pallidoluysian Atrophy Natural History and Biomarkers Study acronym: DRPLA NHBS overallStatus: RECRUITING date: 2022-05-01 date: 2026-04 date: 2026-04 date: 2024-02-22 date: 2024-02-22 name: University College, London class: OTHER name: University of North Carolina, Chapel Hill name: NYU Grossman School of Medicine briefSummary: DRPLA Natural History and Biomarkers Study (DRPLA NHBS) is a prospective observational study that will lay the foundation for clinical trials in DRPLA. The aims of this project are:

* To characterize the natural history of DRPLA in both juvenile- and adult-onset patients and study different modalities of biomarkers in this condition.
* To identify genetic factors and biomarkers that could predict disease progression.
* To provide a platform to support the design and conduct of clinical trials.

This study has three arms:

1. Adult Participants: this arm of the study will require participants to be 16 years old or over to participate.
2. Pediatric Participants: this arm of the study will require participants to be under 16 years old to participate.
3. Remote Participants: patients that cannot or do not wish to travel to one of the study sites can participate in this arm of the study, irrespective of their age.

Participants will have an annual visit for three years (baseline visit and two follow-up visits, three visits in total). Subjects who complete the whole protocol will be assessed on two consecutive days to reduce patient burden.

This project will allow for a better understanding of DRPLA and its course, and therefore allow for future clinical trials on this condition to be more precisely and effectively conducted. conditions: Dentatorubral-Pallidoluysian Atrophy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 225 type: ESTIMATED name: Positive genetic test for pathological expansion in ATN1 measure: Scale for the assessment and rating of ataxia (SARA) measure: Brain atrophy measure: Neurofilament plasma concentration (NfL) measure: Inventory of non-ataxia signs (INAS) measure: Upper limb function test AIM-S measure: Redenlab DRPLA specific speech battery measure: Clinical Assessment of Dysphagia in Neurodegeneration (CADN) measure: Tau plasma concentration measure: Glial fibrillary acidic protein (GFAP) concentration measure: Ubiquitin carboxyterminal hydrolase L1 (UCH-L1) concentration sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: NYU Grossman School of Medicine status: RECRUITING city: New York state: New York zip: 10017 country: United States name: Claire Miller role: CONTACT phone: 212-263-4838 email: Claire.Miller@nyulangone.org lat: 40.71427 lon: -74.00597 facility: University of North Carolina at Chapel Hill status: RECRUITING city: Chapel Hill state: North Carolina zip: 27599-7025 country: United States name: Yael Shiloh-Malawsky role: CONTACT phone: 919-966-2528 email: yaelm@neurology.unc.edu lat: 35.9132 lon: -79.05584 facility: University College London status: RECRUITING city: London zip: WC1N 3BG country: United Kingdom name: Paola Giunti role: CONTACT phone: +44 7899974923 email: p.giunti@ucl.ac.uk lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06273137 id: 2963 briefTitle: Positive Affect Treatment for Adolescents With Early Life Adversity acronym: PAT4ELA overallStatus: RECRUITING date: 2024-02-03 date: 2026-02-16 date: 2026-10-16 date: 2024-02-22 date: 2024-02-28 name: University of California, Irvine class: OTHER briefSummary: Youth exposed to early life adversity (ELA) are known to be at greater risk for depression and suicidality and account for almost half of the youth suffering from psychiatric diseases today. Youth exposed to ELA consistently report symptoms of anhedonia as well as dysregulated positive affect. The present project will test the efficacy of PAT in a sample of ELA-exposed adolescents in order to determine whether PAT increases positive affect, and subsequently symptoms of depression. For this pilot, the investigators will recruit 22 adolescents exposed to two or more childhood adversities (ACEs) who do not currently have major depressive disorder, and randomize them (1:1) to either participate in PAT or a waitlist control condition. At study enrollment, then 4-, 8, and 12-months thereafter the investigators will measure positive affect and depressive symptoms (including anhedonia). The results of this study will be used to inform whether PAT has the potential to prevent major depressive episodes among adversity-exposed youth. conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Participants will be randomized 1:1 to either receive PAT upon enrollment or after a waitlist period. primaryPurpose: PREVENTION masking: NONE count: 22 type: ESTIMATED name: Positive affect treatment measure: Positive affect measure: depressive symptoms - total measure: depressive symptoms - anhedonia subscale measure: Systemic inflammation - C-reactive protein (CRP) measure: Inflammatory gene expression sex: ALL minimumAge: 12 Years maximumAge: 16 Years stdAges: CHILD facility: University of California Irvine status: RECRUITING city: Irvine state: California zip: 92617 country: United States name: Kate R Kuhlman role: CONTACT phone: 949-824-5574 email: krkuhl@uci.edu lat: 33.66946 lon: -117.82311 hasResults: False

 nctId: NCT06273124 id: 150-1261-00 briefTitle: Investigational Extended Wear Insulin Infusion Set in People With Type 1 Diabetes overallStatus: RECRUITING date: 2024-03-07 date: 2025-01-15 date: 2025-01-15 date: 2024-02-22 date: 2024-04-25 name: Tandem Diabetes Care, Inc. class: INDUSTRY name: Jaeb Center for Health Research briefSummary: The purpose of this study is to collect clinical data to support a 7-day wear of the Extended Wear Infusion Set (EWIS).

Participants will be asked to:

1. Wear the EWIS for up to 7 consecutive days for 12 consecutive wear periods
2. Perform blood glucose and ketone measurements if continuous glucose meter is ≥250mg/dL for one hour conditions: Type1diabetes studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Device Extended Wear Infusion Set Each participant will wear each extended wear infusion set for up to 168 hours for 12 sequential wear periods. primaryPurpose: TREATMENT masking: NONE count: 260 type: ESTIMATED name: SteadiSet Extended Wear Infusion Set measure: Primary Outcome Measure measure: Primary Outcome sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hoag Memorial Hospital Presbyterian status: RECRUITING city: Newport Beach state: California zip: 92663 country: United States name: Brittany Dennis role: CONTACT phone: 949-764-6896 email: brittany.dennis@hoag.org name: David Ahn, MD role: PRINCIPAL_INVESTIGATOR lat: 33.61891 lon: -117.92895 facility: Stanford University status: NOT_YET_RECRUITING city: Stanford state: California zip: 94305 country: United States name: Rayhan Lal role: CONTACT phone: 925-727-1317 email: inforay@stanford.edu name: Rayhan Lal, MD role: PRINCIPAL_INVESTIGATOR lat: 37.42411 lon: -122.16608 facility: Barbara Davis Center status: NOT_YET_RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: Samantha Lange role: CONTACT phone: 303-724-7514 email: samantha.lange@cuanschutz.edu name: Erin Cobry, MD role: PRINCIPAL_INVESTIGATOR lat: 39.72943 lon: -104.83192 facility: Endocrine Research Solutions status: RECRUITING city: Roswell state: Georgia zip: 30076 country: United States name: Jessica Tapia role: CONTACT phone: 678-878-4750 email: jtapia.ers@gmail.com name: John C Reed, MD role: PRINCIPAL_INVESTIGATOR lat: 34.02316 lon: -84.36159 facility: Rocky Mountain Clinical Research status: NOT_YET_RECRUITING city: Idaho Falls state: Idaho zip: 83404 country: United States name: Wyatt Larson role: CONTACT phone: 208-525-3736 email: Wyatt.larson@idahomed.com name: David Liljenquist, MD role: PRINCIPAL_INVESTIGATOR lat: 43.46658 lon: -112.03414 facility: Northwestern University status: NOT_YET_RECRUITING city: Evanston state: Illinois zip: 60208 country: United States name: Grazia Aleppo role: CONTACT phone: 312-926-5431 email: aleppo@northwestern.edu name: Grazia Aleppo, MD role: PRINCIPAL_INVESTIGATOR lat: 42.04114 lon: -87.69006 facility: Massachusetts General Hospital status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02114 country: United States name: Amy Sabean role: CONTACT phone: 617-726-1729 email: asabean@mgh.harvard.edu name: Melissa Putman, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Henry Ford Health System status: NOT_YET_RECRUITING city: Detroit state: Michigan zip: 48202 country: United States name: Davida Kruger role: CONTACT phone: 313-916-3906 email: dkruger1@hfhs.org name: Davida Kruger, NP role: PRINCIPAL_INVESTIGATOR lat: 42.33143 lon: -83.04575 facility: International Diabetes Center - HealthPartners Institute status: NOT_YET_RECRUITING city: Minneapolis state: Minnesota zip: 55416 country: United States name: Kathryn Leet, RD,LD, CDCES role: CONTACT phone: 952-993-9793 email: kathryn.leet@parknicollet.com name: Richard Bergenstal, MD role: PRINCIPAL_INVESTIGATOR lat: 44.97997 lon: -93.26384 facility: Mayo Clinic status: NOT_YET_RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Corey Kurek role: CONTACT phone: 507-255-0316 email: reid.corey@mayo.edu name: Yogish Kudva, MD role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 facility: Icahn School of Medicine at Mt. Sinai status: NOT_YET_RECRUITING city: New York state: New York zip: 10029 country: United States name: Denisa Tamarez role: CONTACT phone: 212-241-9089 email: denisa.tamarez@mssm.edu name: Camilla Levister, MS, ANCP-C role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: SUNY Upstate Medical University status: RECRUITING city: Syracuse state: New York zip: 13210 country: United States name: Suzan Bzdick, RN, CDCES role: CONTACT phone: 315-464-9006 email: bzdicks@upstate.edu name: Ruth Weinstock, MD role: PRINCIPAL_INVESTIGATOR lat: 43.04812 lon: -76.14742 facility: Texas Diabetes and Endocrinology status: NOT_YET_RECRUITING city: Austin state: Texas zip: 78731 country: United States name: Emmanuel Lopez role: CONTACT phone: 512-334-3505 email: elopez@texasdiabetes.com name: Jean Chen, MD role: PRINCIPAL_INVESTIGATOR lat: 30.26715 lon: -97.74306 facility: Rainier Clinical Research Center status: NOT_YET_RECRUITING city: Renton state: Washington zip: 98057 country: United States name: Tina Mitchell role: CONTACT phone: 425-251-1720 email: TMitchell@rainier-research.com name: Frances Broyles, MD role: PRINCIPAL_INVESTIGATOR lat: 47.48288 lon: -122.21707 facility: University of Washington status: NOT_YET_RECRUITING city: Seattle state: Washington zip: 98109 country: United States name: Dori Khakpour role: CONTACT phone: 206-945-4965 email: dorik@uw.edu name: Irl Hirsch, MD role: PRINCIPAL_INVESTIGATOR lat: 47.60621 lon: -122.33207 hasResults: False

 nctId: NCT06273111 id: 73840 briefTitle: Topical Simvastatin for Treating Infantile Hemangioma acronym: TSTIH overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-07-31 date: 2025-12-31 date: 2024-02-22 date: 2024-02-22 name: Joyce Teng class: OTHER name: Stanford University briefSummary: This is a 24-week, open-label pilot study to evaluate the safety and preliminary efficacy of 5% simvastatin ointment in treating 12 children with superficial IH.

The primary objective:

To evaluate the safety and tolerability of topical treatment with 5% simvastatin ointment for superficial IH over 24 weeks.

The secondary objective:

1.1 To evaluate the efficacy of 5% simvastatin ointment when topical treatment is administered twice daily for 24 weeks. Evaluation is performed at each clinic visit via investigator global assessment (IGA) based on standardized 3D digital photography and hemangioma activity score (HAS).

1.2 To evaluate the impact of 5% simvastatin ointment on quality of life using the IH-QoL questionnaire. conditions: Hemangioma Skin studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: 5% simvastatin ointment measure: Number of Participants with Treatment-Related Adverse Events measure: Percentage of participants achieved a 50% HAS reduction at week 12 compared to baseline measure: Percentage of participants achieved a 75% HAS reduction from baseline by the end of the study (week 24) compared to baseline. measure: Percentage of targeted hemangiomas with complete or nearly complete resolution (IGA 0 or 1), defined as a minimal degree of telangiectasia, skin thickening, and no definitive palpable cutaneous texture changes. measure: Percentage of targeted hemangiomas that are stabilized (no noticeable change to baseline) or continue to progress. measure: Percentage of participants with a significant improvement in quality-of-life, defined as > 50% reduction in the IH-QoL questionnaire score from baseline to week 24. sex: ALL minimumAge: 3 Months maximumAge: 5 Years stdAges: CHILD facility: Stanford University city: Palo Alto state: California zip: 94304 country: United States name: Ramrada Lekwuttikarn, MD role: CONTACT phone: 650-313-8207 email: ramrada1@stanford.edu name: Thomas Buschbacher role: CONTACT phone: 352-278-7603 email: tbusch@stanford.edu lat: 37.44188 lon: -122.14302 hasResults: False

 nctId: NCT06273098 id: 73162 briefTitle: School-Based Bladder Health Intervention overallStatus: WITHDRAWN date: 2028-01-01 date: 2033-12-31 date: 2033-12-31 date: 2024-02-22 date: 2024-04-24 name: Stanford University class: OTHER briefSummary: The aim of this study is to promote healthy bladder behaviors among school children. We hypothesize that a combination of bladder health education and awareness events, additional resources such as a water station to support healthy bladder behaviors, and tailored changes to classroom bathroom policies can promote healthy bladder behaviors among school children. conditions: Urinary Dysfunction conditions: Lower Urinary Tract Symptoms conditions: Urinary Tract Infections conditions: Urinary Tract Infections in Children studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 0 type: ACTUAL name: Bladder Health Education measure: Bathroom use measure: Symptom score measure: Urine volume sex: ALL minimumAge: 5 Years maximumAge: 10 Years stdAges: CHILD facility: Stanford Hospital and Clinics city: Palo Alto state: California zip: 94304 country: United States lat: 37.44188 lon: -122.14302 hasResults: False

 nctId: NCT06273085 id: MOD00016877 briefTitle: Intensive Education Versus Usual Education of Patients for Improving Guideline Directed Medical Therapy (GDMT) Prescription in Heart Failure With Reduced Ejection Fraction overallStatus: RECRUITING date: 2024-02-01 date: 2025-02 date: 2025-02 date: 2024-02-22 date: 2024-02-26 name: Medstar Health Baltimore class: OTHER briefSummary: The goal of this randomized clinical trial is to test the effect of patient education on extent of use of guideline directed medical treatment (GDMT) of heart failure with reduced ejection fraction. The main question that our study aims to answer is if patient education can improve the adherence to GDMT in heart failure with reduced ejection fraction. Participants will receive educations about GDMT benefits in 1,3 and 5 months after discharge from hospital. conditions: Heart Failure conditions: Patient Acceptance of Health Care studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 500 type: ESTIMATED name: Patient education measure: Change in GDMT score measure: Heart Failure hospitalization measure: cardiovascular death/Left Ventricular Assist Device implantation/Cardiac Transplant measure: Number of GDMT classes of medications in use sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medstar Union Memorial Hospital status: RECRUITING city: Baltimore state: Maryland zip: 21218 country: United States name: Ahmad Amin, MD role: CONTACT phone: 401-533-0696 email: ahmad.amin@medstar.net lat: 39.29038 lon: -76.61219 facility: Medstar Harbor Hospital status: RECRUITING city: Baltimore state: Maryland zip: 21225 country: United States name: Sumanth Bandaru, MBBS role: CONTACT phone: 646-240-5289 email: sumanthkumar.bandaru@medstar.net lat: 39.29038 lon: -76.61219 facility: Medstar Franklin Medical Center status: RECRUITING city: Baltimore state: Maryland zip: 21237 country: United States name: Anup Agarwal, MD role: CONTACT phone: 505-620-7815 email: anup.agarwal@medstar.net lat: 39.29038 lon: -76.61219 facility: Medstar Good Samaritan Hospital status: RECRUITING city: Baltimore state: Maryland zip: 21239 country: United States name: Sumanth Bandaru, MBBS role: CONTACT phone: 646-240-5289 email: sumanthkumar.bandaru@medstar.net lat: 39.29038 lon: -76.61219 hasResults: False

 nctId: NCT06273072 id: IRB00409080 id: R34HL166438-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/R34HL166438-01A1 briefTitle: Metformin IN Asthma for Overweight and Obese Individuals (MINA) overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-09-30 date: 2028-12-31 date: 2024-02-22 date: 2024-03-15 name: Johns Hopkins University class: OTHER name: Baylor College of Medicine name: National Heart, Lung, and Blood Institute (NHLBI) name: Temple University briefSummary: This is a randomized clinical trial of metformin among overweight or obese adults with not well-controlled asthma despite maintenance inhaler therapy. conditions: Asthma conditions: Asthma Chronic conditions: Overweight and Obesity studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Metformin hydrochloride extended-release tablets name: Visually identical placebo Metformin hydrochloride extended-release tablets measure: Number of completed telemedicine visits measure: Adherence to study drug measure: Retention rate measure: Asthma control as assessed by the Asthma Control Test (ACT) score measure: Change in Asthma exacerbations rate measure: Pre-bronchodilator lung function measure: Fractional exhaled nitric oxide (FeNO) measure: Airways hyperresponsiveness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06273059 id: 22-07-0717 briefTitle: Genomic Study of Young-Onset Diabetes Mellitus overallStatus: RECRUITING date: 2022-09-12 date: 2024-12-12 date: 2024-12-12 date: 2024-02-22 date: 2024-02-22 name: Indonesia University class: OTHER briefSummary: Diabetes Mellitus (DM) has been a major contributor to health burden in Indonesia and currently its burden still continues to rise. This is a result of increasing DM prevalence in the country as well as high rates of chronic complications from DM. Findings in Indonesia show that there is a high proportion of young people with diabetes, and also a high risk of therapeutic failure and complications from DM occurring in the younger population.

Young-onset DM has a wide clinical spectrum, including autoimmune DM, polygenic DM, and monogenic DM such as Mature Onset Diabetes of the Young (MODY). Identification and proper diagnosis of young-onset DM spectrum is crucial to treatment outcomes, as certain spectrums, such as some subtypes of MODY, may benefit from cost-efficient alternatives with better outcomes.

However, proper diagnosis of young-onset DM in Indonesia is still a great challenge, as currently some examinations, including genetic testing, has not yet been feasibly done in the country. With current advances in genomics, genetic testing may prove to be fundamental in providing optimal and personalized treatment and care for DM patients.

This study is a pilot project aimed to initiate genomic research in young-onset DM patients in Indonesia. In the short term, this study aims to identify genetic variants that may be able to increase diagnostic accuracy of the young-onset DM spectrum. In the long term, this study aims to identify new genetic variants of young-onset DM. The study also aims to identify genetic variants associated with risks of chronic complications. conditions: Genomic conditions: Diabetes Mellitus conditions: MODY studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 1000 type: ESTIMATED measure: The overall objective of this study is to identify and describe genetic variation of young-onset DM in Indonesia. measure: To describe the proportion of MODY in young-onset DM measure: To describe genetic variation of MODY in Indonesia. measure: To describe genetic variation in young-onset DM with diabetic complications in various systems: sex: ALL minimumAge: 8 Years maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: Cipto Mangunkusumo Hospital status: RECRUITING city: Jakarta Pusat state: DKI Jakarta zip: 10430 country: Indonesia role: CONTACT phone: 1 500 135 lat: -6.1818 lon: 106.8223 hasResults: False

 nctId: NCT06273046 id: PR(AG)614/2023 briefTitle: Treatment of Fecal Incontinence and Functional Defecation Disorders Using Non-instrumental Biofeedback overallStatus: RECRUITING date: 2024-04-19 date: 2025-04-28 date: 2025-12-31 date: 2024-02-22 date: 2024-04-25 name: Hospital Universitari Vall d'Hebron Research Institute class: OTHER briefSummary: Background. Rehabilitation and re-education using instrumental anorectal biofeedback are the main treatment of anorectal functional disorders producing incontinence and outlet obstructed defecation. These treatments imply intubation of patient and several sessions of treatment leading to high consumption of resources and costs.

Hypothesis. A cognitive intervention based on original audiovisual programs developed specifically for the management of anorectal functional disorders is effective in correcting anorectal function disorders that cause fecal incontinence and evacuation disorders.

Aim. To prove in two different protocols (fecal incontinence and dyssinergic defecation) the efficacy of specifically developed non-instrumental biofeedback techniques.

Selection criteria. Patients with fecal incontinence and altered sphincter function and patients with outlet obstructed evacuation referred for biofeedback treatment.

Intervention. In separate studies (incontinence and dyssynergic defecation) patients will be randomized into biofeedback and placebo groups. One session of either biofeedback or placebo intervention will be performed at the beginning of the intervention period and patients will be instructed to performed the assigned daily treatment at home. A visit for outcome assessment will be performed at 3 months in incontinence study and at 4 weeks in the dyssinergic defecation study. In addition, in the incontinence study a phone call will be performed after 6 months of the beginning of the study to evaluate treatment outcome.

Biofeedback: patients will be taught to control anal and abdominal muscular activity by providing instructions using original video supports. Patients will be instructed to perform the same exercises daily at home in scheduled times.

Placebo: a pill of placebo containing 0.3 g glucose will be administered every day at home. conditions: Fecal Incontinence conditions: Outlet Dysfunction Constipation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 96 type: ESTIMATED name: Biofeedback name: Placebo measure: Fecal incontinence study: Number of anal leaks measure: Dyssinergic defecation study: Number of bowel movements measure: Incontinence study: Wexner scale measure: Incontinence study: Quality of life measure: Incontinence study: anxiety and depression measure: Incontinence study: Anal sphincter function measure: Dyssinergic defecation study: sensation of outlet obstructed evacuation measure: Dyssinergic defecation study: Wexner scale measure: Dyssinergic defecation study: Quality of life measure: Dyssinergic defecation study: anxiety and depression measure: Dyssinergic defecation study: defecatory maneuvers sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Vall d'Hebron status: RECRUITING city: Barcelona country: Spain name: Jordi Serra, MD role: CONTACT lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06273033 id: CONCORDE briefTitle: Implementation of Contemporary Coronary CT Angiography in Clinical Practice acronym: CONCORDE overallStatus: RECRUITING date: 2023-10-10 date: 2024-10 date: 2025-01 date: 2024-02-22 date: 2024-03-01 name: Humanitas Hospital, Italy class: OTHER briefSummary: Coronary CT angiography (CCTA) has been recognized as the first-line diagnostic test for most patients with suspected coronary syndrome, often acting as a gatekeeper for invasive coronary angiography. It is therefore pivotal to understand instances of discrepancies that are encountered in clinical practice. Moreover, most of the literature on this topic relies on obsolete machines or definitions of coronary artery stenosis that cannot be defined as severe.

The investigators aim 1) to report the real word data on the performance of last-generation CCTA in identifying obstructive coronary artery disease (also considering different thresholds of stenosis, i.e., moderate or severe) and 2) to identify predictors of discrepancies. conditions: Coronary Artery Disease of Significant Bypass Graft conditions: Coronary Syndrome conditions: Coronary Arteriosclerosis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED measure: Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥70% in a patient with suspected CAD. measure: Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥50% in a patient with suspected CAD. measure: Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥70% in a vessel of a patient with suspected CAD measure: Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥50% in a vessel of a patient with suspected CAD sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Humanitas Research Hospital status: RECRUITING city: Rozzano state: Milano zip: 20089 country: Italy name: Carlo Andrea Pivato, MD role: CONTACT phone: +39 02 8224 7235 email: carlo.pivato@humanitas.it lat: 45.38193 lon: 9.1559 hasResults: False

 nctId: NCT06273020 id: MI22-00013 briefTitle: Effect of Cerebrolysin on the Blood Brain Barrier in Patients With Diabetes and Ischemic Stroke overallStatus: RECRUITING date: 2022-11-17 date: 2024-11 date: 2024-12 date: 2024-02-22 date: 2024-02-22 name: Hospital Universitario Dr. Jose E. Gonzalez class: OTHER name: Ever Neuro Pharma GmbH briefSummary: A prospective, single-center study would be carried out in the Neurology Department of the University Hospital "Dr. José Eleuterio González" in order to analyze the effect of cerebrolysin on the blood-brain-barrier in patients with ischemic stroke with personal history of type-2 diabetes conditions: Ischemic Stroke, Acute conditions: Diabetes Mellitus, Type 2 conditions: Blood Brain Barrier studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: There are 3 groups in this clinical trial

Group 1: 20 patients with previous intravenous thrombolysis (IVT) in the qualifying stroke and who agreed to receive and got selected (through randomization) cerebrolysin.

Group 2 : 20 patients with previous IVT in the qualifying stroke and who agreed to receive cerebrolysin but they were not choose through randomization.

Group 3: 20 patients that they were not candidates to receive IVT (out of therapeutic window) but agreed to receive cerebrolysin (randomization not used) primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 60 type: ESTIMATED name: Cerebrolysin name: Brain-MRI with contrast after 10-14 days of cerebrolysin measure: Blood-Brain-Barrier Permeability after 10-14days of cerebrolysin in patients with AIS of the middle cerebral artery measure: Comparison of clinical severity, using NIH Stroke Scale in patients with and withouth cerebrolysin measure: Comparison of functional prognosis, using modified Rankin scale in patients with and withouth cerebrolysin measure: Comparison of cognitive impairment, using Montreal Cognitive Assessment in patients with and withouth cerebrolysin sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Servicio de Neurología del Hospital Universitario "Dr.José E. González" status: RECRUITING city: Nuevo León state: Monterrey zip: 64020 country: Mexico name: Servicio F de Neurología del Hospital Universitario "Dr.José E. González" role: CONTACT phone: +528183591111 email: neurologiahu.posgrado@gmail.com name: José C Becerra-Cruz, M.D. role: CONTACT phone: +522324393970 email: becerracruz@hotmail.com hasResults: False

 nctId: NCT06273007 id: EFP_2023_02_19 briefTitle: Improving Intrapartum Care for Saving Life at Birth in Ethiopia Through PartoMa Approach acronym: PartoMa-Eth overallStatus: RECRUITING date: 2023-06-01 date: 2025-12-31 date: 2027-12-31 date: 2024-02-22 date: 2024-02-22 name: Haramaya Unversity class: OTHER name: University of Copenhagen name: Leiden University Medical Center name: Laerdal Foundation briefSummary: Overall Objective

To introduce PartoMa approach (locally agreed and achievable intrapartum guidelines and a continual in-house training program) to Ethiopian context through continuous fetal heart rate (FHR) monitoring using MOYO device and co-creation of context specific intrapartum care guideline for improving decision making in intrapartum care in Eastern Ethiopia.

Interventions

1. Locally agreed and achievable intrapartum guidelines
2. Low dose high frequency trainings (LDHF)
3. Partograph Overall Design

A quasi-experimental pre-post study (PartoMa study)

Setting

Department of Obstetrics and Gynaecology Haramaya Hospital and Hiwot Fana University Hospital, Ethiopia.

Population

Laboring women delivering at the study site from February 2023 to March 2025 and their offspring, as well as health providers. Women and their offspring will be enrolled at/after onset of labour and followed until discharge.

Endpoints

The primary endpoint is perinatal mortality. For further description and secondary outcomes, please see below.

Study Time

Data collection from June 2023 to May 2025.

Specific Objectives i. To assess FHR monitoring practice and use of obstetric guideline for decision making in Hiwot Fana University Hospital ii. To improve feto-maternal outcome through applying PartoMa approach in Hiwot Fana University Hospital.

iii. To determine the feasibility, acceptability and sustainability of low-dose high frequency trainings and PartoMa seminars in Hiwot Fana University Hospital.

iv. To document changes in pregnancy outcomes after the introduction of PartoMa approaches-seminars, low dose high frequency trainings, continuous FHR monitoring and tailored interventions-in Hiwot Fana University Hospital.

Setting

PartoMa Ethiopia will be implemented at Haramaya General Hospital and Hiwot Fana Comprehensive Specialized University Hospital, which are both busy maternity units in Eastern Ethiopia. Both are government hospitals with an annual delivery number of around 5,000. conditions: Stillbirth conditions: Obstetric Complication conditions: Maternal Death conditions: Perinatal Death conditions: Perinatal Morbidity studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 500 type: ESTIMATED name: PartoMa intervention(Locally achievable intrapartum care guideline), in house LDHF trainings measure: stillbirth measure: Birth Asphyxia measure: Maternal death measure: Cesarean sections and vacuum extractions measure: Process indicators of quality of intrapartum care measure: Birth attendant's perception of their work condition in the labour and delivery rooms measure: The women's experience of care received during delivery. sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Haramaya Hospital status: RECRUITING city: Harar state: Oromia country: Ethiopia name: Roba Ararsa, MD role: CONTACT lat: 9.31387 lon: 42.11815 facility: Hiwot Fana University Hospital status: NOT_YET_RECRUITING city: Harar country: Ethiopia name: Redwan Ahmed, MD role: CONTACT lat: 9.31387 lon: 42.11815 hasResults: False

 nctId: NCT06272994 id: 231724 briefTitle: Swab Testing to Optimize Pneumonia Treatment With Empiric Vancomycin acronym: STOP-Vanc overallStatus: ENROLLING_BY_INVITATION date: 2024-04-03 date: 2027-12-01 date: 2027-12-31 date: 2024-02-22 date: 2024-04-08 name: Vanderbilt University Medical Center class: OTHER briefSummary: This is a single center, pragmatic, randomized clinical trial (pRCT) examining whether reporting the results of a negative rapid PCR back to the provider via a pager alert results in decreased vancomycin utilization for critically ill adults with community-acquired pneumonia when compared with usual care. conditions: Community-acquired Pneumonia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study will be performed as a single center, pragmatic, randomized clinical trial. primaryPurpose: TREATMENT masking: NONE count: 212 type: ESTIMATED name: MRSA Nasal Swab PCR measure: Vancomycin-free hours alive measure: Time Alive off Vancomycin measure: 30-day all-cause mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vanderbilt University Medical Center city: Nashville state: Tennessee zip: 37232 country: United States lat: 36.16589 lon: -86.78444 hasResults: False

 nctId: NCT06272981 id: BWI202308 briefTitle: A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic PAFOUS acronym: PulseSmart overallStatus: RECRUITING date: 2024-02-28 date: 2025-08-29 date: 2025-08-29 date: 2024-02-22 date: 2024-04-26 name: Biosense Webster, Inc. class: INDUSTRY briefSummary: The purpose of this study is to demonstrate safety and effectiveness of the Biosense Webster (BWI) ablation system (THERMOCOOL SMARTTOUCH surround flow \[STSF\] catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF), an irregular heart rate that causing abnormal blood flow. conditions: Atrial Fibrillation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 135 type: ESTIMATED name: Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation measure: Number of Participants with Primary Adverse Events (PAEs) measure: Rate of Freedom from Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia (Atrial Fibrillation (AF), Atrial Tachycardia (AT) or Atrial Flutter (AFL) of Unknown Origin) within 91-365 Days Post Index Procedure measure: Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Royal Prince Alfred Hospital status: NOT_YET_RECRUITING city: Camperdown zip: 2050 country: Australia lat: -33.88965 lon: 151.17642 facility: Canberra Heart Rhythm status: RECRUITING city: Garran zip: 2605 country: Australia lat: -35.34206 lon: 149.10846 facility: John Hunter Hospital status: WITHDRAWN city: New Lambton Heights zip: 2305 country: Australia lat: -32.92466 lon: 151.69364 facility: Westmead Hospital status: RECRUITING city: Westmead zip: 2145 country: Australia lat: -33.80383 lon: 150.98768 facility: Southlake Regional Health Centre status: NOT_YET_RECRUITING city: Newmarket state: Ontario zip: L3Y 2P9 country: Canada lat: 44.05011 lon: -79.46631 facility: University of Ottawa Heart Institute status: NOT_YET_RECRUITING city: Ottawa state: Ontario zip: K1Y 4W7 country: Canada lat: 45.41117 lon: -75.69812 facility: Montreal Heart Institute status: NOT_YET_RECRUITING city: Montreal state: Quebec zip: H1T 1C8 country: Canada lat: 45.50884 lon: -73.58781 facility: McGill University Health Centre status: NOT_YET_RECRUITING city: Montreal state: Quebec zip: H3G 1A4 country: Canada lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06272968 id: EA2/252/23 briefTitle: Predicting Cognition After DBS for Parkinson's Disease 2 overallStatus: NOT_YET_RECRUITING date: 2024-02-25 date: 2027-12-01 date: 2030-12-01 date: 2024-02-22 date: 2024-02-22 name: Charite University, Berlin, Germany class: OTHER briefSummary: The aim of the study is to improve estimation of cognitive outcome after STN-DBS in PD in order to avoid risk factors by optimizing peri- and intraoperative management personalize therapeutic strategies for optimal long-term benefit.

The investigators will test possible predictors (clinical, neuropsychological, neuroimaging, electrophysiological and molecular) for the risk of cognitive dysfunction after deep brain stimulation of the subthalamic nucleus (STN-DBS) in Parkinson's disease (PD) at a single center (Charité - Universitätsmedizin Berlin, Germany). Data collection takes place prior to as well as 3, 12 and 60 months after the STN-DBS operation. Participation is proposed to all PD patients that are planned to undergo STN-DBS after careful examination of eligibility for this treatment according to standard operation procedures. conditions: Cognitive Impairment studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Neuropsychological Testing measure: Change in cognitive performance after STN-DBS measure: Incidence of postoperative neurocognitive disorder sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Charité - Universitätsmedizin Berlin city: Berlin zip: 13351 country: Germany lat: 52.52437 lon: 13.41053 hasResults: False

 nctId: NCT06272955 id: H-54417 briefTitle: LONG TERM EFFECTS OF SPINAL CORD STIMULATION acronym: SCS for FOG OL overallStatus: ENROLLING_BY_INVITATION date: 2024-01-04 date: 2025-06-30 date: 2025-06-30 date: 2024-02-22 date: 2024-02-22 name: Nora Vanegas class: OTHER briefSummary: Parkinson Disease (PD) patients experience a variety of motor issues such as walking difficulties, loss of balance, and freezing while walking, which impacts their quality of life. Some symptoms, like freezing of gait (FOG), do not respond to medications typically used to treat PD. Current surgical procedures used to alleviate PD symptoms also do not always improve FOG. Since many traditional therapies have failed for the treatment of FOG, researchers have proposed the use of newer treatments. Recent research in animal models and clinical human data using Spinal Cord Stimulation (SCS) has produced promising results, specifically showing improvement in FOG with the use of SCS in patients with PD.

The purpose of this study is to explore the long-term motor and non-motor effects of SCS in PD patients after completing participation on H-49023. The investigators hypothesize that SCS significantly decreases FOG episodes in patients with PD.

1. Assess the long-term safety, tolerability and preliminary evidence of effectiveness of upper thoracic spinal cord stimulation for freezing of gait in Parkinson's (PD) patients.
2. Allowing patients to choose between the two SCS programming paradigms based on their motor, nonmotor and quality of life measures in PD patients with freezing of gait. conditions: Parkinson Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 10 type: ESTIMATED name: Spinal Cord Stimulator (SCS) measure: Safety and Tolerability measure: New Freezing of Gait Questionnaire (NFOG-Q) score measure: Gait and Falls Questionnaire (GFQ) measure: MDS-UPDRS score measure: Timed Up and Go test (TUG) measure: Timed 10-meter walk (T10MW) measure: Mini-Mental State Examination (MMSE) measure: Montreal Cognitive Assessment Scale (MoCA) measure: Beck Depression Inventory (BDI-2) measure: Beck Anxiety Inventory (BAI) measure: Parkinson's Disease Questionnaire - 39 (PDQ39) measure: Non-Motor Symptoms Scale (NMSS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Baylor College of Medicine city: Houston state: Texas zip: 77005 country: United States lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06272942 id: 22722 briefTitle: An Observational Study to Identify New Health Problems Arising After an Intensive Care Unit Admission in People With Acute Respiratory Distress Syndrome in the United States acronym: SeeMe Tool overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-31 date: 2025-08-30 date: 2025-08-30 date: 2024-02-22 date: 2024-04-23 name: Bayer class: INDUSTRY briefSummary: This is an observational study in which data already collected from people with acute respiratory distress syndrome (ARDS) admitted to an intensive care unit (ICU) are studied.

ARDS is a life-threatening condition in which fluid builds up in the lungs making breathing difficult.

In observational studies, only observations are made without participants receiving any advice or any changes to health care.

People who are admitted to ICU for serious illnesses, like ARDS, often experience new health problems during and after their ICU stays. These health problems that may include physical, mental, and/or emotional disorders, are called post-intensive care syndrome (PICS). Identifying these new health problems early can help people by timely treatments and care.

In this study, researchers want to identify any health problems that arise after ICU admission in people with ARDS in the United States (US). To do this, researchers will collect information on health problems, treatments, medicines, and healthcare visits in people with ARDS, 1 year before and after an ICU admission.

They will then look to see whether the health problems are in areas that have been described as the post intensive care syndrome (PICS).

In addition, they will measure healthcare related costs in the one year after admission and compare it to the one year prior to admission.

Researchers will also compare this information with data collected for people with pneumonia who did not require ICU admission. This will help them to identify any new health problems arising due to ICU stays.

The data will come from participants' medical claims information stored in the Optum Clinformatics Data Mart database from 2016 to 2022. The claims data will only be collected for people in the US.

Researchers will collect data from participants admitted to ICU for ARDS for a maximum of 1 year before and after their stay. conditions: Acute Respiratory Distress Syndrome (ARDS) conditions: Post Intensive Care Syndrome (PICS) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 140000 type: ESTIMATED name: An ICU admission and a temporally related ARDS diagnosis measure: Morbidity measure: Post ICU Syndrome-related morbidity measure: Incident morbidity measure: Post ICU Syndrome-related incident morbidity measure: Difference in prevalence rates pre versus post index hospitalization measure: Average total healthcare costs based on healthcare billing data in the one year post index ICU admission measure: Exploratory, descriptive difference in ranking of PICS domain comorbidity ratios observed for ARDS (ICU admissions) versus pneumonia (non ICU admissions). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bayer city: Whippany state: New Jersey zip: 07981 country: United States lat: 40.82454 lon: -74.4171 hasResults: False

 nctId: NCT06272929 id: behcet and vascular briefTitle: Serum Elafin and Vascular Affection in Behcet Disease overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-04-01 date: 2024-02-22 date: 2024-02-22 name: Assiut University class: OTHER briefSummary: To measure the level of serum elafin in patients with BD. To assess the relation between serum elafin levels and disease activity. To evaluate the vascular complications in BD and determine their relationship with disease activity.

To assess the correlation between serum elafin and vascular affection and their relation with disease activity. conditions: Behcet Disease and Vascular Affection studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 90 type: ESTIMATED name: doppler ultrasound measure: Measuring the level of serum Elafin in patients with BD in comparison to healthy participants. sex: ALL minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06272916 id: Effect drugs on headache inCS briefTitle: Comparison of the Effect of Aminophylline, Magnesium Sulphate and Placebo in Prevention of Post Dural Puncture Headache in Parturient Undergoing Caesarean Section. overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-04 date: 2025-06 date: 2024-02-22 date: 2024-02-22 name: Assiut University class: OTHER briefSummary: This study will be conducted to better comprehend the effect of aminophylline in comparison to magnesium sulphate on preventing and/or treating PDPH. conditions: Post-Dural Puncture Headache studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 630 type: ESTIMATED name: Aminophylline , magnesium sulphate and placebo measure: Effect of the study drugs on the incidence and severity of PDPH sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT hasResults: False

 nctId: NCT06272903 id: MBRU IRB-2023-228 briefTitle: Effect of Benzocaine 20% Topical Anesthesia on Pain Levels When Placing Separators in Children Receiving Hall Technique Crowns overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-09 date: 2024-12 date: 2024-02-22 date: 2024-02-22 name: Mohammed Bin Rashid University of Medicine and Health Sciences class: OTHER briefSummary: The goal of this RCT is to investigate the immediate effect of benzocaine 20% topical anesthesia on initial pain and discomfort levels associated with the placement of elastomeric orthodontic separators in children who are receiving Hall Technique crowns on primary molars, among children who have attended the Pediatric Dentistry Department, Dubai Dental Hospital (DDH), Mohammed Bin Rashid University (MBRU) in Dubai, the United Arab Emirates (UAE). conditions: Effect of Benzocaine on Pain studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 32 type: ESTIMATED name: 20% benzocaine, topical anesthetic name: Children's Toothpaste measure: Immediate Pain Levels measure: Patient Satisfaction During Procedure sex: ALL minimumAge: 4 Years maximumAge: 10 Years stdAges: CHILD facility: Mohammed Bin Rashid University Of Medicine and Health Sciences city: Dubai country: United Arab Emirates name: Iyad Hussein role: CONTACT phone: 971564715509 email: iyad.hussein@mbru.ac.ae name: Simran Kaur Sura role: PRINCIPAL_INVESTIGATOR lat: 25.0657 lon: 55.17128 hasResults: False

 nctId: NCT06272890 id: GiresunU briefTitle: THE EFFECT OF MOTIVATIONAL INTERVIEWING ON NURSING STUDENTS WITH SOCIAL ANXIETY overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-05-20 date: 2024-07-20 date: 2024-02-22 date: 2024-02-22 name: Gazi University class: OTHER briefSummary: Studies support the idea that people diagnosed with social anxiety disorder score significantly lower on self-acceptance than healthy controls, and that self-compassion is inversely related to anxiety. Motivational interviewing has been shown to improve treatment outcomes as well as predict higher self-compassion and reduced resistance among participants.It also has the ability to increase the effectiveness of motivational interviewing as an intervention with perpetrators of intimate partner violence, promoting readiness for change and progression through stages of change. In this context, this study aims to examine the effect of motivational interviewing on social anxiety level, dating violence and self-compassion in nursing students with social anxiety. conditions: Motivation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The research was planned as a randomized controlled experimental study in a two-center parallel group pretest-posttest design. primaryPurpose: OTHER masking: SINGLE maskingDescription: In order to prevent detection bias in the study, all measurements will be made using an online survey form. In order to prevent reporting bias, the data obtained from the research will be coded as A and B by an independent statistician, transferred to the SPSS program and analyzed. whoMasked: OUTCOMES_ASSESSOR count: 58 type: ESTIMATED name: motivational interviewing measure: Motivational interviewing has an effect on nursing students' social anxiety. measure: Motivational interviewing has an effect on nursing students' dating violence. measure: Motivational interviewing has an effect on nursing students' self-compassion. sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT hasResults: False

 nctId: NCT06272877 id: 129944-54 briefTitle: Fluidotherapy in Patients With Distal Radius Fractures overallStatus: RECRUITING date: 2024-02-20 date: 2024-06-20 date: 2024-07-20 date: 2024-02-22 date: 2024-02-22 name: Ahi Evran University Education and Research Hospital class: OTHER briefSummary: Distal radius fractures are the most common fractures when looking at upper extremity fractures. The incidence of distal radius fractures is increasing day by day, and when looking at the databases of various countries, its annual prevalence reaches 70,000 in the UK and 640,000 in the USA. Most of these fractures are related to osteoporosis and require appropriate treatment. If not, it causes loss of work force, permanent disability, and limitation in daily activities.

Fluidotherapy has also proven to be effective in reducing hand edema in patients with carpal tunnel syndrome and stroke, examining its effect on nerve conduction velocities, and warming hypothermic patients. Compared to these treatment methods, fluid therapy reduces both joint capsule and muscle temperature by 9°C and 5.7°C, respectively. has been reported to increase. conditions: Distal Radius Fractures conditions: Edema Arm conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised controlled primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The Investigator and the outcomes assesor will be different persons. Statician will be different person. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Fluidotherapy name: conventional rehabilitation program measure: Visual analog scale measure: Visual analog scale measure: Visual analog scale measure: Wrist joint range of motion measure: Wrist joint range of motion measure: Wrist joint range of motion measure: Circumference (mm) measure: Circumference (mm) measure: Circumference (mm) measure: Gross Grip Strength: measure: Gross Grip Strength: measure: Gross Grip Strength: measure: Patient-Rated Wrist Evaluation (PRWE) questionnaire measure: Patient-Rated Wrist Evaluation (PRWE) questionnaire measure: Patient-Rated Wrist Evaluation (PRWE) questionnaire sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kirsehir Research and Training Hospital status: RECRUITING city: Kirsehir state: Kişrsehşr zip: 40100 country: Turkey name: Levent Horoz, Asst Prof role: CONTACT phone: :+90 386 280 39 00 email: dr.leventhoroz@gmail.com lat: 39.14583 lon: 34.16389 hasResults: False

 nctId: NCT06272864 id: BEGIN study briefTitle: BostonGene and Exigent Genomic INsight Study acronym: BEGIN overallStatus: NOT_YET_RECRUITING date: 2024-03-08 date: 2026-01-08 date: 2028-01-08 date: 2024-02-22 date: 2024-02-22 name: BostonGene class: INDUSTRY name: Exigent briefSummary: The BEGIN Study by BostonGene and Exigent Genomic INsight evaluates the efficacy of comprehensive molecular testing in advanced cancer patients. Using the BostonGene Tumor Portrait test, the study aims to identify actionable findings, assess feasibility, and determine patient enrollment in clinical trials. Four cohorts of 100 patients each will be studied over two years, focusing on treatment decisions and patient outcomes. This study seeks to demonstrate the clinical utility of genomic testing in guiding therapy for advanced cancer patients in community settings. conditions: Breast Cancer conditions: Non-small Cell Lung Cancer conditions: Melanoma conditions: Sarcoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED measure: Frequency of actionable findings measure: Test turn-around time measure: Frequency of patients who receive molecularly matched therapy measure: Frequency of patients who receive molecularly matched therapy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northwest Medical Specialities city: Puyallup state: Washington zip: 98373 country: United States name: Sibel Blau, MD role: CONTACT lat: 47.18538 lon: -122.2929 hasResults: False

 nctId: NCT06272851 id: Choroidal thickness by OCT briefTitle: Measuring Choroidal Thickness Using Optical Coherence Tomography overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2029-03-30 date: 2029-05-15 date: 2024-02-22 date: 2024-02-22 name: Assiut University class: OTHER briefSummary: To compare the choroidal thickness in eyes of diabetic patients with eyes of age matched controls using optical coherence tomography. conditions: Choroid Disease conditions: Diabetes Mellitus studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 122 type: ESTIMATED name: optical coherence tomography measure: comparison between choroidal thickness sex: ALL minimumAge: 30 Years maximumAge: 95 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06272838 id: 2023-19/145 briefTitle: Biodex Balance System in Patients With Parkinson's Disease overallStatus: RECRUITING date: 2024-02-28 date: 2024-09-14 date: 2024-10-14 date: 2024-02-22 date: 2024-02-22 name: Kirsehir Ahi Evran Universitesi class: OTHER briefSummary: Conventional balance exercises are an effective rehabilitation method applied in routine rehabilitation programs for Parkinson's patients. With technological developments, balance exercises conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised controlled primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Investigator and Outcomes Assessor will be different persons whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Biodex balance system name: The conventional balance exercise program measure: Berg Balance Scale measure: Berg Balance Scale measure: Berg Balance Scale measure: Biodex dynamic balance score measure: Biodex dynamic balance score measure: Biodex dynamic balance score measure: The fall efficacy scale measure: The fall efficacy scale measure: The fall efficacy scale measure: Time up and go test measure: Time up and go test measure: Time up and go test measure: The 8-item version of the Parkinson's Disease Questionnaire (PDQ-8) measure: The 8-item version of the Parkinson's Disease Questionnaire (PDQ-8) measure: The 8-item version of the Parkinson's Disease Questionnaire (PDQ-8) measure: The Five Times Sit to Stand Test measure: The Five Times Sit to Stand Test measure: The Five Times Sit to Stand Test measure: Beck Depression Inventory measure: Beck Depression Inventory measure: Beck Depression Inventory sex: ALL minimumAge: 40 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kırşehir Ahi Evran University Faculty of Medicine status: RECRUITING city: Kırşehir state: City Center zip: 40100 country: Turkey name: Basak Cigdem Karacay, Asist Prof role: CONTACT phone: 0905445094803 email: basak.cigdemkaracay@ahievran.edu.tr name: Basak Cigdem Karacay, Asist Prof role: PRINCIPAL_INVESTIGATOR lat: 39.14583 lon: 34.16389 hasResults: False

 nctId: NCT06272825 id: 2023-19/140 briefTitle: Virtual Reality in Patients With Knee Osteoarthritis overallStatus: RECRUITING date: 2024-02-28 date: 2024-07-14 date: 2024-08-14 date: 2024-02-22 date: 2024-02-22 name: Kirsehir Ahi Evran Universitesi class: OTHER briefSummary: One of the main challenges facing the therapist in the treatment of adhesive capsulitis is to motivate the patient throughout conventional therapy. As noted in a recent review, individuals are more interested in leisure activities rather than performing repetitive tasks during therapy. Virtual reality (VR) is a three-dimensional computer-aided programme built with a system that creates virtual reality movements and generates a high amount of visual and sensory feedback during exercise. As a result, virtual reality (VR) has been used in many medical indications and has been shown to promote adherence to treatment by increasing patient motivation. conditions: Knee Osteoarthritis conditions: Pain conditions: Quality of Life studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised controlled primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Investigator and Outcomes Assessor will be different persons. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Virtual reality name: conventional rehabilitation measure: Visual Analog Scale measure: Visual Analog Scale measure: Visual Analog Scale measure: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measure: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measure: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measure: Biodex Balance System measure: Biodex Balance System measure: Biodex Balance System measure: Short Form 36 (SF36) measure: Short Form 36 (SF36) measure: Short Form 36 (SF36) sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kırşehir Ahi Evran University Faculty of Medicine status: RECRUITING city: Kırşehir state: City Center zip: 40100 country: Turkey name: Basak Cigdem Karacay, Asist Prof role: CONTACT phone: 0905445094803 email: basak.cigdemkaracay@ahievran.edu.tr name: Basak Cigdem Karacay, Asist Prof role: PRINCIPAL_INVESTIGATOR lat: 39.14583 lon: 34.16389 hasResults: False

 nctId: NCT06272812 id: IAVI C113 briefTitle: A Study to Evaluate the Efficacy, Safety and Immunogenicity of MTBVAC in IGRA Positive Adolescents and Adults Living in a TB Endemic Region. overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2028-03 date: 2028-03 date: 2024-02-22 date: 2024-02-22 name: International AIDS Vaccine Initiative class: NETWORK name: Biofabri, SLU name: Universidad de Zaragoza briefSummary: A Phase 2b, double-blind, randomized, placebo-controlled study to evaluate the efficacy, safety and immunogenicity of a candidate tuberculosis (TB) vaccine, MTBVAC, against TB disease in interferon gamma release assay positive adolescents and adults aged 14-45 years, living in a TB endemic region. conditions: Tuberculosis (TB) studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: Double blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 4300 type: ESTIMATED name: MTBVAC name: Placebo measure: To evaluate the protective efficacy of of MTBVAC against bacteriologically confirmed pulmonary TB disease, diagnosed by more than one diagnostic test with sputum obtained before initiation of TB treatment as compared to placebo. measure: To evaluate the protective efficacy of one dose of MTBVAC against bacteriologically confirmed pulmonary TB disease, not associated with HIV infection, diagnosed with sputum obtained before initiation of TB treatment, as compared to placebo. measure: To evaluate the protective efficacy of MTBVAC candidate vaccine against definite Xpert MTB/RIF Ultra positive pulmonary TB disease diagnosed with sputum obtained before initiation of TB treatment, as compared to placebo. measure: To evaluate the protective efficacy of one dose of MTBVAC candidate vaccine against clinical TB, as compared to placebo measure: To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine. measure: To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine. measure: To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine. measure: To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine. measure: To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine. measure: To assess the safety and reactogenicity of one dose of MTBVAC candidate vaccine. measure: To assess the immunogenicity of one dose of the MTBVAC candidate vaccine via assessment of humoral and cell-mediated immune (CMI) responses in a subset of the enrolled participants. measure: To assess the immunogenicity of one dose of the MTBVAC candidate vaccine via assessment of humoral and cell-mediated immune (CMI) responses in a subset of the enrolled participants. sex: ALL minimumAge: 14 Years maximumAge: 45 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06272799 id: RS1480/21 briefTitle: Tolerability and Efficacy of Adjuvant T-DM1 in Patients With HER2 Positive Breast Cancer After Incomplete Pathological Response to Neoadjuvant Chemotherapy Including Anti-HER2 Agents. Real-world Multicenter Retrospective-prospective Study acronym: ATD overallStatus: RECRUITING date: 2022-09-20 date: 2024-09-20 date: 2024-09-20 date: 2024-02-22 date: 2024-02-22 name: Regina Elena Cancer Institute class: OTHER briefSummary: Multicenter, retrospective-prospective, real-world observational study, with the aim of evaluating tolerability and efficacy in a population of patients treated according to clinical practice outside of studies randomized. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 160 type: ESTIMATED name: T-DM1 adjuvant measure: Evaluate the tolerability. measure: Evaluate the effectiveness of treatment. sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: "Regina Elena" National Cancer Institute status: RECRUITING city: Rome zip: 00144 country: Italy name: Patrizia Vici, Doctor role: CONTACT phone: 06-5266.5584 phoneExt: +39 email: patrizia.vici@ifo.it lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06272786 id: 2023-18/128 briefTitle: Suprascapular Nerve Block in Patients Rehabilitated After Arthroscopic Rotator Cuff Repair overallStatus: RECRUITING date: 2024-02-28 date: 2024-09-01 date: 2024-10-01 date: 2024-02-22 date: 2024-02-22 name: Kirsehir Ahi Evran Universitesi class: OTHER briefSummary: Suprascapular nerve block is an injection method that has been shown to be effective in shoulder rehabilitation in diseases such as adhesive capsulitis and stroke .. Applying the block under USG guidance instead of blinding increases the effectiveness and reduces complications. conditions: Rotator Cuff Tears conditions: Pain conditions: Nerve Block studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised controlled primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Investigator and outcome assessor will be different persons. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: conventional physiotherapy program. name: Suprascapular nerve block measure: Visual Analog Scale (VAS) measure: Visual Analog Scale (VAS) measure: Visual Analog Scale (VAS) measure: Shoulder joint range of motion (ROM) measure: Shoulder joint range of motion (ROM) measure: Shoulder joint range of motion (ROM) measure: Shoulder Pain and Disability İndex (SPADİ) measure: Shoulder Pain and Disability İndex (SPADİ) measure: Shoulder Pain and Disability İndex (SPADİ) measure: Modified Constant-Murley Scoring measure: Modified Constant-Murley Scoring measure: Modified Constant-Murley Scoring sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ahi Evran University status: RECRUITING city: Kirşehir state: City Centre zip: 40100 country: Turkey name: Basak Cigdem Karacay, Assist Prof role: CONTACT phone: :+90 386 280 39 00 email: basak.cigdemkaracay@ahivran.edu.tr name: Basak Cigdem Karacay, Assist Prof role: PRINCIPAL_INVESTIGATOR lat: 39.14583 lon: 34.16389 hasResults: False

 nctId: NCT06272773 id: IRAS Ref: 333663 briefTitle: Forced Oscillation and Breathing Pattern in Asthma overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-10 date: 2025-03 date: 2024-02-22 date: 2024-02-22 name: Karl Sylvester class: OTHER briefSummary: Asthma is a chronic respiratory disease characterised by airway inflammation, bronchoconstriction, and airway hyperresponsiveness. Accurate and reliable assessment of lung function is crucial in diagnosing and monitoring asthma. The forced oscillation technique (FOT) is a non-invasive method that has gained attention in recent years as a valuable tool for evaluating respiratory mechanics in asthma.

FOT involves applying small amplitude oscillations at various frequencies to the respiratory system and measuring the resulting pressure and flow responses. These measurements provide valuable insights into the mechanical properties of the airways, including resistance, compliance, and reactance. FOT offers several advantages over traditional spirometry, such as its ability to assess peripheral airway function, sensitivity to small airway abnormalities, and ease of use, particularly in young children or individuals with severe airflow limitation. FOT also allows for assessment of respiratory mechanics in individuals who may struggle with performing spirometry manoeuvres.

However, it is unclear whether a change in breathing pattern in patients with obstructive lung disease impacts the assessment of a response to treatment utilising FOT.

Several studies have demonstrated a high prevalence of Breathing Pattern Disorders (BPDs) in individuals with asthma. These findings suggest that BPDs may be common in asthma and could contribute to the manifestation and severity of respiratory symptoms. Evidence suggests that BPDs can adversely affect pulmonary function in individuals with asthma. One study demonstrated that children with asthma and dysfunctional breathing exhibited significantly reduced forced expiratory volume in one second (FEV1) compared to asthmatics without BPD. This suggests that abnormal breathing patterns may contribute to airflow limitation in asthma, leading to decreased lung function.

We therefore wish to determine the impact of different breathing frequencies on parameters measured using FOT in patients diagnosed with asthma and concomitant obstructive lung function abnormality. conditions: Asthma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 65 type: ESTIMATED name: Forced Oscillation Test measure: Change in airway resistance at 5 Hertz (Hz) and 19Hz sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06272760 id: 2024-02-060 briefTitle: Development of a Remote Therapy Protocol for Upper Limb Function Enhancement in Children With Cerebral Palsy overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-09-30 date: 2026-02-28 date: 2024-02-22 date: 2024-02-22 name: Samsung Medical Center class: OTHER briefSummary: The perpose of this study: Development and demonstration of a teletherapy protocol to improve upper limb function in children with cerebral palsy. conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controlled Trial primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Single blinding whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Home-based hand-arm bimanual intensive training (Tele-HABIT) name: Hand-arm bimanual intensive training (In-clinic-HABIT) measure: Change from Assisting Hand Assessment (AHA) score at post-intervention test (T1-T0). measure: Change from Baseline Pediatric Motor Activity Log (PMAL) score at post-intervention test (T1-T0). measure: Change from Baseline Melbourne Assessment 2 (MA2) score at post-intervention test (T1-T0). measure: Change from Canadian Occupational Performance Measure (COPM) score at post-intervention test (T1-T0). measure: Change from Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) score at post-intervention test (T1-T0). measure: Change from baseline Magnitude ratio (Accelerometer) at post-intervention test (T1-T0). measure: Change from baseline Bilateral magnitude(Accelerometer) at post-intervention test (T1-T0). sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD hasResults: False

 nctId: NCT06272747 id: XH-S003-I-101 briefTitle: A Phase I Study of XH-S003 in Healthy Volunteers overallStatus: NOT_YET_RECRUITING date: 2024-02-22 date: 2024-07-30 date: 2024-10-30 date: 2024-02-22 date: 2024-02-22 name: S-Infinity Pharmaceuticals Co., Ltd class: INDUSTRY briefSummary: The purpose of the study is to assess the safety, tolerability and pharmacokinetics of XH-S003 in healthy volunteers under SAD (Single ascending dose) and MAD (Multiple ascending dose) studies. In addition, this study evaluates the food effects of XH-S003. conditions: Healthy Adults studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 44 type: ESTIMATED name: XH-S003 name: Placebo measure: Number of participants with adverse events (AEs) measure: Number of participants with adverse events (AEs) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Beijing Friendship Hospital,Capital Medical University city: Beijing country: China name: Ruihua Dong, MD role: CONTACT phone: 010-63139033 email: Ruihua_Dong_RW@163.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06272734 id: RCV-0007 briefTitle: Reprieve System Pilot Study overallStatus: RECRUITING date: 2024-01-23 date: 2024-12-31 date: 2025-01-31 date: 2024-02-22 date: 2024-02-22 name: Reprieve Cardiovascular, Inc class: INDUSTRY briefSummary: The objective of the study is to evaluate the use of the Reprieve System to decongest subjects with acute decompensated heart failure. conditions: Acute Decompensated Heart Failure studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Reprieve System measure: Functional Device Success sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tbilisi Heart and Vascular Clinic status: RECRUITING city: Tbilisi zip: 0159 country: Georgia name: Tamaz Shaburishvili, MD role: CONTACT phone: +995 322 479300 email: tamaz_shaburishvili@yahoo.com lat: 41.69411 lon: 44.83368 hasResults: False

 nctId: NCT06272721 id: 6272 briefTitle: Hypothyroidism in Pregnancy and Neuropsychological Development in Children acronym: OHPLDO overallStatus: NOT_YET_RECRUITING date: 2024-02-19 date: 2024-04-30 date: 2024-05-31 date: 2024-02-22 date: 2024-02-22 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Thyroid dysfunction, particularly hypothyroidism and thyroid autoimmunity, impacts a significant proportion of pregnant women, affecting 3% and 17% respectively. The management of thyroid-stimulating hormone (TSH) levels is crucial, with subclinical hypothyroidism often defined by a TSH upper reference limit of 4 mU/L, and overt hypothyroidism by TSH levels above 10 mU/L and potentially low free thyroxine (FT4) levels. Levothyroxine (LT4) treatment is strongly advised for TSH levels above 10 mU/L, with the timing of intervention being critical during the first trimester for optimal fetal brain development.

Research shows that untreated maternal hypothyroidism can significantly impact the neuropsychological development of the child, affecting cognitive, verbal, and motor skills. Even subclinical maternal hypothyroidism has been associated with lower IQ and motor scores in children. Early pregnancy intervention is key, as treatment after the first trimester may not improve children's neurocognitive outcomes.

Regarding sensory and linguistic development, evidence is mixed, but recent studies suggest that maternal hypothyroidism can lead to expressive language delays. The Development Quotient (DQ) is used to assess cognitive and motor development in children, with the Griffiths Mental Development Scales II being a common tool.

This study aims to explore the effects of treated maternal hypothyroidism during pregnancy on children's neurodevelopment, focusing on learning and language. It includes 31 women diagnosed with hypothyroidism and a control group of 21 euthyroid women, along with their children. The study emphasizes the importance of early detection and treatment of maternal hypothyroidism for preventing adverse neurodevelopmental outcomes in offspring. Statistical analysis will be conducted using SPSS, with a focus on maternal-fetal outcomes and cognitive-neuropsychological outcomes, highlighting the significance of early intervention. conditions: Thyroid Dysfunction conditions: Pregnancy Related conditions: Language Development studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 104 type: ESTIMATED name: Griffiths Scale measure: total development quotient measured using the Griffiths scale sex: ALL minimumAge: 2 Years maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: Fondazione Policlinico Universitario A. Gemelli IRCCS city: Roma zip: 00168 country: Italy name: ALFREDO PONTECORVI role: CONTACT phone: +390630155701 email: alfredo.pontecorvi@policlinicogemelli.it name: ALFREDO PONTECORVI role: PRINCIPAL_INVESTIGATOR lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06272708 id: IIT-2023-0356 briefTitle: Preliminary Exploration of Thromboelastography in the Monitoring of Anticoagulation in Maintenance Hemodialysis Patients overallStatus: RECRUITING date: 2024-01-29 date: 2024-02-29 date: 2024-05-31 date: 2024-02-22 date: 2024-02-22 name: RenJi Hospital class: OTHER briefSummary: Objectives: To investigate the role of thromboelastography parameters (R, K, Angle, MA) in monitoring anticoagulation in maintenance hemodialysis (MHD) patients.

Subjects: Two hundred stable MHD patients. Methods: An observational study. Primary outcome: Relationship between thromboelastography parameter R Value and coagulation of hemodialysis circuit and dialyzer.

Secondary outcome: Relationship between thromboelastography parameters (K Value, Angle and MA) and coagulation of hemodialysis circuit and dialyzer. conditions: Thromboelastography conditions: Hemodialysis conditions: Anticoagulation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 200 type: ESTIMATED measure: thromboelastography parameter R value measure: thromboelastography parameter K value measure: thromboelastography parameter Angle measure: thromboelastography parameter MA sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University status: RECRUITING city: Shanghai state: Shanghai zip: 200127 country: China name: Yunyue Guo role: CONTACT phone: 0086-021-68383312 email: guoyunyue@renji.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06272695 id: R477-203 briefTitle: Glucagon Rescue of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes Treated With Volagidemab overallStatus: RECRUITING date: 2024-02-15 date: 2025-06-15 date: 2025-06-15 date: 2024-02-22 date: 2024-04-10 name: REMD Biotherapeutics, Inc. class: INDUSTRY briefSummary: This trial is designed to evaluate the effect of glucagon receptor antagonism by volagidemab (once weekly) on glucose recovery from hypoglycemia after treatment with glucagon in adults with type 1 diabetes. After informed consent, Screening procedures to establish subject eligibility will be performed within a period of 28 days. Approximately 24 subjects with type 1 diabetes mellitus (T1DM) on stable doses of insulin will be enrolled.

After enrollment, subjects will undergo a baseline Hypoglycemia Recovery Procedure (with glucagon rescue). Subjects will then receive volagidemab subcutaneously (SC) once weekly for 6 weeks. At the end of the treatment phase, subjects will undergo a second Hypoglycemia Recovery Procedure. Subjects will be followed for 6 weeks after the last volagidemab dose with a final End-of-Study (EOS) visit during Week 12. The primary outcome will be the change in time to glucagon treatment success at Week 6 versus baseline. conditions: Type 1 Diabetes Mellitus studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Volagidemab measure: Change in Time to glucagon treatment success at Week 6. measure: Blood glucose response to glucagon rescue treatment during insulin-induced hypoglycemia. measure: Treatment emergent adverse events (AEs) measure: Hypoglycemia symptoms - Edinburgh Hypoglycemia Scale measure: Hypoglycemia symptoms - Clarke Survey measure: Hypoglycemia symptoms - Gold Questionnaire measure: Change from baseline in hemoglobin A1c (HbA1c) at Week 6. sex: ALL minimumAge: 18 Years maximumAge: 72 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Altman Clinical and Translational Research Institute status: NOT_YET_RECRUITING city: San Diego state: California zip: 92037 country: United States name: Schafer Boeder, MD role: CONTACT name: Schafer Baoder, MD role: PRINCIPAL_INVESTIGATOR lat: 32.71533 lon: -117.15726 facility: Diablo Clinical Research status: RECRUITING city: Walnut Creek state: California zip: 94598 country: United States name: Mark Christiansen, MD role: CONTACT email: mchristiansen@diabloclinical.com name: Mark Christiansen, MD role: PRINCIPAL_INVESTIGATOR lat: 37.90631 lon: -122.06496 hasResults: False

 nctId: NCT06272682 id: 6669 briefTitle: Corticosteroids in Carpal Tunnel Syndrome. Prospective Randomised Controlled Non-inferiority Study overallStatus: RECRUITING date: 2023-07-17 date: 2024-08-11 date: 2025-10-11 date: 2024-02-22 date: 2024-02-22 name: Hospital Italiano de Buenos Aires class: OTHER briefSummary: The goal of this prospective, randomised, controlled, non-inferiority analytical study is to compare the Boston score in patients treated with systemic (intramuscular) versus local infiltration corticosteroids in mild and moderate carpal tunnel syndrome in patients over 18 years of age with mild or moderate carpal tunnel syndrome.

The main questions it aims to answer are:

* What is the effectiveness of intramuscular injection of corticosteroids compared to local infiltration in the treatment of mild/moderate carpal tunnel syndrome?
* What are the adverse effects and application site pain associated with each route of administration?

Patients who meet the inclusion criteria will be asked to participate in the study and sign an informed consent form.

The Redcap randomizer will be used to assign the patient to one of the branches.

Researchers will compare

* Branch A: patients treated with local corticosteroid infiltration in carpal tunnel under ultrasound
* Branch B: patients treated with intramuscular corticosteroid injection.

Researchers will:

* Compare Boston Carpal Tunnel Questionnaire score at 1.5 months, 3 months, 6 months and 12 months post-procedure.
* Describe adverse reactions associated with the route of administration.
* Compare the pain at the site of application associated with the route of administration. conditions: Carpal Tunnel Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, randomised, controlled, non-inferiority analytical study primaryPurpose: TREATMENT masking: NONE count: 106 type: ESTIMATED name: Systemic bethametasone injection name: Local bethametasone injection measure: Compare the Boston Carpal Tunnel Syndrome Questionnaire measure: Adverse reactions measure: Pain at the site of application sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Italiano de Buenos Aires status: RECRUITING city: Buenos Aires zip: C1199 country: Argentina name: Jorge Boretto, MD role: CONTACT phone: +541169026969 email: jorge.boretto@hospitalitaliano.org.ar name: Rocio Avanzi, MD role: CONTACT phone: +541157727055 email: rocio.avanzi@hospitalitaliano.org.ar lat: -34.61315 lon: -58.37723 hasResults: False

 nctId: NCT06272669 id: HSEARS20220216004 briefTitle: Cumulative and Booster Effects of Multisession Prefrontal tDCS in Adolescents With ASD overallStatus: RECRUITING date: 2022-06-02 date: 2025-09 date: 2025-12 date: 2024-02-22 date: 2024-02-22 name: The Hong Kong Polytechnic University class: OTHER briefSummary: Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by disturbances in communication, poor social skills, and aberrant behavior. To date, ASD has no known cure, and the disorder remains a highly disabling condition. Recently, transcranial direct-current stimulation (tDCS), a non-invasive brain stimulation technique, has shown great promise as a potentially effective and cost-effective tool for reducing the core symptoms in patients with autism, such as anxiety, aggression, impulsivity, and inattention. Although the preliminary findings in patients with ASD are encouraging, it remains to be determined whether this experimental data can translate into benefits in real life. Further studies are needed to determine the factors that can lengthen the therapeutic effects or cognitive benefits of tDCS, and to determine possible risk factors associated with relapse in patients with ASD. Booster sessions of tDCS is an important component of treatment planning and prognosis and may promote better outcomes to control for resurgence of symptoms. This study has three aims. First, the investigators aim to evaluate the therapeutic effects of tDCS on improving cognitive function in patients with ASD. Second, the investigators aim to better understand the neural mechanisms underlying the neuro-enhancing effects of tDCS in patients with ASD. Third, the investigators aim to assess the effectiveness of booster treatment cycles of tDCS for enhancing cognitive and social functions in individuals with ASD. conditions: Transcranial Direct Current Stimulation conditions: Autistic Spectrum Disorder conditions: Electroencephalography studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This study comprises 3 phases: Phase 1 will be a randomized controlled trial in which 90 participants will be randomly assigned to receive either active or sham-tDCS combined with computerized executive function training for 10 consecutive working days over 2 weeks period. The other 2 phases will be an open-label, crossover phase, in which for Phase 2, participants in the sham-tDCS group will receive 10-day active tDCS and assessments will be performed before and after the 10-tDCS session. Whereas bimonthly booster tDCS sessions will be provided to all tDCS responders for the first 3 months and monthly booster tDCS in the subsequent 3 months (Total 9 sessions in phase 3), and with assessments performed every month in Phase 3. primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Active-tDCS name: Sham-tDCS measure: Change in social responsiveness - Social Responsiveness Scale-2nd edition (SRS-2) measure: Clinical response in tDCS outcome measure: Change in neuropsychological measures - CANTAB® cognitive tests sex: ALL minimumAge: 12 Years maximumAge: 21 Years stdAges: CHILD stdAges: ADULT facility: The Hong Kong Polytechnic University status: RECRUITING city: Hung Hom state: Kowloon zip: Hong Kong country: Hong Kong name: Yvonne Han, PhD role: CONTACT phone: +852 27667578 email: yvonne.han@polyu.edu.hk lat: 22.30715 lon: 114.18532 hasResults: False

 nctId: NCT06272656 id: AKR-TACE-001 briefTitle: Evaluation of AKR1B10 as a New Marker for Interventional Therapy of Hepatocellular Carcinoma overallStatus: RECRUITING date: 2024-04-01 date: 2025-06-30 date: 2025-06-30 date: 2024-02-22 date: 2024-04-03 name: Hebei Medical University Third Hospital class: OTHER briefSummary: Primary liver cancer is currently the fourth most common malignant tumor and the second leading cause of tumor mortality in China, posing a serious threat to the lives and health of the Chinese people . At present, non-surgical treatment methods are often used, such as radiofrequency ablation (RFA), Transcatheter arterial chemoembolization (TACE), radiation therapy, and systemic anti-tumor therapy. However, whether it is surgical treatment or non-surgical treatment, commonly used liver cancer related biomarkers in clinical practice during the evaluation of treatment efficacy or regular follow-up of patients include AFP, AFP-L3%, DCP, etc. , but there are no reports on whether AKR1B10 can be used for the efficacy evaluation of these treatment methods.Therefore, this project aims to explore the clinical value of AKR1B10 in evaluating the efficacy of liver cancer treatment. conditions: Hepatocellular Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: comparison of liver cancer markers AKR1B10, AFP, AFP-L3% and DCP before and after TACE measure: long-term survival (1-year, 3-year, 5-year) measure: progression- free - time sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: HebeiMUTH status: RECRUITING city: Shijia Zhuang state: Hebei zip: 050000 country: China name: Yuemin Nan role: CONTACT phone: +8633188602489 email: Hb20231221@163.com name: Pei Guo role: CONTACT phone: 17835683894 email: G545632518@163.com lat: 34.17775 lon: 109.84894 typeAbbrev: Prot_ICF hasProtocol: True hasSap: False hasIcf: True label: Study Protocol and Informed Consent Form date: 2023-12-25 uploadDate: 2024-02-02T21:48 filename: Prot_ICF_000.pdf size: 258859 hasResults: False

 nctId: NCT06272643 id: EPIC36-EMPERATRIZ briefTitle: Comparison Between Optical Coherence Tomography and Intravascular Ultrasound for Intermediate Left Main Coronary Artery Lesions acronym: EMPERATRIZ overallStatus: RECRUITING date: 2024-04-04 date: 2025-01-20 date: 2026-01-20 date: 2024-02-22 date: 2024-04-09 name: Fundación EPIC class: OTHER briefSummary: Significant coronary disease of the left main coronary artery (LMCA) is found in 4%-5% of all coronary angiography procedures. Classically, it has been determined that a significant angiographic stenosis should reach at least 50% of the vessel diameter by visual estimation, which corresponds to 75% of the vessel area. However, angiography has a number of limitations inherent to the technique and location of stenosis, and other techniques are therefore available for evaluation. Intracoronary ultrasound (IVUS) deserves, together with the pressure guidewire, special consideration in determining the severity assessment (anatomical and functional) of lesions in this location. Using IVUS the most commonly used cut-off value is 6 mm2. in ambiguous lesions of the LMCA, a MLA \>6 mm2 would indicate no revascularisation, a MLA \<4.5-5 mm2 would indicate revascularisation, and MLA values between 4.5-5 and 6 mm2 would make it advisable to use FRF/iFR to decide. Optical coherence tomography (OCT) is another intracoronary imaging modality, with greater resolution and significant differences from IVUS. no MLA cut-off point with OCT has been demonstrated for the management of LMCA lesions. Due to the differences in imaging with both techniques, the thresholds established as cut-off points in IVUS cannot be extrapolated to OCT. The objective is to compare the minimal luminal area by IVUS and OCT of angiographically intermediate LCMA lesions and to assess the prognostic value of TCFA assessed by OCT. conditions: Coronary Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 129 type: ESTIMATED name: IVUS (Intravascular Ultrasound) and OCT (Optical Coherence Tomography) measure: To assess the agreement between minimum luminal area measured by IVUS and OCT in intermediate LCMA lesions measure: Cardiac Death measure: Cardiovascular Death measure: Acute myocardial infarction of treated/functionally assessed lesion measure: Acute myocardial infarction of any lesion measure: Need for revascularisation of lesion treated/functionally assessed measure: Need for revascularisation of any lesion measure: Secondary efficacy endpoint: Clear Image Length measure: Extend of detectable EEL in LM measure: Correlation between contrast volume used and results, as well as the average contrast volume used in the study. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitario Juan Ramon Jimenez status: RECRUITING city: Huelva zip: 21005 country: Spain lat: 37.26638 lon: -6.94004 facility: Hospital Universitario de Leon status: RECRUITING city: León zip: 24071 country: Spain lat: 42.60003 lon: -5.57032 hasResults: False

 nctId: NCT06272630 id: DW_DWJ1464401 briefTitle: Study to Evaluate the Efficacy and Safety of DWJ1464 in Patients With Chronic Liver Disease overallStatus: ENROLLING_BY_INVITATION date: 2023-02-06 date: 2024-05-31 date: 2024-08-31 date: 2024-02-22 date: 2024-04-26 name: Daewoong Pharmaceutical Co. LTD. class: INDUSTRY briefSummary: This study aims to assess the effect of DWJ1464 on improvement of liver function in patients with Chronic liver disease. Patients with Chronic liver disease aged 19 years or over will participate in the study. The study design is a multi-center double-blinded randomized placebo-controlled trial. The patients were diagnosed with Chronic liver disease based on our criteria and were randomized to either the placebo or DWJ1464 administration group. Primary endpoint was the change of ALT level after 8 weeks compared to the baseline. Secondary endpoints included the change of ALT level after 4 weeks, the change rate of ALT level after 8 weeks and improvement of fatigue, compared to the baseline. the adverse effect of DWJ1464 were also recorded. conditions: Chronic Liver Disease studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 258 type: ESTIMATED name: DWJ1464 name: Placebo of DWJ1464 measure: At 8 weeks, the change of ALT level compared to baseline measure: At 4 weeks, the change of ALT level compared to baseline measure: At 4, 8 weeks, the change of AST level compared to baseline measure: At 4, 8 weeks, the change of liver function comparator GGT level compared to baseline measure: At 8 weeks, the change of liver function comparator Fibrotest compared to baseline measure: At 8 weeks, the change of liver function comparator Fibroscan compared to baseline measure: At 4, 8 weeks, the change of K-CFQ(Korean version of Chalder Fatigue Scale) scores, compared to the baseline sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SoonChunHyang University Seoul Hospital city: Seoul zip: 04401 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06272617 id: 2023-960 briefTitle: Acupuncture for Prevention and Treatment of Oral-related Complications Caused by Radiotherapy for Head and Neck Cancer overallStatus: RECRUITING date: 2023-07-25 date: 2024-07-24 date: 2025-07-24 date: 2024-02-22 date: 2024-02-22 name: West China Hospital class: OTHER name: West China Fourth Hospital, Sichuan University briefSummary: A study on the efficacy and safety of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors conditions: Malignant Tumor of Head and/or Neck conditions: Radiotherapy; Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 138 type: ESTIMATED name: verum acupuncture name: sham acupuncture measure: Xerostomia questionnaire scores measure: Salivary flow rate measure: Taste function assessed by patients measure: Taste function assessed by electrogustometer test measure: Taste function assessed by taste strips test measure: Oral mucositis measure: Dysphagia measure: Quality of Life assessed by EORTC QLQ-C30 measure: Quality of Life assessed by QLQ-H&N35 measure: Adverse effects measure: Changes of oral flora measure: Tongue range of motion measure: Neck Fibrosis sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: West China Hospital, Sichuan University status: RECRUITING city: Chengdu state: Sichuan country: China name: Xingchen Peng role: CONTACT phone: 0086-18980606753 email: pxx2014@scu.edu.cn lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06272604 id: 2024-IRB-0015-P-01 briefTitle: Exercise Rehabilitation for Children With Asthma overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-04-01 date: 2027-10-01 date: 2024-02-22 date: 2024-02-22 name: The Children's Hospital of Zhejiang University School of Medicine class: OTHER briefSummary: Asthma, a prevalent chronic condition among children and adolescents, substantially impairs their quality of life. In addressing this significant health concern, this study focuses on the potential of a customized exercise rehabilitation program tailored for this young demographic. By employing a randomized controlled trial design, the research aims to divide participants into two distinct groups: one undergoing a personalized exercise regimen and the other receiving standard medical care. The 12-week intervention for the exercise group includes a combination of aerobic activities, strength training, and targeted breathing exercises. The study's primary aim is to rigorously evaluate the impact of this specialized exercise protocol on critical health aspects such as lung function, physical endurance, frequency of asthma attacks, and overall quality of life. The anticipated findings from this research are expected to shed new light on effective asthma management strategies and offer invaluable guidance for clinical practices dedicated to improving health outcomes in young asthma patients. conditions: Asthma in Children conditions: Rehabilitation conditions: Exercise studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Personalized Exercise Rehabilitation measure: Lung Function measure: Daily Physical Activity Level measure: Asthma Control Status measure: Fractional Exhaled Nitric Oxide (FeNO) measure: Body Composition measure: Sleep measure: Health Related Quality of Life measure: Anxiety and Depression measure: Inflammatory Mediators sex: ALL minimumAge: 6 Years maximumAge: 17 Years stdAges: CHILD hasResults: False

 nctId: NCT06272591 id: IRBN1192023/CHUSTE briefTitle: Comparison of Patient Satisfaction With Home Induction and In-patient Induction. overallStatus: RECRUITING date: 2023-11-20 date: 2024-05 date: 2024-05 date: 2024-02-22 date: 2024-02-22 name: Centre Hospitalier Universitaire de Saint Etienne class: OTHER briefSummary: Induced labour is a medical intervention designed to initiate or accelerate the childbirth process when clinically indicated.

Induced labour concerns 25.8% of pregnant women in France, according to the latest National Perinatal Survey 2021. This rate is rising steadily, since in 2016 induction concerned 22% of pregnancies. There are many medical indications for induction, both maternal and foetal. Induced labour in hospitals is beginning to reach its limits, given the reduction in the number of nursing staff and the reduction in the number of beds available. In some cases, patients are hospitalised for 24 to 72 hours before going into labour. In this context, the place where the birth takes place, whether at home or in hospital, is essential, with a potential impact on patient satisfaction and the experience of induction.

Cervical ripening can be a difficult experience for women, with a feeling of loss of control at this crucial stage. The duration of induction is one of the factors that women would like to see changed when asked about the aftermath of induction. The option of inducing at home might seem to improve women's experience and reduce the length of their stay in hospital. conditions: Induced; Birth conditions: Pregnancy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Preliminary search in the patient's file name: A posteriori research in the patient's file name: First questionnaire : choice of induction method reason for choice name: Second questionnaire : experience of induction measure: Questionnaire on patients' experience of induction in hospital and at home. measure: Questionnaire on patients' satisfaction of induction in hospital and at home. measure: Questionnaire on patients' choice of induction method measure: Questionnaire on reasons for choosing home induction. measure: Maternal morbidity measure: Maternal mortality measure: Neonatal morbidity measure: Neonatal mortality sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chu Saint Etienne status: RECRUITING city: St Etienne zip: 42100 country: France name: Tiphaine BARJAT, MD PhD role: CONTACT phone: (0)477828609 phoneExt: +33 email: tiphaine.barjat@chu-st-etienne.fr name: Clara CHIARADONNA, resident role: CONTACT phone: (0)634100341 phoneExt: +33 email: clara.chiaradonna@etu.univ-st-etienne.fr name: Tiphaine BARJAT, MD PhD role: PRINCIPAL_INVESTIGATOR name: Clara CHIARADONNA, resident role: SUB_INVESTIGATOR lat: 45.43389 lon: 4.39 hasResults: False

 nctId: NCT06272578 id: 20021405 briefTitle: Screen CardRen - A Cross-sectional Observational Cohort Study overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-02-27 date: 2025-06-30 date: 2024-02-22 date: 2024-02-23 name: Charite University, Berlin, Germany class: OTHER name: AstraZeneca briefSummary: In this single-centre, cross-sectional study, the investigators aim to assess the prevalence of asymptomatic echocardiographic structural and functional cardiac abnormalities in adult CKD patients with additional cardiovascular risk factors. Furthermore, with the use of Olink technology, analyses of the plasma proteome will be performed to identify potential protein pathways associated with early structural changes.The investigators hypothesize that protein expression will be altered in patients with prevalent echocardiographic abnormalities that indicate stage B heart failure. conditions: Heart Failure conditions: Chronic Kidney Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 400 type: ESTIMATED name: Echocardiography measure: prevalence of significant asymptomatic cardiac structural abnormalities and cardiac dysfunction measure: Proteomic analysis measure: Duration of echocardiographic examination measure: Time saved by portable echocardiography and automated image analysis measure: Image quality of cart-based vs. portable echo images sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06272565 id: 2023KYPJ292 briefTitle: Exploring the Interaction Between Metabolic Disorders and NLPR3 Inflammasome Activation in DR Inflammatory Damage acronym: DR overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-12-30 date: 2026-12-30 date: 2024-02-22 date: 2024-02-22 name: Zhongshan Ophthalmic Center, Sun Yat-sen University class: OTHER briefSummary: Diabetic retinopathy (DR) is one of the most serious microvascular complications of diabetes. Early diagnosis and treatment of diabetes is the key to prevent visual impairment in DR patients. This study aims to use a non-targeted metabolomics detection technique combined with ultra-high performance liquid chromatography time-of-flight mass spectrometry to analyze the metabolomics profile in aqueous humor sample of DR patents, and further explore the mechanism of the relationship between differential metabolites and their metabolic pathways with NLRP3 activation in DR inflammatory damage. DR patients with macular edema will receive anti-vascular endothelial growth factor (anti-VEGF) treatment; these patients will be divided into two groups: responders group and non-responders group. conditions: Diabetic Retinopathy conditions: Diabetic Macular Edema conditions: Anti-vascular Endothelial Growth Factor studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 240 type: ESTIMATED measure: Untargeted metabolomics for metabolic profile using UHPLC/MS measure: Best-corrected visual acuity measure: Central subfield thickness sex: ALL minimumAge: 40 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhongshan Ophthalmic Center of Sun Yat-sen University city: Guangzhou state: Guangdong zip: 510623 country: China name: Zhongshan Ophthalmic Center of Sun Yat-sen University role: CONTACT phone: 86+13560323773 email: chh5413@126.com lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06272552 id: PI21-00026 id: 2021/10182/I type: OTHER domain: CEIm Parc de Salut Mar briefTitle: Implementing PROMs and PREMs in Routine Clinical Care: Assessment of Requirements and Impact acronym: PROMs & PREMs overallStatus: RECRUITING date: 2023-10-25 date: 2027-10 date: 2027-10 date: 2024-02-22 date: 2024-02-22 name: Parc de Salut Mar class: OTHER name: Instituto de Salud Carlos III briefSummary: There has been increasing interest in the use of patient-reported outcomes and experience measures (PROMs and PREMs) in clinical practice; yet few empirical studies have been conducted to evaluate the usefulness of such implementation.

Objective: To evaluate the efficacy of the implementation of PROMs and PREMs in routine clinical care for improving health outcomes and satisfaction with health management.

Design: Randomized control trial. Setting: In and outpatient departments of a public hospital in Spain.

Participants: 1,440 adult patients managed for breast cancer, prostate cancer, chronic kidney disease, or bariatric surgery.

Intervention: Patients will monthly complete, through an App from their smartphones, PROMs and PREMs (arm A, n=480), or only PREMs (arm B, n=480). Responses to PROMs will be transformed into a graphic summary, accessible for physicians and patients at the follow-up visits of the project (9 and 18 months after recruitment).

Main outcome measures: Comparison of change among arms on the assessment variables - such as health-related quality of life (EQ-5D-5L), satisfaction with care, or patient-professionals communication. These constructs will be measured at recruitment and at follow up visits for all patients, regardless of their arm allocation (arm C would only be administered these questionnaires, without intervention, n=480).

Expected results: Incorporating PROMs and PREMs in routine clinical care may improve patients\&#39; and health professionals\&#39; experiences on health care, as well as improve patients\&#39; health. conditions: PROMs conditions: PREMs conditions: Implementation Research conditions: Impact Evaluation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 1440 type: ESTIMATED name: PROMs and PREMs name: PREMs name: Control name: Healthcare professionals measure: Evaluation quesionnaire (PRMIAT) of the implementation to be completed by all patients and healthcare professionals measure: Health-related quality of life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital del Mar Reseach Institute status: RECRUITING city: Barcelona state: Catalonia zip: 08003 country: Spain name: Olatz Garin role: CONTACT phone: +34 636210255 email: ogarin@research.net name: Olatz Garin role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06272539 id: 2023 101435 briefTitle: Spinal Cord Stimulation Combined With Exercise in Persistent Spinal Pain Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-01-01 date: 2026-01-01 date: 2024-02-22 date: 2024-02-28 name: Fundación Universidad Católica de Valencia San Vicente Mártir class: OTHER name: Instituto de Investigación Biomédica de Salamanca briefSummary: Introduction. At the neurophysiological level, it is possible to observe an increase in the central processing of pain in patients diagnosed with persistent Spinal Pain Syndrome (PSPS-T1/2), potentially stemming from dysfunctions in the endogenous facilitation and inhibition of pain. Administration of high doses of spinal cord stimulation to individuals with PSPS-T1/2 may induce supraspinal descending activation. Similarly, exercise is recognized as a fundamental aspect of spinal pain management. Studies have demonstrated its impact on neurophysiological factors, including the release of spinal and supraspinal beta-endorphins, which activate μ-opioid receptors. Therefore, the purpose of this study will be to examine the effect of SCS in combination with lumbo-pelvic stability core training on perceived low back pain, quality of life and disability in failed back surgery syndrome (FBSS) patients. Methods/Materials. A double-blind randomized clinical trial (RCT) has been designed. All participants will be randomized from a pre-set sequence. The intervention design has been elaborated from the CONSORT guidelines. This study protocol has been approved by the Ethics Committee in research of Salamanca Health Area (protocol number PI 2023 101435 in (24/01/2024) in accordance with the ethical guidelines of the Helsinki declaration. Sample size was calculated using G Power® Sample size software (University of Düsseldorf). The calculation was based on a moderate effect size of 0.4 (partial η2 = 0.40, α = .05, power = 0.90), resulting in a total of 28 patients. Assuming a 30% dropout rate, 36 participants will be recruited in total. Two sessions per week will be scheduled for 8 weeks with a total of 16 sessions. Each work session will have a duration of 60 minutes. The exercise will be adapted according to the phases based on the results already published, limiting in each phase the degrees of flexion and extension of the spine in order to avoid the risk of electrode migration. Primary outcomes will be functionality, satisfaction, strength, psychosocial variables, quality of life and pain perception. conditions: Failed Back Surgery Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: By doing so, we will aim to eliminate or reduce potential biases due to the order of patients and any transference effects that might occur if one profile clinical patients will influence the performance in several evaluations. Specifically, each patient will complete a sequence of allocation in the order of A, B, B, A, where 'A' represents SCS treatment isolated and 'B' denotes combined treatment. Subsequently, the average of the two 'A' conditions was calculated, and the same process was applied for the 'B' conditions whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: Exercise name: Spinal Cord Stimulation measure: Disability (Oswestry Disability Index) measure: Perception Pain (Visual analogue scale) measure: Quality of life (Short Form 36 Health Survey, SF36) measure: Patient's satisfaction measure: Strength (Sorensen Test) measure: Fear of Movement (Tampa Scale of Kinesiophobia, TSK) measure: Individual's belief in their own ability to successfully execute tasks (Self-efficacy Scale) measure: Catastrophic thinking (Pain Catastrophizing Scale) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Juan Vicente-Mampel city: Torrent state: Valencia zip: 46900 country: Spain lat: 39.43705 lon: -0.46546 hasResults: False

 nctId: NCT06272526 id: SOCIALANX_1 briefTitle: Internet-Based Self-Help Intervention for Social Anxiety Symptoms overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-01 date: 2024-12-31 date: 2024-02-22 date: 2024-02-22 name: Anadolu University class: OTHER briefSummary: This study is a randomized-controlled trial in which the assumed superiority of the module internet-based cognitive behavioral therapy intervention for social anxiety disorder is evaluated compared to a waitlist control group. Participants will be assigned to one of two groups, treatment which have web-based intervention (guided), and waitlist.

The intervention program will be offered to treatment group participants (guided) through the website https://kendikendineyardim.org, the unique online self-help platform in Turkey. Participants in the web-based treatment group will receive feedback message within 24 hours after each completed module from the guides. conditions: Mental Health Issue studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: Internet Based Intervention - GUIDED measure: Liebowitz Social Anxiety Scale (LSAS) Turkish Form measure: Social Appearance Anxiety Scale (SAAS) Turkish Form measure: Patient Health Questionnaire-9 (PHQ-9) Turkish Form measure: Generalized Anxiety Disorder-7 (GAD-7) Turkish Form measure: Sociodemographic Information Form measure: System Usability Scale (SUS-10) Turkish Form measure: Attitudes Toward Internet-Based Interventions Scale (ETAM) Turkish Form measure: Adherence to Intervention measure: Guide Evaluation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06272513 id: ProAct-HNC-02 briefTitle: Influencing Factors for Physical Activity in People With Head and Neck Cancer acronym: ProAct-HNC overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03-31 date: 2025-06-30 date: 2024-02-22 date: 2024-02-26 name: Kantonsspital Winterthur KSW class: OTHER name: Eastern Switzerland University of Applied Sciences name: University of Applied Sciences of Western Switzerland name: UMC Utrecht name: University of Lausanne name: Zurich University of Applied Sciences briefSummary: The goal of this qualitative study is to explore influencing factors for physical activity participation in people affected by an advanced head and neck cancer from the perspective of people affected and their significant others.

Individual interviews will be conducted with people affected by head and neck cancer and focus group interviews will be held with significant others of people being affected to answer the following research questions:

* What capabilities and opportunities for physical activity participation do people with advanced head and neck cancer experience?
* What motivates people with advanced head and neck cancer to be physically active?
* How do significant others view capabilities, opportunities, and motivation for physical activity participation in people with head and neck cancer?

The interviews will be transcribed verbatim and analysed with a structuring content analysis approach. conditions: Advanced Head and Neck Squamous Cell Carcinoma studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 20 type: ESTIMATED measure: interview transcripts measure: personal information of participants sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-02-09 uploadDate: 2024-02-15T04:21 filename: Prot_000.pdf size: 1702659 hasResults: False

 nctId: NCT06272500 id: 2024-KY-0146-001 briefTitle: Exploring Methods for Treating Hypergastrinemia in Patients With Autoimmune Gastritis overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-05-31 date: 2024-05-31 date: 2024-02-22 date: 2024-02-22 name: Jianning Yao class: OTHER briefSummary: Autoimmune atrophic gastritis (AAG) is an organ-specific autoimmune disease that primarily affects the gastric body and fundus while sparing the antrum. Its characteristics include destruction of gastric wall cells, loss of intrinsic factors, and atrophy of the gastric mucosa. Endoscopic examination reveals features of reverse atrophy, with significant atrophy in the gastric body and fundus, appearing as a mosaic of red and white patches. Currently, AAG is believed to result from a pathological CD4+ T-cell-mediated autoimmune response against the gastric H+/K+-ATPase. CD4+ T lymphocytes target the parietal cells' H+/K+-ATPase, stimulating plasma cells to secrete autoantibodies, including parietal cell antibodies (PCA) and intrinsic factor antibodies (IFA). The former plays a key role in parietal cell destruction and glandular atrophy. AAG is considered a premalignant condition, with the potential development of gastric dysplasia, cancer, and type 1 gastric neuroendocrine tumours (type 1 g-NET).

Gastric neuroendocrine tumors (g-NETs), also known as gastric carcinoids, account for approximately 23% of gastrointestinal and pancreatic neuroendocrine tumors. Clinically, g-NETs are mainly classified into three types. Type III is typically sporadic tumors associated with normal gastrin levels and poor prognosis. Although type 1 g-NETs caused by AAG are usually well-differentiated, studies have reported that 8%-23% of type 1 g-NETs extending into the deep submucosal layer may metastasize to regional lymph nodes or even to the liver. Furthermore, 3% of patients may develop neuroendocrine carcinoma, highlighting the need for appropriate attention.

Due to the destruction of gastric glands (including parietal and chief cells) in AAG patients, there is a deficiency in intrinsic factor, gastric acid, and a decrease in pepsinogen I (PG-I) levels. Insufficient gastric acid secretion leads to a compensatory increase in gastrin secretion by G cells in the gastric antrum, which acts on receptors present in enterochromaffin-like cells (ECL) in the gastric body and fundus, promoting ECL cell proliferation. Prolonged stimulation by hypergastrinemia can result in the development of ECL cell tumors, namely type 1 g-NETs. Considering the close association between type 1 g-NETs and AAG, primarily related to hypergastrinemia resulting from reduced gastric acid secretion, it is hypothesized that supplementation with gastric acid could provide negative feedback regulation of gastrin, reducing the risk of type 1 g-NET development in AAG patients. This study aims to investigate the impact of oral apple cider vinegar on gastrin levels in AAG patients, thus exploring a simple and cost-effective method to reduce the risk of type 1 g-NETs in AAG patients. conditions: Autoimmune Gastritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 150 type: ESTIMATED name: oral administration of a compound digestive enzyme capsule name: oral administration of apple cider vinegar name: oral administration of both the compound digestive enzyme capsule and apple cider vinegar measure: serum gastrin levels measure: serum gastrin levels measure: the adverse reaction rates sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-01-30 uploadDate: 2024-02-15T10:32 filename: Prot_SAP_000.pdf size: 152941 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-01-30 uploadDate: 2024-02-15T10:32 filename: ICF_001.pdf size: 156619 hasResults: False

 nctId: NCT06272487 id: ALN-AGT01-007 briefTitle: Zilebesiran as Add-on Therapy in Patients With High Cardiovascular Risk and Hypertension Not Adequately Controlled by Standard of Care Antihypertensive Medications (KARDIA-3) acronym: KARDIA-3 overallStatus: RECRUITING date: 2024-02-29 date: 2025-03-20 date: 2025-12-19 date: 2024-02-22 date: 2024-04-18 name: Alnylam Pharmaceuticals class: INDUSTRY briefSummary: The purpose of this study is to evaluate the effect of zilebesiran as add-on therapy in patients with high cardiovascular risk and hypertension not adequately controlled by standard of care antihypertensive medications. conditions: High Cardiovascular Risk conditions: Hypertension studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 390 type: ESTIMATED name: Zilebesiran name: Placebo measure: Change from Baseline at Month 3 in Mean Seated Office Systolic Blood Pressure (SBP) measure: Change from Baseline at Month 3 in 24-Hour Mean SBP Assessed by Ambulatory Blood Pressure Monitoring (ABPM) measure: Change from Baseline at Month 6 in Mean Seated Office SBP measure: Change from Baseline at Month 6 in 24-Hour Mean SBP Assessed by ABPM measure: Proportion of Patients with Mean Seated Office SBP <140 mmHg and/or Reduction ≥10 mmHg without Intensification of Antihypertensive Regimen at Month 6 measure: Proportion of Patients with 24-hour Mean SBP assessed by ABPM <130 mmHg and/or Reduction ≥10 mmHg without Intensification of Antihypertensive Regimen at Month 6 measure: Change from Baseline at Month 3 and Month 6 in Daytime and Nighttime Mean SBP and Diastolic Blood Pressure (DBP) assessed by ABPM measure: Change from Baseline at Month 3 and Month 6 in Mean Seated Office DBP measure: Change from Baseline at Month 3 and Month 6 in 24-hour Mean DBP Assessed by ABPM measure: Change from Baseline Over Time in Serum Angiotensinogen (AGT) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Trial Site status: RECRUITING city: Flint state: Michigan zip: 48504 country: United States lat: 43.01253 lon: -83.68746 hasResults: False

 nctId: NCT06272474 id: 0266-07/2021 - 18/07/2021 briefTitle: Virtual Reproduction of Mandibular Movement for Assessing Occlusal Interferences and Adjustments overallStatus: COMPLETED date: 2022-09-11 date: 2023-12-09 date: 2023-12-09 date: 2024-02-22 date: 2024-02-22 name: Hams Hamed Abdelrahman class: OTHER briefSummary: Computer-aided designs have considered dynamic occlusion with virtual articulator systems. However, the process involved is currently lengthy. The simplified transfer of casts from a mechanical to a virtual articulator has required bulky and expensive instruments. Recently, new methods based on mandibular motion tracking using optical devices have been introduced for integrating individual functional movement into occlusal morphology.

The aim of this study: This study will clinically assess the reliability of the virtual reproduction of mandibular movement for detecting occlusal interferences and adjustments of designed and milled CAD-CAM zirconia crowns using a digital occlusal analyzer.

Materials and methods: Intraoral optical impression will be made for thirteen selected patients with endodontically treated maxillary first premolars after abutment preparation followed by buccal and lateral interocclusal records taking. Two zirconia crowns will be fabricated for each patient following regular digital workflow with twenty six zirconia crowns, which will be allocated according to the virtual method of adjustment of occlusal interferences into two groups (Group I: Virtual occlusal interferences adjustment of CAD-CAM zirconia crowns using buccal interocclusal record (n=13) and Group II: Virtual occlusal interferences adjustment of CAD-CAM zirconia crowns using buccal and lateral interocclusal records (n=13)). Then milling and sintering of all crowns will be performed following the manufacturer's instructions. The occlusion of all crowns will be analyzed using an electronic pressure analyzer. All data will be statistically analyzed and discussed in light of the results obtained. conditions: Dental Occlusion studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Single group is receiving the two interventional arms primaryPurpose: DIAGNOSTIC masking: NONE count: 26 type: ACTUAL name: CAD-CAM zirconia crowns using buccal interocclusal record. name: CAD-CAM zirconia crowns using lateral interocclusal records. measure: Static occlusal interference measure: Dynamic occlusal interference sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Alexandria Faculty of Dentistry city: Alexandria country: Egypt lat: 31.21564 lon: 29.95527 hasResults: False

 nctId: NCT06272461 id: UTEM ELKI briefTitle: Comparison of Intravenous Lidocaine vs Ketamine in Colorectal Surgery overallStatus: RECRUITING date: 2023-10-01 date: 2024-05-30 date: 2024-06-30 date: 2024-02-22 date: 2024-04-16 name: University Tunis El Manar class: OTHER briefSummary: Patients undergoing open colorectal surgery were randomly divided into two groups: Intravenous Lidocaine (IV-Lido) vs Intravenous Ketamine (IV-Keta).

For the IV-Lido group, patients received a loading dose of Lidocaine than a continuous infusion over twenty-four hours.

For the IV-Keta goup, patients received a loading dose of Ketamine than a continuous injection of Ketamine over twenty-four hours.

Plasma concentrations of Interleukin-6(IL-6) were measured preoperatively before anesthetic induction and at twenty-four hour post operatively. conditions: Colorectal (Colon or Rectal) Cancer conditions: Inflammation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intravenous Lidocaine vs intravenous ketamine primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 50 type: ESTIMATED name: Lidocaine IV name: Ketamine Injectable Solution measure: The variation of Interleukin-6 levels measure: Pain assessed by Numerical Rating Scale (NRS) measure: Post-operative nausea and vomiting measure: Bowel function. measure: Hospital length of stay. measure: Post-operative complications. sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tunisia status: RECRUITING city: Nabeul zip: 8000 country: Tunisia name: BEN ALI MECHAAL role: CONTACT phone: 53890987 phoneExt: 00216 email: mechaal_benali@yahoo.fr lat: 36.45606 lon: 10.73763 hasResults: False

 nctId: NCT06272448 id: CERM2022-27 21042022 briefTitle: teleRehabilitation for pAtients With ParkInson's Disease at Any mOment acronym: RAPIDO overallStatus: RECRUITING date: 2022-11-15 date: 2024-05-31 date: 2024-05-31 date: 2024-02-22 date: 2024-02-22 name: Università Politecnica delle Marche class: OTHER name: Universita di Verona briefSummary: The goal of this clinical trial is to test the feasibility and safety of a telerehabilitation and telemonitoring approach in people with Parkinson's disease at any stage. The main questions it aims to answer are: will patients with Parkinson's disease comply with the recommended level of training at home using an ad hoc developed telerehabilitation platform? • Will this training be safe and impact the patient's well-being perception? Participants will be given a tablet and instructed to access an online platform to observe different motor tasks presented in as many video clips by experienced therapists.They will be requested to perform the motor tasks per a predetermined protocol over 3 months. Their compliance with the recommended training will be checked by physiotherapists every 15 days during phone calls, whereas their daily level of motor activity will be recorded by a smartwatch. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Before-after study with one follow-up at 3 months of treatment end primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Telerehabilitation measure: Compliance with the telerehabilitation system measure: Perceived usability of system measure: Incidence of treatment-emergent adverse events measure: User satisfaction measure: Compliance with the monitoring system measure: Feasibility of telemonitoring approach measure: Motor symptom and disability progression measure: Non motor symptom progression measure: Patients' Quality of life measure: Caregiver's burden sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Neurorehabilitation Clinic status: RECRUITING city: Ancona zip: 60126 country: Italy name: Elisa Andrenelli, Dr role: CONTACT phone: 0715965794 email: e.andrenelli@univpm.it lat: 43.5942 lon: 13.50337 facility: Università di Verona status: RECRUITING city: Verona zip: 37100 country: Italy name: Marialuisa Gandolfi, Prof role: CONTACT phone: +39 045 812 4943 email: marialuisa.gandolfi@univr.it lat: 45.4299 lon: 10.98444 hasResults: False

 nctId: NCT06272435 id: PRO-FY2024-64 briefTitle: Beverage Hydration Index: Assessment of Four Rehydration Solutions overallStatus: RECRUITING date: 2023-12-23 date: 2024-05-31 date: 2024-05-31 date: 2024-02-22 date: 2024-02-22 name: University of Memphis class: OTHER briefSummary: No studies to date to evaluate the effects of the three different liquid IV electrolyte products on the beverage hydration index (BHI). Therefore, the purpose of this study is to determine the impact of three different LIV products (Hydration multiplier, Sugar Free formulation with Amino Acids, and Sugar Free with allulose) on hydration status in young and active men and women compared to a control (water). The study will follow the same approach as used by Maughan and colleagues (2016) to measure the fluid balance (the difference between the amount of water consumed and passed as urine) and BHI (the relative amount of urine passed after consumption of a drink compared to water) including time in positive fluid balance, as well as determining electrolyte concentrations, osmolality, specific gravity, and sodium and potassium in urine. conditions: Hydration studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Semi-blinded, placebo controlled, crossover design primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Treatments will be labeled A-D. Subjects will be provided prepared beverages prepared in cup. whoMasked: PARTICIPANT count: 28 type: ESTIMATED name: Multiplier name: Sugar Free name: Sugar Free with Amino Acids name: Water measure: Beverage Hydration Index measure: Beverage Hydration Index measure: Beverage Hydration Index measure: Beverage Hydration Index measure: Beverage Hydration Index measure: Net Fluid Balance measure: Net Fluid Balance measure: Net Fluid Balance measure: Net Fluid Balance measure: Net Fluid Balance measure: Urine Osmolality measure: Urine Osmolality measure: Urine Osmolality measure: Urine Osmolality measure: Urine Osmolality measure: Urine Osmolality measure: Urine Sodium measure: Urine Sodium measure: Urine Sodium measure: Urine Sodium measure: Urine Sodium measure: Urine Sodium measure: Urine Potassium measure: Urine Potassium measure: Urine Potassium measure: Urine Potassium measure: Urine Potassium measure: Urine Potassium measure: Urine Specific Gravity measure: Urine Specific Gravity measure: Urine Specific Gravity measure: Urine Specific Gravity measure: Urine Specific Gravity measure: Urine Specific Gravity measure: Urine Specific Gravity measure: Sodium balance measure: Sodium balance measure: Sodium balance measure: Sodium balance measure: Sodium balance measure: Potassium balance measure: Potassium balance measure: Potassium balance measure: Potassium balance measure: Potassium balance measure: Body Mass measure: Body Mass measure: Mood and Digestive Questionnaire measure: Mood and Digestive Questionnaire measure: Mood and Digestive Questionnaire measure: Mood and Digestive Questionnaire measure: Mood and Digestive Questionnaire measure: Mood and Digestive Questionnaire sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Center for Nutraceutical and Dietary Supplement Research status: RECRUITING city: Memphis state: Tennessee zip: 38152 country: United States name: Jackie Pence, Ph.D. role: CONTACT phone: 901-678-1547 email: jpence1@memphis.edu name: Richard J Bloomer, Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 35.14953 lon: -90.04898 hasResults: False

 nctId: NCT06272422 id: 2022/0472 id: 2023-A00358-37 type: OTHER domain: IDRCB - ANSM ID briefTitle: Comparison of the Restoration of Hip Biomechanical Parameters by CT Measurement Between the 3 Surgical Techniques: RSA/Minihip/THA - Hip Replacement: 3D Planning acronym: HIP3D overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2026-03 date: 2024-02-22 date: 2024-02-22 name: University Hospital, Lille class: OTHER briefSummary: The study will analyze hip biomechanical parameters using EOS radiographic measurements pre- and post-operatively (3 months) and post-operatively (3 months) CT scans after total hip replacement (THR), neck-preserving THR of the Minihip type or hip resurfacing (HR). Clinical results will be assessed at 3 months and 1 year after surgery.

To this end, two types of examination are carried out, both of which are used in current practice:

* Pre-operatively: EOS radiography
* Post-operatively: EOS radiograph and CT scan

Inclusion (m-3; m-1) :

* Patient information at pre-operative visit
* Non-opposition of patient, family member or legal guardian, if applicable
* Questionnaires and clinical examination (standard management)
* EOS during anesthetic consultation

Follow-up visit (m+3):

- Post-operative follow-up consultation EOS and CT scan (1 week prior to visit) + questionnaire and clinical examination

Follow-up visit (m+12):

- Post-operative check-up, questionnaire and clinical examination conditions: Coxarthrosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 165 type: ESTIMATED name: hip arthroplasty measure: Comparing the restoration of femoral hip offset between hip resurfacing procedures (HRP), THA and Minihip-type neck-preserving total hip arthroplasty. measure: Compare the anatomical restoration of frontal and axial parameters between the 3 types of intervention (PTH, Minihip and RSA). measure: Compare clinical outcomes and patient satisfaction between the 3 procedures (PTH, Minihip and RSA). measure: Correlate restoration of hip femoral offset and patient functional outcome at 3 months. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06272409 id: DEP114-III-0123 briefTitle: Efficacy and Safety of DEP114 in the Treatment of Moderate to Severe Persistent Allergic Rhinitis in Children. acronym: SIERRA overallStatus: NOT_YET_RECRUITING date: 2025-02-15 date: 2025-03-15 date: 2027-04-15 date: 2024-02-22 date: 2024-02-22 name: EMS class: INDUSTRY briefSummary: The purpose of this study is to evaluate the efficacy and safety of DEP114 in the treatment of Moderate to Severe Persistent Allergic Rhinitis in children aged between 6 and 11 years. conditions: Allergic Rhinitis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 318 type: ESTIMATED name: DEP114 name: Desloratadine 0.5 MG/ML measure: To demonstrate the superiority of DEP114 in relation to desloratadine 0.5 mg/mL in relieving the nasal symptoms of moderate to severe persistent allergic rhinitis in children, five days after starting treatment. measure: To evaluate the effectiveness of DEP114 in relieving nasal symptoms of moderate to severe persistent allergic rhinitis in children, throughout the treatment. measure: Evaluate the efficacy of DEP114 to relieve nasal obstruction present in moderate to severe persistent allergic rhinitis in children through the treatment. measure: Evaluate the efficacy of DEP114 to relieve coryza present in moderate to severe persistent allergic rhinitis in children, three and five days after the start of treatment. measure: Evaluate the efficacy of DEP114 to relieve nasal itching present in moderate to severe persistent allergic rhinitis in children, three and five days after the start of treatment. measure: Evaluate the efficacy of DEP114 to relieve sneezing present in persistent allergic rhinitis moderate to severe in children, three and five days after the start of treatment. measure: Evaluate the efficacy of DEP114 to relieve symptoms of moderate to severe persistent allergic rhinitis in children according to the perception of the person responsible for the participant. measure: Evaluate the efficacy of DEP114 to relieve symptoms of moderate to severe persistent allergic rhinitis in children according to the investigator's perception. sex: ALL minimumAge: 6 Years maximumAge: 11 Years stdAges: CHILD hasResults: False

 nctId: NCT06272396 id: CHUBX 2023/64 briefTitle: Feasibility and Diagnostic Relevance of Recording an ECG Trace With a Connected Watch acronym: ECG-MC overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2027-03-20 date: 2028-03-20 date: 2024-02-22 date: 2024-02-22 name: University Hospital, Bordeaux class: OTHER briefSummary: Over the past few years, various systems have been developed to record ECG traces on an ambulatory basis. The latest connected watch models feature 2-electrode ECG recording. This single or six derivations can be used to derive a wealth of information about the heart's rhythm. The information that can be derived from an ECG recording with a derivation goes far beyond̀ simple differentiation between atrial fibrillation and sinus rhythm. In contrast, in various clinical situations, a tracing restricted to an ICD may prove falsely normal, wrongly reassuring a patient and delaying management. The primary objective of the study is to evaluate the sensitivity of ECG-1D or 6D recordings from a connected watch in measuring electrical parameters, compared with a standard ECG-12D, also to obtain a bank of tracings, to create and validate an artificial intelligence algorithm for the automatic analysis of ECG tracings recorded with a connected watch and also to validate the feasibility and sensitivity of recording an ECG tracing with a connected watch in children. conditions: Arrhythmias, Cardiac studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 3000 type: ESTIMATED name: Smart watch measure: Comparison of electrical parameters measured using the 2 ECG methods: P-wave amplitude measure: Comparison of electrical parameters measured using the 2 ECG methods: P-wave duration measure: Comparison of electrical parameters measured using the 2 ECG methods: QRS amplitude measure: Comparison of electrical parameters measured using the 2 ECG methods: QRS duration measure: Comparison of electrical parameters measured using the 2 ECG methods: QT/QTc measure: Creation of bank of anormal ECG trace measure: Compare the diagnostic capabilities of an ECG trace recorded with a watch against the reference method, the 12-lead ECG measure: Validate the feasibility of recording and sending of ECG tracings with a connected watch at the patient's home measure: Validate the feasibility of recording an ECG trace with a connected watch for a child measure: Validate the sensibility of an ECG trace with a connected watch for a child sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Haut-Lévèque city: Pessac zip: 33604 country: France name: Pierre BORDACHAR role: CONTACT lat: 44.81011 lon: -0.64129 hasResults: False

 nctId: NCT06272383 id: HS26166 (B2023:092) briefTitle: Croup Dosing Study overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-03 date: 2024-02-22 date: 2024-02-22 name: University of Manitoba class: OTHER briefSummary: Croup is a common childhood respiratory disease that often leads to frequent emergency department visits. It is a viral infection that causes cough, throat, and airway swelling, making breathing difficult. Dexamethasone is a medication that helps to reduce swelling, making breathing easier for children. A standard dose of 0.6mg/kg is used in children. However, a lower amount (due to side effects of steroids in children) has been suggested. We will examine whether 25% less than the standard dose is equally effective in treating croup. Investigators will conduct a clinical study with the support of patients with lived experience (which, in this case, are the parents of the children) to better care for children with croup. If proven, this study can improve the outcome in children with croup. conditions: Croup studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is an internal double-blinded vanguard randomized controlled trial (RCT), which will be conducted at the Winnipeg Children's Hospital (WCH). Computerized randomization will be performed by a statistician at the George and Fay Yee Centre for HealthCare Innovation to generate the randomization list. Investigators will perform a computerized randomization stratified by age. Investigators will do a block randomization with random blocks of undisclosed block sizes over the seasons to ensure temporal distribution of croup cases is captured. Investigators will randomly assign patients to either the intervention or control in ratio 1:1. While croup is common between 6 months and 5 years, a typical croup affects children between 6 months and 3 years. Based on this, we will randomize such that this age category (6 months-3years) has almost similar distribution in each arm. primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: 0.15 mg/kg dexamethasone measure: Return visits or readmissions to the hospital measure: Adverse events sex: ALL minimumAge: 6 Months maximumAge: 5 Years stdAges: CHILD hasResults: False

 nctId: NCT06272370 id: PLACER-2021C3-24737-IC briefTitle: Individualizing Treatment for Asthma in Primary Care acronym: iTREAT-PC overallStatus: RECRUITING date: 2024-02-01 date: 2024-06-30 date: 2024-09-30 date: 2024-02-22 date: 2024-02-22 name: DARTNet Institute class: OTHER_GOV name: Penn State University name: Icahn School of Medicine at Mount Sinai name: University of Colorado, Denver name: RAND name: University of Washington name: Rutgers University name: University of North Carolina name: Brigham and Women's Hospital name: Reliant Medical Group name: Kelsey Research Foundation name: Wake Forest University Health Sciences briefSummary: This is a patient level randomized trial for teenagers and adults with asthma who will be randomized to four arms - enhance usual care, rescue inhaled corticosteroids, azithromycin and both rescue inhaled corticosteroids and azithromycin. Participants in all arms will be offered access to an online asthma symptom monitoring system. conditions: Asthma conditions: Bronchial Diseases conditions: Respiratory Tract Infections conditions: Lung Diseases, Obstructive conditions: Lung Diseases conditions: Respiratory Hypersensitivity conditions: Immune System Diseases studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: patient randomized trial of three different drug combinations primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 125 type: ESTIMATED name: Asthma Symptom Monitoring online tools name: Inhaled Steroids name: Azithromycin Pill measure: The annualized rate of major asthma exacerbations (a hospitalization for asthma or 72+ hours of oral/parenteral steroids). measure: Asthma control as measured by the Asthma Control Test measure: Asthma Quality of Life as measured by the Juniper Mini Asthma Quality of Life Questionnaire measure: Days Per Year Lost from Work or School/Days Unable to Carry Out Usual Activities Due to Asthma. sex: ALL minimumAge: 12 Years maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: DARTNet Insitute status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: Brian K Manning, MPH role: CONTACT phone: 800-434-0278 phoneExt: 82 email: brian.manning@dartnet.info name: Joel Shields, MA role: CONTACT phone: 80004340278 phoneExt: 84 email: joel.shields@dartnet.info name: Michelle Hernandez, MD role: PRINCIPAL_INVESTIGATOR name: Kari Stephens, PhD role: PRINCIPAL_INVESTIGATOR name: John Valenta, PhD role: PRINCIPAL_INVESTIGATOR name: Juan Wisniveski, MD role: PRINCIPAL_INVESTIGATOR name: Lipika Samal, MD role: PRINCIPAL_INVESTIGATOR lat: 39.72943 lon: -104.83192 hasResults: False

 nctId: NCT06272357 id: Antiarrhythmic drugs briefTitle: The Use of Antiarrhythmic Drugs in Pediatrics overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2025-03-31 date: 2024-02-22 date: 2024-02-22 name: Assiut University class: OTHER briefSummary: A study on the use of antiarrhythmic drugs in pediatric age group, in Assiut University Children's Hospital, a clinical audit conditions: Antiarrhythmic Drug Adverse Reaction studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 158 type: ESTIMATED name: Antiarrhythmic drugs measure: Detect the rate of use of antiarrhythmic drugs in pediatrics and the different indications for them other than the control of arrhythmia. sex: ALL minimumAge: 30 Days maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06272344 id: CHUBX 2022/38 briefTitle: Remote Programming of Cardiac Implantable Electronic Devices 2 acronym: REACT 2 overallStatus: RECRUITING date: 2023-04-24 date: 2024-10-24 date: 2024-10-24 date: 2024-02-22 date: 2024-02-22 name: University Hospital, Bordeaux class: OTHER briefSummary: Cardiac Implantable Electronic Devices (CIEDs) such as pacemakers and implantable cardioverter defibrillators need to be regularly and systematically interrogated and reprogrammed to ensure proper functioning. While remote monitoring allows for partial interrogation at a remote location, full CIED check-up and reprogramming is only possible when the patient visits a cardiologist capable of performing device programming. This can be challenging for patients and may cause unnecessary delays, particularly in settings of limited resources, enforced physical distancing, and quarantines. In this study we aim to evaluate our previously validated remote programming solution (REACT study, NCT05366660) in outpatient device clinics which are close to the patient's home but remote from the CIED expert. conditions: Pacemaker conditions: Defibrillator conditions: Telemedecine studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, single-center, single-arm, pairwise comparison trial primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 50 type: ESTIMATED name: Teleconsultation measure: assess the satisfaction of patients benefiting from a teleconsultation compared to a standard consultation at hospital measure: Time saving for patient measure: Savings on medical transport measure: Costs associated with teleconsultation measure: safety of teleconsultation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bordeaux University Hospital status: RECRUITING city: Pessac zip: 33604 country: France name: Sylvain MD Ploux role: CONTACT phone: (0)5 57 65 64 71 phoneExt: +33 email: sylvain.ploux@chu-bordeaux.fr name: Estel HUGOT role: CONTACT phone: (0)5 57 62 32 26 phoneExt: +33 email: estel.hugot@chu-bordeaux.fr name: Sylvain MD Ploux role: PRINCIPAL_INVESTIGATOR lat: 44.81011 lon: -0.64129 hasResults: False

 nctId: NCT06272331 id: NL83162.091.22 briefTitle: Milk and Plant Protein Digestion acronym: MAPP-D overallStatus: RECRUITING date: 2024-01-15 date: 2024-07-01 date: 2024-07-01 date: 2024-02-22 date: 2024-02-22 name: Wageningen University class: OTHER name: FrieslandCampina briefSummary: The goal of this study is to explore the effect of protein quantity and quality in plant-based drinks. Healthy normal-weight males aged between 18 and 45 years will be included in the study.

The main objectives are to examine the differences in postprandial amino acid profiles, and to examine differences in gastric behavior between cow's milk and plant based drinks.

Participants will visit after an overnight fast three times and have blood draws before and after consumption one of the study drinks. There will be MRI scans of the stomach before and after consumption of the drink to assess gastric behavior. conditions: Food Digestion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 12 type: ESTIMATED name: Low-protein plant-based drink name: High-protein plant-based drink name: Cow's milk measure: Postprandial plasma amino acid profile as characterized by the peak height and iAUC measure: Gastric behavior measure: Postprandial plasma response measure: Verbal ratings of wellbeing measure: MRI markers of digestion sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Human Research Unit - Division of Human Nutrition and Health status: RECRUITING city: Wageningen zip: 6708WE country: Netherlands name: Paul Smeets, PhD role: CONTACT phone: + 31317484681 email: paul.smeets@wur.nl name: Paul Smeets, PhD role: PRINCIPAL_INVESTIGATOR lat: 51.97 lon: 5.66667 hasResults: False

 nctId: NCT06272318 id: 74131 briefTitle: Vital Signs Blood Pressure Trial overallStatus: NOT_YET_RECRUITING date: 2024-02-20 date: 2024-06-30 date: 2026-12-31 date: 2024-02-22 date: 2024-02-22 name: Stanford University class: OTHER briefSummary: The purpose of this study is collect subject vitals with a blood pressure cuff, electrocardiogram (ECG), and photoplethysmogram (PPG). This data can then be used to develop a reliable, accurate, noninvasive, and continuous blood pressure monitoring device. conditions: Cardiovascular Diseases conditions: Hypertension conditions: Blood Pressure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Blood Pressure Cuff, EKG, PPG measure: Collection of Subject Name (optional) measure: Collection of Subject Height measure: Collection of Subject Weight measure: Collection of Subject Age measure: Collection of Subject Medical Comorbidities measure: Blood Pressure Measurement measure: Collection of ECG Waveforms measure: Collection of PPG Waveforms sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT hasResults: False

 nctId: NCT06272305 id: 49RC21_0301 briefTitle: TREC - Evaluation of the Impact of Eversion Technical Features on the Rate of Carotid Restenosis acronym: TREC overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-06-01 date: 2024-06-01 date: 2024-02-22 date: 2024-02-22 name: University Hospital, Angers class: OTHER_GOV briefSummary: Restenosis due to myo-intimal hyperplasia remains a concern after carotid endarterectomy. It occurs in around 6% of cases. Several risk factors for restenosis have already been identified, such as smoking, hypertension, female gender, diabetes, dyslipidemia and small carotid diameter. The main objective of this prospective multicenter study was to determine whether the technical characteristics of the eversion technique have an influence on the rate of restenosis at 1 year.

Between September 2021 and November 2022, we followed all patients undergoing carotid endarterectomy by eversion in 8 French hospitals. Demographic data, operative indications and technical characteristics of the endarterectomies performed were collected. These were defined by the circumferential nature of the carotid bulb according to 3 types (TREC A, B or C), and the length and depth of the endarterectomy according to anatomopathological reports. Post-operative complications were collected as much as doppler ultrasonography at three months and 1 year to quantify restenosis. conditions: Hyperplasia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 500 type: ESTIMATED name: This research does not require any specific investigation and does not imply any modification of treatment. measure: Rate of restenosis measure: Morbidity and mortality rate measure: Major cardiological event measure: Minor neurological events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06272292 id: S66441 briefTitle: Biomechanical Investigation of Symptomatic FAI and Two Groups of Asymptomatic Controls acronym: CAM-FAI adult overallStatus: RECRUITING date: 2022-07-28 date: 2024-03-01 date: 2024-03-01 date: 2024-02-22 date: 2024-02-22 name: Universitaire Ziekenhuizen KU Leuven class: OTHER briefSummary: Femoroacetabular impingement (FAI) is an orthopaedic condition that is primarily characterized by the presence of anatomic bony abnormalities in the femoral head and/or the acetabulum resulting in an abnormal contact between the two during hip motion, especially in positions of increased hip flexion and rotation, ultimately leading to hip pain. Unfortunately, a FAI diagnosis is frequently only made once symptoms have become severe to an extent that they limit everyday life activities. Moreover, another important aspect that has been consistently overlooked in past FAI movement studies is the influence muscle strength and activation can have on movement pattern and symptom presentation. The diagnosis and management of FAI needs to be addressed through a more wholesome investigation of the biomechanical influence on the manifestation of symptoms.

This project aims to further unravel the link between spinopelvic anatomy, its biomechanical contribution to femoro-pelvic motion and the manifestation of femoroacetabular impingement in adult male population. By, for the first time, integrating three-dimensional (3D) instrumented motion analysis with state-of-the-art full-body biplanar X-ray imaging (EOS imaging, Paris France), we will more specifically investigate the presence of an association between spinopelvic kinematics and the link to symptomatic FAI morphology, as well as investigate the presence of differences in these measures between symptomatic and asymptomatic subjects with comparable femoral morphology. conditions: Femoroacetabular Impingement studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Cross-sectional, case-control prospective clinical study primaryPurpose: DIAGNOSTIC masking: SINGLE maskingDescription: 3 study groups, based on clinical examination and medical imaging:

* symptomatic CAM-FAI patients
* asymptomatic CAM controls
* healthy controls whoMasked: PARTICIPANT count: 99 type: ESTIMATED name: EOS name: 3D motion lab analysis measure: The presence of CAM morphology in combination with symptoms measure: The Copenhagen Hip and Groin Outcome Score (HAGOS) measure: Radiographic spinopelvic parameters measure: 3D motion analysis parameters sex: MALE minimumAge: 21 Years maximumAge: 35 Years stdAges: ADULT facility: University Hospitals of Leuven status: RECRUITING city: Leuven state: Vlaams-Brabant zip: 3000 country: Belgium name: Stijn Ghijselings, MD role: CONTACT phone: +32 16 33 88 18 email: stijn.ghijselings@uzleuven.be name: Orthopedic Research role: CONTACT phone: +32 16 33 88 18 email: orthopedie.research@uzleuven.be lat: 50.87959 lon: 4.70093 hasResults: False

 nctId: NCT06272279 id: HS23666(B2020:015) briefTitle: Neuromodulation With Spinal Stimulation Methods overallStatus: RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2025-02-01 date: 2024-02-22 date: 2024-02-22 name: University of Manitoba class: OTHER briefSummary: This is a pilot research study to test the protocols needed for transcutaneous spinal electrical stimulation in persons living with spinal cord injury (SCI). Up to 24 participants will be enrolled. A variety of stimulation parameters and outcome measures will be assessed. conditions: Spinal Cord Injuries conditions: Spinal Cord Injury at C5-C7 Level conditions: Paraplegia, Spinal conditions: Paraplegia, Incomplete studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Semi-blinded, randomized block entry design, crossover intervention study. primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: The participant will be connected to the stimulation device(s) but will not know if it has been turned on during each trial. In addition, the person analyzing the outcome data will not be aware of the stimulation status of the participant. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: spinal stimulation-DCS name: spinal stimulation-sham DCS name: spinal stimulation-EPS name: sham spinal stimulation-EPS measure: Motor response measure: Motor evoked potentials measure: Blood pressure sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Manitoba status: ENROLLING_BY_INVITATION city: Winnipeg state: Manitoba zip: R3E 0J9 country: Canada lat: 49.8844 lon: -97.14704 facility: University of Manitoba status: RECRUITING city: Winnipeg state: Manitoba zip: R3E 0J9 country: Canada name: Katinka Stecina, Ph.D. role: CONTACT phone: 2047893761 email: Katinka.Stecina@umanitoba.ca name: Kristine Cowley, Ph.D. role: CONTACT phone: 2047893305 email: Kristine.Cowley@umanitoba.ca lat: 49.8844 lon: -97.14704 hasResults: False

 nctId: NCT06272266 id: 2021/03-26 briefTitle: The Aerobic Exercise Capacity and Muscle Strenght in Individuals With COVID-19 overallStatus: COMPLETED date: 2022-04-20 date: 2022-05-30 date: 2023-02-15 date: 2024-02-22 date: 2024-02-22 name: Selda Sarıkaya class: OTHER name: Zonguldak Bulent Ecevit University briefSummary: The subject of the project is the impact of COVID-19 on the exercise capacity of patients. The long-term sequelae of COVID-19 infection are still unknown. It is not yet clear whether pulmonary sequelae, which may be a consequence of the disease, are associated with a measurable functional deficit. In this project, the aerobic capacity of healthy people will be compared with individuals who have experienced Covid-19, and the amount of increase in aerobic capacity will be determined at the end of 15 sessions by applying a rehabilitation program including bicycle ergometry to individuals who have experienced Covid-19 Detailed description : In December 2020, in the pneumonia epidemic in which the city of Wuhan, China is the center, pneumonia developed due to the newly defined SARS-CoV-2 factor was defined as Coronavirus disease 2019 (COVID-19). It has been observed that clinical findings of SARS-CoV-2 infection in patients hospitalized in Wuhan range from mild manifestations such as asymptomatic disease and mild upper respiratory tract infection to severe viral pneumonia accompanied by respiratory failure and may result in death.The long-term sequelae of COVID19 are still unknown. Pulmonary sequelae that impair physical fitness have been predominantly defined for hospitalized patients with COVID-19. Although lung lesions have been identified as asymptomatically in infected individuals, it is not yet clear whether these observations are related to a measurable functional deficit in physical fitness. They measured the change in the predicted maximum aerobic capacity (VO2 max) of non-infected,asymptomatically infected, and recovering COVID-19 individuals with a well-established and validated physical fitness test before and after the COVID-19 outbreak among young Swiss adults.They demonstrated decreased aerobic capacity in young adults 1 to 2 months after symptomatic COVID-19 without physical strength being affected. In their study, 19% of young adults who recovered after COVID-19 had a VO2 max decrease of more than 10% compared to baseline before infection. It has been identified that decreased VO2 max value is the hallmark of interstitial lung disease. SARS-CoV-2 infection causes lung damage even in asymptomatic cases.

A total of 64 people, including 32 people in 2 groups between the ages of 18-55, who have or have not had corona virus infection, who applied to Bülent Ecevit University Faculty of Medicine Physical Therapy and Rehabilitation or Infectious Diseases outpatient clinics for different reasons, will be included in our project. The research start date is February 2021 and the end date is February 2023. At the beginning of the study, demographic information of the individuals such as gender, age,height, weight, occupation, education, body mass index, physical activity level (international physical activity index-IPAQ), the most used hand (dominant hand) in daily life activities will be recorded. In the control group, resting heart rate, blood pressure, saturation measurement, ECG will be performed before exercise. In addition, in order to evaluate their muscle strength, microFET3 manual muscle measurement device will be used to measure the triceps muscle strength in the upper extremity they actively use, and the quadriceps muscle strength of the same side will be measured, and their grip strength will be measured with the JAMAR hydraulic hand dynamometer. Using the international physical activity index(IPAQ), activity status in daily life will be assessed. The exercise capacity of all individuals will be measured with the aid of the COSMED Quark CPET device using the bicycle ergometry test recommended by the American Society of Cardiovascular and Pulmonary Rehabilitation. In this test, submaximal exercise test will be performed by providing 25 W increase in 2 minutes periods after the warm-up period at 0 load (W) for 2 minutes. In addition, the borg scale obtained at the end of the test, metabolic equivalent of task (MET) and maximum work (W), test duration, maximum heart rate parameters will also be recorded in order to evaluate the exercise capacity.

Individuals who have been confirmed by the previous SARS-COV 2 real-time reverse transcriptase polymerase chain reaction (RT-PCR) test to have coronovirus infection after the test will be included in a treatment program of 15 sessions, at least 3 sessions per week, with bicycle ergometry. After 15 sessions, exercise capacity will be re-evaluated using the cycling test, the aforementioned triceps and grip muscle strengths, V02 max, maximum conjugate (MET), maximum work (w), borg scale, maximum heart rate, test time parameters will be saved again after treatment. conditions: COVID-19 Pneumonia conditions: COVID-19 studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 41 type: ACTUAL name: Kardiopulmonary exercise test (Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system) name: Peripheral muscle strength measurement (microFET3 (Hoggan Health Industries, Fabrication Enterprises, lnc) and JAMAR hydraulic hand dynamometer (Sammons Preston, Rolyon, Bolingbrook). name: Standard exercise tolerance test (a bicycle ergometer and recorded through the ergoline rehabilitation system 2 Version 1.08 SPI.) name: Aerobic exercise training (a bicycle ergometer and recorded through the ergoline rehabilitation system 2 Version 1.08 SPI.) measure: Assessment of Triceps muscle strength by using the Micro FET3 muscle strength device measure: Assessment of Maximum work (watts) ın the standard exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI. measure: Assessment of Metabolic Equivalent (MET) in the standard exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI. measure: Assessment of VO2peak (ml/kg/min) in the exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI. measure: Assessment of VO2peakpredictive (%) in the standard exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI. measure: Assessment of Hand grip strength (kg) by using a JAMAR hydraulic hand dynamometer (Sammons Preston, Rolyon, Bolingbrook). measure: Assessment of Exchange Ratio(RER ) by using cardiopulmonary exercise test, a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, measure: Assessment of Anaerobik Treshold (VAT) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, measure: Assessment of Maximum Oxygen Capacity (VO2peak) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, measure: Assessment of Maximum Oxygen Capacity at Ventilatory Anaerobic Threshold (VO2AT) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, measure: Assessment of Carbon Dioxide Ventilatory Equivalent (VE/CO2) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, measure: Assessment of Heart Rate Recovery (HRR) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, measure: Assessment of Heart Rate Recovery at first minute (HRR1) by using cardiopulmonary exercise test with a Quark KPET C12x/T12x device connected to the Omnia version 1.6.8 COSMED system, measure: Assessment of quadriceps muscle strength by using the Micro FET3 muscle strength device measure: Assessment of Physical activity by using the International Physical Activity Questionnaire (IPAQ) measure: Assessment of Test Duration (min) in the standard exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI. measure: Assessment of Perceived Difficulty by using the Borg Scale measure: Assessment of Maximum heart rate (beats/min) in the standard exercise tolerance test using a bicycle ergometer and recording it via ergoline rehab system 2 Version 1.08 SPI. measure: Assessment of Systolic and diastolic blood pressure (mmHg) by using a blood pressure monitor measure: Assessment of resting heart rate (beats/min) by using a a pulse oximeter sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Zonguldak Bülent Ecevit University city: Zonguldak zip: 67100 country: Turkey lat: 41.45139 lon: 31.79305 hasResults: False

 nctId: NCT06272253 id: UNAIR-MP-INAKTIF-R-010 briefTitle: UNAIR Inactivated COVID-19 Vaccine INAVAC as Heterologue Booster (Immunobridging Study) in Adolescent Subjects overallStatus: ACTIVE_NOT_RECRUITING date: 2023-09-19 date: 2024-03-19 date: 2024-07-19 date: 2024-02-22 date: 2024-02-22 name: Dr. Soetomo General Hospital class: OTHER_GOV name: Indonesia-MoH name: Universitas Airlangga name: PT Biotis Pharmaceuticals, Indonesia briefSummary: This is an open label trial. There will only be 1 group in the study. All subjects will receive INAVAC vaccine and be followed for 6 months.

The vaccine will be administered intramuscularly. This study will be started after the interim analysis of the phase III INAVAC trial in adolescent. This study will have two interim and one full analysis reports. conditions: COVID-19 Pandemic conditions: COVID-19 Vaccines studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 250 type: ACTUAL name: INAVAC (Vaksin Merah Putih - UA- SARS CoV-2 (Vero Cell Inactivated) 5 μg measure: Humoral Immune Response (Neutralizing antibody) measure: Incidence of Adverse Events measure: Humoral Immune Response - The neutralizing antibody measure: Humoral Immune Response-IgG SARS-CoV-2 neutralizing titer by CLIA measure: Exploratory Endpoints-Whole Genome Sequencing sex: ALL minimumAge: 12 Years maximumAge: 17 Years stdAges: CHILD facility: Dr. Soetomo General Hospital city: Surabaya state: Jawa Timur zip: 67161 country: Indonesia lat: -7.24917 lon: 112.75083 hasResults: False

 nctId: NCT06272240 id: 17380 briefTitle: Tumor Microenvironment in Ovarian Cancer acronym: MICO overallStatus: RECRUITING date: 2024-01-02 date: 2024-07 date: 2027-01 date: 2024-02-22 date: 2024-02-22 name: University of Udine class: OTHER briefSummary: A detailed understanding of molecular mechanism of cancer genesis is fundamental to develop innovative and personalized therapies. The new frontier in biomedical research is represented by organoids, a three-dimensional cell culture system obtained from a tissue fragment that accurately reproduces the essential properties of the original tissue in vitro, which could provide a valuable model for explanation of ovarian cancers pathogenesis and will allow to predict the response to a specific therapy. With this research project, we expect to generate ovarian cancer organoids to characterize in vitro interactions and molecular pathway among tumor cells, immune cells, and resident microbiota (intratumoral bacteria and/or microbial-derived molecules). conditions: Ovarian Cancer Stage III conditions: Ovarian Cancer Stage IV studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Ovarian Cancer Organoids measure: • Composition of the tumor microenvironment (including the immune system and intratumoral microbiota). • Generate organoids sex: FEMALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Università degli Studi di Udine status: RECRUITING city: Udine state: UD zip: 33100 country: Italy lat: 46.0693 lon: 13.23715 hasResults: False

 nctId: NCT06272227 id: 4-2023-0986 briefTitle: Effect of Alfacalcidol on Muscle Function in Osteoporosis Patients overallStatus: NOT_YET_RECRUITING date: 2024-02-13 date: 2025-09-01 date: 2025-09-01 date: 2024-02-22 date: 2024-02-22 name: Yonsei University class: OTHER briefSummary: This study aims to investigate the potential improvement in muscle function, compared to the placebo group, through the concurrent administration of denosumab and alfacalcidol over a one-year period in postmenopausal women with functional sarcopenia and osteoporosis aged 65 and older. The study is planned as a double-blinded randomized controlled trial, intending to recruit a total of 340 participants. Primary outcome is the improvement in SPPB score of 0.5 or more compared to the control group. conditions: Sarcopenia studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 340 type: ESTIMATED name: alfacalcidol name: placebo name: Denosumab measure: Improvement in SPPB score of 0.5 or more compared to the control group sex: FEMALE minimumAge: 65 Years stdAges: OLDER_ADULT facility: Division of Endocrinology, Department of internal Medicine, Yonsei University College of Medicine, Severance Hospital city: Seoul zip: 03722 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06272214 id: ZJCCRT005 briefTitle: Adjuvant Radiotherapy for Esophageal Squamous Cell Carcinoma in the Era of Immunotherapy overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2027-03-01 date: 2029-03-01 date: 2024-02-22 date: 2024-02-22 name: Zhejiang Cancer Hospital class: OTHER briefSummary: This study is a multicenter, prospective, randomized phase II trial aimed at exploring the value of adjuvant radiotherapy in patients at high risk of recurrence after neoadjuvant chemoradiotherapy for esophageal cancer. The study primarily includes patients with esophageal cancer who underwent neoadjuvant chemoradiotherapy and surgery and did not achieve complete pathological response (non-pCR) postoperatively and were defined as preoperative clinical stage at T3-4N+M0.

Eligible patients will be randomized in a 1:1 ratio into two groups: the observation group and the adjuvant radiotherapy group. The control group consists of patients who receive surgery after neoadjuvant chemotherapy combined with immunotherapy for esophageal cancer, followed by maintenance therapy with PD1/PDL1 inhibitors for up to 1 year or until tumor progression. The adjuvant radiotherapy group receives additional adjuvant radiotherapy on top of the control group's treatment. The specific treatment process involves receiving 2 cycles of neoadjuvant chemotherapy combined with immunotherapy (PD1/PDL1 inhibitors) before potentially curative esophageal cancer surgery. The chemotherapy regimen includes paclitaxel in combination with platinum agents, with a preference for albumin-bound paclitaxel (280mg/m2 on Day 1, or 100mg on Days 1, 8, and 15) in combination with carboplatin (AUC=5). Following surgery, patients start adjuvant radiotherapy 4-6 weeks after the operation, with a radiation dose of 45Gy/25F/5W, completed no later than 8 weeks post-surgery. Two weeks after completing radiotherapy, patients continue with immunotherapy maintenance therapy for up to 1 year or until tumor progression. Subsequently, follow-up visits are scheduled every 3-4 months for the first 3 years, every 6 months for the next 2 years, and annually thereafter. The primary endpoint is 2-year disease-free survival (DFS), and secondary endpoints include overall survival (OS), local recurrence-free survival (LRFS), distant metastasis-free survival (DMFS), recurrence patterns, and safety assessment. Additionally, the study will explore biomarkers predicting treatment efficacy and adverse reactions in subjects, including PD-L1 expression, ctDNA clearance status, infiltrating immune cell types and quantities, cytokine expression, and other tumor biomarkers. This exploration aims to guide stratified precision treatment for patients. conditions: Adjuvant Radiotherapy studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 146 type: ESTIMATED name: Adjuvant radiotherapy name: Observation measure: 2-year DFS measure: OS measure: LRFS measure: DMFS measure: HRQoL measure: Adverse effects recorded during radiotherapy and PD1/PDL1 inhibitors maintaince period measure: Incidence of Recurrence sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhejiang Cancer Hospital city: Hangzhou state: Zhejiang country: China name: YANG YANG, M.D. role: CONTACT phone: +8657188128182 email: yangyang@zjcc.org.cn name: Youhua Jiang role: PRINCIPAL_INVESTIGATOR name: Yongling Ji role: PRINCIPAL_INVESTIGATOR lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06272201 id: 50620 TPR briefTitle: Incisionless Suture Plications in a POSE2.0 Interventional Randomized Obesity Study acronym: INSPIRO overallStatus: NOT_YET_RECRUITING date: 2024-11 date: 2026-08 date: 2026-08 date: 2024-02-22 date: 2024-02-22 name: USGI Medical class: INDUSTRY briefSummary: This is a multi-center, open-label, 2-group randomized pivotal study evaluating a minimally invasive weight loss procedure. The intent is to evaluate the safety and effectiveness of POSE2.0 (sutures placed in the mid + distal body without placement in the fundus), with a moderate intensity diet and exercise program, as compared to diet and exercise alone. The procedure will be performed using the g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors (AKA g-Cath or g-Cath EZ) and associated devices (g-Prox EZ, g-Lix and Transport), known collectively as the Incisionless Operating Platform (IOP). conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 186 type: ESTIMATED name: POSE2.0 procedure with g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors measure: Percentage of total body weight loss (%TBWL) following randomization measure: Responder rate of at least 50% in the POSE2.0 treatment group measure: Safety- Incidence of device and procedure related adverse events through 12 months sex: ALL minimumAge: 22 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06272188 id: 09.2023.1435 briefTitle: Preconception Care for Couples Planning Pregnancy overallStatus: NOT_YET_RECRUITING date: 2024-02-15 date: 2025-07-15 date: 2025-08-15 date: 2024-02-22 date: 2024-02-22 name: Yuzuncu Yıl University class: OTHER name: Marmara University name: Kocaeli University name: Kastamonu University name: Maltepe University name: Izmir Katip Celebi University briefSummary: Preconception care is to optimize health, address modifiable risk factors, and eliminate or reduce health-threatening factors for the woman, fetus, and newborn by working with couples to achieve a healthy pregnancy. Preconception care is the best way to protect against risks in pregnancy and plan risk management. Preconception care offers women and their partners the opportunity to gain healthy lifestyle behaviors, make conscious choices, and gain awareness of factors that threaten health before, during and after pregnancy. However, the rate of receiving preconception care is only 12.3% in our country.

The aim of this project is to examine the effect of online preconception counseling on information and care practices for couples planning pregnancy for healthy starts.

Materials and Methods:

The randomized controlled experimental study will be conducted between February 1, 2024 and February 1, 2026 in the provinces of Istanbul, Izmir, Kastamonu, Ankara and Van. The population of the research will consist of all couples who applied to the marriage offices in the above provinces between February 1, 2024 and February 1, 2026. In the sample calculation, it was calculated that at least 80 couples (experimental group: 40 couples, control group: 40 couples) should be included in the study. Couples that meet the sampling criteria will be assigned to the experimental or control group according to the random numbers table. Online preconception care counseling will be provided to couples in the experimental group 1 month after their wedding date. Preconception care counseling, consisting of 17 titles, was prepared in line with the relevant literature and standardized by the researchers. After the counseling, the couples will be introduced to the preconception care website, which they can use if they need it, and will be given login information.

Data will be obtained before and in the 3rd month after counseling with the Introductory Information Form (TBF), Preconceptional Period Risk Assessment Form, Preconceptional Care Health Literacy Scale and Preconceptional Period Health Behavior Scale. The data will be transferred to the SPSS 22 program and evaluated by the researchers. Chi-square test, t-test, Mann Whitney-U Test, Wilcoxon test and paired simple t test will be used to analyze the data. conditions: Preconception Care, Preconception Risk studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: We do not use a model primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 160 type: ESTIMATED name: web-based online preconceptional counselling measure: Identifying Information Form measure: Preconceptional Period Risk Assessment Form measure: Preconceptional Care Health Literacy Scale measure: Preconceptional Period Health Behavior Scale sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Van Yuzuncu Yil University city: Van country: Turkey lat: 38.49457 lon: 43.38323 hasResults: False

 nctId: NCT06272175 id: 10102023 briefTitle: Immediate Effects of Open and Closed Kinetic Chain Exercises on Upper Extremity in Stroke Patients. overallStatus: RECRUITING date: 2024-03-04 date: 2024-09-30 date: 2024-12-30 date: 2024-02-22 date: 2024-03-07 name: Istinye University class: OTHER briefSummary: Stroke is a sudden disruption of blood flow to the brain, resulting in physical and mental disabilities. It's a global health issue affecting millions each year, often leading to paralysis, altered muscle tone, and loss of motor control and balance. This study aims to examine the immediate effects of open and closed kinetic chain activites on upper extremity spasticity and motor dexterity in hemiplegic patients. This study will be conducted simultaneously at İstinye University Hospital Medical Park Gaziosmanpaşa and İstinye University Physiotherapy and Rehabilitation Application and Research Center (İSÜFİZYOTEM). 50 stroke patients will be included in the study, and all participants will be asked to sign an informed consent form. At the beginning of the session, all participants will be evaluated for their socio-demographic characteristics by a questionnaire created by the researchers, muscle viscoelastic properties by MyotonPRO, upper extremity muscle tone by Modified Ashworth Scale, upper extremity motor dexterity by Box and Block Test, and upper extremity joint range of motion by goniometer and by a phone application named as PhysioMaster. After the assessment, participants will be randomly assigned to two groups: open kinetic chain activity group and closed kinetic chain activity group. After performing the exercises, all evaluations will be conducted again. Thus, the aim is to understand the immediate effects of two different group exercises on the evaluated parameters. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Open Kinetic Chain Activity name: Closed Kinetic Chain Activity measure: MyotonPRO digital palpation device measure: Box and Block Test measure: Modified Ashworth Scale measure: Goniometer measure: PhysioMaster sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istinye University Hospital Medical Park Gaziosmanpasa status: RECRUITING city: Istanbul country: Turkey name: Mehmet Salih Baran, Assist. Prof. role: CONTACT lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06272162 id: NL85622.041.24 id: 15030 type: OTHER_GRANT domain: KWF id: 23U-0725 type: OTHER domain: NedMec briefTitle: Locally Advanced Pancreatic Cancer After Systemic Therapy: Ablative MR-guided Radiotherapy acronym: LAPSTAR overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2030-01 date: 2030-01 date: 2024-02-22 date: 2024-02-22 name: UMC Utrecht class: OTHER name: Amsterdam UMC, location VUmc name: Radboud University Medical Center name: Catharina Ziekenhuis Eindhoven name: Centre for Human Drug Research, Netherlands name: Dutch Pancreatic Cancer Group (DPCG) briefSummary: A randomized controlled trial comparing the effect of local ablative MR-guided radiotherapy (MRgRT) after systemic therapy with current standard treatment alone, on health-related quality of life in patients with locally advanced pancreatic cancer (LAPC). conditions: Locally Advanced Pancreatic Adenocarcinoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: RCT primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: MR guided radiotherapy measure: HRQoL deterioration-free survival measure: Overall survival measure: Patient reported Quality of Life EORTC QLQ-PAN26 measure: Patient reported Quality of Life EORTC QLQ-C30 measure: Patient reported Quality of Life EQ5D-5L measure: The need of subsequent treatments measure: Treatment response assessed on CT-imaging (graded according to RECIST guidelines) measure: CA 19.9 response measure: Trial@home monitoring related outcome: feasibility Withings Steel HR smartwatch measure: Trial@home monitoring related outcome: feasibility Body+ scale measure: Trial@home monitoring related outcome: feasibility Whitings Sleep measure: Trial@home monitoring related outcome: feasibility ePRO application measure: Trial@home monitoring related outcome: digital biomarkers measure: Intervention arm related outcome toxicity measure: Intervention arm related outcome, completion of therapy measure: Intervention arm related outcome diffusion weighted images sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Catharina Hospital city: Eindhoven state: Noord- Brabant zip: 5623 EJ country: Netherlands name: J. C.M. Scheepens, MD role: CONTACT email: j.c.m.scheepens-7@umcutrecht.nl name: H. M.U. Peulen, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 51.44083 lon: 5.47778 facility: Amsterdam University Medical Center, VUmc city: Amsterdam state: Noord-Holland zip: 1081 HV country: Netherlands name: J. C.M. Scheepens, MD role: CONTACT email: j.c.m.scheepens-7@umcutrecht.nl name: A. M.E. Bruynzeel, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 52.37403 lon: 4.88969 facility: Radboud University Medical Center city: Nijmegen zip: 6525 GA country: Netherlands name: J. C.M. Scheepens, MD role: CONTACT email: j.c.m.scheepens-7@umcutrecht.nl name: H. D. Heerkens, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 51.8425 lon: 5.85278 facility: University Medical Center Utrecht city: Utrecht zip: 3584CX country: Netherlands name: J. C.M. Scheepens, MD role: CONTACT email: j.c.m.scheepens-7@umcutrecht.nl name: L. A. Daamen, MD, PhD role: PRINCIPAL_INVESTIGATOR name: M. P.W. Intven, MD, PhD role: SUB_INVESTIGATOR lat: 52.09083 lon: 5.12222 hasResults: False

 nctId: NCT06272149 id: VGN-R08b-001 briefTitle: An Exploratory Clinical Trial of VGN-R08b in Patients With Type II Gaucher Disease overallStatus: RECRUITING date: 2023-03-01 date: 2025-01-15 date: 2029-02-28 date: 2024-02-22 date: 2024-02-22 name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine class: OTHER name: Shanghai Vitalgen BioPharma Co., Ltd. briefSummary: This exploratory trial is to prove the tolerability and safety of VGN-R08b to treat infants with type II Gaucher disease. conditions: Type II Gaucher Disease studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: VGN-R08b measure: Number of Adverse Events (AEs), Serious Adverse Events (SAEs) measure: Long-term safety follow-up measure: Survival ratio at age of 24 months measure: Changes in the activity of glucose cerebroside lipase (GCase) measure: Changes in the activity of glucose cerebroside (GC) levels measure: Changes in the activity of glucose sphingosine (Lyso GL1) levels in peripheral blood and CSF after medication measure: Immunogenicity measure: Changes in the genomic level of VGN-R08b vector in peripheral blood after medication sex: ALL minimumAge: 0 Months maximumAge: 24 Months stdAges: CHILD facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine status: RECRUITING city: Shanghai state: Shanghai zip: 200097 country: China name: Zhang Huiwen, Dr. role: CONTACT phone: 18117165075 email: zhanghuiwen@xinhuamed.com.cn lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06272136 id: SPN-007 briefTitle: Spiden Non-invasive Continuous Glucose Monitor "Clinical Demo" (niCGM) overallStatus: RECRUITING date: 2024-02-23 date: 2024-11-30 date: 2024-12-31 date: 2024-02-22 date: 2024-02-28 name: Spiden AG class: INDUSTRY name: Profil Institut für Stoffwechselforschung GmbH briefSummary: This is a single-centre, multiple sequential-cohort, open study. conditions: Type 1 Diabetes conditions: Type2diabetes studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 40 type: ESTIMATED name: Clinical Demo 2.0 measure: Glucose changes will be measured noninvasively and transcutaneously in dynamic states of glycaemia sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Profil for Stoffwechselforschung GmbH status: RECRUITING city: Neuss state: Nordrhein-Westfallen zip: 41460 country: Germany name: Marc Stoffel, MD role: CONTACT phone: 0049213140180 lat: 51.19807 lon: 6.68504 hasResults: False

 nctId: NCT06272123 id: 20D.776 briefTitle: Endotypic Stability in CRS overallStatus: RECRUITING date: 2024-01-01 date: 2026-01-31 date: 2026-01-31 date: 2024-02-22 date: 2024-02-22 name: Thomas Jefferson University class: OTHER name: GlaxoSmithKline briefSummary: A Case control study with 150 cases and 50 controls will be conducted. Immunologic (cytokines measurements in nasal secretions and sinonasal tissues), histopathologic (tissue eosinophilia) and clinical parameters (Lund-Mackay and Lund-Kennedy score, lung function tests), surveys (SNOT- 22, SF-36 quality of life survey) will be compared between different groups of patients conditions: Chronic Sinusitis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 200 type: ESTIMATED name: no intervention measure: Endotypic markers measure: SF-36 measure: SNOT-22 sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Thomas Jefferson University Department of Otolaryngology status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19107 country: United States name: Elizabeth Kangas, RN, BSN role: CONTACT phone: 215-955-6784 email: elizabeth.kangas@jefferson.edu lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06272110 id: 22-01303 briefTitle: Promoting Equitable Access to Language Services in Health and Human Services overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-07 date: 2025-08 date: 2024-02-22 date: 2024-02-22 name: NYU Langone Health class: OTHER name: Department of Health and Human Services briefSummary: This is a community-based study that will engage community and health care stakeholders to develop, implement, and evaluate a Health Literacy (HL)-informed, culturally- and linguistically- sensitive approach to improving language access services for patients with limited English proficiency (LEP) to promote health equity and reduce disparities in preventive health services use and health outcomes in New York City (NYC). This study will have a total of 4 phases that include a preparatory work phase (Non-Human Subjects Research), a pre-implementation phase, an implementation phase, and a post-implementation phase.

Findings from the preparatory work and pre-implementation phase and discussions with key partners will inform the co-design of intervention strategies and endpoints for the later phases (implementation and post-implementation phase). conditions: Appropriate Use of Language Across Services studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 17500 type: ESTIMATED name: System level Language Access (LA) intervention measure: Percentage of appropriate interpreter use measure: Percentage of appropriate interpreter use measure: Percentage of patients up to date with preventive screenings and vaccinations measure: Percentage of patients up to date with preventive screenings and vaccinations measure: Percentage of patients with knowledge of federal rights related to LA services measure: Percentage of patients with knowledge of federal rights related to LA services measure: Percentage using untrained interpreters measure: Percentage using untrained interpreters measure: Percentage using recommended HL-informed verbal counseling practices (e.g., teach-back) measure: Percentage using recommended HL-informed verbal counseling practices (e.g., teach-back) measure: Percentage of patients with satisfaction with LA services preventive health services utilization measure: Percentage of patients with satisfaction with LA services preventive health services utilization sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Health + Hospitals Diagnostic/Treatment Centers city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 facility: NYC Health + Hospitals/Bellevue city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 facility: NYC Health + Hospitals/Woodhull city: New York state: New York zip: 11206 country: United States lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06272097 id: 201328 briefTitle: Postoperative Difficult-to-Heal Wounds of Clinical Trial Registration overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-10-01 date: 2024-11-15 date: 2024-02-22 date: 2024-02-22 name: Danni Feng class: OTHER briefSummary: This study aims to investigate the effectiveness of an optimized care management protocol for refractory postoperative wounds based on the TIME CDST tool. Through a randomized controlled trial approach, the investigators will conduct a rigorous comparative analysis of the experimental group and the control group. The intervention group will receive an intervention plan based on the TIME CDST tool led by wound specialist nurses at each dressing change, while the control group receive a routine wound care program of wound cleaning and dressing changes at each dressing change. The main research objective is to evaluate the superiority of the experimental group compared with the control group in terms of wound healing time, healing quality, and patient satisfaction. Through the implementation of this study, the investigators expect to provide an effective optimization scheme for the management of refractory postoperative wounds in clinical practice, thereby improving patient outcomes and quality of life. conditions: Wound Heal studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 144 type: ESTIMATED name: Intervention program based on TIME-CDST tool led by wound specialist nurses name: A routine wound care program measure: Wound healing time measure: The wound healing rate measure: The rate of wound area reduction measure: The Pressure Ulcer Scale for Healing (PUSH) measure: The positive rate of bacterial culture measure: The pain intensity measure: Patient comfort score measure: Patient satisfaction score measure: The levels of albumin measure: The number of dressing changes measure: Medical costs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06272084 id: CRRT-TPE-01-DE briefTitle: Analysis of TPE Treatments With multiFiltratePRO acronym: TPEopt overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-09 date: 2024-12 date: 2024-02-22 date: 2024-04-19 name: Fresenius Medical Care Deutschland GmbH class: INDUSTRY name: X-act Cologne Clinical Research GmbH briefSummary: Analysis of therapeutic plasma exchange (TPE) treatments to assess the performance of the TPE mode of multiFiltratePRO based on the successful exchange of plasma from whole blood. The multiFiltratePRO is a device for extracorporeal blood purification treatments. conditions: Autoimmune Diseases studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 60 type: ESTIMATED name: Therapeutic Plasma Exchange (TPE) option of multiFiltratePRO measure: Total amount of exchange plasma (prescribed vs achieved exchange volume) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Klinikum Aschaffenburg-Alzenau city: Aschaffenburg state: Bavaria zip: 63739 country: Germany name: Stefan Büttner, Dr. med. role: CONTACT email: Stefan.buettner@klinikum-ab-alz.de lat: 49.97704 lon: 9.15214 hasResults: False

 nctId: NCT06272071 id: 2023YFC2308802-01 briefTitle: A Multicenter Prospective Clinical Cohort Study on the Pathogen Spectrum of Severe Hepatitis (Liver Failure) Complicated With Infection overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-11 date: 2026-11 date: 2024-02-22 date: 2024-03-04 name: Zhejiang University class: OTHER name: Beijing Ditan Hospital name: Beijing YouAn Hospital name: Huashan Hospital name: Qilu Hospital of Shandong University briefSummary: The goal of this observational study is to expound the population and characteristics of pathogenic microorganisms with co-infection, draw the pedigree of pathogenic microorganisms, and evaluate its influence on disease outcome in patients with severe hepatitis (liver failure). The main questions it aims to answer are:

* Mapping of infectious agents in patients with severe hepatitis (liver failure)
* Constructing early warning predictive models to explore how to give an individualized regimen of integrated immune function. conditions: Liver Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED measure: Occurrence of secondary infections in patients with severe viral hepatitis (liver failure) at 4 weeks, including site of infection and pathogen of infection. measure: quick SEPSIS RELATED ORGAN FAILURE ASSESSMENT(qSOFA) at 4 weeks measure: Occurrence of secondary infections in patients with severe viral hepatitis (liver failure) at 8 weeks, including site of infection and pathogen of infection. measure: Occurrence of secondary infections in patients with severe viral hepatitis (liver failure) at 12 weeks, including site of infection and pathogen of infection. measure: qSOFA score at 8 weeks measure: qSOFA score at 12 weeks sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06272058 id: 1366-0034 briefTitle: A Study to Test How Avenciguat (BI 685509) is Taken up in the Body of People With and Without Liver Problems overallStatus: RECRUITING date: 2024-03-20 date: 2024-10-01 date: 2024-10-01 date: 2024-02-22 date: 2024-03-25 name: Boehringer Ingelheim class: INDUSTRY briefSummary: This study is open to people with and without severe liver problems. People can join the study if they are 18 to 80 years of age and have a body mass index (BMI) between 18.5 and 42 kg/m2.

Avenciguat (BI 685509) is a medicine that is being developed to treat high blood pressure in the portal vein (main vessel going to the liver). The purpose of this study is to find out whether having liver problems influences how Avenciguat (BI 685509) is taken up in the body. All participants take Avenciguat (BI 685509) once as a tablet.

Participants are in the study for slightly longer than 1 month. Following the screening period of about 4 weeks, they stay at the study site for 4 nights. Afterwards, there are 2 visits to the study site. The site staff measures the amount of Avenciguat (BI 685509) in the blood. The doctors also regularly check participants' health and take note of any unwanted effects. conditions: Healthy conditions: Liver Diseases studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 16 type: ESTIMATED name: Avenciguat (BI 685509) measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) measure: Maximum measured concentration of the analyte in plasma (Cmax) measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) measure: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Orlando Clinical Research Center status: RECRUITING city: Orlando state: Florida zip: 32809 country: United States name: Boehringer Ingelheim role: CONTACT phone: 833-602-2368 email: unitedstates@bitrialsupport.com lat: 28.53834 lon: -81.37924 hasResults: False

 nctId: NCT06272045 id: IRB00398712 id: 5U24HL163114-02 type: NIH link: https://reporter.nih.gov/quickSearch/5U24HL163114-02 briefTitle: Early Intervention to Promote Cardiovascular Health of Mothers and Children acronym: ENRICH overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-09 date: 2028-07 date: 2024-02-22 date: 2024-03-12 name: JHSPH Center for Clinical Trials class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) is a cluster randomized clinical trial, funded by the National Heart Lung \& Blood Institute. The study is designed to test the effectiveness of home visiting intervention to promote cardiovascular health and reduce disparities in maternal and early childhood cardiovascular health. Sites, in partnership with evidence-based home visiting programs, are recruiting 6400 participants in total (i.e., 3200 parent-dyads which includes 3200 parents and 3200 children) from diverse community settings with a high burden of cardiovascular disease risk factors. conditions: Cardiovascular Health studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: cluster randomized at the home visiting supervisor level, stratified within home visiting agencies whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 6400 type: ESTIMATED name: Enriched home visiting name: Routine home visiting measure: Parent physical activity measure: Parent diet measured by Mediterranean Eating Pattern for Americans (MEPA) scale measure: Parent body mass index measure: Parent blood pressure measure: Child body mass index sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: California Polytechnic Institute city: San Luis Obispo state: California zip: 93407 country: United States name: Noemi Alarcon role: CONTACT phone: 805-756-5694 email: noalarco@calpoly.edu name: Suzanne Phelan role: PRINCIPAL_INVESTIGATOR lat: 35.28275 lon: -120.65962 facility: Colorado University city: Aurora state: Colorado zip: 80045-7464 country: United States name: Katharine Gamalski role: CONTACT phone: 720-499-4501 email: katharine.gamalski@cuanschutz.edu name: Mandy Allison role: PRINCIPAL_INVESTIGATOR lat: 39.72943 lon: -104.83192 facility: Northwestern University city: Chicago state: Illinois zip: 60208 country: United States name: Danielle Lorch role: CONTACT phone: 630-222-2194 email: dmlorch@northwestern.edu name: Darius Tandon role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 facility: Washington University city: Saint Louis state: Missouri zip: 63130 country: United States name: Cindy Schwartz role: CONTACT phone: 314-346-7101 email: cschwarz@wustl.edu name: Debra Haire-Joshu role: PRINCIPAL_INVESTIGATOR lat: 38.62727 lon: -90.19789 facility: Wake Forest University city: Winston-Salem state: North Carolina zip: 27109 country: United States lat: 36.09986 lon: -80.24422 facility: University of Pittsburgh city: Pittsburgh state: Pennsylvania zip: 15260 country: United States lat: 40.44062 lon: -79.99589 facility: Pennsylvania State University city: State College state: Pennsylvania zip: 16801 country: United States lat: 40.79339 lon: -77.86 facility: Lifespan city: Providence state: Rhode Island zip: 02903 country: United States name: Angelica McHugh role: CONTACT phone: 401-793-8978 email: amchugh1@lifespan.org name: Rena Wing role: PRINCIPAL_INVESTIGATOR lat: 41.82399 lon: -71.41283 hasResults: False

 nctId: NCT06272032 id: 2023KFKT001 briefTitle: Prospective Multicenter Observational Study and Promotion of the Application of Focused Ultrasound in Allergic Rhinitis overallStatus: RECRUITING date: 2023-08-01 date: 2025-07-31 date: 2025-07-31 date: 2024-02-22 date: 2024-02-22 name: Chongqing Medical University class: OTHER briefSummary: Allergic rhinitis (AR) is a common condition, with nearly 300 million affected individuals in China, significantly impacting the quality of life. Despite standardized drug treatments, approximately 20% of AR patients experience inadequate control and require surgical intervention. AR manifests as nasal itching, sneezing, clear nasal discharge, nasal congestion, primarily associated with inflammation-induced hypertrophy of nasal turbinates and a heightened neurogenic state of the nasal mucosa. Surgical treatment focuses on "reducing hypertrophy" of nasal turbinates and "desensitizing" neurogenic hyperreactivity.High-intensity focused ultrasound (HIFU), as a minimally invasive therapeutic modality in AR, is still in its early stages of application and requires further multicenter clinical studies and widespread adoption. This project collaborates with six established institutions proficient in ultrasound treatment for AR. It aims to conduct a prospective multicenter observational study and subsequent dissemination, emphasizing the application of "reduction of hypertrophy" and "desensitization" in AR.Through standardized case selection, subjective and objective measures such as subjective symptom scores, quality of life assessments, nasal reflex, and nasal resistance tests before and after treatment will be employed to evaluate the effectiveness and safety of HIFU in "reducing hypertrophy" and "desensitizing" aspects of AR. Simultaneously, building on our established Otolaryngology Head and Neck Surgery Alliance and Southwest Allergy Alliance, the research results will be promoted through lectures, hands-on guidance, training sessions, academic conferences, and other means to facilitate the application of HIFU in AR and benefit a larger population of AR patients. conditions: Allergic Rhinitis studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 240 type: ESTIMATED name: High-intensity focused ultrasound (HIFU) name: intranasal corticosteroids, oral antihistamines, oral leukotriene receptor antagonists, and intranasal antihistamines measure: Nasal Symptom Score measure: daily medication score sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chongqing Medical University status: RECRUITING city: Chongqing state: Chongqing country: China name: Shen Yang, Doctoral role: CONTACT phone: 15111953398 email: sy_smile@sina.cn lat: 29.56278 lon: 106.55278 hasResults: False

 nctId: NCT06272019 id: HREC-DCU 2023-074 briefTitle: Alternative Application Methods of Pre-procedural Povidone Iodine Mouthrinse overallStatus: COMPLETED date: 2023-09-01 date: 2024-04-20 date: 2024-04-20 date: 2024-02-22 date: 2024-04-23 name: Chulalongkorn University class: OTHER briefSummary: To compare the iodine remaining in saliva between gargle method and swab method conditions: The Retention of Iodine in Saliva Over the Time conditions: The Comparison of Iodine in Saliva Between Gargle and Swab studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: the participant will use iodine gargle in 2 method primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 25 type: ACTUAL name: Iodine gargle measure: The rate of retention of iodine in saliva measure: The comparison of the retention of iodine between gargle and swab sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Faculty of Dentistry, Chulalongkorn University city: Bangkok country: Thailand lat: 13.75398 lon: 100.50144 hasResults: False

 nctId: NCT06272006 id: Anatomical recession briefTitle: The Comparison of Different Root Coverage Techniques Using the Anatomical Recession Area Approach overallStatus: NOT_YET_RECRUITING date: 2024-02-24 date: 2025-03-04 date: 2025-04-05 date: 2024-02-22 date: 2024-02-22 name: Hacettepe University class: OTHER briefSummary: The goal of this clinical trial is to compare the effectiveness of two treatments for gingival recession. The main questions it aims to answer are:

Which treatment method, Coronally Positioned Flap with Connective Tissue Graft or Modified Coronally Advanced Tunnel with connective tissue graft, is more effective in treating gum recession? How does the Anatomical Recession Rate, a new measurement technique, help in evaluating the success of these treatments?

The patients will be treated with coronally advanced flap or modified coronally advanced tunnel + connective tissue graft to see which method is more effective in reducing gum recession, as measured by using anatomical recession rate. conditions: Gingival Recession studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This randomized controlled trial compares two gingival recession treatments: Coronally Advanced Flap (CAF) with Connective Tissue Graft (CTG) versus Modified Coronally Advanced Tunnel (MCAT) with CTG. Participants are randomized 1:1 to either intervention. Outcomes assessors are blinded to allocation, ensuring unbiased evaluation of the primary outcome, Anatomical Recession Rate (ARR), and secondary clinical outcomes over a 12-month follow-up. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: This study implements single-blind masking where outcomes assessors are unaware of participants' group assignments to minimize bias. While blinding participants and care providers is not feasible due to the nature of surgical interventions, strict protocols ensure assessors remain blinded to treatment allocation throughout the study, enhancing outcome evaluation objectivity. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Coronally Positioned Flap with Connective Tissue Graft name: Modified Coronally Advanced Tunnel with Connective Tissue Graft measure: Anatomical Recession Rate (ARR) measure: Clinical Attachment Level (CAL) measure: Gingival Thickness (GT) measure: Keratinized Tissue Thickness (KTT) measure: Wound healing index (WHI) measure: Tissue appearance measure: Aesthetic evaluation measure: Dentin hypersensitivity sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Hacettepe University city: Ankara zip: 06100 country: Turkey name: Abdullah Akman, PHD role: CONTACT phone: +905327609139 email: dtacakman@yahoo.com lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06271993 id: 23-233 briefTitle: SPT for Sensitization of Collagen Dressing overallStatus: RECRUITING date: 2024-02-08 date: 2024-02-16 date: 2024-03-15 date: 2024-02-22 date: 2024-02-23 name: Covalon Technologies Inc. class: INDUSTRY name: ALS Beauty and Personal Care briefSummary: The goal of this clinical trial is to determine the sensitization (contact allergy) potential of the test product ColActive Plus Collagen Matrix Dressing after a skin prick test on the skin of healthy human subjects. The main question it aims to answer is:

• Does the product induce any sensitization (contact allergy) after a skin prick using a UniTest PC (pain control) device in healthy human subjects? Participants will have the test product and both positive and negative controls applied, and skin response will be evaluated by an allergist at 15 minutes, 6 hours, and 24-48 hours post-application to see if sensitization occurs. conditions: Allergy Skin conditions: Allergic Skin Reaction studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This will be a single center, with no randomization or blinding, study design in 20 healthy adult subjects, age 18-70 years. Based on prior experience approximately 30 subjects will be enrolled to ensure 20 subjects complete the study. primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: ColActivePlus Collagen Matrix Dressing measure: Wheal measurement measure: Wheal measurement measure: Wheal measurement sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ALS Beauty and Personal Care status: RECRUITING city: Torrance state: California zip: 90501 country: United States name: Ashley Glavis, BS role: CONTACT phone: 424-307-5900 email: ashley.glavis@alsglobal.com name: Jordan DeSantis, MHI, BS role: PRINCIPAL_INVESTIGATOR lat: 33.83585 lon: -118.34063 hasResults: False

 nctId: NCT06271980 id: 23228/ENCORE briefTitle: Early-Onset Colorectal Cancer Recurrence acronym: ENCORE overallStatus: COMPLETED date: 2023-04-15 date: 2024-02-01 date: 2024-02-01 date: 2024-02-22 date: 2024-03-12 name: City of Hope Medical Center class: OTHER name: IRCCS San Raffaele Hospital, Milan, Italy name: Institute of Biomedical Research of Salamanca, Salamanca, Spain briefSummary: Survivors of early-onset colorectal cancer (diagnosed before age 50) may experience colorectal cancer recurrence several years after curative-intent treatments, but clinical guidelines provide unclear guidance on endoscopic surveillance.

This study aims to predict recurrence-free survival and overall survival, in survivors of early-onset colorectal cancer, using a tumor-based molecular assay based on microRNA (ribonucleic acid) conditions: Colorectal Cancer Recurrent conditions: Colorectal Cancer conditions: Colorectal Neoplasms conditions: Colorectal Adenocarcinoma conditions: Colorectal Cancer Stage I conditions: Colorectal Cancer Stage II conditions: Colorectal Cancer Stage III studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 177 type: ACTUAL name: ENCORE measure: Recurrence Free Survival measure: Overall Survival sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: City of Hope Medical Center city: Duarte state: California zip: 91010 country: United States lat: 34.13945 lon: -117.97729 hasResults: False

 nctId: NCT06271967 id: ABT-CIP-10518 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-02-22 date: 2024-02-22 name: [Redacted] hasResults: False

 nctId: NCT06271954 id: 202300096A3 briefTitle: The Relationship Between Emotion Regulation and Psychiatric Disorder in Youth overallStatus: RECRUITING date: 2023-03-27 date: 2025-03-26 date: 2025-03-26 date: 2024-02-22 date: 2024-03-26 name: Chang Gung Memorial Hospital class: OTHER name: National Taiwan University Hospital briefSummary: According to the increasing worldwide prevalence rate of psychiatric disorders in youth, the mental health of youth is becoming more and more important.

Taiwan's Ministry of Health and Welfare reported the clibing suicide rate of youth in past five years and showed the prevention work and related intervention for youth's mental health was noteable. The definition of emotion regulation was "consists of the extrinsic and intrinsic processes responsible for monitoring, evaluating, and modifying emotional reactions, especially their intensive and temporal features, to accomplish one's goals." Emotion regulation strategies including "rumination", "avoidance", "suppression", "Problem-solving", "reappraisal", "acceptance", "social support", and "distraction".

Previous studies had examined the relationship between emotion regulation and mental health in youth; maladaptive emotion regulation would increase the individual's depressive and anxiety symptoms. Carstensen proposed social emotion theory in 1995 Selectivity theory (SST) refers to the need for emotion regulation, which activates Social participation in late adulthood. SST assumes that young people are more interested in social interaction behaviors related to information seeking and building self-concept. characteristics of youth affected by many normative challenges such as adolescence, school transitions, and more complex social Landscape; Adaptive emotion regulation will reduce risk of clinical emotion attacks of illness, especially depression and anxiety.To explore the relationship between emotion regulation and mental health from a psychosocial developmental aspect, we focused on the interaction between individual and environment. Compared with the previous generation, most youths of this generation were participating in social activities and building up interpersonal relationships through the internet, suggesting the internet was an important social context. conditions: Major Depressive Disorder conditions: Anxiety Disorder conditions: Attention Deficit Hyperactivity Disorder (ADHD) conditions: Adjustment Disorder studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 200 type: ESTIMATED measure: The Difference and Similarity in Emotional Regulation Strategy Patterns between Western and Eastern Countries. sex: ALL minimumAge: 15 Years maximumAge: 24 Years stdAges: CHILD stdAges: ADULT facility: Chang-Geng Medical Foundation Chang-Geng Memorial Hospital status: RECRUITING city: Keelung zip: 204 country: Taiwan name: Tzuyu Liu role: CONTACT phone: (02)24329292 phoneExt: 2720 email: tzuyu35@cgmh.org.tw lat: 25.12825 lon: 121.7419 hasResults: False

 nctId: NCT06271941 id: HAPC-RCT briefTitle: Prophylactic Double Thermal Ablation and Complete Closure After Endoscopic Mucosal Resection of Large Non-Pedunculated Colorectal Polyps: A Randomized Controlled Trial overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-10-01 date: 2028-04-01 date: 2024-02-22 date: 2024-02-22 name: Centre hospitalier de l'Université de Montréal (CHUM) class: OTHER briefSummary: Large (≥20mm) colorectal polyps often harbor areas of advanced neoplasia, making them immediate colorectal cancer (CRC) precursors. Such polyps have to be completely removed to prevent CRC and to avoid surgery and/or adjuvant therapy. The laterally spreading lesions (LSLs) are removed via endoscopic mucosal resection (EMR). However, recurrence is common. Recent studies have found that the use of hybrid argon plasma coagulation (h-APC) for the ablation of the margin and base of resection post-EMR could significantly reduce the recurrence rate, and complete closure of the post-EMR defect can prevent other adverse pre- and post-procedure outcomes such as bleeding.

We hypothesize that performing hybrid argon plasma coagulation (h-APC) margin and base ablation post-EMR for large (≥20mm) colorectal LSLs will demonstrate a lower recurrence rate compared to Snare Tip Soft Coagulation (STSC) margin ablation. We also hypothesize that performing complete closure of the EMR defect will result in lower rates of adverse events compared to cases where no defect closure is performed. conditions: Colorectal Cancer conditions: Polyp of Colon studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 892 type: ESTIMATED name: Hybrid Argon Plasma Coagulation (h-APC) name: Snare tip soft coagulation (STSC) measure: To compare the recurrence rates after EMR colorectal between the h-APC and SSTC methods measure: To assess the potential advantages associated with a complete defect closure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier de l'Université de Montréal city: Montréal state: Quebec country: Canada lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06271928 id: TJ-IRB20220634-yijingkeli briefTitle: A Multicenter Clinical Study of Yijing Keli in the Treatment of Ovarian Aging overallStatus: RECRUITING date: 2021-10-01 date: 2024-01-01 date: 2025-01-01 date: 2024-02-22 date: 2024-02-22 name: Tongji Hospital class: OTHER briefSummary: Ovarian aging (OA) seriously affects the physical and mental health of women. Nowadays, Chinese herbs have huge appeal and potential in treating OA. We have created a new Chinese herbal combination Yijing Keli, whereas its safety and efficacy still need to be validated. Hence, we will perform a population-based, multicenter study to confirm the safety and efficacy of Yijing Keli in therapy of OA. We aim to provide a solid evidence for TCM in therapy of OA. conditions: Ovarian Aging studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Yijing Keli measure: the recovery rate of ovarian function sex: FEMALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology status: RECRUITING city: Wuhan country: China name: jinjin zhang, professor role: CONTACT phone: +8683663078 email: jinjinzhang@tjh.tjmu.edu.cn name: yan zhang, MD role: CONTACT phone: +8683663078 lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06271915 id: cervical spine mobilization briefTitle: Role of Cervical Spine Mobilization on Lateral Epicondylitis overallStatus: RECRUITING date: 2024-02-15 date: 2024-05-15 date: 2024-06-15 date: 2024-02-22 date: 2024-03-05 name: Cairo University class: OTHER briefSummary: The study's primary goal is to examine the effectiveness of Mulligan's technique in reducing hyperalgesia in lateral epicondylitis, focusing on cervical spine, while also investigating its influence on central sensitization in relation to lateral epicondylitis. conditions: Lateral Epicondylitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: SNAGs - eccentric exercise measure: Leeds assessment of neuropathic symptoms and sign (LANSS) scale measure: Pain-free hand grip test measure: The Numeric Rating Scale (NRS) sex: ALL minimumAge: 30 Years maximumAge: 50 Years stdAges: ADULT facility: Outpatient physical therapy, Faculty of physical therapy status: RECRUITING city: Giza zip: 2334 country: Egypt name: Ahmed ElMelhat role: CONTACT phone: 01112595022 email: ahmed.elmelhat@cu.edu.eg lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06271902 id: IRB-2023-531 briefTitle: Effects of the Singapore Youth Shoulder Overuse Injury Prevention Program Among Youth Volleyball Athletes in Singapore overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-02-22 date: 2024-02-22 name: Nanyang Technological University class: OTHER briefSummary: The Singapore Youth Shoulder Overuse Injury Prevention Program (YoSO-IPP) includes an exercise segment and an education segment. This study will (1) assess the effects of the exercise segment, and (2) assess the effects of the education segment among youth volleyball athletes using a randomized controlled trial over 12 weeks. Performance outcome measures of shoulder eccentric external rotation strength, shoulder internal rotation range of motion, and thoracic rotation range of motion will be used to assess the effects of the exercise segment. Knowledge scores via an online questionnaire will be used to assess the effects of the education segment.

Hypothesis: The YoSO-IPP will have an effect on shoulder eccentric external rotation strength, shoulder internal rotation range of motion, and thoracic rotation range of motion and on knowledge scores. conditions: Sport Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a randomized controlled trial with an intervention group and a control group to evaluate the effects of the YoSO-IPP. The intervention group will perform the exercises and attend the online educational workshop. The control group will only perform lower body stretching exercises which is considered as a sham program. primaryPurpose: PREVENTION masking: NONE count: 50 type: ESTIMATED name: Singapore Youth Shoulder Overuse Injury Prevention Program name: Lower body stretching program measure: Shoulder external rotation strength measure: Internal rotation range of motion measure: Thoracic rotation range of motion measure: Knowledge of overuse injuries measure: Shoulder overuse injury prevalence measure: Elbow overuse injury prevalence measure: Shoulder overuse injury severity measure: Elbow overuse injury severity sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Nanyang Technological University city: Singapore country: Singapore lat: 1.28967 lon: 103.85007 hasResults: False

 nctId: NCT06271889 id: B.10.1.TKH.4.34.H.GP.0.01/330 briefTitle: The Effect of Electro-fetal monıtorısıon Sound on Anxiety, paın and Postpartum Bonding at the First Phase of Delivery overallStatus: RECRUITING date: 2021-11-24 date: 2024-02-24 date: 2024-11-20 date: 2024-02-22 date: 2024-02-22 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: University of Health Sciences, Istanbul Umraniye training and Research Hospital, Clinic of Obstetrics and gynecology, birth, maternity and Child Health Hospital, Aydın to the clinic, pregnant women, pregnant women in active labor act, and received acceptance to delivery to the fetal heart sound by existing tripped; fetal heart sounds of pregnant women, anxiety, pain and the birth in order to determine the effect of connecting the end of the level will be conducted. The study will guide midwives in reducing the anxiety or pain of pregnant women. conditions: Delivery Fear conditions: Labor Pain conditions: Maternal-Fetal Relations studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized parallel controlled experimental design primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Which of the participants is the control or intervention group will be selected by randomization. whoMasked: PARTICIPANT count: 128 type: ESTIMATED name: Non-stress test measure: VİSUAL ANALOG SCALE measure: STATUS AND CONTINUOUS ANXIETY SCALE measure: Postpartum Attachment Scale (PASAS): sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Saglık Bilimleri Universitesi status: RECRUITING city: Istanbul country: Turkey name: YASEMİN AYDIN KARTAL role: CONTACT phone: +90 5432870029 email: yasemin.aydin@sbu.edu.tr lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06271876 id: 0011 briefTitle: Influence of an Inspiratory Muscle Fatigue Protocol on Healthy Youngs on Respiratory Muscle Strength, Vertical Jump Performance and Muscle Oxygen Saturation overallStatus: NOT_YET_RECRUITING date: 2024-03-03 date: 2024-03-09 date: 2024-03-19 date: 2024-02-22 date: 2024-02-22 name: Sierra Varona SL class: OTHER name: Universidad Europea de Madrid 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 inspiratory muscle fatigue and muscular strength in lower limbs, in both healthy and pathological subjects, as well as the association between such fatigue and other variables, including maximal inspiratory pressure and muscle tissue oxygen levels.

According to our hypothesis, the execution of a protocol inducing inspiratory muscle fatigue in healthy youngs could influence muscular strength, exercise capacity and muscle tissue oxygenation.

In this study, subjects will be divided into three groups: experimental group , activation group and control group.

Measurements of variables, such as maximal inspiratory pressure, peripheral muscle tissue oxygen levels, diaphragmatic strength (ultrasound image) and vertical jump performance, will be conducted. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT 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 count: 18 type: ESTIMATED name: Inspiratory muscle training measure: Respiratory muscle strength measure: Diaphragmatic thickness and thickening fraction measure: Diaphragm movement curve measure: Vertical jump performance sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06271863 id: Soh-Med-23-11-08MS briefTitle: Outcome of Conservative Management in Cases of Pre Mature Rupture of Membranes (PROM) Between 20 and 28 Weeks of Pregnancy in Sohag City Hospitals overallStatus: ENROLLING_BY_INVITATION date: 2023-06-01 date: 2024-06-01 date: 2024-07-01 date: 2024-02-22 date: 2024-02-22 name: Sohag University class: OTHER briefSummary: Prospective observational study conditions: PROM, Preterm (Pregnancy) studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Conservation vs termination in cases of PROM 20 to 28 weeks of pregnancy sex: FEMALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Sohag university hospital city: Sohag country: Egypt lat: 26.55695 lon: 31.69478 hasResults: False

 nctId: NCT06271850 id: P.T.REC/012/004949 briefTitle: Effect of Pilates Exercises on Forward Head Posture in Breastfeeding Women overallStatus: NOT_YET_RECRUITING date: 2024-02-20 date: 2024-06-20 date: 2024-07-20 date: 2024-02-22 date: 2024-02-23 name: Cairo University class: OTHER briefSummary: Musculoskeletal postural issues stemming from infant care positions can exert a significant impact on the cervical, thoracic, and lumbar spine. These positions can induce mechanical alterations in the spine's natural curvature, potentially resulting in long-term deformities in postnatal women such as forward head posture (FHP), ultimately contributing to physical disability over the long term.so, The purpose of this study is to determine the effect of Pilates exercises on FHP in breastfeeding women. conditions: Breastfeeding studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Ergonomics breastfeeding training name: Pilates exercises measure: Measurement of craniovertebral angle (CVA) measure: Assessment of neck pain intensity measure: Measurement of cervical range of motion measure: Evaluation of disability due to neck pain measure: Assessment of neck muscle fatigue measure: Assessment of breastfeeding self-efficacy measure: Measurement of weight and height of baby measure: Assessment of Health-Related Quality of Life sex: FEMALE minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT hasResults: False

 nctId: NCT06271837 id: D781AC00001 briefTitle: A Study of T-DXd in Patients With Selected HER2-overexpressing Tumors overallStatus: RECRUITING date: 2024-02-18 date: 2025-10-30 date: 2026-04-17 date: 2024-02-22 date: 2024-04-23 name: AstraZeneca class: INDUSTRY name: Daiichi Sankyo Co., Ltd. briefSummary: This is an open-label, multicenter, Phase II study to evaluate the efficacy and safety of trastuzumab deruxtecan for the treatment in locally advanced, unresectable, or metastatic patients with selected HER2 overexpressingsolid tumors which are not eligible for curative therapy. conditions: Advanced Solid Tumors (Excluding Gastric Cancer and Breast Cancer) studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE maskingDescription: This study is Open-Label Study. count: 50 type: ESTIMATED name: Trastuzumab deruxtecan measure: Confirmed Objective Response Rate (ORR) by Independent Central Review (ICR) measure: Confirmed Objective Response Rate (ORR) by investigator assessment measure: Duration of Response (DoR) by Independent Central Review (ICR) measure: Duration of Response (DoR) by investigator assessment measure: Disease control rate (DCR) by Independent Central Review (ICR) measure: Disease control rate (DCR) by investigator assessment measure: Confirmed best objective response (BOR) by Independent Central Review (ICR) measure: Confirmed best objective response (BOR) by investigator assessment measure: Progression-free survival (PFS) by Independent Central Review (ICR) measure: Progression-free survival (PFS) by investigator assessment measure: Overall survival (OS) measure: Occurrence of adverse events (AEs) and serious adverse events (SAEs) measure: Pharmacokinetics (PK) of T-DXd measure: Immunogenicity of T-DXd sex: ALL minimumAge: 18 Years maximumAge: 130 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site status: NOT_YET_RECRUITING city: Beijing zip: 100142 country: China lat: 39.9075 lon: 116.39723 facility: Research Site status: NOT_YET_RECRUITING city: Changchun zip: 130021 country: China lat: 43.88 lon: 125.32278 facility: Research Site status: NOT_YET_RECRUITING city: Changsha zip: 410013 country: China lat: 28.19874 lon: 112.97087 facility: Research Site status: NOT_YET_RECRUITING city: Changzhou zip: 213004 country: China lat: 31.77359 lon: 119.95401 facility: Research Site status: NOT_YET_RECRUITING city: Chengdu zip: 610041 country: China lat: 30.66667 lon: 104.06667 facility: Research Site status: NOT_YET_RECRUITING city: Chongqing zip: 400030 country: China lat: 29.56278 lon: 106.55278 facility: Research Site status: NOT_YET_RECRUITING city: Dongyang zip: 322100 country: China lat: 29.26778 lon: 120.22528 facility: Research Site status: NOT_YET_RECRUITING city: Guangzhou zip: 510145 country: China lat: 23.11667 lon: 113.25 facility: Research Site status: NOT_YET_RECRUITING city: Guangzhou zip: 510630 country: China lat: 23.11667 lon: 113.25 facility: Research Site status: WITHDRAWN city: Haikou zip: 570311 country: China lat: 20.04583 lon: 110.34167 facility: Research Site status: NOT_YET_RECRUITING city: Hangzhou zip: 310022 country: China lat: 30.29365 lon: 120.16142 facility: Research Site status: RECRUITING city: Harbin zip: 150081 country: China lat: 45.75 lon: 126.65 facility: Research Site status: NOT_YET_RECRUITING city: Hefei zip: 230031 country: China lat: 31.86389 lon: 117.28083 facility: Research Site status: NOT_YET_RECRUITING city: Kunming zip: 650118 country: China lat: 25.03889 lon: 102.71833 facility: Research Site status: NOT_YET_RECRUITING city: Lishui zip: 323000 country: China lat: 28.46042 lon: 119.91029 facility: Research Site status: NOT_YET_RECRUITING city: Nanchang zip: 330029 country: China lat: 28.68396 lon: 115.85306 facility: Research Site status: NOT_YET_RECRUITING city: Shanghai zip: 200011 country: China lat: 31.22222 lon: 121.45806 facility: Research Site status: NOT_YET_RECRUITING city: Shanghai zip: 200032 country: China lat: 31.22222 lon: 121.45806 facility: Research Site status: NOT_YET_RECRUITING city: Shenyang zip: 110016 country: China lat: 41.79222 lon: 123.43278 facility: Research Site status: NOT_YET_RECRUITING city: Xuzhou zip: 221009 country: China lat: 34.18045 lon: 117.15707 facility: Research Site status: NOT_YET_RECRUITING city: Yinchuan zip: 750004 country: China lat: 38.46806 lon: 106.27306 facility: Research Site status: NOT_YET_RECRUITING city: Zhengzhou zip: 450008 country: China lat: 34.75778 lon: 113.64861 hasResults: False

 nctId: NCT06271824 id: 23-1519 briefTitle: Self-Compassion to Enhance the Well-Being of Caregivers of Children With Physical Disabilities overallStatus: RECRUITING date: 2024-03-21 date: 2024-06 date: 2024-06 date: 2024-02-22 date: 2024-03-26 name: University of North Carolina, Chapel Hill class: OTHER briefSummary: The goal of this clinical trial is to test the feasibility, acceptability and preliminary social/emotional well-being outcomes of a tailored, online self-compassion-based resilience course for caregivers of children with physical disabilities. The main questions it aims to answer are:

1. Is the online resilience course feasible and acceptable to caregivers of children with physical disabilities?
2. Is participation in the resilience course associated with improvements in caregiver stress, anxiety, depression, burden, caregiver uplifts, self-compassion, emotion regulation and/or resilience?

Participants will complete a screening, a verbal consent process and an electronic pre-course survey. Then, they will participate in a 6-session weekly online course with other caregivers and led by a certified Mindful Self-Compassion instructor. The course has been created with feedback from caregivers and includes skills for recognizing and coping with difficult emotions while connecting with others who have similar caregiving experiences. After the course, participants will repeat the electronic survey and will provide feedback on the course during a live, online feedback session. conditions: Stress conditions: Caregiver Burden conditions: Anxiety conditions: Depressive Symptoms studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 12 type: ESTIMATED name: Self-Compassion Based Resilient Caregiving Course measure: Percentage of participants who withdraw from course measure: Percentage of participants who attend at least 4 of 6 intervention sessions measure: Percentage of participants who rate the course as "acceptable" or "completely acceptable" measure: Percentage of intervention topics covered measure: Mean Change in Perceived Stress as Measured by the Perceived Stress Scale (PSS-10 item) at 6 weeks measure: Mean Change in Resilience as measured by the Connor-Davidson Resilience Scale-10 at 6 weeks measure: Mean Change in Anxiety as measured by the PROMIS-SF 7-item Anxiety Scale at 6 weeks measure: Mean Change in Depressive symptoms as measured by the PROMIS-SF 8-item Depression Scale at 6 weeks measure: Mean Change in Self-Compassion as measured by the Self-Compassion Scale-Short form (SCS-SF) at 6 weeks measure: Mean Change in Caregiver Burden as measured by the 12-item Zarit Caregiver Burden Scale (ZBI-12) at 6 weeks measure: Mean Change in Caregiver Uplifts as measured by the Uplifts subscale of the Revised Burden Measure at 6 weeks measure: Mean Change in Difficulties with Emotion Regulation as measured by the Difficulties in Emotion Regulation-Short Form Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of North Carolina at Chapel Hill status: RECRUITING city: Chapel Hill state: North Carolina zip: 27599 country: United States name: Monica Coudurier role: CONTACT email: m_coudurier@unc.edu lat: 35.9132 lon: -79.05584 hasResults: False

 nctId: NCT06271811 id: UJAPFPS briefTitle: Flossing Band Integration in Conventional Physiotherapy for Patellofemoral Pain Syndrome acronym: flossing overallStatus: COMPLETED date: 2023-01-09 date: 2023-11-14 date: 2023-11-20 date: 2024-02-22 date: 2024-02-23 name: University of Jaén class: OTHER name: University of Jaen briefSummary: The goal of this clinical trial is to assess the efficacy of adding flossing band therapy to conventional physiotherapy in patients diagnosed with Patellofemoral Pain Syndrome (PFPS). The main questions it aims to answer are:

* Does combining flossing band therapy with conventional physiotherapy lead to greater improvements in pain, strength, and function compared to conventional physiotherapy alone?
* What are the effects of flossing band therapy on knee functionality and muscle strength in PFPS patients? Participants will be randomly assigned to either the Standard Physiotherapy group or the Flossing Band and Physiotherapy group. In addition to conventional physiotherapy, participants in the Flossing Band group will undergo sessions where a flossing band is applied around the knee joint to provide moderate compression. Researchers will compare the two groups to determine if the addition of flossing band therapy enhances treatment outcomes for PFPS. conditions: Anterior Knee Pain Syndrome conditions: Patellofemoral Pain Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ACTUAL name: Flossing band name: Conventional physiotherapy measure: Disability related to patellofemoral pain measure: Knee extensor muscle strength measure: Pain report measure: Self-reported function measure: Short Form-36 (SF-36) measure: Berg Balance Scale (BBS) measure: Pittsburgh Sleep Quality Index measure: Brief Pain Questionnaire measure: Perceived Stress Scale sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: University of Jaen city: Jaen zip: 23009 country: Spain lat: 37.76922 lon: -3.79028 hasResults: False

 nctId: NCT06271798 id: P.T.REC/012/004867 briefTitle: Effect Of Resistive Exercises Versus Aerobic Exercises On Varicose Veins In Postmenopausal Women overallStatus: RECRUITING date: 2024-02-20 date: 2024-04-05 date: 2024-04-19 date: 2024-02-22 date: 2024-03-05 name: Cairo University class: OTHER briefSummary: The purpose of this study will be to determine the effect of resistive exercises on varicose veins in postmenopausal women, the effect of aerobic exercise on varicose veins in postmenopausal women and to compare between the effect of resistive exercise versus aerobic exercise on varicose veins in post menopausal women. conditions: Varicose Veins studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 44 type: ESTIMATED name: Life style modification advice name: Resistive exercise name: Aerobic exercises measure: Peak popliteal vein velocity measure: Visual analogue scale measure: Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) measure: 6-minute. walk test sex: FEMALE minimumAge: 50 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cairo University status: RECRUITING city: Giza country: Egypt name: Mai Saif Elnasr Ghietah, M.Sc. Stud role: CONTACT name: Mai Mohamed Ali, PhD role: CONTACT name: Soheir Mahmoud Elkosery, PhD role: PRINCIPAL_INVESTIGATOR name: Hossam Aldin H. Kamel, PhD role: PRINCIPAL_INVESTIGATOR lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06271785 id: 49RC22_0354 briefTitle: Prognostic Value of High-resolution Electrical Source Imaging on the Success of Pediatric Focal Epilepsy Surgery acronym: ISEPEE overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-10-01 date: 2026-10-01 date: 2024-02-22 date: 2024-03-12 name: University Hospital, Angers class: OTHER_GOV briefSummary: This study investigates the usefulness of high resolution electrical source imaging (HR-ESI) in the setting of presurgical evaluation of drug-resistant focal epilepsy in children.

This method is based on an estimation of the intra-cerebral source that produces a signal recorded by scalp electrodes by solving the inverse problem, taking into account attenuation factors resulting from particular conductivity properties of the cerebral, peri-cerebral and cranial tissues.

Electrical sources are then fused on structural magnetic resonance imaging (MRI).

Scalp EEG recorded using 64 to 256 electrodes refers to as high resolution EEG (HR-EEG), leading to HR-ESI.

Studies based on small population of children or on mixt population of children and adults showed that HR-ESI has accuracy values, i.e. percentage of true positives (electrical source localized in the brain area resected and success of surgery) and true negatives (electrical source localized outside the brain area resected and failure of surgery) among the total population, ranging from 50 to 80%.

Discrepancies between studies could be explained by the limited number of patients included or by the mixture of pediatric and adult data.

Another limitation of previously published studies is that the spatial pattern of dipole source distribution was not taken into account to determine prediction accuracy of ESI.

Studies using magnetoencephalography (MEG) to perform magnetic source imaging (MSI) suggest that the spatial pattern of dipole source distribution needs to be considered, a spatially-restricted dipole distribution being associated with better post-surgical outcome when resected.

To tackle these issues, the investigators aim to conduct the first large prospective multicentric study in children with focal epilepsy candidates to surgery to assess prediction accuracy of ESI based on the finding of tight clusters of dipoles.

This is original as this pattern (tight versus loose cluster of dipoles) has been studied by several researchers using MEG but not using HR-EEG.

The investigators make the hypothesis that HR-EEG will allow to identity good candidates for epilepsy surgery and thus to offer this underutilized treatment in more children with better post-surgical outcome.

Among the secondary objectives, the investigators will address methodological issues related to the resolution of the inverse problem (methods using distributed sources models versus methods based on equivalent dipole estimation), the potential added value to model high-frequency oscillations (HFO), and the investigators will assess the cost-utility of the HR-ESI procedure. conditions: Epilepsy in Children studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: HR-EEG recording measure: Prediction accuracy index measure: Localization of the epileptogenic zone (Baseline) measure: Localization of the epileptogenic zone (After Surgery) measure: preoperative accuracy of epileptogenic source localization measure: prognostic value of HFO measure: Impact of method of sources reconstruction, conditions of EEG recordings and sampling rate measure: health-economic modeling sex: ALL minimumAge: 2 Years maximumAge: 17 Years stdAges: CHILD facility: Angers university hospital, Pédiatric department city: Angers zip: 49000 country: France name: Patrick Van Bogaert, Professor role: CONTACT phone: 02 41 35 48 46 email: Patrick.VanBogaert@chu-angers.fr lat: 47.46667 lon: -0.55 facility: Lille University Hospital, Clinical Neurophysiology Department city: Lille zip: 59000 country: France name: Philippe DERAMBURE, Professor role: CONTACT phone: 03 20 44 63 62 email: Philippe.DERAMBURE@CHRU-LILLE.FR lat: 50.63297 lon: 3.05858 facility: Civil Hospices of Lyon, Functional Neurology Department city: Lyon zip: 69677 country: France name: Julien Jung, Doctor role: CONTACT phone: 04 72 35 79 00 email: julien.jung@chu-lyon.fr lat: 45.74848 lon: 4.84669 facility: Marseille Timone University Hospital, Epileptology and Cerebral Rhythmology Department city: Marseille zip: 13000 country: France name: Fabrice BARTOLOMEI, Professor role: CONTACT phone: 04 91 38 46 84 email: Fabrice.BARTOLOMEI@ap-hm.fr lat: 43.29551 lon: 5.38958 facility: Nancy University Hospital, Neurology Department city: Nancy zip: 54000 country: France name: Louis Maillard, Professor role: CONTACT phone: 03 83 85 16 09 email: l.maillard@chru-nancy.fr lat: 48.68439 lon: 6.18496 facility: Paris Neck University Hospital city: Paris zip: 75015 country: France lat: 48.85341 lon: 2.3488 facility: Paris Robert-Debré University Hospital, Department of Physiology, Pediatric functional explorations city: Paris zip: 75019 country: France name: François-Xavier MAUVAIS, Doctor role: CONTACT phone: 01 40 03 20 00 email: francois-xavier.mauvais@aphp.fr lat: 48.85341 lon: 2.3488 facility: Rothschild Ophtalmologic Fondation, Pediatric neurosurgery Department city: Paris zip: 75019 country: France name: Emmanuel Raffo, Professor role: CONTACT phone: 01 48 03 68 17 email: eraffo@for.paris lat: 48.85341 lon: 2.3488 facility: Rennes University Hospital, Pediatric department city: Rennes zip: 35000 country: France name: Silvia Adriana NAPURI PEIRANO, Doctor role: CONTACT phone: 02 99 26 58 34 email: Silviaadriana.NAPURI.PEIRANO@chu-rennes.fr lat: 48.11198 lon: -1.67429 hasResults: False

 nctId: NCT06271772 id: 18-26045-RII briefTitle: Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II acronym: REAGIR II overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-12-31 date: 2025-07-31 date: 2024-02-22 date: 2024-02-22 name: University of California, San Francisco class: OTHER name: Stanford University name: Aravind Eye Care System name: Federal University of São Paulo briefSummary: Rose Bengal Electromagnetic Activation with Green light for Infection Reduction II (REAGIR II) is a randomized, double-masked feasibility study. The purpose of this study is to determine differences in 6-month visual acuity between medical antimicrobial treatments alone versus antimicrobial treatment plus cross-linking with rose Bengal (RB-PDT).

Patients presenting to one of the Aravind Eye Hospitals in India or to the Federal University of São Paulo ophthalmology clinic in Brazil with smear-positive and/or culture positive typical (I.e. non-Nocardia or Mycobacteria) bacterial corneal ulcers and moderate to severe vision loss, defined as Snellen visual acuity of 20/40 of worse, will be eligible for inclusion. Those who agree to participate will be randomized to one of two treatment groups:

* Group 6, RB-PDT Plus Early Steroids: topical 0.5% moxifloxacin plus topical difluprednate 0.05% plus RB-PDT
* Group 7, Sham RB-PDT Plus Early Steroids: topical 0.5% moxifloxacin plus topical difluprednate 0.05% plus sham RB-PDT conditions: Bacterial Keratitis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Difluprednate Ophthalmic name: Rose Bengal name: Moxifloxacin Ophthalmic measure: Best Spectacle-Corrected Visual Acuity measure: Best Spectacle-Corrected Visual Acuity measure: Scar size measure: Scar depth measure: Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Federal University of São Paulo city: São Paulo country: Brazil name: Ana Luisa Hofling Lima, MD, PhD role: CONTACT email: analhofling@gmail.com lat: -23.5475 lon: -46.63611 facility: Aravind Eye Care System city: Madurai state: Tamil Nadu country: India name: N V Prajna role: CONTACT email: prajna@aravind.org lat: 9.91769 lon: 78.11898 hasResults: False

 nctId: NCT06271759 id: PSYFRAG briefTitle: Psychological Effects of a Set of Functional Fragrances acronym: PSYFRAG overallStatus: RECRUITING date: 2024-03-15 date: 2024-08-15 date: 2024-08-15 date: 2024-02-22 date: 2024-04-09 name: University of Bucharest class: OTHER name: IFF (International Flavors & Fragrances) briefSummary: The goal of this clinical trial is to test the effectiveness of an intervention designed to improve wellness through aromatherapy. The main question it aims to answer is whether this intervention can deliver beneficial psychological effects on stress, anxiety and mood, as well as overall well-being.

Participants will receive a bottle with a no/neutral odor or an essential oil (or a blend of essential oils) for home administration and will be asked to complete a series of scales pre and post self-administration twice one week apart. conditions: Stress conditions: Anxiety conditions: Well-Being, Psychological conditions: Mood studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 80 type: ESTIMATED name: Fragrance inhalation measure: Affective states - relaxation measure: Affective states - contentment measure: Affective states - happiness measure: Affective states - stress measure: Affective states - motivation measure: Affective states - tension measure: Emotional changes measure: General mental health - Depression measure: General mental health - Anxiety measure: General mental health - Stress sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Bucharest status: RECRUITING city: Bucharest zip: 050663 country: Romania name: Cezar Giosan, PhD role: CONTACT phone: +40730908050 email: giosan@outlook.com lat: 44.43225 lon: 26.10626 hasResults: False

 nctId: NCT06271746 id: TCH101 briefTitle: Treatment of Fibromyalgia With the FibroNova Neuromodulation Device overallStatus: RECRUITING date: 2024-03-04 date: 2025-03-01 date: 2025-06-01 date: 2024-02-22 date: 2024-04-11 name: Theranica class: INDUSTRY briefSummary: Fibromyalgia (FM) is a chronic disorder that affects the musculoskeletal system, causing widespread pain, tenderness, and fatigue. It is estimated to affect 1-5% of the population. The primary symptom of fibromyalgia is widespread pain throughout the body, accompanied by tenderness and sensitivity to pressure.

Pharmacological treatments include drugs such as antidepressants, anticonvulsants, and painkillers. Another treatment option for fibromyalgia is the use of devices such as Quell. Other non-pharmacological treatment options for fibromyalgia include cognitive-behavioral therapy (CBT), biofeedback, and relaxation techniques.

Remote Electrical Neuromodulation (REN) is a non-pharmacological technology that induces subthreshold, non-painful neurostimulation signals that activate an endogenic pain-management system termed Conditioned Pain Modulation (CPM), to produce generalized pain relief in remote body areas. Multiple studies have shown that REN is safe and effective for the acute treatment of migraine in adults and adolescents, as well as migraine prevention.

The current study examines the safety and efficacy of REN technology, implemented via the FibroNova device for treating fibromyalgia pain and related symptoms. conditions: Fibromyalgia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment. Randomized, double-blind, sham-controlled primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 170 type: ESTIMATED name: FibroNova (Active mode) name: FibroNova (Sham mode) measure: Mean reduction in pain level during the last 14 days of the treatment phase (weeks 15 through 16) compare to the last 14 days of baseline phase (weeks 3 through 4) measure: Device safety (rate of adverse events and device related adverse events) measure: Mean change in the Revised Fibromyalgia Impact Questionnaire FIQR total score measure: Mean change in FIQR functionality sub-scale score measure: Mean change in FIQR pain item score measure: Mean change in Brief Pain Inventory (BPI) score measure: Improvement in patient global impression according to PGIC score measure: Mean reduction in functional disability during the last 14 days of the treatment phase (weeks 15 through 16) compare to the last 14 days of baseline phase (weeks 3 through 4) measure: Improvement in quality of life measure: Improvement in sleep quality measure: Mean change in level of depression measure: Mean change in level of anxiety measure: Mean change in level of cognitive impairment measure: Mean change in level of cognitive presenteeism measure: Mean reduction of at least 30% in pain level measure: Rate of treatment tolerability measure: User experience measure: Patient Global Impression- change (PGI-C measure: Patient Global Impression- change (PGI-C)- mid study: sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Research Professionals status: RECRUITING city: Chesterfield state: Missouri zip: 63005 country: United States name: Shahmir Kahn role: CONTACT phone: 636-220-1200 email: skhan@clinicalresearchprofessionals.net name: Daniel Mattson, MD role: PRINCIPAL_INVESTIGATOR lat: 38.66311 lon: -90.57707 facility: ClinVest Headlands Research status: RECRUITING city: Springfield state: Missouri zip: 65807 country: United States name: Brittni kendrick role: CONTACT phone: 417-883-7889 email: brittni.kendrick@clinvest.com name: David True, MD role: PRINCIPAL_INVESTIGATOR lat: 37.21533 lon: -93.29824 facility: Gershon Pain Specialists status: RECRUITING city: Virginia Beach state: Virginia zip: 23454 country: United States name: Erika Dorman role: CONTACT phone: 757-496-2050 email: edorrman@gershonpain.com name: Steven Gershon, MD role: PRINCIPAL_INVESTIGATOR lat: 36.85293 lon: -75.97799 facility: Tel Aviv Sourasky Medical Center status: NOT_YET_RECRUITING city: Tel Aviv zip: 6423906 country: Israel name: Sara Pel role: CONTACT phone: +972-52-4266605 email: sarap@tlvmc.gov.ii name: Ori Elkayam, MD role: PRINCIPAL_INVESTIGATOR lat: 32.08088 lon: 34.78057 hasResults: False

 nctId: NCT06271733 id: 21110503 briefTitle: TMS for Veterans Attending a 2-week Intensive Outpatient Program for PTSD overallStatus: ENROLLING_BY_INVITATION date: 2022-01-11 date: 2026-01-31 date: 2027-01-31 date: 2024-02-22 date: 2024-02-29 name: Rush University Medical Center class: OTHER briefSummary: The goal of this study is to determine whether complementing regular intensive PTSD treatment with intermittent theta burst stimulation (iTBS) applied to the right dorsolateral prefrontal cortex (DLPFC) can improve treatment response for individuals attending a 2-week intensive outpatient program (IOP) for PTSD. Specifically, the present study will compare iTBS versus a sham condition during the second week of the 2- week IOP for veterans who have not experienced PTSD symptom reductions over the course of the first week of the Road Home Program intensive PTSD treatment program. conditions: PTSD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: TMS name: Sham measure: PTSD Checklist for DSM-5 (PCL-5) measure: Patient Health Questionnaire-9 (PHQ-9) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rush University Medical Center city: Chicago state: Illinois zip: 60612 country: United States lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06271720 id: faculty of physical therapy briefTitle: Impact of Visceral Manipulation Versus Integrated Neuromuscular Inhibition Technique in Shoulder Impingement Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-05 date: 2024-05 date: 2024-02-22 date: 2024-02-22 name: Noha Elserty class: OTHER briefSummary: This study will be conducted To evaluate the effect of Visceral Manipulation versus Integrated Neuromuscular Inhibition Technique on the upper fiber of trapezius on pain intensity, pain threshold, shoulder range of motion, and function in shoulder impingement syndrome conditions: Shoulder Impingement studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 75 type: ESTIMATED name: visceral manipulation name: integrated neuromuscular inhibition measure: pain intensity measure: pain pressure threshold measure: shoulder range of motion measure: shoulder functional level sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT hasResults: False

 nctId: NCT06271707 id: ANES-2024-32720 briefTitle: Stellate Ganglion Block overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-06-30 date: 2026-09-30 date: 2024-02-22 date: 2024-04-23 name: University of Minnesota class: OTHER briefSummary: The purpose of this study is to determine if the addition of an ultrasound guided left sided stellate ganglion block with bupivacaine in patients undergoing esophagectomy, pneumonectomy, or lobectomy will result in lower rates of postoperative atrial fibrillation as compared to standard of care. conditions: Esophagectomy conditions: Pneumonectomy conditions: Lobectomy studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: This is a double blind randomized prospective controlled trial. Randomization will be 1:1. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: 0.5% bupivacaine name: Saline measure: an ultrasound guided left stellate ganglion block with 5 mL of saline. measure: Atrial fibrillation; Other arrhythmias; Adverse events. sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06271694 id: STUDY22020027 id: 1K23DC020215-01 type: NIH link: https://reporter.nih.gov/quickSearch/1K23DC020215-01 briefTitle: Activity and Participation in Vestibular Disorders acronym: APV overallStatus: RECRUITING date: 2024-01-01 date: 2024-11-29 date: 2025-01-31 date: 2024-02-22 date: 2024-04-25 name: University of Pittsburgh class: OTHER name: National Institute on Deafness and Other Communication Disorders (NIDCD) briefSummary: This study will examine whether impairments and personal factors are associated with activity and participation in people with vestibulopathy. Data collection will occur prior to starting vestibular rehabilitation and after completing vestibular rehabilitation. conditions: Vestibular Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 50 type: ESTIMATED name: Vestibular Rehabilitation measure: Late-life Function and Disability Instrument measure: Dizziness Handicap Inventory sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UPMC-Rehab Institute status: RECRUITING city: Pittsburgh state: Pennsylvania zip: 15206 country: United States name: Chelsea Behling role: CONTACT phone: 412-624-8811 email: chb317@pitt.edu lat: 40.44062 lon: -79.99589 hasResults: False

 nctId: NCT06271681 id: 2120135-1 briefTitle: Evaluation of PCV15 Vaccination Among PPSV23-experienced, Immunocompromised Elderly Veterans overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-08-01 date: 2025-02-01 date: 2024-02-22 date: 2024-02-22 name: VA Sierra Nevada Health Care System class: FED name: Merck Sharp & Dohme LLC briefSummary: The investigators will evaluate the immune response of immunocompromised adults, who have previously received at least 1 dose of 23-valent pneumococcal polysaccharide vaccine, to the booster series of 15-valent pneumococcal conjugate vaccine followed by 23-valent pneumococcal polysaccharide vaccine 8 weeks later. Immune response will be assessed by opsonophagocytic assay reactivity and IgG Geometric mean concentration changes. conditions: Pneumococcal Vaccines conditions: Immunosuppression studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: 15-valent pneumococcal conjugate vaccine name: 23-valent pneumococcal polysaccharide vaccine measure: Change in opsonophagocytic assay (OPA) geometric mean titers (GMT) measure: Change in Immunoglobulin G (IgG) geometric mean concentrations (GMC) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06271668 id: 23-2356 id: R61DA057610 type: NIH link: https://reporter.nih.gov/quickSearch/R61DA057610 briefTitle: Clinical Decision Support to Improve System Naloxone Co-prescribing overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-03 date: 2026-09 date: 2024-02-22 date: 2024-02-29 name: University of Colorado, Denver class: OTHER name: National Institutes of Health (NIH) name: National Institute on Drug Abuse (NIDA) briefSummary: The objective of this study is to evaluate the impact of a clinical decision support (CDS) alert to facilitate the co-prescribing of naloxone, an opioid overdose reversal agent, with high-risk opioid prescriptions. Prescribing naloxone with opioids is a best practice described in the 2022 US Center for Disease Control and Prevention (CDC) guidelines on opioid prescribing. The CDS can improve quality of care delivered by improving compliance with the guideline defined best practices. The project will compare CDS alert facilitated co-prescribing of naloxone with high-risk opioid prescriptions vs usual care to evaluate the effectiveness of the CDS alert for improving naloxone prescribing. The patients are not assigned to an intervention and will be receiving any changes in care as part of their routine medical care, rather than a specific intervention that is distinct from their usual medical care. The researchers hypothesize that the CDS alert will be acceptable to providers while increasing naloxone co-prescribing which will reduce the number of opioid overdoses in subsequent 6 months. conditions: Medication Abuse conditions: Harm Reduction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200000 type: ESTIMATED name: Naloxone Co-prescribing Clinical Decision Support (CDS) measure: Percentage of a high-risk opioid analgesic prescriptions receiving a co-prescription of naloxone measure: Clinical decision support (CDS) acceptance rate measure: Subsequent opioid overdose/poisonings rates measure: Naloxone dispensed rate sex: ALL minimumAge: 12 Years maximumAge: 89 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of Colorado Hospital city: Aurora state: Colorado zip: 80045 country: United States lat: 39.72943 lon: -104.83192 hasResults: False

 nctId: NCT06271655 id: BFD-RST-23-004 briefTitle: Rapid Diagnosis of Viral Acute Respiratory Infection to Decrease Unnecessary Antibiotic Utilization in the Emergency Department (RADIATE) acronym: RADIATE overallStatus: RECRUITING date: 2024-03-12 date: 2024-09-30 date: 2024-09-30 date: 2024-02-22 date: 2024-04-09 name: Christopher Payette class: OTHER name: BioMérieux briefSummary: The study titled " The Effect of Definitive Identification of Viral Etiology in Emergency Department Patients with Acute Respiratory Infection on Antibiotic Utilization (RADIATE)" aims to investigate the effectiveness of a rapid diagnostic approach in reducing unnecessary antibiotic use in the emergency department (ED) for patients presenting with acute respiratory illness (ARI) due to a virus. Using a prospective design, eligible participants are individuals who visit the ED with complaints related to acute respiratory illness. The study will employ a single-arm consecutive enrollment approach. The intervention involves the implementation of a rapid point-of-care multiplex polymerase chain reaction (PCR) test to promptly identify the viral cause of the infection. By utilizing a rapid diagnostic tool to identify viral etiology, the study aims to provide healthcare professionals in the ED with more accurate information to guide treatment decisions. Ultimately, the goal is to decrease the unnecessary use of antibiotics for ARI's due to a virus, which has several negative outcomes including promotion of antibiotic resistance, exacerbating ED length of stay and encouraging unnecessary additional diagnostic tests. conditions: Acute Respiratory Infection conditions: Viral Infection conditions: Upper Respiratory Tract Infections studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 200 type: ESTIMATED name: SPOTFIRE R Panel measure: Antibiotic Use measure: Emergency Department Length of Stay measure: Utilization of Alternative Tests measure: Patient Confidence in Diagnosis measure: Provider Confidence in Diagnosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: George Washington University Hospital status: RECRUITING city: Washington state: District of Columbia zip: 20037 country: United States name: Ryan Heidish role: CONTACT email: rheidish@mfa.gwu.edu name: Christopher Payette, MD role: CONTACT email: cpayette@mfa.gwu.edu name: Christopher Payette, MD role: PRINCIPAL_INVESTIGATOR name: Andrew Meltzer, MD, MS role: SUB_INVESTIGATOR lat: 38.89511 lon: -77.03637 hasResults: False

 nctId: NCT06271642 id: 73822 briefTitle: Impact of Bluetooth Haptics Device Distraction on Mechanical Pain Thresholds Induced by PinPrick Stimulators overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-05-31 date: 2025-05-31 date: 2024-02-22 date: 2024-02-22 name: Stanford University class: OTHER briefSummary: This is a prospective, crossover study of healthy participants evaluating the mechanical pain threshold for weighted pinprick stimuli. conditions: Pain conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 120 type: ESTIMATED name: Bluetooth Haptic Device (Experimental Frequency) + Needle Sham only name: Bluetooth Haptic Device (Control Frequency) + Needle Sham only measure: Mechanical Pain Threshold measure: Mechanical pain sensitivity measure: Anxiety scores sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06271629 id: 2204-042-1314 briefTitle: Impact of Quality of Life in the Patients With Sleep Disturbance From Low Anterior Resection Syndrome in Advanced Rectal Cancer Patients overallStatus: COMPLETED date: 2022-02-26 date: 2023-11-30 date: 2024-02-29 date: 2024-02-22 date: 2024-03-26 name: Seoul National University Hospital class: OTHER name: Ministry of Health, Republic of Korea briefSummary: The preservation surgery of the anal sphincter has become a standard procedure for the treatment of rectal cancer and is now possible even when the tumor is close to the anus, thanks to the advancement of surgical techniques. This procedure allows patients to avoid a permanent artificial anus and enables them to evacuate through the anus, maintaining the continuity of the intestine, making it a highly preferred surgical option. Additionally, advancements in tumor treatments have led to improved long-term survival rates.

However, this anal sphincter preservation surgery inevitably can cause functional abnormalities in the rectum, and around 90% of patients experience changes in bowel habits after surgery. The characteristic symptoms occurring after rectal cancer surgery, such as diarrhea, urgency of bowel movements, frequent bowel movements, and fecal incontinence, are referred to as Anterior Resection Syndrome (ARS). Particularly, symptoms following low anterior resection surgery for lower rectal cancer are termed Low Anterior Resection Syndrome (LARS). These symptoms are most severe immediately after surgery, persisting up to 1-2 years, with some improvement over time. However, in many patients, LARS can remain a lifelong challenge, significantly impacting their quality of life. Currently, there is no definitive method to treat LARS, and symptom management is achieved through empirical treatment methods or medications.

Many patients with LARS experience these symptoms predominantly at night, and it is presumed that their sleep quality is severely compromised, significantly affecting their overall quality of life. However, there is a lack of research on the prevalence of such patients and the appropriate treatments for them. conditions: Rectal Cancer conditions: Low Anterior Resection Syndrome conditions: Insomnia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ACTUAL name: Insomnia severity index measure: Impairment in the quality of sleep and quality of life in patients with Low Anterior Resection Syndrome (LARS). measure: European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) measure: European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR29) sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul National University Hospital city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06271616 id: MC1873 id: NCI-2024-01061 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 18-008754 type: OTHER domain: Mayo Clinic Institutional Review Board briefTitle: Ibrutinib for the Prevention of Chronic Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplant overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-31 date: 2027-05-31 date: 2024-02-22 date: 2024-03-20 name: Mayo Clinic class: OTHER briefSummary: This phase II trial tests how well ibrutinib works in preventing chronic graft-versus-host disease (GVHD) in patients undergoing donor (allogeneic) hematopoietic cell transplantation (HCT). An allogeneic hematopoietic cell transplantation (allo-HCT) is a treatment in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a genetically similar, but not identical donor. When healthy stem cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets. However, sometimes the transplanted cells from a donor can attack the body's normal cells (called GVHD). Giving ibrutinib after the transplant may stop that from happening. Ibrutinib is in a class of medications called kinase inhibitors. It works by blocking a protein in the blood called Bruton's tyrosine kinase (BTK). By blocking BTK, ibrutinib inhibits certain immune cells that play a role in cGVHD. Giving ibrutinib after an allo-HCT may prevent the development of chronic GVHD. conditions: Chronic Graft Versus Host Disease conditions: Hematopoietic and Lymphatic System Neoplasm studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 40 type: ESTIMATED name: Biospecimen Collection name: Echocardiography name: Ibrutinib measure: Cumulative incidence of NIH moderate/severe chronic graft-versus-host disease (GVHD) measure: Cumulative incidence of non-relapse mortality (NRM) measure: Cumulative incidence of relapse measure: Cumulative incidence of moderate/severe chronic GVHD measure: Cumulative incidence of moderate/severe chronic GVHD measure: Cumulative incidence of chronic GVHD of all grades measure: Cumulative incidence of late acute GVHD measure: Overall survival (OS) measure: NIH moderate/severe GVHD and relapse free survival (CRFS) measure: Type and duration of immune suppressive therapy measure: Cumulative incidence of complete immune suppression (IS) discontinuation measure: Incidence of adverse events (AE) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Florida city: Jacksonville state: Florida zip: 32224-9980 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Mohamed A. Kharfan Dabaja, M.D., M.B.A. role: PRINCIPAL_INVESTIGATOR lat: 30.33218 lon: -81.65565 hasResults: False

 nctId: NCT06271603 id: 23.02645.000357-MS01 id: CPP Ile de France III type: OTHER domain: 23.02645.000357-MS01 briefTitle: Evaluation of the Efficiency and Economic Impact of LC-OCT (Line-field Confocal Optical Coherence Tomography) for the Diagnosis and Management of Basal Cell Carcinomas acronym: ECOBASO overallStatus: NOT_YET_RECRUITING date: 2024-02-26 date: 2026-02 date: 2026-02 date: 2024-02-22 date: 2024-02-22 name: Damae Medical class: INDUSTRY briefSummary: This is a comparative, randomized, prospective, multicenter clinical investigation aimed at evaluating the efficiency and economic impact of LC-OCT (Line-field Confocal Optical Coherence Tomography) for the diagnosis and management of basal cell carcinomas. conditions: Basal Cell Carcinoma of the Skin studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 704 type: ESTIMATED name: diagnosis based on deepLive™ LC-OCT device name: diagnosis based on skin biopsy measure: The primary objective is to demonstrate, at 1 year, the clinical non-inferiority and organizational and economic superiority of the management of primary BCC through diagnosis with LC-OCT compared to traditional management. measure: The primary objective is to demonstrate, at 1 year, the clinical non-inferiority and organizational and economic superiority of the management of primary BCC through diagnosis with LC-OCT compared to traditional management. measure: The primary objective is to demonstrate, at 1 year, the clinical non-inferiority and organizational and economic superiority of the management of primary BCC through diagnosis with LC-OCT compared to traditional management. measure: Compare, after the diagnosis announcement and at 1 year, the quality of life of patients in the LC-OCT arm versus the standard management arm. measure: Compare, after the diagnosis announcement and at 1 year, the anxiety levels of patients in the LC-OCT arm versus the standard management arm. measure: Compare patient satisfaction with their management at 1 year in the LC-OCT arm versus the standard management arm. measure: Evaluate the performance of LC-OCT for the diagnosis and subtyping of BCC for all patients operated on or biopsied in the LC-OCT arm. measure: Compare dermatologists' satisfaction with patient management in the LC-OCT arm versus the standard management arm measure: Estimate the actual cost of conducting the diagnosis with LC-OCT technology. measure: Compare healthcare consumption between the two groups at 1 year. measure: Conduct a cost-consequence analysis of patient management with LC-OCT technology versus standard management. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Ambroise Paré city: Boulogne-Billancourt zip: 92100 country: France name: Professeur Philippe SAIAG role: CONTACT phone: 800-555-5555 email: philippe.saiag@uvsq.fr name: Philippe SAIAG role: PRINCIPAL_INVESTIGATOR lat: 48.83333 lon: 2.25 hasResults: False

 nctId: NCT06271590 id: CM-US-R03 briefTitle: MagicTouch™Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels acronym: MAGICAL-SV overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-04 date: 2031-04 date: 2024-02-22 date: 2024-02-22 name: Concept Medical Inc. class: INDUSTRY name: Cardiovascular Research Foundation, New York briefSummary: This is a multicenter, randomized, single-blind pivotal study to evaluate the safety and efficacy of the MagicTouchTM Drug coated balloon in treatment of small vessels in patients with coronary artery disease. The objective is to establish the safety and efficacy of the Magic TouchTM Drug coated balloon in treatment of small vessels (≤2.75 mm).

A total of 1605 subjects will be enrolled in a maximum of 50 study sites located in North America. Additional sites located in Europe and South America may also participate in the study, with non-US sites contributing a maximum of \~50% of enrollees. conditions: Coronary Artery Disease conditions: Native Coronary Artery Stenosis conditions: Cardiovascular Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 2:1 randomized trial (MagicTouchTM Sirolimus-Coated Balloon VS Drug eluting stent (ZES or EES) primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 1605 type: ESTIMATED name: Sirolimus Drug Coated Balloon name: Drug eluting stents (DES) measure: Target lesion failure (TLF) measure: Procedural success measure: Target lesion failure (TLF) measure: Ischemia driven target vessel revascularization (ID-TVR) measure: Target vessel revascularization (TVR) measure: Any revascularization measure: Target vessel failure (TVF) measure: Q-wave myocardial infarction (MI) measure: Non Q-wave myocardial infarction (MI) measure: Any myocardial infarction (MI) measure: Target vessel myocardial infarction (TV MI) measure: Spontaneous myocardial infarction (MI) measure: Procedural myocardial infarction (MI) measure: Cardiovascular mortality measure: All-cause mortality measure: Cardiovascular mortality or myocardial infarction (MI) measure: All-cause mortality or MI measure: All-cause mortality, myocardial infarction (MI) or target vessel revascularization (TVR) measure: Any probable or definite stent thrombosis measure: Probable stent thrombosis measure: Definite stent thrombosis measure: Angina as assessed by SAQ-7 (Seattle Angina Questionnaire) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06271577 id: PRO-0013 briefTitle: Smartphone Twelve-Lead ECG Utility In ST-Elevation Myocardial Infarction II acronym: STLEUISII overallStatus: RECRUITING date: 2024-03-12 date: 2024-11 date: 2024-12 date: 2024-02-22 date: 2024-03-19 name: AliveCor class: INDUSTRY briefSummary: AliveCor (www.alivecor.com) has developed several electrocardiogram (ECG) devices that interface with iOS and Android smartphones and tablets via various Kardia apps. The current Kardia family of devices can measure single lead and six limb-lead ECGs, depending on the device. KardiaMobile, KardiaMobile 6L, and KardiaMobile Card have FDA clearance for ECG rhythm recording. A modified single-lead Kardia smartphone 12-lead ECG was previously validated in the multicenter ST LEUIS study for the diagnosis of ST-Segment Elevation Myocardial Infarction (STEMI) and Non-ST-Elevation Myocardial Infarction (NSTEMI).

Recently, AliveCor developed a new device: AliveCor (AC) 12-lead (12L) ECG System to record simultaneously 4 leads of ECG and then generate complete 12-lead ECGs. A previous protocol at the University of Oklahoma involved 200 subjects with early prototypes of the AC 12L device with the specific aim to validate that it accurately generated 12-lead ECGs as compared to simultaneously acquired FDA-cleared 12-lead ECGs. The prototype version of the AliveCor 12L ECG System simultaneously measured four channels of ECG (leads I, II, V2, V4), calculated the remaining limb leads as is standard for 12-lead ECGs (Leads III, aVR, aVL, aVF) and synthesized the remaining 4 precordial ECG leads (V1, V3, V5, V6). This protocol will serve to validate the production version of the system against standard 12-Lead ECGs for the diagnosis of STEMI and NSTEMI in patients admitted to the Emergency Department or directly to the Cardiac Cath Lab for the evaluation of chest pain. It is anticipated that the waveforms for each of the 12 leads from the AC 12L ECG System will be highly correlated with the corresponding leads from the comparator commercially available 12-lead ECG devices used at participating sites. The purpose of this study is to clinically validate that the four-channel AC 12L ECG device can enable the diagnosis of STEMI and NSTEMI in a non-inferior manner to existing 12-lead ECG devices. conditions: Myocardial Infarction conditions: Ischemia conditions: Myocardial Ischemia conditions: Heart Diseases conditions: Cardiovascular Diseases conditions: Vascular Diseases conditions: Heart Attack conditions: Heart Failure studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 1000 type: ESTIMATED name: AliveCor 12-lead ECG measure: Inter-rater variability for Standard 12-lead ECG readings measure: Inter-rater variability for AC 12L ECG readings measure: Number of standard 12-lead ECG readings requiring a consensus consultation measure: Number of AC 12L ECG readings requiring a consensus consultation measure: Sensitivity of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI measure: Specificity of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI measure: Positive predictive value of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI measure: Negative predictive power of the AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI measure: Mean subjective correlation score for AC 12L ECGs in which the standard 12-lead ECG diagnosis is STEMI measure: Mean subjective correlation score for AC 12L ECGs in which the standard 12-lead ECG diagnosis is not STEMI measure: Mean summative ST-segment elevation, summative ST-segment depression and summative ST-segment deviation for AC 12L ECGs compared to standard 12-lead ECGs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic status: RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Julianne Rumer role: CONTACT phone: 507-255-1034 email: Rumer.Julianne@mayo.edu name: Anna Pick role: CONTACT phone: 507-775-0630 email: Pick.Anna@mayo.edu name: Gregory Barsness, MD role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06271564 id: FDASU-Rec IM012415 briefTitle: Effectiveness of Topical Magnetite Zinc Oxide Composite Nanoparticles in the Management of Oral Potentially Malignant Lesions overallStatus: RECRUITING date: 2024-02-29 date: 2024-07 date: 2024-12 date: 2024-02-22 date: 2024-03-05 name: Ain Shams University class: OTHER briefSummary: ZnO nanoparticles are now being widely researched for their anticancer properties. They show relatively high biocompatibility. They also show selective cytotoxicity against cancerous cells in in vitro condition compared with other nanoparticles. They can be further surface engineered to show increased selective cytotoxicity. The synthesis process of ZnO nanoparticles is relatively easy, with a wide variety of methods. Owing to these different methods of synthesis, their size and size distribution can be easily controlled. One of the novel methods of synthesis of ZnO is Magnetite ZnO-Fe3O4 Composite Nanoparticles.Magnetite ZnO-Fe3O4 conjugated NPs retained inherent selective property of ZnO and magnetic property of Fe3O4 NPs and showed preferential cytotoxicity towards breast cancer cell line MDA-MB-231, with no significant cytotoxicity towards noncancerous Mouse Fibroblast NIH 3T3 cell. conditions: Oral Potentially Malignant Lesions studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Magnetite ZnO Composite Nanoparticles name: Topical Placebo Gel measure: Change in the clinical size in Low to Moderate Dysplastic OPLs using Magnetite ZnO-Fe3O4 Composite NPs using standardized photographs of the oral marker lesion for each patient measure: Effect of Magnetite ZnO-Fe3O4 Composite NPs on the change of the degree of Dysplasia during histopathological examination using a biopsy sex: ALL minimumAge: 25 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of Dentistry Ain shams University status: RECRUITING city: Cairo country: Egypt name: Nourhane Omara, Master's role: CONTACT lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06271551 id: ESTRACISE briefTitle: Transdermal Estradiol and Exercise in Mitigating Adverse Effects of Androgen Deprivation Therapy for Prostate Cancer Radiation Therapy acronym: ESTRACISE overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2028-12 date: 2029-12 date: 2024-02-21 date: 2024-02-21 name: Central Finland Hospital District class: OTHER name: Tampere University name: University of Jyvaskyla name: Tampere University Hospital briefSummary: The goal of the clinical trial is to find out whether transdermal estradiol will reduce the adverse effects of androgen deprivation therapy in prostate cancer patients.

The primary aim of this study is to estimate the efficacy of transdermal estradiol (E2) in reducing androgen deprivation therapy induced adverse effects on sexual function. A secondary aim of this study is to estimate the utility of E2 and the combination of E2 with supervised exercise in reducing other androgen deprivation therapy related adverse effects.

Participants (n=310) will use transdermal estradiol for 12 months concomitant to androgen deprivation therapy. The use of transdermal estradiol will start at the beginning of the trial, at the same time as androgen deprivation therapy. A subgroup of participants (n=120) will also be allocated to perform six months supervised resistance training.

Researchers will compare transdermal estradiol group to control group, and resistance training groups and non-training control groups. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants are randomized in a 1:1 fashion to receive transdermal estradiol and androgen deprivation or solely androgen deprivation therapy. In addition subgroup of participants are randomized in a 1:1 fashion to perform resistance training or to be allocated in non-training control group. primaryPurpose: TREATMENT masking: NONE count: 310 type: ESTIMATED name: Transdermal estrogen name: Active Comparator: Androgen deprivation therapy name: Resistance training measure: The efficacy of transdermal estradiol in mitigating the deterioration of EPIC-26 (The Expanded Prostate Cancer Index Composite) sexual function domain scores caused by androgen deprivation therapy. measure: The occurrence of androgen deprivation therapy induced adverse effects. measure: Number of participants with transdermal estradiol-related adverse events as assessed by CTCAE (Common Terminology Criteria for Adverse Events). measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on one repetition maximum tests of both the leg press and barbell biceps curl, and maximal hand grip strength assessed with a dynamometer. measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on explosive strength of the leg extensors assessed with a countermovement jump (CMJ). measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on 6-minute walk (functional capacity). measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on loaded 10-stair climb test (functional capacity). measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on body composition. measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on bone mineral density. measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on mid-thigh muscle mass. measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on mid-thigh fat mass. measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on hormone (testosterone and estradiol) levels, and cancer (PSA) status. measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on concentration of PVK, IL-6, TNF-α, AFOS, Alat, Krea, Cholesterol, LDL-C, HDL-C, and triglycerides). measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on type I and II myofibers' cross-sectional area, myonuclei, myonuclear domain, the satellite cell count, androgen receptor and myostatin content measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on muscle cellular function (e.g., HSP70, alpha B-crystallin, HSP60, cytochrome c oxidase subunit IV proteins) measure: Number of participants with resistance training induced adverse events. measure: The World Health Organization Quality of Life Brief Version (WHOQOL-BREF). measure: The Patient Health Questionnaire score (PHQ-9) overall and subdomain score. sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06271538 id: EP-USM-122023-001 briefTitle: Evaluation of Efficacy of Skål Pro Powder on Symptoms of Irritable Bowel Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2024-11-30 date: 2025-03-30 date: 2024-02-21 date: 2024-04-26 name: EP Plus Group Sdn Bhd class: INDUSTRY briefSummary: The objective of this randomized, double-blind, placebo-controlled study is to evaluate the effectiveness of Skal Pro in alleviating symptoms, enhancing stool consistency, improving quality of life, and addressing psychological distress in individuals diagnosed with irritable bowel syndrome (IBS), as compared to those who receive no intervention. conditions: Irritable Bowel Syndrome conditions: Gastrointestinal Diseases conditions: Colonic Diseases, Functional conditions: Intestinal Disease conditions: Digestive System Disease conditions: Pathologic Processes conditions: Colonic Disease conditions: Disease studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Skal Pro name: Placebo measure: Improving the severity of symptoms in individuals with IBS, assessed by IBS Symptom Severity Scale (IBSSSS) measure: Change in stool consistency (Bristol Stool Scale), assessed by daily stool diary measure: Change in stool frequency and satisfaction after passing stool, assessed by daily stool diary measure: Change in abdominal bloating, assessed by Bloating Severity Questionnaire (BSQ) measure: Improvement in Quality of Life, assessed by EQ-5D-5L Questionnaire measure: Change in Visceral Sensitivity Index measure: Assessment of psychological dysfunction suing Catastrophizing Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universiti Sains Malaysia city: Kubang Kerian state: Kelantan zip: 16150 country: Malaysia name: Yeong Yeh Lee, MD, PhD role: CONTACT phone: +6097676846 phoneExt: 6845 email: yylee@usm.my name: Yeong Yeh Lee, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Thai Hau Koo, MD role: SUB_INVESTIGATOR lat: 6.09123 lon: 102.27938 hasResults: False

 nctId: NCT06271525 id: P.T.REC/012/002532 briefTitle: Effect of Cupping Therapy on Nitric Oxide Level in Patients With Cervical Spondylosis acronym: CT overallStatus: NOT_YET_RECRUITING date: 2024-02-20 date: 2024-05-20 date: 2024-05-20 date: 2024-02-21 date: 2024-02-21 name: Shady Abdelsattar Refaat class: OTHER briefSummary: this study will be conducted to investigate the effect of cupping therapy on the nitric oxide level in patients with cervical spondylosis conditions: Cervical Spondylosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: cupping therapy primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: cupping therapy measure: the nitric oxide level measure: cervical range of motion measure: pain intensity sex: ALL minimumAge: 24 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06271512 id: REG-501 briefTitle: A Study of Participants With β-Thalassemia Treated With Betibeglogene Autotemcel overallStatus: RECRUITING date: 2024-01-23 date: 2043-12 date: 2043-12 date: 2024-02-21 date: 2024-02-21 name: bluebird bio class: INDUSTRY name: Center for International Blood and Marrow Transplant Research briefSummary: The main aim of this study is to collect real-world longitudinal data on participants with β-thalassemia treated with betibeglogene autotemcel (beti-cel) in the post marketing setting. To assess the long-term safety, including the risk of newly diagnosed malignancies, after treatment with beti-cel and evaluate the long-term effectiveness of treatment with beti-cel. conditions: Beta-Thalassemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: No Intervention measure: Number of Participants who Experience Each Individual Adverse Events of Interest (AEIs) measure: Number of Participants with Serious Adverse Events (SAEs) measure: Number of Participants with beti-cel related AEs measure: Event-Free Survival measure: Percentage of Participants Achieving Transfusion Independence sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: UCSF Benioff Children's Hospitals status: RECRUITING city: Oakland state: California zip: 94609 country: United States lat: 37.80437 lon: -122.2708 hasResults: False

 nctId: NCT06271499 id: AnkaraU-Smart-cannulation briefTitle: The Effect of Using Smart Glasses Integrated Ultrasonography on Radial Artery Catheterization overallStatus: COMPLETED date: 2022-08-01 date: 2022-12-28 date: 2023-02-14 date: 2024-02-21 date: 2024-02-21 name: Ankara University class: OTHER name: Ayşegül Güven name: Bengi Safak name: Ahmet Onat Bermede briefSummary: The use of Ultrasonography (USG) in arterial catheterization, in which the comfort of the practitioner and hand-eye coordination become very important, is frequently needed by anesthesiologists in their daily practice. The aim of this study is to evaluate the success rate and anesthesiologist's satisfaction between two practitioners with different levels of experience in radial artery catheterization with smart glasses USG. conditions: Catheterization conditions: Cannulation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 120 type: ACTUAL name: Radial artery catheterization with USG name: Radial artery catheterization with smart glasses integrated UGG measure: The success rate measure: The anesthesiologist's satisfaction measure: The cannulation time measure: Complications sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara University Medical Faculty city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06271486 id: RC. 40.5.2023 briefTitle: Pregabalin in Treatment of Postdural Puncture Headache overallStatus: RECRUITING date: 2024-02-28 date: 2024-08-15 date: 2024-08-15 date: 2024-02-21 date: 2024-03-15 name: Al-Azhar University class: OTHER name: Benha University briefSummary: Lumbar puncture (LP), often known as a "spinal tap," is a standard medical technique pioneered in the late 1900s by Heinrich Quincke. It involves the retrieval and analysis of cerebrospinal fluid (CSF) from the spinal cord, serving as the benchmark for diagnosing conditions like subarachnoid hemorrhage, meningitis, and specific neurological conditions. Pregabalin, an anticonvulsant medicine that blocks calcium entry, is used to treat a variety of diseases. It has been used to relieve pain in a variety of patient groups, including those with chronic pain, epilepsy, and anxiety disorders conditions: Postdural Puncture Headache studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 75 type: ESTIMATED name: Pregabalin 75mg name: An epidural blood patch (EBP) name: conservative treatment. measure: the incidence of complete relief measure: The intensity of the headache sex: ALL minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Neveen Kohaf status: RECRUITING city: Tanta zip: 11865 country: Egypt name: Neveen Kohaf role: CONTACT phone: +201060383012 email: nevenabdo@azhar.edu.eg name: Nahed F. Abo-Elmatey, M.D role: PRINCIPAL_INVESTIGATOR name: Hany Bauiomy, M.D role: PRINCIPAL_INVESTIGATOR name: Ahmed M. Abosakaya, M.D role: PRINCIPAL_INVESTIGATOR lat: 30.78847 lon: 31.00192 hasResults: False

 nctId: NCT06271473 id: AinShamsU3 briefTitle: Effect of PPV+ILM Peeling +/- Subretinal Injection of Ringer Lactate in Management of Nontractional Refractory DME overallStatus: RECRUITING date: 2023-08-30 date: 2024-12-30 date: 2025-06-30 date: 2024-02-21 date: 2024-02-21 name: Ain Shams University class: OTHER briefSummary: To evaluate the efficacy and safety of combined pars plana vitrectomy and planned foveal detachment through subretinal injection of ringer's solution in patients with non-tractional refractory diabetic macular edema. conditions: Efficacy conditions: Safety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 20 eyes of 20 patients will be divided randomly into 2 groups:

* Group (A): 10 eyes subjecting to vitrectomy + ILM peeling only
* Group (B): 10 eyes subjecting to vitrectomy + ILM peeling + planned foveal detachment via subretinal injection of ringer's solution. primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution. measure: change in CMT by OCT at final visit measure: change in BCVA at final visit measure: any surgical complication or recurrence of DME sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ain Shams university status: ACTIVE_NOT_RECRUITING city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 facility: Ain Shams university status: RECRUITING city: Cairo country: Egypt name: Azza MA Said, MD role: CONTACT phone: +201006228992 email: dr_azza_22@hotmail.com name: David G Samuel, Msc role: CONTACT phone: +201064442469 email: david.samuel.ophth@gmail.com lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06271460 id: 2023-21-728 briefTitle: Disability in Patients With Non-specific Chronic Low Back Pain overallStatus: RECRUITING date: 2024-03-04 date: 2024-08 date: 2024-10 date: 2024-02-21 date: 2024-03-08 name: Acibadem University class: OTHER briefSummary: To investigate the reliability and sensitivity of the Turkish versions of the Roland-Morris Disability Questionnaire, The Quebec Back Pain Disability Scale, and the Oswestry Disability Index in patients with chronic non-specific low back pain and to increase confidence in their use in clinical practice and research by determining the most appropriate minimal clinically significant difference values for this patient population. conditions: Chronic Nonspecific Low Back Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Traditional physiotherapy measure: Visual Analog Scale measure: The Roland-Morris Disability Questionnaire measure: The Quebec Back Pain Disability Scale measure: The Oswestry Disability Index measure: The Perceived Global Impact sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Acıbadem Health Group status: RECRUITING city: Istanbul state: None Selected zip: 34752 country: Turkey name: Elif E Safran, asst. prof. role: CONTACT phone: 500 4047 phoneExt: 216 email: elif.bayraktar@acibadem.edu.tr name: Irmak Çavuşoğlu, asst. prof. role: CONTACT phone: 500 4184 phoneExt: 216 email: irmak.cavusoglu@acibadem.edu.tr name: Elif E Safran, asst. prof. role: PRINCIPAL_INVESTIGATOR name: Irmak Çavuşoğlu, asst. prof. role: PRINCIPAL_INVESTIGATOR name: Nuray Alaca, assoc. prof. role: SUB_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06271447 id: 2023-21-705 briefTitle: Answerability and Minimal Clinical Significance of the Pain Questionnaires overallStatus: RECRUITING date: 2024-03-04 date: 2024-06 date: 2024-08 date: 2024-02-21 date: 2024-03-08 name: Acibadem University class: OTHER briefSummary: To investigate the reliability and sensitivity of the Turkish versions of the Fear-Avoidance Beliefs Questionnaire, Tampa Scale for Kinesiophobia, and The Pain Catastrophizing Scale in patients with chronic non-specific low back pain undergoing multidisciplinary rehabilitation. conditions: Chronic Low-back Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Traditional therapy measure: Visual Analog Scale measure: Fear-Avoidance Beliefs Questionnaire measure: Tampa Scale for Kinesiophobia measure: The Pain Catastrophizing Scale measure: The Perceived Global Impact sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Elif Esma Safran status: RECRUITING city: Istanbul state: None Selected zip: 34752 country: Turkey name: Elif E Safran, asst. prof. role: CONTACT phone: 500 4047 phoneExt: 216 email: elif.bayraktar@acibadem.edu.tr name: Nuray N Alaca, assoc. prof. role: CONTACT phone: 500 4184 phoneExt: Safran email: elifesmabayraktar@hotmail.com name: Elif E Safran, asst. prof. role: PRINCIPAL_INVESTIGATOR name: Irmak I Çavuşoğlu, asst. prof. role: PRINCIPAL_INVESTIGATOR name: Nuray N Alaca, assoc. prof. role: SUB_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06271434 id: Olej z kryla/jelita briefTitle: Effects of Krill Oil on Intestinal Integrity Markers in Elite Rowers. overallStatus: NOT_YET_RECRUITING date: 2024-03-23 date: 2024-06-24 date: 2024-06-24 date: 2024-02-21 date: 2024-03-18 name: Poznan University of Physical Education class: OTHER briefSummary: The study aims to check the influence of krill oil on markers of intestinal injury and intoxication.

Research group: the research will be conducted in a homogeneous group of professional rowers (N=30), all competitors qualified for the Polish Youth Rowing Team, aged 18 - 24. The sample size was confiremed in statistical analyses.

Rowing performance test will be conducted at the beginning and at the end of the training camp. Participants will perform a test on a rowing ergometer (Concept II, USA); each subject will have to cover a distance of 2000 m in the shortest possible time which is the distance starting in rowing competitions. The results of both tests will be considered in the selection for the championship team; therefore, athletes will be well motivated to perform both tests with maximum effort.

Hypotesis:

The krill oil will infleunce the gut barier integrity. conditions: Endothelial Dysfunction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: All competitors will be randomly divided into two groups (double-blind):

A. supplemented (n = 15), who will receive one capsule of a supplement called THYROX (Atlantic krill oil) four times a day.

B. control (n = 15) receiving placebo. The supplementation period will be six weeks. primaryPurpose: BASIC_SCIENCE masking: TRIPLE maskingDescription: Triple whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: THYROX (Atlantic krill oil name: Placebo measure: I-FABP (intestinal fatty acid binding protein) measure: CLDN-3 measure: LBP (lipopolysaccharide binding protein) measure: Catechyloamines, cortisol measure: CD14 measure: Food intake sex: ALL minimumAge: 18 Years maximumAge: 24 Years stdAges: ADULT hasResults: False

 nctId: NCT06271421 id: 01/24 briefTitle: NanoTherm In Adjuvant Therapy of Glioblastoma Multiforme acronym: ANCHIALE overallStatus: RECRUITING date: 2024-01-01 date: 2027-02-01 date: 2027-09-01 date: 2024-02-21 date: 2024-02-26 name: Poznan University of Medical Sciences class: OTHER name: MagForce USA briefSummary: Glioblastoma multiforme (GBM), the most common and malignant primary brain tumor in adults is classified as a World Health Organisation (WHO) grade 4. Surgical removal of the tumor is the primary method of treatment. Unfortunately, because GBM is a disease of the entire brain, total resection is not possible. Therefore, the use of radiotherapy and/or chemotherapy is considered as Stupp protocol. Patients with recurrent GBM will be included in the ANCHIALE study.

The goal of the trial is to evaluate the efficacy and tolerance of using the NanoTherm therapy system in recurrent GBM.

The main questions it aims to answer are:

1. how NanoTherm therapy influences overall survival, and progression free survival;
2. what is the tolerance of NanoTherm therapy in terms of side effects (allergies, intracranial bleeding, infections, brain edema, increased intracranial pressure) and quality of life.

Participants will undergo:

* initial visit, considering the inclusion/exclusion criteria, neurological examination, and surveys regarding daily functioning and quality of life;
* standard neurosurgical operation aimed, if possible, complete removal of the recurrent GBM and administration of NanoTherm ASI - a sterile suspension of iron oxide nanoparticles. A catheter will be implanted allowing for measurement of temperature during the first activation in the magnetic field;
* between the 6th and 10th day after tumor resection, a standard computerized tomography (CT) scan of the head will be performed for routine postoperative evaluation;
* after the first activation (10th day), the catheter will be removed;
* subsequently, for 6 times, the patient will be subjected to the variable magnetic field of the NanoActivator® to induce hyperthermia - activations will be conducted on the 10th, 14th, 17th, 21st, 24th, and 28th day;
* for up to 2 years post-procedure, a CT scan with an evaluation of treatment efficacy will be performed;
* during follow-up visits for up to 2 years after the surgical procedure, a neurological examination, assessment of adverse symptoms, number of hospitalizations, number of medical visits, clinimetric assessment regarding quality of life, neurological deficit and degree of disability will be conducted.

Researchers will compare NanoTherm group with patients undergoing Stupp protocol treatment for the abovementioned effects. conditions: Glioblastoma Multiforme studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A prospective longitudinal study will be performed recurrent glioblastoma multiforme patients who:

1. are included for NanoTherm therapy (group A),
2. are included for standard Stupp protocol (surgery/chemo-radiotherapy) (group B) primaryPurpose: TREATMENT masking: NONE maskingDescription: ANCHIALE is open-label study count: 100 type: ESTIMATED name: NanoTherm therapy name: Glioma Resection name: radiotherapy according to Stupp protocol name: chemotherapy according to Stupp protocol measure: Survival following the surgery [units months 1-24] measure: Progression free survival [units months 1-24] measure: Response Assessment in Neuro-oncology [1 - complete response; 4 -progressive disease] measure: EuroQuality of Life 5-dimensions-5 levels scale (EQ-5D-5L) [arbitraty units 0- worst ; 100 - best] measure: Neurologic Assessment in Neuro-Oncology (NanoScale 2) [0-best; 23-worst] measure: modified Rankin scale [0-best; 6-worst] measure: Barthel index [range 0-100; 0-best, 100-worst] sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital status: RECRUITING city: Poznań zip: 60-355 country: Poland name: Slawomir Michalak, Prof. role: CONTACT phone: +4861 8691 535 email: swami@ump.edu.pl name: Jakub Moskal, MD, PhD role: CONTACT phone: +4861 8691 422 email: jakub.moskal@usk.poznan.pl lat: 52.40692 lon: 16.92993 hasResults: False

 nctId: NCT06271408 id: POL-Xe-005 briefTitle: Comparison of Bronchodilator Response From Three Different Aerosol Delivery Methods in Patients With COPD Using Hyperpolarized Xe 129 MRI Ventilation Imaging overallStatus: RECRUITING date: 2024-02 date: 2024-04 date: 2024-04 date: 2024-02-21 date: 2024-02-21 name: Polarean, Inc. class: INDUSTRY name: Aerogen briefSummary: The goal of this clinical trial is to compare responses to bronchodilator treatment delivered by three different aerosol delivery methods in patients with chronic obstructive pulmonary disease (COPD). The main question it aims to answer is whether there are differences in lung ventilation following treatment with each of the three methods as measured using hyperpolarized Xe 129 with MRI.

Participants will:

Receive a standard dose of albuterol delivered using each of 3 aerosol delivery devices. In total, participants will receive three treatments separated by at least 1 week each.

Following each treatment, participants will have inhale an MRI contrast agent called hyperpolarized Xe 129 and will have images of their lungs taken with an MRI.

Researchers will compare the different lung images taken after each treatment to see if there are differences in the distribution of air in the lungs (known as ventilation). conditions: Chronic Obstructive Pulmonary Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 6 type: ESTIMATED name: Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation Solution name: Vibrating Mesh Nebulizer name: Metered Dose Inhaler name: Jet Nebulizer measure: Ventilation Defect Percent measure: Distribution of ventilated space measure: Membrane uptake of Xe 129 measure: Red blood cell Xe 129 transfer sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Virginia Sheridan Snyder Translational Fontaine Research Unit status: RECRUITING city: Charlottesville state: Virginia zip: 22947 country: United States name: Roselove Roselove Nunoo-Asare role: CONTACT phone: 434-243-6074 email: rnn3b@virginia.edu lat: 38.02931 lon: -78.47668 hasResults: False

 nctId: NCT06271395 id: Chaoshengqiunang briefTitle: Ultrasound-guided Botulinum Toxin Injection on Cricopharyngeal Muscle Dysfunction overallStatus: RECRUITING date: 2024-02-28 date: 2024-10 date: 2024-10 date: 2024-02-21 date: 2024-03-07 name: Zeng Changhao class: OTHER briefSummary: Ultrasound-guided injection is a visual, convenient, and radiation-free technique that allows real-time observation of the needle insertion process and drug injection location. The combination with a balloon for fixation further enhances the precision of the injection. In this study, we employed ultrasound-guided injection combined with balloon localization for cricopharyngeal muscle botulinum toxin injection treatment and conducted clinical observations. conditions: Cricopharyngeal Achalasia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Injectable Type A Botulinum Toxin measure: functional oral intake scale measure: Penetration-Aspiration Scale measure: The Fiberoptic Endoscopic Dysphagia Severity Scale measure: Murray secretion scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xinzhu Rehabilitation Hospital status: RECRUITING city: Xinzhu country: Taiwan name: Haim Liu role: CONTACT lat: 22.46205 lon: 120.47335 hasResults: False

 nctId: NCT06271382 id: AIBU-SBF-SA-05 briefTitle: The Effect Of Acupressure and Foot Exercise on Ankle Brachial Index in Individuals With Type 2 Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-02-15 date: 2025-02-15 date: 2025-02-15 date: 2024-02-21 date: 2024-02-21 name: Abant Izzet Baysal University class: OTHER briefSummary: This study was planned with a randomized controlled experimental design to examine the effects of acupressure and ankle exercises on ankle brachial index in individuals with Type 2 diabetes. conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 66 type: ESTIMATED name: Acupressure Group name: Sham Acupressure Group name: Foot Ankle Exercise Group measure: Ankle Brachial Index sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06271369 id: CCTL019CUS13 briefTitle: Real-World HRU and Costs in DLBCL Pts With Tisa-cel and Axi-cel, a Medicare Study. overallStatus: COMPLETED date: 2022-08-11 date: 2023-02-15 date: 2023-02-15 date: 2024-02-21 date: 2024-02-21 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: This was a retrospective non-interventional cohort study design using the Centers for Medicare and Medicaid Services (CMS) 100% Medicare data (2015Q1-2020Q4).

Eligible adult patients with r/r DLBCL who were treated with CAR-T therapy were identified from the CMS 100% Medicare data. Patients who received chimeric antigen receptor modified T cell (CAR-T) therapy were further classified into tisa-cel and axi-cel cohorts based on the type of CAR-T treatment received. The index date was defined as the date of tisa-cel or axi-cel therapy administration. Baseline period was defined as three months prior to the index date. Study period was defined from the index date to the end of health plan coverage based on insurance enrollment file or death, whichever occurred earlier. conditions: Diffuse Large B-cell Lymphoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 613 type: ACTUAL measure: Number of patients with IP admission measure: Number of IP admissions measure: IP days measure: Number of ICU stays measure: ICU days measure: Number of patients with OP visit measure: Number of OP visits measure: Number of patients with ER visit measure: Number of ER visits measure: Healthcare reimbursement costs measure: Overall survival (OS) measure: Time to next treatment (TTNT) or death sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Novartis city: East Hanover state: New Jersey zip: 07936 country: United States lat: 40.8201 lon: -74.36487 hasResults: False

 nctId: NCT06271356 id: STU00220278 briefTitle: Breast Cancer - Navigate - Prospective Cohort overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-04 date: 2024-02-21 date: 2024-02-21 name: Northwestern University class: OTHER name: The Chrysalis Initiative briefSummary: The Chrysalis Initiative (TCI) has with its technology partner Eversana/Intouch developed the BC-Navigate website/application to help guide women through care delivery during breast cancer treatment.

TCI a nonprofit, breast cancer education and navigation organization is developing methods to address health inequities in cancer care delivery. TCI and its new academic/clinical partner, The Robert H. Lurie Comprehensive Cancer Center of Northwestern University, propose to apply TCI's developed patient navigation support techniques to enhance knowledge and self-advocacy among a cohort of Black and African American women, and other women of color (WOC), receiving care in Northwestern's breast cancer program.

Therefore, the purpose of this study is to apply TCI's patient navigation-and-coaching program and its website/mobile app (Breast Cancer-Navigate) platform to improve timely initiation to patient adjuvant treatment among WOC breast cancer patients and evaluate the feasibility and preliminary efficacy of this approach. conditions: Breast Cancer conditions: Quality of Life conditions: Chemotherapy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 150 type: ESTIMATED name: BC-Navigate measure: Demand of BC-Navi: Recruitment Rate measure: Demand of BC-Navi: Rentention Rate measure: Acceptability of BC-Navi measure: Preliminary Efficacy: Chemotherapy Initiation sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northwestern University city: Chicago state: Illinois zip: 60611 country: United States name: Diana Buitrago role: CONTACT phone: 312-503-2866 email: diana.buitrago@northwestern.edu lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06271343 id: RC23_0394 briefTitle: Kidney Graft Tolerance KTOL acronym: KTOL overallStatus: RECRUITING date: 2024-03-20 date: 2026-03-01 date: 2026-06-01 date: 2024-02-21 date: 2024-03-21 name: Nantes University Hospital class: OTHER name: Institut National de la Santé Et de la Recherche Médicale, France briefSummary: Prospective experimental study using PBMC from a limited number of adult patients (15) treated at Nantes University Hospital for a kidney transplant from a related living donor.

The study will be carried out on PBMC from both donors and recipients, collected during visits scheduled as part of the clinical management of the donor/recipient pair.

The study will test the hypothesis that DP8α Tregs expressing CD73, whose frequency in blood increases stably after non-rejected kidney transplants, but not when patients have undergone or will subsequently undergo rejection, are enriched in donor-specific cells, which would be a strong argument in favor of a direct role for these Tregs in preventing transplant rejection, through their ability to inhibit immune responses directed against donor alloantigens. conditions: Kidney Transplant Tolerance studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 15 type: ESTIMATED measure: To test the role of donor-specific DP8α Tregs in preventing kidney transplant rejection. measure: Determine whether the increased anti-donor reactivity of the patient's DP8α Tregs after transplantation results from the amplification among them of clones and establish, if possible, the anti-donor reactivity of amplified clones. measure: Determine whether clones of DP8α Tregs (reactive or not to donor antigens) are reactive to F. prausnitzii bacteria. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nantes University Hospital status: RECRUITING city: Nantes state: Loire-Atlantique zip: 44093 country: France name: Christophe MASSET, PH role: CONTACT phone: 33 2 76 64 39 61 email: christophe.masset@chu-nantes.fr lat: 47.21725 lon: -1.55336 hasResults: False

 nctId: NCT06271330 id: AP_JBD_FarWest_004 briefTitle: Multicenter Real-life Observational Study Switched Aflibercept or Ranibizumab to Faricimab in Patients With AMD. acronym: FAR-WEST overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2026-09 date: 2024-02-21 date: 2024-02-21 name: Nantes University Hospital class: OTHER name: Rennes University Hospital briefSummary: Age-related macular degeneration (AMD) is a degenerative retinal disease. The prognosis of the exudative form was transformed by the introduction of the anti-VEGF monoclonal antibody treatments ranibizumab \[1\] and aflibercept \[2\] in the 2010s. In 2022, a new molecule, Faricimab, proved its efficacy in exudative AMD. It is a bi-specific monoclonal antibody against VEGF-A and ANG2. The drug has been granted marketing authorization in France, with reimbursement due to begin in October 2023 for naïve patients as well as for those already treated with ranibizumab or aflibercept. The main advantage of this compound \[3\] is that it extends the injection interval in the Treat and Extend (T\&E) protocol, which is more extensive than with previous anti-VEGF agents.

The patients included in the faricimab Phase III study were all naïve to any anti-VEGF treatment. In practice, faricimab is likely to offer hope to patients already treated with anti-VEGF with a short injection interval to lengthen the number of weeks between injections.

As the treatment will be on sale in pharmacies from October 2023, a switch study from previous anti-VEGF drugs to faricimab would contribute to an initial real-life evaluation of the drug in this indication. conditions: AMD studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: Faricimab measure: Difference in number of weeks between previous treatment (ranibizumab or aflibercept) and after 6 months of Faricimab treatment. measure: Difference between time to recurrence before switch and after switch. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ducloyer city: Nantes zip: 44000 country: France name: Jean-Baptiste Ducloyer, MD role: CONTACT phone: 02 40 08 46 51 email: jeanbaptiste.ducloyer@chu-nantes.fr name: Yann Maucourant, MD role: CONTACT phone: 85 658 email: Yann.MAUCOURANT@chu-rennes.fr lat: 47.21725 lon: -1.55336 hasResults: False

 nctId: NCT06271317 id: AP_CL_001 briefTitle: Evaluation of Possible Postoperative Complications After Nissen Sleeve Gastrectomy. French Multicenter Study overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2027-03 date: 2027-03 date: 2024-02-21 date: 2024-02-21 name: Nantes University Hospital class: OTHER briefSummary: The purpose of this study is to evaluate the impact about complications between the procedure (sleeve gastrectomy technique with a Nissen fundoplication (N-Sleeve)) and conventional sleeve gastrectomy technique conditions: Obesity studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Study postoperative morbidity after nissen sleeve gastrectomy in Nantes measure: postoperative morbidity of nissen sleeve gastrectomy with sleeve gastrectomy in France sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06271304 id: BLUES briefTitle: Stabilizing Mood and Sleep With Blue Blocking Eyewear in Bipolar Disorder acronym: BLUES overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2026-03-01 date: 2026-06-01 date: 2024-02-21 date: 2024-04-17 name: Mental Health Services in the Capital Region, Denmark class: OTHER briefSummary: The study investigates whether add-on treatment with eyewear that blocks the short wavelengths of visible light (\<500nm) reduces manic symptoms and improves sleep in patients receiving outpatient treatment as usual for bipolar disorder.

When in a hypomanic or manic phase, participants will be randomized to receive add-on treatment with either blue blocking or low filtration eyewear from 18 PM to 8 AM daily for 7 days.

After this initial intervention phase, the eyewear is used daily for 3 months in either antimanic dose (14 hours) or maintenance dose (2 hours before bedtime). conditions: Bipolar Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Outcome assessors will be blinded to the treatment assignment. At the beginning of each assessment, participants will be instructed not to describe or discuss their glasses with the assessor. Because the two types of glasses are of different color (clear (LF) and orange (BB)), we cannot guarantee a full blinding of the participants. Participants will be informed that we are studying the effects of two different types of light filters without more detail so they will not be provided with certain knowledge of which condition is expected to yield the largest effect. We will assess the integrity of the blind by asking participants whether they think they received glasses with high or low filtration lenses at the end of the study. Participants will be discouraged from actively seeking information about sleep glasses during the study primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Participants are instructed not to discuss the appearance of their designated eyewear with their care providers or the investigator or outcome assessor. Participants are not informed of the exact filtration level of their eyewear. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: Blue blocking eyewear name: Low filtration eyewear measure: Manic symptoms measure: Mood instability measure: Objective sleep quality measure: Objective sleep quality measure: Subjective sleep quality measure: Subjective sleep quality sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06271291 id: 23-000161 id: NCI-2024-00504 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 23-000161 type: OTHER domain: Mayo Clinic in Rochester id: P30CA015083 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA015083 id: U01CA210138 type: NIH link: https://reporter.nih.gov/quickSearch/U01CA210138 id: U24CA274496 type: NIH link: https://reporter.nih.gov/quickSearch/U24CA274496 briefTitle: Pancreatic Cancer Detection Consortium (PCDC) Prospective Cohorts overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2029-05-01 date: 2029-05-01 date: 2024-02-21 date: 2024-03-20 name: Mayo Clinic class: OTHER name: National Cancer Institute (NCI) briefSummary: This study evaluates individuals without pancreatic cancer, but who have been determined to be at higher-than-average lifetime risk of developing pancreatic cancer to help detect pancreatic cancer or other cancers at an earlier time when they might be more easily treated and cured. conditions: Pancreatic Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 15000 type: ESTIMATED name: Non-Interventional Study measure: Develop a biobank of biospecimens and data of subjects without pancreatic cancer who are at high risk for pancreatic cancer measure: Follow subjects longitudinally and collect biospecimens and follow-up data and record medical outcomes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City of Hope city: Duarte state: California zip: 91010 country: United States name: Ajay Goel, Ph.D. role: CONTACT phone: 626-256-4673 phoneExt: 85200 name: Ajay Goel, Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 34.13945 lon: -117.97729 facility: Mayo Clinic in Rochester city: Rochester state: Minnesota zip: 55905 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Shounak Majumder, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 facility: University of Pittsburgh city: Pittsburgh state: Pennsylvania zip: 15232 country: United States name: Randall Brand, M.D. role: CONTACT phone: 412-864-7516 lat: 40.44062 lon: -79.99589 hasResults: False

 nctId: NCT06271278 id: 2023-17 briefTitle: The Effect of Emotional Freedom Techniques Application on Nurses overallStatus: RECRUITING date: 2023-11-02 date: 2024-02-28 date: 2024-02-28 date: 2024-02-21 date: 2024-02-22 name: Gurkan KAPIKIRAN class: OTHER briefSummary: Nurses working in surgical intensive care units face numerous health and safety stressors. The introduction of new health technologies, medical devices (such as bedside monitors, pump and perfuser devices, and mechanical ventilators), and changing health environments have contributed to increased work stress among nurses. This, in turn, has had negative effects on their physical and mental health outcomes. One of the hazards associated with medical devices is alarm fatigue. Noise pollution caused by bells, beeps, and horns in intensive care units can lead to alarm fatigue, defined as desensitisation to monitor alarms. Nurses are particularly susceptible to this due to their constant exposure to these sounds, which can also cause stress. Occupational stress is a recognised issue in this demanding field, characterised by disproportionate workloads and negative effects on performance.Work-related stress can lead to a loss of compassion towards patients and an increase in malpractice, negatively affecting the quality of care. Thus, this study aimed to investigate the impact of applying emotional freedom techniques on work-related stress and alarm fatigue experienced by nurses working in surgical intensive care units. conditions: Occupational Stress conditions: Alert Fatigue, Health Personnel studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study was conducted as a randomised controlled study with experimental and control groups. primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE maskingDescription: Participants will be blinded to their group assignment. The subjects will be selected in a randomized order using software. Data collection will be conducted without involvement from research analysts. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 144 type: ESTIMATED name: Emotional Freedom Technique measure: Subjective Units of Disturbance Scale measure: Alarm Fatigue Scale measure: The General Work Stress Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Inonu University Turgut OzaL Medical Center status: RECRUITING city: Malatya zip: 44090 country: Turkey name: Turgut Ozal Medical Center role: CONTACT phone: +904223770100 email: totm@inonu.edu.tr role: CONTACT email: gurkankpkrn@gmail.com name: Gurkan Kapikiran, Ph.D role: PRINCIPAL_INVESTIGATOR name: Seher Çevik Aktura, Ph.D role: SUB_INVESTIGATOR name: Şerafettin Okutan, Ph.D role: SUB_INVESTIGATOR name: Remziye Cici, Ph.D role: SUB_INVESTIGATOR lat: 38.35018 lon: 38.31667 hasResults: False

 nctId: NCT06271265 id: 402-C-125 briefTitle: Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-07 date: 2025-07 date: 2024-02-21 date: 2024-02-21 name: Pacira Pharmaceuticals, Inc class: INDUSTRY briefSummary: This Phase 1, multicenter, open-label, randomized, bupivacaine-controlled study is designed to evaluate the pharmacokinetics (PK) and safety of EXPAREL vs. bupivacaine HCl for postsurgical analgesia in pediatric subjects aged 0 to less than 6 years of age undergoing cardiac surgery, utilizing local infiltration analgesia (LIA). conditions: Postoperative Pain studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: EXPAREL name: bupivacaine measure: The following model-predicted PK endpoint will be determined: measure: The following model-predicted PK endpoint will be determined: measure: The following model-predicted PK endpoint will be determined: measure: The following model-predicted PK endpoint will be determined: measure: The following model-predicted PK endpoint will be determined: measure: The following model-predicted PK endpoint will be determined: measure: Vitals change from Baseline: measure: Vitals change from Baseline: measure: Vitals change from Baseline: measure: Vitals change from Baseline: measure: Vitals change from Baseline: measure: Incidence of treatment-emergent adverse events (TEAEs) measure: Incidence of adverse events of special interest (AESIs) measure: Incidence of serious adverse events (SAEs) sex: ALL minimumAge: 0 Years maximumAge: 6 Years stdAges: CHILD hasResults: False

 nctId: NCT06271252 id: OriCAR-017 US-P1 briefTitle: A Study to Evaluate the Safety, PK/PD of (OriCAR-017) in Subjects With RR/MM - RIGEL Study overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-12-01 date: 2026-04-01 date: 2024-02-21 date: 2024-04-16 name: OriCell Therapeutics Co., Ltd. class: INDUSTRY briefSummary: The is a first clinical study for Oricell Therapeutics Inc. in the United States to evaluate the safety, PK, PD and preliminary efficacy of our anti-GPRC5D cell product (OriCAR-017) in subjects with relapsed/refractory multiple myeloma.

RIGEL Study conditions: Neoplasms, Plasma Cell conditions: Neoplasms by Histologic Type conditions: Neoplasms conditions: Hemostatic Disorders conditions: Vascular Diseases conditions: Cardiovascular Diseases conditions: Paraproteinemias conditions: Blood Protein Disorders conditions: Hematologic Diseases conditions: Hemorrhagic Disorders conditions: Lymphoproliferative Disorders conditions: Immunoproliferative Disorders conditions: Immune System Diseases conditions: Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 81 type: ESTIMATED name: OriCAR-017 measure: Maximum tolerated dose (MTD) of OriCAR-017 US-P1 measure: Dose-limiting toxicity (DLT) measure: Evaluate PK parameters of OriCAR-017 in subjects with relapsed/refractory MM measure: Evaluate PD parameters of OriCAR-017 in subjects with relapsed/refractory MM measure: Assessment of Duration of Response (DOR) of treatment in patients with RR/MM measure: Progress-Free Survival (PFS) of treatment in patients with RR/MM measure: Assessment of Overall Survival (OS) of treatment in patients with RR/MM measure: Assessment of MRD negative Rate measure: Assessment of Overall Response Rate (ORR) measure: Assessment of Disease Control Rate (DCR) measure: Assessment of Clinical Benefit Rate (CBR) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northside Hospital city: Atlanta state: Georgia zip: 30342 country: United States name: Melhem Solh role: CONTACT email: msolh@bmtga.com name: Caitlin Guzowski role: CONTACT email: caitlin.guzowski@northside.com lat: 33.749 lon: -84.38798 hasResults: False

 nctId: NCT06271239 id: U1111-1299-9167 id: 65318722.0.0000.5336 type: OTHER domain: IRB-Pontifical Catholic University of Rio Grande do Sul id: RBR-2tq2jky type: OTHER domain: The Brazilian Registry of Clinical Trials (ReBEC) briefTitle: Effect of Multicomponent Exercises VIVIFRAIL® in Older Adults overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-12-31 date: 2025-03-30 date: 2024-02-21 date: 2024-02-21 name: Pontificia Universidade Católica do Rio Grande do Sul class: OTHER name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. briefSummary: This study employs a randomized, controlled, paired, single-blind clinical trial design. The targeted demographic comprises individuals aged 60 and above. Following the initial assessment, participants will be randomly allocated to two groups: the Intervention Group (ViviFrail) and the Group Suggestions for a Healthy Life (CG), maintaining a 1:1 allocation ratio. Both the ViviFrail group and CG group will exhibit homogeneity in terms of their clinical characteristics and functional performance. The allocation of participants into respective groups will remain concealed from all assessors, ensuring a single-blind approach.

In the intervention group (ViviFrail), 25 participants will be instructed to engage in tailored physical exercises outlined in the VIVIFRAIL® protocol within the confines of their homes, with adaptations made according to their clinical conditions and functional performance.

Conversely, the Group Suggestions for a Healthy Life (CG) comprising 25 participants will receive exercise suggestions and guidance to maintain a healthy routine for a duration of three months. Subsequently, participants in the CG will undergo the VIVIFRAIL® program intervention for an additional three months. conditions: Frailty conditions: Aging conditions: Physical Disability studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In the Intervention Group (ViviFrail), participants will perform a six-month VIVIFRAIL® protocol-based exercise, adapted to their clinical profile.

The Group Suggestions for a Healthy Life (CG) will receive exercise suggestions and guidance for maintaining a healthy routine for three months. After, they will undergo a three-month intervention using the VIVIFRAIL® protocol.

Sample size determination was based on Casas-Herrero et al. (2022). The study assessed the impact of multicomponent training on intrinsic functional capacity, utilizing the Short Physical Performance Battery (SPPB) to gauge balance, gait speed, and lower limb strength on a 0 to 12 scale. Control group: -0.33±1.60 point difference; Treatment group: 1.07±1.52 point difference.

Considering a 5% alpha and 80% power, 20 participants per group are required. Anticipating a 25% dropout rate, as observed by Tiecker (2021), we plan to enroll 25 participants per group. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The assessments will be conducted by trained researchers whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Intervention group (ViviFrail) name: Group Suggestions for a Healthy Life (CG) measure: Short physical performance battery measure: Barthel Index measure: ICOPE questionnaire measure: Lawton Scale measure: 4-meter gait speed measure: Five Times Sit-to-Stand measure: Balance test in three positions measure: Self-perceived health measure: Adverse health outcomes - falls measure: Adverse health outcomes - hospitalization measure: Adverse health outcomes - institutionalization sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06271226 id: OMUKAEK 2022/75 id: OMUKAEK 2022/75 type: OTHER domain: ONDOKUZ MAYIS UNIVERSTY briefTitle: The Effect of Acupressure Applied to Icu on Pain and Physiological Parameters acronym: EFFECTOFACU overallStatus: RECRUITING date: 2023-03-20 date: 2024-06-30 date: 2024-12-31 date: 2024-02-21 date: 2024-02-21 name: Ondokuz Mayıs University class: OTHER briefSummary: The aim of this experimental study is to determine the effect of acupressure applied to intensive care patients on pain and physiological parameters (blood pressure, heart rate, respiration and oxygen saturation).

The main questions that the study aims to answer are:

Acupressure applied to intensive care patients has no effect on pain. Acupressure applied to intensive care patients has an effect on pain. Acupressure applied to intensive care patients has no effect on physiological parameters.

Acupressure applied to intensive care patients has an effect on physiological parameters.

Participants will be included in the study after obtaining consent from patients who were treated in the intensive care unit, who scored 9 and above on the glaskow coma scale by evaluating their consciousness status, and had pain after evaluating their pain. conditions: Intensive Care Patients conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Since there will be variability in patient admissions to intensive care units, block randomization will be used. Three different groups will be coded with different letters (A,B,C) and blocks will be created. Then randomization will be performed by assigning random numbers on the computer. The letters determined in the randomization will be written in closed envelopes and stored, and the randomization process will be carried out by an independent researcher. After the patient who meets the inclusion criteria is identified, the independent researcher will be contacted to find out which group the patient is in. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: participant and statistical analysis expert is blind. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: acupressure name: placebo acupressure name: control group measure: neurological evaluation measure: evaluation of pain measure: evaluation of physiological parameters measure: evaluation of physiological parameters sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Giresun Eğitim Araştırma Hastanesi status: RECRUITING city: Giresun zip: 28000 country: Turkey name: emine yaman lezki role: CONTACT phone: +9005458026622 email: e_yaman95@hotmail.com lat: 40.91698 lon: 38.38741 hasResults: False

 nctId: NCT06271213 id: 303841 briefTitle: The Gut-Lung Axis and Respiratory Illness in Children overallStatus: RECRUITING date: 2024-02-04 date: 2027-11-01 date: 2028-05-01 date: 2024-02-21 date: 2024-02-21 name: NHS Greater Glasgow and Clyde class: OTHER name: University of Glasgow briefSummary: The goal of this single-centre observational study conducted at the Royal Hospital for Children in Glasgow, Scotland, is to employ a multi-omics approach to investigate the "gut-lung axis" in health and disease.

Part A is a cross-sectional study design investigating the postulated bidirectional link between the gut and lung microbiomes in children suffering from respiratory or gastrointestinal conditions. Children with no GI or respiratory issues attending for orthopaedic care will be used as a benchmark for a healthy gut-lung axis. The main questions we aim to answer are:

* What does a healthy gut-lung axis look like?
* Do children with respiratory issues show an altered gut microbiome?
* Do children with GI issues show an altered lung microbiome?

Part B is a longitudinal study design, that aims to assess the effects of biologics on the gut-lung axis by comparing the gut and lung microbiomes in children with asthma at two time-points who are indicated to start biologics therapy (Asthma treatment) or will not receive biologics therapy (asthma control).

Participants will provide:

* airway samples (to investigate the lung microbiome)
* blood samples (to assess inflammatory and metabolic factors which may mediate communication between the two sites) whilst under general anaesthetic for a treatment related to their standard of care
* stool samples (to assess gut microbiome)
* dietary information (food diary and/or food frequency questionnaire) to assess relationships between diet and the gut-lung axis. conditions: Respiration Disorders conditions: Respiratory Disease conditions: Asthma in Children conditions: Wheezing conditions: Gastro-Intestinal Disorder conditions: Healthy studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 150 type: ESTIMATED name: observational only - no interventions as part of study measure: Assess differences in gut and lung microbiota diversity between groups measure: Assess changes in gut and lung microbiota in children with asthma receiving biologics measure: Determine mediators of gut-lung axis in health and disease measure: Nutritional influence in gut-lung axis measure: Multi-omics integration sex: ALL minimumAge: 0 Years maximumAge: 16 Years stdAges: CHILD facility: NHS Greater Glasgow and Clyde: Royal Hospital for children, Glasgow status: RECRUITING city: Glasgow country: United Kingdom name: Ross J Langley, MRCPCH role: CONTACT phone: 0141 451 6683 email: ross.langley@ggc.scot.nhs.uk lat: 55.86515 lon: -4.25763 hasResults: False

 nctId: NCT06271200 id: MG-113-GP-03 briefTitle: Intervention on Metabolism and Related Chronic Diseases overallStatus: NOT_YET_RECRUITING date: 2024-02-20 date: 2026-01-19 date: 2027-12-31 date: 2024-02-21 date: 2024-02-21 name: National Health Research Institutes, Taiwan class: OTHER name: Tri-Service General Hospital name: Chang Gung Memorial Hospital name: National Taiwan University Hospital Hsin-Chu Branch name: Taichung Armed Forces General Hospital briefSummary: This study is a randomized, parallel-group, observer-masked clinical trial. A total of 120 obese participants with MetS will be enrolled. Eligible subjects will be randomly assigned to the ILI group or ULI group with an allocation ratio of 2:1. The ILI group will be instructed to eat in 8 hours while fasting in 16 hours on daily basis over 24 weeks. Furthermore, enhanced daily physical activities with walking more than 10,000 steps will be implemented. The enrolled participants will be instructed to follow a diet with reduction of daily intake of 500 kcals per day. ILI group will be asked to use the Health2Sync mobile app to track self-measured outcomes and daily diet control. The investigators objectively measure step counts for participants of ILI group during 24-week intervention period using a wearable device (Fitbit Inspire 2). Participants are asked to attach the pedometer on their waist belt, except while bathing and sleeping. The ULI group will be instructed to follow habitual meal timing. In addition, all participants of both groups will receive the health education. Anthropometric, sociodemographic data, biochemical variables, and metabolic variables will be measured at baseline and during follow-up visit. DEXA and MRI of abdomen will be measured at baseline and during following up visits. The proposed trial is designed to provide 85% statistical power to detect a significant difference in changes in the metabolic syndrome severity score after reduction \> 5% body weight over 24 weeks. conditions: Metabolic Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is a randomized, parallel-group, observer-masked clinical trial. A total of 120 obese participants with MetS will be enrolled. Eligible subjects will be randomly assigned to the ILI group or ULI group with an allocation ratio of 2:1. primaryPurpose: PREVENTION masking: NONE count: 120 type: ESTIMATED name: Intermittent fasting and 10,000 steps per day measure: Change in the metabolic syndrome severity score (Z score) after reduction > 5% body weight from baseline to 24 weeks sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Molecular and Genomic Medicine, National Health Resesarch Institutes city: Zhunan state: Miaoli County zip: 350 country: Taiwan name: Vivian Wang, Master role: CONTACT phone: +886-37-206166 phoneExt: 35374 email: ywwang@nhri.edu.tw lat: 22.57358 lon: 120.54147 hasResults: False

 nctId: NCT06271187 id: A-ER-110-507 briefTitle: Dynamic-orthosis Programs for Stroke Hand Function overallStatus: RECRUITING date: 2023-01-22 date: 2024-10-31 date: 2024-12-31 date: 2024-02-21 date: 2024-02-21 name: National Cheng-Kung University Hospital class: OTHER briefSummary: This study aims to investigate the training benefits of modular 3D printed dynamic orthoses on upper limb function in stroke survivors. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Dynamic-orthosis name: Traditional stroke occupational therapy training measure: Fugl-Meyer Assessment- Upper Extremity measure: Box and Block Test measure: Motor Activity Log measure: Modified Ashworth scale measure: Upper limb joint range of motion sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cheng Kung University status: RECRUITING city: Tainan zip: 701 country: Taiwan name: JER-HAO CHANG, PH.D. role: CONTACT phone: 886-6-2353535 phoneExt: 5912 email: jerhao@ncku.edu.tw lat: 22.99083 lon: 120.21333 hasResults: False

 nctId: NCT06271174 id: RC23_0009 briefTitle: Avoid With Locoregional Analgesia Persistant Postoperative Pain In Children acronym: AWA3PASIC overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-05 date: 2026-05 date: 2024-02-21 date: 2024-04-09 name: Nantes University Hospital class: OTHER name: Fondation Apicil briefSummary: Persistent postoperative pain is a substantial pain (scores 4-10 using a 0-10 numeric scale) that develops 3 months after surgery.

Persistent postoperative pain can be a problem even in ambulatory surgery. Loco-regional analgesia could prevent the occurrence of this pathology but contradictory results are found in ancient studies.

This study is the first randomized controlled study in children about loco-regional analgesia and persistent postoperative pain in traumatologic orthopedic surgery.

One interventional arm will receive a locoregional analgesia after general anesthesia and before incision. The other arm will only receive systemic analgesia during general anesthesia.

The incidence of persistent postoperative pain at 3, 6 and 12 months will be compared in these two groups.

The goal is to show the decrease of the incidence of the persistent postoperative pain in the group "locoregional analgesia". conditions: Persistent Postoperative Pain studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 208 type: ESTIMATED name: Carbocaine name: Profofol and/or Suxaméthonium and/or Sévoflurane measure: Persistent Postoperative Pain measure: Screening of neuropathic pain if persistent postoperative pain - 3 months measure: Screening of neuropathic pain if persistent postoperative pain - 6 months measure: Screening of neuropathic pain if persistent postoperative pain - 12 months measure: 1st EN score in immediate post-operative ICU before morphine titration measure: Persistent postoperative pain at 6 months. measure: Persistent postoperative pain at 12 months. measure: Postoperative nausea and vomiting measure: Time in Post Interventional Care Unit measure: Opioïd dose received - Per-operative measure: Opioïd dose received - in Post Interventional Care Unit measure: Opioïd dose received measure: Intravenous Morphine dose received in Post Interventional Care Unit sex: ALL minimumAge: 5 Years maximumAge: 183 Months stdAges: CHILD hasResults: False

 nctId: NCT06271161 id: F002 briefTitle: The Effect of Pharyngeal Cooling Applications on Postoperative Throat Pain and Nausea Vomiting overallStatus: COMPLETED date: 2023-01-01 date: 2023-11-01 date: 2024-01-01 date: 2024-02-21 date: 2024-02-21 name: Selcuk University class: OTHER briefSummary: The goal of this observational study is to to evaluate the effects of a throat pack soaked with saline at +4 ºC on postoperative throat pain (POTP) and postoperative nausea and vomiting (PONV) in dental surgical procedures performed under general anesthesia. The main questions it aims to answer are: 1. How long can we keep the pharyngeal mucosa cold using tampons and cold wash solutions? 2. Does cooling the pharyngeal mucosa reduce the incidence of postoperative sore throat and nausea and vomiting? conditions: Postoperative Pain conditions: Postoperative Nausea and Vomiting conditions: Throat, Sore conditions: Anesthesia studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 84 type: ACTUAL measure: The incidence of postoperative sore throat and noise vomiting was investigated in dental surgery involving the application of cooling to the pharyngeal area, particularly when a throat pack was used. measure: Intraoperative change in nasopharyngeal temperature from baseline (ºC ), intraoperative opioid usage (mcg), postoperative analgesic usage (mg),antiemetic usage(mg) and any adverse events due to throat pack were recorded. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Funda Arun city: Selçuklu state: Konya zip: 42000 country: Turkey lat: 37.8842 lon: 32.49222 hasResults: False

 nctId: NCT06271148 id: Mutah University id: Myah REC/133/2023 type: REGISTRY domain: Mutah university school of medicine briefTitle: Career and Lifestyle Among Female Surgeons in Jordan overallStatus: COMPLETED date: 2023-02-03 date: 2023-12-17 date: 2023-12-31 date: 2024-02-21 date: 2024-02-21 name: Mohammad Abu-Jeyyab class: OTHER briefSummary: A study conducted to evaluate the female surgeons in Jordan from different lifestyle conditions: Surgery conditions: Lifestyle studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 224 type: ACTUAL name: Interview measure: Career and Lifestyle Among Female Surgeons in Jordan measure: Working Hours measure: Sex Bias measure: inadequate mentorship measure: having 30 days of leave measure: salary sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Mutah University city: Al-Karak zip: 61710 country: Jordan lat: 31.16368 lon: 35.76204 hasResults: False

 nctId: NCT06271135 id: LU20170508 briefTitle: Assessing the Quality of Life of Patients With Rosacea overallStatus: COMPLETED date: 2017-05-08 date: 2018-11-30 date: 2018-11-30 date: 2024-02-21 date: 2024-02-21 name: Medical University of Bialystok class: OTHER name: University of Lomza briefSummary: The study population consisted of 160 patients (123 women and 37 men) with rosacea, who agreed to participate in this study. Patients were qualified for the study among people visiting the cosmetic studio in Choroszcz in the period from June 2017 to November 2018, based on the diagnosis of a dermatologist and cosmetologist. The cosmetic intervention was performed using CAPILLARY REPAIR SERUM (30ml). Study participants completed self-reported questionnaire and standardized questionnaires. conditions: Rosacea studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 160 type: ACTUAL name: CAPILLARY REPAIR SERUM 30ml measure: Elements influenced on quality of life of participants with rosacea measure: Self-reported questionnaire measure: Dietary Questionnaire measure: The Physical Activity Questionnaire measure: DLQI (Dermatology Life Quality Index) measure: SWLS (Satisfaction With Life Scale) measure: BDI (Beck Depression Inventory) sex: ALL minimumAge: 30 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of Bialystok city: Białystok zip: 15-089 country: Poland lat: 53.13333 lon: 23.16433 hasResults: False

 nctId: NCT06271122 id: COMPET-1 briefTitle: Identification of Explanatory Factors for the Lack of Muscle Strength Gain Following a Pulmonary Rehabilitation Program in COPD Patients overallStatus: RECRUITING date: 2024-01-18 date: 2025-05-16 date: 2025-05-16 date: 2024-02-21 date: 2024-02-21 name: Korian class: OTHER briefSummary: Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory disease associated with various comorbidities, including muscle weakness (MW), which is very worrying due to its negative impact on patients' quality of life and survival. To address this issue, muscle strengthening is incorporated into pulmonary rehabilitation programs. However, its effectiveness is unclear, as although there is an average improvement in muscle strength, one in two patients does not show a clinically relevant improvement. To understand this non-response, it is crucial to examine the effect of muscle strengthening programs on the two main determinants of force production: the muscle and the central command. Muscle adaptations following a muscle strengthening program are well-documented, showing improvements in muscle function (cross-sectional area, lean mass, etc.). Conversely, only one study has investigated central adaptations after a muscle strengthening program, clearly demonstrating a lack of effect.

The investigators hypothesize that patients showing no improvement in muscle strength after pulmonary rehabilitation (non-responders) have a significantly lower level of voluntary activation before starting the program compared to responding patients (responders). conditions: Chronic Obstructive Pulmonary Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 36 type: ESTIMATED name: Voluntary activation assessed by magnetic stimulation measure: Central voluntary activation assessed by transcranial magnetic stimulation (TMS) measure: Muscle excitability assessed by femoral magnetic stimulation (FMS) measure: Contractile properties assessed by femoral magnetic stimulation (FMS) measure: Corticospinal excitability assessed by transcranial magnetic stimulation (TMS) measure: Intra-cortical inhibitions transcranial magnetic stimulation (TMS) measure: Voluntary activation assessed by femoral magnetic stimulation (FMS) sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinique du Souffle La Vallonie status: RECRUITING city: Lodève zip: 34700 country: France name: Nelly Heraud, PhD role: CONTACT phone: +33467888491 email: nelly.heraud@clariane.fr name: Nicolas Oliver, MD role: PRINCIPAL_INVESTIGATOR lat: 43.71667 lon: 3.31667 hasResults: False

 nctId: NCT06271109 id: Soh-Med-24-01-04MD briefTitle: Short Term Surgical Outcomes of Anatomical Versus Non Anatomical Laparoscopic Liver Resection for Liver Tumors overallStatus: ENROLLING_BY_INVITATION date: 2021-12-01 date: 2025-06-01 date: 2025-06-01 date: 2024-02-21 date: 2024-02-21 name: Sohag University class: OTHER briefSummary: aimed to discuss the short term surgical outcomes of Anatomical versus Non anatomical laparoscopic Liver resection for Liver tumors. conditions: Liver Neoplasms studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 50 type: ESTIMATED name: Anatomical laparoscopic liver resection for liver neoplasms name: Non-Anatomical laparoscopic liver resection for liver neoplasms measure: complete resection of the neoplasm measure: residual liver tissue measure: recurrence rate sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sohag University city: Sohag country: Egypt lat: 26.55695 lon: 31.69478 hasResults: False

 nctId: NCT06271096 id: 638/ADR/KMC briefTitle: Intramuscular Midazolam Versus Intravenous Diazepam for Acute Seizure in Children overallStatus: COMPLETED date: 2019-11-01 date: 2022-11-01 date: 2024-01-01 date: 2024-02-21 date: 2024-02-23 name: Arooj Khan class: OTHER briefSummary: IM-midazolam in acute seizures, whenever IV cannulation is not possible. It is easy to administer and can be used in prehospital settings as IV cannulation requires experience, especially in pediatric age group. Moreover, the transit time to the hospital can be prolonged in our areas which can delay the treatment if intravenous cannulation is considered. More studies are required to assess the feasibility of administering IM-midazolam in a prehospital setting to control acute seizures conditions: Seizures studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study was a randomized controlled trial carried out between November 2019 to November 2022 in the Pediatric department of Khyber Teaching Hospital. A total of 150 children who presented to the emergency department with seizures were enrolled in this study via consecutive sampling. This study was approved by the Ethical Review primaryPurpose: TREATMENT masking: NONE count: 150 type: ACTUAL name: Intra muscular Midazolam name: Intravascular Diazepam measure: Fits Controlled sex: ALL minimumAge: 3 Months maximumAge: 5 Years stdAges: CHILD facility: Khyber Teaching Hospital city: Peshawar zip: 25000 country: Pakistan lat: 34.008 lon: 71.57849 hasResults: False

 nctId: NCT06271083 id: 2023-06541-01 briefTitle: Internet-based Behavior Therapy for Adults With Tourette Syndrome acronym: TICNET overallStatus: RECRUITING date: 2024-02-02 date: 2026-05 date: 2028-05 date: 2024-02-21 date: 2024-02-21 name: Karolinska Institutet class: OTHER briefSummary: This study protocol outlines a parallel-group, randomized controlled trial (RCT) designed to evaluate the effectiveness of Internet-delivered behavior therapy (BT) based on exposure with response prevention (ERP) for adults with Tourette syndrome (TS) or chronic tic disorder (CTD). The primary aim is to evaluate the effects of Internet-delivered ERP-based BT on tic severity compared to a control condition offering general psychological support at week 11 counting from the treatment start. The primary outcome measure is the Yale Global Tic Severity Scale - Total Tic Severity subscale (YGTSS-TTS). Secondary outcomes include measures of tics-related impairment, work and social adjustment, rates of responders, self-rated tic severity, symptoms of depression, and quality of life. Long-term maintenance of results will be assessed at week 23 and 14 months after the treatment start. Participants will be recruited nationwide. The intervention group will receive 10 weeks of ERP-based therapy delivered through an online platform, with therapist support. The control group will receive psychoeducational content and general psychological support. Adherence to treatment, adverse events, and patient safety will be closely monitored throughout the trial. The study population will be intent-to-treat and the between-group differences at the primary endpoint will be assessed using an analysis of covariance (ANCOVA) with pre-score of the measure as covariate. A health-economic evaluation will assess the cost-effectiveness of the intervention. conditions: Tourette Syndrome conditions: Chronic Tic Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 110 type: ESTIMATED name: Exposure with response prevention name: Brief psychoeducation with general psychological support measure: Yale Global Tic Severity Scale - Total Tic Severity subscale (YGTSS-TTS) measure: Yale Global Tic Severity Scale (YGTSS) - impairment scale measure: Clinical Global Impression (CGI) measure: Gilles de la Tourette Syndrome Quality of Life Scale (QTS-QoL) measure: Montgomery-Asberg Depression Rating Scale (MADRS) measure: Adult Tic Questionnaire (ATQ) measure: Work and social adjustment scale (WSAS) measure: Treatment Inventory of Costs in Psychiatric Patients (TIC-P) measure: Assessing Quality of Life 6 Dimensions (AQoL-6D) measure: Internet Intervention Patient Adherence Scale for Guided Internet-Delivered Behavioural Interventions (iiPAS) measure: Credibility/Expectancy Questionnaire (CEQ) measure: Working Alliance Inventory-Short Form Revised (WAI-SR) measure: Checklist for negative events measure: Events during treatment and adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Karolinska Institutet status: RECRUITING city: Stockholm zip: 14157 country: Sweden name: Ekaterina Ivanova, PhD role: CONTACT phone: 0046765807416 email: ekaterina.ivanova@ki.se lat: 59.33258 lon: 18.0649 hasResults: False

 nctId: NCT06271070 id: 2023-R23 briefTitle: Analysis of Correlation Between Skin Carotenoid Level and Basic Indicators of Health Status Related to Lifestyle in Vietnamese: An Observational Study overallStatus: RECRUITING date: 2024-01-16 date: 2024-05-31 date: 2024-12-31 date: 2024-02-21 date: 2024-02-21 name: KAGOME CO., LTD. class: INDUSTRY name: Dr. Binh_Teleclinic - Branch of E2E Solution Company Limited briefSummary: To clarify the relationship between vegetable intake and lifestyle-related disease in Vietnam, we measure skin carotenoid levels and basic indicators of health status related to lifestyle and analyze the correlation between them. This is an important study that can lead to dietary suggestions for preventing lifestyle-related diseases in Vietnam. conditions: Lifestyle Risk Reduction studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 300 type: ESTIMATED name: Non-intervention measure: Skin carotenoid level measure: Blood markers of lifestyle-related diseases measure: BMI measure: Body fat percentage measure: Blood pressure measure: Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dr. Binh_Teleclinic - Branch of E2E Solution Company Limited status: RECRUITING city: Hanoi zip: 11612 country: Vietnam name: Nguyen Thuy Lan, Doctor role: CONTACT phone: +84 243 622 7799 lat: 21.0245 lon: 105.84117 hasResults: False

 nctId: NCT06271057 id: CARMOD briefTitle: Golcadomide Post-CAR T-cell in R/R Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2026-01-15 date: 2027-10-20 date: 2024-02-21 date: 2024-02-21 name: The Lymphoma Academic Research Organisation class: OTHER name: Lymphoma Study Association briefSummary: This study is an open-label, multicenter, proof of concept, phase 2 trial. Patients will be recruited over 18 months. Safety analysis will be performed with a stop of the enrollment after 3 patients have either 1 complete treatment cycle or permanently discontinued treatment whichever occurs first.

Approximatively 65 patients with aggressive large B-cell lymphoma (LBCL) (including diffuse large B-cell lymphoma (DLBCL), Primary mediastinal B-cell lymphoma (PMBCL), any transformed follicular or marginal zone lymphoma, high-grade B-cell lymphoma (HGBL)) will be enrolled in the study.

The duration of treatment with golcadomide (CELMoD) is 24 weeks with 6 cycles of 28 days (4 weeks), starting at 5 days after CAR-T cells infusion.

The primary objective of the study is to estimate the efficacy of golcadomide administered post-anti-CD19 CAR T-cell infusion, Efficacy determination will be based upon the primary endpoint of complete metabolic response (CMR) rate at 3 months after infusion of anti-CD19 CAR T-cell assessed by study investigator. conditions: Diffuse Large B-cell Lymphoma Refractory conditions: Refractory Primary Mediastinal Large B-Cell Lymphoma conditions: Refractory Transformed B-cell Non-Hodgkin Lymphoma conditions: Refractory High Grade B-Cell Lymphoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 65 type: ESTIMATED name: golcadomide measure: Complete metabolic response rate (CMR rate) measure: Objective response rate (ORR) measure: Objective response rate (ORR) measure: Complete response rate (CRR) measure: Duration of response (DR) measure: Event-free survival (EFS) measure: Progression-free survival (PFS) measure: Time To Next anti-Lymphoma Treatment (TTNLT) measure: Overall survival (OS) measure: Incidence of Adverse Events and Serious Adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hopital Henri Mondor city: Créteil zip: 94010 country: France lat: 48.78333 lon: 2.46667 facility: Chu Dijon Bourgogne city: Dijon zip: 21000 country: France lat: 47.31667 lon: 5.01667 facility: Chu de Grenoble city: La Tronche zip: 38700 country: France lat: 45.20429 lon: 5.73645 facility: Chru de Lille city: Lille zip: 59037 country: France lat: 50.63297 lon: 3.05858 facility: Institut Paoli Calmettes city: Marseille zip: 13273 country: France lat: 43.29551 lon: 5.38958 facility: Chu de Montpellier city: Montpellier zip: 34090 country: France lat: 43.61092 lon: 3.87723 facility: Chu de Nantes city: Nantes zip: 44093 country: France lat: 47.21725 lon: -1.55336 facility: Hopital Saint-Louis city: Paris zip: 75475 country: France lat: 48.85341 lon: 2.3488 facility: Chu de Bordeaux city: Pessac zip: 33604 country: France lat: 44.81011 lon: -0.64129 facility: Chu Pontchaillou city: Rennes zip: 35033 country: France lat: 48.11198 lon: -1.67429 facility: Centre Henri Becquerel city: Rouen zip: 76038 country: France lat: 49.44313 lon: 1.09932 facility: Iuct Oncopole city: Toulouse zip: 31059 country: France lat: 43.60426 lon: 1.44367 facility: Chu Brabois city: Vandœuvre-lès-Nancy zip: 54511 country: France lat: 48.65 lon: 6.18333 hasResults: False

 nctId: NCT06271044 id: RAILESS briefTitle: a. Reducing Radioiodine Treatment in Papillary Thyroid Cancer. RAILESS overallStatus: ACTIVE_NOT_RECRUITING date: 2014-10 date: 2024-12 date: 2027-12-31 date: 2024-02-21 date: 2024-02-21 name: Helsinki University Central Hospital class: OTHER briefSummary: To study if its is safe to reduce the amount of postoperative treatments in those patients, who have been operated on because of a low-risk intrathyroidal papillary thyroid cancer with diameter of 11-20mm, and in whom postoperative thyroglobulin levels are of low level. conditions: to Omit Radioiodine Treatment Safely in Patients With Low -Risk Papillary Thyroid Cancer With Seize of 11-20mm studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients with low risk papillary thyroid cancer either received a radioiodine treatment according to the normal Finnish treatment schedule or were schedulded for only follow-up . primaryPurpose: OTHER masking: NONE maskingDescription: No masking. count: 61 type: ACTUAL name: With radioiodine treatment name: With postoperative radioiodine treatment measure: Event free situation during follow-up event free /disease free sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06271031 id: LHS0211 briefTitle: Process Mapping and Data Collection to Inform a Computer Simulation Model of Hospitalised Patients With Bloodstream Infection, Sepsis and Systemic Infection acronym: CSM-BSI overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-12-31 date: 2026-03-31 date: 2024-02-21 date: 2024-02-21 name: Liverpool University Hospitals NHS Foundation Trust class: OTHER_GOV briefSummary: The goal of this study is to create a computer simulation of patients with bloodstream infection to understand how changes in healthcare policies and resources affect patient treatment. This simulation will help doctors and health-care decision makers make better choices in treating these patients and avoid overusing antibiotics that can lead to antibiotic resistance. Antibiotic resistance is when bacteria can't be killed by antibiotics anymore. Participants will not receive treatments as this is an observational study, but the study will involve:

* Interviews with healthcare staff to understand patient care pathways.
* Analysis of historical data on bacteria causing infections and antibiotic treatments.
* A 30-day observational study to observe patient treatment for bloodstream infections. conditions: Sepsis conditions: Bloodstream Infection conditions: Bacteraemia studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED measure: Generation of a software simulation model that is fine tuned to the observed data. measure: Exploration of the performance of the model in different hypothesised scenarios. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot_ICF hasProtocol: True hasSap: False hasIcf: True label: Study Protocol and Informed Consent Form date: 2023-10-10 uploadDate: 2023-11-14T09:05 filename: Prot_ICF_000.pdf size: 2058603 hasResults: False

 nctId: NCT06271018 id: GMIO-2024-0001 briefTitle: TocILizumab in aorTitis in GCA (TILT) acronym: TILT overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-10-01 date: 2028-04-01 date: 2024-02-21 date: 2024-02-21 name: GMIOFrance class: UNKNOWN briefSummary: This is a french multicenter observational study assessing safety and efficacy of biosimilar of Tocilizumab in Giant Cell Arteritis (GCA) with active aortitis, including 14 reference centers from the Groupe d'Etude Français des vascularites des gros vaisseaux (GEFA).

Giant Cell Arteritis (GCA), formerly known as temporal arteritis, is the most common form of systemic vasculitis in patients aged ≥ 50 years. GCA is defined by granulomatous arteritis that affects large#sized and medium#sized blood vessels with a predisposition to affect the cranial arteries. Aortitis accounted for more than 50% of GCA patients with the new imaging techniques. Aortitis is typically diagnosed using imaging tests such as magnetic resonance imaging (MRI) or Computed Tomography (CT) scans. Aortitis is an inflammation of the aorta, leading to a range of symptoms such as fever, weight loss, fatigue, and chest pain. In severe cases, aortic aneurysms or aortic dissection can occur, which can be life-threatening.

Multiple reports have demonstrated the presence of abnormal pro-inflammatory cytokine production in large-vessel vasculitis patients, particularly those with GCA, including interleukin-1 (IL-1), IL-6, IL-18, tumor necrosis factor-α (TNF-α), and interferon-γ, by T lymphocytes and macrophages. IL-6 has been implicated as a crucial cytokine in the pathogenesis of aortitis and targeting its signaling has shown promising results in treating the condition. IL-6 inhibitors such as tocilizumab have been found to effectively reduce disease activity and improve clinical outcomes in GCA patients.

The GIACTA study (GiAnt cell arteritis roActemra (tocilizumab) study) was a randomized, double-blind, placebo-controlled trial that evaluated the efficacy and safety of tocilizumab in the treatment of GCA. The study included 251 patients with newly diagnosed or relapsing GCA and found that treatment with tocilizumab significantly increased the proportion of patients who achieved sustained remission from GCA at 52 weeks, compared to placebo. Additionally, tocilizumab was associated with a lower incidence of disease flares and a reduced need for glucocorticoid therapy.

Following the positive results of the GIACTA study, tocilizumab was approved for the treatment of GCA in adults with active disease, including aortitis, who have not responded to glucocorticoids, or for whom glucocorticoid therapy is not appropriate, by regulatory agencies around the world, including the US Food and Drug Administration and the European Medicines Agency.

However, the efficacy of IL-6 inhibitors on aorta inflammation as assessed by modern and powerful imaging techniques has never been specifically studied in GCA.

This observational study will provide important informations on the impact of Tyenne® (tocilizumab) associated with short term low dose steroids on clinical manifestations and vessel inflammation and damage in aortitis of GCA. conditions: Giant Cell Arteritis conditions: Aortitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED measure: To evaluate the proportion of patients with remission of GCA measure: To assess the cumulative incidence of relapse measure: To assess the proportion of GCA in remission (according to EULAR consensus definitions) after treatment start measure: To assess the cumulative dose of prednisone measure: To assess the cumulative incidence of severe adverse events measure: To assess the proportion of radiological vascular progression measure: To assess the cumulative incidence of vascular revascularization procedures sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06271005 id: 000824 briefTitle: Neurological Dry Eye Study Stimulating Both Lacrimal and Vagus Nerves overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-10-01 date: 2024-10-01 date: 2024-02-21 date: 2024-02-21 name: Genetic Disease Investigators class: OTHER briefSummary: This is a study on neurological dry eye disease, focusing on a patented over-the-counter supplement supporting tear production neurologically, including the lacrimal and vagus nerves. conditions: Dry Eye Disease conditions: Dry Eye studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 75 type: ESTIMATED name: NeuroTears name: Placebo measure: OSDI sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06270992 id: 123R030 briefTitle: Oral Microbiome Diagnostics of Lung Cancer overallStatus: RECRUITING date: 2023-11-15 date: 2025-02-15 date: 2026-05-15 date: 2024-02-21 date: 2024-02-21 name: TC Erciyes University class: OTHER name: THE SCIENTIFIC AND TECHNOLOGICAL RESEARCH COUNCIL OF TÜRKİYE briefSummary: The study aims to develop a deep learning-based diagnostic method for lung cancer using the oral microbiome. This innovative approach involves establishing an observational cohort of 576 individuals, including lung cancer patients, non-cancerous benign lung disease patients, and healthy controls, to collect tongue swab samples for 16S rRNA sequencing. Additionally, an international cohort of approximately 1700 individuals will be formed using in silico data. The project will utilize deep learning methods to analyze all data integratively and develop an AI diagnostic algorithm capable of distinguishing lung cancer patients from others. The diagnostic method's performance will be tested in a pilot clinical trial with 96 individuals using a PRoBE design. Led by experts in chest surgery, molecular microbiology, and bioinformatics, the project spans over 30 months and aims to create a non-invasive, easily accessible lung cancer screening method that could lead to significant diagnostic advancements and potential spin-off companies in the field of liquid biopsy/molecular diagnosis. conditions: Lung Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 676 type: ESTIMATED name: NCCN (National Comprehensive Cancer Network) diagnosis measure: Diagnostics accuracy assessment sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erciyes University Hospital status: RECRUITING city: Kayseri zip: 38039 country: Turkey name: Aycan Gundogdu, PhD role: CONTACT phone: +90 352 207 6666 email: agundogdu@erciyes.edu.tr lat: 38.73222 lon: 35.48528 hasResults: False

 nctId: NCT06270979 id: ISHA briefTitle: Intrinsic Capacity and Functional Ability Monitoring With an Integrated Data Eco-System for Healthy Ageing. acronym: ISHA overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-04-01 date: 2024-02-21 date: 2024-02-21 name: Prof. Ivan Bautmans class: OTHER name: Leiehome vzw name: University Hospital, Antwerp name: Universiteit Antwerpen name: INNOVIRIS name: AAL briefSummary: In this study, 120 older adults (aged 65 years or older) either patients undergoing rehabilitation or older nursing home residents will be provided with an Eforto® device and the eco-System for Healthy Ageing (ISHA) mobile application to self-monitor intrinsic capacity for 4 months (if needed with assistance by an (in)formal caregiver). Preferably, the participants will use their own smartphone because mitigating smartphone-use-related issues.

The aims of the study are:

1. to evaluate the usability and feasibility of self-monitoring intrinsic capacity by using the ISHA system in rehabilitation and nursing home settings.
2. to investigate if changes and variability in intrinsic capacity as measured with ISHA are related to changes in functional ability and quality of life.
3. to explore individual trajectories of intrinsic capacity with the ISHA system. conditions: Frailty studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 120 type: ESTIMATED name: ISHA measure: Potential technical problems of the ISHA system measure: Potential technical problems of the ISHA system measure: Potential technical problems of the ISHA system measure: Potential technical problems of the ISHA system measure: Potential technical problems of the ISHA system measure: Potential technical problems of the ISHA system measure: Potential technical problems of the ISHA system measure: Potential technical problems of the ISHA system measure: Potential technical problems of the ISHA system measure: Potential technical problems of the ISHA system measure: Potential technical problems of the ISHA system measure: Potential technical problems of the ISHA system measure: Potential technical problems of the ISHA system measure: Potential technical problems of the ISHA system measure: Potential technical problems of the ISHA system measure: Potential technical problems of the ISHA system measure: Experiences with ISHA (usability, feasibility and acceptability outcome) measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition) measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition) measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition) measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition) measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition) measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition) measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent) measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent) measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent) measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent) measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent) measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent) measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent) measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent) measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent) measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent) measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent) measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent) measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in quality of life (Qol) measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol) measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in Qol measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol) measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in Qol measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol) measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol) measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol) measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol) measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol). measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol). measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol). measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol). measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol). measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol). sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06270966 id: 28287 08/11/2023 briefTitle: Cognitive Remediation VR Tool for People With MCI: a Feasibility RCT overallStatus: NOT_YET_RECRUITING date: 2024-03-07 date: 2024-12-01 date: 2025-12-01 date: 2024-02-21 date: 2024-02-21 name: University of Cagliari class: OTHER briefSummary: The need to promote research in active aging trough multidisciplinary and innovative approaches is strongly indicated by the European Union. Our study aims to assess the feasibility and provide a preliminary measure of effectiveness for an intervention using immersive virtual reality (VR) technology for cognitive remediation (CR) in individuals with Mild Cognitive Impairment (MCI) conditions: Mild Cognitive Impairment conditions: Cognitive Remediation conditions: Virtual Reality conditions: Psychiatric Rehabilitation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controlled Trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Virtual Reality Cognitive Remediation measure: Side effects; Dropout rates; Proportion of recruited participants among those considered eligible measure: Short Form Health Survey, 12 items (SF-12) measure: Brief Social Rhythms Scale (BSRS) measure: Patient Health Questionnaire (PHQ-9) measure: Generalized Anxiety Disorder-7 item (GAD-7) measure: Addenbrooke's Cognitive Examination (ACE-R) measure: Matrix test measure: Rey's Word Test measure: Trail Making Test (TMT) measure: Digit Span measure: Stroop Test measure: Frontal Assessment Battery (FAB) measure: Cognitive Estimates Test (CET) measure: Rey Figure Test sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: San Giovanni di Dio Hospital city: Cagliari state: CA zip: 09100 country: Italy lat: 39.23054 lon: 9.11917 hasResults: False

 nctId: NCT06270953 id: DZ_NX_US briefTitle: Non-invasive Monitoring: Impact on Patient Management and Outcomes overallStatus: RECRUITING date: 2024-01-19 date: 2024-03-30 date: 2024-06-30 date: 2024-02-21 date: 2024-02-28 name: Turtle Shell Technologies Pvt. Ltd. class: INDUSTRY briefSummary: Enhancing patient monitoring in SNFs and ALFs is crucial due to challenges in recognizing deteriorating health. Gaps in vital sign checks lead to missed indicators and adverse outcomes. Turtle Shell Technologies' Dozee Pro NX offers continuous non-invasive monitoring, alerting healthcare providers of vital sign changes. This clinical study aims to evaluate Dozee Pro Nx's impact on patient outcomes, practitioner efficiency, and healthcare costs in SNFs and ALFs, addressing gaps in care delivery. conditions: No Specific Medical Conditions or Disease States studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: Dozee Pro NX measure: Number of Care Escalation and/or Transfers (Subgroup- ER visits, Surgical Interventions & Hospitalizations, ICU Admissions), measure: HCP experience response data measure: Care pathway mapping sex: ALL minimumAge: 18 Months maximumAge: 120 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Oak Village Healthcare status: RECRUITING city: Lake Jackson state: Texas zip: 77566 country: United States name: Lindsay Darthard, LNFA role: CONTACT phone: 979-319-2306 email: lindsaydarthard@gcltc.com name: Lindsay Darthard, LNFA role: PRINCIPAL_INVESTIGATOR name: Marc A Wilson, MD role: SUB_INVESTIGATOR lat: 29.03386 lon: -95.43439 hasResults: False

 nctId: NCT06270940 id: 2023.0922 briefTitle: Pulsed Radiofrequency Therapy on Peripheral Nerves Monitoring Pain, Quality of Life, Patient Satisfaction and Efficacy acronym: PURPOSE overallStatus: RECRUITING date: 2024-03-04 date: 2025-10-31 date: 2026-02-28 date: 2024-02-21 date: 2024-04-24 name: Amsterdam UMC, location VUmc class: OTHER briefSummary: Neuropathic pain is a chronic condition caused by damage to the somatosensory nervous system. The pain associated with neuropathic pain is often severe and debilitating, and can significantly interfere with the quality of life and daily functioning of affected patients. Current pharmacologic treatments, such as antidepressants, antiepileptics, and opioids, can offer only partial relief for 40-60% of patients, and are often accompanied by severe side effects. This has led to increasing interest in non-pharmacologic management options for neuropathic pain. One such promising treatment option is pulsed radiofrequency (PRF) treatment applied to the affected peripheral nerve in conjunction with local anesthetic and/or corticosteroid medication. Several studies, including case reports, retrospective studies, and small randomized controlled trials, have shown that PRF treatment to the affected peripheral nerve can be beneficial and effective for managing chronic peripheral neuropathic pain. Several peripheral neuralgias, such as thoracic postherpetic neuralgia, occipital neuralgia, pudendal neuralgia, meralgia paresthetica, painful shoulder, post-thoracotomy syndrome, and carpal tunnel syndrome, have been successfully treated with PRF. PRF treatment has garnered significant interest among ultrasound-skilled pain physicians because of its superior, safe, and non-destructive percutaneous approach to peripheral nerves, visualized by today's excellent visual ultrasound guidance. Our academic pain center performs approximately more than 1000 ultrasound-guided peripheral nerve blocks per year on a wide range of peripheral nerves. Moderate evidence for treating peripheral nerves with PRF treatment is available; however, PRF treatment settings such as voltage, number of cycles, and treatment duration vary, and it is not clear which setting contributes most substantially to pain reduction results. The aim of this prospective longitudinal observational data collection is to evaluate the efficacy of PRF treatment applied to peripheral nerves, to observe the clinical course of chronic peripheral neuropathic pain under conditions of routine clinical practice, and to link these observations with clinical outcomes. conditions: Neuropathic Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: Pulsed Radiofrequency (PRF) Treatment measure: Duration PRF measure: Type of PRF measure: Pain intensity measure: Health Related Quality of life measure: Patient Global Impression of Change: PGIC measure: Use of opioids measure: PROMIS-29 measure: PROMIS Global-10 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Amsterdam UMC status: RECRUITING city: Amsterdam zip: 1081 HV country: Netherlands name: Katrin Stoecklein, Dr role: CONTACT phone: 0031 20 444 386 email: k.stoecklein@amsterdamumc.nl lat: 52.37403 lon: 4.88969 hasResults: False

 nctId: NCT06270927 id: 00003830 briefTitle: A Feasibility Study for Randomization of Code Stroke Imaging Strategies acronym: CSI overallStatus: RECRUITING date: 2023-10-23 date: 2024-03-30 date: 2024-07-10 date: 2024-02-21 date: 2024-02-21 name: University of Texas at Austin class: OTHER name: Lone Star Stroke Research Consortium briefSummary: The purpose of this study is to test feasibility of a comparative effectiveness framework for acute stroke imaging using prospective electronic health data. This is a prospective, cohort feasibility study of patients presenting to the Emergency Department with suspected acute ischemic stroke. The clinical stroke team will not be blinded to the imaging modality given the nature and purpose of the interventions/imaging. Knowledge of the imaging modality used and the knowledge gained from the resulting data will need to be considered for treatment decisions. Blinding will be maintained for data abstraction and analyses. Analysis will be on an "intent-to-scan" basis and all qualifying patients will be included in their assigned cohort. conditions: Brain Ischemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 600 type: ESTIMATED name: MRI name: CT measure: compliance sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ascension Seton status: RECRUITING city: Austin state: Texas zip: 78712 country: United States name: Adrienne N Dula, PhD role: CONTACT phone: 512-495-5922 email: adrienne.dula@austin.utexas.edu name: Karinne Berstis, MA role: CONTACT email: karinne@austin.utexas.edu lat: 30.26715 lon: -97.74306 hasResults: False

 nctId: NCT06270914 id: IBIS briefTitle: Inclusive Positive Behaviour Supports acronym: IBIS overallStatus: RECRUITING date: 2023-08-25 date: 2025-09-30 date: 2025-12-31 date: 2024-02-21 date: 2024-02-21 name: Uppsala University class: OTHER name: The Swedish Research Council briefSummary: Background: While positive school climate is important for students' well-being and mental health, school personnel may experience challenges in creating a nurturing school climate. School-Wide Positive Behavioral Interventions and Supports (SW-PBIS) have shown positive effects on school climate, but fewer studies have been conducted in the European context. Aim: The present project aims to investigate the effectiveness of SW-PBIS programs for students' social-emotional skills and academic achievement as well as teachers' and students' perceptions of the learning environment. Furthermore, the study intends to evaluate how school-level factors mediate or moderate the effects of the intervention. In addition, the study includes a qualitative evaluation of the dynamic interaction processes that occur during program implementation in local school contexts. Methods: Data on school- and individual-level measures are collected in intervention and control schools. With regard to challenges in retaining control groups over extended time periods, two waves of recruitment are used. In the first wave, an active control group is used, and data are collected during three time points. In the second wave, a wait-list control group is used, and data are collected during two time points during one school year. Hierarchical regression analyses will be conducted to explore the effects of SW-PBIS on the outcomes of the study. An ethnomethodological approach will be applied to provide a detailed examination of the social interactional and meaning-making practices of different school implementation teams, and the negotiation of normative expectations and rules of conduct in peer-teacher-student interactions in different classrooms. Discussion: The study is expected to contribute knowledge on the effects of the SWPBIS program and how these effects may be mediated or moderated by school-level factors. Combining quantitative and qualitative methods to explore the significance of school contexts in the implementation of the SWPBIS program constitutes the strength of the study. The challenge in the study is the extended period of implementation of SWPBIS, which entails difficulties in retaining a control group over the required time period. Therefore, two waves of recruitment are used, encompassing different procedures of allocation to intervention or control groups. conditions: Behavior Problem conditions: Social Skills studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study utilizes quasi-experimental non-randomized design, including two waves of participant recruitment. Two waves of recruitment are used. In the first wave of recruitment, intervention and active control group are used and outcomes will be measured at three time points. In addition to quantitative data, qualitative observations and interviews are conducted to get a deeper understanding of the process of implementation of SWPIS. In the second wave of data recruitment, intervention and wait-list control group are used and outcomes will be measured at two time points (pre- and post). primaryPurpose: PREVENTION masking: NONE count: 5000 type: ESTIMATED name: Inclusive Positive Behavior Interventions and Supports measure: Social emotional skills measure: Classroom environment measure: Students' achievement measure: Collective self-efficacy measure: Problem behavior in classroom and school measure: Implementation fidelity sex: ALL minimumAge: 9 Years maximumAge: 15 Years stdAges: CHILD facility: Department of Education status: RECRUITING city: Uppsala state: Uppland zip: 752 37 country: Sweden name: Martin Karlberg, PhD role: CONTACT phone: 018-471 1669 email: martin.karlberg@edu.uu.se name: Nina Klang, PhD role: CONTACT phone: 018-471 1674 email: nina.klang@edu.uu.se lat: 59.85882 lon: 17.63889 hasResults: False

 nctId: NCT06270901 id: BMEL: 2822EPS008 briefTitle: Acute Effects of Legume-enriched Meals Compared to Western Diet Meals on Postprandial Metabolism in Participants With Increased Cardiometabolic Risk acronym: LeguPlan_1 overallStatus: RECRUITING date: 2024-05-01 date: 2024-07-30 date: 2024-07-30 date: 2024-02-21 date: 2024-04-15 name: University of Bonn class: OTHER name: Federal Ministry of Food and Agriculture (BMEL) name: Federal Office for Agriculture and Food (BLE) briefSummary: The aim of the study is to investigate the postprandial effects of legume-enriched meals compared to Western Diet meals on postprandial metabolism. In this context, older adults with increased risk for cardiometabolic diseases consume 4 mixed meals with 36 g or 62 g of protein either designed according to the Planetary Health Diet with legumes as primary protein source or the Western Diet with animal foods as primary protein source, in a randomized order. In a postprandial observation period of 6 hours, parameters of lipid metabolism, glucose and insulin metabolism, amino acid profile, as well as markers of inflammation and vascular function are analysed. Furthermore, neuropsychological parameters and satiety-associated hormones are investigated. conditions: Cardiovascular Diseases conditions: Metabolic Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: High Protein Planetary Health Diet name: Low Protein Planetary Health Diet name: High Protein Western Diet name: Low Protein Western Diet measure: Parameters of lipid metabolism in blood measure: Parameters of lipid metabolism in blood measure: Parameters of lipid metabolism in blood measure: Parameters of lipid metabolism in blood measure: Parameters of lipid metabolism in blood measure: Parameters of glucose metabolism in blood measure: Parameters of glucose metabolism in blood measure: Parameters of glucose metabolism in blood measure: Parameters of glucose metabolism in blood measure: Parameters of glucose metabolism in blood measure: Blood amino acid profile measure: Blood urea measure: Uric acid in blood measure: Parameters of hunger and satiety in blood measure: Parameters of endothelial function in blood measure: Parameters of inflammation in blood measure: Endothelial function measure: Neuropsychological parameters measure: Neuropsychological parameters measure: Neuropsychological parameters sex: ALL minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Bonn, Institute of Nutritional and Food Sciences, Nutrition Physiology status: RECRUITING city: Bonn state: North-Rhine Westphalia zip: 53115 country: Germany name: Sarah Egert, Prof. Dr. role: CONTACT phone: + 49 (0) 228 / 73 59 email: s.egert@uni-bonn.de lat: 50.73438 lon: 7.09549 hasResults: False

 nctId: NCT06270888 id: IRB23-1011 briefTitle: Hypofractionation (Radiation) Trial for Multiple Myeloma overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-05-01 date: 2028-05-01 date: 2024-02-21 date: 2024-02-21 name: University of Chicago class: OTHER briefSummary: This study if for people who have been diagnosed with multiple myeloma and their doctors are recommending radiation to help treat it. Typically, radiation consists of 2-3 weeks of external beam radiation therapy. Doctors leading this study would like to see if a shorter radiation course (i.e., hypofractionation) for pelvic radiation is safe for multiple myeloma. Because participants in this study will receive a shortened radiation course, each daily treatment dose that is delivered would be slightly higher than normal. This higher daily dose would be delivered because the study team would like to see if higher doses of radiation are as safe given over a shorter number of days compared to 2-3 weeks. The purpose of this study is to make sure that hypofractionation is safe and effective for individuals with multiple myeloma. conditions: Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Radiation measure: Maximum Tolerated Dose of Radiation of Per Fraction measure: Rate of Grade 3 or Higher Adverse Events measure: Rate of Long-Term Adverse Events measure: Overall Response Rate measure: Progression-free Survival measure: Local Control of the treated Lesion sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Chicago Comprehensive Cancer Center city: Chicago state: Illinois zip: 60637 country: United States lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06270875 id: PROJECT ADAPT-HF briefTitle: Addressing Pain Through Navigator-Led Palliative Care Optimized for Heart Failure (ADAPT-HF) acronym: ADAPT HF overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-03 date: 2025-01-03 date: 2024-02-21 date: 2024-03-07 name: University of Alabama at Birmingham class: OTHER briefSummary: Using the MOST framework, factorial pilot design, and an iterative, community-based process, the purpose of this study is to pilot test to further develop and refine a palliative care (PC) intervention addressing pain of Black adults (age \> 18) with advanced HF. Thirty-six persons with advanced heart failure (HF) will be randomized to receive one of 16 conditions (different combinations of navigator coach-delivered PC pain intervention components). conditions: Heart Failure NYHA Class III conditions: Heart Failure NYHA Class IV conditions: Chronic Illness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Data collectors and principal investigator will be blind to participant condition; participants will be instructed NOT to discuss their assignment with data collectors. Trials participants will know their intervention condition as will the palliative care coach involved in delivering the intervention. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: ADAPT HF measure: Feasibility of Intervention Delivery and Data Collection measure: Acceptability of Intervention Measure (AIM) measure: PROMIS Pain Intensity Scale measure: Pain Interference Scale Short Form 6b measure: Feasibility of Intervention Measure measure: Edmonton Symptom Assessment Scale (ESES-r) measure: Kansas City Cardiomyopathy Questionnaire- Short Form measure: Hospital Anxiety and Depression Scale (HADS) measure: PROMIS General Self-efficacy measure: Self-care of Heart Failure Index measure: Multidimensional Scale of Perceived Social Support (MSPSS) measure: Patient Activation Measure (PAM) Short Form measure: Brief Multidimensional Measure of Religiousness / Spirituality (BMMRS) - 6-item subscale for Religious/Spiritual Coping + 1 overall Q measure: Connor-Davidson Resilience Scale (CD-RISC-10) measure: Discrimination in Medical Settings Scale Scale measure: Cost/Resource Utilization Form measure: SF Global Health Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06270862 id: SSHRC-PEG2023-AAT briefTitle: A Digital Active Aging Training Program for Older Adults acronym: AAT overallStatus: RECRUITING date: 2024-04-08 date: 2024-10-30 date: 2024-12-31 date: 2024-02-21 date: 2024-04-10 name: Toronto Metropolitan University class: OTHER name: Social Sciences and Humanities Research Council of Canada name: AGE-WELL and the Canadian Frailty Network name: Cogniciti name: Cognifit name: Aging in Cloud briefSummary: The proposed project aims to develop and validate a multi-dimensional digital active aging program integrated with resilience to promote the biopsychosocial functions of older adults aged 60, including Chinese older immigrants in Canada (Study 1) and English-speaking White Canadian older adults (Study 2).

The proposed study takes a typical pretest-training-posttest design. Pretest and posttest: a battery of outcome measures on physical, psychological, and social functions will be administered to all participants. Data will also be used to identify sociodemographic risk predictors for outcome variables (i.e., biopsychosocial functions and resilience). Training: the participants will be randomly assigned to three arms to receive 4 weeks of 16 training/practice/control treatment sessions delivered via Zoom.

In the "active aging with resilience (AR)" condition, participants will complete physical, cognitive, and social engagement training modules, starting with a 30-min resilience-building module. The traditional "active aging" (AA) training involves the same multi-domain active aging training without the initial resilience-building module. The "workshop training" (WT) control condition involves workshops following the same 4-week schedule on aging-related topics. conditions: Healthy Aging conditions: Cognitive Change conditions: Psychological Stress conditions: Loneliness conditions: Social Interaction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: PARTICIPANT count: 240 type: ESTIMATED name: Resilience training name: cognitive training name: physical exercise name: social interaction name: workshop series measure: Exercise Self-efficacy level (ESES) measure: the 5-item World Health Organization WellBeing Index (WHO-5) measure: Kessler Psychological Distress Scale (K10) measure: Multidimensional Scale of Perceived Social Support (MSPSS) measure: Conner-Davidson Resilience Scale 10-item (CD RISC-10) measure: Emotional regulation Questionnaire (ERQ) measure: Positive and Negative Affect Schedule (PANAS) measure: Visual working memory test measure: Divided attention test measure: Visual memory test measure: Stroop test measure: Sustained attention to response test measure: Satisfaction with life scale (SWLS) measure: Instrumental Activities of Daily Living(IADL) measure: The 6-item De Jong Gierveld Loneliness Scale measure: The Brief Approach/Avoidance Coping Questionnaire (BACQ) sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cognitive Aging Lab status: RECRUITING city: Toronto state: Ontario zip: M5B 2K3 country: Canada name: Lixia Yang, PhD role: CONTACT phone: 416-979-5000 phoneExt: 556522 email: lixiay@torontomu.ca name: Lixia Yang, PhD role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06270849 id: MTU-EC-SU-0-002/66 briefTitle: Validity and Reliability of ICIQ-FLUTS LF in Thai Version and Correlation With IPSS overallStatus: COMPLETED date: 2023-02-24 date: 2023-12-31 date: 2024-01-20 date: 2024-02-21 date: 2024-02-21 name: Thammasat University Hospital class: OTHER briefSummary: The investigators recruited participants, who were female with LUTS 50 participants for known group validity and 80 normal control females to evaluate for construct validity and test for reliability by statistical analysis. conditions: Validity of Thai Version of the ICIQ-FLUTS LF Questionnaire conditions: Reliability of Thai Version of the ICIQ-FLUTS LF studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 130 type: ACTUAL name: Questionnaire measure: How well the ICIQ-FLUTS LF questionnaire in the Thai version can differentiate between females with LUTS and normal females, was assessed by the construction validity. measure: The correlation between items within a subscale of the ICIQ-FLUTS LF questionnaire assessed by internal consistency. measure: The consistency of the repeated measurements by the Thai version of the ICIQ-FLUTS LF was assessed by the test-retest reliability. measure: The correlation between the IPSS questionnaire and ICIQ-FLUTS LF questionnaire was assessed by convergent validity. sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Thammasat University Hospital city: Khlong Luang state: Pathumthani zip: 12120 country: Thailand lat: 14.06467 lon: 100.64578 hasResults: False

 nctId: NCT06270836 id: KS301P108 briefTitle: A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer Compared With Sham Treatment in Participants With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy (NPDR) acronym: GLOW2 overallStatus: RECRUITING date: 2024-03-27 date: 2025-12-30 date: 2025-12-30 date: 2024-02-21 date: 2024-04-08 name: Kodiak Sciences Inc class: INDUSTRY briefSummary: This study will demonstrate that tarcocimab 5 mg is superior to sham treatment in participants with moderately severe to severe NPDR. conditions: Non-proliferative Diabetic Retinopathy studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized 1:1 into one of two arms: KSI-301 or sham. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: To preserve masking, 2 investigators are required for this study. The masked investigator will be responsible for examinations and safety assessments. The unmasked investigator will perform the injections and post-treatment assessments. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 250 type: ESTIMATED name: Tarcocimab name: Sham injection measure: Proportion of eyes improving ≥2 steps on the Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS) measure: Proportion of eyes developing a Sight-Threatening Complication(s) of diabetic retinopathy measure: Proportion of eyes improving ≥3 steps on Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Retina Consultants of Orange County status: NOT_YET_RECRUITING city: Fullerton state: California zip: 92835 country: United States lat: 33.87029 lon: -117.92534 facility: Global Research Management, Inc. - Lugene Eye Institute status: NOT_YET_RECRUITING city: Glendale state: California zip: 91204 country: United States lat: 34.14251 lon: -118.25508 facility: Northern California Retina Vitreous Associates status: NOT_YET_RECRUITING city: Mountain View state: California zip: 94040 country: United States lat: 37.38605 lon: -122.08385 facility: Retina Consultants of Southern California status: NOT_YET_RECRUITING city: Redlands state: California zip: 92374 country: United States lat: 34.05557 lon: -117.18254 facility: Blue Ocean Clinical Research status: NOT_YET_RECRUITING city: Clearwater state: Florida zip: 33761 country: United States lat: 27.96585 lon: -82.8001 facility: Florida Eye Associates status: NOT_YET_RECRUITING city: Melbourne state: Florida zip: 32901 country: United States lat: 28.08363 lon: -80.60811 facility: Center for Retina and Macular Disease status: NOT_YET_RECRUITING city: Winter Haven state: Florida zip: 33880 country: United States lat: 28.02224 lon: -81.73286 facility: Southeast Retina Center status: NOT_YET_RECRUITING city: Augusta state: Georgia zip: 30909 country: United States lat: 33.47097 lon: -81.97484 facility: Springfield Clinic LLP status: NOT_YET_RECRUITING city: Springfield state: Illinois zip: 62703 country: United States lat: 39.80172 lon: -89.64371 facility: Cumberland Valley Retina Consultants status: NOT_YET_RECRUITING city: Hagerstown state: Maryland zip: 21740 country: United States lat: 39.64176 lon: -77.71999 facility: Envision Ocular, LLC status: NOT_YET_RECRUITING city: Bloomfield state: New Jersey zip: 07003 country: United States lat: 40.80677 lon: -74.18542 facility: Cascade Medical Research Institute status: NOT_YET_RECRUITING city: Springfield state: Oregon zip: 97477 country: United States lat: 44.04624 lon: -123.02203 facility: Mid Atlantic Retina status: NOT_YET_RECRUITING city: Bethlehem state: Pennsylvania zip: 18017 country: United States lat: 40.62593 lon: -75.37046 facility: Southeastern Retina Associates PC status: NOT_YET_RECRUITING city: Knoxville state: Tennessee zip: 37922 country: United States lat: 35.96064 lon: -83.92074 facility: Retina Research Institute of Texas status: RECRUITING city: Abilene state: Texas zip: 79606 country: United States lat: 32.44874 lon: -99.73314 facility: Panhandle Eye Group, LLP. - Southwest Retina Specialists status: NOT_YET_RECRUITING city: Amarillo state: Texas zip: 79106 country: United States lat: 35.222 lon: -101.8313 facility: Star Vision Research status: NOT_YET_RECRUITING city: Burleson state: Texas zip: 76028 country: United States lat: 32.54208 lon: -97.32085 facility: Texas Retina Associates status: NOT_YET_RECRUITING city: Plano state: Texas zip: 75075 country: United States lat: 33.01984 lon: -96.69889 facility: Strategic Clinical Research Group, LLC status: NOT_YET_RECRUITING city: Willow Park state: Texas zip: 76087 country: United States lat: 32.76263 lon: -97.65058 facility: Piedmont Eye Center status: NOT_YET_RECRUITING city: Lynchburg state: Virginia zip: 24502 country: United States lat: 37.41375 lon: -79.14225 facility: Emanuelli Research & Development Center, LLC status: NOT_YET_RECRUITING city: Arecibo zip: 00612 country: Puerto Rico lat: 18.47245 lon: -66.71573 hasResults: False

 nctId: NCT06270823 id: NIMR/HQ/R.8a/Vol.IX/4331 briefTitle: Reducing Respiratory Distress After Elective Caesarean Birth Through Knee-chest-flexion: a Randomized Controlled Trial overallStatus: RECRUITING date: 2024-02-14 date: 2025-02-14 date: 2025-02-14 date: 2024-02-21 date: 2024-02-21 name: Kilimanjaro Clinical Research Institute class: OTHER name: Leiden University Medical Center briefSummary: Planned caesarean birth is a risk factor for the development of neonatal respiratory distress commonly known as transient tachypnoea of the newborn. This is due to the absence of labor physiology which facilitates the clearance of fetal lung fluid. We hypothesized that by mimicking flexion induced by uterine contractions by manually performing knee-to-chest flexion directly at birth to achieve expulsion of excess lung liquid, we could reduce the incidence of respiratory distress in term children born by planned CS.

The goal of this clinical trial is to test whether performing a knee-to-chest flexion maneuver directly after elective caesarean section will decrease the incidence of respiratory distress in term infants when compared to the standard care conditions: Transient Tachypnea of the Newborn studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 562 type: ESTIMATED name: Knee-to-chest-flexion manoeuvre measure: respiratory distress measure: adverse outcome of knee-to-chest flexion maneuver sex: ALL maximumAge: 30 Minutes stdAges: CHILD facility: Kilimanjaro Christian Medical Centre status: RECRUITING city: Moshi state: Kilimanjaro zip: P.O.Box 3010 country: Tanzania name: Febronia L Shirima, MD role: CONTACT phone: +255714143368 email: febbylaw17@gmail.com name: Bariki Mchome, PhD role: CONTACT phone: +255784280027 email: barikimchome@gmail.com name: Febronia L Shirima, MD role: SUB_INVESTIGATOR name: Bariki Mchome, PhD role: PRINCIPAL_INVESTIGATOR name: Blandina T Mmbaga, PhD role: PRINCIPAL_INVESTIGATOR lat: -3.35 lon: 37.33333 hasResults: False

 nctId: NCT06270810 id: Aero-PA briefTitle: Cardiometabolic Effects of Combined Aerobic Exercise and Non-Exercise Physical Activity overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-11 date: 2025-03-18 date: 2025-06-01 date: 2024-02-21 date: 2024-03-15 name: Kastamonu University class: OTHER briefSummary: The goal of this clinical trial is to investigate whether increasing non-exercise physical activity combined with aerobic exercise in overweight young women is superior to performing aerobic exercise alone in terms of some cardiometabolic variables.

The main question it aims to answer is:

• Do both increasing non-exercise physical activity and doing aerobic exercise add more beneficial cardiometabolic effects to performing aerobic exercise alone in overweight young women?

To answer this question, overweight young women will be randomly assigned to two different groups of this research. Volunteers in one of the groups will do moderate-intensity aerobic training and the other group will increase their non-exercise physical activities in addition to moderate-intensity aerobic training. Then researchers will compare two groups to see the differences in cardiometabolic variables. conditions: Overweight studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 32 type: ESTIMATED name: Aerobic Exercise name: Increasing non-Exercise Physical Activity measure: Low Density Lipoprotein (LDL) Cholesterol measure: High Density Lipoprotein (HDL) Cholesterol measure: Total Cholesterol measure: Glycated Hemoglobin (HbA1C) measure: Serum Triglycerides measure: Maximal Oxygen Consumption measure: Systolic Blood Pressure measure: Diastolic Blood Pressure measure: Body Fat Percentage measure: Fat-free Mass measure: Waist Circumference measure: Hip Circumference sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Kastamonu University, Çatalzeytin Vocational School city: Çatalzeyti̇n state: Kastamonu zip: 37 country: Turkey hasResults: False

 nctId: NCT06270797 id: KMUHIRB-E(I)-20230184 briefTitle: Pre-anesthesia Imaging-based Respiratory Assessment and Analysis overallStatus: RECRUITING date: 2024-03-01 date: 2026-12-31 date: 2026-12-31 date: 2024-02-21 date: 2024-02-21 name: Kaohsiung Medical University Chung-Ho Memorial Hospital class: OTHER briefSummary: This study is to establish a preoperative respiratory imaging assessment database and develop a difficult intubation risk prediction model and further risk analysis. We attempt to construct it into a pre-anesthesia intubation risk assessment software as the clinical decision support system. conditions: Clinical Decision Support System studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30000 type: ESTIMATED name: intubation for general anesthesia measure: A pre-anesthesia evaluation measure: Perform non-invasive imaging capture. measure: difficult intubation prediction measure: time to successfully extubate the nasotracheal tube after anesthesia measure: safely discharged from post-anesthesia care unit (postoperative recovery room) measure: side effects and adverse events sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kaohsiung Medical University Chung-Ho Memorial Hospital status: RECRUITING city: Kaohsiung state: Sanmin Dist zip: 80756 country: Taiwan name: Tz Ping Gau, MD role: CONTACT phone: +886912060962 email: u9401066@gap.kmu.edu.tw lat: 22.61626 lon: 120.31333 hasResults: False

 nctId: NCT06270784 id: 09.2024.122 briefTitle: Traditional vs Orthodontic Extraction of Impacted Teeth Related to the Inferior Alveolar Nerve overallStatus: RECRUITING date: 2024-01-17 date: 2024-07-17 date: 2024-09-17 date: 2024-02-21 date: 2024-02-21 name: Marmara University class: OTHER briefSummary: The aim of this clinical study was to compare the effects of traditional and orthodontic extraction methods on postoperative nerve damage in impacted third molars associated with the inferior alveolar nerve. The main question it aims to answer is:

-Does the orthodontic extraction method reduce the risk of nerve injury compared to traditional extraction?

Participants will:

* undergo either traditional or orthodontic extraction
* be monitored for postoperative paresthesia.

Researchers will compare traditional and orthodontic extraction methods to see if extraction methods affect postoperative nerve damage. conditions: Inferior Alveolar Nerve Injuries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Traditional Extraction name: Orthodontic Extraction measure: The effect of the extraction method on nerve injury measure: 2-point discrimination test sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Marmara University status: RECRUITING city: Istanbul state: Basibuyuk zip: 34854 country: Turkey name: Senem Askin Ekinci, DDS role: CONTACT phone: +902167775000 email: askinsenem@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06270771 id: 5823 briefTitle: OURA Ring Wearable Testing in MDS Patients: a Feasibility and Discovery Pilot Study acronym: OURA MDS overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-08-01 date: 2026-02-01 date: 2024-02-21 date: 2024-02-21 name: Sunnybrook Health Sciences Centre class: OTHER briefSummary: A prospective, single center, single arm phase 2 cohort feasibility study of the OURA ring in adult MDS patients. Patients with MDS will wear the OURA ring and upload biometrics weekly. Quality of life measures will be clinically evaluated and correlated with biometrics. We hypothesize that it will be feasible for MDS patients to wear the OURA ring 70% of the time for 3 months. conditions: MDS conditions: Myelodysplastic Syndromes studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: OURA Ring measure: Feasibility of patients with MDS wearing the OURA ring measure: Exploratory correlations between physiologic changes captured by the wearable device and physical functioning sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sunnybrook Health Sciences Research Centre city: Toronto state: Ontario zip: M4N 3M5 country: Canada name: Rena Buckstein role: CONTACT phone: 416-480-5000 phoneExt: 689565 email: rena.buckstein@sunnybrook.ca name: Geetha Yogendran role: CONTACT phone: 416-480-5000 phoneExt: 689565 email: geetha.yogendran@sunnybrook.ca name: Rena Buckstein role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06270758 id: 453/2023/Sper/IOR briefTitle: Clinical Validation of BBCT-hip acronym: ValidaBBCT-hip overallStatus: RECRUITING date: 2023-11-07 date: 2030-11-06 date: 2030-11-06 date: 2024-02-21 date: 2024-02-21 name: Istituto Ortopedico Rizzoli class: OTHER briefSummary: The clinical study is aimed at assessing the accuracy of the in silico methodology BBCT-hip. BBCT-hip takes as inputs the subject-specific height and weight, and the CT scan of his femur to predict the risk of fracture for the femur upon falling. In the study, 150 subjects who suffered from a fracture will be enrolled, in addition to 150 control subjects. CT scans will be carried out for both groups (no later than 3 months for the fracture group) and BBCT-hip run,in order that the risk of fracture will be obtained. First, a transversal study will be performed, where the stratification accuracy of BBCT-hip will be assessed in terms of the ability of the predicted risk of fracture to separate fracture and control subjects. Furthermore, the control subjets will be followed up to assess BBCT-hip predictive accuracy through a longitudinal study. conditions: Osteoporosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: CT scan at the femur measure: Femoral fracture event measure: BBCT-hip risk prediction measure: T-score sex: FEMALE minimumAge: 65 Years maximumAge: 85 Years stdAges: OLDER_ADULT facility: Rizzoli Orthopaedic Institute status: RECRUITING city: Bologna zip: 40136 country: Italy name: Alessandra Aldieri, PhD role: CONTACT phone: +390516366565 email: alessandra.aldieri@ior.it name: Fabio Baruffaldi role: CONTACT phone: +390516366850 email: fabio.baruffaldi@ior.it lat: 44.49381 lon: 11.33875 facility: Rizzoli Orthopaedic Institute status: RECRUITING city: Bologna zip: 40136 country: Italy name: Alessandra Aldieri, PhD role: CONTACT phone: +39 051 636 6565 email: alessandra.aldieri@polito.ior.ir name: Fabio Baruffaldi role: CONTACT phone: + 39 051 6366850 email: fabio.baruffaldi@ior.it lat: 44.49381 lon: 11.33875 hasResults: False

 nctId: NCT06270745 id: sdycllyy001 briefTitle: ICG Anastomotic Control in Digestive System Surgery overallStatus: RECRUITING date: 2018-01-01 date: 2024-02-01 date: 2024-06-01 date: 2024-02-21 date: 2024-02-23 name: Shandong Linglong Yingcheng Hospital class: NETWORK briefSummary: This was a parallel single-center retrospective cohort study conducted at Linglong Yingcheng Hospital, Shandong, China. The purpose of this study was to investigate the effect of indocyanine green (ICG) on patients undergoing digestive system surgery (subtotal gastrectomy, partial hepatectomy, transverse colectomy, left colectomy, including sigmoid resection, and splenic colic resection). ) of anastomotic leakage (AL). Secondary objectives were to detect and study the impact of various risk factors on AL and on morbidity and surgical performance within 30 days of surgery. conditions: Surgical Anastomosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: indocyanine green measure: Anastomotic leak at 30 days measure: Post-operative morbidity sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shandong Linglong Yingcheng Hospital status: RECRUITING city: Yantai state: Shandong zip: 264000 country: China name: Xuan Qiu, MD role: CONTACT phone: 8618354280081 email: qiuxuan100@163.com name: Ni Wang, MD role: CONTACT phone: 8618705353551 email: wangni1989@163.com lat: 37.47649 lon: 121.44081 hasResults: False

 nctId: NCT06270732 id: PID2021-125444OB-100-II-iM briefTitle: Efficacy of iMentalize and MISC-SA to Foster Parents' Mentalization and Children Mental Health in General Population. acronym: iMentalize overallStatus: RECRUITING date: 2024-02-05 date: 2025-02-21 date: 2025-03-03 date: 2024-02-21 date: 2024-02-21 name: Universitat Autonoma de Barcelona class: OTHER name: Ministerio de Economía y Competitividad, Spain briefSummary: OBJECTIVES: The goal of this parallel randomized controlled trial is to test the efﬁcacy of the iMentalize program and the Mediational Intervention for Sensitizing Caregivers - Self Administered version (MISC-SA) to foster parents' mentalization and children mental health in families from general population.

PARTICIPANTS will randomly receive one of the 3 interventions, all based in 30 weekly online non-synchronic sessions extended across 1 year: the iMentalize program (based on parent-child sessions where they see and talk about cartoon shorts), the MISC-SA (self-administered MISC version based on guided video-feedback using recordings of one's own parent-child interactions), and MISC-R (also self-administered but mainly based on readings and cognitive exercises instead of video-feedback), which is used here as Treatment as Usual (TAU, control group) because it is the most similar to most other intellectual and mainly theoretical trainings.

COMPARISONS: Researchers will compare all 3 groups among them to see to what extent:

* iMentalize program shows efficacy in fostering mentalization compared with MISC-SA and TAU (control group).
* iMentalize program shows efficacy in fostering children's mental health compared with TAU (control group).
* MISC-SA shows efficacy in fostering parent's mentalization and children mental health compared with TAU (control group). conditions: Emotional Intelligence conditions: Social Interaction conditions: Mental Health Wellness 1 conditions: Well-Being, Psychological studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double-blind, parallel group, randomized controlled trial primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 105 type: ESTIMATED name: iMentalize Program (iMentalize) name: Mediational Intervention for Sensitizing Caregivers, Self-Administered version (MISC-SA) name: Mediational Intervention for Sensitizing Caregivers - Readings version (MISC-R): Treatment as Usual (TAU) measure: Parental Reﬂective Function Questionnaire (PRFQ) measure: Trait Meta-Mood Scale (24 items) (TMMS-24) measure: Basic Empathy Scale (BES) measure: Movie for the Assessment of Social Cognition (MASC) measure: Stirling Children's Wellbeing Scale (SCWBS) measure: Child Well-Being Level (CWBL) measure: Strengths and Difﬁculties Questionnaire (SDQ) measure: Achenbach System for Empirically Assessment (ASEBA) measure: Observing Mediational Interaction (OMI) measure: Parental Stress Questionnaire (PSI) measure: Goldberg Health Questionnaire (28 items) (GHQ-28) measure: Difﬁculties in Emotional Regulation Scale (DERS) measure: Oxford Happiness Questionnaire (OHQ) measure: Rosenberg's Self-Esteem Scale (RSES) measure: Parental Sense of Competence Scale (PSOC) measure: Self-Other Mentalization Scale (SOMS) measure: Reﬂective Functioning Scale - Youth (5 items version) (RFQ-Y5) measure: Trait Meta-Mood Scale - Children version (TMMS-C) measure: Big Five Questionnaire for Children and Adolescents (BFQ-NA) measure: BarOn Inventory of Emotional Intelligence for children aged 7 to 18 years old (BarOn) measure: Rosenberg's Self-Esteem Scale - Child version (RSES-C) measure: Battery of Socialization (BAS) measure: Inventory of Learning Patterns, reduced version (60 items) (ILP-60) measure: Relationship Questionnaire (RQ) measure: Time with the Child (TC) sex: ALL minimumAge: 25 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sergi Ballespí status: RECRUITING city: Barcelona zip: 08193 country: Spain name: Anna Ciraso, Researcher role: CONTACT phone: +34661858272 email: anna.ciraso@uab.cat name: Ana Carolina Pacheco, Researcher role: CONTACT phone: +573153561564 email: anacarolina.pacheco@autonoma.cat lat: 41.38879 lon: 2.15899 facility: Universitat Autònoma de Barcelona status: RECRUITING city: Barcelona zip: 08193 country: Spain name: Anna Ciraso, Researcher role: CONTACT phone: +34661858272 email: anna.ciraso@uab.cat name: Ana Carolina Pacheco, Researcher role: CONTACT phone: +573153561564 email: anacarolina.pacheco@autonoma.cat lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06270719 id: SRP-9001-401 briefTitle: An Observational Study Comparing Delandistrogene Moxeparvovec With Standard of Care in Participants With Duchenne Muscular Dystrophy acronym: ENDURE overallStatus: RECRUITING date: 2024-02-07 date: 2029-12-31 date: 2038-12-31 date: 2024-02-21 date: 2024-04-12 name: Sarepta Therapeutics, Inc. class: INDUSTRY briefSummary: This is a multicenter, prospective, observational Phase 4 study in the United States. The study is designed to collect both medical history and prospective data on Duchenne muscular dystrophy (DMD) treatment outcomes in participants receiving delandistrogene moxeparvovec as part of clinical care, compared to participants with DMD receiving or prescribed to start chronic glucocorticoid treatment at baseline in routine clinical practice. In addition, treatment outcomes will be collected prospectively from post-trial participants who have received delandistrogene moxeparvovec through participation in select SRP-9001 studies. conditions: Duchenne Muscular Dystrophy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: delandistrogene moxeparvovec name: Standard of Care measure: All Cohorts: Mean Change From Baseline in Time to Walk/Run 10 Meters (and Calculated Velocity) at Month 12 measure: All Cohorts: Time to Rise From Floor (Supine to Stand) measure: All Cohorts: Loss of Ambulation (LOA) measure: All Cohorts: Performance of Upper Limb (PUL) Version 2.0 Entry Item Score measure: All Cohorts: Patient-reported Outcomes Measurement Information (PROMIS) Domain Scores of Mobility, Upper Extremity and Fatigue measure: All Cohorts: Pulmonary Function, as Measured Forced Vital Capacity (FVC) (% Predicted) measure: All Cohorts: Cardiac Function, Including Left Ventricular Ejection Fraction (LVEF) as Measured by Echocardiogram (ECHO) measure: All Cohorts: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) measure: Delandistrogene Moxeparvovec Cohorts: Time to Walk/Run 10 Meters (Calculated Velocity) measure: Delandistrogene Moxeparvovec Post-trial Cohort: North Star Ambulatory Assessment (NSAA) sex: MALE minimumAge: 4 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Arkansas Children's Hospital status: RECRUITING city: Little Rock state: Arkansas zip: 72202 country: United States role: CONTACT email: SareptAlly@sarepta.com name: Aravindhan Veerapandiyan, MD role: PRINCIPAL_INVESTIGATOR lat: 34.74648 lon: -92.28959 facility: Penn State Health Milton S. Hershey Medical Center status: NOT_YET_RECRUITING city: Hershey state: Pennsylvania zip: 17033 country: United States role: CONTACT email: SareptAlly@sarepta.com name: Ashutosh Kumar, MD role: PRINCIPAL_INVESTIGATOR lat: 40.28592 lon: -76.65025 facility: Cook Children's Hospital status: RECRUITING city: Fort Worth state: Texas zip: 76104 country: United States role: CONTACT email: SareptAlly@sarepta.com lat: 32.72541 lon: -97.32085 facility: Children's Hospital of the King's Daughters status: RECRUITING city: Norfolk state: Virginia zip: 23507 country: United States role: CONTACT email: SareptAlly@sarepta.com name: Crystal Proud, MD role: PRINCIPAL_INVESTIGATOR lat: 36.84681 lon: -76.28522 hasResults: False

 nctId: NCT06270706 id: PLN-101095-ONC-101 briefTitle: A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors overallStatus: RECRUITING date: 2023-08-30 date: 2025-06 date: 2025-12 date: 2024-02-21 date: 2024-02-21 name: Pliant Therapeutics, Inc. class: INDUSTRY briefSummary: This is a Phase 1a/1b, dose-escalation/expansion, consecutive-cohort, open-label study to evaluate the safety, tolerability, PK, PD, and preliminary evidence of antitumor activity of PLN-101095 in combination with pembrolizumab (the study treatment regimen) in adult participants with advanced or metastatic solid tumors for which pembrolizumab is indicated but have documented disease progression (refractory \[primary resistance\]) or relapsed \[secondary resistance\]) after at least 3 months from the start of treatment with pembrolizumab.

The study will consist of 2 main parts:

* Part 1: Consecutive dose-escalation cohorts using a Bayesian optimal interval (BOIN) dose escalation design
* Part 2: Dose-expansion cohorts using Simon's 2-stage design conditions: Metastatic Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 77 type: ESTIMATED name: PLN-101095 name: Pembrolizumab measure: Proportion of participants with treatment-emergent adverse events and serious adverse events per CTCAE Version 5.0. measure: Number of participants with a Dose Limiting Toxicity (DLT) defined as toxicities that meet predefined severity criteria, assess as having a suspected relationship to study drug, unrelated to disease, inter-current illness, or concomitant medications. measure: Maximum observed plasma concentration (Cmax) to characterize the plasma pharmacokinetics (PK). measure: Time to maximum observed concentration (Tmax) to characterize the plasma pharmacokinetics (PK). measure: Area under the concentration-time curve over a dosing interval (AUC0-τ) to characterize the plasma pharmacokinetics (PK). measure: Disease control rate (DCR) is defined by the proportion of participants who maintain disease control (iCR, iPR or iSD) per iRECIST Version 1.1. measure: Objective response rate (ORR) is defined by the proportion of participants with an iCR or iPR per iRECIST Version 1.1. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: South Texas Accelerated Research Therapeutics (START) status: RECRUITING city: Grand Rapids state: Michigan zip: 49546 country: United States lat: 42.96336 lon: -85.66809 facility: NEXT Austin status: RECRUITING city: Austin state: Texas zip: 78758 country: United States lat: 30.26715 lon: -97.74306 facility: University of Texas MD Anderson Cancer Center status: RECRUITING city: Houston state: Texas zip: 77030 country: United States lat: 29.76328 lon: -95.36327 facility: NEXT Virginia status: RECRUITING city: Fairfax state: Virginia zip: 22031 country: United States lat: 38.84622 lon: -77.30637 hasResults: False

 nctId: NCT06270693 id: Dr Sushma briefTitle: hsCRP & CH Indices in Patients With Coronary Artery Disease With and Without Apical Periodontitis overallStatus: ACTIVE_NOT_RECRUITING date: 2022-11-01 date: 2024-02-01 date: 2024-04-01 date: 2024-02-21 date: 2024-02-21 name: Postgraduate Institute of Dental Sciences Rohtak class: OTHER briefSummary: Endodontic treatment is done in Patients with chronic pulp exposure in patients with Coronary Artery Disease and systemic inflammatory markers recorded before and and after treatment and compared with patients with Coronary Artery Disease without chronic pulp exposure. conditions: Apical Periodontitis conditions: Coronary Artery Disease studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 70 type: ACTUAL name: Endodontic treatment measure: Serum hsCRP measure: complete hemogram indices measure: Periapical index SCORE CHANGE sex: ALL minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: PGIDS city: Rohtak state: Haryana zip: 124001 country: India lat: 28.89447 lon: 76.58917 hasResults: False

 nctId: NCT06270680 id: STUDY00023019 briefTitle: Carotenoids for Collision Athletes overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2024-12-20 date: 2024-12-20 date: 2024-02-21 date: 2024-03-18 name: Penn State University class: OTHER name: MacuHealth name: Orlando Regional Medical Center briefSummary: This is a supplement study being conducted to find out if collision sport athletes who are exposed to repetitive head impacts while supplementing with carotenoids will have decreased pro-inflammatory blood biomarkers, increases in macular pigment optical density, improved contrast sensitivity, greater retinal nerve fiber thickness, and better overall visual quality of life scores compared to collision athletes taking a placebo. conditions: Head Injury conditions: Carotenoids studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 52 type: ESTIMATED name: Vision Edge Pro name: Placebo measure: Blood and saliva biomarkers via venous blood draw and spitting into sterile cup. measure: Visual Performance: Speed of visual processing measure: Visual Performance: Contrast Sensitivity measure: Skin carotenoid concentration measure: Retinal Nerve Fiber Layer Thickness measure: Macular Pigment Optical Density measure: Visual Quality of Life Scores measure: Visual Quality of Life Scores measure: Demographic information measure: Demographic information sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Pennsylvania State University city: University Park state: Pennsylvania zip: 16802 country: United States name: Semyon Slobounov, PhD role: CONTACT phone: 814-571-4298 email: sms18@psu.edu name: Jonathan Kelly, MS role: CONTACT phone: 9495565035 email: jtk5577@psu.edu name: Semyon Slobounov, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.80201 lon: -77.85639 hasResults: False

 nctId: NCT06270667 id: LYMfit briefTitle: Effects of Exercise Training in Survivors of Lymphoma acronym: LYMfit overallStatus: RECRUITING date: 2024-03-20 date: 2028-09-01 date: 2028-09-01 date: 2024-02-21 date: 2024-03-22 name: Norwegian School of Sport Sciences class: OTHER name: Uppsala University briefSummary: This study aims to compare the effects of aerobic exercise with or without addition of resistance exercise to usual care in individuals treated with anthracyclines for lymphomas and to compare exercise effects to age- and sex-matched individuals with no prior history of malignant diseases. conditions: Lymphoma conditions: Physical Exercise conditions: Cardiotoxicity conditions: Cardiovascular Diseases conditions: Chemotherapeutic Toxicity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 280 type: ESTIMATED name: Aerobic Exercise name: Combined Aerobic and Resistance Exercise measure: VO2peak measure: Systolic- and diastolic heart chamber dimensions measure: Systolic- and diastolic longitudinal strain measure: Lean body mass measure: Fat mass measure: Forced Vital Capacity measure: Forced Expiratory Volume 1 sec measure: Maximal voluntary ventilation measure: Diffusion capacity measure: Physical activity measure: Physical activity measure: Global Health related Quality of life measure: Blood volume measure: Muscle fiber area measure: Muscle fiber type measure: Muscle mitochondria mass measure: Muscle genome-wide DNA methylation and gene expression measure: Adverse events sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Norweigan School of Sport Sciences status: NOT_YET_RECRUITING city: Oslo country: Norway name: Tormod S. Nilsen, PhD role: CONTACT lat: 59.91273 lon: 10.74609 facility: Helena Igelström status: RECRUITING city: Uppsala country: Sweden name: Helena Igelström, PhD role: CONTACT name: Anna Henriksson, PhD role: CONTACT phone: 709394175 phoneExt: 0046 email: anna.km.henriksson@uu.se name: Helena Igelström, PhD role: PRINCIPAL_INVESTIGATOR name: Anna Henriksson, PhD role: SUB_INVESTIGATOR lat: 59.85882 lon: 17.63889 hasResults: False

 nctId: NCT06270654 id: 2023322-12280 briefTitle: Management of Perioperative Pain Using Erector Spinae Plane Block in Open Microscopic Lumbar Surgery overallStatus: RECRUITING date: 2023-06-01 date: 2024-05-01 date: 2024-06-01 date: 2024-02-21 date: 2024-02-21 name: University of Malaya class: OTHER briefSummary: The aim of this study is to compare patients receiving bilateral erector spinae block with ropivacaine vs control group in terms of pain score, total opioid consumption, hemodynamic changes intraoperatively, length of hospitalisation , time to ambulation post surgery and quality of recovery. conditions: Lumbar Spine Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Erector spinae plane block name: Skin infiltration LA measure: Pain score at recovery, 30mins, 1, 2, 4, 8,12, 24 hours post-surgery measure: Total opioid consumption intraoperative measure: Total opioid consumption post-operative measure: Timing of first rescue dose of iv morphine measure: The quality of recovery score (QoR)-15 questionnaire at 24 hours post-operation measure: Hemodynamic changes intraoperative measure: Hemodynamic changes intraoperative measure: Length of hospital stays measure: Time to ambulation after surgery sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universiti Malaya Medical Centre status: RECRUITING city: Kuala Lumpur state: Wilayah Persekutuan zip: 51100 country: Malaysia name: Wei Keang Tan, M.D. role: CONTACT phone: +60126655489 email: weikeang@ummc.edu.my name: Wei Keang Tan, MD. role: PRINCIPAL_INVESTIGATOR name: Tzi Sen Lee, MBBS role: SUB_INVESTIGATOR name: Dharmendra Ganesan, MBBS, FRCS role: SUB_INVESTIGATOR lat: 3.1412 lon: 101.68653 hasResults: False

 nctId: NCT06270641 id: STUDY00018628 briefTitle: Increasing Physical Activity for Adults With Multiple Sclerosis (MS) overallStatus: RECRUITING date: 2024-02-16 date: 2025-04-30 date: 2026-09-30 date: 2024-02-21 date: 2024-02-22 name: University of Washington class: OTHER briefSummary: This study aims to advance the scientific understanding and potential future implementation of physical activity promotion by testing the efficacy of a phone-based app for increasing activity in insufficiently active patients with multiple sclerosis (MS). conditions: Multiple Sclerosis (MS) conditions: Fatigue conditions: Physical Inactivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 106 type: ESTIMATED name: ExerciseRx intervention measure: Physical activity: daily average step count measure: Activity volume measure: Minutes/week of moderate intensity aerobic activity measure: Fatigue - PROMIS Fatigue-MS Short Form 8a measure: Pain intensity - PROMIS Pain Intensity Short Form 3a measure: Depressive symptom severity - PROMIS Depression Short Form 8a measure: Sleep disturbance - PROMIS Sleep Disturbance Short Form 6a measure: Physical functioning - PROMIS Physical Function 10a measure: Pain interference - PROMIS Pain Interference Scale Short Form 6a measure: Social participation - PROMIS Satisfaction with Social Roles and Activities Short Form 8a measure: Social participation - PROMIS Ability to Participate in Social Roles and Activities Short Form 8a sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UW Medicine status: RECRUITING city: Seattle state: Washington zip: 98133 country: United States name: Laurie Kavanagh, MPH role: CONTACT phone: 206-668-4168 email: lauriek@uw.edu lat: 47.60621 lon: -122.33207 hasResults: False

 nctId: NCT06270628 id: NL85029.018.23 briefTitle: Personalized Live-remote Exercise Training for Cancer Survivors acronym: LION overallStatus: NOT_YET_RECRUITING date: 2024-02-20 date: 2026-10-31 date: 2027-10-31 date: 2024-02-21 date: 2024-02-21 name: UMC Utrecht class: OTHER name: German Cancer Research Center (DKFZ), Heidelberg, Germany name: German Sport University Cologne (DSHS), Cologne, Germany name: Cabrini Health (CAB), Malvern, Australia name: Karolinska Institute (KI), Stockholm, Sweden name: Netherlands Cancer Institute (NKI), Amsterdam, The Netherlands name: Heidelberg University Clinic and National Center for Tumor Diseases, Heidelberg, Germany name: Fundacion Onkologikao (ONK), San Sebastian, Spain name: Associação de Investigação e Cuidados de Suporte em Oncologia (AISCO), Nova de Gaia, Portugal briefSummary: Background

Many people with cancer face ongoing problems from their disease and treatments, like fatigue, reduced physical fitness, feeling anxious or down, and neuropathy. While exercise might help with these problems, most studies did not focus on tailoring exercise to address these specific complaints. Exercise programs under supervision (like with a trainer) seem to work better, but barriers for following such sessions are travel distance and time. Therefore, following an exercise program at home with a trainer guiding via video (live-remote) might be a good solution. But, it is unclear how effective this remote exercise program is for cancer patients.

Goal of the study:

The main goal of this study is to assess the effectiveness of a personalized, live-remote exercise intervention for cancer survivors on quality of life and the patients' main complaint. The four complaints tackled in this study are: 1) fatigue, 2) reduced physical functioning, 3) anxiety and/or depressive symptoms, and 4) neuropathy.

Design of the study

In the LION study, 350 cancer patients will be randomly divided into the exercise group or control group. These patients all have at least one of these complaints: 1) fatigue, 2) reduced physical functioning, 3) anxiety and/or depressive symptoms, and/or 4) neuropathy. Patients cannot participate in the study if they are already very active.

The exercise group will start a 12-week exercise program right away, and the other group will wait for 12 weeks before starting. The exercise program consists of three sessions per week. Two sessions per week include aerobic training and strength training. These sessions will be followed by all patients; and aim to improve fitness and strength. The third session specifically aims at improvement of the main complaint, for example fatigue.

Participants will get an app and a fitness tracker to help them stay on track with their exercises. Furthermore, patients get information on the effects of exercise for cancer patients and why exercise is important for specific complaints.

Measurements

The main outcomes of this study are quality of life and the main side-effect of the patient. Other measurements include all kind of patient reported outcomes (like sleep problems and pain), physical fitness, muscle strength, balance, anthropometrics, and (inflammatory) markers in blood.

Conclusion:

This study investigates if personalized exercises done at home, with video guidance, can make cancer survivors feel better and manage their side effects more effectively. conditions: Neoplasms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: RCT with two study arms: exercise group and wait list control group primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 350 type: ESTIMATED name: Exercise group measure: Health-Related Quality of Life measure: A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline measure: A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline measure: A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline measure: A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline measure: Health-related quality of life measure: Fatigue measure: Anxiety and Depression measure: CIPN_1 measure: CIPN_2 measure: Sleep measure: Pain measure: Cognitive problems measure: Work limitations measure: Body image measure: Fear of cancer recurrence measure: Habitual physical activity measure: Aerobic capacity on bike measure: Aerobic capacity on step measure: Handgrip strength measure: Upper body muscle strength measure: Lower body muscle strength measure: Sit to stand test measure: Physical function measure: Balance measure: Physical activity measure: Blood pressure measure: Resting heart rate measure: Weight measure: Height measure: Waist circumference measure: Hip circumference measure: Body composition measure: Inflammatory state measure: Growth factors measure: CRP measure: Hemoglobin measure: Leucocyte counts measure: Quality-adjusted life years measure: Health-care, patient and family costs measure: Productivity losses measure: Exercise-related (serious) adverse events measure: Participants experience of sensor-based guidance measure: Trainer experience of sensor-based guidance measure: Compliance sensor-based guidance measure: Technical feasibility of sensor-based guidance measure: Aerobic capacity measure: Upper body muscle strength measure: Lower body muscle strength measure: Core muscle strength measure: Physical functioning measure: Balance measure: Socio-demographics measure: Self-efficacy measure: Social Support measure: Medical history measure: Concomitant diseases measure: Cancer + concomitant medication measure: Cancer characteristics measure: Cancer treatment history sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Medical Center Utrecht city: Utrecht country: Netherlands lat: 52.09083 lon: 5.12222 hasResults: False

 nctId: NCT06270615 id: CRCBDD1712 briefTitle: Prospective Validation of the SHOCKMATRIX Hemorrhage Predictive Model acronym: SHOCKMATRIX overallStatus: RECRUITING date: 2022-07-01 date: 2024-06 date: 2024-06 date: 2024-02-21 date: 2024-02-21 name: Assistance Publique - Hôpitaux de Paris class: OTHER name: Traumabase Group name: Capgemini Invent name: Ecole polytechnique name: EHESS (Ecole des hautes études en sciences sociales) name: CNRS (Centre national de la recherche scientifique) briefSummary: Management of post-traumatic severe hemorrhage remains a challenge to any trauma care system. Studying integrated and innovative tools designed to predict the risk of early severe hemorrhage (ESH) and resource needs could offer a promising option to improve clinical decisions and then shorten the time of intervention in the context of pre-hospital severe trauma. As evidence seems to be lacking to address this issue, this ambispective validation study proposes to assess on an independent cohort the predictive performance of a newly developed machine learning-based model, as well as the feasibility of its clinical deployment under real-time healthcare conditions. conditions: Wounds and Injuries conditions: Traumatic Shock conditions: Hemorrhagic Shock studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 1500 type: ESTIMATED name: Ambispective validation of machine learning-based predictive model measure: Fβ-score, with β = 4 measure: Common binary classification metrics sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beaujon Hospital AP-HP, Anesthesia-Intensive Care Department status: RECRUITING city: Clichy zip: 92110 country: France name: Mathilde Holleville, MD role: CONTACT email: mathilde.holleville@aphpr.fr lat: 48.90018 lon: 2.30952 facility: Grenoble Alpes University Hospital status: RECRUITING city: La Tronche zip: 38700 country: France name: Tobias Gauss, MD role: CONTACT phone: +33476769288 email: tgauss@chu-grenoble.fr name: Samia Salah role: CONTACT phone: +33476769288 email: SSalah1@chu-grenoble.fr lat: 45.20429 lon: 5.73645 facility: Bicêtre Hospital AP-HP, Anesthesia-Intensive Care Department status: RECRUITING city: Le Kremlin-Bicêtre zip: 94270 country: France name: Marie Werner, MD role: CONTACT email: marie.werner@aphp.fr lat: 48.81471 lon: 2.36073 facility: Lille University Hospital, Anaesthesia and Intensive Care Unit status: RECRUITING city: Lille zip: 59037 country: France name: Benjamin Bijok, MD role: CONTACT email: Benjamin.BIJOK@CHRU-LILLE.FR lat: 50.63297 lon: 3.05858 facility: Pitié-Salpêtrière Hospital AP-HP, Anesthesia-Intensive Care Department status: RECRUITING city: Paris zip: 75013 country: France name: Arthur James, MD role: CONTACT email: arthur.james@aphp.fr lat: 48.85341 lon: 2.3488 facility: Georges-Pompidou European Hospital AP-HP, Anesthesia-Intensive Care Department status: RECRUITING city: Paris zip: 75015 country: France name: Nathalie Delhaye, MD role: CONTACT email: nathalie.delhaye@aphp.fr lat: 48.85341 lon: 2.3488 facility: University Hospitals Strasbourg, Anaesthesia, Intensive Care and Peri-Operative Medicine Department status: RECRUITING city: Strasbourg zip: 67200 country: France name: Alain Meyer, MD role: CONTACT email: alain.meyer@chru-strasbourg.fr lat: 48.58392 lon: 7.74553 facility: University Hospital of Toulouse, Polyvalent Intensive Care status: RECRUITING city: Toulouse zip: 31059 country: France name: Véronique Ramonda, MD role: CONTACT email: ramonda.v@chu-toulouse.fr lat: 43.60426 lon: 1.44367 hasResults: False

 nctId: NCT06270602 id: ONCOCAMP id: 6/23 oss type: OTHER domain: IRCCS I.N.T. "G. Pascale" briefTitle: The ONCOCAMP Study overallStatus: RECRUITING date: 2023-07-14 date: 2024-07 date: 2026-07 date: 2024-02-21 date: 2024-02-21 name: National Cancer Institute, Naples class: OTHER briefSummary: The present study is a retrospective-prospective observational and multicentric study aiming to collect data relating to all patients included in the ROC platform. All ROC centers will be involved in the present study. conditions: Oncology studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 15000 type: ESTIMATED name: Data collection (retrospective) name: Data collection (prospective) measure: Incidence for each tumor of the patients included in the ROC platform measure: Evaluation of the time interval between GOM activities measure: Evaluation of the time interval between GOM activities measure: Evaluation of the time interval between GOM activities measure: Evaluation of the time interval between GOM activities measure: Evaluation of the time interval between GOM activities measure: Frequency of use of the services of the ROC platform measure: Descriptive analysis of each subgroup of patients (subdivision by tumor type) measure: Spatial analysis for each patient measure: Frequency of adherence to guidelines of the Diagnostic Therapeutic Assistance Paths (PDTA) measure: Percentage of patient included in clinical trial measure: Assessment of costs arising due to inefficiencies (repetition and inappropriateness of diagnostic tests; passive health mobility rate measure: Prevalence for each tumor of the patients included in the ROC platform measure: Description of pharmacological strategies measure: Description of diagnostic activities measure: Description of surgical strategies measure: Appropriateness of diagnostic tests (taking as reference the guidelines reported in each PDTA) measure: Description of each surgical approach measure: Description of the different surgical techniques among the centers measure: Patients' quality of life measure: Patients' reported outcome measure: Patients' satisfaction and evaluation of the diagnostic / therapeutic path measure: Correlation analysis among risk factors and diagnostic / therapeutic delay or poor prognosis measure: Dependence analysis between the conditions of social deprivation of ROC patients and the time to the first GOM visit measure: Dependence analysis among costs, socio-demographic characteristics and some variables related to the diagnostic / therapeutic path measure: Survival analysis for each tumor measure: Life status assessment for each patient sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Asl Napoli 2 Nord status: RECRUITING city: Casavatore state: Napoli zip: 80020 country: Italy name: Filomena Sibilio, M.D. role: CONTACT lat: 40.89921 lon: 14.27663 facility: Asl Napoli 3 Sud status: RECRUITING city: Ercolano state: Napoli zip: 80056 country: Italy name: Mario Fusco, M.D. role: CONTACT lat: 40.80783 lon: 14.35012 facility: A.O. Moscati status: RECRUITING city: Avellino zip: 83100 country: Italy name: Cesare Gridelli, M.D. role: CONTACT lat: 40.91494 lon: 14.79103 facility: Asl Avellino status: RECRUITING city: Avellino zip: 83100 country: Italy name: Giuseppe Genua, M.D. role: CONTACT lat: 40.91494 lon: 14.79103 facility: A.O. Rummo status: RECRUITING city: Benevento zip: 82100 country: Italy name: Antonio Grimaldi, M.D. role: CONTACT lat: 41.1307 lon: 14.77816 facility: Asl Benevento status: RECRUITING city: Benevento zip: 82100 country: Italy name: Elena Fossi, M.D. role: CONTACT lat: 41.1307 lon: 14.77816 facility: Asl Caserta status: RECRUITING city: Caserta zip: 81035 country: Italy name: Antonella Guida, M.D. role: CONTACT lat: 41.07262 lon: 14.33231 facility: A.O. S.Anna S. Sebastiano status: RECRUITING city: Caserta zip: 81100 country: Italy name: Michele Orditura, M.D. role: CONTACT lat: 41.07262 lon: 14.33231 facility: A.O. Cardarelli status: RECRUITING city: Napoli zip: 80131 country: Italy name: Ferdinando Riccardi, M.D. role: CONTACT lat: 40.85216 lon: 14.26811 facility: A.O. Dei Colli status: RECRUITING city: Napoli zip: 80131 country: Italy name: Vincenzo Montesarchio, M.D. role: CONTACT lat: 40.85216 lon: 14.26811 facility: Federico II status: RECRUITING city: Napoli zip: 80131 country: Italy name: Sabino De Placido, M.D. role: CONTACT lat: 40.85216 lon: 14.26811 facility: I.N.T. Pascale status: RECRUITING city: Napoli zip: 80131 country: Italy name: Sandro Pignata, M.D. role: CONTACT lat: 40.85216 lon: 14.26811 facility: A.O.U. Luigi Vanvitelli status: RECRUITING city: Napoli zip: 80138 country: Italy name: Fortunato Ciardiello, M.D. role: CONTACT lat: 40.85216 lon: 14.26811 facility: Asl Napoli 1 Centro status: RECRUITING city: Napoli zip: 80145 country: Italy name: Tiziana Spinosa, M.D. role: CONTACT lat: 40.85216 lon: 14.26811 facility: Ospedale del Mare status: RECRUITING city: Napoli zip: 80147 country: Italy name: Bruno Daniele, M.D. role: CONTACT lat: 40.85216 lon: 14.26811 facility: Asl Salerno status: RECRUITING city: Salerno zip: 84124 country: Italy name: Giuseppe Di Lorenzo, M.D. role: CONTACT lat: 40.67545 lon: 14.79328 facility: A.O.U. Ruggi status: RECRUITING city: Salerno zip: 84126 country: Italy name: Stefano Pepe, M.D. role: CONTACT lat: 40.67545 lon: 14.79328 hasResults: False

 nctId: NCT06270589 id: IRB-2023-1684 briefTitle: Acute Effects of High-intensity Interval Training With Mindfulness-based Recovery on Executive Function in Children overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-05 date: 2026-05 date: 2024-02-21 date: 2024-02-21 name: Purdue University class: OTHER name: University of Oregon briefSummary: The goal of this randomized cross-over trial is to learn about the effect of a single bout of 20-min mindfulness-based high-intensity interval training (MF-HIIT), MF-only, and HIIT-only in relative to sitting rest on executive function (EF) in 10-12 years old children. The main question it aims to answer are:

Question 1: Whether a single bout of 20-min MF-HIIT has larger beneficial effect on EF performance than that following a 20-min session of MF-only and HIIT-only in relative to the sitting rest

Question 2: Whether a single bout of 20-min MF-HIIT has a larger beneficial effect on brain functioning, as measured by the N2 and P3 components of event-related potential (ER) during EF performance than that following a 20-min session of MF-only and HIIT-only in relative to the sitting rest

Participants will visit the laboratory on 5 separate days (\> 2-day washout between days) in which they have not previously participated in structured physical activities.

Participants will complete the testing and/or receive treatments below:

Day 1:

* Kaufman Brief Intelligence Test (KBIT) to assess intelligence quotient
* Treadmill-based exercise test to measure cardiorespiratory fitness (maximum oxygen consumption)

Days 2-5

* Each day, participants will complete each of the four intervention conditions (MF-HIIT, MF-only, HIIT-only, sitting)
* Participants' heart rate and self-reported affect and rating of physical exertion will be measured
* Participants will complete a modified flanker task and a task-switching task to assess inhibitory control and cognitive flexibility
* Participants will wear an EEG cap to measure the N2 and P3 components of the event-related potential during the inhibitory control and cognitive flexibility performance

Researcher will compare the cognitive outcome measures following the MF-HIIT, MF-only, and HIIT-only conditions with the sitting condition to see if MF and HIIT has beneficial effects on children's EF.

Further, researcher will compare the cognitive outcome measures following the MF-HIIT compared with MF-only and HIIT-only conditions to see if combining MF with HIIT has greater beneficial effects on children's EF than MF and HIIT alone. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: MF-HIIT name: MF-only name: HIIT-only name: Sitting rest measure: Inhibition speed measure: Inhibition accuracy measure: Shifting speed measure: Shifting accuracy measure: N2-ERP measure: P3-ERP measure: State Mindfulness Scale for Physical Activity (SMSPA) measure: Rating of perceived exertion measure: Heart Rate measure: Dispositional mindfulness sex: ALL minimumAge: 10 Years maximumAge: 12 Years stdAges: CHILD hasResults: False

 nctId: NCT06270576 id: HS3131 briefTitle: Nasal Inflammation Following Endotoxin Challenge in Patients With Asthma acronym: Nasal-LPS overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-04 date: 2028-06 date: 2024-02-21 date: 2024-02-21 name: National Jewish Health class: OTHER briefSummary: A phase I clinical research study aimed at determining mechanisms that regulate airway mucosal inflammation in asthma endotypes using intranasal administration of endotoxin (lipopolysaccharide from E. coli) in healthy controls and subjects diagnosed with asthma. conditions: Asthma; Eosinophilic conditions: Asthma studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 60 type: ESTIMATED name: Lipopolysaccharides measure: Neutrophil heterogeneity using single cell RNA sequencing sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Jewish Health city: Denver state: Colorado zip: 80206 country: United States name: William J Janssen, MD role: CONTACT phone: 303-398-1366 name: Olivia M VerBurg, BA role: CONTACT phone: 303-398-1201 name: William J Janssen, MD role: PRINCIPAL_INVESTIGATOR lat: 39.73915 lon: -104.9847 hasResults: False

 nctId: NCT06270563 id: P.T.REC/012/003967 briefTitle: High Intensity Laser Therapy Versus Scapular Stabilization Exercises on Ventilatory Function in Forward Head Posture overallStatus: COMPLETED date: 2022-10-01 date: 2023-12-01 date: 2023-12-01 date: 2024-02-21 date: 2024-02-21 name: Cairo University class: OTHER briefSummary: The purpose of the study is to compare between the efficacy of high intensity LASER therapy and scapular stabilization exercises on ventilatory functions in forward head posture patients conditions: Forward Head Posture studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: Postural advice name: Traditional exercise treatment name: Scapular stabilization exercises name: High intensity Laser therapy measure: Forced vital capacity (FVC) measure: Forced expiratory volume at one second (FEV1) measure: FEV1/FVC measure: Maximum voluntary ventilation (MVV) measure: Craniovertebral angle (CVA) measure: Neck Disability Index (NDI) measure: Upper thoracic chest expansion measure: Middle thoracic chest expansion measure: Lower thoracic chest expansion measure: Visual analogue scale (VAS) sex: ALL minimumAge: 30 Years maximumAge: 40 Years stdAges: ADULT facility: Cairo University city: Giza country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06270550 id: DMI in Spastic Diplegia briefTitle: Role of Dynamic Movement Intervention in Children With Spastic Diplegia overallStatus: RECRUITING date: 2024-03-01 date: 2024-11-01 date: 2024-12-01 date: 2024-02-21 date: 2024-02-21 name: Cairo University class: OTHER briefSummary: The study aims to investigate the effect of dynamic movement intervention approach on static and dynamic balance, quality of step length and cadence of walking pattern of children with spastic diplegic cerebral palsy. conditions: Spastic Diplegia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: Dynamic Movement Intervention measure: Effect of Dynamic movement intervention on balance and quality of walking of the study group compared to control group, measured using Humac Balance System. sex: ALL minimumAge: 4 Years maximumAge: 7 Years stdAges: CHILD facility: Cairo University status: RECRUITING city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06270537 id: Dominus PMCF briefTitle: Post-market Clinical Trial of the Dominus® Stent-Graft acronym: DominusPMCF overallStatus: RECRUITING date: 2023-10-24 date: 2025-07-30 date: 2029-02-28 date: 2024-02-21 date: 2024-02-21 name: Braile Biomedica Ind. Com. e Repr. Ltda. class: INDUSTRY briefSummary: Real-world clinical trial evidence post-market, evaluating the safety and efficacy of the Dominus® StentGraft Endoprosthesis in treating thoracic aortic diseases, following the Instructions for Use conditions: Thoracic Aortic Dissection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Stent-Graft Dominus® Endoprosthesis measure: Early occurrence of adverse events (Safety Outcome) measure: Device Success measure: Absence of endoprosthesis fracture measure: Endoleak measure: Reintervention-free measure: Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Evangélico de Vila Velha status: NOT_YET_RECRUITING city: Vila Velha state: Espirito Santo zip: 29118-060 country: Brazil name: Rodrigo Argenta role: CONTACT lat: -20.32972 lon: -40.2925 facility: Hospital Nossa Senhora da Conceição status: NOT_YET_RECRUITING city: Porto Alegre state: Rio Grande Do Sul zip: 91350-200 country: Brazil name: Eduardo A Silva role: CONTACT lat: -30.03306 lon: -51.23 facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo status: RECRUITING city: Ribeirão Preto state: São Paulo zip: 14048-900 country: Brazil name: Ewaldo Joviliano role: CONTACT lat: -21.1775 lon: -47.81028 hasResults: False

 nctId: NCT06270524 id: RCAPHM21_0433 briefTitle: Study of the C5a/C5aR1 Axis in IgG4-associated Disease: a Potential Therapeutic Target acronym: C5-MAG4 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2026-12-31 date: 2024-02-21 date: 2024-02-21 name: Assistance Publique Hopitaux De Marseille class: OTHER briefSummary: This is a monocentric, comparative, cross-sectional, case-control study seeking to identify abnormalities of the C5a-C5aR1 axis between a population of patients with active IgG4-associated disease (MAG4) and two control groups: healthy subjects without MAG4 and patients with MAG4 in remission. conditions: Immunoglobulin G4-Related Disease studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 66 type: ESTIMATED name: Blood sampling measure: Serum C5a concentration measure: frequency of C5aR1+ monocytes among total monocytes measure: frequency of Tumor Growth Factor B+ (TGF-B+) monocytes among total monocytes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06270511 id: 2222T1412 briefTitle: A Study to Investigate Different Formulations of S-337395 in Healthy Adult Participants overallStatus: RECRUITING date: 2024-03-13 date: 2024-05-31 date: 2024-06-19 date: 2024-02-21 date: 2024-03-19 name: Shionogi class: INDUSTRY briefSummary: The aim of this study is to investigate different formulations of S-337395. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: Part A will be open label; Part B will be double blind count: 50 type: ESTIMATED name: S-337395 name: Placebo measure: Part A: Plasma Concentration of S-337395 measure: Part B: Number of Participants Experiencing Treatment-emergent Adverse Events measure: Part A: Number of Participants Experiencing Treatment-emergent Adverse Events measure: Part A: Plasma Concentration of S-337395 (Venous Samples Versus Capillary Microsamples) measure: Part B: Plasma Concentration of S-337395 sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: ICON Lenexa status: RECRUITING city: Lenexa state: Kansas zip: 66219 country: United States lat: 38.95362 lon: -94.73357 hasResults: False

 nctId: NCT06270498 id: 24811 briefTitle: Effect of Oral sucRosomIal Iron on exerciSE Capacity and Quality of Life in Patients With Heart Failure acronym: RISE-HF overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-06-01 date: 2024-02-21 date: 2024-02-21 name: Raffaele De Caterina class: OTHER name: University of Pisa, Italy briefSummary: The goal of this study is to investigate the effect of oral sucrosomial iron on exercise capacity and quality of life in patients with heart failure (HF) and iron deficiency (ID).

The main question the study aims to answer is whether oral sucrosomial iron improved exercise capacity, assessed by six-minute walk test, and quality of life, assessed by Kansas City Cardiomyopathy Questionnaire, compared with placebo.

One group of participants will receive treatment with oral sucrosomial iron and the other group will receive treatment with placebo. conditions: Chronic Heart Failure conditions: Iron-deficiency conditions: Left Ventricular Systolic Dysfunction studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Sucrosomial iron name: Placebo measure: Exercise capacity measure: Quality of life measure: 6MWT distance improvement measure: Quality of life improvement measure: Exercise capacity (peak oxygen consumption) measure: F2-isoprostanes measure: Soluble NOX2-derived peptide (sNOX2-dp) measure: H2O2 measure: Phosphate measure: Fibroblast growth factor (FGF)-23 measure: N-terminal pro-B-type natriuretic peptide (NTproBNP) measure: Transferrin saturation (TSAT) measure: Ferritin measure: Serum iron measure: Soluble transferrin receptor (sTfR) measure: Hepcidin measure: Cardiac structure and function 1 measure: Cardiac structure and function 2 measure: Cardiac structure and function 3 measure: Cardiac structure and function 4 measure: Cardiac structure and function 5 measure: Cardiac structure and function 6 measure: Clinical outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06270485 id: EA2/224/23 briefTitle: Influence of Positive-End-Expiratory-Pressure (PEEP) on Cardiac Output in Mechanically Ventilated Children acronym: IPCOM overallStatus: RECRUITING date: 2023-11-27 date: 2024-12 date: 2025-06 date: 2024-02-21 date: 2024-02-21 name: Charite University, Berlin, Germany class: OTHER name: University Medical Center Groningen briefSummary: Interventional Trial to determine the Effect of different PEEP levels on Cardiac output and right-ventricular function in mechanically ventilated children \< 5 years of age conditions: Ventilation Therapy; Complications conditions: Congenital Heart Disease conditions: Children, Only conditions: Hemodynamic Instability studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 56 type: ESTIMATED name: PEEP measure: Cardiac Output measure: TAPSE (cm) measure: respiratory mechanics measure: TAPSV (cm/s) measure: Global Strain RV (%/sec) measure: Lung Compliance (ml/Min/kg) measure: Esophageal Pressure (mbar) measure: EIT sex: ALL minimumAge: 1 Day maximumAge: 5 Years stdAges: CHILD facility: Deutsches Herzzentrum der Charité status: RECRUITING city: Berlin zip: 13353 country: Germany name: Jan Clausen, MD role: CONTACT phone: 004917620808764 email: jan-christoph.clausen@dhzc-charite.de name: Michael Emeis, MD role: SUB_INVESTIGATOR lat: 52.52437 lon: 13.41053 facility: UMCG status: RECRUITING city: Groningen country: Netherlands name: Martin Kneyber, PhD, MD role: CONTACT email: m.c.j.kneyber@umcg.nl name: Richard Hollander, MD role: CONTACT email: r.a.hollander@umcg.nl lat: 53.21917 lon: 6.56667 hasResults: False

 nctId: NCT06270472 id: tipp technique briefTitle: Transinguinal Periperitoneal Technique in Inguinal Hernioplasty overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-04-01 date: 2024-02-21 date: 2024-02-21 name: Assiut University class: OTHER briefSummary: evaluation of feasibility and efficacy of trans inguinal periperitoneal technique by using conventional mesh inguinal hernia repair in general surgery department in Assiut university hospitals conditions: Hernia, Inguinal studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: hernioplasty measure: Recurrence rate of inguinal hernia 2 years follow up . measure: Numerical rating score of pain sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False

 nctId: NCT06270459 id: DSRB 2023/00954 briefTitle: Telerehabilitation Robotics for Upper Limb Rehabilitation After STroke acronym: TRUST overallStatus: NOT_YET_RECRUITING date: 2024-02-15 date: 2025-08-14 date: 2025-08-14 date: 2024-02-21 date: 2024-02-21 name: Tan Tock Seng Hospital class: OTHER name: National University Hospital, Singapore name: Singapore General Hospital briefSummary: There has been an observed decrease in motor and functional ability and non-use of the impaired limb in chronic patients. This is due to the immediate drop in intensive daily therapy (5 days per week for 3 hours/day) that is usually provided during the inpatient (acute) phase upon discharge from the hospital.

In this study, the investigators plan to address the low dosage of therapy in the post-acute discharge phase for stroke survivors. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The study is a multi-site prospective clinical trial, with single-arm study design with independent assessment of outcome measures (i.e., robotic metrics, standardized outcomes, quality of life, subjective measures). primaryPurpose: TREATMENT masking: NONE count: 54 type: ESTIMATED name: HMAN Robot measure: Compliance Rates measure: Fugl Meyer Motor Assessment (FMA) measure: Action Research Arm Test (ARAT) measure: Grip strength (KgF) measured by Digital Dynamometer (mean of 3 readings will be recorded) measure: System Usability Scale (SUS) measure: Intrinsic Motivation Inventory (IMI) sex: ALL minimumAge: 21 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06270446 id: DSRB 2019/01135 briefTitle: Community Based Rehabilitation Model After Total Knee Replacement overallStatus: COMPLETED date: 2021-01-01 date: 2022-07-01 date: 2022-07-01 date: 2024-02-21 date: 2024-02-21 name: Tan Tock Seng Hospital class: OTHER briefSummary: To investigate the clinical efficacy of community-based early stage knee replacement rehabilitation program as compared with usual care in acute hospital outpatient clinic conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE maskingDescription: Data analysis blinded count: 59 type: ACTUAL name: Community based physiotherapy name: Outpatient physiotherapy measure: TUG measure: 30 sec chair stand test measure: Pain intensity measure: Knee flexion and extension measure: Passive range of motion measure: Presence of lag measure: OKS sex: ALL minimumAge: 55 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tan Tock Seng Hospital city: Singapore country: Singapore lat: 1.28967 lon: 103.85007 hasResults: False

 nctId: NCT06270433 id: 2023-KY142-01 briefTitle: Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets Versus Desvenlafaxine Succinate Sustained-release Tablets Targeting Anhedonia in Patients With Major Depression Disorder overallStatus: RECRUITING date: 2024-02-19 date: 2024-12-31 date: 2024-12-31 date: 2024-02-21 date: 2024-04-29 name: Jiangsu Province Nanjing Brain Hospital class: OTHER briefSummary: The purpose of this study is to evaluate efficacy and safety of toludesvenlafaxine hydrochloride sustained-release tablets in the treatment of anhedonia in patients with major depression disorder compared to desvenlafaxine succinate sustained-release tablets, to provide evidence-based basis for clinical rational drug use. conditions: Anhedonia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Toludesvenlafaxine hydrochloride sustained-release tablets name: Desvenlafaxine succinate sustained-release tablets measure: Snaith-Hamilton Pleasure Scale (SHAPS) Total Score measure: Snaith-Hamilton Pleasure Scale (SHAPS) Total Score measure: Snaith-Hamilton Pleasure Scale (SHAPS) Reductive Rate measure: Dimensional Anhedonia Rating Scale (DARS) Score measure: Montgomery-Asberg Depression Rating Scale (MADRS) Score measure: 17-item Hamilton Depression Rating Scale (HAM-D17) Score measure: Sheehan Disability Scale (SDS) Score measure: Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Score measure: Rating Scale for Side Effects (SERS) Score measure: Arizona Sexual Experience Scale (ASEX) Score measure: Count of red blood cell in blood measure: Count of white blood cell in blood measure: Count of platelet in blood measure: Concentration of hemoglobin in blood measure: Concentration of alanine aminotransferase in blood measure: Concentration of aspartate aminotransferase in blood measure: Concentration of gamma-glutamyltransferase in blood measure: Concentration of blood glucose in blood measure: Concentration of serum creatinine in blood measure: Concentration of urea in blood measure: Concentration of total cholesterol in blood measure: Concentration of high density lipoprotein in blood measure: Concentration of low density lipoprotein in blood measure: Concentration of triglyceride in blood measure: Concentration of thyroid-stimulating hormone in blood measure: Concentration of protein in urine measure: Concentration of sugar in urine measure: Count of white blood cell in urine measure: Count of red blood cell in urine measure: ECG QT Interval measure: Changes in weight measure: Changes in pulse measure: Changes in both systolic and diastolic blood pressure measure: Changes in respiration rate measure: Changes in armpit temperature sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanjing Brian Hospital status: RECRUITING city: Nanjing state: Jiangsu zip: 210024 country: China name: Hao Tang, MD role: CONTACT phone: +8618913821366 email: tanghao997@163.com lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06270420 id: 2022.04 briefTitle: Technological Devices and Home Automation System in Neurological Rehabilitation acronym: SMART overallStatus: RECRUITING date: 2023-02-05 date: 2024-03-31 date: 2024-05-30 date: 2024-02-21 date: 2024-02-21 name: IRCCS San Camillo, Venezia, Italy class: OTHER briefSummary: The use of home automation system may be useful in rehabilitation to collect data about the environment and the amount of therapy. Then, the data may be stored in a cloud and integrated with data collected during training provided by technological devices.

The main goal of this longitudinal pilot study is to define the productivity of the rehabilitation room (i.e., HoSmartAI room) in the IRCCS San Camillo Hospital (Venice, Italy) service, where the investigators will install home automation sensors and treat patients with neurological disease using technological devices (e.g., robotic and virtual reality). The secondary goals are to define the patients' satisfaction, usability of the system and the clinical effect of treatments delivered with technological devices in the HoSmartAI room. The patient will be assessed to personalized the treatment based on their needs. The treatment will consist of 15 sessions (1h/day, 5day/week, 3 weeks). At the end of the study, the patients will be assessed to define any clinical improvements. Finally, the investigators will define the characteristics of the patients who will benefit from the rehabilitation provided in the HoSmartAI room. conditions: Neurological Disease conditions: Motor Disorders studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Longitudinal Pilot study primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 80 type: ESTIMATED name: Technological Motor Rehabilitation measure: Key performance indicator (KPI) of the room - Number of treatments measure: Key performance indicator (KPI) ot the room - Number of sessions measure: Room Key performance indicator (KPI) of the room - Number of minutes of therapy measure: Key performance indicator (KPI) of the room - Number of physiotherapists involved measure: Key performance indicator (KPI) of the room - Number of adverse events measure: Box and Blocks Test measure: Reaching Performance Scale measure: Nine Hole Pegboard Test measure: Berg balance scale (BBS) measure: 10 Meter Walk Test (10MWT) measure: Functional Ambulation Categories (FAC) measure: Trunk Control Test (TCT) measure: EuroQol questionnaire (EQ-5D) measure: System Usability Scale (SUS) measure: Short Form Patient Satisfaction Questionnaire (PSQ-18) measure: User Experience Questionnaire (UEQ) measure: Number of falls sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS San Camillo Hospital status: RECRUITING city: Venice-Lido state: Venice zip: 30126 country: Italy name: Giorgia Pregnolato role: CONTACT phone: +0412207 phoneExt: 214 email: giorgia.pregnolato@hsancamillo.it lat: 45.4131 lon: 12.3742 hasResults: False

 nctId: NCT06270407 id: 270777 id: 2022-001580-28 type: EUDRACT_NUMBER id: 2023-510381-28-00 type: REGISTRY domain: CTIS European Clinical Trial Identification System briefTitle: The Effect of Local Application of Tranexamic Acid Versus Placebo on Postoperative Complications in Plastic Surgery. overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-12-31 date: 2029-12-31 date: 2024-02-21 date: 2024-02-21 name: St. Olavs Hospital class: OTHER name: Smerud Medical Research International AS name: Sykehuset Asker og Baerum name: Oslo universitetssykehus HF name: Sykehuset Telemark name: Sykehuset Innlandet HF name: Molde Hospital name: Haukeland University Hospital name: Haraldsplass Deaconess Hospital name: Helse Stavanger HF name: University Hospital of North Norway name: Bodø sykehus name: Helsinki University Central Hospital briefSummary: Study objective:

This is a study to investigate whether applying the drug tranexamic acid (TXA) onto a surgical wound surface may affect the incidence of surgical complications such as re-bleeding needing intervention, wound complications such as infection, wound rupture or seroma, or if it may increase the risk of blood clots.

Eligible patients:

Patients undergoing plastic surgical procedures with wounds that would normally receive application of TXA to reduce bleeding after surgery.

Study intervention:

Participants will receive a single local application of study drug onto their wound surfaces at the end of surgery. Study drug will be identical looking ampoules which contain either TXA or placebo (saline). Neither participants nor study personnel will know the contents of the ampoules. conditions: Surgical Complication studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Randomized controlled prospective interventional trial primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: Identically shaped ampoules containing traneamic acid (Cyklokapron, Pfizer) and 0.9% NaCl (Lavoisier, France) have been identified. The ampoule top part is camouflaged with a tight-fitting black tube which preserves the breaking point on the neck of the ampoule. The ampoules will be re-labeled with study-specific labels (text will be in accordance with Regulation 546/2014, annex VI). Randomized study envelopes will be provided in packages of two, with a 1:1 TXA:Placebo randomization, enabling a within-patient randomization in bilateral procedures.

Randomization, blinding, labelling, shipment of ampoules and keeping of the randomization code will be done by Smerud Medical Research International AS. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 3000 type: ESTIMATED name: Tranexamic Acid 100 MG/ML name: 0.9%sodium chloride measure: Postoperative re-bleeding measure: Postoperative wound infection measure: Postoperative wound rupture measure: Postoperative thromboembolic events measure: Postoperative seroma measure: Any other postoperative complication sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06270394 id: MJX briefTitle: FAP PET/CT or PET/MR Production in the Diagnosis, Staging, and Efficacy Assessment of Malignant Tumors Application overallStatus: SUSPENDED date: 2022-04-28 date: 2023-07-28 date: 2027-03-31 date: 2024-02-21 date: 2024-02-21 name: The First Affiliated Hospital of Anhui Medical University class: OTHER name: National Natural Science Foundation of China briefSummary: This clinical trial aims to investigate the value of fibroblast activation protein PET/CT(PET/MR) in the diagnosis, staging, and evaluation of treatment outcomes in malignant tumors. The main question it aims to answer is:

Fibroblast Activation Protein PET/CT(PET/MR) whether or in which cases this assay is superior to conventional FDG examination in the diagnosis, staging, and assessment of therapeutic efficacy of malignant tumors, thinking about the reasons behind this.

Investigators will screen suitable participants among patients undergoing routine FDG examination.

* Participants will sign an informed consent form
* Undergo 68Ga-FAPI PET/CT (PET/MR) before surgery or biopsy
* Surgical resection or puncture biopsy to obtain pathologic results. Diagnosis of patients with malignant tumors at first diagnosis; clinical staging of tumors; and clinical outcomes of patients with confirmed diagnoses will be assessed after postoperative investigator follow-up.

The researchers will compare the FDG exams the participants have had to determine the effectiveness of the fibroblast activating protein test. conditions: Malignant Tumors conditions: Positron-Emission Tomography studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 60 type: ESTIMATED name: 68Ga-Fibroblast activation protein inhibitor measure: 68Ga-Fibroblast Activation Protein Inhibitor-04 Uptake in Gastrointestinal Cancer: Comparison with 18F-FDG measure: Utility of 68Ga-FAPI-04 PET/MRI combines 18F-FDG PET/CT in the postoperative evaluation of gastrointestinal cancers sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: FirstHAnhuiMU city: Hefei state: Anhui zip: 230032 country: China lat: 31.86389 lon: 117.28083 hasResults: False

 nctId: NCT06270381 id: UIDB/05299/2020 briefTitle: Empower-Grief: A Study on a Selective Intervention to Prevent Prolonged Grief Disorder overallStatus: RECRUITING date: 2023-08-07 date: 2024-11-01 date: 2024-11-01 date: 2024-02-21 date: 2024-02-21 name: ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida class: OTHER briefSummary: The goal of this clinical trial is to test, through a Randomized Controlled Trial (RCT), the efficacy of a selective and short intervention based on second and third-wave cognitive-behavioral interventions (named EMPOWER) for the initial problematic grief reactions and to study potential predictors of adherence and efficacy in bereaved relatives of palliative and oncological patients. The main question is whether EMPOWER intervention is more effective than Treatment as Usual (TAU) in preventing Prolonged Grief Disorder (PGD). Participants with initial indicators of risk of developing PGD will be randomly allocated to EMPOWER and TAU. The primary outcome considered will be symptoms of PGD. The assessment also includes measures of anxiety and depression, attachment, coping, psychological flexibility, posttraumatic growth, and therapeutic alliance. Apart from screening, three assessment moments will be considered: T1: before the first session; T2: at the last session (up to twelve weeks); and T3: follow-up assessment period at 6 months after the previous assessment. conditions: Grief Disorder, Prolonged studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 44 type: ESTIMATED name: EMPOWER name: Treatment as usual (TAU) measure: Prolonged Grief measure: Anxiety and depression measure: Sociodemographic data measure: Risk Assessment for Grief measure: Coping strategies measure: Adult attachment measure: Psychological inflexibility measure: Social Support measure: Therapeutic alliance measure: Posttraumatic Growth sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Unidade Local de Saúde Santa Maria status: RECRUITING city: Lisboa country: Portugal name: Alexandra Coelho, PhD role: CONTACT phone: 919957534 email: alexandra.moura.coelho@gmail.com lat: 38.71667 lon: -9.13333 hasResults: False

 nctId: NCT06270368 id: PREHMO briefTitle: Children Born Preterm: Sustainable Health Monitoring overallStatus: RECRUITING date: 2020-08-05 date: 2025-08-31 date: 2025-12-31 date: 2024-02-21 date: 2024-02-21 name: Meyer Children's Hospital IRCCS class: OTHER name: IRCCS Fondazione Stella Maris briefSummary: Children born preterm are recognized to be at higher risk of short and long term complications and a formal follow-up of infants and children born preterm is recommended by international and national scientific societies. However, in Italy as well as in Tuscany, such a follow up is not usually done, and data are not collected in a structured way. The goal of this observational study is to evaluate the association between a large number of early life exposures and health outcomes and access to care during childhood in infants born preterm. The main questions it aims to answer are: • what is the role of prenatal and perinatal factors in influencing health outcomes during childhood in preterm infants? • What is the role of prenatal and perinatal factors in influencing access to care during childhood? Participants will be asked to attend a follow-up visit for the purpose of collecting health data. conditions: Premature Birth studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 650 type: ESTIMATED measure: Infant development measure: Childhood development measure: Presence of visual or hearing impairement measure: Presence of asthma measure: Access to care sex: ALL minimumAge: 20 Months maximumAge: 66 Months stdAges: CHILD facility: Azienda Ospedaliero-Universitaria Careggi (AOUC) status: RECRUITING city: Firenze country: Italy name: Simone Pratesi role: CONTACT lat: 43.77925 lon: 11.24626 facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Firenze country: Italy name: Vieri Lastrucci role: CONTACT email: vieri.lastrucci@meyer.it lat: 43.77925 lon: 11.24626 facility: Azienda Ospedaliero Universitaria Pisana (AOUP) status: RECRUITING city: Pisa country: Italy name: Rosa Scaramuzzo role: CONTACT lat: 43.70853 lon: 10.4036 facility: Azienda Ospedaliero Universitaria Senese (AOUS) status: RECRUITING city: Siena country: Italy name: Carlo Valerio Bellieni role: CONTACT lat: 43.31822 lon: 11.33064 hasResults: False

 nctId: NCT06270355 id: 2023-06555-01 briefTitle: Stockholm Mammography Risk Stratified Trial acronym: SMART overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2028-04-08 date: 2032-04-08 date: 2024-02-21 date: 2024-02-28 name: Karolinska Institutet class: OTHER briefSummary: SMART is a Phase III, randomised, non-blinded screening trial. Women who consent to participate in SMART are randomised to either individualised screening or screening according to the Swedish National Breast Cancer Screening Program. Women randomised to individualised screening get their 2-year risk of breast cancer assessed and women with the highest short-term risk are offered contrast enhanced mammography and a mammogram at 12 months. conditions: Breast Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: NONE count: 70000 type: ESTIMATED name: Risk based screening measure: Incidence of interval cancers measure: Number of recalled women measure: Number of biopsies measure: Breast cancer measure: Tumor characteristics - Stage measure: Tumor characteristics - Multifocality measure: Tumor characteristics - Receptor status measure: Tumor characteristics - Proliferation measure: Cancer worry measure: Cancer anxiety measure: Side effects related to contrast enhanced mammography measure: Cost-effectiveness measure: Willingness-to-pay sex: FEMALE minimumAge: 40 Years maximumAge: 74 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06270342 id: DTMS briefTitle: The Effect of Dual Task On Upper Extremity Functions In Multiple Sclerosis Patients overallStatus: COMPLETED date: 2023-06-01 date: 2023-09-01 date: 2023-12-15 date: 2024-02-21 date: 2024-02-21 name: Kutahya Health Sciences University class: OTHER briefSummary: The primary aim of this study was to investigate the effect of dual tasking on upper extremity functions in individuals with multiple sclerosis (MS) and compare with healthy controls. Additionally, another aim of our study was to compare the cognitive status, quality of life, fatigue and emotional states of individuals with MS and healthy controls. conditions: Multiple Sclerosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 60 type: ACTUAL name: dual task assessment measure: The Minnesota Manual Dexterity Test measure: Dual Task Questionnaire measure: Edinburgh Handedness Questionnaire measure: Expanded Disability Status Scale measure: Brief International Cognitive Assessment Battery for Multiple Sclerosis measure: Beck Depression Scale measure: Fatigue Impact Scale measure: Multiple Sclerosis Quality of Life Questionnaire-54 sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kutahya Health Sciences University city: Kütahya zip: 43100 country: Turkey lat: 39.42417 lon: 29.98333 hasResults: False

 nctId: NCT06270329 id: NMTwithKOA briefTitle: Neuromuscular Training Program in Patients With Knee OA (Osteoarthritis) acronym: OA overallStatus: COMPLETED date: 2022-01-15 date: 2023-01-15 date: 2023-06-15 date: 2024-02-21 date: 2024-02-21 name: Kutahya Health Sciences University class: OTHER briefSummary: The aim of this study was to compare the effects of neuromuscular training program and conventional physical therapy program on pain, functional status, physical performance, balance, muscle strength and quality of life in patients with knee osteoarthritis (KOA). conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized controlled clinical trial design primaryPurpose: TREATMENT masking: NONE count: 70 type: ACTUAL name: Neuromuscular training program name: conventional physical therapy program measure: Visual Analog Scale measure: Western Ontario and McMasterUniversities Osteoarhritis Index measure: Time on One Leg Standing measure: Five Times Sit to Stand Test measure: Manual Muscle Test measure: Short Form sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kutahya Health Science University city: Kütahya zip: 43100 country: Turkey lat: 39.42417 lon: 29.98333 hasResults: False

 nctId: NCT06270316 id: CT-AMT-191-01 briefTitle: Safety, PK/PD, and Exploratory Efficacy Study of AMT-191 in Classic Fabry Disease overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2027-04-01 date: 2027-04-29 date: 2024-02-21 date: 2024-02-21 name: UniQure Biopharma B.V. class: INDUSTRY briefSummary: This is an open-label multi-center study to evaluate safety and biomarkers of efficacy of a single dose of intravenously-administered AMT-191. The study will also include exploratory functional efficacy assessments. The plan is to investigate 2 sequential dose cohorts in 3-6 Participants per cohort. Participants will be monitored for 24 hours following AMT-191 administration then follow-up study visits will continue for 24 months, during which safety, pharmacokinetics/pharmacodynamics, biomarkers, and efficacy assessments will be performed. Participants will continue receiving their regularly scheduled enzyme replacement therapy (ERT) until they meet the criteria for withdrawal. conditions: Fabry Disease studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: AMT-191 measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] measure: Duration of Vector deoxyribonucleic acid (DNA) shedding presented in blood, saliva, feces, semen, and urine sex: MALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False

 nctId: NCT06270303 id: 2023-00383-01 briefTitle: Use of a Bone Substitute Material in the Surgical Therapy of Furcation Defects overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2027-03-01 date: 2036-03-01 date: 2024-02-21 date: 2024-02-21 name: Göteborg University class: OTHER name: Johann Wolfgang Goethe University Hospital name: Charite University, Berlin, Germany name: King's College London name: Queen Mary University of London name: Geistlich Pharma AG name: Vastra Gotaland Region briefSummary: The aim of this randomized clinical trial is to evaluate the potential benefit of the use of a bone substitute material in the treatment of furcation degree II-involved molars. The main question it aims to answer is: What is the benefit of the adjunctive use of a bone substitute material in the surgical treatment of furcation degree II-involved molars when compared to open-flap debridement alone?

200 patients with ≥1 molar presenting with a furcation defect degree II will be included and randomized to either control (open-flap debridement) or test treatment (open-flap debridement + bone substitute material). The primary outcome of the study is furcation closure defined as absence of clinically detectable furcation involvement degree \>I. Secondary outcomes include changes in bleeding on probing, probing depth, vertical and horizontal attachment levels, soft tissue level, marginal bone level, need for surgical retreatment, tooth loss, patient-reported outcomes and adverse events. A composite outcome based on furcation closure (degree ≤I) in combination with shallow probing depth (≤5 mm) and absence of bleeding on probing will also be evaluated. conditions: Periodontitis conditions: Furcation Defects studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The project will be conducted as a two-armed randomized controlled trial in multiple clinical centers. The primary outcome will be assessed at 1 year post-surgery with a subsequent follow-up of 10 years. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Clinical assessments following intervention will be conducted by assessors unaware of group allocation. whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Access flap & surgical debridement name: Application of bone substitute material (BioOss Collagen) measure: Proportion of patients/teeth displaying furcation closure. measure: Proportion of patients/teeth displaying furcation closure. measure: Proportion of patients/teeth displaying furcation closure. measure: Proportion of patients/teeth displaying furcation closure. measure: Proportion of patients/teeth displaying furcation closure. measure: Proportion of patients/teeth displaying furcation closure. measure: Changes in probing pocket depth. measure: Changes in probing pocket depth. measure: Changes in probing pocket depth. measure: Changes in probing pocket depth. measure: Changes in probing pocket depth. measure: Changes in probing pocket depth. measure: Changes in bleeding on probing. measure: Changes in bleeding on probing. measure: Changes in bleeding on probing. measure: Changes in bleeding on probing. measure: Changes in bleeding on probing. measure: Changes in bleeding on probing. measure: Changes in vertical and horizontal clinical attachment level. measure: Changes in vertical and horizontal clinical attachment level. measure: Changes in vertical and horizontal clinical attachment level. measure: Changes in vertical and horizontal clinical attachment level. measure: Changes in vertical and horizontal clinical attachment level. measure: Changes in vertical and horizontal clinical attachment level. measure: Changes in marginal soft tissue levels. measure: Changes in marginal soft tissue levels. measure: Changes in marginal soft tissue levels. measure: Changes in marginal soft tissue levels. measure: Changes in marginal soft tissue levels. measure: Changes in marginal soft tissue levels. measure: Changes in radiographic bone levels. measure: Changes in radiographic bone levels. measure: Changes in radiographic bone levels. measure: Changes in radiographic bone levels. measure: Patient satisfaction assessed by visual analogue scale. measure: Patient satisfaction assessed by visual analogue scale. measure: Patient discomfort as expressed on a visual analogue scale. measure: Patient discomfort as expressed on a visual analogue scale. measure: Esthetic appreciation as expressed on a visual analogue scale. measure: Esthetic appreciation as expressed on a visual analogue scale. measure: Rate of adverse events. measure: Rate of adverse events. measure: Tooth loss. measure: Tooth loss. measure: Tooth loss. measure: Tooth loss. measure: Tooth loss. measure: Need for retreatment. measure: Need for retreatment. measure: Need for retreatment. measure: Need for retreatment. measure: Need for retreatment. measure: Change of inflammatory markers. measure: Change of inflammatory markers. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Periodontology, Institute of Odontology city: Göteborg zip: 40530 country: Sweden name: Jan Derks, PhD role: CONTACT phone: 0046 76 618 3124 email: jan.derks@odontologi.gu.se name: Jan Derks, PhD role: PRINCIPAL_INVESTIGATOR name: Karolina Karlsson, PhD role: SUB_INVESTIGATOR name: Kostas Bougas, PhD role: SUB_INVESTIGATOR lat: 57.70716 lon: 11.96679 hasResults: False

 nctId: NCT06270290 id: 327648 briefTitle: The COSP-RBD Study: Concussions and Contact Sports in RBD vs Controls acronym: COSP-RBD overallStatus: RECRUITING date: 2024-04-22 date: 2025-03-30 date: 2025-03-30 date: 2024-02-21 date: 2024-04-23 name: Guy's and St Thomas' NHS Foundation Trust class: OTHER briefSummary: The goal of this observational study is to investigate concussions and contact sports practices in REM sleep behaviour disorder (RBD).

The main questions it aims to answer are:

* What is the proportion of patients with RBD that have a history of concussions or exposure to contact sports?
* Is this proportion higher to that in control patients without a diagnosis of RBD?

Participants will undergo an interview with a sleep medicine specialist to answer questions about history of concussions and contact sports practices.

Researchers will compare an RBD group and a control group (without RBD) to see if the proportion of concussions and exposure to contact sports differ. conditions: REM Sleep Behavior Disorder conditions: Concussion, Brain studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 140 type: ESTIMATED name: Exposure to contact sports or history of concussions measure: Proportion of history of contact sports practice / concussion in RBD and control participants. measure: Differences in concussions characteristics between RBD and control participants. measure: Demographic or clinical differences between RBD participants with and without concussions history. sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guy's & St Thomas' NHS Foundation Trust status: RECRUITING city: London zip: SE1 9RT country: United Kingdom name: Gill Radcliffe role: CONTACT phone: 02071888070 email: gillian.radcliffe@gstt.nhs.uk lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06270277 id: 30.01.2024-4272 briefTitle: Evaluation of Quality of Life and Psychosocial Status in Children With Inflammatory Bowel Disease overallStatus: COMPLETED date: 2024-02-14 date: 2024-02-20 date: 2024-02-21 date: 2024-02-21 date: 2024-02-22 name: Sisli Hamidiye Etfal Training and Research Hospital class: OTHER briefSummary: Inflammatory bowel disease (IBD) is a chronic condition that affects the psychosocial status and physical activities of children and their parents in many ways. Our study aimed to investigate the variability of disease-related quality of life and behavioral and emotional adjustment issues compared to a healthy control group among adolescents and their families diagnosed with IBD. Children with IBD and the healthy control group, as well as the parents of both groups, will administered the Pediatric Quality of Life Inventory (PedsQL) and Strengths and Difficulties Questionnaire (SDQ). The PedsQL is a scale used to assess physical and psychosocial functioning based on the individual's own experiences, commonly employed in clinical trials and quality improvement initiatives. The scale evaluates physical activity status and psychosocial functioning through questions related to emotional, social, and school-related issues. conditions: Inflammatory Bowel Diseases conditions: Psychosocial Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Adolescents with Inflammatory bowel diseases and healthy control group in same age will be administered Pediatric Quality of Life Inventory (PedsQL) and Strengths and Difficulties Questionnaire (SDQ). primaryPurpose: DIAGNOSTIC masking: NONE count: 159 type: ACTUAL name: Pediatric Quality of Life Inventory (PedsQL) name: Strengths and Difficulties Questionnaire (SDQ) measure: Pediatric Quality of Life Inventory (PedsQL) score measure: Strengths and Difficulties Questionnaire (SDQ) sex: ALL minimumAge: 8 Years maximumAge: 17 Years stdAges: CHILD facility: Sisli Hamidiye Etfal Research and Training Hospital city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06270264 id: 111-2023 briefTitle: Nociception Monitoring in Intensive Care overallStatus: COMPLETED date: 2023-08-01 date: 2023-12-15 date: 2024-01-01 date: 2024-02-21 date: 2024-02-21 name: Haseki Training and Research Hospital class: OTHER briefSummary: Precisely, pain in the ICU is a multidimensional problem with a multivariate of reasons. Still, it would be simpler to manage it in unconscious palliative patients with less source of pain, but only if we can detect it practically with the help of nociception monitors. Using five parameters, nociception level index (NOL) monitoring (Medasense) is differentiated from its alternatives. Other than pain detection, this monitoring can titrate analgesic administration. This study investigates the validity of a new nociception monitoring tool, the nociception level index, and its practical impact on providing adequate analgesia in palliative patients in intensive care. conditions: Unconscious State conditions: Pressure Ulcer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized, prospective and controlled primaryPurpose: TREATMENT masking: NONE count: 40 type: ACTUAL name: the Nociception level index monitoring measure: total fentanyl consumption measure: systolic blood pressure measure: heart rate sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Haseki Training and Research Hospital city: Istanbul state: Sultangazi country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06270251 id: PSYCH-2023-32292 briefTitle: Modeling Tic Change During Behavior Therapy for Tics overallStatus: RECRUITING date: 2024-03-01 date: 2028-03-01 date: 2028-09-01 date: 2024-02-21 date: 2024-04-01 name: University of Minnesota class: OTHER briefSummary: Chronic tics are a disabling neuropsychiatric symptom associated with multiple child-onset mental disorders. Chronic tics affect 1-3% of youth and can be associated with impaired functioning, emotional and behavioral problems, physical pain, diminished quality of life, and peer victimization. Chronic tics are the primary symptom of Tourette Syndrome (TS) and Persistent Motor/Vocal Tic Disorders.

CBIT is a manualized treatment focused on increasing tic controllability. Its core procedure is competing response training (CRT), in which patients learn to inhibit tics by learning and applying a competing motor action to one tic at a time. CBIT is recommended as a first-line treatment relative to medications and other therapies. However, only 52% of children and 38% of adults show clinically meaningful tic improvement. Large randomized trials have demonstrated the superiority of CBIT over supportive therapy in child and adult patients, and meta-analysis shows comparable effect sizes for CBIT and medication. Although increasing tic controllability is the primary goal of CBIT, tic controllability nor its correlates have been examined longitudinally during the intervention.

The overall objective of this study is to use fine-grained data collection strategies to identify patterns in tic controllability and other relevant related variables that are associated with treatment response to CBIT. Participants with chronic tics will complete a manualized course of 8-session CBIT. Behavioral, psychosocial, and global functioning will be assessed longitudinally to examine predictors and correlates of response. CBIT sessions will be video recorded. conditions: Chronic Tic Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: CBIT measure: Tic Severity measure: Sheehan Disability scale measure: Behavior Rating Inventory of Executive Function measure: Ask Suicide-Screening Questions (ASQ) measure: Child Attitudes Toward Illness Scale (CATIS) measure: Rosenberg Self-Esteem Scale measure: Caregiver Strain Questionnaire measure: Clinical Global Impressions (CGI) measure: Parent/Adult Tic Questionnaire measure: Premonitory Urge for Tics Scale measure: Tic Suppression Task measure: Stop signal task sex: ALL minimumAge: 12 Years maximumAge: 21 Years stdAges: CHILD stdAges: ADULT facility: University of Minnesota status: RECRUITING city: Minneapolis state: Minnesota zip: 55414 country: United States name: Brianna Wellen role: CONTACT lat: 44.97997 lon: -93.26384 hasResults: False

 nctId: NCT06270238 id: 2023-11-164 briefTitle: Efficacy of Personalized Repetitive Transcranial Magnetic Stimulation Protocol Based on Functional Reserve to Enhance Upper Limb Function in Subacute Stroke Patients overallStatus: RECRUITING date: 2024-02-13 date: 2025-09-30 date: 2025-09-30 date: 2024-02-21 date: 2024-02-29 name: Samsung Medical Center class: OTHER name: National Research Foundation of Korea name: Ministry of Food and Drug Safety, Korea name: Seoul National University Hospital name: Bucheon St. Mary's Hospital name: Saint Vincent's Hospital, Korea name: Severance Hospital name: Kumoh National Institute of Technology name: NEUROPHET briefSummary: The objective of this study was to determine the effects of protocols of repetitive transcranial magnetic stimulation (rTMS) therapy based on the functional reserve of each hemiplegic stroke patient in subacute phase, compared to conventional low-frequency rTMS therapy on contralateral M1. Investigators hypothesized that the functional reserve of each hemiplegic stroke patient will be different, and therefore an appropriate simulating target for rTMS therapy is needed. In addition, this approach could be more effective compared to conventional protocols applied to stroke patients regardless of their severity, predicted mechanism of motor function recovery, or functional reserves. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: prospective, single-blind with blind observer, parallel-group design, multi-center, randomized controlled clinical trial primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The participants, assessors, and investigators will be blinded, not be aware of the group allocation. Statistical analysis will also be conducted by data analysts without awareness of the group allocation. Only clinicians applying rTMS intervention will not be blinded, as they will apply rTMS over different stimulation sites based on the protocols. Blinding will be continued until the end of the study, including data analysis. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: High-Frequency1 name: cTBS1 name: High-Frequency2 name: cTBS2 name: High-Frequency3 name: cTBS3 measure: Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL) measure: Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL) measure: Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL) measure: Differences of Fugl-Meyer Assessment score (FMA) measure: Differences of Fugl-Meyer Assessment score (FMA) measure: Differences of Fugl-Meyer Assessment score (FMA) measure: Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL) measure: Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL) measure: Differences of Fugl-Meyer Assessment score of Lower Extremity (FMA-LL) measure: Differences of Box and block test measure: Differences of Box and block test measure: Differences of Box and block test measure: Differences of Functional Ambulation Category (FAC) measure: Differences of Functional Ambulation Category (FAC) measure: Differences of Functional Ambulation Category (FAC) measure: Differences of Action Research Arm Test (ARAT) measure: Differences of Action Research Arm Test (ARAT) measure: Differences of Action Research Arm Test (ARAT) measure: Differences of Jebsen-Taylor hand function test measure: Differences of Jebsen-Taylor hand function test measure: Differences of Jebsen-Taylor hand function test measure: Differences of Hand grip strength test measure: Differences of Hand grip strength test measure: Differences of Hand grip strength test sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Samsung Medical Center status: RECRUITING city: Seoul zip: 06351 country: Korea, Republic of name: Won Hyuk Chang, PhD role: CONTACT phone: +82-2-3410-6068 email: wh.chang@samsung.com lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06270225 id: SSGJ-613-PGF-II-01 briefTitle: A Study of SSGJ-613 in Gout Subjects Initiating Urate-Lowering Treatment. overallStatus: RECRUITING date: 2024-03-30 date: 2024-06 date: 2024-12 date: 2024-02-21 date: 2024-04-10 name: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study is to determine the efficacy and safety of recombinant anti-interleukin-1β humanized monoclonal antibody injection in Chinese gout participants Initiating Urate-Lowering Treatment. conditions: Gout Arthritis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg name: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg name: Colchicine 0.5 mg measure: Numbers of acute gout flares measure: Numbers of acute gout flares measure: Proportions of subjects with at least 1 acute gout flare measure: Proportions of subjects with at least 1 acute gout flare measure: Time from randomization to first acute flare. measure: Duration of acute gout flares. measure: Duration of acute gout flares. measure: Subject's overall assessment of response to treatment measure: Investigator's overall assessment of response to treatment measure: 36-item Short Form Survey (SF-36) measure: Adverse events (AE) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Huashan Hospital Fudan University-Rheumatology status: RECRUITING city: Shanghai state: Shanghai zip: 200040 country: China name: Hejian Zou, MD role: CONTACT phone: +86 13311881366 email: hjzou@fudan.edu.cn name: Hejian Zou role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06270212 id: CIV-ID 23-08-043797 briefTitle: Medical Device for Airway Patency During Sedation acronym: STAIRWAY-2 overallStatus: RECRUITING date: 2024-02-01 date: 2024-06-30 date: 2024-12-31 date: 2024-02-21 date: 2024-02-21 name: Stairway Medical AB class: INDUSTRY name: Lund University briefSummary: OVERALL SYNOPSIS

PART A: Systematic evaluation in spontaneously breathing healthy volunteer study participants

* of cumulative duration of manual measures for airway patency and for mask ventilation with airway device prototype (STAIRWAY) vs. standard procedure (no device) during target-controlled induction of mild and moderate-to-deep sedation with propofol in the supine position
* of minimum anteroposterior and lateral transpharyngeal distances at tongue-base and soft-palate levels, determined by magnetic resonance imaging (MRI) with STAIRWAY vs. biteblock or no device during no, mild and moderate-to-deep steady-state sedation with propofol in the supine position.

PART B: Systematic evaluation (in the body position \[normally supine\] considered most optimal for the procedural intervention) of the cumulative duration

* of adjuvant manual airway support and ventilation
* of respiratory arrest (interrupted monitoring of endtidal carbon dioxide \[ETCO2\])
* of hypoxemia (hemoglobin saturation of oxygen \[SpO2\] \<95 %), and
* of perceived sedational comfort, of sedational and procedural usability, and of sedational and procedural preference with STAIRWAY vs. standard procedure (biteblock or no device) during PS according to SOC for scheduled diagnostic or therapeutic procedures planned to be carried out under PS with propofol in spontaneously breathing study patients. conditions: Airway Obstruction conditions: Sedation Complication conditions: Perioperative Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Prospective randomized unpaired, and paired crossover, evaluations of study outcome measures in healthy volunteer study participants (PART A), and prospective randomized unpaired evaluation of study outcome measures in study patients (PART B).

The number of arms reported below (3) refers to unpaired comparisons (PARTS A-B). primaryPurpose: PREVENTION masking: SINGLE maskingDescription: For practical reasons, study participants, sedationists and study investigators on site cannot be masked to study interventions.

However, procedural interventionists on site and study investigators scrutinizing study outcome data will be masked to study interventions.

The number of enrolled study participants reported below (46) refers to evaluable ones. whoMasked: OUTCOMES_ASSESSOR count: 46 type: ESTIMATED name: STAIRWAY name: NO DEVICE measure: Transpharyngeal distance during moderate-to-deep steady-state sedation. measure: Duration of manual airway support during PS for clinical procedures. measure: Transpharyngeal distance during mild steady-state sedation. measure: Duration of interrupted capnometric monitoring during sedation. measure: Duration of manual airway support during induction of steady-state sedation. measure: Sedational comfort measure: Conditions for sedation measure: Conditions for procedural intervention sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Skåne University Hospital status: RECRUITING city: Malmö state: Skåne zip: 20502 country: Sweden name: Magnus Ljungvall, MD role: CONTACT phone: +46-705445502 email: magnus.ljungvall@med.lu.se name: Jonas Åkeson, PhD, Professor role: CONTACT phone: +46-708311113 email: jonas.akeson@med.lu.se lat: 55.60587 lon: 13.00073 hasResults: False

 nctId: NCT06270199 id: PULMESCELL-2 briefTitle: Use of Mesenchymal Stem Cells in Pre-term Patients With Bronchopulmonary Dysplasia. overallStatus: RECRUITING date: 2024-01-11 date: 2025-12 date: 2026-12 date: 2024-02-21 date: 2024-02-21 name: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal class: OTHER briefSummary: Bronchopulmonary dysplasia (BPD) is a disease that affects preterm newborn patients, preventing their lungs from developing properly. Allogeneic fetal stem mesenchymal cells from umbilical cord could reduce the prevalence of BPD in this patients. conditions: Bronchopulmonary Dysplasia studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Group Assignment primaryPurpose: TREATMENT masking: NONE count: 75 type: ESTIMATED name: Control name: Allogenic fetal mesenchymal stem cells from umbilical cord - three infusions name: Allogenic fetal mesenchymal stem cells from umbilical cord - six infusions measure: Security of MSC therapy in very low birth weight preterm babies at risk of developing bronchopulmonary dysplasia measure: feasibility variable measure: Incidence of BPD and PH in very low birth weight babies treated with MSC measure: Diagnosis and stage of bronchopulmonary dysplasia on week 36 of post-menstrual age according to Jensen measure: Exitus on week 36 and 40 of post-menstrual age or at hospital discharge measure: Incidence of comorbidities resulting from prematurity from the time of screening to 40 weeks' EPM, hospital discharge or death. measure: Biomarker analysis (IL-1beta, IL-6, IL8, TGF beta, TNF alfa, GM-CSF, NLRP3, RAGE, HMGB1, VEGF, HGF, GREMLIN1, sVEGFR1, SP-D, SMPD1, SMPD3, IsoPs, IsoFs, NeuroPs, NeuroFs, miRNAs). measure: Variations in echocardiographic parameters of pulmonary hypertension (PH) before and after mesenchymal cell therapy. measure: Changes in modified respirator score during therapy and up to week 36 of port-menstrual age measure: Changes in Respiratory Severity Score (RSS) during therapy and up to week 36 of port-menstrual age measure: Date of hospital discharge and respiratory care at discharge. measure: Need for supplemental O2 at home discharge and during follow-up (Number if patients that need supplemental O2). measure: Duration of invasive and non-invasive mechanical ventilation. measure: Use of postnatal corticosteroids indicated measure: Respiratory readmission rates. measure: Bayley Neurodevelopmental Scale at 24 months measure: Date and cause of death. sex: ALL minimumAge: 1 Month maximumAge: 28 Weeks stdAges: CHILD facility: Complejo Hospitalario La Coruña status: RECRUITING city: La Coruña country: Spain name: Alejandro Dávila role: CONTACT lat: 43.37135 lon: -8.396 facility: Hospital Clínico San Carlos status: RECRUITING city: Madrid country: Spain name: Luis Arruza role: CONTACT lat: 40.4165 lon: -3.70256 facility: Hospital Universitario La Paz status: RECRUITING city: Madrid country: Spain name: Paloma Lopez role: CONTACT lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Carlos Haya status: RECRUITING city: Málaga country: Spain name: Tomás Sánchez Tamayo role: CONTACT lat: 36.72016 lon: -4.42034 facility: Hospital Vírgen del Rocío status: RECRUITING city: Sevilla country: Spain name: Antonio Pavón Delgado role: CONTACT name: María José Moreno Valera role: PRINCIPAL_INVESTIGATOR lat: 37.38283 lon: -5.97317 facility: Hospital Universitario y Politécnico La Fe status: RECRUITING city: Valencia country: Spain name: Máximo Vento role: CONTACT lat: 39.46975 lon: -0.37739 hasResults: False

 nctId: NCT06270186 id: 20-AOIP-04 briefTitle: Evaluation of Cognitive Functions in 20 Patients With Type 1 Myotonic Dystrophy With Virtual Reality Approach acronym: GoodDiagNMD overallStatus: WITHDRAWN date: 2023-11 date: 2024-11 date: 2024-11 date: 2024-02-21 date: 2024-02-21 name: Centre Hospitalier Universitaire de Nice class: OTHER briefSummary: Type 1 myotonic dystrophy (MD1) is a genetic and hereditary disease that primarily affects muscle tissue, resulting in myotonia (difficulty relaxing after contraction) and atrophy (progressive muscle weakening with decreased muscle volume). It also affects eyes, heart, endocrine system, gastrointestinal system and central nervous system. Specific cognitive abilities are impaired in patients with MD1 such as attention, visio-spatial or visio-building abilities as well as executive dysfunctions.

Currently, the cognitive assessment of MD1 patients is based on classical neuropsychological tests, which are time-consuming and require a MD1 expert neuropsychologist. Moreover, it is usually very difficult for MD1 patients to accept performing these tests, and when they agree to perform them, they usually give up before the end. This finding is more frequent in MD1 patients with high level of cognitive impairment.

In order to overcome these difficulties in assessing cognitive functions of MD1 patients, the investigators decided to use innovative tools such as virtual reality, which allow individuals to experience a sensory-motor and cognitive experience in a digitally world through a helmet, glasses and joysticks.

The start-up My Cyber Royaume from Lille, in collaboration with the reference center of neuromuscular diseases from Nice coordinated by Pr Sacconi, have developed a software "Good Diag NMD" which uses virtual reality to assess cognitive disorders, more specifically executive functions in patients with type 1 myotonic dystrophy. conditions: Myotonic Dystrophy 1 studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 0 type: ACTUAL name: Type 1 myotonic dystrophy measure: Evaluate the feasibility of the use "Good Diag NMD" software in the evaluation of cognitive executive dysfunctions in patients with dystrophy myotonia 1 measure: Establish a possible relationship between the genotype of DM1 patients and the scores obtained during "Good Diag NMD" session measure: To compare the satisfaction score of type 1 myotonic dystrophy patients between classic neuropsychological tests and the Good Diag NMD session measure: Compare the scores of "Good Diag NMD" session (scores of perseveration, inhibition and flexibility) with the scores of the classical neuropsychological tests measure: Establish a possible correlation between the severity of the disease, the severity of muscular impairment and the scores of Good Diag NMD session sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06270173 id: TWM-C-2202 briefTitle: Post-Market Study of The Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures overallStatus: RECRUITING date: 2024-02-16 date: 2025-07-31 date: 2025-12-31 date: 2024-02-21 date: 2024-02-21 name: Wiltrom Co., Ltd. class: INDUSTRY name: Maxis Medical GmbH briefSummary: The objective of this Post-Market Clinical Follow-Up Study is to evaluate the safety and performance of the Tripod-Fix in the treatment of vertebral compression fractures (VCF) resulting from osteoporosis. conditions: Osteoporotic Vertebral Compression Fractures studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Tripod-Fix Vertebral Body Augmentation System (Tripod-Fix) measure: Proportion of participants with study success sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Klinikum Friedrichshafen status: NOT_YET_RECRUITING city: Friedrichshafen state: Baden-Württemberg zip: 88048 country: Germany name: Ludwig Oberkircher, Prof Dr med role: PRINCIPAL_INVESTIGATOR lat: 47.65689 lon: 9.47554 facility: University Hospital Mannheim status: NOT_YET_RECRUITING city: Mannheim state: Baden-Württemberg zip: 68167 country: Germany name: Frederic Bludau, PD Dr med role: PRINCIPAL_INVESTIGATOR lat: 49.4891 lon: 8.46694 facility: Johann Wolfgang Goethe University Frankfurt/Main status: NOT_YET_RECRUITING city: Frankfurt am Main state: Hesse zip: 60596 country: Germany name: Thomas Vogl, Prof Dr med role: PRINCIPAL_INVESTIGATOR lat: 50.11552 lon: 8.68417 facility: Krankenaus Mechernich status: RECRUITING city: Mechernich state: North-Rhine-Westphalia zip: 53894 country: Germany name: Robert Pflugmacher, Prof Dr med role: PRINCIPAL_INVESTIGATOR lat: 50.59304 lon: 6.65224 hasResults: False

 nctId: NCT06270160 id: KampalaLivelihoodsStudy briefTitle: Livelihoods Intervention With Urban Refugee Youth in Kampala, Uganda overallStatus: RECRUITING date: 2024-03-01 date: 2024-08-01 date: 2024-12-31 date: 2024-02-21 date: 2024-03-01 name: University of Toronto class: OTHER briefSummary: Displaced and refugee youth in Uganda are more vulnerable to health risks due to financial insecurity. As such, the investigators aim to explore the utility of an intervention aimed at improving livelihoods, called Creating Futures. Creating Futures is a group intervention that aims to help young people build their livelihoods, and was designed for use with youth (18-24) in urban informal settlements in South Africa.

Since there is a dearth of knowledge regarding efficacious interventions in refugee camps/settlements to engage young people in HIV testing and linkage to care, the investigators will harness various health promotion techniques including mHealth, comics, and the Creating Futures livelihoods intervention to address the urgent needs for: 1) HIV testing interventions with refugee/displaced adolescent and young people in Kampala, and 2) innovative HIV self test (HIVST) delivery strategies to increase linkage to confirmatory testing and HIV care. The investigators will conduct a three-arm cluster randomized controlled trial (cRCT) to evaluate the effectiveness of HIVST delivery methods among AYP living in Kampala. The specific objectives are to: Evaluate the feasibility and effectiveness of: 1) HIVST alone; 2) HIVST in combination with mHealth; and 3) HIVST, mHealth and Creating Futures in combination in increasing routine HIV testing, HIV status knowledge, and linkage to confirmatory testing and HIV care. The investigators aim to examine if adding a livelihoods program to HIV self-testing improves HIV prevention outcomes and other facets of well-being among urban refugee youth in Kampala. conditions: Financial Stress conditions: Social Functioning conditions: Social Skills studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The intervention arms will be compared to the control arm of the study using a pre- and post-intervention survey. There will also be a follow-up survey after the study is complete. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 432 type: ESTIMATED name: HIVST name: mHealth name: Creating Futures Livelihoods program measure: Number of participants engaged in HIV testing measure: Number of participants with knowledge of their HIV status measure: Number of participants linked to confirmatory HIV testing measure: Frequency of linkage to HIV care measure: Brief HIV Knowledge Questionnaire measure: Sexual Risk sex: ALL minimumAge: 16 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: Young African Refugees for Integral Development status: RECRUITING city: Kampala country: Uganda name: Robert Hakiza role: CONTACT phone: 256 2009 12345 email: roberthakiza2001@gmail.com lat: 0.31628 lon: 32.58219 hasResults: False

 nctId: NCT06270147 id: 16935 briefTitle: Timing of TAP Blocks in Bariatric Surgery overallStatus: NOT_YET_RECRUITING date: 2024-03-04 date: 2024-06-28 date: 2024-06-28 date: 2024-02-21 date: 2024-02-21 name: McMaster University class: OTHER briefSummary: This clinical trial aims to determine the optimal timing for administering a Transversus Abdominis Plane (TAP) block in bariatric surgery, specifically investigating whether initiating TAP blocks at the beginning of surgery is more beneficial than at the end, which is the current practice. The study targets obese patients undergoing bariatric surgery, with a focus on reducing postoperative pain and opioid use. Key outcomes include recovery duration, pain levels, opioid consumption, and respiratory function. Successful results could establish early TAP block initiation as a standard practice, offering faster recovery, decreased opioid reliance, and reduced healthcare costs. conditions: Opioid Use conditions: Pain, Postoperative studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Bupivacaine-epinephrine measure: Opioid Consumption measure: Length of Stay measure: Anesthesia requirements measure: Sedation requirements measure: Nausea and vomiting measure: Respiratory Status measure: Opioid consumption sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06270134 id: 14410 briefTitle: Dial-Bicarb Trial: Effects of a Lower vs. Higher Concentration of Dialysate Bicarbonate overallStatus: NOT_YET_RECRUITING date: 2025-01 date: 2029-01 date: 2029-01 date: 2024-02-21 date: 2024-02-21 name: McMaster University class: OTHER name: Canadian Institutes of Health Research (CIHR) briefSummary: This is a pragmatic, two-arm, parallel-group, open-label, individual-randomized, superiority trial that will be conducted in hemodialysis units across Ontario. Patients at each dialysis unit will be randomly allocated into one of two study arms in a 1:1 ratio to receive a dialysate bicarbonate concentration of either 32 or 38 mmol/L. The intervention will be embedded into routine care and delivered by hemodialysis unit personnel. conditions: Hemolysis conditions: Renal Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a pragmatic, two-arm, parallel-group, open-label, individual-randomized, superiority trial that will be conducted in hemodialysis units across Ontario. Patients at each dialysis unit will be randomly allocated into one of two study arms in a 1:1 ratio to receive a dialysate bicarbonate concentration of either 32 or 38 mmol/L. primaryPurpose: TREATMENT masking: NONE count: 5000 type: ESTIMATED name: Bicarbonate measure: Non-elective hospitalizations or mortality measure: Hospitalizations and fractures sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06270121 id: R2111483 briefTitle: Development of a Healthcare Service Platform for Successful Aging overallStatus: RECRUITING date: 2020-10-21 date: 2026-11-30 date: 2030-11-30 date: 2024-02-21 date: 2024-02-21 name: Sunmi Song class: OTHER briefSummary: The goal of this living-lab clinical trial is to test the effectiveness of digital health monitoring and feedback platform for community dwelling older adults. The main questions it aims to answer are:

* Identify digital sensing variables that are predictive of mental and physical health declines and health emergencies of older adults
* Develop digital health monitoring service to inform individualized daily health status of older adults users
* Develop ICT network to share the daily health status and emergency signals with community based healthcare service providers and family caregivers if an older adult user approves of them to receive their health information.

Participants will be asked to participate in a living lab using a wearable sensor, motion sensor, and smartphone applications for 6 weeks and also take part in pre-mid-post surveys to evaluate the usability, accuracy, and effectiveness of the digital healthcare service platform to improve health managements and connections with community and family caregivers.

If there is a comparison group: Researchers will compare age and gender matched control group to see if health status of the living-lab group is better than the control group. conditions: Depression in Old Age conditions: Chronic Pain conditions: Sleep Disorder Insomnia Chronic studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Control group was informed that they participated in the study with a repeated measure survey about digital healthcare for elderly without detailed descriptions on the living-lab intervention. whoMasked: PARTICIPANT count: 84 type: ESTIMATED name: Living-lab digital intervention group measure: Patient Health Questionnaire-9 (PHQ-9) measure: Sleep fragmentation index measure: Daily steps measure: Intensity of physical activity measure: Heart rate variability measure: Geriatic depression measure: SF-12 Quality of life measure: Pain related functional limitations measure: Chronic pain sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Korea University status: RECRUITING city: Seoul zip: 02841 country: Korea, Republic of name: Sunmi Song, PhD role: CONTACT phone: +821087489593 email: sunmi.song0715@gmail.com lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06270108 id: 22/SS/0040 id: 299382 type: OTHER domain: Integrated Research Application System briefTitle: The Role of Glutamatergic Function in the Pathophysiology of Treatment-resistant Schizophrenia acronym: RESTORE overallStatus: RECRUITING date: 2022-11-14 date: 2024-12-31 date: 2024-12-31 date: 2024-02-21 date: 2024-03-05 name: King's College London class: OTHER name: South London and Maudsley NHS Foundation Trust briefSummary: The goal of this basic science study is to to explore the responsivity of glutamate in the brain of treatment-resistant schizophrenia patients to the drug riluzole. The main aims of the study are:

To assess the role of glutamate in treatment-resistant schizophrenia using magnetic resonance spectroscopy.

To assess the relationship between glutamate levels and brain structural and functional measures (using: structural MRI; functional MRI (fMRI) and arterial spin labelling (ASL)) at baseline.

To assess the relationship between longitudinal change in glutamate levels and brain structural and functional measures.

To assess the relationship between longitudinal change in glutamate levels and changes in psychopathology.

The researchers will compare the changes with healthy controls and those without treatment-resistant schizophrenia. conditions: Treatment-resistant Schizophrenia conditions: Treatment-responsive Schizophrenia conditions: Healthy Controls studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a basic science study the purpose of which is to to explore the responsivity of glutamate in treatment-resistant schizophrenia to a given challenge (riluzole). primaryPurpose: BASIC_SCIENCE masking: NONE count: 288 type: ESTIMATED name: Riluzole measure: Change in glutamate levels (using magnetic resonance spectroscopy) pre- and post-riluzole administration measure: Correlation of glutamate (using magnetic resonance spectroscopy) with brain functional measures at baseline (using functional magnetic resonance imaging) measure: Longitudinal change in glutamate levels (using magnetic resonance spectroscopy) correlated with longitudinal change in brain functional measures (using functional magnetic resonance imaging) measure: Longitudinal change in glutamate levels (using magnetic resonance spectroscopy) correlated with changes in psychopathology sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Psychiatry, Psychology and Neuroscience status: RECRUITING city: London zip: SE5 8AB country: United Kingdom name: James Scott role: CONTACT phone: +44 207 848 0002 email: james.1.scott@kcl.ac.uk name: Guy Gitlin-Leigh role: CONTACT email: guy.1.gitlin-leigh@kcl.ac.uk name: Oliver D Howes role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06270095 id: C21-57 briefTitle: " Fume Events in Air Flights: Consequences on Cabin Air Quality and on Aircrews Health of a French Fleet of Aircraft" acronym: AVISAN overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-04 date: 2025-04 date: 2024-02-21 date: 2024-02-21 name: Institut National de la Santé Et de la Recherche Médicale, France class: OTHER_GOV name: Université Paris Cité name: National Agency for Sanitary Safety of the Food of the Environment and Labor briefSummary: The subject of the study focuses on commercial aircraft's cabins air quality, under conditions of both fume events and non-fume events. It also delves into the immediate and delayed repercussions of these events on the health of aviation crew members. The expological facet of this study is directed at the detection and quantification of organophosphorus compounds originating from engine oils. The epidemiological facet is geared towards the identification of potential neurological consequences. conditions: Neurologic Symptoms conditions: Neurologic Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1200 type: ESTIMATED name: Neurocognitive, neuromuscular and neurosensitive tests. measure: Neurocognitive self-assessment tests on digital tablet - CANTAB test battery: Paired Associates Learning measure: Neurocognitive self-assessment tests on digital tablet - CANTAB test battery: Rapid Visual Information Processing measure: Neurocognitive self-assessment tests on digital tablet - CANTAB test battery: One Touch Stockings of Cambridge measure: Neurosensitive test to explore superficial and deep sensitivity deficits in peripheral neuropathies measure: Neuromuscular test to evaluate muscle strength assessment measure: Symptoms experienced during the flight or within 72 hours after the flight, duration of symptoms, symptoms experienced previously outside the flight measure: Characteristics of plane and fume event and possible causes of fume event measure: Measurement of organophosphorus and carbon monoxide in cabin air using an air sampler and a piston syringe. sex: ALL minimumAge: 18 Years maximumAge: 67 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06270082 id: IK595-001 briefTitle: Study of IK-595 in RAS- or RAF-altered Advanced Tumors overallStatus: RECRUITING date: 2023-12-18 date: 2027-07 date: 2027-07 date: 2024-02-21 date: 2024-03-12 name: Ikena Oncology class: INDUSTRY briefSummary: This is a Phase 1, FIH, Dose Escalation and Dose Expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) effects, and preliminary antitumor activity of IK-595, a MEK/RAF molecular glue, administered orally as monotherapy in patients with advanced solid tumors with gene alterations in the RAS- MAPK pathway for whom there are no further treatment options known to confer clinical benefit. conditions: Solid Tumor, Adult conditions: Colorectal Cancer conditions: Pancreatic Cancer conditions: Malignant Melanoma conditions: Ras (Kras or Nras) Gene Mutation conditions: BRAF Gene Mutation conditions: CRAF Gene Mutation conditions: Non-Small Cell Lung Carcinoma conditions: Thyroid Carcinoma conditions: Gliomas, Malignant studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Dose Escalation: BOIN design Dose Expansion: 4 genetically/molecularly defined cohorts using Simon 2-stage adaptive design primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: IK-595 measure: Treatment-emergent adverse events, including treatment-related adverse events, and serious adverse events measure: Dose Limiting Toxicities measure: Treatment-Emergent Adverse Events measure: Recommended Phase 2 Dose (RP2D) and/or maximum tolerated dose (MTD) of IK-595 measure: Pharmacokinetics of IK-595: half-life (t1/2) measure: Pharmacokinetics of IK-595: Area Under the Curve (AUC) measure: Pharmacokinetics of IK-595: Maximum Plasma Concentration (Cmax) measure: Pharmacokinetics of IK-595: Minimum Plasma Concentration (Cmin) measure: To evaluate pERK fold change from baseline in paired tumor biopsies measure: Antitumor activity per RECIST 1.1: Disease control rate (DCR) of IK-595 as a single agent measure: Antitumor activity per RECIST 1.1: Time to response (TTR) of IK-595 as a single agent measure: Antitumor activity per RECIST 1.1: Duration of response (DOR) of IK-595 as a single agent measure: Antitumor activity per RECIST 1.1: Objective response rate (ORR) of IK-595 as a single agent measure: Antitumor activity: Median progression-free survival (PFS) of IK-595 as a single agent measure: Antitumor activity: Median overall survival (OS) of IK-595 as a single agent sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: START Midwest status: RECRUITING city: Grand Rapids state: Michigan zip: 49546 country: United States name: Jacob Goldberg, BA role: CONTACT phone: 616-954-5554 email: jacob.goldberg@startmidwest.com name: Nehal J Lakhani, MD,PhD role: PRINCIPAL_INVESTIGATOR lat: 42.96336 lon: -85.66809 facility: University of Pittsburgh Medical Center- Hillman Cancer Center status: NOT_YET_RECRUITING city: Pittsburgh state: Pennsylvania zip: 15232 country: United States name: Jason Luke, MD role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 facility: Sarah Cannon Research Institute status: NOT_YET_RECRUITING city: Nashville state: Tennessee zip: 37203 country: United States name: Meredith McKean, MD role: PRINCIPAL_INVESTIGATOR lat: 36.16589 lon: -86.78444 facility: Next Oncology- San Antonio status: RECRUITING city: San Antonio state: Texas zip: 78229 country: United States name: Carmen Gonzalez role: CONTACT phone: 210-580-9521 email: cgonzalez@nextoncology.com name: Anthony W Tolcher, MD role: PRINCIPAL_INVESTIGATOR lat: 29.42412 lon: -98.49363 facility: Next Oncology- Virginia Cancer Specialists status: RECRUITING city: Fairfax state: Virginia zip: 22031 country: United States name: Blake Paterson role: CONTACT phone: 703-783-4505 email: mpoole@nextoncology.com name: Alexander Spira, MD role: PRINCIPAL_INVESTIGATOR lat: 38.84622 lon: -77.30637 hasResults: False

 nctId: NCT06270069 id: 2024-001 briefTitle: Responsiveness and Minimal Important Change of Two Measures of Pain Intensity in People With Low Back Pain overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-02-28 date: 2025-02-28 date: 2024-02-21 date: 2024-02-21 name: International Institute of Behavioral Medicines class: OTHER briefSummary: This is an observational study aimed at evaluating the responsiveness and minimal important change of two measures of pain intensity in people with low back pain. It consists of a battery of self-administered questionnaires which will be given to individuals with low back pain to complete before and after a rehabilitation treatment. Relationships among the different outcome measures will be also evaluated. conditions: Low Back Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: Excercise-based therapy measure: NRS measure: Gauge of pain measure: ODI measure: PCS measure: TSK measure: PSEQ measure: GPE sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06270056 id: 1058 briefTitle: Evaluation of Telemedicine Medical Abortion Service in Ecuador overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-02 date: 2025-02 date: 2024-02-21 date: 2024-02-21 name: Gynuity Health Projects class: OTHER briefSummary: This research seeks to demonstrate that a telemedicine model for the provision of legal abortion services in Ecuador is safe, feasible and acceptable to users requesting a medication abortion and who are less than 12 weeks pregnant. conditions: Pregnancy studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Misoprostol measure: Adverse events (safety) measure: Feasibility of telemedicine service measure: Acceptability of telemedicine service sex: FEMALE minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: El Comité de Derechos Sexuales y Reproductivos de Ecuador (CODESER) city: Ambato country: Ecuador name: Maria Fernanda Morales role: CONTACT phone: 593 998220369 email: mafer_moca@yahoo.es lat: -1.24908 lon: -78.61675 facility: Cemoplaf city: Quito country: Ecuador name: Gabriela Rivera role: CONTACT phone: 593 995512828 email: gabyrivera2398@hotmail.com lat: -0.22985 lon: -78.52495 facility: Federación Nacional de Obstetrices y Obstetras del Ecuador (FENOE) city: Quito country: Ecuador name: Paola Tito role: CONTACT phone: 593 22951737 email: paojaime@hotmail.es lat: -0.22985 lon: -78.52495 hasResults: False

 nctId: NCT06270043 id: 809622 briefTitle: Focal Therapy for Localized Prostate Cancer overallStatus: RECRUITING date: 2024-02-01 date: 2034-02-01 date: 2034-02-01 date: 2024-02-21 date: 2024-02-26 name: University of California, San Diego class: OTHER briefSummary: This prospective registry and longitudinal study that is designed to carefully measure details of prostate cancer patients' outcomes with focal therapy. The goal of which is to improve patient care. conditions: Prostate Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Focal Therapy measure: Oncological Response measure: Erectile Dysfunction measure: Incontinence measure: Prostate cancer recurrence. Patients will be monitored with a Prostate Specific Antigen (PSA) every 6 months until 10 years from the intervention. Patients with a rising PSA will receive a prostate biopsy to determine if they have a recurrence. sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, San Diego status: RECRUITING city: La Jolla state: California zip: 92121 country: United States name: Juan Javier-DesLoges, MD role: CONTACT phone: 858-657-8786 email: jjavierdesloges@health.ucsd.edu lat: 32.84727 lon: -117.2742 hasResults: False

 nctId: NCT06270030 id: JX07002 id: CTR20240460 type: OTHER domain: China Center for Drug Evaluation (CDE), NMPA briefTitle: Safety, Tolerability and Pharmacokinetics of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Chinese With Presbyopia overallStatus: COMPLETED date: 2024-03-04 date: 2024-04-10 date: 2024-04-10 date: 2024-02-21 date: 2024-04-23 name: Ji Xing Pharmaceuticals (Shanghai) Co., Ltd. class: INDUSTRY name: LENZ Therapeutics, Inc briefSummary: Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LNZ101 and LNZ100 Ophthalmic Solutions in Chinese Healthy Adult Subjects with Presbyopia conditions: Presbyopia studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 21 type: ACTUAL name: LNZ101 (Aceclidine /Brimonidine) ophthalmic solution name: LNZ100 (Aceclidine) ophthalmic solution name: Placebo (Vehicle) ophthalmic solution measure: Cmax measure: Tmax measure: AUC0-t measure: AUC0-∞ measure: T1/2 measure: Safety: adverse event reporting sex: ALL minimumAge: 45 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai General Hospital city: Shanghai state: Shanghai zip: 200080 country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06270017 id: 282242 briefTitle: Evaluation of Metastatic Disease and Oncological Treatment in Patients With Colon Cancer Using Zebra Fish Avatars acronym: ZEBRA-COLON overallStatus: RECRUITING date: 2022-01-10 date: 2025-12-31 date: 2028-12-31 date: 2024-02-21 date: 2024-02-21 name: University Hospital, Linkoeping class: OTHER briefSummary: In order to improve and individualize cancer treatment personalized treatments developed much further. Colon cancer is treated with surgery and thereafter adjuvant oncological treatment. The selection of chemotherapy is today mainly done according to best guess. Today only a small fraction of oncological treatment may be known to be effective in a person before treatment start, most often it is trial and error. A fast reliable system for looking at response to different treatments in each unique patient is much needed and would, if successful, completely change the way we give oncological treatment today. This system would also be possible to use to evaluate new treatments and if successful, implement in the clinical setting. In this project we will implant a part of the patient's tumour tissue into a zebrafish embryo and evaluate tumour growth and frequency of metastatic disease as well as response to given oncological treatment.

2.2 Objective: The objective of this project is to explore the usefulness of zebrafish (Danio Rerio) embryo models to determine tumor biology and treatment response in colon cancer. An overarching goal would be, before start of any oncological treatment in a patient, to have evaluated the response of oncological treatment in the zebrafish avatar and only treat with a combination of drugs known to have effect against the patient's own tumour.

2.3 Study design: This protocol describes a series of prospective studies in different cohorts of patients with colon cancer to investigate the applicability of zebrafish embryo models. The common denominator of the sub-studies is prospective collection of tumor tissue implanted in zebrafish embryos in order to evaluate if the model is robust enough for growing colon cancer tissue and evaluate growth pattern and response to chemotherapy. This study protocol is designed according to and in adherence with the SPIRIT guidelines.

2.4 Intervention: In all sub-studies the intervention is inoculation of tumor cells in zebrafish embryos followed by observation of tumor behavior and testing of treatments. conditions: Colon Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Evaluation of patients derived colon cancer tumour cell growth in zebra fish embryos and response evaluation of combinations of chemotherpy primaryPurpose: DIAGNOSTIC masking: NONE count: 300 type: ESTIMATED name: Chemotherapy drug measure: Tumour growth measure: response evaluation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Per Sandström status: RECRUITING city: Linköping state: Ostergotland zip: 58185 country: Sweden name: Per Sandström, Prof role: CONTACT phone: +46734058581 email: per.sandstrom@liu.se name: Bergthor Bjornsson, MD PhD role: CONTACT phone: +46101033666 email: bergthor.bjornsson@liu.se lat: 58.41086 lon: 15.62157 hasResults: False

 nctId: NCT06270004 id: nonsurgical periodontal briefTitle: Effect of Nonsurgical Periodontal Therapy on Salivary Biomarkers Related to Bone Turnover in Smoker and Nonsmoker Periodontitis Patients overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-11-01 date: 2024-12-01 date: 2024-02-21 date: 2024-02-21 name: University of Baghdad class: OTHER briefSummary: 1. To assess the alteration in the level of salivary osteopontin (OPN), osteonectin(ON) and histatin-1 following NSPT in smoker and nonsmoker unstable periodontitis patients at different time intervals(one month and three months) .
2. To evaluate the response of clinical periodontal parameters ( plaque index ,bleeding on probing ,probing pocket depth ,clinical attachment loss)following NSPT in smoker and nonsmoker unstable periodontitis patients at different time intervals (one month and three months) conditions: Non Surgical Periodontal Therapy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: smoker and non smoker patients with unstable periodontitis primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: nonsurgical periodontal therapy measure: Effect of nonsurgical periodontal therapy(NSPT) on salivary biomarkers related to bone turnover in smoker and nonsmoker periodontitis patients. measure: Effect of nonsurgical periodontal therapy(NSPT) on salivary biomarkers related to bone turnover in smoker and nonsmoker periodontitis patients. measure: Effect of nonsurgical periodontal therapy(NSPT) on salivary biomarkers related to bone turnover in smoker and nonsmoker periodontitis patients sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06269991 id: SBA23/083 briefTitle: Fascial Anthropometry in Archery Athletes overallStatus: NOT_YET_RECRUITING date: 2024-02-15 date: 2024-09-06 date: 2025-09-06 date: 2024-02-21 date: 2024-02-21 name: Hacettepe University class: OTHER briefSummary: In archery, the body morphological and anthropometric characteristics of the prominent athletes change. It is important to examine facial anthropometry, especially since the athlete's equipment touches the facial area, and there are no studies on this subject. The aim of this study is to determine the relationship between facial anthropometric measurements and anthropometry-related parameters and sports performance in archery athletes. conditions: Sports Physical Therapy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED measure: evaluation of cervical region biomechanic measure: fat tissue distribution measure: head circumference measure: extremity circumference measure: extremity lengt measurement measure: knee and elbow diameter measure: nose width measure: chin width measure: face width measure: head width measure: nose protrusion measure: nose lenght measure: head lenght measure: face lenght measure: lip lenght measure: Assessment of Perıpheral Muscle Strength measure: postural analysis measure: Evaluation of shooting performance measure: The seated medicine ball throw (SMBT) measure: Closed Kinetic Chain Upper Extremity Stability Test measure: Upper Quarter Y Balance Test sex: ALL minimumAge: 9 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Hacettepe University city: Ankara zip: 06100 country: Turkey name: Aynur Demirel role: CONTACT phone: +905545295057 phoneExt: 178 email: aynur.demirel@hacettepe.edu.tr name: Nisanur Kutay role: CONTACT phone: +905515549957 email: kutaynisanur@gmail.com name: Nisanur Kutay role: SUB_INVESTIGATOR lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06269978 id: OSU-23195 id: NCI-2023-10497 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: R21CA282536 type: NIH link: https://reporter.nih.gov/quickSearch/R21CA282536 briefTitle: Intraperitoneal Oxaliplatin and Fluorouracil for the Treatment of Patients With Peritoneal Metastases From Colorectal Cancer overallStatus: RECRUITING date: 2024-04-30 date: 2025-12-31 date: 2025-12-31 date: 2024-02-21 date: 2024-03-27 name: Arjun Mittra class: OTHER name: National Cancer Institute (NCI) briefSummary: This phase I trial tests the safety, side effects, and best dose of intraperitoneal oxaliplatin and fluorouracil in treating patients with colorectal cancer that has spread to the peritoneal cavity (peritoneal metastasis). Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill cancer cells. Fluorouracil stops cells from making DNA and it may kill cancer cells. Both oxaliplatin and fluorouracil are approved by the Food and Drug Administration to treat patients with colorectal cancer, however administration of these drugs directly into the area between the muscles and organs in the abdomen (intraperitoneal) for the treatment of peritoneal metastases is experimental. Giving oxaliplatin and fluorouracil directly into the peritoneal space may be a safe and effective way of treating patients with peritoneal metastases from colorectal cancer. conditions: Metastatic Colorectal Carcinoma conditions: Metastatic Malignant Neoplasm in the Peritoneum conditions: Stage IV Colorectal Cancer AJCC v8 studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Biopsy name: Biospecimen Collection name: Computed Tomography name: Diagnostic Laparoscopy name: Fluorouracil name: Magnetic Resonance Imaging name: Oxaliplatin name: Surgical Procedure measure: Maximum tolerated dose (MTD) measure: Incidence of adverse events measure: Area under the curve measure: Clearance measure: Volume of distribution measure: Half-life measure: Tumor-cell intrinsic effects in response to IP 5FU+oxaliplatin measure: Modulation of the tumor microenvironment in response to IP 5FU+oxaliplatin measure: Changes in the makeup of circulating immune cells in response to IP 5FU+oxaliplatin measure: Rate of conversion from unresectable to resectable measure: Overall response rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ohio State University Comprehensive Cancer Center status: RECRUITING city: Columbus state: Ohio zip: 43210 country: United States name: Arjun Mittra, MD role: CONTACT phone: 614-293-6529 name: Arjun Mittra, MD role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False

 nctId: NCT06269965 id: 2023-A02181-44 briefTitle: Assessment of Collagen Membrane Interest in Distal Cuff Lesions Repair acronym: REGENECUFF overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2027-04-15 date: 2027-04-15 date: 2024-02-21 date: 2024-02-29 name: GCS Ramsay Santé pour l'Enseignement et la Recherche class: OTHER briefSummary: Rotator cuff refers to a set of 4 shoulder tendons. These tendons are the sub-scapularis, supra-spinatus, infra-spinatus and teres minor. Rotator cuff tear corresponds to total or partial tendon disinsertion at the greater tuberosity level or a few centimeters in upstream.

Rotator cuff surgery is an increasingly popular procedure practiced in France. In limited cuff lesions (distal or intermediates) and in absence of contraindication, absence of tendons' healing is around 10 to 20%. Sofcot estimates that 90% of caps' heals remain healed 10 years after surgery in distal lesions. However, even in case of a healed cuff, if tendon quality is not good, function will be impaired.

Bioinductive implant Regeneten® is an advanced healing solution for biological improvement and regeneration of tendons on all types rotator cuff tear. A randomized study was initiated whose main objective was to evaluate integrity of repaired tendon with MRI one year after intervention according to Sugaya's classification. Results showed a recurrence rate of 8.3% in Regeneten® group compared to 25.8% in witness group.

In this context, this study is based on hypothesis that adding Regeneten® during rotator cuff repair could be beneficial on tendon healing rate but also on tendon quality healing. conditions: Cuff Rotator Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 204 type: ESTIMATED name: Regeneten® adding measure: Rotator cuff healing quality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06269952 id: MVarmafalk briefTitle: Intimate Partner Violence Among People Who Inject Drugs - Prevalence, Risk Factors and Experiences overallStatus: RECRUITING date: 2023-10-05 date: 2025-03 date: 2028-12 date: 2024-02-21 date: 2024-02-21 name: Region Stockholm class: OTHER_GOV briefSummary: There are around 15,6 million people who inject drugs (PWID) worldwide, of which around 3,5 million are women who inject drugs (WWID) (1). In Sweden, estimates suggest 8000-21000 PWID (2). PWID are exposed to substantial health risks that are directly linked to injection drug use, such as blood borne viruses (hepatitis and HIV), overdoses and skin and tissue infections. Additionally psychiatric disorders are common and PWID's general health is often neglected (3,4,5).

In Sweden, harm reduction units such as needle and syringe programs (NSP) have scaled-up in recent years. In Stockholm the first NSP opened in 2013 and the second in 2018. In 2022, 4600 individuals were enrolled in the program since it opened, of which approximately 25% were women. Around 2000 were active participants, defined as having visited the program at least once during the last 12 months. In 2021 54% of the participants stated amphetamine as the last drug injected, 31% heroin, 4% buprenorphine and 11% other drugs. Most participants were between 30-49 years of age. In addition to distribution of sterile needles and injection paraphernalia, the NSP staff (nurses, doctors, midwifes, counselors) provides services such as testing for blood borne viruses, vaccinations, wound care, take-home naloxone, reproductive health services, counselling, support in contact with social service and referrals for substance use disorder treatment and hepatitis C/HIV treatment.

Gender-based violence (GBV) is a global health issue and WHO estimates that one in three women globally have been exposed to some sort of partner violence during their lifespan (7). Intimate partner violence (IPV) is defined as violent behavior between two people who have a close relationship, such as partners, ex-partners, siblings, relatives, friends and alike. In Sweden around 14% of women and 5% of men are exposed to physical violence in an intimate partner relationship during their lifespan however 20-25% of women and around 17% of men are exposed to psychological violence during their lifespan (8; 9). The prevalence of IPV among PWID is estimated to be significantly higher than in the general population (10). A study from USA found the risk of IPV to be three times higher and the prevalence estimated between 35-57% (7). In international studies, IPV exposure is found to be a significant risk factor for needle sharing among WWID (11, 12). There are other well-known consequences of IPV including impact on sexual and reproductive health rights, physical and psychological wellbeing, increased risk of contracting HIV and hepatitis C (13; 14). IPV exposure disproportionately affects WWID worldwide, however studies in Sweden on IPV exposure in the PWID population is scarce. To date there are studies that address this among women with substance use disorders but none with an exclusive focus on PWID or WWID. In clinical research of women diagnosed with substance use disorders (SUD) with psychiatric comorbidities and social challenges, one study indicates that the majority (91%, n=79) of women had been exposed to some form of IPV (15). Another study of women with SUD (n=52), 50% reported exposure of serious violence and the majority (96%) reported exposure to psychological violence (10). There are different types of IPV; psychological, physical, sexual, financial, latent, digital, neglect, honor related, aftermath of IPV (16). Our research team has previously carried out a qualitative interview study among WWID at the Stockholm NSP in 2019 to investigate reasons and barriers for participation among women (17). The interviews illustrated that IPV is common. In the proposed studies, for this doctoral thesis, we have chosen to focus on physical, sexual, psychological and financial violence among PWID motivated by findings in our previous research.

PWID and specifically WWID are regarded as groups who are especially vulnerable for IPV exposure and should therefore be prioritized in the national efforts to prevent IPV (15). However, there are no studies estimating the prevalence and frequency of IPV among PWID in Sweden. Previous international studies suggest that PWID are exposed to IPV to a greater extent than the general population, and women with substance use disorders are exposed to an alarming degree of violence (15). In Sweden there are no tailored interventions for PWID or WWID who are exposed to IPV, it is reasonable to believe that there is a need for a multi-faceted program for PWID exposed to IPV, however this is still unexplored.

The overall aim of this project is to increase knowledge about IPV among PWID and WWID as particularly vulnerable groups in regards to IPV. More specifically, the aim is to investigate the prevalence and frequency of different types of IPV among PWID at the Stockholm NSP and to explore the experiences' of IPV, needs and preferences for IPV support among WWID to facilitate tailored support and prevention programs for those exposed. conditions: People Who Inject Drugs, Injection Risk Behaviour, Gender-based Violence, Intimate Partner Violence studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 500 type: ESTIMATED name: No intervention measure: Intimate partner violence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Needle syringe program status: RECRUITING city: Stockholm country: Sweden name: Malin Värmå Falk role: CONTACT lat: 59.33258 lon: 18.0649 hasResults: False

 nctId: NCT06269939 id: R-1253-24 briefTitle: Theory-Driven Manualized Approach to Improving New Learning and Memory in Healthy Aging and MCI overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-30 date: 2025-03-30 date: 2024-02-21 date: 2024-02-21 name: Kessler Foundation class: OTHER briefSummary: The purpose of this research study is to investigate the effectiveness of a memory enhancement technique in an aging population. conditions: Aging studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: STEM measure: Verbal Leaning task measure: Participation in Everyday life measure: Functional Neuroimaging sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kessler Foundation city: East Hanover state: New Jersey zip: 07936 country: United States name: Samantha Schmidt role: CONTACT phone: 973-323-3686 email: sschmidt@kesslerfoundation.org lat: 40.8201 lon: -74.36487 hasResults: False

 nctId: NCT06269926 id: IRB00431182 briefTitle: Cognitive Behavioral Therapy for Chronic Pain in Adults With Cerebral Palsy overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-04 date: 2025-04 date: 2024-02-21 date: 2024-02-23 name: Hugo W. Moser Research Institute at Kennedy Krieger, Inc. class: OTHER name: Johns Hopkins University briefSummary: The purpose of this study is to understand if cognitive behavioral therapy can improve pain-related thought patterns and pain-related impairment in adults with cerebral palsy. conditions: Cerebral Palsy conditions: Pain, Chronic conditions: Pain Catastrophizing conditions: Brain Diseases conditions: Central Nervous System Diseases conditions: Coping Strategies conditions: Catastrophizing Pain conditions: Coping Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The investigators will randomize 40 adults with cerebral palsy and pain-related impairment in daily activities into two study arms: Group 1 (Education-CBT) will receive enhanced usual care (a pain education booklet in addition to usual medical care) followed by Cognitive Behavioral Therapy for Chronic Pain (CBT-CP; the primary intervention-a once weekly, 12-week group therapy course). Group 2 (CBT-Education) will instead receive CBT-CP first. To maintain reasonable therapy cohort sizes (n=10 per cohort), each group (n=20 participants) will consist of two separate therapy cohorts (n=10 each). Participants will be evaluated at the beginning of the study, and then once every 3 months during the 12-month duration of the study. primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Cognitive Behavioral Therapy for Chronic Pain name: Pain education measure: Pain Catastrophizing measure: Global Impressions of Change measure: Pain Interference measure: Pain Intensity measure: Anxiety/Mood symptoms sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kennedy Krieger Institute city: Baltimore state: Maryland zip: 21205 country: United States name: Paul Salib, B.S role: CONTACT phone: 443-923-9272 email: salib@kennedykrieger.org name: Eric Chin, M.D role: PRINCIPAL_INVESTIGATOR name: Paul Salib, B.S role: SUB_INVESTIGATOR lat: 39.29038 lon: -76.61219 hasResults: False

 nctId: NCT06269913 id: 23-0826 briefTitle: A Novel Iron-Based Supplement for Athletes Aged 18-25: Phase II overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-09 date: 2024-12 date: 2024-02-21 date: 2024-03-26 name: University of Calgary class: OTHER name: Mitacs name: Natural Sciences and Engineering Research Council, Canada briefSummary: Female endurance athletes are susceptible to iron deficiency and this can impact their exercise performance. This study aims to assess the efficacy of a novel iron supplement in improving iron status, gut microbiome, and exercise performance in endurance-trained females. conditions: Iron Deficiencies studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: FeSC measure: Iron Status measure: Hemoglobin measure: Upper Gut Microbiome measure: Lower Gut microbiome measure: Exercise Capacity measure: Hemoglobin Mass measure: Gastrointestinal Symptoms 1 measure: Gastrointestinal Symptoms 2 measure: Sleepiness measure: Stress and Recovery sex: FEMALE minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT hasResults: False

 nctId: NCT06269900 id: RC23_0358 briefTitle: Dexamethasone for Treating Severe Hospital-acquired Pneumonia in Critically Ill Patients With a Proinflammatory Phenotype acronym: HAP-DEX overallStatus: NOT_YET_RECRUITING date: 2024-02-15 date: 2026-03-14 date: 2026-08-15 date: 2024-02-21 date: 2024-02-21 name: Nantes University Hospital class: OTHER briefSummary: Determine the efficacy of dexamethasone plus standard of care (SOC) as compared to placebo plus SOC for treating severe hospital-acquired pneumonia in critically ill patients with a proinflammatory phenotype; It's an international phase III, double-blind, placebo-controlled, randomized trial. conditions: Hospital Acquired Pneumonia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 450 type: ESTIMATED name: Dexamethasone name: Placebo measure: Clinical cure rate at the test-of-cure visit (TOC visit) measure: The rate of all-cause mortality on Day 28. measure: Rate of death measure: Rate of pleural empyema at Day 28. measure: Rate of microbiological failure measure: Rate of pneumonia relapse measure: Duration of hospitalization and hospital-free days measure: Rates of non-respiratory hospital-acquired infection measure: Antibiotic-free days at Day 28 measure: Duration of invasive mechanical ventilation and invasive mechanical ventilation-free days measure: Rate of SUSAR ( suspected unexpected serious adverse reaction) and AE ( Adverse event) measure: Rate of gastric ulcer measure: Anxiety and depression were measured with the HADS (Hospital Anxiety and Depression Scale measure: Changes in subjective well-being with the Satisfaction With Life Scale (SWLS) measure: Changes in health-related quality of life measured with the Short Form (SF)-36 measure: the cost-effectiveness analysis (CEA ) will estimate an incremental cost-effectiveness ratio (ICER) sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Angers city: Angers country: France lat: 47.46667 lon: -0.55 facility: CHU Brest city: Brest country: France name: Xavier CHAPALAIN role: CONTACT email: xavier.chapalain@chu-brest.fr lat: 48.3903 lon: -4.48628 facility: CHU Caen city: Caen country: France name: Clément GAKUBA role: CONTACT email: gakuba-c@chu-caen.fr lat: 49.18585 lon: -0.35912 facility: CHU Clermont - Ferrand city: Clermont-Ferrand country: France name: Russell CHABANNE role: CONTACT email: rchabanne@chu-clermontferrand.fr lat: 45.77966 lon: 3.08628 facility: CHU Clermont-Ferrand city: Clermont-Ferrand country: France lat: 45.77966 lon: 3.08628 facility: CHU Clermont-Ferrand city: Clermont-Ferrand country: France name: Pierre COUHAULT role: CONTACT email: couhault@chu-clermontferrand.fr lat: 45.77966 lon: 3.08628 facility: CHU Beaujon city: Clichy country: France name: Emmanuel WEISS role: CONTACT email: emmanuel.weiss@aphp.fr lat: 48.90018 lon: 2.30952 facility: CHU Limoges city: Limoges country: France name: Bruno FRANCOIS role: CONTACT email: bruno.francois@chu-limoges.fr lat: 45.83153 lon: 1.25781 facility: CHU Marseille city: Marseille country: France name: Marc LEONE role: CONTACT email: marc.leone@ap-hm.fr lat: 43.29551 lon: 5.38958 facility: CHU Nancy city: Nancy country: France name: Gérard AUDIBERT role: CONTACT email: g.audibert@chru-nancy.fr lat: 48.68439 lon: 6.18496 facility: CHU Nantes (HGRL) city: Nantes zip: 44000 country: France lat: 47.21725 lon: -1.55336 facility: CHU Nantes city: Nantes zip: 44000 country: France name: Antoine ROQUILLY role: CONTACT phone: +33253482835 email: antoine.roquilly@chu-nantes.fr lat: 47.21725 lon: -1.55336 facility: CHU Nantes (HGRL) city: Nantes country: France name: Mickael VOURC'H role: CONTACT email: mickael.vourch@chu-nantes.fr lat: 47.21725 lon: -1.55336 facility: CHU Pitié Salpétrière city: Paris country: France lat: 48.85341 lon: 2.3488 facility: CHU Poitiers city: Poitiers country: France name: Claire DAHYOT FIZELIER role: CONTACT email: claire.dahyot-fizelier@chu-poitiers.fr lat: 46.58333 lon: 0.33333 facility: CHU Rennes city: Rennes country: France name: Yoann LAUNEY role: CONTACT email: yoann.launey@chu-rennes.fr lat: 48.11198 lon: -1.67429 facility: CHU Rennes city: Rennes country: France name: Jean-Marc TADIE role: CONTACT email: jeanmarc.tadie@chu-rennes.fr lat: 48.11198 lon: -1.67429 hasResults: False

 nctId: NCT06269887 id: Karabuk-001 briefTitle: Dominant Non-Dominant Upper Extremity in Gender overallStatus: RECRUITING date: 2023-11-07 date: 2024-03-15 date: 2024-03-30 date: 2024-02-21 date: 2024-03-12 name: Karabuk University class: OTHER briefSummary: There are strength and functional differences between non-dominant and dominant extremities. This is important in the hand and extremity rehabilitation process. This situation also differs between genders. Comparison of the dominant and non-dominant limb can provide important clinical or rehabilitation field-related information. It is reported in the literature that manual dexterity, grip strength and joint position sense may differ between extremities. However, the relationship between this situation and the difference between genders has not been explained. It is thought that examining this difference can be extremely useful in determining achievable goals in hand rehabilitation and in customizing care for different groups. conditions: Upper Extremity Problem conditions: Gender Issues studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 210 type: ESTIMATED measure: Hand Preference measure: Grip Strength measure: Joint Position Sense measure: Manual Dexterity sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Karabük University status: RECRUITING city: Karabük zip: 78000 country: Turkey name: Metehan YANA Phd role: CONTACT phone: 05072665522 email: metehanyana@karabuk.edu.tr lat: 41.20488 lon: 32.62768 hasResults: False

 nctId: NCT06269874 id: ASPERA-ANOCA id: 20240124 type: OTHER domain: JohannesGU briefTitle: Study Comparing Two Administration Pathways for Adenosine During Microvascular Function Assessment acronym: ASPERA-ANOCA overallStatus: NOT_YET_RECRUITING date: 2024-03-02 date: 2024-07-31 date: 2024-08-31 date: 2024-02-21 date: 2024-02-23 name: Johannes Gutenberg University Mainz class: OTHER briefSummary: The aim of this study is to investigate the agreement and reproducibility between intravenous and intracoronary adenosine administration during invasive assessment of microvascular function.

Goals of this study are:

1. Agreement and reproducibility between intravenous and intracoronary adenosine administration in the IMR (Index of microvascular resistance) value.
2. Agreement and reproducibility of FFR(fractional flow reserve), CFR (coronary flow reserve), MRR (microvascular resistance reserve), RRR (resistive reserve ratio) and reproducibility of each of these as compared with CFRabs (absolute coronary flow).
3. Time required for IMR measurements conditions: Microvascular Coronary Artery Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients will be randomized 1:1 to one of the two study arms and then the following study procedures will repeated in cross-over. Randomization will be done by using a computer-generated random sequence (medcalc, mariakerke, BE). primaryPurpose: DIAGNOSTIC masking: DOUBLE maskingDescription: Patients and outcome assessors will be blinded to the randomization group. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: microvascular function assessment measure: Agreement between intravenous and intracoronary adenosine responses (IMR) measure: Agreement between secondary parameters and reproducibility as compared with absolute measure: Time required for IMR measurements sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center of Cardiology, Cardiology I, university hospital Mainz city: Mainz state: Rheinland-Pfalz zip: 55131 country: Germany lat: 49.98419 lon: 8.2791 hasResults: False

 nctId: NCT06269861 id: GaziUtipNBDundar003 briefTitle: Comparison of Body Weights Via Visual Estimation, Anthropometric Calculation, and Actual Measured in Critically Ill Patients overallStatus: RECRUITING date: 2023-11-01 date: 2024-08-31 date: 2024-10-31 date: 2024-02-21 date: 2024-02-21 name: Gazi University class: OTHER briefSummary: Rapid and accurate determination of body weight in adult intensive care patients is very important for both calculating target tidal volume during invasive mechanical ventilation support and dose dependent drug administration. In this patient group, measuring actual body weight with a calibrated scale by standing the patient up is often impossible due to acute illness. Instead, estimated body weight determined by health care personnel or estimated body weights calculated according to anthropometric measurements are used. These calculations have some limitations in showing actual body weight, and there is some controversial information in current literature regarding their validity in critically ill patients. There is newly developed patient transfer scale called Marsden M-999® manufactured by Marsden Weighing Machine Group Ltd, which has the advantage of being used in patients who are unable to stand up, in rapidly and accurately measuring the current body weight in critically ill patients. This study aimed to evaluate the validity of these methods by comparing the body weights calculated by visual estimation and various anthropometric methods in critically ill Turkish patients with the actual weight measured by the mentioned scale. conditions: Critically Ill conditions: Body Weight studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: SCREENING masking: DOUBLE maskingDescription: To avoid self-calibration, all measurements will be recorded by a different doctor other than the primary care physician.

The all calculations will be performed by a different doctor other than the primary care physician. whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: patient transfer scale measure: determining actual weight measure: determining the ideal estimated body weight in critically ill patients sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gazi University status: RECRUITING city: Ankara state: Yenimahalle zip: 06560 country: Turkey name: Nazlıhan Boyacı Dündar, assist.prof. role: CONTACT phone: +905054790794 email: nazlihan_boyaci@yahoo.com name: Kamil İnci, assist.prof. role: CONTACT phone: +905442122545 email: kamilinci@gmail.com lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06269848 id: ITaDeBo briefTitle: Identification of Sports Talents in Boxers overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-29 date: 2024-03-11 date: 2024-06-30 date: 2024-02-21 date: 2024-03-01 name: Dynamical Business and Science Society - DBSS International SAS class: NETWORK briefSummary: This study aims to identify sporting talents by profiling a group of young boxers residing in the State of Mexico using unsupervised machine learning methods. This study is supported by Asociación de Boxeo del Estado de México AC (ABEM) and powered by DBSS. conditions: Body Composition conditions: Exercise Test conditions: Psychological Well-Being studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 178 type: ACTUAL measure: Anthropometry-Based Analysis of Adiposity measure: The acceleration of the fists in straight boxing punches measure: Number of punches thrown within a specific timeframe measure: Punch impact force measure: Reactive force index measure: Cardiorespiratory fitness measure: Isometric Mid-Thigh Pull measure: Load-velocity profile measure: Well-being profile measure: Ways of Coping Questionnaire measure: Attention and Perceptual Processes sex: ALL minimumAge: 15 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Centro Ceremonial Otomí city: México zip: 50868 country: Mexico lat: 19.42847 lon: -99.12766 hasResults: False

 nctId: NCT06269835 id: NAOTAN-IOE briefTitle: Intermittent Multifunctional Nutrition Tube in Cerebral Palsy and Dysphagia overallStatus: RECRUITING date: 2024-02-28 date: 2024-12 date: 2024-12 date: 2024-02-21 date: 2024-03-06 name: Zeng Changhao class: OTHER briefSummary: This was a randomized controlled study including 80 infants with cerebral palsy and dysphagia. The Participants were evenly divided into the observation group (with intermittent oro-esophageal tube feeding, n=40) and the control group (with persistent nasogastric tube feeding , n=40). Nutritional status and physical development, condition of dysphagia, and pneumonia before and after 3-month treatment were compared. conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: systemic therapy name: Intermittent Oro-Esophageal Tube Feeding name: Persistent Nasogastric Tube Feeding measure: The Oral Motor Assessment Scale measure: Pneumonia measure: Hemoglobin measure: Total Protein measure: Albumin measure: Prealbumin measure: body weight measure: upper arm circumference measure: Penetration-Aspiration Scale measure: Functional Oral Intake Scale for Infants measure: Feeding amount sex: ALL minimumAge: 6 Months maximumAge: 12 Months stdAges: CHILD facility: Center Rehabilitation Hospital status: RECRUITING city: Seoul country: Korea, Republic of name: Wei Liu, Master role: CONTACT lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06269822 id: SSR, HRV, QEEG in TLE briefTitle: Autonomic Dysfunction in Temporal Lobe Epilepsy and SUDEP overallStatus: COMPLETED date: 2022-09-01 date: 2023-11-25 date: 2024-01-01 date: 2024-02-21 date: 2024-02-21 name: Cairo University class: OTHER briefSummary: The study aimed at detection of autonomic dysfunction among cases with temporal lobe epilepsy; using different electrophysiological techniques.

Moreover, it aimed at finding any correlation between electrophysiological tests and SUDEP risk. conditions: Temporal Lobe Epilepsy studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 54 type: ACTUAL name: Sympathetic skin response, heart rate variability test, quantitative EEG measure: Detection of autonomic dysfunction (sympathetic domain) among cases of temporal lobe epilepsy measure: Detection of autonomic dysfunction (Para-sympathetic domain) among cases of temporal lobe epilepsy measure: Detection of the sudden unexpected death of epileptic patient (SUDEP) risk using Quantitative EEG (QEEG) in temporal lobe epilepsy(TLE) patients sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Clinical Neurophysiology unit- Kasr alainy-Cairo University city: Cairo state: Cairo Governorate zip: Cairo, Egypt country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06269809 id: s67279 briefTitle: Temporary Artery Clipping for Robotically-assisted Myomectomy, a Multicentric Randomized Controlled Trial acronym: TACROM overallStatus: RECRUITING date: 2023-05-04 date: 2025-05-30 date: 2025-05-30 date: 2024-02-21 date: 2024-02-21 name: Universitaire Ziekenhuizen KU Leuven class: OTHER name: Amsterdam UMC, location VUmc name: Bichat Hospital name: Rennes University Hospital briefSummary: This study aims to investigate the efficacy of temporary clipping of the uterine artery and utero-ovarian ligament during robotically assisted myomectomy (RAM) for uterine fibroids. While RAM is increasingly used for myomectomy, bleeding control remains challenging. Temporary clipping of arteries has shown promise in conventional laparoscopy but has not been studied in RAM. This randomized controlled trial will assess primary endpoints such as estimated blood loss, need for transfusion, and hemoglobin drop, alongside secondary outcomes like complication rates and operation time. conditions: Fibroid Uterus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multicentric non-blinded randomized controlled trial primaryPurpose: TREATMENT masking: NONE count: 82 type: ESTIMATED name: Temporary clipping of the uterine arteries and the utero-ovarian ligmants. name: No temporary clipping of the uterine arteries and the utero-ovarian ligmants. measure: Peri-operative blood loss: Estimated blood loss measure: Peri-operative blood loss: Hemoglobin drop perioperatively >2g/dL measure: Peri-operative blood loss: Need for peri-operative blood transfusion measure: Hospitalisation time measure: Operation time in minutes measure: Number of patients with complications postoperatively, graded by Clavien Dindo classification measure: Number of patients requiring secondary hemostatic measures sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospitals Leuven status: RECRUITING city: Leuven zip: 3000 country: Belgium name: Wouter Froyman, MD, PhD role: CONTACT phone: +3216342612 email: wouter.froyman@uzleuven.be lat: 50.87959 lon: 4.70093 facility: Department of Gynecology and Obstetrics, Hopital Bichat status: NOT_YET_RECRUITING city: Paris country: France name: Martin Koskas, MD, PhD role: CONTACT email: martin.koskas@aphp.fr lat: 48.85341 lon: 2.3488 facility: Service de gynécologie, Centre Hospitalier Universitaire de Rennes status: NOT_YET_RECRUITING city: Rennes country: France name: Vincent Lavoué, MD, PhD role: CONTACT lat: 48.11198 lon: -1.67429 facility: Amsterdam UMC, locatie VUmc status: NOT_YET_RECRUITING city: Amsterdam country: Netherlands name: Robert De Leeuw, MD, PhD role: CONTACT email: r.a.deleeuw@amsterdamumc.nl lat: 52.37403 lon: 4.88969 hasResults: False

 nctId: NCT06269796 id: little-dcdq briefTitle: Identification of Neuromotor Signs in Preschool Children Suspected of Developmental Coordination Disorder overallStatus: COMPLETED date: 2021-03-01 date: 2021-07-31 date: 2021-09-30 date: 2024-02-21 date: 2024-04-03 name: University of Thessaly class: OTHER briefSummary: This prospective study aimed to detect neuromotor signs early in preschool children suspected of Developmental Coordination Disorder (DCD). Preschool children aged 3-5 years old from municipal kindergartens in Thessaloniki participated in this study. The Little DCDQ questionnaire and the BOT-2 (Bruininks-Oseretsky Test of Motor Proficiency) were used for assessment. conditions: Motor Skills Disorders conditions: Child Development conditions: Child, Preschool studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 424 type: ACTUAL name: Little Developmental Coordination Disorder Questionnaire (LDCDQ) name: Bruininks- Oseretsky Test of Motor Proficiency 2nd Edition (BOT-2) measure: Parent Screening Questionnaire for Motor Coordination Difficulties (DCD) measure: Screening Test for Detection of Developmental Coordination Disorder (DCD) sex: ALL minimumAge: 3 Years maximumAge: 5 Years stdAges: CHILD facility: Human Performance & Rehabilitation Laboratory, Department of Physiotherapy, University of Thessaly city: Lamía state: Pthiotis zip: 35100 country: Greece lat: 38.9 lon: 22.43333 hasResults: False

 nctId: NCT06269783 id: STUDY00022968 briefTitle: Dual-process Mechanisms of Action for sipIT Intervention Effects in Patients With Urolithiasis overallStatus: RECRUITING date: 2024-01-10 date: 2024-10-31 date: 2024-10-31 date: 2024-02-21 date: 2024-02-22 name: Penn State University class: OTHER briefSummary: The purpose of this study is to clarify the fundamental processes underlying behavior change, maintenance, and adherence during and after a 3-month fluid intake intervention period. conditions: Kidney Stone conditions: Urolithiasis conditions: Nephrolithiasis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 155 type: ESTIMATED name: sipIT measure: Urine volume (intervention) measure: Urine volume (maintenance) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Pennsylvania State University status: RECRUITING city: University Park state: Pennsylvania zip: 16802 country: United States name: Shiyu Li, PhD role: CONTACT email: shiyu.li@psu.edu lat: 40.80201 lon: -77.85639 hasResults: False

 nctId: NCT06269770 id: Tapentadol briefTitle: Tapentadol vs Tramadol in Total Knee Arthroplasty overallStatus: RECRUITING date: 2023-05-01 date: 2025-05-01 date: 2025-06-01 date: 2024-02-21 date: 2024-02-22 name: University of Thessaly class: OTHER briefSummary: Compare the effectiveness of tapentadol and tramadol as part of a multimodal analgesia treatment for Total Knee Replacement (TKR). conditions: Total Knee Replacement conditions: Post-operative Pain conditions: Chronic Pain studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 96 type: ESTIMATED name: Tapentadol name: Tramadol measure: Post-operative pain measure: Post-operative pain measure: Post-operative pain measure: Post-operative pain measure: Post-operative pain measure: Post-operative pain measure: Post-operative pain measure: Post-operative pain measure: Neuropathic pain measure: Quality of life postoperatively measure: Patient Satisfaction measure: Depression measure: Function measure: Outcome measure: Arthritis impact measure: Health Status measure: Pain severity sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Of Larissa status: RECRUITING city: Larissa state: Thessaly zip: 41110 country: Greece lat: 39.63689 lon: 22.41761 hasResults: False

 nctId: NCT06269757 id: 23-01514 briefTitle: Exercise Program for ITB Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-08-01 date: 2026-04-01 date: 2024-02-21 date: 2024-02-21 name: NYU Langone Health class: OTHER briefSummary: Patients with diagnosed iliotibial band (ITB) syndrome indicated for non-operative management will be randomized to individualized exercise program or standard physical therapy over the course of 3 months to determine any possible difference in clinical outcomes. conditions: Iliotibial Band Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Individualized Exercise Program name: Standard Physical Therapy measure: Knee injury and Osteoarthritis Outcome Score Physical Short-Form (KOOS-PS) Score measure: Visual Analogue Scale (VAS) Score sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06269744 id: 23-01032 briefTitle: Proactive Outreach With FIT acronym: PROOF overallStatus: ENROLLING_BY_INVITATION date: 2024-03-13 date: 2025-07-31 date: 2026-04-30 date: 2024-02-21 date: 2024-03-29 name: NYU Langone Health class: OTHER briefSummary: The purpose of the study is to boost colorectal cancer (CRC) screening rates in an underserved population in Brooklyn through organized, proactive outreach of mailed Fecal Immunochemical Tests (FIT), utilizing evidence-based interventions tailored to the needs of the population. conditions: Colorectal Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 3000 type: ESTIMATED name: Proactive Screening Outreach measure: Proportion of Participants who Complete FIT Test by Month 6 measure: Proportion of Participants with Positive FIT who Complete Colonoscopy by Month 6 sex: ALL minimumAge: 45 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NYU Langone Health city: Brooklyn state: New York zip: 11203 country: United States lat: 40.6501 lon: -73.94958 facility: Community Health Care Network of New York city: Brooklyn state: New York zip: 11206 country: United States lat: 40.6501 lon: -73.94958 hasResults: False

 nctId: NCT06269731 id: Thyroid cancer briefTitle: Anxiety & Depression in Thyroid Cancer Patients overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-12 date: 2026-03 date: 2024-02-21 date: 2024-02-21 name: Assiut University class: OTHER briefSummary: 1. To identify the prevalence of both anxiety and depression in thyroid cancer patients
2. To assess quality of life in thyroid cancer patients conditions: Thyroid Cancer studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 159 type: ESTIMATED name: Hamilton depression Rating Scale measure: the prevalence of anxiety in thyroid cancer patients measure: the prevalence of depression in thyroid cancer patients measure: assess quality of life in thyroid cancer patients sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06269718 id: CMRPG8N0471 briefTitle: The Changes of Masticatory / Swallowing Functions and Oropharyngeal Muscle Mass on Sonography After Comprehensive Swallowing Training and Tongue - Pressure Resistance Training in Stroke Patients With Dysphagia overallStatus: RECRUITING date: 2023-12-01 date: 2024-07-31 date: 2024-07-31 date: 2024-02-21 date: 2024-02-21 name: Chang Gung Memorial Hospital class: OTHER briefSummary: The aims of this study are:

1. Comparing the ultrasound imaging performance of swallowing and chewing function, tongue pressure and oropharyngeal muscle thickness in stroke patients with different levels of swallowing function
2. To explore the changes in clinical mastication and swallowing functions, tongue pressure and oropharyngeal muscle thickness in patients with dysphagia and stroke after swallowing treatment and neuromuscular electrical stimulation training.
3. To explore the correlation between clinical mastication and swallowing functions, tongue pressure, oropharyngeal muscle thickness and ultrasound imaging results in patients with dysphagia and stroke. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: swallowing therapy name: IOPI therapy measure: the change from baseline to time of swallowing muscle strength measure: the change from baseline to time of Masster thickness measure: the change from baseline to time of tongue muscles thickness measure: the change from baseline to time of general muscle mass measure: Measure the change in grip strength (by Jamar hand dynamometer) measure: the change from baseline to time of swallowing functions measure: the change from baseline to time of clinical nutrition status measure: the change from baseline to time of swallowing functions 100 ml water test measure: the change from baseline to time of quality of life sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ChangGungMH status: RECRUITING city: Kaohsiung zip: 833 country: Taiwan name: Yuchi Huang, MD role: CONTACT phone: 886-7-7317123 phoneExt: 6286 email: hyuchi@gmail.com lat: 22.61626 lon: 120.31333 hasResults: False

 nctId: NCT06269705 id: 006-C-301 briefTitle: ZILRETTA in Subjects With Glenohumeral Osteoarthritis overallStatus: RECRUITING date: 2024-02-05 date: 2025-08 date: 2025-08 date: 2024-02-21 date: 2024-04-03 name: Pacira Pharmaceuticals, Inc class: INDUSTRY briefSummary: Primary Objective: To assess the efficacy of ZILRETTA on pain following an intra-articular (IA) injection in subjects with glenohumeral osteoarthritis (OA) relative to normal saline placebo

Secondary Objective:

* To assess the efficacy of ZILRETTA on pain following an IA injection in subjects with glenohumeral OA relative to triamcinolone acetonide injectable suspension, immediate release (TCA-IR) and normal saline placebo
* To assess the safety of ZILRETTA in subjects with glenohumeral OA relative to normal saline placebo and TCA-IR conditions: Glenohumeral Osteoarthritis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Only unblinded team (pharmacist, unblinded coordinator, drug administrator) will know the treatment assignment. A site-specific blinding plan will be developed to ensure blinding. Unblinded team will only interact with the subject at treatment and will not have any blinded roles on the study (only exception- informed consent). The subject and the assessor responsible for assessments/safety monitoring will be blinded. Site and Sponsor personnel/representatives will be blinded, with the following Sponsor/representative exceptions: unblinded monitors for performing drug accountability, unblinded clinical manager for reviewing unblinded monitoring visit reports and escalation of site unblinded issues, inventory manager for addressing product-related issues, and regulatory personnel for safety reporting. Information regarding treatment assignments will be kept securely at Sponsor. whoMasked: INVESTIGATOR count: 250 type: ESTIMATED name: ZILRETTA name: TCA-IR name: Placebo measure: Change from Baseline on the Worst Daily Pain (24-hr) mean score at Week 12 for ZILRETTA relative to placebo measure: Change from Baseline on the Worst Daily Pain (24-hr) mean score at Week 12 for ZILRETTA relative to TCA-IR measure: Change from Baseline on the Worst Daily Pain (24-hr) mean score at Week 18 for ZILRETTA relative to TCA-IR measure: Change from Baseline on the Worst Daily Pain (24-hr) mean score at Week 2 for ZILRETTA relative to placebo measure: Change from Baseline on the Worst Daily Pain (24-hr) mean score at Week 4 for ZILRETTA relative to placebo measure: Change from Baseline on the Worst Daily Pain (24-hr) mean score at Week 8 for ZILRETTA relative to placebo measure: Change from Baseline at Week 12 on the SPADI total score and subscales for ZILRETTA relative to placebo measure: Change from Baseline at Week 12 on the SPADI total score and subscales for ZILRETTA relative to TCA-IR sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alabama Orthopaedic Center- Research status: RECRUITING city: Birmingham state: Alabama zip: 35243 country: United States name: Robert Sorrell, MD role: CONTACT lat: 33.52066 lon: -86.80249 hasResults: False

 nctId: NCT06269692 id: 2023-A01353-42 briefTitle: MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators acronym: SMART-DEF overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2030-04-01 date: 2030-04-01 date: 2024-02-21 date: 2024-02-21 name: Central Hospital, Nancy, France class: OTHER briefSummary: Implantable cardioverter-defibrillators (ICD) are currently recommended for the primary prevention of sudden cardiac death (SCD) in patients with a remote (\>6 weeks) myocardial infarction (MI) and a low (≤35%) left ventricular ejection fraction (LVEF).

Ventricular tachycardia (VT) and/or ventricular fibrillation (VF), which are responsible for most SCDs, result from the presence of surviving myocytes embedded within fibrotic MI-scar. The presence of these surviving myocytes, as well as their specific arrhythmic characteristics, is not captured by LVEF. Hence, the use of LVEF as a unique risk-stratifier of SCD results in a low proportion (17 to 31%) of appropriate ICD device therapy at 2 years. Consequently, most patients with a prophylactic ICD do not present VT/VF requiring ICD therapy prior to their first-ICD battery depletion. Thus, many patients are exposed to ICD complications, such as inappropriate shocks, without deriving any health benefit. Therefore, the current implantation strategy of prophylactic ICDs, based on LVEF only, needs to be improved in post-MI patients. conditions: Myocardial Infarction conditions: Ventricular Tachycardia conditions: Ventricular Fibrillation conditions: Sudden Cardiac Death studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 1812 type: ESTIMATED name: MRI screening name: Implantable Loop Recorder name: Implantable Cardioverter Defibrillator measure: Occurrence of Sudden Cardiac Death (SCD) during the follow-up period measure: Total number of deaths during the follow-up period measure: Total number of deaths from cardiovascular cause during the follow-up period measure: Total number of SCD due to ventricular arrhythmia during the follow-up period measure: Total number (per patient) of sustained VT episodes treated by the ICD or recorded by the ILR during the follow-up period measure: Total number (per patient) of VF episodes treated by the ICD or recorded by the ILR during the follow-up period measure: Total number of hospitalizations due to cardiovascular causes during the follow-up period measure: Duration of hospitalizations due to cardiovascular causes during the follow-up period measure: Total number of hospitalizations from any cause during the follow-up period measure: Duration of hospitalizations from any cause during the follow-up period measure: Quality of life assessed by the scoring obtained from EuroQol questionnaires (EQ-5D-5L) during the follow-up period measure: Measurements of the estimated costs measure: Dice scores of the segmentation of the left ventricle and scar obtained from new MR sequences measure: Contour distance metrics of the segmentation of the left ventricle and scar obtained from new MR sequences measure: Dice scores of the accuracy of fully automated segmentation of the left ventricle and scar measure: Contour distance metrics of the accuracy of fully automated segmentation of the left ventricle and scar sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHRU Nancy city: Vandœuvre-lès-Nancy zip: 54511 country: France name: Christian de CHILLOU, MD, PhD role: CONTACT email: c.dechillou@chru-nancy.fr name: Guillaume DROUOT, PhD role: CONTACT email: g.drouot@chru-nancy.fr lat: 48.65 lon: 6.18333 hasResults: False

 nctId: NCT06269679 id: RC23_0336 briefTitle: CBCT vs OPT on the Oral Health Status at 12 Months of Patients Hospitalized for Infective Endocarditis. acronym: 3D STARS overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-05-01 date: 2028-05-01 date: 2024-02-21 date: 2024-02-21 name: Nantes University Hospital class: OTHER briefSummary: 1. Infective Endocarditis (IE) is a rare and serious disease with high morbidity and mortality; 2. Streptoccoci of oral origin are the second more frequent microorganisms responsible for IE; 3. Oral Infectious Foci (OIF) are underdetected using the current recommended clinical examination/Orthopantomogram (OPT) approach; 4. Cone Beam Computed Tomography (CBCT) has a better sensitivity and sensibility to detect OIF than OPT; 5. To date, no study has been performed to assess the potential benefit of a clinical examination/CBCT approach on the oral health status in IE patients.

Thus, conducting a randomized controlled trial is highly desirable to assess the potential impact of a clinical examination/CBCT approach on the oral health status of patients hospitalized for IE and potentially to reduce IE new episodes. conditions: Infective Endocarditis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 170 type: ESTIMATED name: CBCT measure: Superiority of CBCT measure: Superiority of CBCT measure: Superiority of CBCT measure: Diagnostic at inclusion measure: Incident symptomatic OIF measure: Incident asymptomatic OIF measure: Oral hygiene measure: Follow-up habits measure: Follow-up habits measure: Oral health quality of life measure: Premature end of study sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Bordeaux - Site Pellegrin city: Bordeaux country: France name: Elise ARRIVE role: CONTACT phone: +33/5 56 79 56 79 email: elise.arrive@u-bordeaux.fr lat: 44.84044 lon: -0.5805 facility: CHU Grenoble city: Grenoble country: France name: Cécile CHATEL role: CONTACT phone: +33/4 76 76 50 26 email: cchatel1@chu-grenoble.fr lat: 45.16667 lon: 5.71667 facility: CHRU Nancy city: Nancy country: France name: Vanessa MOBY role: CONTACT phone: +33/3 83 39 18 00 email: vanessa.moby@univ-lorraine.fr lat: 48.68439 lon: 6.18496 facility: CHU Nantes city: Nantes country: France name: Philippe LESCLOUS role: CONTACT phone: +33/2.40.41.29.40 email: philippe.lesclous@chu-nantes.fr name: Astrid GARREAU role: CONTACT email: astrid.garreau@chu-nantes.fr lat: 47.21725 lon: -1.55336 facility: AP-HP - Site Bretonneau city: Paris country: France name: MESSECA Clément role: CONTACT phone: +33/1 53 11 18 00 email: clement.messeca@aphp.fr lat: 48.85341 lon: 2.3488 facility: CHU Toulouse city: Toulouse country: France name: Sarah COUSTY role: CONTACT phone: +33/5.61.32.20.30 email: cousty.s@chu-toulouse.fr lat: 43.60426 lon: 1.44367 facility: CHRU Tours city: Tours country: France name: Frédéric DENIS role: CONTACT phone: +33/2 47 47 47 47 email: frederic.denis@univ-tours.fr lat: 47.38333 lon: 0.68333 hasResults: False

 nctId: NCT06269666 id: OPT1100 briefTitle: P200TxE Diseased Eye Image Collection overallStatus: RECRUITING date: 2024-01-31 date: 2024-06-30 date: 2024-06-30 date: 2024-02-21 date: 2024-02-21 name: Optos, PLC class: INDUSTRY briefSummary: The primary objective is to collect images on the P200TxE device in diseased eyes. conditions: Retinal Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: P200TxE measure: Number of images sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bennett and Bloom Eye Centers status: RECRUITING city: Louisville state: Kentucky zip: 40215 country: United States name: Megan Kingdon role: CONTACT phone: 513-305-8654 email: megankingdon@eyecare-partners.com lat: 38.25424 lon: -85.75941 hasResults: False

 nctId: NCT06269653 id: 10001944 id: 001944-AG briefTitle: Measuring Protein Turnover in Humans Across the Lifespan by Metabolic Labeling With Deuterium Oxide overallStatus: RECRUITING date: 2024-05-01 date: 2026-03-01 date: 2026-03-01 date: 2024-02-21 date: 2024-04-26 name: National Institute on Aging (NIA) class: NIH briefSummary: Background:

Proteins are essential to the health and structure of the cells that make up body tissues. Most proteins become damaged over time and are replaced with new ones. This process is called "protein turnover." Stress, disease, and aging can affect this process. Researchers want to better understand how aging affects protein turnover.

Objective:

To measure rates of protein turnover in healthy adults.

Eligibility:

Healthy people aged 20 years and older with a body mass index between 20 and 30.

Design:

Participants will have 6 study visits over 4 to 6 weeks. They will fast 12 hours before each visit.

Participants will be screened. They will have a physical exam, with blood and urine tests and tests of their heart function. They will lie down while blood pressure cuffs are used on their arms and legs.

Participants will be given bottles of heavy water to drink at home on a schedule for 21 days. Each bottle holds about 3.5 tablespoons. Heavy water is odorless, colorless, and tasteless, like normal drinking water. It is safe to drink and has been used in research for many years.

Participants will have tests during study visits, including:

Imaging scans of a leg.

Exercise on a treadmill.

Biopsies of muscle, skin, and fat: Small samples of tissue will be cut from the calf and abdomen.

Resting metabolic rate: Participants will lie still and breathe into a mask for 20 minutes.

Knee/grip strength: Participants will do strength tests with their legs. They will squeeze a device with their hands.

D3-Creatine: Participants will take 1 pill of D3-Creatine, which occurs naturally in muscle. conditions: Healthy Volunteers studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 75 type: ESTIMATED measure: Measure the turnover proteins in humans across tissues, age, and sex. measure: Test the hypothesis that older age is associated with diminished protein turnover. sex: ALL minimumAge: 20 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Institute of Aging, Clinical Research Unit status: RECRUITING city: Baltimore state: Maryland zip: 21224 country: United States name: Luigi Ferrucci, M.D. role: CONTACT phone: 410-558-8110 email: ferruccilu@grc.nia.nih.gov lat: 39.29038 lon: -76.61219 hasResults: False

 nctId: NCT06269640 id: 10001640 id: 001640-H briefTitle: NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Early Feasibility Study overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-10-01 date: 2027-10-01 date: 2024-02-21 date: 2024-04-26 name: National Heart, Lung, and Blood Institute (NHLBI) class: NIH briefSummary: Background:

Some people have a condition in which the wall (septum) that separates the two main pumping chambers of the heart is too thick. This thick septum causes a condition called "left ventricular outflow tract obstruction" (LVOTO), which reduces blood flow out of the heart. LVOTO can cause serious heart disease; symptoms may include shortness of breath, chest pain, heart failure, or death. Researchers want to find better ways to treat LVOTO.

Objective:

To test a new procedure where excess tissue is sliced away from the septum in people with LVOTO. This procedure is called "septal scoring along midline endocardium" (SESAME).

Eligibility:

Adults aged 21 years with LVOTO.

Design:

Participants will have baseline tests. They will have imaging scans and tests of their heart structure and function. They will take a walking test and answer questions about how their heart condition affects their life.

Participants will stay in the hospital 2 to 6 days for the SESAME procedure.

They will be completely or partially asleep for the procedure. A tube will be inserted into the mouth and down the throat to take pictures of the heart. Pictures may also be taken with a tube inserted inside the heart.

Next, tubes will be inserted into the groin and guided through the blood vessels up to the heart. Guidewires will be inserted into the heart. Doctors will watch the path the wires take with x-rays and ultrasound. When the wire is in the correct place, it will be electrified to slice excess tissue away from the septum.

Participants will have 3 follow-up visits within 1 year. conditions: Hypertrophic Cardiomyopathy conditions: Left Ventricular Septal Hypertrophy conditions: Mitral Valve Disease conditions: Aortic Valve Stenosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Septal Scoring Along Midline Endocardium measure: Technical success measure: Safety measure: Complete heart block requiring permanent pacemaker sex: ALL minimumAge: 21 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Emory University Hospital city: Atlanta state: Georgia zip: 30322 country: United States name: Robert Lederman, M.D. role: CONTACT phone: 301-402-6769 email: lederman@nih.gov lat: 33.749 lon: -84.38798 hasResults: False

 nctId: NCT06269627 id: 10001644 id: 001644-AA briefTitle: Temporally-Resolved Electrophysiology of Acamprosate Treatment of Alcohol Use Disorder overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2026-12-31 date: 2024-02-21 date: 2024-04-26 name: National Institute on Alcohol Abuse and Alcoholism (NIAAA) class: NIH briefSummary: Background:

Chronic heavy drinking can cause alcohol use disorder (AUD). AUD changes how the brain works. People with AUD may drink compulsively or feel like they cannot control their alcohol use. Acamprosate is an FDA-approved drug that reduces anxiety and craving in some, but not all, people with AUD.

Objective:

To learn more about how acamprosate affects brain function in people with AUD.

Eligibility:

People aged 21 to 65 years with moderate to severe AUD.

Design:

Participants will stay in the clinic for 21 days after a detoxification period of approximately 7 days.

Acamprosate is a capsule taken by mouth. Half of participants will take this drug 3 times a day with meals. The other half will take a placebo. The placebo looks like the study drug but does not contain any medicine. Participants will not know which capsules they are taking.

Participants will have a procedure called electroencephalography (EEG): A gel will be applied to certain locations on their scalp, and a snug cap will be placed on their head. The cap has sensors with wires. The sensors detect electrical activity in the brain. Participants will lie still and perform 2 tasks: they will look at different shapes and press a button when they see a specific one; and they will listen to tones and press dedicated buttons when they hear the corresponding tones.

Participants will have 2 EEGs: 1 on day 2 and 1 on day 23 of their study participation. They may opt to have up to 4 more EEG studies (one on day 13 and one on each of the three follow-up visits) and 2 sleep studies, in which they would have sensors attached to their scalp while they sleep.

Participants may have up to three follow-up visits for 6 months. conditions: Alcohol Use Disorder studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: Acamprosate calcium name: Placebo measure: Reduction of beta power measure: Promotion of alpha power in active group compared to placebo group. measure: No change in slow band (delta and theta) power in active group compared to placebo group. measure: Reduction of theta event-related synchronization in active group compared to placebo group. measure: Amplification and hastening of P300 in active group compared to placebo group. measure: Correlation of EEG markers of acamprosate treatment with clinical measures of anxiety and alcohol craving measure: Correlation of EEG markers of acamprosate treatment with polysomnography markers measure: Correlation of polysomnography markers of acamprosate treatment with clinical measures of anxiety and alcohol craving sex: ALL minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Institutes of Health Clinical Center city: Bethesda state: Maryland zip: 20892 country: United States name: NIH Clinical Center Office of Patient Recruitment (OPR) role: CONTACT phone: 800-411-1222 phoneExt: TTY dial 711 email: ccopr@nih.gov lat: 38.98067 lon: -77.10026 hasResults: False

 nctId: NCT06269614 id: QOL334829 briefTitle: Assessing the Gut Microbiome and Its Association With Pediatric Stress and Cognition overallStatus: RECRUITING date: 2023-01-12 date: 2025-12-31 date: 2025-12-31 date: 2024-02-21 date: 2024-02-21 name: Nova Southeastern University class: OTHER briefSummary: Using a metabolomics approach in combination with eye-tracking data, this research study proposes to gather evidence from two interrelated body systems (gut and brain) in order to assess how the microbiome is involved in stress modulated symptoms in children with autism and children exposed to repeated stress in comparison to a control group. conditions: Autism Spectrum Disorder conditions: Adverse Childhood Experiences conditions: Stress Reaction studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: NONE count: 75 type: ESTIMATED name: Probiotic measure: Enteric Microbiome abundance measure: Enteric Microbiome diversity measure: Improved response to stressor measure: Improved physiological response to stressor sex: ALL minimumAge: 4 Years maximumAge: 95 Months stdAges: CHILD facility: Nova Southeastern University College of Nursing status: RECRUITING city: Davie state: Florida zip: 33314 country: United States name: Gesulla Cavanaugh, PhD role: CONTACT phone: 954-262-1980 email: gcavanaugh@nova.edu lat: 26.06287 lon: -80.2331 hasResults: False

 nctId: NCT06269601 id: HÜ- FTR- BD- 02 briefTitle: The Reliability of the Upper Limb Rotation Test in Adolescent Male Basketball Players overallStatus: COMPLETED date: 2023-08-10 date: 2023-09-15 date: 2023-09-15 date: 2024-02-21 date: 2024-02-28 name: Hacettepe University class: OTHER briefSummary: The objective of the study is to examine the reliability of the Upper Limb Rotation Test in adolescent male basketball players aged between 14 and 16. According to the sample size calculation for the study, 51 athletes were included. The Upper Limb Rotation Test was administered to the athletes twice, with a one-week interval. The athlete was positioned in a plank stance with shoulder, elbow lateral epicondyle, greater trochanter, and ankle lateral malleolus making contact with the wall. The athletes were instructed to perform a 90° abduction and 90° external rotation of the shoulder, accompanied by trunk rotation for a duration of 15 seconds. The number of repetitions was recorded. The tested side was the upper extremity in which the closed kinetic chain position was maintained. The test was repeated three times, and the average of the results was calculated. The Upper Extremity Rotation Test is a reliable assessment tool for evaluating performance in adolescent basketball players aged 14-16, particularly in relation to shooting skills. conditions: Sports Physical Therapy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: 14-18 years basketball players primaryPurpose: OTHER masking: NONE count: 51 type: ACTUAL name: Upper Limb Rotation Test measure: The Reliability of the Upper Limb Rotation Test sex: MALE minimumAge: 14 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Hacettepe University city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06269588 id: NBM-NP004 briefTitle: Efficacy and Safety of Nexpowder™ for Non-variceal, Upper Gastrointestinal Bleeding overallStatus: RECRUITING date: 2024-02 date: 2024-12 date: 2024-12 date: 2024-02-21 date: 2024-02-21 name: Changi General Hospital class: OTHER name: Next Biomedical Co., Ltd. name: Tan Tock Seng Hospital name: National University Hospital, Singapore briefSummary: The purpose of this pilot clinical trial is to confirm the efficacy and safety of Nexpowder™ for hemostasis in pilot cohort of patients with NVUGIB in Singapore conditions: Gastrointestinal Hemorrhage conditions: Hematemesis; With Ulcer conditions: Endoscopy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: prospective single arm intervention cohort primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Nexpowder measure: endoscopic hemostasis measure: recurrent bleeding rate on second-look endoscopy measure: hydrogel persistence rate at the bleeding site measure: Recurrent bleeding within 30 days after endoscopic therapy sex: ALL minimumAge: 21 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Changi General Hospital status: RECRUITING city: Singapore zip: 529889 country: Singapore name: Tiing Ang, MRCP (UK) role: CONTACT phone: 69365737 email: ang.tiing.leong@singhealth.com.sg lat: 1.28967 lon: 103.85007 hasResults: False

 nctId: NCT06269575 id: Dysphagia briefTitle: Evaluation Of The Effectiveness Of Safe Nutrition Program Applied To Acute Stroke Patients With Dysphagia overallStatus: COMPLETED date: 2020-10-05 date: 2023-08-15 date: 2023-12-15 date: 2024-02-21 date: 2024-02-21 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: It was planned in a quasi-experimental design with a non-randomized control group. The study was planned to be completed in three stages: control, preparation and intervention periods.

Question 1: Does a safe nutrition program prevent aspiration pneumonia, dehydration and malnutrition in acute stroke patients with dysphagia? Question 2: Is the safe nutrition program effective on addiction level, quality of life and depression in acute stroke patients with dysphagia? Question 3: Does a safe nutrition program shorten the hospital stay and NG tube duration in acute stroke patients with dysphagia? conditions: DYSPHAGIA studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: non-randomized controlled primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 78 type: ACTUAL name: SAFE NUTRITION PROGRAM measure: Complications of dysphagia measure: Complications of dysphagia measure: Complications of dysphagia measure: Stroke-Specific Quality of Life Scale (SS-QOL) measure: Swallowing Anxiety Scale (YKÖ) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul Universitesi-Cerrahpasa city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06269562 id: clavicle briefTitle: SPSIPB and CPB on Clavicle Surgeries overallStatus: COMPLETED date: 2023-06-20 date: 2023-12-20 date: 2024-02-04 date: 2024-02-21 date: 2024-02-21 name: Cumhuriyet University class: OTHER briefSummary: Clavicular fractures represent a common occurrence often necessitating effective pain management strategies, particularly following surgical interventions. This study involved a cohort of five patients who underwent clavicular fracture surgery under general anesthesia. A novel analgesic approach combining two distinct nerve block techniques-Serratus Posterior Superior Intercostal Plane Block (SPSIPB) and Clavipectoral Plane Block (CPB)-was employed for postoperative pain control. The procedural methodology encompassed the administration of SPSIPB preceding anesthesia induction, followed by CPB subsequent to induction. SPSIPB targeted specific neural regions responsible for sensory blockade within the innervation of the clavicular skin, whereas CPB focused on the clavipectoral fascia. Standard anesthesia protocols were utilized, and postoperative pain levels were evaluated using Numeric Rating Scores (NRS). conditions: Clavicle Fracture conditions: Postoperative Pain conditions: Analgesia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 5 type: ACTUAL name: Serratus posterior superior intercostal plane block and clavipectoral plane block measure: Numerical Rating Scale measure: tramadol consumption sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sivas Cumhuriyet University city: Sivas zip: 58050 country: Turkey lat: 39.74833 lon: 37.01611 hasResults: False

 nctId: NCT06269549 id: KDS_KOA briefTitle: Kinesiological / Dietary Supplement Intervention in Knee Osteoarthritis acronym: KDSKOA overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-09-30 date: 2025-12-31 date: 2024-02-21 date: 2024-02-26 name: University of Primorska class: OTHER name: Community Healthcare Center dr. Adolf Drolc Maribor (HCM) briefSummary: The goal of this clinical trial is to assess the effectiveness of dietary supplement combined with exercise in managing knee osteoarthritis (KOA). The main questions it aims to answer are:

* Is adding a dietary supplement to exercise additionally effective in managing KOA?
* Is adding exercise to the dietary supplement additionally effective in managing KOA?

Participants will be given in three groups:

1. Real dietary supplement alone
2. Real dietary supplement with exercise
3. Placebo dietary supplement with exercise

Investigators will compare groups 1 and 2, or 2 and 3, to answer the research questions.

The hypothesis is that participants who receive the dietary supplement along with exercise will experience greater reduction in pain level, improved physical function, and enhanced quality of life compared to those who receive a placebo combined with exercise or dietary supplement alone. conditions: Osteoarthritis, Knee studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: The differences between groups will be tested using a two-way analysis of variance for repeated measures (factor 1 = group, factor 2 = time) primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE maskingDescription: Placebo blinding / masked for dietary supplement whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 120 type: ESTIMATED name: Non-training Real Dietary Supplement (G1) name: Training Placebo Dietary Supplement (G2) name: Training Real Dietary Supplement (G3) measure: Change from baseline in severity grading of knee osteoarthritis from X-ray Images at week 12 measure: Change from baseline in thickness of the articular cartilage and cross-section of muscles around knee joint at week 12 measure: Change from baseline in self-assessment pain, stiffness, and physical function (WOMAC questionaire) at week 12 measure: Change from baseline in self-assessment quality of life (SF-36 questionaire) at week 12 measure: Change from baseline in time spent sleeping, awake/sedentary, and physical activity within 24 hour (DAB-Q) at week 12 measure: Change from baseline in knee pain on visual analogue scale at week 12 measure: Change from baseline in static balance time at week 12 measure: Change from baseline in direction-specific amplitude from the center of pressure in static balance at week 12 measure: Change from baseline in direction-specific velocity from the center of pressure in static balance at week 12 measure: Change from baseline in direction-specific frequency from the center of pressure in static balance at week 12 measure: Change from baseline in number of repetitions in Chair Stand Test at week 12 measure: Change from baseline in time for Five Times Sit to Stand Test at week 12 measure: Change from baseline in number of repetitions in Arm Curl Test at week 12 measure: Change from baseline in lower body flexibility at week 12 measure: Change from baseline in upper body flexibility at week 12 measure: Change from baseline in 6-minute walk distance at week 12 measure: Change from baseline in maximal isometric voluntary contraction of knee flexor and extensor at week 12 measure: Change from baseline in explosive strength of knee extensor at week 12 measure: Change from baseline in 24-hour time use at week 12 measure: Change from baseline in presence of inflammatory markers in blood sample at week 12 sex: ALL minimumAge: 55 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Primorska, Faculty of Health Sciences city: Izola zip: 6310 country: Slovenia name: Nejc Šarabon, PhD role: CONTACT phone: 05 662 64 66 phoneExt: +386 email: nejc.sarabon@fvz.upr.si name: Tina Čeh, MSc role: SUB_INVESTIGATOR lat: 45.53694 lon: 13.66194 facility: Community Healthcare Center dr. Adolf Drolc city: Maribor zip: 2000 country: Slovenia name: Jernej Završnik, PhD role: CONTACT phone: 02 2286 257 phoneExt: +386 email: jernej.zavrsnik@zd-mb.si name: Tina Čeh, MSc role: SUB_INVESTIGATOR lat: 46.55472 lon: 15.64667 hasResults: False

 nctId: NCT06269536 id: UC-SK004 briefTitle: Stress-reducing Intervention in Urothelial Carcinoma overallStatus: RECRUITING date: 2024-02-15 date: 2027-02-15 date: 2029-02-15 date: 2024-02-21 date: 2024-02-21 name: Comenius University class: OTHER briefSummary: The aim of this interventional study is to test the heart-rate variability biofeedback intervention (HRV BI) in patients with muscle-infiltrating bladder carcinoma (MIBC) treated with chemotherapy based on cisplatin in neoadjuvant setting followed by local therapy (standard of care, SOC) compared to SOC alone. conditions: Bladder Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 50 type: ESTIMATED name: HRV biofeedback measure: Primary Objective: Inflammation measure: Primary Objective: Heart Rate Variability (HRV) measure: Primary Objective: Quality of Life (QoL) measure: Primary Objective: Working memory measure: Primary objective: Executive function measure: Primary objective: Salivary Cortisol Slopes measure: Primary objective: Sleep Quality measure: Secondary objective: Serious Adverse Events measure: Secondary objective: Disease-Free Survival (DFS) measure: Secondary objective: Overall Survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Institute status: RECRUITING city: Bratislava zip: 83310 country: Slovakia name: Katarina Rejlekova role: CONTACT email: katarina.rejlekova@nou.sk name: Patrik Palacka role: PRINCIPAL_INVESTIGATOR lat: 48.14816 lon: 17.10674 hasResults: False

 nctId: NCT06269523 id: MFR032024 briefTitle: Effects of Rehabilitation and Kinesio Taping to Prevent Axillary Web Syndrome After Breast Cancer Surgery overallStatus: COMPLETED date: 2021-07-21 date: 2023-01-31 date: 2024-01-31 date: 2024-02-21 date: 2024-02-21 name: University of Palermo class: OTHER briefSummary: Axillary web syndrome (AWS) is a complication associated with breast cancer surgery, characterized by pain, functional limitation of the shoulder and decreased quality of life. There are several physical treatment options to reduce pain and improve the functionality of the upper limb in women with AWS. This study evaluates the effectiveness of an early rehabilitation approach to prevent axillary web syndrome consisting in functional and proprioceptive re-education, manual lymphatic drainage and kinesio taping after breast cancer surgery. conditions: Axillary Web Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 18 type: ACTUAL name: Kinesio taping, Lymphatic drainage name: Lymphatic drainage measure: NRS Scale measure: Joint excursion shoulder measure: Muscular strength of the upper limbs measure: Constant Murley Score measure: upper limbs circumferenze (cyrtometry) sex: FEMALE minimumAge: 45 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone city: Palermo zip: 90127 country: Italy lat: 38.13205 lon: 13.33561 hasResults: False

 nctId: NCT06269510 id: HUM00242997 id: 1R01AA030748-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01AA030748-01 briefTitle: Enhancing Alcohol Treatment Engagement in Associated Liver Disease (ALD) Patients overallStatus: NOT_YET_RECRUITING date: 2025-04 date: 2027-07 date: 2027-07 date: 2024-02-21 date: 2024-03-26 name: University of Michigan class: OTHER name: National Institute on Alcohol Abuse and Alcoholism (NIAAA) briefSummary: The purpose of this trial is to see if providing patients with alcohol-related liver disease with tailored alcohol use treatment options will increase engagement with treatment and correct possible misconceptions. conditions: Alcohol-related Liver Disease conditions: Liver Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Computer-generated urn randomization will ensure balanced groups based on stage of ALD (advanced ALD and non-advanced ALD) and inpatient versus outpatient status at time of recruitment. Second stage randomization to 3-month intervention conditions will be stratified based on response and non-response status. Urn randomization using stage of ALD and inpatient versus outpatient recruitment will also be used at the second stage randomization. Re-randomization of non-responders will be computerized and stratified by stage of ALD and inpatient vs outpatient status. primaryPurpose: TREATMENT masking: NONE count: 268 type: ESTIMATED name: ENGAGE-ALD Application (APP) name: Treatment Facilitation bundle name: Enhanced Usual Care measure: Alcohol treatment engagement measure: Alcohol Use Frequency as Measured by a 30-day alcohol recall calendar method measure: Percent heavy drinking days (PHDD) measure: Change in Liver health based on liver laboratory values (aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase) for all participants measure: Change in Liver health based on liver laboratory values (total bilirubin) for all participants measure: Change in Liver health based on The Model for End-Stage Liver Disease (MELD) score in participants with cirrhosis or alcoholic hepatitis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States name: Haila Asefa role: CONTACT phone: 734-232-0284 email: asefah@umich.edu name: Jessica Mellinger, MD, MSc role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 hasResults: False

 nctId: NCT06269497 id: 2018/2300 briefTitle: TiO2-scaffolds for Alveolar Ridge Preservation acronym: TIOSCAFF overallStatus: COMPLETED date: 2021-11-09 date: 2022-06-20 date: 2023-08-10 date: 2024-02-21 date: 2024-02-21 name: University of Oslo class: OTHER briefSummary: The goal of this clinical trial is to evaluate the safety of placing TiO2 scaffolds in alveolar ridge and to evaluate if the scaffold material contributes to maintain the anatomy and the volume of the alveolar process after tooth extraction. conditions: Alveolar Bone Resorption studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Observational study / clinical trial primaryPurpose: OTHER masking: NONE count: 10 type: ACTUAL name: Scaffold placement name: CBCT measure: Adverse reactions measure: Anatomy measure: Inflammation measure: Mineralization sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Dentistry, University of Oslo city: Oslo zip: Postboks 1142 Blindern country: Norway lat: 59.91273 lon: 10.74609 hasResults: False

 nctId: NCT06269484 id: D4326C00004 briefTitle: A Phase IIb Study to Evaluate the Safety of Zibotentan/Dapagliflozin in Participants With Cirrhosis-ZEAL-UNLOCK acronym: ZEAL UNLOCK overallStatus: RECRUITING date: 2024-02-15 date: 2025-01-17 date: 2025-01-17 date: 2024-02-21 date: 2024-03-25 name: AstraZeneca class: INDUSTRY briefSummary: This is a Phase IIb multicentre, randomised, double-blind, parallel-group, placebo-controlled study to evaluate the safety of zibotentan/dapagliflozin in combination as compared to zibotentan monotherapy as well as zibotentan/dapagliflozin and zibotentan monotherapy as compared to placebo in patients with cirrhosis. conditions: Liver Cirrhosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 66 type: ESTIMATED name: Placebo (placebo matching zibotentan capsule and placebo matching dapagliflozin tablet) name: Zibotentan + placebo (placebo matching dapagliflozin tablet) name: Zibotentan + dapagliflozin measure: Occurence of any of the following components of this composite endpoint: >2kg increase in body weight (office-based), >2 L increase in total body water, increase in 2 or more loop-diuretic equivalents, fluid retention adverse event (AE) measure: Occurence of any of the following components of this composite endpoint: >2kg increase in body weight (office-based), >2 L increase in total body water, increase in 2 or more loop-diuretic equivalents, fluid retention adverse event (AE) measure: Change in body weight (kg) over time course of study measure: Change in body weight (kg) over time course of study measure: Change in total dosage of loop-diuretic equivalents use measure: Change in total dosage of loop-diuretic equivalents use measure: Occurence of either of the two components of this composite: 1. >3 L increase in total body water volume from baseline to Week 6 2. Increase in 3 or more loop-diuretics equivalents use measure: Occurence of either of the two components of this composite: 1. >3 L increase in total body water volume from baseline to Week 6 2. Increase in 3 or more loop-diuretics equivalents use measure: Absolute change in systolic and diastolic blood pressure measure: Absolute change in systolic and diastolic blood pressure measure: Change from baseline in body weight measure: Change from baseline in total body water measure: Change from baseline in extracellular water volume measure: Change from baseline in intracellular water volume measure: Change from baseline in body fat mass measure: Change from baseline in body weight measure: Change from baseline in total body water measure: Change from baseline in extracellular water volume measure: Change from baseline in intracellular water volume measure: Change from baseline in body fat mass sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site status: NOT_YET_RECRUITING city: Englewood state: Colorado zip: 80113 country: United States lat: 39.64777 lon: -104.98776 facility: Research Site status: NOT_YET_RECRUITING city: Charleston state: South Carolina zip: 29425 country: United States lat: 32.77657 lon: -79.93092 facility: Research Site status: RECRUITING city: San Antonio state: Texas zip: 78215 country: United States lat: 29.42412 lon: -98.49363 facility: Research Site status: NOT_YET_RECRUITING city: Adelaide zip: 5000 country: Australia lat: -34.92866 lon: 138.59863 facility: Research Site status: NOT_YET_RECRUITING city: Kogarah zip: 2217 country: Australia lat: -33.98333 lon: 151.11667 facility: Research Site status: NOT_YET_RECRUITING city: Mitcham zip: 3132 country: Australia lat: -37.81667 lon: 145.2 facility: Research Site status: NOT_YET_RECRUITING city: Edegem zip: 2650 country: Belgium lat: 51.15662 lon: 4.44504 facility: Research Site status: NOT_YET_RECRUITING city: Mechelen zip: 2800 country: Belgium lat: 51.02574 lon: 4.47762 facility: Research Site status: NOT_YET_RECRUITING city: Liberec zip: 460 63 country: Czechia lat: 50.76711 lon: 15.05619 facility: Research Site status: NOT_YET_RECRUITING city: Mladá Boleslav zip: 293 01 country: Czechia lat: 50.41135 lon: 14.90318 facility: Research Site status: NOT_YET_RECRUITING city: Plzeň zip: 323 00 country: Czechia lat: 49.74747 lon: 13.37759 facility: Research Site status: NOT_YET_RECRUITING city: Praha 4 zip: 140 21 country: Czechia lat: 50.08804 lon: 14.42076 facility: Research Site status: NOT_YET_RECRUITING city: Aachen zip: 52074 country: Germany lat: 50.77664 lon: 6.08342 facility: Research Site status: NOT_YET_RECRUITING city: Kiel zip: 24146 country: Germany lat: 54.32133 lon: 10.13489 facility: Research Site status: NOT_YET_RECRUITING city: Leipzig zip: 04103 country: Germany lat: 51.33962 lon: 12.37129 facility: Research Site status: NOT_YET_RECRUITING city: Tuebingen zip: 72076 country: Germany lat: 48.52266 lon: 9.05222 facility: Research Site status: NOT_YET_RECRUITING city: Milano zip: 20122 country: Italy lat: 45.46427 lon: 9.18951 facility: Research Site status: NOT_YET_RECRUITING city: Padova zip: 35128 country: Italy lat: 45.40797 lon: 11.88586 facility: Research Site status: NOT_YET_RECRUITING city: Roma zip: 00168 country: Italy lat: 41.89193 lon: 12.51133 facility: Research Site status: NOT_YET_RECRUITING city: Gifu-shi zip: 500-8513 country: Japan lat: 35.42291 lon: 136.76039 facility: Research Site status: RECRUITING city: Iizuka-shi zip: 820-8505 country: Japan lat: 33.63654 lon: 130.68678 facility: Research Site status: NOT_YET_RECRUITING city: Kawasaki-shi zip: 215-0026 country: Japan lat: 35.52056 lon: 139.71722 facility: Research Site status: NOT_YET_RECRUITING city: Kitakyusyu-shi zip: 806-8501 country: Japan facility: Research Site status: RECRUITING city: Nagaoka-shi zip: 940-2085 country: Japan lat: 37.45 lon: 138.85 facility: Research Site status: RECRUITING city: Niigata-shi zip: 951-8520 country: Japan lat: 37.88637 lon: 139.00589 facility: Research Site status: NOT_YET_RECRUITING city: Sapporo-shi zip: 006-8555 country: Japan lat: 43.06667 lon: 141.35 facility: Research Site status: NOT_YET_RECRUITING city: Yokohama-shi zip: 236-0004 country: Japan lat: 35.43333 lon: 139.65 facility: Research Site status: NOT_YET_RECRUITING city: Bydgoszcz zip: 85-794 country: Poland lat: 53.1235 lon: 18.00762 facility: Research Site status: NOT_YET_RECRUITING city: Katowice zip: 40-081 country: Poland lat: 50.25841 lon: 19.02754 facility: Research Site status: NOT_YET_RECRUITING city: Kraków zip: 31-513 country: Poland lat: 50.06143 lon: 19.93658 facility: Research Site status: NOT_YET_RECRUITING city: Mysłowice zip: 41-400 country: Poland lat: 50.20745 lon: 19.16668 facility: Research Site status: NOT_YET_RECRUITING city: Poznań zip: 61-848 country: Poland lat: 52.40692 lon: 16.92993 facility: Research Site status: NOT_YET_RECRUITING city: Wrocław zip: 52-210 country: Poland lat: 51.1 lon: 17.03333 facility: Research Site status: NOT_YET_RECRUITING city: Bratislava zip: 83104 country: Slovakia lat: 48.14816 lon: 17.10674 facility: Research Site status: NOT_YET_RECRUITING city: Nitra zip: 950 01 country: Slovakia lat: 48.30763 lon: 18.08453 facility: Research Site status: NOT_YET_RECRUITING city: Trnava zip: 91702 country: Slovakia lat: 48.37741 lon: 17.58723 facility: Research Site status: NOT_YET_RECRUITING city: Aberdeen zip: AB25 2ZN country: United Kingdom lat: 57.14369 lon: -2.09814 facility: Research Site status: NOT_YET_RECRUITING city: Hull zip: HU3 2KZ country: United Kingdom lat: 53.7446 lon: -0.33525 facility: Research Site status: NOT_YET_RECRUITING city: Ipswich zip: IP4 5PD country: United Kingdom lat: 52.05917 lon: 1.15545 facility: Research Site status: NOT_YET_RECRUITING city: London zip: SE5 9RS country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Research Site status: NOT_YET_RECRUITING city: Nottingham zip: NG7 2UH country: United Kingdom lat: 52.9536 lon: -1.15047 hasResults: False

 nctId: NCT06269471 id: 2023-A02039-36 briefTitle: On the ICC's Path: a Prevalence Study acronym: SSICC overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-05-30 date: 2024-07-30 date: 2024-02-21 date: 2024-02-21 name: University Hospital, Grenoble class: OTHER briefSummary: The number of trailers is growing all the time, and TRu seems to be a risky activity for the ankle joint. Ankle sprains can lead to significant health consequences, as in the case of chronic ankle instability.

However, there are no studies informing of the prevalence of chronic ankle instability in trail running. The aim of this study is therefore to take stock of chronic ankle instability in trail running in France. conditions: Chronic Ankle Instability studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 385 type: ESTIMATED measure: Prevalence of chronic ankle instability in trailers measure: Socio-demographic data (1/4) measure: Socio-demographic data (2/4) measure: Socio-demographic data (3/4) measure: Socio-demographic data (4/4) measure: Trail running and prevalence reports (1/11) measure: Trail running and prevalence reports (2/11) measure: Trail running and prevalence reports (3/11) measure: Trail running and prevalence reports (4/11) measure: Trail running and prevalence reports (5/11) measure: Trail running and prevalence reports (6/11) measure: Trail running and prevalence reports (7/11) measure: Trail running and prevalence reports (8/11) measure: Trail running and prevalence reports (9/11) measure: Trail running and prevalence reports (10/11) measure: Trail running and prevalence reports (11/11) measure: Associated pathologies (1/2) measure: Associated pathologies (2/2) measure: Medical care (1/3) measure: Medical care (2/3) measure: Medical care (3/3) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Grenoble Alpes city: Grenoble zip: 38000 country: France name: Leo Druart role: CONTACT email: leo.druart@univ-grenoble-alpes.fr name: Audrey Milon role: PRINCIPAL_INVESTIGATOR name: Massamba M'Baye role: SUB_INVESTIGATOR name: Thomas Lathière role: SUB_INVESTIGATOR name: Maïa Dolopogoloff role: SUB_INVESTIGATOR name: Guillaume Néron role: SUB_INVESTIGATOR lat: 45.16667 lon: 5.71667 hasResults: False

 nctId: NCT06269458 id: ABU-001 briefTitle: The Effects of Mother-Baby Yoga and Baby Massage on Attachment and Sleep overallStatus: COMPLETED date: 2023-01-01 date: 2023-11-25 date: 2023-12-26 date: 2024-02-21 date: 2024-02-21 name: Antalya Bilim University class: OTHER briefSummary: Purpose: This study was conducted to examine the effects of mother-baby yoga and massage on mother-baby bonding and the baby's sleep.

Method: A randomised, crossover pilot study was conducted in the postpartum service of a hospital between January and November 2023, with 60 mothers and their babies in the postpartum period, 30 in each group. To the mothers and their babies included in the research, baby massage was applied to one group and mother-baby yoga was applied to the other. After four weeks, the groups' practices were changed. In the results of the research, characteristics related to attachment and sleep were evaluated. conditions: Newborn conditions: Yoga conditions: Mother-Infant Interaction conditions: Sleep studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: Baby Massage name: Monther-Baby Yoga measure: Attachment measure: Weight and Sleep sex: ALL minimumAge: 0 Days maximumAge: 5 Days stdAges: CHILD facility: Antalya Bilim Üniversitesi city: Antalya country: Turkey lat: 36.90812 lon: 30.69556 hasResults: False

 nctId: NCT06269445 id: 2023-942-01 briefTitle: The Efficacy and Safety of Lcaritin Combined With Bevacizumab and FOLFIRI in Treatment of Liver Metastases From Colorectal Cancer overallStatus: RECRUITING date: 2024-01-01 date: 2025-02-01 date: 2026-02-01 date: 2024-02-21 date: 2024-02-21 name: Sir Run Run Shaw Hospital class: OTHER briefSummary: To evaluate the efficacy and safety of the combination regimen of Icaritin with bevacizumab + FOLFIRI in patients with liver metastases from advanced colorectal cancer. conditions: Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Icaritin Combined With Bevacizumab and FOLFIRI measure: Progression-free survival(PFS) measure: Objective remission rate (ORR) measure: Overall survival (OS) measure: Disease Control Rate (DCR) measure: Duration of ongoing remission (DOR) measure: TRAEs measure: Quality of life of the patients sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine status: RECRUITING city: Hangzhou state: Zhejiang zip: 310000 country: China name: Fei Wang role: CONTACT phone: 13732236150 email: 21418531@zju.edu.cn lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06269432 id: 2023YFS0042 briefTitle: Precise Antiplatelet THerapy Guided by Platelet Aggregation Function in Acute Ischemic STROKE（PATH-STROKE） acronym: PATH-STROKE overallStatus: RECRUITING date: 2023-01-01 date: 2025-12-31 date: 2025-12-31 date: 2024-02-21 date: 2024-02-21 name: Sichuan Provincial People's Hospital class: OTHER briefSummary: Objectives of Study:To explore the efficacy and safety of antiplatelet therapy in patients with non-cardiogenic cerebral infarction under the guidance of platelet aggregation function. conditions: Ischemic Stroke conditions: Antiplatelet Drug studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 3524 type: ESTIMATED name: Precision Antiplatelet Therapy Trial Group name: Traditional Antiplatelet Therapy Control Group measure: 3-month major ischemic events and major bleeding events measure: disability measure: Cardiovascular or cerebrovascular mortality sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sichuan Provincial People's Hospital status: RECRUITING city: Chengdu state: Sichuan zip: 610072 country: China name: Jie Yang, doctor role: CONTACT phone: +86 13678130516 email: yangjie1126@163.com lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06269419 id: 2023-KY295 briefTitle: Study of Natural Course Progression of Diabetic Retinopathy overallStatus: RECRUITING date: 2024-02-25 date: 2029-01-01 date: 2029-01-01 date: 2024-02-21 date: 2024-03-12 name: Jie Li class: OTHER briefSummary: The goal of this observational study is to observe the formation and development of the non-perfusion area of diabetic retinopathy in the posterior area of the retina in type 2 diabetes patients aged 18-75 years old, who can cooperate with all examinations and sign informed consent, clinical myopathy examination and Optos 7 field of vision with mild than severe NPDR, and no other exclusion indicators.The main questions it aims to answer are whether posterior retinal non-perfusion area occurs earlier than peripheral non-perfusion area and whether the rate of non-perfusion area expansion is a risk factor for the progression of diabetic retinopathy.

Participants will have protocol-specific follow-up examinations at 1, 2, 3, 4, and 5 years (± 3 months). Additional visits are made as required by the study and the patient's condition.

The contents of follow-up examinations are:

History of other diseases, medications being used, eye diseases, surgeries, treatments, height, weight, and blood pressure.

Best corrected vision, logarithmic visual acuity chart. Tupai OCTA, 24×20mm range, 6×6mm range scan. Optos fundus imaging, color and no red light images. Fundus fluorescence angiography (only preliminary examination for the first time found mild to moderate NPDR patients, who have been angiographed in the past, only at the 5th year, or as required by the condition).

Glycosylated hemoglobin. Creatinine, urea, glomerular filtration rate. Total cholesterol, triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol.

Urinary microalbumin/urinary creatinine ACR. Microvisual field. conditions: Biomarkers of Diabetic Retinopathy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Observation and follow-up of biomarkers of diabetic retinopathy measure: Level of Glycosylated hemoglobin measure: Creatinine measure: Total cholesterol measure: Urinary microalbumin measure: Urea measure: Glomerular filtration rate measure: Triglycerides measure: Low-density lipoprotein cholesterol measure: High-density lipoprotein cholesterol measure: Urinary creatinine ACR sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sichuan Academy of Medical Science Sichuan Provincial Hosptial status: RECRUITING city: Chendu state: Sichuan zip: 610014 country: China name: Jie Li, doctor role: CONTACT phone: +86 13908094675 email: lijieyk@med.uestc.edu.cn hasResults: False

 nctId: NCT06269406 id: SW008 briefTitle: A Combination of Ibuprofen With Curcumin Covered With Liquorice Root Supplementation in the Management of Postoperative Dental Pain in Adults acronym: ICLID overallStatus: NOT_YET_RECRUITING date: 2024-03-10 date: 2024-07-10 date: 2024-09-10 date: 2024-02-21 date: 2024-02-21 name: S.LAB (SOLOWAYS) class: OTHER name: NMSI DENTMASTER briefSummary: Dental pain, a common issue in stomatology, requires a multifaceted treatment approach. This study explores the efficacy of combining Ibuprofen with curcumin and liquorice root supplements for managing postoperative dental pain. Curcumin, known for its antioxidant and anti-inflammatory properties, along with liquorice root, may enhance pain relief beyond conventional NSAIDs like Ibuprofen. This randomized, double-blind, placebo-controlled trial aims to evaluate the safety and effectiveness of this combination therapy in adults undergoing the removal of impacted third molars. Participants, aged 18-85, were divided into groups receiving different doses of Ibuprofen and curcumin with liquorice root, compared to a control group receiving Ibuprofen and placebo. The primary outcome is the sum of pain intensity differences over 8 hours, with secondary outcomes including total pain relief and the occurrence of any adverse events. The anticipated sample size, considering a 20% dropout rate, is 264 participants, ensuring the study is powered to detect significant differences in pain management efficacy. conditions: Dental Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 264 type: ESTIMATED name: ibuprofen 400 mg in combination with Curcumin covered with liquorice root 100 mg name: ibuprofen 200 mg in combination with Curcumin covered with liquorice root 100 mg name: The combination of ibuprofen 400 mg and placebo in patients after 2-4 molars procedure measure: Sum of pain intensity differences (SPID), SPID on the visual analog score VAS (points) measure: Total pain relief (TOTPAR) % measure: Time to pain half pain gone (in minutes) measure: Duration of pain half gone (in minutes) measure: Any adverse events (facial swelling, nausea, vomiting, headache) (%) sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nmsi Dentmaster city: Novosibirsk state: Novosibirsk Region zip: 630090 country: Russian Federation name: Gatilova A Tatyana, MD role: CONTACT phone: 9529399919 phoneExt: +7 lat: 55.0415 lon: 82.9346 hasResults: False

 nctId: NCT06269393 id: CIBI311Y101 briefTitle: A Study of IBI311 in Subjects With Steroid-resistant, Thyroid Associated Ophthalmopathy overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-01 date: 2025-06-01 date: 2026-02-01 date: 2024-02-21 date: 2024-02-21 name: Peking University People's Hospital class: OTHER briefSummary: This is an exploratory study of the efficacy and safety of IBI311, a modified anti-IGF-1R antibody, in patients with steroid-resistant, thyroid associated ophthalmopathy (TAO). This study includes two stages. Stage I is a single-center, single-arm, open-label clinical study designed to evaluate the safety and tolerability of IBI311 in subjects with TAO. Approximately 10 subjects meeting the study eligibility criteria will be enrolled. Stage II is a single-center, randomized, double-masked, placebo-controlled clinical trial designed to evaluate the efficacy and safety of IBI311 in subjects with steroid-resistant TAO. Approximately 54 subjects meeting the study eligibility criteria will be randomly assigned to IBI311 or placebo on day 1 (D1) in a 2:1 ratio stratified by disease activity. conditions: Thyroid Associated Ophthalmopathy studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 54 type: ESTIMATED name: Placebo name: IBI311 measure: The proptosis responder rate (defined as percentage of subjects with a ≥ 2mm reduction from baseline in proptosis in the study eye, without deterioration [≥ 2 mm increase] of proptosis in the non-study eye) of the study eye. measure: Overall responder rate in proptosis of the study eye. measure: Percentage of subjects with a CAS value of 0 or 1 measure: Diplopia responder rate (defined as percentage of subjects with a ≥ 1-grade improvement in diplopia) measure: Safety and tolerability of intravenous IBI311 in subjects with TAO sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University People's Hospital city: Beijing state: Beijing zip: 100034 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06269380 id: 30.01.2024-4274 briefTitle: Evaluation of Antral Biopsies Obtained in Normal Esophagogastroduodenoscopy overallStatus: COMPLETED date: 2024-02-13 date: 2024-02-20 date: 2024-02-21 date: 2024-02-21 date: 2024-02-23 name: Sisli Hamidiye Etfal Training and Research Hospital class: OTHER briefSummary: Esophagogastroduodenoscopy (EGD) is commonly performed in patients presenting with abdominal pain and dyspeptic symptoms, serving as a valuable diagnostic and therapeutic tool. While various methods are available for biopsy sampling when mucosal pathology is observed during EGD, the practice of obtaining biopsies from endoscopically normal mucosa remains controversial. Although there is literature suggesting that routine biopsies from the antrum and duodenum for surveillance purposes increase costs, pathological findings can sometimes be detected in areas that appear normal on mucosal examination, leading to potential changes in treatment approach if biopsies are obtained.

In this study, a retrospective evaluation of the prevalence of various pathologies detected in biopsies obtained from endoscopically normal mucosa in patients who underwent EGD was reported as normal. conditions: Gastritis H Pylori conditions: Gastritis Chronic conditions: Intestinal Metaplasia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The biopsies obtained from patients who underwent esophagogastroduodenoscopy and were found to have normal endoscopic findings will be evaluated. The histopathological findings and their frequencies in these biopsies will be examined to assess the necessity of routine biopsy during esophagogastroduodenoscopy. primaryPurpose: DIAGNOSTIC masking: NONE count: 671 type: ACTUAL name: Esophagogastroduodenoscopy name: Endoscopic biopsy sampling measure: Rate of abnormal histopathologic findings measure: Rate of intestinal metaplasia measure: Rates of gastritis severity and activity measure: Rate of Helicobacter Pylori positivity sex: ALL minimumAge: 18 Years maximumAge: 95 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sisli Hamidiye Etfal Research and Training Hospital city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06269367 id: HUM00226149 id: 1R41HD111289-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R41HD111289-01 briefTitle: NewGait: A Low-Cost Rehabilitation System to Improve Post-Stroke Gait (Biomechanical Adaptations) overallStatus: RECRUITING date: 2024-04-01 date: 2024-12 date: 2024-12 date: 2024-02-21 date: 2024-04-03 name: University of Michigan class: OTHER name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) briefSummary: An affordable and easy to use gait-assistive device for stroke survivors to use at home is yet to be developed. This study is intended to modify the current design of the NewGait device to specifically work for stroke survivors based on feedback from patients and clinicians. Consequently, conducting a short-term biomechanical gait study is planned to determine the usability and functionality of the NewGait device compared to other comparative devices. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Participants will be randomly assigned to the two device interventions but will receive both interventions. primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: NewGait name: Control wearable limb orthotic device measure: Gait speed measure: Ankle Muscle Activation measure: Changes in paretic leg propulsive force measure: Changes in paretic leg loading (i.e., vertical ground reaction force) measure: Changes in other lower extremity muscle activation measure: Muscle Coordination sex: ALL minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Physical Medicine & Rehabilitation 325 E Eisenhower Pkwy Suite 3011 status: RECRUITING city: Ann Arbor state: Michigan zip: 48108 country: United States name: Chanramouli Krishnan, PT, PhD role: CONTACT phone: 734-936-4031 email: mouli@umich.edu lat: 42.27756 lon: -83.74088 hasResults: False

 nctId: NCT06269354 id: 20231121-71479 briefTitle: Multi-center Study on Comprehensive Diagnosis and Treatment of Lower Limb Bone Defect Based on Three-dimensional Printing Technology overallStatus: RECRUITING date: 2023-11-01 date: 2026-06-01 date: 2026-12-31 date: 2024-02-21 date: 2024-02-21 name: Peking University Third Hospital class: OTHER briefSummary: The clinical diagnosis and treatment of lower limb bone defect is a difficult problem in orthopedics. The traditional treatment has the shortcomings of long treatment period, no weight bearing in the early stage of the limb, weak mechanical strength, many complications, and difficulty in repairing deformed and large segment bone defects around the joint. The Orthopedics Department of Peking University Third Hospital, the lead unit of this study, developed the TCBridge system based on three-dimensional (3D) printing technology in the early stage, which is the first approved 3D printing lower limb long bone defect repair system in China. The system can achieve personalized and accurate repair of lower limb bone defects, and ensure patients to carry out limb weight and functional exercise safely in the early stage after surgery. On this basis, this study will establish a multi-center clinical case cohort to achieve accurate comprehensive diagnosis and treatment of lower limb bone defects, benefiting patients and contributing to society. conditions: Bone Defects studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: 3D printed prostheses measure: Evaluation of implant stability, new bone growth- limb length measure: Evaluation of bone healing measure: Pain assessment measure: Evaluation of life quality and health status. measure: Evaluation of knee function measure: Evaluation of hip function measure: Evaluation of ankle function sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University Third Hospital status: RECRUITING city: Beijing state: Haidian country: China name: Bingchuan Liu role: CONTACT phone: +86 18310188678 email: liubc@bjmu.edu.cn lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06269341 id: SCCH-TS2208 briefTitle: Outcomes of Smoker and Drinker With Esophageal Squamous Cell Carcinoma After Esophagectomy acronym: OSinEC overallStatus: RECRUITING date: 2010-02-01 date: 2024-07-30 date: 2024-08-30 date: 2024-02-21 date: 2024-02-21 name: Sichuan Cancer Hospital and Research Institute class: OTHER briefSummary: Our study demonstrates that patients who did not consume alcohol or smoke had a significant advantage in overall survival (OS) after undergoing esophagectomy. Furthermore, our findings indicate that there was no statistically significant difference in OS between patients with a history of both smoking and drinking, and those who only smoked or drank conditions: Outcomes of Smoker and Drinker After Esophagectomy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 2957 type: ESTIMATED name: No intervention measure: Overall Survival sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sichuan Cancer Hospital and Research Institute status: RECRUITING city: Chengdu state: Sichuan zip: 610041 country: China name: Lin Peng, M.D. role: CONTACT phone: +8618908190013 email: penglinms@126.com name: Wenwu He, M.D. role: CONTACT phone: +8613350055340 email: wenwu_he@126.com lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06269328 id: 2011-KAEK-26/463 briefTitle: Measuring Sleep Quality In Patients That Posterior Spinal Instrumentatıon Plannıng overallStatus: COMPLETED date: 2022-07-01 date: 2023-09-01 date: 2024-01-01 date: 2024-02-21 date: 2024-02-28 name: Uludag University class: OTHER briefSummary: Postoperative sleep disorders have serious problems with cognition, pain perception, sustained circadian rhythm, psychomotor function, metabolic function, catabolic responses, and continuity. The relationship between general anesthesia and sleep disturbances following surgery is still unclear. Since the risk of sleep disorders after surgery is high, it is important to determine the efficiency of the interval with automatic sleep disorders. By evaluating how major orthopedic surgery and general anesthesia applied to posterior spinal instrumentation divides sleep quality, risk management allows determining the factors involved in the peroperative period and thus facilitating surgical results and patient comfort. conditions: Sleep Disorder conditions: Sleep, Inadequate conditions: Total ıntravenous Anesthesia conditions: Inhalation Anesthesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 39 type: ACTUAL name: Total ıntravenous anesthesia with propofol and remifentanil for anesthetic maintenance name: Inhalation anesthesia with sevoflurane for anesthetic maintenance measure: Subjective sleep quality (evaluated by PIRS-20 (Pitssburg Insomnia Rating Scale) measure: Subjective anxiety level measure: Subjective pain level sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Elifgül Ulutaş city: Bursa state: Nilüfer zip: 16240 country: Turkey lat: 40.19559 lon: 29.06013 hasResults: False

 nctId: NCT06269315 id: SBDDCP briefTitle: Assessment of Skin Barrier Disruption Due to Daily Use of Cleaning Products and Hand Disinfectants acronym: SBDDCP overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2025-04-01 date: 2024-02-21 date: 2024-02-21 name: Swiss Institute of Allergy and Asthma Research class: OTHER name: University Hospital, Zürich briefSummary: The goal of this clinical trial is to assess the effects of household detergents and hand disinfectants on human skin barrier integrity among healthy adult volunteers.

The main questions it aims to answer are:

* How does exposure to household detergents and hand disinfectants impact skin barrier function?
* Are there differences in skin barrier disruption between various types of cleaning agents and disinfectants?

Participants will:

Undergo patch testing with controlled amounts of household detergents and hand disinfectants on a small area of their skin.

Be monitored for adverse reactions during and after exposure. Have their skin barrier integrity assessed using electrical impedance spectroscopy at multiple time points post-exposure.

If there is a comparison group:

Researchers will compare the effects of different types of cleaning agents, hand disinfectants, and their ingredients on skin barrier integrity to determine variations in their impact. conditions: Control Condition (PBS) conditions: Household Detergent Exposure conditions: Hand Disinfectant Exposure conditions: Surfactant Exposure conditions: Other Ingredients Exposure studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: 1. Skin Cleansing and Testing Patch Preparation:

   Prepare a test set of patch testing tapes, each containing a small amount of a different household cleaner, hand disinfectant, their ingredients, and control with proper dilution. The safety dose of the tested products and agents will be defined beforehand.

   Before exposure, selected areas of forearm skin will be cleaned and moistened. Electrical impedance will be measured by electrical impedance spectroscopy (EIS) to assess skin barrier integrity.
2. Patch Application:

Apply the prepared patches on the skin of the forearm. Patches will be removed after 5 minutes of exposure.

During the exposure period, subjects will be instructed not to touch, wash, or wet the exposed area to avoid interfering with the action of the testing reagents. 3. Patch Removal and Post-Exposure Monitoring:

The patch will be gently removed from the skin. Exposed areas of skin will be evaluated by EIS at specific times up to 24 hours after the treatment. primaryPurpose: BASIC_SCIENCE masking: NONE count: 50 type: ESTIMATED name: Cleaning product exposure measure: Skin barrier evaluation sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Swiss Institute of Allergy and Asthma Research city: Davos state: Graubuenden zip: 7265 country: Switzerland name: Yasutaka Mitamura, MD PhD role: CONTACT phone: +41 (0) 81 410 08 48 email: yasutaka.mitamura@siaf.uzh.ch name: Cezmi A Akdis, MD professor role: CONTACT phone: +41 (0) 81 410 08 48 email: cezmi.akdis@siaf.uzh.ch name: Manru Li role: SUB_INVESTIGATOR name: Marie-Charlotte Brueggen, MD PhD professor role: SUB_INVESTIGATOR lat: 46.80429 lon: 9.83723 hasResults: False

 nctId: NCT06269302 id: 2 briefTitle: Comparison of the Effect of Warfarin and Direct Oral Anticoagulants overallStatus: COMPLETED date: 2022-01-01 date: 2022-12-31 date: 2022-12-31 date: 2024-02-21 date: 2024-02-21 name: Samsun Education and Research Hospital class: OTHER briefSummary: In this study, it was aimed to compare the frequency of new oral anticoagulants and warfarin usage, and to reveal the rates of recurrent upper gastrointestinal bleeding among patients who applied to our hospital with upper gastrointestinal bleeding conditions: Anticoagulants and Bleeding Disorders conditions: Gastrointestinal Hemorrhage studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 346 type: ACTUAL measure: Change in the incidence of recurrent bleeding sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Samsun Education and Research Hospital city: Samsun state: İlkadım country: Turkey lat: 41.27976 lon: 36.3361 hasResults: False

 nctId: NCT06269289 id: SBU-KOMSERN-001 briefTitle: Effects of Web-Based Education on Patient Empowerment and Asthma Control in Asthma Patients overallStatus: NOT_YET_RECRUITING date: 2024-05-30 date: 2024-06-30 date: 2024-09-30 date: 2024-02-21 date: 2024-02-21 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: Asthma is defined as a chronic inflammatory disorder of the airways associated with an extreme increase in airway hyperresponsiveness leading to recurrent wheezing, shortness of breath, chest tightness, and coughing attacks. The World Health Organization states that approximately 339 million individuals worldwide have asthma and more than 400 thousand deaths occur due to asthma every year.

With effective and sustainable asthma management, it is possible to reduce disease-related complaints, admissions to emergency units and hospitalizations, limit the physiological and psychological effects of the disease, prevent dependence on healthcare professionals and caregivers, increase the quality of life and reduce the mortality of the disease. Patient education, which is within the educational role of professional nurses, is very important in asthma management. The research was planned in a single-center, randomized control group pretest-posttest design. The sample will consist of individuals who applied to the Allergy and Immunology clinic of Sureyyapasa Chest Diseases and Surgery Training and Research Hospital between May 2024 and January 2024, who have been diagnosed with asthma for at least one year and who accept the study \[25 intervention group - 25 control group\]. Groups will be determined using the random numbers table from the simple random sampling method. A web-based asthma education module will be created in line with the literature, and participants in the intervention group will be given synchronous training in 5 modules. After meeting the individuals in the intervention and control groups and obtaining verbal and written consent, they will be asked to fill out the Patient Information Form, Patient Empowerment Scale and Asthma Control Test prepared via Google Forms. A 30-minute training session will be given to the intervention group every week and there will be short evaluations after each training. When the 5th Module is completed, the intervention group will be asked to fill out the Patient Empowerment Scale and Asthma Control Test Scale. No intervention will be applied to the control group. 5. At the end of the module, the Patient Empowerment Scale and Asthma Control Test will be completed by individuals in the control group. It is thought that web-based asthma education that individuals will receive will positively affect their empowerment levels and increase their disease control. conditions: Asthma conditions: Patient Empowerment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The research was designed as a randomized controlled experimental study with a pretest-posttest design. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 50 type: ESTIMATED name: web based education name: Standard education brochure measure: patient empowerment scale (PES) measure: Asthma Control Test (ACT) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital city: Istanbul zip: 34854 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06269276 id: CAVCU briefTitle: Caregiver Contribution to Self-Care in Ostomy Patient Index: Turkish Validity and Reliability Study overallStatus: COMPLETED date: 2020-09-20 date: 2021-01-15 date: 2021-01-15 date: 2024-02-21 date: 2024-02-21 name: Namik Kemal University class: OTHER briefSummary: This study was conducted to evaluate the Turkish validity and reliability of the Caregiver Contribution to Self-Care in Ostomy Patient Index, to evaluate the relatives of patients with stoma who contribute to their self-care in Turkish society, and to contribute to the nursing literature of the measurement tool.

This methodological type of research was carried out between September 2020 and January 2021 in a state and a university hospital in Tekirdağ. The research sample consisted of 223 individuals who contributed to the self-care of individuals with colostomy, ileostomy and urostomy who applied for outpatient control. In the analysis of the data, descriptive statistics, language and content validity, confirmatory factor analysis, item analysis, internal consistency and test-retest methods were used.

At the end of the study, it was determined that the scale was suitable for Turkish society and was valid and reliable in Turkish. conditions: Stoma Colostomy conditions: Stoma Ileostomy conditions: Caregiver conditions: Self Care studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 223 type: ACTUAL name: Caregiver Contribution to Self-Care in Ostomy Patient Index measure: Caregiver Contribution to Self-Care in Ostomy Patient Index sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tekirdag Namık Kemal University city: Tekirdag state: Suleymanpasa zip: 59000 country: Turkey lat: 40.9781 lon: 27.51101 hasResults: False

 nctId: NCT06269263 id: 339/23-ek briefTitle: Pilot Study to Determine Feasibility of Home-based Cardiac Rehabilitation in Patients With Chronic Heart Failure (Pilot-CRHF) acronym: Pilot-CRHF overallStatus: NOT_YET_RECRUITING date: 2024-02-19 date: 2025-02 date: 2025-02 date: 2024-02-21 date: 2024-02-21 name: University of Leipzig class: OTHER briefSummary: The proposed study will determine the willingness of patients for participation. Furthermore, the assessment of tests to identify eligible patients and the type of exercise intervention that goes along with a high patient compliance is crucial. Also, more information about possible factors preventing patients from participating is required. Therefore, if the patient is willing to participate, we will assess patients' medical history, medication and QoL as well as parameters of routine diagnostics (i.e. echocardiography, laboratory testing, MRI). Following, while the in-patient stay due to cardiac decompensation, we will conduct several assessment-tests to determine the physical status, the exercise capacity and the cognitive function. Moreover, physiotherapists will instruct the patients in the exercise program. After discharge from the hospital, physiotherapist will visit the patient at home to instruct them again in the exercises. Then, the patients will conduct the program on their own for a period of 12 weeks. During the exercise period, a doctoral student will visit the patients at home every 3 weeks to check whether they are doing the exercises correctly and to determine whether there are any problems with the program. After the exercise period of 12 weeks, the baseline characteristics will be assessed again at the University Hospital Leipzig. conditions: Heart Failure studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Pilot study of home-based cardiac rehabilitation primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 30 type: ESTIMATED name: Home-based cardiac rehabilitation measure: Percentage of patients completing the program measure: Quality of life measure: Exercise capacity sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Universitätsklinikum Leipzig city: Leipzig state: Saxony zip: 04103 country: Germany lat: 51.33962 lon: 12.37129 hasResults: False

 nctId: NCT06269250 id: ANDI-MFA2023_10 briefTitle: Acceptance and Perceived Benefits of Digitalization by Medical Assistants acronym: ANDI-MFA overallStatus: RECRUITING date: 2023-11-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-21 date: 2024-02-21 name: Jacobs University Bremen gGmbH class: OTHER name: Mirjam Jansen; medmedia Academy briefSummary: The aim of this project is to improve the integration of digital processes, including e-prescriptions, within medical and dental practices for healthcare professionals. Through a better understanding of the obstacles healthcare workers encounter during the adoption of digital processes and their feedback post-implementation, this study will add to the current state of science, contributing to digital process optimization in healthcare. conditions: Health Care Providers conditions: Patient Safety conditions: eHealth studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Policy Change measure: Adoption and acceptance of information technology (IT) measure: Requests by patients regarding IT measure: Perceived Benefits of IT measure: Knowledge and Digital health literacy measure: Preferred learning format sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Germany status: RECRUITING city: Bremen zip: 28759 country: Germany name: Sonia Lippke, Prof. Dr. role: CONTACT phone: +49 421 200 4730 email: slippke@constructor.university name: Keller Franziska, PhD role: CONTACT phone: +49 421 200 4730 email: fkeller@constructor.university lat: 53.07516 lon: 8.80777 hasResults: False

 nctId: NCT06269237 id: 2023LTA briefTitle: Point of Care Test of LTA Level in Tear Fluid, Measured With a POCT Test, in DE Patients Following IPL Treatment overallStatus: NOT_YET_RECRUITING date: 2024-02-22 date: 2024-06-01 date: 2024-07-01 date: 2024-02-21 date: 2024-02-21 name: He Eye Hospital class: OTHER briefSummary: To quantify and compare tear levels of Intense pulsed light (IPL) and traditional dry eye clinical tests in dry eye patients before and after Intense pulsed light (IPL) treatment. conditions: Dry Eye studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: M22 name: sham M22 measure: LTA measure: Non-invasive tear break-up time (NITBUT) measure: Fluorescein and lissamine conjunctival and cornea staining (CFS) measure: Meibomian quality measure: Tear Film Lipid Layer Score(TFLL) measure: Tear meniscus height (TMH) measure: Conjunctival hyperemia (RS score) measure: Ocular Surface Disease Index (OSDI) sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06269224 id: HU-FTR-KS-01 briefTitle: Examining Factors Influencing Thoracolumbar Mobility in Runners overallStatus: COMPLETED date: 2022-09-01 date: 2023-01-01 date: 2024-01-01 date: 2024-02-21 date: 2024-02-22 name: Hacettepe University class: OTHER briefSummary: The presence of to is thoracolumbar (TL) mobility a significant aspect in the context of running. Most of the factors may be related to certain kinematic parameters of the lumbopelvic-hip complex during running. conditions: Runners conditions: Mobility conditions: Fascia conditions: Range of Motion studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 90 type: ACTUAL name: Participants were recreational runners who run between 20 to 50 km weekly; each one has 35 runners. measure: Myoton Assessment sex: ALL minimumAge: 30 Years maximumAge: 45 Years stdAges: ADULT facility: Hacettepe University city: Ankara state: Altındağ zip: 06100 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06269211 id: RTS-019 briefTitle: Neoadjuvant Toripalimab for Clinically Stage II-IIIB Resectable Non-small Cell Lung Cancer With EGFR Mutation and PD-L1 Positive Expression acronym: TOPLINE overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2027-01-31 date: 2030-01-31 date: 2024-02-21 date: 2024-02-21 name: Ruijin Hospital class: OTHER name: Guangdong Provincial People's Hospital briefSummary: The study is a prospective, open label, multicenter, single arm Phase II clinical trial, aiming to explore the use of neoadjuvant Toripalimab for clinically stage II-IIIB NSCLC patients with EGFR mutations and PD-L1 positive expression, providing a novel perspective for further improving the prognosis of NSCLC patients. This study will provide valuable information for further clinical trials of neoadjuvant Toripalimab and other immune checkpoint inhibitors in NSCLC patients with EGFR mutations and PD-L1 positive expression. conditions: Carcinoma, Non-Small-Cell Lung studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This study has only one arm, neoadjuvant Toripalimab treatment arm. Primary endpoint is MPR. We apply the optimal design of Simon's two-stage model to calculate the sample size and set both sides α= 0.05 and power=0.8, resulting in a total sample size of 29. Among them, 10 patients will be enrolled in the first stage. If the number of MPR cases in the first stage is less than or equal to 1, the study will be terminated in the early stage; On the contrary, participants in the second stage will continue to be enrolled. If the total number of MPR cases is greater than or equal to 5 after the completion of the second stage, the study is considered positive. primaryPurpose: TREATMENT masking: NONE count: 29 type: ESTIMATED name: Toripalimab measure: Major Pathological Response (MPR) measure: Pathological Complete Response (pCR) measure: Objective Response Rate (ORR) measure: 2-year Event Free Survival (EFS) measure: 2-year Overall Survival (OS) measure: Safety (Number of Participants With Grade 3 and Higher-grade Treatment-related Adverse Events) measure: Feasibility (Number of Participants Who Finished Neoadjuvant therapy and Receive Surgery Within 3-6 Weeks After Neoadjuvant Therapies) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guangdong Provincial People's Hospital city: Guangzhou state: Guangdong zip: 510180 country: China lat: 23.11667 lon: 113.25 facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine city: Shanghai state: Shanghai zip: 200025 country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06269198 id: WARD - SX - RCT II briefTitle: Postoperative Complications in Cancer Patients Monitored With Intelligent Continuous Monitoring System acronym: WARD-SX-RCT-II overallStatus: RECRUITING date: 2023-10-31 date: 2025-04-01 date: 2027-04-01 date: 2024-02-21 date: 2024-03-25 name: Rigshospitalet, Denmark class: OTHER name: Bispebjerg Hospital name: Hvidovre University Hospital briefSummary: The primary objective of this study is to determine the effect on complication severity of using a clinical monitoring system with automatic vital sign alerts in addition to routine monitoring versus routine monitoring alone in high-risk postoperative cancer patients within 30 days after surgery.

Other objectives include documentation of the severity of complications within seven days of surgery, frequency of serious adverse events, mortality, length of stay and delay of planned chemotherapy. conditions: Postoperative Complications conditions: Cancer, Treatment-Related studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomisation stratified by study site primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Participants will not be given information on group allocation. Care-providers will not be blinded, due to having to carry out the intervention.

Investigator will not be blinded to carrie out roles such as safety surveillance, error-solving and quality assurance.

Outcome assessor will be blinded to study allocation. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 504 type: ESTIMATED name: WARD-CSS measure: Overall complication severity - 30 days measure: Overall complication severity - 7 days measure: Frequency of Serious adverse events measure: Days alive and out of hospital measure: Days alive and out of hospital measure: Time to initiation of post-operative adjuvant chemotherapy measure: Completion of post-operative adjuvant chemotherapy measure: Frequency of severe clinical complications measure: ICU admission measure: Surgical reintervention of any kind measure: Post-discharge readmission measure: Health-economic cost-effectiveness. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Copenhagen University hospital - Rigshospitalet status: RECRUITING city: Copenhagen state: Other (Non US) zip: 1665 country: Denmark name: Jesper Mølgaard, PhD role: CONTACT phone: +4535453545 email: jesper.moelgaard@regionh.dk name: Eske K Aasvang, DMSc role: CONTACT phone: +4535450802 email: eske.kvanner.aasvang.01@regionh.dk lat: 55.67594 lon: 12.56553 facility: Bispebjerg Hospital status: RECRUITING city: Copenhagen state: Other (Non US) zip: 2400 country: Denmark name: Christian S Meyhoff, PhD role: CONTACT phone: +4524910542 email: christian.sylvest.meyhoff@regionh.dk name: Christian S Meyhoff, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.67594 lon: 12.56553 facility: Hvidovre Hospital status: NOT_YET_RECRUITING city: Hvidovre state: Other (Non US) zip: 2650 country: Denmark name: Katja B L Glud, RN role: CONTACT phone: +4538625713 email: katja.balle.levring.glud@regionh.dk name: Søren Kjær, MD role: PRINCIPAL_INVESTIGATOR lat: 55.65719 lon: 12.47364 hasResults: False

 nctId: NCT06269185 id: 2024_IFXvsADAinUC briefTitle: Comparison Between Infliximab and Adalimumab on Patients With Ulcerative Colitis overallStatus: RECRUITING date: 2024-03-06 date: 2025-03-01 date: 2025-03-01 date: 2024-02-21 date: 2024-03-15 name: Vastra Gotaland Region class: OTHER_GOV briefSummary: Anti-TNF (tumor necrosing factor) treatment with infliximab (IFX) and adalimumab (ADA) are established first-line biological therapies used in treatment of patients with ulcerative colitis (UC). There are no head-to-head comparative studies between these two drug but meta-analysis of randomized controlled trials states that IFX might be more effective than ADA for the induction of clinical remission. However, several observational studies conclude that ADA seem to have similar effect as IFX in treating patients with UC but these studies have limitations.

The overall aim of this retrospective multicenter observational cohort study is to evaluate if there is a difference in efficacy between infliximab (IFX) and adalimumab (ADA) in treating bio-naive patients with UC in the short and long term during the modern era when therapeutic drug monitoring have been used to optimize anti-TNF treatment. conditions: Ulcerative Colitis conditions: Inflammatory Bowel Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 270 type: ESTIMATED name: Infliximab name: Adalimumab measure: Percentage of patients achieving steroid-free clinical remission measure: Percentage of patients achieving clinical response measure: Percentage of patients achieving clinical remission measure: Percentage of patients achieving biochemical remission measure: Percentage of patients achieving clinical remission measure: Percentage of patients achieving biochemical remission measure: Percentage of patients achieving endoscopic response measure: Percentage of patients achieving endoscopic remission measure: Remission rates in the subpopulations of UC-patients with severe, moderate and mild disease respectively sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Västra Götalandsregionen status: RECRUITING city: Göteborg country: Sweden name: Börje Jonefjäll role: CONTACT phone: +46703753933 email: borje.jonefjall@vgregion.se lat: 57.70716 lon: 11.96679 hasResults: False

 nctId: NCT06269172 id: 162076 id: 322453 type: OTHER domain: HRA briefTitle: Perceptions Across Ethnicities to Develop an Adapted Intervention for Breathlessness acronym: Paint overallStatus: RECRUITING date: 2024-02-12 date: 2025-11-30 date: 2025-11-30 date: 2024-02-21 date: 2024-02-21 name: University Hospitals, Leicester class: OTHER briefSummary: An individual's experience of their breathlessness is influenced by multiple factors including their medical condition, psychology, sociological and situational circumstances which will include ethnicity. There is currently a lack of evidence exploring the impact of ethnicity in the experience and presentation of breathlessness.

The non-medical management of breathlessness in respiratory diseases includes pulmonary rehabilitation (PR). PR is a highly evidenced exercise-based intervention to help manage breathlessness, improving health-related quality of life and improving survival. Recent audits in England and Wales showed 89% of patients attending PR were recorded as having a White British ethnicity which is in contrast to national ethnicity demographics. This may be because the cultural acceptability of PR components are not fully considered. Therefore, this study will explore how individuals with cardiorespiratory disease from different ethnicities from the Leicestershire population experience and manage their breathlessness through art workshops, focus groups and interviews. Informed by these results, the study team will work with individuals from under-represented ethnicities and key stakeholders to co-design adaptations of PR that may improve the management of breathlessness in underrepresented ethnicities that do not attend conventional PR programmes.

The study is funded by the Wellcome Trust as part of the Leicestershire Health Inequalities Improvement Programme at the University of Leiceste conditions: Cardiovascular Diseases studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 45 type: ESTIMATED name: intereviews measure: Art Workshops, Focus Groups and Semi-Structured Interviews measure: : Experience Based Co-design The co-development of an intervention for breathlessness for under-represented ethnicities. sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Glenfield Hospital status: RECRUITING city: Leicester state: Leicestershire zip: LE39QP country: United Kingdom name: Holly Ms Drover role: CONTACT email: hd225@leicester.ac.uk lat: 52.6386 lon: -1.13169 hasResults: False

 nctId: NCT06269159 id: ONZ-2023-0185 briefTitle: The Power of 24-hour: Co-designing Intervention Components overallStatus: RECRUITING date: 2023-09-05 date: 2025-03-31 date: 2025-03-31 date: 2024-02-21 date: 2024-02-21 name: University Hospital, Ghent class: OTHER briefSummary: Most of the existing lifestyle interventions in adults with overweight or obesity focus on one movement behavior in isolation (i.e. moderate to vigorous physical activity (MVPA)). However, recent research suggests to incorporate all movement behaviors performed in one day to explore the possible synergistic health effects of targeting more than one behavior. Moreover, more optimal 24-hour movement behavior compositions are related with better cardiometabolic health. Literature shows that adults with obesity have less optimal 24-hour compositions (8-9). Therefore it would be of interest to discover the needs related to an optimal 24-hour movement behavior intervention for a group of adults with overweight and obesity using co-design to develop an intervention.

This study will conduct a concept mapping protocol to explore the needs to of people with overweight and obesity to change their sedentary behavior into more physical activity as well to include the opinion of health care providers (HCP are physiotherapists) on the needs of their patients. conditions: Overweight and Obesity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 210 type: ESTIMATED name: Concept mapping: brainstorm name: Concept mapping: clustering and rating measure: Themes measure: Score of effectiveness measure: Score of feasibility measure: Score of modifiability sex: ALL minimumAge: 25 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ghent university Hospital status: RECRUITING city: Ghent zip: 9000 country: Belgium name: Bruno Lapauw role: CONTACT email: bruno.lapauw@uzgent.be lat: 51.05 lon: 3.71667 hasResults: False

 nctId: NCT06269146 id: 806035 id: 1R61MH129380-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R61MH129380-01 briefTitle: Pramipexole to Enhance Social Connections overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-03 date: 2025-03 date: 2024-02-21 date: 2024-02-21 name: University of California, San Diego class: OTHER name: National Institute of Mental Health (NIMH) name: New York State Psychiatric Institute briefSummary: This study seeks to understand if the medication pramipexole improves social connectedness and functioning in adults (ages 18-50) who experience anxiety or depression. The study plans to enroll 108 participants total across two sites (University of California San Diego and New York State Psychiatric Institute). Pramipexole will be given in a 6-week randomized, double-blind, placebo-controlled trial. Social reward processing will be assessed using measures of brain function (fMRI), behavior, and self-report at baseline and week 6. Knowledge gained from this study will help determine the therapeutic potential of targeting the dopamine system to remediate social disconnection as an anxiety and depression intervention. conditions: Anxiety Disorders conditions: Anxiety conditions: Depression conditions: Social Disconnection studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The pharmacy will blind drug and placebo through identical encapsulation. Placebo will match the study drug in mode of administration, color, size, and taste. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 108 type: ESTIMATED name: Pramipexole Pill name: Placebo Pill measure: Neural activation during social reward anticipation measure: Neural activation during opportunities to disclose to others measure: Motivation to engage in shared experiences with others measure: Positive affect in response to the social affiliation task measure: Social approach goals during the social affiliation task measure: Social approach behavior during the social affiliation task measure: Future approach motivation measure: Blood plasma pramipexole concentrations measure: Negative affect in response to the social affiliation task measure: Neural activation during social punishment anticipation measure: Social avoidance goals during the social affiliation task measure: Anxious behavior during the social affiliation task sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: University of California, San Diego city: San Diego state: California zip: 92093 country: United States name: Margaret K Satchwell, BS role: CONTACT phone: 858-822-4357 email: mksatchwell@health.ucsd.edu lat: 32.71533 lon: -117.15726 facility: New York State Psychiatric Institute city: New York state: New York zip: 10032 country: United States name: Liza Handler, BS role: CONTACT phone: 917-652-6355 email: liza.handler@nyspi.columbia.edu lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06269133 id: R2810-ONC-22115 briefTitle: Evaluation of Cemiplimab in Combination With Platinum-Doublet Chemotherapy in First-Line (1L) Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) in Adult United States (US) Patients overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-21 date: 2027-03-31 date: 2027-06-23 date: 2024-02-21 date: 2024-03-13 name: Regeneron Pharmaceuticals class: INDUSTRY briefSummary: This multi-year cohort study will assess the real-world safety and effectiveness of 1L treatment with cemiplimab in combination with platinum-doublet chemotherapy across advanced NSCLC patient subgroups defined by age, sex, race, and ethnicity. Patients will be retrospectively identified from at least two US electronic health record (EHR)-based databases. conditions: Advanced Non-small Cell Lung Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 1000 type: ESTIMATED name: REGN2810 name: Platinum-doublet chemotherapy measure: Real-world response rate (rwRR) measure: Any treatment-emergent immune-mediated adverse event (imAE) measure: Any treatment-emergent imAE resulting in hospitalization measure: Any treatment-emergent imAE resulting in death measure: Specific treatment-emergent imAEs measure: Real-world duration of response (rwDOR) measure: Real-world progression-free survival (rwPFS) measure: Real-world overall survival (rwOS) measure: Treatment-emergent immune-mediated adverse events (imAEs) measure: Infusion-related reaction (IRR) measure: IRR resulting in hospitalization measure: IRR resulting in death sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Regeneron Research Facility city: Tarrytown state: New York zip: 10591 country: United States lat: 41.07621 lon: -73.85875 hasResults: False

 nctId: NCT06269120 id: NN9924-7787 id: U1111-1290-8109 type: OTHER domain: World Health Organization (WHO) briefTitle: SEMA-CardioDiab HUNGARY: A Research Study to Understand the Effects of Oral Semaglutide on Blood Sugar Levels, Weight, and Cardiovascular Risk in People With Type 2 Diabetes Patients in Hungary overallStatus: NOT_YET_RECRUITING date: 2024-02-15 date: 2024-09-30 date: 2024-09-30 date: 2024-02-21 date: 2024-02-21 name: Novo Nordisk A/S class: INDUSTRY briefSummary: Participant will get oral semaglutde as prescribed by the study doctor. The study will last for about 26 ± 4 weeks (5 to 7 months). Participant will be asked to complete a questionnaire about how they take oral semaglutide tablets during normal scheduled visit with doctor. Participant will also be asked questions about health and their diabetes treatment and lab tests as part of normal doctor's appointment. conditions: Type 2 Diabetes studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 470 type: ESTIMATED name: Oral Semaglutide measure: Glycated haemoglobin (HbA1c ) reduction greater than or equal to (≥) 0.5%-point and body weight reduction ≥ 5% measure: Change in HbA1c measure: Change in fasting plasm glucose (FPG) measure: Absolute change in body weight (BW) measure: Relative change in BW measure: HbA1c less than (<) 7.0% measure: HbA1c <6.5% measure: Body weight reduction ≥5% measure: HbA1c reduction ≥1%-point and BW reduction ≥5% measure: HbA1c reduction ≥1%-point and BW reduction ≥3% measure: Change in waist circumference measure: Change in blood pressure (BP) (systolic and diastolic) measure: Change in lipid parameters (total cholesterol, low density lipoprotein cholesterol [LDL-C], high density lipoprotein cholesterol [HDL-C], triglycerides [TG]) measure: Change in high sensitive C-reactive protein (hsCRP) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06269107 id: NN1535-4988 id: U1111-1283-8648 type: OTHER domain: World Health Organization (WHO) id: 2022-502484-38-00 type: OTHER domain: European Medicines Agency (EMA) briefTitle: A Research Study to See How Well New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Levels in People With Type 2 Diabetes (T2D), Compared to Daily Insulin Glargine (COMBINE 4) acronym: COMBINE 4 overallStatus: RECRUITING date: 2024-02-15 date: 2025-06-05 date: 2025-07-10 date: 2024-02-21 date: 2024-04-18 name: Novo Nordisk A/S class: INDUSTRY briefSummary: This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin glargine (mentioned as insulin glargine in this form) taken daily in people with type 2 diabetes. The study will look at how well IcoSema controls blood sugar levels as compared to insulin glargine in people with type 2 diabetes who do not have their blood sugar properly controlled with other oral diabetes medicines. Participant will either get IcoSema or insulin glargine. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe insulin glargine in many countries. The study will last for about 11 months (47 weeks). conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 474 type: ESTIMATED name: IcoSema name: Insulin glargine measure: Change in glycated haemoglobin (HbA1c) measure: Change in body weight measure: Time in range 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligram per deciliter [mg/dL]) measure: Time spent less than (<) 3.0 mmol/L (54 mg/dL) measure: Time spent greater than (>) 10.0 mmol/L (180 mg/dL) measure: Weekly basal insulin dose measure: Change in fasting plasma glucose (FPG) measure: Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in total treatment satisfaction measure: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by blood glucose meter) or severe hypoglycaemic episodes (level 3) measure: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) measure: Number of severe hypoglycaemic episodes (level 3) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Scripps Whittier Diabetes Inst status: RECRUITING city: La Jolla state: California zip: 92037 country: United States lat: 32.84727 lon: -117.2742 facility: First Valley Med Grp Lancaster status: RECRUITING city: Lancaster state: California zip: 93534 country: United States lat: 34.69804 lon: -118.13674 facility: Clinical Trials Research_Sacramento status: RECRUITING city: Lincoln state: California zip: 95648 country: United States lat: 38.89156 lon: -121.29301 facility: Desert Oasis Hlthcr Med Group status: RECRUITING city: Palm Springs state: California zip: 92262 country: United States lat: 33.8303 lon: -116.54529 facility: Northeast Research Institute status: RECRUITING city: Fleming Island state: Florida zip: 32003 country: United States lat: 30.0933 lon: -81.71898 facility: Clinical Research of Central Florida_Winter Haven status: RECRUITING city: Winter Haven state: Florida zip: 33880 country: United States lat: 28.02224 lon: -81.73286 facility: Atlanta Diabetes Associates status: RECRUITING city: Atlanta state: Georgia zip: 30318 country: United States lat: 33.749 lon: -84.38798 facility: Endo Res Solutions Inc status: RECRUITING city: Roswell state: Georgia zip: 30076 country: United States lat: 34.02316 lon: -84.36159 facility: Elite Clinical Trials status: RECRUITING city: Blackfoot state: Idaho zip: 83221 country: United States lat: 43.19047 lon: -112.34498 facility: Cedar-Crosse Research Center status: RECRUITING city: Chicago state: Illinois zip: 60607 country: United States lat: 41.85003 lon: -87.65005 facility: NorthShore Univ Hlth Sys status: RECRUITING city: Skokie state: Illinois zip: 60077 country: United States lat: 42.03336 lon: -87.73339 facility: Cotton-O'Neil Diab & Endo Ctr status: RECRUITING city: Topeka state: Kansas zip: 66606 country: United States lat: 39.04833 lon: -95.67804 facility: Methodist Phys. Clinic status: RECRUITING city: Omaha state: Nebraska zip: 68114 country: United States lat: 41.25626 lon: -95.94043 facility: Albuquerque Clin Trials, Inc. status: RECRUITING city: Albuquerque state: New Mexico zip: 87102 country: United States lat: 35.08449 lon: -106.65114 facility: Albany Medical College - Endo status: RECRUITING city: Albany state: New York zip: 12206 country: United States lat: 42.65258 lon: -73.75623 facility: Southgate Medical Group, LLP status: RECRUITING city: West Seneca state: New York zip: 14224 country: United States lat: 42.85006 lon: -78.79975 facility: Physician's East Endocrinology status: RECRUITING city: Greenville state: North Carolina zip: 27834 country: United States lat: 35.61266 lon: -77.36635 facility: Diab & Endo Assoc of Stark Co status: RECRUITING city: Canton state: Ohio zip: 44718 country: United States lat: 40.79895 lon: -81.37845 facility: Advanced Medical Research status: RECRUITING city: Maumee state: Ohio zip: 43537 country: United States lat: 41.56283 lon: -83.65382 facility: New Venture Medical Research status: RECRUITING city: Wadsworth state: Ohio zip: 44281-9236 country: United States lat: 41.02561 lon: -81.72985 facility: Holston Medical Group status: RECRUITING city: Kingsport state: Tennessee zip: 37660 country: United States lat: 36.54843 lon: -82.56182 facility: Amarillo Med Spec LLP status: RECRUITING city: Amarillo state: Texas zip: 79106 country: United States lat: 35.222 lon: -101.8313 facility: Velocity Clinical Research- Cedar Park status: RECRUITING city: Cedar Park state: Texas zip: 78613 country: United States lat: 30.5052 lon: -97.82029 facility: Velocity Clinical Res-Dallas status: RECRUITING city: Dallas state: Texas zip: 75230 country: United States lat: 32.78306 lon: -96.80667 facility: North Texas Endocrine Center status: RECRUITING city: Dallas state: Texas zip: 75231 country: United States lat: 32.78306 lon: -96.80667 facility: Diabetes and Thyroid Ctr of FW status: RECRUITING city: Fort Worth state: Texas zip: 76132 country: United States lat: 32.72541 lon: -97.32085 facility: Fmc Science, Llc status: RECRUITING city: Lampasas state: Texas zip: 76550 country: United States lat: 31.06378 lon: -98.1817 facility: Consano Clinical Research, LLC status: RECRUITING city: Shavano Park state: Texas zip: 78231 country: United States lat: 29.58495 lon: -98.55252 facility: Wade Family Medicine status: RECRUITING city: Bountiful state: Utah zip: 84010 country: United States lat: 40.88939 lon: -111.88077 facility: Peking University People's Hospital status: RECRUITING city: Beijing state: Beijing zip: 100044 country: China lat: 39.9075 lon: 116.39723 facility: Beijing Friendship Hospital, Capital Medical University status: RECRUITING city: Beijing state: Beijing zip: 100050 country: China lat: 39.9075 lon: 116.39723 facility: Chongqing University Three Gorges Hospital status: RECRUITING city: Chongqing state: Chongqing zip: 404000 country: China lat: 29.56278 lon: 106.55278 facility: Huizhou Central People's Hospital status: RECRUITING city: Huizhou state: Guangdong zip: 516001 country: China lat: 23.11147 lon: 114.41523 facility: The Second Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu zip: 210011 country: China lat: 32.06167 lon: 118.77778 facility: The Second Affiliated Hospital of Nanjing Medical University status: NOT_YET_RECRUITING city: Nanjing state: Jiangsu zip: 210011 country: China lat: 32.06167 lon: 118.77778 facility: The Affiliated Hospital of Jiangsu University status: RECRUITING city: Zhenjiang state: Jiangsu zip: 212001 country: China lat: 32.21086 lon: 119.45508 facility: Jinan Central Hospital status: RECRUITING city: Jinan state: Shandong zip: 250013 country: China lat: 36.66833 lon: 116.99722 facility: Jinan Central Hospital status: NOT_YET_RECRUITING city: Jinan state: Shandong zip: 250013 country: China lat: 36.66833 lon: 116.99722 facility: Shanghai Pudong New Area People's Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 201200 country: China lat: 31.22222 lon: 121.45806 facility: Harrison International Peace Hospital status: WITHDRAWN city: Hengshui zip: 053000 country: China lat: 37.73222 lon: 115.70111 facility: Evangelismos Hospital status: RECRUITING city: Athens zip: GR-10676 country: Greece lat: 37.97945 lon: 23.71622 facility: 'G. Gennimatas' General Hospital of Athens status: RECRUITING city: Athens zip: GR-115 27 country: Greece lat: 37.97945 lon: 23.71622 facility: "Laiko" General Hospital of Athens status: RECRUITING city: Athens zip: GR-11527 country: Greece lat: 37.97945 lon: 23.71622 facility: General Hospital of Kalamata status: RECRUITING city: Kalamata zip: 24100 country: Greece lat: 37.03913 lon: 22.11265 facility: Univ Gen Hospital Larisa, Endocrinology & Metabolic Disease status: RECRUITING city: Larissa zip: GR-41110 country: Greece lat: 39.63689 lon: 22.41761 facility: "Thermi" Private Hosital status: RECRUITING city: Thessaloniki zip: GR-57001 country: Greece lat: 40.64361 lon: 22.93086 facility: Ramaiah Memorial Hospital status: RECRUITING city: Bangalore state: Karnataka zip: 560054 country: India lat: 12.97194 lon: 77.59369 facility: Ramaiah Memorial Hospital status: NOT_YET_RECRUITING city: Bangalore state: Karnataka zip: 560054 country: India lat: 12.97194 lon: 77.59369 facility: Mysore Medical College and Research Institute status: NOT_YET_RECRUITING city: Mysore state: Karnataka zip: 570001 country: India lat: 12.29791 lon: 76.63925 facility: BYL Nair Hospital and T N Medical College Department of endo status: RECRUITING city: Mumbai state: Maharashtra zip: 400008 country: India lat: 19.07283 lon: 72.88261 facility: BYL Nair Hospital and T N Medical College Department of endo status: NOT_YET_RECRUITING city: Mumbai state: Maharashtra zip: 400008 country: India lat: 19.07283 lon: 72.88261 facility: Seth GS Medical College & KEM Hospital status: RECRUITING city: Mumbai state: Maharashtra zip: 400012 country: India lat: 19.07283 lon: 72.88261 facility: Seth GS Medical College & KEM Hospital status: NOT_YET_RECRUITING city: Mumbai state: Maharashtra zip: 400012 country: India lat: 19.07283 lon: 72.88261 facility: BSES MG hospital status: RECRUITING city: Mumbai state: Maharashtra zip: 400058 country: India lat: 19.07283 lon: 72.88261 facility: BSES MG hospital status: NOT_YET_RECRUITING city: Mumbai state: Maharashtra zip: 400058 country: India lat: 19.07283 lon: 72.88261 facility: Chellaram Diabetes Institute status: RECRUITING city: Pune state: Maharashtra zip: 411021 country: India lat: 18.51957 lon: 73.85535 facility: SMS Medical College & Hospital status: NOT_YET_RECRUITING city: Jaipur state: Rajasthan zip: 302004 country: India lat: 26.91962 lon: 75.78781 facility: Diabetes, Thyroid and Endocrine Centre status: RECRUITING city: Jaipur state: Rajasthan zip: 302006 country: India lat: 26.91962 lon: 75.78781 facility: Madras Diabetes Research Foundation status: RECRUITING city: Chennai state: Tamil Nadu zip: 600086 country: India lat: 13.08784 lon: 80.27847 facility: Madras Diabetes Research Foundation status: NOT_YET_RECRUITING city: Chennai state: Tamil Nadu zip: 600086 country: India lat: 13.08784 lon: 80.27847 facility: Udyaan Health Care status: RECRUITING city: Lucknow state: Uttar Pradesh zip: 226002 country: India lat: 26.83928 lon: 80.92313 facility: Post Graduate Institute of Medical Education & Research status: NOT_YET_RECRUITING city: Chandigarh zip: 160012 country: India lat: 30.73629 lon: 76.7884 facility: IPGME&R and SSKM Hospital status: NOT_YET_RECRUITING city: Kolkata zip: 700020 country: India lat: 22.56263 lon: 88.36304 facility: Ospedale San Salvatore, Dipartimento Medico ASL1 Abruzzo, UOC Diabetologia status: RECRUITING city: L'Aquila state: Abbruzzo zip: 67100 country: Italy lat: 42.35055 lon: 13.39954 facility: Casa Sollievo della Sofferenza reparto endocrinologia status: RECRUITING city: San Giovanni Rotondo state: FG zip: 71013 country: Italy lat: 41.70643 lon: 15.7277 facility: I.N.R.C.A. Istituto Nazionale di Riposo E Cura Per Gli Anziani status: NOT_YET_RECRUITING city: Ancona zip: 60127 country: Italy lat: 43.5942 lon: 13.50337 facility: Casa della Salute di Ceccano (FR) status: RECRUITING city: Ceccano (Frosinone) zip: 03023 country: Italy facility: ASL 4 Chiavarese status: NOT_YET_RECRUITING city: Chiavari (genova) zip: 16034 country: Italy facility: ASST Grande Ospedale Metropolitano Niguarda status: RECRUITING city: Milano zip: 20162 country: Italy lat: 45.46427 lon: 9.18951 facility: Azienda Ospedaliera di Perugia;Ospedale S. Maria della Miser status: RECRUITING city: Perugia zip: 06129 country: Italy lat: 43.1122 lon: 12.38878 facility: A.O.U. Policlinico Umberto I status: RECRUITING city: Rome zip: 00161 country: Italy lat: 41.89193 lon: 12.51133 facility: Heiwadai Hospital status: RECRUITING city: Miyazaki-shi state: Miyazaki zip: 880-0034 country: Japan lat: 31.91667 lon: 131.41667 facility: Tokuyama clinic status: RECRUITING city: Chiba zip: 261-0004 country: Japan lat: 35.6 lon: 140.11667 facility: Oodouri Diabetes, Internal medicine Clinic status: RECRUITING city: Hokkaido zip: 060-0001 country: Japan lat: 43.41104 lon: 142.88878 facility: Oyama East Clinic status: RECRUITING city: Tochigi zip: 323-0022 country: Japan lat: 36.38333 lon: 139.73333 facility: Tokyo-Eki Center-building Clinic status: RECRUITING city: Tokyo zip: 103-0027 country: Japan lat: 35.6895 lon: 139.69171 facility: Fukuwa Clinic status: RECRUITING city: Tokyo zip: 104-0031 country: Japan lat: 35.6895 lon: 139.69171 facility: Juntendo University Hospital status: RECRUITING city: Tokyo zip: 113-8431 country: Japan lat: 35.6895 lon: 139.69171 facility: NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska status: RECRUITING city: Bialystok state: Podlaskie zip: 15-435 country: Poland lat: 53.13333 lon: 23.16433 facility: SNZOZ Lege Artis status: RECRUITING city: Bialystok zip: 15-404 country: Poland lat: 53.13333 lon: 23.16433 facility: Uniwersyteckie Centrum Kliniczne Regionalne Centrum Diabetologii status: RECRUITING city: Gdansk zip: 80-214 country: Poland lat: 54.35205 lon: 18.64637 facility: Grazyna Pulka Specjalistyczny Osrodek "All-Med" status: RECRUITING city: Krakow zip: 30-033 country: Poland lat: 50.06143 lon: 19.93658 facility: Gabinet Lekarski Malgorzata Saryusz-Wolska status: RECRUITING city: Lodz zip: 90-132 country: Poland lat: 51.75 lon: 19.46667 facility: Centrum Terapii Wspolczesnej status: RECRUITING city: Lodz zip: 90-338 country: Poland lat: 51.75 lon: 19.46667 facility: Ko-Med Nova Sp.zo.o. Lublin II status: RECRUITING city: Lublin zip: 20-362 country: Poland lat: 51.25 lon: 22.56667 facility: Ko-Med Nova Sp.zo.o. STASZOW status: RECRUITING city: Staszow zip: 28-200 country: Poland lat: 50.56307 lon: 21.16593 facility: NBR Polska Tomasz Klodawski status: RECRUITING city: Warszawa zip: 00-710 country: Poland lat: 52.22977 lon: 21.01178 facility: PANSTWOWY INSTYTUT MEDYCZNY MSWiA status: RECRUITING city: Warszawa zip: 02-507 country: Poland lat: 52.22977 lon: 21.01178 facility: Clinhouse Centrum Medyczne status: RECRUITING city: Zabrze zip: 41-807 country: Poland lat: 50.32492 lon: 18.78576 facility: Advanced Clinical Research LLC status: RECRUITING city: Bayamon zip: 00959 country: Puerto Rico lat: 18.39856 lon: -66.15572 facility: Dr R Dulabh status: RECRUITING city: Johannesburg state: Gauteng zip: 1812 country: South Africa lat: -26.20227 lon: 28.04363 facility: Dr R Dulabh status: NOT_YET_RECRUITING city: Johannesburg state: Gauteng zip: 1812 country: South Africa lat: -26.20227 lon: 28.04363 facility: Newtown Clinical Research status: RECRUITING city: Johannesburg state: Gauteng zip: 2001 country: South Africa lat: -26.20227 lon: 28.04363 facility: Roodepoort Medicross Clinical Research Centre status: RECRUITING city: Roodepoort state: Gauteng zip: 1724 country: South Africa lat: -26.1625 lon: 27.8725 facility: Clinical Research Institute of South Africa status: RECRUITING city: KwaDukuza state: KwaZulu Natal zip: 4449 country: South Africa lat: -29.32816 lon: 31.28954 facility: Dr Pillay's Rooms status: RECRUITING city: Durban state: KwaZulu-Natal zip: 4450 country: South Africa lat: -29.8579 lon: 31.0292 facility: Dr Pillay's Rooms status: NOT_YET_RECRUITING city: Durban state: KwaZulu-Natal zip: 4450 country: South Africa lat: -29.8579 lon: 31.0292 facility: Langeberg Clinical Trials status: RECRUITING city: Cape Town state: Western Cape zip: 7572 country: South Africa lat: -33.92584 lon: 18.42322 facility: Akdeniz University Tip Fakultesi Hastanesi status: RECRUITING city: Antalya zip: 07058 country: Turkey lat: 36.90812 lon: 30.69556 facility: Seyrantepe Hamidiye Etfal Egitim ve Arastirma Hastanesi status: RECRUITING city: Istanbul zip: 34371 country: Turkey lat: 41.01384 lon: 28.94966 facility: Istanbul Universitesi Istanbul Tip Fakultesi - Endokrinoloji status: RECRUITING city: Istanbul zip: 34390 country: Turkey lat: 41.01384 lon: 28.94966 facility: T.C. Saglik Bakanligi Pendik Egitim ve Arastirma Hastanesi status: RECRUITING city: Istanbul zip: 34899 country: Turkey lat: 41.01384 lon: 28.94966 facility: Tekirdag Namık Kemal UTF status: RECRUITING city: Tekirdag zip: 59030 country: Turkey lat: 40.9781 lon: 27.51101 hasResults: False

 nctId: NCT06269094 id: MB-2312 briefTitle: A Study to Understand How Continuous Glucose Monitors Impact Eating Behavior overallStatus: RECRUITING date: 2024-02-14 date: 2024-05 date: 2024-05 date: 2024-02-21 date: 2024-03-13 name: Midwest Center for Metabolic and Cardiovascular Research class: OTHER briefSummary: The purpose of this study is to evaluate if and how continuous glucose monitors (CGMs) impact food consumption, choice, and purchasing in individuals attempting to lose weight using their own weight management approach. conditions: Weight Loss studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 20 type: ESTIMATED name: CGM measure: Qualitative insights on consumer behavior sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Biofortis, Inc. status: RECRUITING city: Addison state: Illinois zip: 60101 country: United States name: Grace Mooney, MS role: CONTACT phone: 630-617-2000 email: grace.mooney@mxns.com name: Gina Castiglione, RD role: CONTACT phone: 6306172000 email: gina.castiglione@mxns.com name: Aditi M Shah, MD role: PRINCIPAL_INVESTIGATOR lat: 41.9317 lon: -87.98896 hasResults: False

 nctId: NCT06269081 id: R01NR020770 type: NIH link: https://reporter.nih.gov/quickSearch/R01NR020770 id: R01NR020770 type: NIH link: https://reporter.nih.gov/quickSearch/R01NR020770 briefTitle: Testing Two Interventions to Improve Health Outcomes and Quality of Life Among Rural Older Adults Living With HIV overallStatus: RECRUITING date: 2024-04-08 date: 2027-01-31 date: 2027-01-31 date: 2024-02-21 date: 2024-04-03 name: Medical College of Wisconsin class: OTHER name: National Institute of Nursing Research (NINR) briefSummary: Engagement in HIV medical care and adherence to HIV medications are both essential in improving health outcomes among people living with HIV (PLH), but PLH living in rural areas-who suffer higher mortality rates than their urban counterparts-can confront multiple barriers to care engagement and adherence, especially as they face the logistical, medical, and social challenges associated with aging. This project will test the efficacy of two interventions to determine their impact on HIV health outcomes and quality of life among rural, older PLH living in the Southern U.S. The two interventions, adapted from evidence-based interventions and delivered remotely, are: (1) supportive-expressive peer social support groups and (2) strengths-based case management. We hypothesize that both interventions will increase viral suppression, antiretroviral therapy adherence, and health-related quality of life and decrease depressive symptoms. Results from this study will provide us with tools to improve health outcomes for rural older people living with HIV. conditions: HIV studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: NONE count: 352 type: ESTIMATED name: Supportive-Expressive Peer Social Support Group Intervention name: Individual Strengths-Based Case Management Intervention measure: Viral Suppression measure: Antiretroviral Treatment Medication Adherence measure: Health-Related Quality of Life measure: Depressive Symptoms measure: Social Support measure: Loneliness measure: Internalized HIV Stigma measure: General Self-Efficacy measure: HIV Treatment Adherence Self-Efficacy measure: Accessing Needed Social and Medical Services measure: Structural Barriers sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center for AIDS Intervention Research, Medical College of Wisconsin status: RECRUITING city: Milwaukee state: Wisconsin zip: 53202 country: United States name: Jennifer Walsh role: CONTACT phone: 414-955-7710 email: jwalsh@mcw.edu lat: 43.0389 lon: -87.90647 hasResults: False

 nctId: NCT06269068 id: 12.01.2024.10 briefTitle: Investigation of the Relationship Between Central Sensitization and Neuropathic Pain in Lumbar Disc Herniation overallStatus: RECRUITING date: 2024-01-16 date: 2024-04-10 date: 2024-06-01 date: 2024-02-21 date: 2024-02-21 name: Marmara University class: OTHER briefSummary: Central sensitization (CS) is as increased response to normal or sub-threshold stimuli of central nervous system and its close relationship with in many musculoskeletal diseases with chronic pain has been demonstrated in several studies. CS is also one of the main mechanisms proposed in the generation of neuropathic pain, and the relationship between pain sensitization and neuropathic complaints has been shown in different diseases.In this study, it was aimed to investigate the effect of central sensitization on the distribution pattern and neuropathic character of pain in patients with lumbar disc herniation who applied to the physical medicine and rehabilitation outpatient clinic. conditions: Central Sensitisation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 180 type: ESTIMATED name: Central sensitization inventory name: Short form-36 name: Oswestry Low Back Pain Disability Questionnaire name: Douleur Neuropathique 4 name: Visual analogue scale measure: Central Sensitization Inventory (CSI) measure: DN4 measure: VAS pain measure: SF-36 measure: ODI sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Marmara University School of Medicine status: RECRUITING city: Istanbul state: Fevzi Çakmak Mah, Muhsin Yazıcıoğlu Cd, Pendik zip: 34899 country: Turkey name: Feyza Nur Yücel role: CONTACT phone: 5385577059 email: dr.fny28@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06269055 id: 73151 briefTitle: Long-term Result of DTPA (Diethylenetriamine Pentaacetate) Chelation for Gadolinium Deposition Disease overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-09 date: 2025-12-31 date: 2024-02-21 date: 2024-04-18 name: Stanford University class: OTHER briefSummary: This study is aimed at describing the degree of benefit, if any, and the adverse effects, if any, from receiving 5 or more treatment sessions of Gadolinium Deposition Disease using two-day chelation treatment with the chelating agents Calcium Diethylenetriamine pentaacetate (Ca-DTPA) and Zinc Diethylenetriamine pentaacetate (Zn-DTPA). conditions: Gadolinium Deposition Disease conditions: Ca-DTPA studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 50 type: ESTIMATED name: Interview measure: Rating of Gadolinium Deposition Disease Symptoms at start of GDD and currently measure: PROMIS Item Bank v2.0 - Cognitive Function- Short Form 8a measure: Sheehan Disability Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stanford University Medical Center city: Stanford state: California zip: 94305 country: United States name: Lorrin Koran, M.D. role: CONTACT phone: 650-799-1647 email: lkoran@stanford.edu lat: 37.42411 lon: -122.16608 hasResults: False

 nctId: NCT06269042 id: 0010 briefTitle: Influence of an Inspiratory Muscle Fatigue Protocol on Older Adults on Respiratory Muscle Strength and Heart Rate Variability overallStatus: NOT_YET_RECRUITING date: 2024-03-02 date: 2024-03-07 date: 2024-03-15 date: 2024-02-21 date: 2024-02-21 name: Sierra Varona SL class: OTHER name: Universidad Europea de Madrid 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 inspiratory muscle fatigue and maximal inspiratory pressure, diaphragmatic strength (guided by ultrasound image) and heart rate variability.

According to our hypothesis, the execution of a protocol inducing inspiratory muscle fatigue in older adults could influence cardiorespiratory function.

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, heart rate variability and diaphragmatic strength (ultrasound image), will be conducted. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT 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 count: 18 type: ESTIMATED name: Inspiratory muscle training measure: Respiratory muscle strength measure: Diaphragmatic thickness and thickening fraction measure: Diaphragm movement curve measure: Heart rate variability sex: ALL minimumAge: 60 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06269029 id: P.T.Rec/012/004297 briefTitle: Chest Mobility Exercises Versus Proprioceptive Neuromuscular Facilitation in Patients With COPD overallStatus: RECRUITING date: 2024-02-17 date: 2024-05-30 date: 2024-06-30 date: 2024-02-21 date: 2024-04-18 name: Cairo University class: OTHER briefSummary: Chest mobility exercise versus proprioceptive neuromuscular facilitation in patients with chronic obstructive pulmonary disease conditions: Chronic Obstructive Pulmonary Disease Moderate studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Chest mobility exercises name: proprioceptive neuromuscular facilitation measure: Pulmonary function test sex: MALE minimumAge: 50 Years maximumAge: 60 Years stdAges: ADULT facility: Cairo university- faculty of physical therapy status: RECRUITING city: Cairo state: Dokki zip: 12556 country: Egypt name: Zahraa Serry, PHD role: CONTACT phone: 012854566880 phoneExt: 02 email: Isaaczakaria5@gmail.com lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06269016 id: P.T.REC/012/003888 briefTitle: Effect of Hip Strengthening Exercises and Pelvic Floor Exercises on Stress Urinary Incontinence in Postnatal Women overallStatus: ACTIVE_NOT_RECRUITING date: 2023-02-20 date: 2023-08-25 date: 2024-04-20 date: 2024-02-21 date: 2024-02-21 name: Cairo University class: OTHER briefSummary: this study will investigate effect of hip strengthening exercises and pelvic floor exercises on stress urinary incontinence in postnatal women. Clinical practice guidelines recommend PFMT as the first-line treatment for female SUI . Also, it has been speculated that the hip muscles are involved in the continence mechanism and that their deficiency could destabilize the normal function of the system. The addition of hip muscle exercises, regardless of PFM contractions, aimed to improve muscular condition for the motor or synergic strategies in PFM contraction. Secondary effects of these techniques, such as the influence of passive lumbar rotational mobilization in improving hip flexor strength, have been of high interest in physiotherapy in general conditions: Stress Urinary Incontinence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 120 type: ACTUAL name: expremental pre and post test measure: hip muscles strengthening exercise. sex: FEMALE minimumAge: 30 Years maximumAge: 35 Years stdAges: ADULT facility: Mai Mohamed Sherif Mohamed Hassan city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06269003 id: STUDY00001223 id: 1K99CA281094-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1K99CA281094-01A1 briefTitle: Responses to Message Source and Presentation Using Psychophysiology overallStatus: ENROLLING_BY_INVITATION date: 2024-02-08 date: 2024-12-31 date: 2024-12-31 date: 2024-02-21 date: 2024-02-21 name: University of Massachusetts, Worcester class: OTHER name: National Cancer Institute (NCI) briefSummary: The goal of this clinical trial is to use psychophysiological methods to test the effects of a message source (expert and peer) and message presentation types (one-sided and two-sided) to identify the optimal message type for young adults who vape and do not vape. conditions: Vaping studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 112 type: ESTIMATED name: Expert name: Peer name: 1 Sided name: 2 Sided measure: Visual attention measure: Orienting response measure: Arousal measure: Attitudes measure: Behavioral intentions sex: ALL minimumAge: 18 Years maximumAge: 24 Years stdAges: ADULT facility: UMass Chan Medical School Shaw Building city: Worcester state: Massachusetts zip: 01605 country: United States lat: 42.26259 lon: -71.80229 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2024-01-17 uploadDate: 2024-01-31T10:39 filename: SAP_000.pdf size: 176628 hasResults: False

 nctId: NCT06268990 id: FE 1159/6-1 briefTitle: FMT in Obesity: RYGB vs. LEAN vs. Autologous FMT acronym: DACH overallStatus: RECRUITING date: 2023-01-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-21 date: 2024-02-21 name: Wiebke Kristin Fenske class: OTHER name: Medical University of Graz briefSummary: This double-blinded proof-of-concept study is proposed to explore the effects of fecal microbiota transfer (FMT) in human subjects. Here we perform FMTs into obese recipients using stool from lean unoperated donors and from previously obese patients after successfull treatment with bariatric Roux-en-Y Gastric Bypass (RYGB) surgery. Obese patients treated with their own material (autologous FMT) serve as controls. After FMT treatment the functional impact of post-surgery microbiome changes on host energy consumption and regulation of blood glucose levels will be analysed. Additionally the variations on the microbiota and metabolite composition will be profiled using extensive sequencing analyses. The major aim of the study is to explore the scientific rationale for targeted gut microbiota modulation in management of obesity and related metabolic diseases.We estimate the transfer of microbiota from RYGB donors is superior to the transfer of lean microbiota at inducing reduced adiposity and improving high blood glucose levels in obese recipients. Each is better than a sham procedure (autologous FMT), which itself can also induce considerable short-term effects. conditions: Morbid Obesity conditions: Metabolic Syndrome conditions: Diabetes conditions: PreDiabetes conditions: Insulin Resistance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Fecal microbiota transplantation measure: Insulin sensitivity measure: Insulin sensitivity measure: Glucose homeostasis measure: Body weight measure: Blood pressure measure: Fasting lipid profile measure: Fasting blood liver enzyme levels measure: Dietary intake levels measure: Metabolic inflammation measure: Gut hormones measure: Hunger and Satiety Scores measure: Fecal microbiota composition measure: Health-related quality of life measure: Tolerability of repeated FMT sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Department of Internal Medicine, Medical University Graz status: RECRUITING city: Graz zip: 8010 country: Austria name: Julia K Mader, Assoc. Prof. role: CONTACT phone: +43 316 38582383 email: julia.mader@medunigraz.at name: Julia K Mader, Assoc. Prof. role: PRINCIPAL_INVESTIGATOR name: Patrizia Kump, PD Dr role: SUB_INVESTIGATOR lat: 47.06667 lon: 15.45 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2021-05-14 uploadDate: 2024-01-29T10:24 filename: Prot_SAP_000.pdf size: 651727 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-09-15 uploadDate: 2024-02-16T08:19 filename: ICF_001.pdf size: 276426 hasResults: False

 nctId: NCT06268977 id: SGLt2i in diabetic type 2 briefTitle: Using of SGLt2 Inhibitors in Patients With Type 2 DM overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-03-30 date: 2024-02-21 date: 2024-02-21 name: Assiut University class: OTHER briefSummary: To detect the efficacy of SGLT2i in improving the metabolic parameters in patients with type 2 diabetes.

- To detect the side-effects of SGLT2i conditions: Type 2 Diabetes studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: SGLT2 inhibitor measure: Effect of adding SGLTi on BP measure: Effect of adding SGLTi on BMI sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06268964 id: 2023-5 briefTitle: Exploring Treatments for Children's Abdominal Pain: Comparing Trimebutine and Probiotics acronym: FAPD_RCT overallStatus: RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2025-06-30 date: 2024-02-21 date: 2024-02-21 name: Universidad de Colima class: OTHER briefSummary: The goal of this clinical trial is to test the effectiveness of trimebutine and probiotics in treating Functional Abdominal Pain Disorders (FAPD) in a pediatric population. The main questions it aims to answer are: Is trimebutine effective in reducing the symptoms of FAPD in children? Are probiotics effective in reducing the symptoms of FAPD in children? Participants will be randomly assigned to one of three treatment groups (trimebutine/probiotics, probiotics/placebo, or trimebutine/placebo). Undergo measurements for pain and other relevant metrics at the start of the study, after 4 weeks, and after 8 weeks.

Researchers will compare the trimebutine/probiotics group to the probiotics/placebo and the trimebutine/placebo groups to see if there are significant differences in the efficacy of these treatments in reducing symptoms of FAPD in children. conditions: Functional Abdominal Pain Syndrome conditions: Functional Gastrointestinal Disorders conditions: Irritable Bowel Syndrome Variant of Childhood studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 82 type: ESTIMATED name: Trimebutine name: Lactobacillus rhamnosus name: Placebo measure: Average Score on Visual Analog Scale for Abdominal Pain measure: Improvement in Quality of Life with PedsQL 3.0 measure: Improvement in Quality of Life with PedsQL 3.0 measure: Average Score on Visual Analog Scale for Abdominal Pain measure: Number of Participants with Treatment-Related Adverse Events sex: ALL minimumAge: 4 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: School of Medicine, University of Colima status: RECRUITING city: Colima zip: 28040 country: Mexico name: Pablo H Sandoval-Villaseñor, MD role: CONTACT phone: +523123007655 email: pablohernan_sandoval@ucol.mx name: Fabián Rojas-Larios, PhD role: CONTACT email: frojas@ucol.mx name: Carmen A Sánchez-Ramírez, PhD role: SUB_INVESTIGATOR name: Pablo H Sandoval-Villaseñor, MD role: PRINCIPAL_INVESTIGATOR name: Fabián Rojas-Larios, PhD role: SUB_INVESTIGATOR lat: 19.24997 lon: -103.72714 typeAbbrev: Prot_SAP_ICF hasProtocol: True hasSap: True hasIcf: True label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form date: 2024-01-09 uploadDate: 2024-02-16T21:12 filename: Prot_SAP_ICF_000.pdf size: 6823982 hasResults: False

 nctId: NCT06268951 id: 23-005485 briefTitle: Recovery and Symptom Relief Following Percutaneous Ablation of Abdominal Wall Endometriosis overallStatus: ENROLLING_BY_INVITATION date: 2024-04 date: 2027-02 date: 2027-12 date: 2024-02-21 date: 2024-04-15 name: Mayo Clinic class: OTHER briefSummary: To determine the characteristics of recovery and symptom relief following ablation of abdominal wall endometriosis. conditions: Endometriosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Symptom severity due to abdominal wall endometriosis following ablation. sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06268938 id: mastoid obliteration briefTitle: Outcomes of Mastoid Obliteration Canal Wall Down Tympanomastoidectomy in Cholesteatoma Surgery overallStatus: ACTIVE_NOT_RECRUITING date: 2023-09-04 date: 2028-11-01 date: 2028-12-01 date: 2024-02-20 date: 2024-02-20 name: Assiut University class: OTHER briefSummary: Randomised study to evaluate the outcomes of mastoid cavity obliteration by muscle versus bone in canal wall down tympanomastoidectomy in cholesteatoma surgery conditions: Cholesteatoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 4 type: ACTUAL name: Canal wall down tympanomastoidectomy measure: Size of mastoid cavity in mm sex: ALL minimumAge: 5 Years maximumAge: 60 Years stdAges: CHILD stdAges: ADULT facility: Assiut university hospital city: Assiut country: Egypt lat: 27.18096 lon: 31.18368 facility: Rehab Abd Elal Mohammed city: Assiut country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False

 nctId: NCT06268925 id: UAHS briefTitle: The Feasibility And Efficacy Of A Telerehabilitation Program For People With Knee Osteoarthiritis In Sri Lanka overallStatus: ENROLLING_BY_INVITATION date: 2024-02-22 date: 2024-04-22 date: 2024-05-03 date: 2024-02-20 date: 2024-02-20 name: University of Peradeniya class: OTHER briefSummary: it will be 8 week zoom program of exercises for knee osteo arthritis. participant will be selected according to elegibilty criteria. pre and post measurements will be obtained. then feasibility and efficacy will be assesed. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: 14 people with knee osteoarthritis will be recruited and conducted group classes through zoom primaryPurpose: TREATMENT masking: NONE count: 14 type: ESTIMATED name: Exercises measure: Efficacy of telerehabilitation program measure: Feasibility and acceptability measure: lower extremity muscle strength and dynamic balance measure: pain, measure: pain stiffness and physical activity sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: M.S.F.Sarjana city: Puttalam state: North Western zip: 61300 country: Sri Lanka lat: 8.0362 lon: 79.8283 hasResults: False

 nctId: NCT06268912 id: END-ECL-2022-01 id: END-ECL-2022-01 type: OTHER domain: UIC briefTitle: Cryoanalgesia for Irreversible Pulpitis acronym: CryPain overallStatus: COMPLETED date: 2022-09-07 date: 2023-09-07 date: 2024-01-07 date: 2024-02-20 date: 2024-02-20 name: Universitat Internacional de Catalunya class: OTHER briefSummary: The aim of the present study was to evaluate the effectiveness of pulpal anesthesia in pain control during endodontic treatment by lowering the temperature of the injected plain 3% cold Mepivacaine (5ºC) compared to 3% Mepivacaine at room temperature in teeth with irreversible pulpitis. conditions: Pulpitis - Irreversible studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 20 type: ACTUAL name: Cold Mepivacaine name: Mepivacaine at room temperature measure: Assessment of Pain and Anxiety sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gonzalo Gomez city: Barcelona zip: 08 country: Spain lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06268899 id: E-77082166-302.08.01-285977 briefTitle: First Mobilization Protocol for Total Knee Arthroplasty Patients overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-08 date: 2024-03-30 date: 2024-03-30 date: 2024-02-20 date: 2024-02-20 name: Gazi University class: OTHER name: Baskent University briefSummary: This single blinded randomized controlled study evaluates the effect of developed First Mobilization Protocol applied to knee arthroplasty patients on state anxiety, kinesiophobia, initial mobilization related symptoms. conditions: Knee Arthroplasty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study protocol describes the design of a single-center, single-blind, statistician-blind randomized controlled trial to be conducted in the Orthopedics and Traumatology Clinic of a provincial university hospital in Turkey. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Participant: the researcher learned the study and control groups after the pre-test data. The study group was trained with the mobilization protocol. The control group received training on the current mobilization procedure of the clinic. Participants did not know which group they were in.

Outcomes Assessor. Study and control groups data were coded into the SPSS programme as group one and group two. Analysis of data was done by an independent statistician. The statistician has no information about which group the patients belong to. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 78 type: ACTUAL name: First mobilization protocol measure: Anxiety evaluated using the Trait Anxiety Inventory (Trait Anxiety Inventory, TAI) measure: Kinesiophobia evaluated using the Tampa Kinesiophobia Scale measure: Anxiety evaluated using the State Anxiety Inventory (State Anxiety Inventory, SAI) measure: Symptoms evaluated using the Numerical Rating Scale for Symptoms Related to First Mobilization sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gazi University Health Research and Application Center city: Ankara zip: 06560 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06268886 id: CN008-0003 id: 2023-504840-32-00 type: REGISTRY domain: EU Trial Number id: U1111-1290-3539 type: REGISTRY domain: WHO briefTitle: Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease acronym: TargetTau-1 overallStatus: RECRUITING date: 2024-03-20 date: 2027-08-31 date: 2027-11-16 date: 2024-02-20 date: 2024-04-29 name: Bristol-Myers Squibb class: INDUSTRY briefSummary: The purpose of this study is to assess the effectiveness, safety, and tolerability of BMS-986446 an Anti-MTBR Tau Monoclonal Antibody in participants with Early Alzheimer's Disease. conditions: Alzheimer Disease, Early Onset studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 475 type: ESTIMATED name: BMS-986446 name: Placebo measure: Mean change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score measure: Mean change from baseline in brain tau deposition as measured by tau positron emission tomography (PET) measure: Mean change from baseline in integrated Alzheimer's Disease Rating Scale (iADRS) score measure: Mean change from baseline in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADASCog14) score measure: Mean change from baseline in Alzheimer's Disease Cooperative Study-instrumental Activities of Daily Living scale (ADCS-iADL) score measure: Mean change from baseline in Mini Mental State Examination (MMSE) score sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD First Research - Chandler status: NOT_YET_RECRUITING city: Chandler state: Arizona zip: 85226-3732 country: United States name: Hemant Pandey, Site 0068 role: CONTACT phone: 480-508-1038 lat: 33.30616 lon: -111.84125 facility: Gilbert Neurology status: NOT_YET_RECRUITING city: Gilbert state: Arizona zip: 85297-0441 country: United States name: Jonathan Hodgson, Site 0102 role: CONTACT phone: 602-761-9631 lat: 33.35283 lon: -111.78903 facility: Xenoscience Inc. - 21st Century Neurology status: NOT_YET_RECRUITING city: Phoenix state: Arizona zip: 85004 country: United States name: Stephen Flitman, Site 0019 role: CONTACT phone: 602-265-6500 lat: 33.44838 lon: -112.07404 facility: Imaging Endpoints LLC status: NOT_YET_RECRUITING city: Scottsdale state: Arizona zip: 85258-4595 country: United States name: Nida Laurin, Site 0026 role: CONTACT lat: 33.50921 lon: -111.89903 facility: Office of Allan M. Block, MD status: NOT_YET_RECRUITING city: Scottsdale state: Arizona zip: 85258-5133 country: United States name: Allan Block, Site 0018 role: CONTACT phone: 480-471-6132 lat: 33.50921 lon: -111.89903 facility: Tucson Neuroscience Research, LLC status: NOT_YET_RECRUITING city: Tucson state: Arizona zip: 85710-6160 country: United States name: Robert Mutterperl, Site 0128 role: CONTACT phone: 520-230-1373 lat: 32.22174 lon: -110.92648 facility: Center for Neurosciences - Tucson status: NOT_YET_RECRUITING city: Tucson state: Arizona zip: 85718-6522 country: United States name: Michael Badruddoja, Site 0077 role: CONTACT phone: 520-320-2147 lat: 32.22174 lon: -110.92648 facility: The Banner Alzheimer's Institute - Tucson status: NOT_YET_RECRUITING city: Tucson state: Arizona zip: 85718-6632 country: United States name: Allan Anderson, Site 0038 role: CONTACT phone: 520-694-4124 lat: 32.22174 lon: -110.92648 facility: Local Institution - 0164 status: NOT_YET_RECRUITING city: Encino state: California zip: 91316-1511 country: United States name: Site 0164 role: CONTACT lat: 34.15917 lon: -118.50119 facility: Local Institution - 0139 status: NOT_YET_RECRUITING city: Fullerton state: California zip: 92835-1040 country: United States name: Site 0139 role: CONTACT lat: 33.87029 lon: -117.92534 facility: Local Institution - 0152 status: NOT_YET_RECRUITING city: La Jolla state: California zip: 92037 country: United States name: Site 0152 role: CONTACT lat: 32.84727 lon: -117.2742 facility: Local Institution - 0183 status: NOT_YET_RECRUITING city: Lakewood state: California zip: 90805-4590 country: United States name: Site 0183 role: CONTACT lat: 33.85363 lon: -118.13396 facility: Local Institution - 0073 status: ACTIVE_NOT_RECRUITING city: Lomita state: California zip: 90717-2101 country: United States lat: 33.79224 lon: -118.31507 facility: Local Institution - 0142 status: NOT_YET_RECRUITING city: Los Alamitos state: California zip: 90720-3589 country: United States name: Site 0142 role: CONTACT lat: 33.80307 lon: -118.07256 facility: Neurovations status: NOT_YET_RECRUITING city: Napa state: California zip: 94558-2415 country: United States name: Eric Grigsby, Site 0037 role: CONTACT phone: 707-252-9666 lat: 38.29714 lon: -122.28553 facility: UCSF Medical Center- Mission Bay status: NOT_YET_RECRUITING city: San Francisco state: California zip: 94143-2350 country: United States name: Peter Ljubenkov, Site 0052 role: CONTACT phone: 415-502-7562 lat: 37.77493 lon: -122.41942 facility: Local Institution - 0137 status: NOT_YET_RECRUITING city: Santa Ana state: California zip: 92705-8675 country: United States name: Site 0137 role: CONTACT lat: 33.74557 lon: -117.86783 facility: Local Institution - 0135 status: NOT_YET_RECRUITING city: Seal Beach state: California zip: 90740-6653 country: United States name: Site 0135 role: CONTACT lat: 33.74141 lon: -118.10479 facility: California Neuroscience Research Medical Group, Inc (CNR) status: NOT_YET_RECRUITING city: Sherman Oaks state: California zip: 91403-2131 country: United States name: Thomas Shiovitz, Site 0046 role: CONTACT phone: 818-986-9716 lat: 34.15112 lon: -118.44925 facility: Rocky Mountain Movement Disorder Center status: NOT_YET_RECRUITING city: Englewood state: Colorado zip: 80113-2776 country: United States name: Rajeev Kumar, Site 0092 role: CONTACT phone: 303-357-5455 lat: 39.64777 lon: -104.98776 facility: Associated Neurologists, P.C. - Danbury Office status: NOT_YET_RECRUITING city: Danbury state: Connecticut zip: 06810-4088 country: United States name: Behzad Habibi Khameneh, Site 0106 role: CONTACT phone: 203-748-2551 lat: 41.39482 lon: -73.45401 facility: Local Institution - 0148 status: NOT_YET_RECRUITING city: New Haven state: Connecticut zip: 06510 country: United States name: Site 0148 role: CONTACT lat: 41.30815 lon: -72.92816 facility: Hasbani Neurology status: NOT_YET_RECRUITING city: New Haven state: Connecticut zip: 06511-5249 country: United States name: Mayer Hasbani, Site 0056 role: CONTACT phone: 212-241-8329 lat: 41.30815 lon: -72.92816 facility: Local Institution - 0153 status: NOT_YET_RECRUITING city: Stamford state: Connecticut zip: 06905-1206 country: United States name: Site 0153 role: CONTACT lat: 41.05343 lon: -73.53873 facility: Neurology of Central Florida status: NOT_YET_RECRUITING city: Altamonte Springs state: Florida zip: 32714-2436 country: United States name: Alicia Cabrera, Site 0022 role: CONTACT phone: 407-790-4990 lat: 28.66111 lon: -81.36562 facility: JEM Research Institute status: NOT_YET_RECRUITING city: Atlantis state: Florida zip: 33462-6631 country: United States name: Linda Pao, Site 0048 role: CONTACT phone: 561-968-2933 lat: 26.5909 lon: -80.10088 facility: Local Institution - 0020 status: NOT_YET_RECRUITING city: Clermont state: Florida zip: 34711-5933 country: United States name: Site 0020 role: CONTACT lat: 28.54944 lon: -81.77285 facility: Arrow Clinical Trials status: RECRUITING city: Daytona Beach state: Florida zip: 32117-5532 country: United States name: David Billmeier, Site 0009 role: CONTACT phone: 386-304-7070 lat: 29.21081 lon: -81.02283 facility: Local Institution - 0059 status: NOT_YET_RECRUITING city: Greenacres City state: Florida zip: 33467 country: United States name: Site 0059 role: CONTACT lat: 26.62368 lon: -80.12532 facility: Local Institution - 0187 status: NOT_YET_RECRUITING city: Jacksonville state: Florida zip: 32256 country: United States name: Site 0187 role: CONTACT lat: 30.33218 lon: -81.65565 facility: Charter Research - Lady Lake status: RECRUITING city: Lady Lake state: Florida zip: 32159 country: United States name: Jeffrey Norton, Site 0151 role: CONTACT phone: 352-775-1000 lat: 28.91749 lon: -81.92286 facility: Local Institution - 0146 status: NOT_YET_RECRUITING city: Lakeland state: Florida zip: 33805-2208 country: United States name: Site 0146 role: CONTACT lat: 28.03947 lon: -81.9498 facility: Local Institution - 0143 status: NOT_YET_RECRUITING city: Maitland state: Florida zip: 32751 country: United States name: Site 0143 role: CONTACT lat: 28.62778 lon: -81.36312 facility: Merritt Island Medical Research status: RECRUITING city: Merritt Island state: Florida zip: 32952-3616 country: United States name: Gregory Kirk, Site 0027 role: CONTACT phone: 386-785-8009 lat: 28.53917 lon: -80.672 facility: Premier Clinical Research Institute - Miami status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33122-1335 country: United States name: Emelina Arocha, Site 0058 role: CONTACT phone: 786-587-9425 lat: 25.77427 lon: -80.19366 facility: Optimus U, Inc. status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33125-4013 country: United States name: Yaneicy Gonzalez Rojas, Site 0013 role: CONTACT lat: 25.77427 lon: -80.19366 facility: Project 4 Research status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33125-4719 country: United States name: Ibrahim Menendez Perez, Site 0034 role: CONTACT phone: 786-536-5755 lat: 25.77427 lon: -80.19366 facility: Vitae Research Center status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33135-2957 country: United States name: Mercedes Ponce De Leon, Site 0014 role: CONTACT phone: 786-288-2598 lat: 25.77427 lon: -80.19366 facility: Advance Medical Research Center status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33135-2968 country: United States name: Ana Acosta, Site 0005 role: CONTACT phone: 786-360-4423 lat: 25.77427 lon: -80.19366 facility: Miami Jewish Health Systems status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33137-2706 country: United States name: Marc Agronin, Site 0008 role: CONTACT phone: 305-514-8710 lat: 25.77427 lon: -80.19366 facility: Local Institution - 0176 status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33155-6540 country: United States name: Site 0176 role: CONTACT lat: 25.77427 lon: -80.19366 facility: Hope Research Network, LLC status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33166-2710 country: United States name: Jorge Jorge, Site 0071 role: CONTACT phone: 305-244-8113 lat: 25.77427 lon: -80.19366 facility: Local Institution - 0156 status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33175-3598 country: United States name: Site 0156 role: CONTACT lat: 25.77427 lon: -80.19366 facility: IMIC Research status: RECRUITING city: Miami state: Florida zip: 33176-7947 country: United States name: Ramon Leon, Site 0039 role: CONTACT phone: 786-600-7005 lat: 25.77427 lon: -80.19366 facility: Suncoast Clinical Research status: NOT_YET_RECRUITING city: New Port Richey state: Florida zip: 34652-4020 country: United States name: Cathy Barnes, Site 0017 role: CONTACT phone: 727-849-4131 lat: 28.24418 lon: -82.71927 facility: Local Institution - 0144 status: NOT_YET_RECRUITING city: Ocala state: Florida zip: 34471 country: United States name: Site 0144 role: CONTACT lat: 29.1872 lon: -82.14009 facility: Headlands Research - Orlando status: RECRUITING city: Orlando state: Florida zip: 32819-8031 country: United States name: Theodore Lee, Site 0035 role: CONTACT phone: 407-705-3471 lat: 28.53834 lon: -81.37924 facility: Local Institution - 0141 status: NOT_YET_RECRUITING city: Palm Beach Gardens state: Florida zip: 33410-4303 country: United States name: Site 0141 role: CONTACT lat: 26.82339 lon: -80.13865 facility: Alzheimer's Research and Treatment Center Stuart status: NOT_YET_RECRUITING city: Stuart state: Florida zip: 34997-5765 country: United States name: Adam Falchook, Site 0012 role: CONTACT lat: 27.19755 lon: -80.25283 facility: Local Institution - 0136 status: NOT_YET_RECRUITING city: Stuart state: Florida zip: 34997-6405 country: United States name: Site 0136 role: CONTACT lat: 27.19755 lon: -80.25283 facility: Baycare Clinical Research, LLC status: NOT_YET_RECRUITING city: Tampa state: Florida zip: 33607-6616 country: United States name: Arnaldo Orellana, Site 0080 role: CONTACT phone: 813-368-5738 lat: 27.94752 lon: -82.45843 facility: First Choice Neurology - Tampa Neurology Associates status: RECRUITING city: Tampa state: Florida zip: 33609-4090 country: United States name: Susan Steen, Site 0087 role: CONTACT phone: 813-353-9613 lat: 27.94752 lon: -82.45843 facility: Johnnie B. Byrd, Sr. Alzheimer's Foundation, Inc status: NOT_YET_RECRUITING city: Tampa state: Florida zip: 33613-4808 country: United States name: Amanda Smith, Site 0042 role: CONTACT phone: 813-974-4355 lat: 27.94752 lon: -82.45843 facility: Alzheimer's Research and Treatment Center - Wellington Location status: NOT_YET_RECRUITING city: Wellington state: Florida zip: 33414-9320 country: United States name: David Watson, Site 0011 role: CONTACT phone: 561-209-2400 lat: 26.65868 lon: -80.24144 facility: Local Institution - 0149 status: NOT_YET_RECRUITING city: West Palm Beach state: Florida zip: 33409-6611 country: United States name: Site 0149 role: CONTACT lat: 26.71534 lon: -80.05337 facility: Waypoint Research LLC status: RECRUITING city: Windermere state: Florida zip: 34786-8919 country: United States name: Craig Curtis, Site 0029 role: CONTACT phone: 352-500-5252 lat: 28.49556 lon: -81.5348 facility: Conquest Research LLC status: RECRUITING city: Winter Park state: Florida zip: 32789-1848 country: United States name: Rekha Gandhi, Site 0101 role: CONTACT phone: 321-285-2369 lat: 28.6 lon: -81.33924 facility: Charter Research - Winter Park status: RECRUITING city: Winter Park state: Florida zip: 32792 country: United States name: Edgardo Rivera, Site 0154 role: CONTACT phone: 407-863-1326 lat: 28.6 lon: -81.33924 facility: Columbus Memory Center status: NOT_YET_RECRUITING city: Columbus state: Georgia zip: 31909-1692 country: United States name: Jonathan Liss, Site 0105 role: CONTACT phone: 706-327-4000 lat: 32.46098 lon: -84.98771 facility: Great Lakes Clinical Trials status: RECRUITING city: Chicago state: Illinois zip: 60640-2831 country: United States name: Jeffrey Ross, Site 0021 role: CONTACT phone: 847-252-7300 lat: 41.85003 lon: -87.65005 facility: Local Institution - 0161 status: NOT_YET_RECRUITING city: Elk Grove Village state: Illinois zip: 60007-3362 country: United States name: Site 0161 role: CONTACT lat: 42.00392 lon: -87.97035 facility: Great Lakes Clinical Trials d/b/a Flourish Research Gurnee status: RECRUITING city: Gurnee state: Illinois zip: 60031 country: United States name: Yevgeniy Bukhman, Site 0003 role: CONTACT phone: 773-275-3500 lat: 42.3703 lon: -87.90202 facility: Local Institution - 0145 status: NOT_YET_RECRUITING city: Park Ridge state: Illinois zip: 60068 country: United States name: Site 0145 role: CONTACT lat: 42.01114 lon: -87.84062 facility: Southern Illinois University School of Medicine - SIU Neurology Clinic status: NOT_YET_RECRUITING city: Springfield state: Illinois zip: 62702-4968 country: United States name: Jennifer Arnold, Site 0081 role: CONTACT phone: 217-545-7200 lat: 39.80172 lon: -89.64371 facility: Boston Clinical Trials status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02131-2515 country: United States name: Deborah Green-LaRoche, Site 0025 role: CONTACT phone: 617-636-7606 lat: 42.35843 lon: -71.05977 facility: Boston Neuropsychiatry status: NOT_YET_RECRUITING city: Braintree state: Massachusetts zip: 02184-1939 country: United States name: Malini Nair, Site 0015 role: CONTACT phone: 617-302-6388 lat: 42.22232 lon: -70.99949 facility: ActivMed Practices & Research, Inc. - Methuen status: NOT_YET_RECRUITING city: Methuen state: Massachusetts zip: 01844-5864 country: United States name: Michael McCartney, Site 0118 role: CONTACT phone: 19789789696897 lat: 42.7262 lon: -71.19089 facility: Boston Center for Memory status: NOT_YET_RECRUITING city: Newton state: Massachusetts zip: 02459-3328 country: United States name: Paul Solomon, Site 0040 role: CONTACT phone: 617-699-6927 lat: 42.33704 lon: -71.20922 facility: Office of Donald S. Marks, M.D., P.C. status: NOT_YET_RECRUITING city: Plymouth state: Massachusetts zip: 02360-7223 country: United States name: Donald Marks, Site 0120 role: CONTACT phone: 508-269-0403 lat: 41.95844 lon: -70.66726 facility: Adams Clinical Trials, LLC status: NOT_YET_RECRUITING city: Watertown state: Massachusetts zip: 02472-4153 country: United States name: Stephanie Rutrick, Site 0045 role: CONTACT phone: 617-697-1843 lat: 42.37093 lon: -71.18283 facility: Local Institution - 0150 status: NOT_YET_RECRUITING city: Ozark state: Missouri zip: 65721 country: United States name: Site 0150 role: CONTACT lat: 37.02089 lon: -93.20602 facility: Local Institution - 0169 status: NOT_YET_RECRUITING city: Saint Louis state: Missouri zip: 63104-1027 country: United States name: Site 0169 role: CONTACT lat: 38.62727 lon: -90.19789 facility: ActivMed Practices & Research, Inc. - Portsmouth status: NOT_YET_RECRUITING city: Portsmouth state: New Hampshire zip: 03801-6822 country: United States name: Marc Shay, Site 0119 role: CONTACT phone: 603-319-8863 lat: 43.07176 lon: -70.76255 facility: Princeton Medical Institute status: NOT_YET_RECRUITING city: Princeton state: New Jersey zip: 08540-2859 country: United States name: Sanjay Varma, Site 0031 role: CONTACT phone: 609-921-3555 lat: 40.34872 lon: -74.65905 facility: Advanced Memory Research Institute of NJ status: NOT_YET_RECRUITING city: Toms River state: New Jersey zip: 08755-5043 country: United States name: Sanjiv Sharma, Site 0062 role: CONTACT phone: 732-341-9500 lat: 39.95373 lon: -74.19792 facility: Neurology Specialists of Monmouth County, PA status: NOT_YET_RECRUITING city: West Long Branch state: New Jersey zip: 07764-1021 country: United States name: Noah Gilson, Site 0130 role: CONTACT phone: 732-935-1850 lat: 40.29039 lon: -74.01764 facility: Neurological Associates of Albany, P.C. status: NOT_YET_RECRUITING city: Albany state: New York zip: 12208-3464 country: United States name: Richard Holub, Site 0060 role: CONTACT phone: 518-426-0575 lat: 42.65258 lon: -73.75623 facility: Local Institution - 0157 status: NOT_YET_RECRUITING city: Amherst state: New York zip: 14226-1727 country: United States name: Site 0157 role: CONTACT lat: 42.97839 lon: -78.79976 facility: The Feinstein Institute for Medical Research status: NOT_YET_RECRUITING city: Manhasset state: New York zip: 11030-3816 country: United States name: Marc Gordon, Site 0061 role: CONTACT phone: 516-562-3492 lat: 40.79788 lon: -73.69957 facility: Neurological Associates of Long Island status: NOT_YET_RECRUITING city: New Hyde Park state: New York zip: 11042-1028 country: United States name: David Podwall, Site 0107 role: CONTACT phone: 516-466-4700 lat: 40.7351 lon: -73.68791 facility: Icahn School of Medicine at Mount Sinai (ISMMS) - Alzheimer's Disease Research Center status: NOT_YET_RECRUITING city: New York state: New York zip: 10029-6504 country: United States name: Laili Soleimani, Site 0104 role: CONTACT lat: 40.71427 lon: -74.00597 facility: Columbia University Medical Center - The Neurological Institute of New York status: NOT_YET_RECRUITING city: New York state: New York zip: 10032-3726 country: United States name: Lawrence Honig, Site 0133 role: CONTACT phone: 212-305-0851 lat: 40.71427 lon: -74.00597 facility: Local Institution - 0095 status: NOT_YET_RECRUITING city: New York state: New York zip: 11220 country: United States name: Site 0095 role: CONTACT lat: 40.71427 lon: -74.00597 facility: Alzheimer's Memory Center status: NOT_YET_RECRUITING city: Matthews state: North Carolina zip: 28105-8336 country: United States name: Mohammad Bolouri, Site 0043 role: CONTACT phone: 7043644000225 lat: 35.11681 lon: -80.72368 facility: Local Institution - 0155 status: NOT_YET_RECRUITING city: Beachwood state: Ohio zip: 44122 country: United States name: Site 0155 role: CONTACT lat: 41.4645 lon: -81.50873 facility: Abington Neurological Associates (ANA) status: NOT_YET_RECRUITING city: Abington state: Pennsylvania zip: 19001-3816 country: United States name: David Weisman, Site 0057 role: CONTACT phone: 215-886-7000 lat: 40.12067 lon: -75.11795 facility: Hospital of the University of Pennsylvania status: NOT_YET_RECRUITING city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Sanjeev Vaishnavi, Site 0032 role: CONTACT phone: 215-662-7810 lat: 39.95233 lon: -75.16379 facility: Keystone Clinical Studies, LLC status: RECRUITING city: Plymouth Meeting state: Pennsylvania zip: 19462-7401 country: United States name: Cherian Verghese, Site 0023 role: CONTACT lat: 40.10233 lon: -75.27435 facility: Rhode Island Mood & Memory Research Institute status: NOT_YET_RECRUITING city: East Providence state: Rhode Island zip: 02914-1318 country: United States name: John Stoukides, Site 0024 role: CONTACT phone: 401-435-8950 lat: 41.81371 lon: -71.37005 facility: Rhode Island Hospital - Alzheimer's Disease and Memory Disorders Center status: NOT_YET_RECRUITING city: Providence state: Rhode Island zip: 02903-4923 country: United States name: Chuang-Kuo Wu, Site 0098 role: CONTACT phone: 401-444-5742 lat: 41.82399 lon: -71.41283 facility: Local Institution - 0163 status: NOT_YET_RECRUITING city: Providence state: Rhode Island zip: 02906-4800 country: United States name: Site 0163 role: CONTACT lat: 41.82399 lon: -71.41283 facility: Neurology Clinic, P.C. - Germantown Park Location status: NOT_YET_RECRUITING city: Cordova state: Tennessee zip: 38018-4254 country: United States name: Kendrick Henderson, Site 0132 role: CONTACT phone: 901-866-9252 lat: 35.15565 lon: -89.7762 facility: Local Institution - 0140 status: NOT_YET_RECRUITING city: Franklin state: Tennessee zip: 37067-5922 country: United States name: Site 0140 role: CONTACT lat: 35.92506 lon: -86.86889 facility: Senior Adults Specialty Research status: NOT_YET_RECRUITING city: Austin state: Texas zip: 78757-8046 country: United States name: Jaron Winston, Site 0069 role: CONTACT phone: 512-476-3556 lat: 30.26715 lon: -97.74306 facility: Gadolin Research status: NOT_YET_RECRUITING city: Beaumont state: Texas zip: 77702 country: United States name: Kandasami Senthilkumar, Site 0033 role: CONTACT phone: 409-331-6040 lat: 30.08605 lon: -94.10185 facility: Kerwin Research Center and Memory Care status: NOT_YET_RECRUITING city: Dallas state: Texas zip: 75231-4316 country: United States name: Diana Kerwin, Site 0051 role: CONTACT phone: 972-433-9100 lat: 32.78306 lon: -96.80667 facility: Neurology Consultants of Dallas status: NOT_YET_RECRUITING city: Dallas state: Texas zip: 75243-1288 country: United States name: Duc Tran, Site 0134 role: CONTACT phone: 214-750-0322 lat: 32.78306 lon: -96.80667 facility: Baylor College of Medicine status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77030 country: United States name: Melissa Yu, Site 0041 role: CONTACT phone: 713-798-6107 lat: 29.76328 lon: -95.36327 facility: Memorial Neurological Association - Main Office status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77074-1812 country: United States name: Nelson Berrios, Site 0016 role: CONTACT lat: 29.76328 lon: -95.36327 facility: Central Texas Neurology Consultants (CTNC) status: NOT_YET_RECRUITING city: Round Rock state: Texas zip: 78681-3578 country: United States name: Elizabeth Peckham, Site 0129 role: CONTACT phone: 512-218-1222 lat: 30.50826 lon: -97.6789 facility: Be Well MD status: NOT_YET_RECRUITING city: Round Rock state: Texas zip: 78681-3596 country: United States name: Mark Carlson, Site 0028 role: CONTACT lat: 30.50826 lon: -97.6789 facility: Local Institution - 0168 status: NOT_YET_RECRUITING city: Richmond state: Virginia zip: 23294 country: United States name: Site 0168 role: CONTACT lat: 37.55376 lon: -77.46026 facility: Local Institution - 0065 status: NOT_YET_RECRUITING city: Madison state: Wisconsin zip: 53792 country: United States name: Site 0065 role: CONTACT lat: 43.07305 lon: -89.40123 facility: Local Institution - 0002 status: NOT_YET_RECRUITING city: Darlinghurst state: New South Wales zip: 2010 country: Australia name: Site 0002 role: CONTACT lat: -33.87939 lon: 151.21925 facility: Local Institution - 0111 status: NOT_YET_RECRUITING city: East Gosford state: New South Wales zip: 2250 country: Australia name: Site 0111 role: CONTACT lat: -33.43874 lon: 151.35338 facility: Local Institution - 0170 status: NOT_YET_RECRUITING city: Macquarie Park state: New South Wales zip: 2113 country: Australia name: Site 0170 role: CONTACT lat: -33.7751 lon: 151.11272 facility: Local Institution - 0116 status: NOT_YET_RECRUITING city: Southport state: Queensland zip: 4215 country: Australia name: Site 0116 role: CONTACT lat: -27.96724 lon: 153.39796 facility: Local Institution - 0115 status: NOT_YET_RECRUITING city: Carlton North state: Victoria zip: 3053 country: Australia name: Site 0115 role: CONTACT lat: -37.78333 lon: 144.96667 facility: Local Institution - 0093 status: NOT_YET_RECRUITING city: Heidelberg state: Victoria zip: 3084 country: Australia name: Site 0093 role: CONTACT lat: -37.75 lon: 145.06667 facility: Local Institution - 0001 status: NOT_YET_RECRUITING city: Malvern state: Victoria zip: 3144 country: Australia name: Site 0001 role: CONTACT lat: -32.02849 lon: 151.32225 facility: Local Institution - 0125 status: NOT_YET_RECRUITING city: Melbourne state: Victoria zip: 03181 country: Australia name: Site 0125 role: CONTACT lat: -37.814 lon: 144.96332 facility: Local Institution - 0147 status: NOT_YET_RECRUITING city: Parkville state: Victoria zip: 3050 country: Australia name: Site 0147 role: CONTACT lat: -37.78333 lon: 144.95 facility: Local Institution - 0094 status: NOT_YET_RECRUITING city: Nedlands state: Western Australia zip: 6009 country: Australia name: Site 0094 role: CONTACT lat: -31.98184 lon: 115.8073 facility: Local Institution - 0122 status: NOT_YET_RECRUITING city: Anderlecht state: Brussels zip: 1070 country: Belgium name: Site 0122 role: CONTACT lat: 50.83619 lon: 4.31454 facility: Local Institution - 0175 status: NOT_YET_RECRUITING city: Antwerpen state: Brussel zip: 2018 country: Belgium name: Site 0175 role: CONTACT lat: 51.21989 lon: 4.40346 facility: Local Institution - 0074 status: NOT_YET_RECRUITING city: Brussel state: BRU zip: 1020 country: Belgium name: Site 0074 role: CONTACT lat: 50.85045 lon: 4.34878 facility: Local Institution - 0082 status: NOT_YET_RECRUITING city: Kortrijk state: VWV zip: 8500 country: Belgium name: Site 0082 role: CONTACT lat: 50.82803 lon: 3.26487 facility: Local Institution - 0078 status: NOT_YET_RECRUITING city: Liege state: WLG zip: 4000 country: Belgium name: Site 0078 role: CONTACT lat: 50.63373 lon: 5.56749 facility: Local Institution - 0097 status: NOT_YET_RECRUITING city: Brussels zip: 1200 country: Belgium name: Site 0097 role: CONTACT lat: 50.85045 lon: 4.34878 facility: Local Institution - 0076 status: NOT_YET_RECRUITING city: Leuven zip: 3000 country: Belgium name: Site 0076 role: CONTACT lat: 50.87959 lon: 4.70093 facility: Local Institution - 0064 status: NOT_YET_RECRUITING city: Kelowna state: British Columbia zip: V1Y 4N7 country: Canada name: Site 0064 role: CONTACT lat: 49.88307 lon: -119.48568 facility: Local Institution - 0049 status: NOT_YET_RECRUITING city: West Vancouver state: British Columbia zip: V7T 2Z3 country: Canada name: Site 0049 role: CONTACT lat: 49.36672 lon: -123.16652 facility: Local Institution - 0112 status: NOT_YET_RECRUITING city: Ottawa state: Ontario zip: K1Z 8R7 country: Canada name: Site 0112 role: CONTACT lat: 45.41117 lon: -75.69812 facility: Local Institution - 0162 status: NOT_YET_RECRUITING city: Peterborough state: Ontario zip: K9H 2P4 country: Canada name: Site 0162 role: CONTACT lat: 44.30012 lon: -78.31623 facility: Local Institution - 0047 status: NOT_YET_RECRUITING city: Toronto state: Ontario zip: M3B 2S7 country: Canada name: Site 0047 role: CONTACT lat: 43.70011 lon: -79.4163 facility: Local Institution - 0044 status: NOT_YET_RECRUITING city: Toronto state: Ontario zip: M5T 2S8 country: Canada name: Site 0044 role: CONTACT lat: 43.70011 lon: -79.4163 facility: Local Institution - 0109 status: NOT_YET_RECRUITING city: Toronto state: Ontario zip: M6A 2E1 country: Canada name: Site 0109 role: CONTACT lat: 43.70011 lon: -79.4163 facility: Local Institution - 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 nctId: NCT06268873 id: D6972C00003 briefTitle: A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure. overallStatus: RECRUITING date: 2024-03-29 date: 2027-12-10 date: 2027-12-10 date: 2024-02-20 date: 2024-04-25 name: AstraZeneca class: INDUSTRY briefSummary: The purpose of this study is to measure the efficacy and safety of baxdrostat/dapagliflozin in participants ≥ 18 years of age with CKD and HTN. This study consists of a screening, a 4-week dapagliflozin run-in period for participants naïve to SGLT2i at baseline; a 24-month double-blind period in which participants will receive either baxdrostat/dapagliflozin or dapagliflozin; and a 6-week open-label period in which all participants will discontinue baxdrostat/placebo and receive dapagliflozin alone.

Site visits will take place at 2-, 4-, 8-, and 16- weeks following randomisation. Thereafter visits will occur approximately every 4 months, until the 24-month visit at which time baxdrostat/placebo will be discontinued. Participants will continue open-label dapagliflozin for another 6-weeks (approximately), where reassessment of GFR will occur for the primary efficacy endpoint. In the event of premature discontinuation of blinded study intervention, participants will continue in the study and receive open-label dapagliflozin monotherapy, unless the participant meets dapagliflozin specific discontinuation criteria, in which case all study interventions will be discontinued. conditions: Chronic Kidney Disease and Hypertension studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Placebo controlled whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 2500 type: ESTIMATED name: Baxdrostat/dapagliflozin name: Dapagliflozin in combination with placebo measure: To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone to slow CKD progression, assessed as the effect on change in eGFR over time. measure: To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone at reducing UACR (urine albumin-creatinine ratio). measure: To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone at reducing SBP. measure: To determine whether baxdrostat/dapagliflozin compared with dapagliflozin alone slows CKD progression and reduces the risk of ESKD (End-stage kidney disease). measure: To determine whether baxdrostat/dapagliflozin compared with dapagliflozin alone slows the rate of kidney function decline after the hemodynamically-mediated acute effect on GFR (Glomerular Filtration Rate). sex: ALL minimumAge: 18 Years maximumAge: 130 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site status: NOT_YET_RECRUITING city: Fairhope state: Alabama zip: 36532 country: United States lat: 30.52297 lon: -87.90333 facility: Research Site status: NOT_YET_RECRUITING city: Phoenix state: Arizona zip: 85016 country: United States lat: 33.44838 lon: -112.07404 facility: Research Site status: NOT_YET_RECRUITING city: Surprise state: Arizona zip: 85374 country: United States lat: 33.63059 lon: -112.33322 facility: Research Site status: NOT_YET_RECRUITING city: Searcy state: Arkansas zip: 72143 country: United States lat: 35.25064 lon: -91.73625 facility: Research Site status: NOT_YET_RECRUITING city: Beverly Hills state: California zip: 90211 country: United States lat: 34.07362 lon: -118.40036 facility: Research Site status: NOT_YET_RECRUITING city: Canyon Country state: California zip: 91351 country: United States lat: 34.42333 lon: -118.47203 facility: Research Site status: RECRUITING city: Fullerton state: California zip: 92835 country: United States lat: 33.87029 lon: -117.92534 facility: Research Site status: NOT_YET_RECRUITING city: Huntington Park state: California zip: 90255 country: United States lat: 33.98168 lon: -118.22507 facility: Research Site status: RECRUITING city: Lincoln state: California zip: 95648 country: United States lat: 38.89156 lon: -121.29301 facility: Research Site status: NOT_YET_RECRUITING city: Los Alamitos state: California zip: 90720 country: United States lat: 33.80307 lon: -118.07256 facility: Research Site status: NOT_YET_RECRUITING city: San Francisco state: California zip: 94110 country: United States lat: 37.77493 lon: -122.41942 facility: Research Site status: NOT_YET_RECRUITING city: Stanford state: California zip: 94305 country: United States lat: 37.42411 lon: -122.16608 facility: Research Site status: RECRUITING city: Tarzana state: California zip: 91356 country: United States lat: 34.17334 lon: -118.55397 facility: Research Site status: NOT_YET_RECRUITING city: Torrance state: California zip: 90502 country: United States lat: 33.83585 lon: -118.34063 facility: Research Site status: NOT_YET_RECRUITING city: Arvada state: Colorado zip: 80002 country: United States lat: 39.80276 lon: -105.08748 facility: Research Site status: NOT_YET_RECRUITING city: Denver state: Colorado zip: 80230 country: United States lat: 39.73915 lon: -104.9847 facility: Research Site 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facility: Research Site status: RECRUITING city: Hollywood state: Florida zip: 33021 country: United States lat: 26.0112 lon: -80.14949 facility: Research Site status: NOT_YET_RECRUITING city: Jacksonville state: Florida zip: 32204 country: United States lat: 30.33218 lon: -81.65565 facility: Research Site status: NOT_YET_RECRUITING city: Lake Worth state: Florida zip: 33467 country: United States lat: 26.61708 lon: -80.07231 facility: Research Site status: NOT_YET_RECRUITING city: Miami Lakes state: Florida zip: 33014 country: United States lat: 25.90871 lon: -80.30866 facility: Research Site status: RECRUITING city: Miami state: Florida zip: 33165 country: United States lat: 25.77427 lon: -80.19366 facility: Research Site status: NOT_YET_RECRUITING city: New Port Richey state: Florida zip: 34652 country: United States lat: 28.24418 lon: -82.71927 facility: Research Site status: NOT_YET_RECRUITING city: Ocoee state: Florida zip: 34761 country: United States lat: 28.56917 lon: 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41.85003 lon: -87.65005 facility: Research Site status: RECRUITING city: Hazel Crest state: Illinois zip: 60429 country: United States lat: 41.5717 lon: -87.69449 facility: Research Site status: NOT_YET_RECRUITING city: Huntley state: Illinois zip: 60142 country: United States lat: 42.16808 lon: -88.42814 facility: Research Site status: NOT_YET_RECRUITING city: Evansville state: Indiana zip: 47714 country: United States lat: 37.97476 lon: -87.55585 facility: Research Site status: NOT_YET_RECRUITING city: Fort Wayne state: Indiana zip: 46804 country: United States lat: 41.1306 lon: -85.12886 facility: Research Site status: RECRUITING city: Hutchinson state: Kansas zip: 67502 country: United States lat: 38.06084 lon: -97.92977 facility: Research Site status: NOT_YET_RECRUITING city: Wichita state: Kansas zip: 67214 country: United States lat: 37.69224 lon: -97.33754 facility: Research Site status: NOT_YET_RECRUITING city: Lexington state: Kentucky zip: 40503 country: United States lat: 37.98869 lon: -84.47772 facility: Research Site status: NOT_YET_RECRUITING city: Bethesda state: Maryland zip: 20889 country: United States lat: 38.98067 lon: -77.10026 facility: Research Site status: NOT_YET_RECRUITING city: Upper Marlboro state: Maryland zip: 20774 country: United States lat: 38.81595 lon: -76.74969 facility: Research Site status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02114 country: United States lat: 42.35843 lon: -71.05977 facility: Research Site status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 facility: Research Site status: NOT_YET_RECRUITING city: New Bedford state: Massachusetts zip: 02740 country: United States lat: 41.63622 lon: -70.93421 facility: Research Site status: RECRUITING city: Plymouth state: Massachusetts zip: 02360 country: United States lat: 41.95844 lon: -70.66726 facility: Research Site status: NOT_YET_RECRUITING city: Detroit state: Michigan zip: 48202 country: United States lat: 42.33143 lon: -83.04575 facility: Research Site status: NOT_YET_RECRUITING city: Pontiac state: Michigan zip: 48341 country: United States lat: 42.63892 lon: -83.29105 facility: Research Site status: NOT_YET_RECRUITING city: Saint Joseph state: Michigan zip: 49085 country: United States lat: 42.10976 lon: -86.48002 facility: Research Site status: NOT_YET_RECRUITING city: Columbia state: Missouri zip: 65201 country: United States lat: 38.95171 lon: -92.33407 facility: Research Site status: NOT_YET_RECRUITING city: Kansas City state: Missouri zip: 64111 country: United States lat: 39.09973 lon: -94.57857 facility: Research Site status: NOT_YET_RECRUITING city: Kansas City state: Missouri zip: 64128 country: United States lat: 39.09973 lon: -94.57857 facility: Research Site status: NOT_YET_RECRUITING city: Kansas City state: Missouri zip: 64151 country: United States lat: 39.09973 lon: -94.57857 facility: Research Site status: NOT_YET_RECRUITING city: Saint Louis state: Missouri zip: 63136 country: United States lat: 38.62727 lon: -90.19789 facility: Research Site status: NOT_YET_RECRUITING city: Saint Peters state: Missouri zip: 63376 country: United States lat: 38.80033 lon: -90.62651 facility: Research Site status: NOT_YET_RECRUITING city: Eatontown state: New Jersey zip: 07724 country: United States lat: 40.29622 lon: -74.05097 facility: Research Site status: NOT_YET_RECRUITING city: Binghamton state: New York zip: 13905 country: United States lat: 42.09869 lon: -75.91797 facility: Research Site status: NOT_YET_RECRUITING city: Buffalo state: New York zip: 14203 country: United States lat: 42.88645 lon: -78.87837 facility: Research Site status: NOT_YET_RECRUITING city: Middletown state: New York zip: 10940 country: United States lat: 41.44593 lon: -74.42293 facility: Research Site status: NOT_YET_RECRUITING city: New Hyde Park state: New York zip: 11042 country: United States lat: 40.7351 lon: -73.68791 facility: Research Site status: NOT_YET_RECRUITING city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 facility: Research Site status: NOT_YET_RECRUITING city: Niagara Falls state: New York zip: 14304 country: United States lat: 43.0945 lon: -79.05671 facility: Research Site status: NOT_YET_RECRUITING city: Orchard Park state: New York zip: 14127 country: United States lat: 42.76756 lon: -78.74392 facility: Research Site status: NOT_YET_RECRUITING city: Greenville state: North Carolina zip: 27834 country: United States lat: 35.61266 lon: -77.36635 facility: Research Site status: NOT_YET_RECRUITING city: Jacksonville state: North Carolina zip: 28546 country: United States lat: 34.75405 lon: -77.43024 facility: Research Site status: NOT_YET_RECRUITING city: New Bern state: North Carolina zip: 28562 country: United States lat: 35.10849 lon: -77.04411 facility: Research Site status: RECRUITING city: Statesville state: North Carolina zip: 28625 country: United States lat: 35.78264 lon: -80.8873 facility: Research Site status: NOT_YET_RECRUITING city: Wilmington state: North Carolina zip: 28401 country: United States lat: 34.22573 lon: -77.94471 facility: Research Site status: NOT_YET_RECRUITING city: Wilmington state: North Carolina zip: 28412 country: United States lat: 34.22573 lon: -77.94471 facility: Research Site status: NOT_YET_RECRUITING city: Columbus state: Ohio zip: 43213 country: United States lat: 39.96118 lon: -82.99879 facility: Research Site status: NOT_YET_RECRUITING city: Columbus state: Ohio zip: 43215 country: United States lat: 39.96118 lon: -82.99879 facility: Research Site status: NOT_YET_RECRUITING city: Maumee state: Ohio zip: 43537 country: United States lat: 41.56283 lon: -83.65382 facility: Research Site status: NOT_YET_RECRUITING city: Roseburg state: Oregon zip: 97471 country: United States lat: 43.2165 lon: -123.34174 facility: Research Site status: NOT_YET_RECRUITING city: Chester state: Pennsylvania zip: 19013 country: United States lat: 39.84967 lon: -75.35707 facility: Research Site status: NOT_YET_RECRUITING city: Langhorne state: Pennsylvania zip: 19047 country: United States lat: 40.17455 lon: -74.92267 facility: Research Site status: RECRUITING city: Uniontown state: Pennsylvania zip: 15401 country: United States lat: 39.90008 lon: -79.71643 facility: Research Site status: NOT_YET_RECRUITING city: East Providence state: Rhode Island zip: 02914 country: United States lat: 41.81371 lon: -71.37005 facility: Research Site status: NOT_YET_RECRUITING city: East Providence state: Rhode Island zip: 02915 country: United States lat: 41.81371 lon: -71.37005 facility: Research Site status: NOT_YET_RECRUITING city: Providence state: Rhode Island zip: 02904 country: United States lat: 41.82399 lon: -71.41283 facility: Research Site status: NOT_YET_RECRUITING city: Columbia state: South Carolina zip: 29203 country: United States lat: 34.00071 lon: -81.03481 facility: Research Site status: NOT_YET_RECRUITING city: Sioux Falls state: South Dakota zip: 57103 country: United States lat: 43.54997 lon: -96.70033 facility: Research Site status: NOT_YET_RECRUITING city: Kingsport state: Tennessee zip: 37660 country: United States lat: 36.54843 lon: -82.56182 facility: Research Site status: NOT_YET_RECRUITING city: Memphis state: Tennessee zip: 38105 country: United States lat: 35.14953 lon: -90.04898 facility: Research Site status: NOT_YET_RECRUITING city: Memphis state: Tennessee zip: 38115 country: United States lat: 35.14953 lon: -90.04898 facility: Research Site status: RECRUITING city: Arlington state: Texas zip: 76015 country: United States lat: 32.73569 lon: -97.10807 facility: Research Site status: NOT_YET_RECRUITING city: Austin state: Texas zip: 78751 country: United States lat: 30.26715 lon: -97.74306 facility: Research Site status: NOT_YET_RECRUITING city: Dallas state: Texas zip: 75230 country: United States lat: 32.78306 lon: -96.80667 facility: Research Site status: NOT_YET_RECRUITING city: Dallas state: Texas zip: 75231 country: United States lat: 32.78306 lon: -96.80667 facility: Research Site status: NOT_YET_RECRUITING city: Dallas state: Texas zip: 75246 country: United States lat: 32.78306 lon: -96.80667 facility: Research Site status: RECRUITING city: Houston state: Texas zip: 77004 country: United States lat: 29.76328 lon: -95.36327 facility: Research Site status: RECRUITING city: Houston state: Texas zip: 77040 country: United States lat: 29.76328 lon: -95.36327 facility: Research Site status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77079 country: United States lat: 29.76328 lon: -95.36327 facility: Research Site status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77084 country: United States lat: 29.76328 lon: -95.36327 facility: Research Site status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77099 country: United States lat: 29.76328 lon: -95.36327 facility: Research Site status: NOT_YET_RECRUITING city: Humble 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21.73444 facility: Research Site status: NOT_YET_RECRUITING city: Thessaloniki zip: 54636 country: Greece lat: 40.64361 lon: 22.93086 facility: Research Site status: NOT_YET_RECRUITING city: Thessaloniki zip: 54642 country: Greece lat: 40.64361 lon: 22.93086 facility: Research Site status: NOT_YET_RECRUITING city: Budapest zip: 1115 country: Hungary lat: 47.49801 lon: 19.03991 facility: Research Site status: NOT_YET_RECRUITING city: Békéscsaba zip: 5600 country: Hungary lat: 46.68333 lon: 21.1 facility: Research Site status: WITHDRAWN city: Dunaújváros zip: 2400 country: Hungary lat: 46.96498 lon: 18.93923 facility: Research Site status: NOT_YET_RECRUITING city: Kecskemét zip: 6000 country: Hungary lat: 46.90618 lon: 19.69128 facility: Research Site status: NOT_YET_RECRUITING city: Nyíregyháza zip: 4400 country: Hungary lat: 47.95539 lon: 21.71671 facility: Research Site status: NOT_YET_RECRUITING city: Pécs zip: 7624 country: Hungary lat: 46.08333 lon: 18.23333 facility: Research Site 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NOT_YET_RECRUITING city: Catanzaro zip: 88100 country: Italy lat: 38.88247 lon: 16.60086 facility: Research Site status: NOT_YET_RECRUITING city: Chiavari zip: 16034 country: Italy lat: 44.31771 lon: 9.32241 facility: Research Site status: NOT_YET_RECRUITING city: Desio zip: 20832 country: Italy lat: 45.61831 lon: 9.20249 facility: Research Site status: NOT_YET_RECRUITING city: Milano zip: 20142 country: Italy lat: 45.46427 lon: 9.18951 facility: Research Site status: NOT_YET_RECRUITING city: Napoli zip: 80131 country: Italy lat: 40.85216 lon: 14.26811 facility: Research Site status: NOT_YET_RECRUITING city: Parma zip: 43126 country: Italy lat: 44.79935 lon: 10.32618 facility: Research Site status: NOT_YET_RECRUITING city: Rozzano zip: 20089 country: Italy lat: 45.38193 lon: 9.1559 facility: Research Site status: NOT_YET_RECRUITING city: San Giovanni Rotondo zip: 71013 country: Italy lat: 41.70643 lon: 15.7277 facility: Research Site status: NOT_YET_RECRUITING city: Torino zip: 10126 country: Italy lat: 45.07049 lon: 7.68682 facility: Research Site status: NOT_YET_RECRUITING city: Chuo-ku zip: 103-0002 country: Japan lat: 35.57779 lon: 139.71685 facility: Research Site status: NOT_YET_RECRUITING city: Chuo-ku zip: 103-0027 country: Japan lat: 35.57779 lon: 139.71685 facility: Research Site status: NOT_YET_RECRUITING city: Chuo-ku zip: 103-0028 country: Japan lat: 35.57779 lon: 139.71685 facility: Research Site status: NOT_YET_RECRUITING city: Daito-shi zip: 574-0074 country: Japan facility: Research Site status: NOT_YET_RECRUITING city: Fujisawa-shi zip: 251-8550 country: Japan lat: 35.34926 lon: 139.47666 facility: Research Site status: NOT_YET_RECRUITING city: Fukuoka-shi zip: 815-8555 country: Japan lat: 33.6 lon: 130.41667 facility: Research Site status: NOT_YET_RECRUITING city: Hiroshima-shi zip: 730-8518 country: Japan lat: 34.4 lon: 132.45 facility: Research Site status: NOT_YET_RECRUITING city: Hiroshima zip: 732-0057 country: Japan lat: 34.4 lon: 132.45 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133.78333 facility: Research Site status: NOT_YET_RECRUITING city: Matsuyama-city zip: 790-0024 country: Japan lat: 33.83916 lon: 132.76574 facility: Research Site status: NOT_YET_RECRUITING city: Naka zip: 311-0113 country: Japan lat: 36.05 lon: 140.16667 facility: Research Site status: NOT_YET_RECRUITING city: Nishinomiya-Shi zip: 662-0918 country: Japan lat: 34.71562 lon: 135.33199 facility: Research Site status: NOT_YET_RECRUITING city: Obihiro-shi zip: 080-0848 country: Japan lat: 42.91722 lon: 143.20444 facility: Research Site status: NOT_YET_RECRUITING city: Oita-shi zip: 870-0033 country: Japan lat: 33.23333 lon: 131.6 facility: Research Site status: NOT_YET_RECRUITING city: Osaka-shi zip: 553-0003 country: Japan lat: 34.69374 lon: 135.50218 facility: Research Site status: NOT_YET_RECRUITING city: Osaka zip: 553-0003 country: Japan lat: 34.69374 lon: 135.50218 facility: Research Site status: NOT_YET_RECRUITING city: Sapporo zip: 064-8570 country: Japan lat: 43.06667 lon: 141.35 facility: Research Site status: NOT_YET_RECRUITING city: Shinjyuku-ku zip: 160-0022 country: Japan facility: Research Site status: NOT_YET_RECRUITING city: Shizuoka-shi zip: 421-0117 country: Japan lat: 34.98333 lon: 138.38333 facility: Research Site status: NOT_YET_RECRUITING city: Takatsuki-shi zip: 569-8686 country: Japan lat: 34.84833 lon: 135.61678 facility: Research Site status: NOT_YET_RECRUITING city: Toride-shi zip: 302-0022 country: Japan lat: 35.9 lon: 140.08333 facility: Research Site status: NOT_YET_RECRUITING city: Toyota-Shi zip: 471-8513 country: Japan lat: 35.08333 lon: 137.15 facility: Research Site status: NOT_YET_RECRUITING city: Tsu-shi zip: 514-8507 country: Japan lat: 34.73333 lon: 136.51667 facility: Research Site status: NOT_YET_RECRUITING city: Ueda-shi zip: 386-8610 country: Japan lat: 36.40265 lon: 138.28161 facility: Research Site status: NOT_YET_RECRUITING city: Urayasu zip: 279-0001 country: Japan lat: 35.67054 lon: 139.88862 facility: Research Site status: NOT_YET_RECRUITING city: Yaizu-shi zip: 425-8505 country: Japan lat: 34.86876 lon: 138.31951 facility: Research Site status: NOT_YET_RECRUITING city: Goyang-si zip: 10380 country: Korea, Republic of lat: 37.65639 lon: 126.835 facility: Research Site status: NOT_YET_RECRUITING city: Seoul zip: 03312 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Research Site status: NOT_YET_RECRUITING city: Seoul zip: 03722 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Research Site status: NOT_YET_RECRUITING city: Seoul zip: 06273 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Research Site status: NOT_YET_RECRUITING city: Seoul zip: 07061 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Research Site status: NOT_YET_RECRUITING city: Uijeongbu zip: 11765 country: Korea, Republic of lat: 37.7415 lon: 127.0474 facility: Research Site status: NOT_YET_RECRUITING city: Wonju-si zip: 26426 country: Korea, Republic of facility: Research Site status: NOT_YET_RECRUITING city: Yangsan-si zip: 50612 country: Korea, Republic of facility: Research Site status: NOT_YET_RECRUITING city: Klang zip: 41200 country: Malaysia lat: 3.03333 lon: 101.45 facility: Research Site status: NOT_YET_RECRUITING city: Kota Kinabalu zip: 88200 country: Malaysia lat: 5.9749 lon: 116.0724 facility: Research Site status: NOT_YET_RECRUITING city: Kuala Lumpur zip: 50586 country: Malaysia lat: 3.1412 lon: 101.68653 facility: Research Site status: NOT_YET_RECRUITING city: Kuala Lumpur zip: 59100 country: Malaysia lat: 3.1412 lon: 101.68653 facility: Research Site status: NOT_YET_RECRUITING city: Kuantan zip: 25200 country: Malaysia lat: 3.8077 lon: 103.326 facility: Research Site status: NOT_YET_RECRUITING city: Seremban zip: 70300 country: Malaysia lat: 2.7297 lon: 101.9381 facility: Research Site status: NOT_YET_RECRUITING city: Taiping zip: 34000 country: Malaysia lat: 4.85 lon: 100.73333 facility: Research Site status: NOT_YET_RECRUITING city: Alkmaar zip: 1815 JD country: Netherlands lat: 52.63167 lon: 4.74861 facility: Research Site status: WITHDRAWN city: Almere zip: 1315 RA country: Netherlands lat: 52.37535 lon: 5.25295 facility: Research Site status: NOT_YET_RECRUITING city: Amersfoort zip: 3813 TZ country: Netherlands lat: 52.155 lon: 5.3875 facility: Research Site status: NOT_YET_RECRUITING city: Dordrecht zip: 3318 AT country: Netherlands lat: 51.81 lon: 4.67361 facility: Research Site status: NOT_YET_RECRUITING city: Hardenberg zip: 7772 SE country: Netherlands lat: 52.57583 lon: 6.61944 facility: Research Site status: NOT_YET_RECRUITING city: Harderwijk zip: 3844 DG country: Netherlands lat: 52.34167 lon: 5.62083 facility: Research Site status: NOT_YET_RECRUITING city: Hilversum zip: 1213 XZ country: Netherlands lat: 52.22333 lon: 5.17639 facility: Research Site status: WITHDRAWN city: Roosendaal zip: 4708 AE country: Netherlands lat: 51.53083 lon: 4.46528 facility: Research Site status: NOT_YET_RECRUITING city: Tilburg zip: 5042AD country: Netherlands lat: 51.55551 lon: 5.0913 facility: Research Site status: NOT_YET_RECRUITING city: Utrecht zip: 3584 CX country: Netherlands lat: 52.09083 lon: 5.12222 facility: Research Site status: NOT_YET_RECRUITING city: Arequipa zip: AREQUIPA01 country: Peru lat: -16.39889 lon: -71.535 facility: Research Site status: NOT_YET_RECRUITING city: Chorrillos zip: Lima 9 country: Peru facility: Research Site status: NOT_YET_RECRUITING city: Lima zip: 15036 country: Peru lat: -12.04318 lon: -77.02824 facility: Research Site status: NOT_YET_RECRUITING city: Lima zip: 15046 country: Peru lat: -12.04318 lon: -77.02824 facility: Research Site status: NOT_YET_RECRUITING city: LIma zip: 15074 country: Peru lat: -12.04318 lon: -77.02824 facility: Research Site status: NOT_YET_RECRUITING city: Lima zip: 15088 country: Peru lat: -12.04318 lon: -77.02824 facility: Research Site status: NOT_YET_RECRUITING city: Lima zip: LIMA 01 country: Peru lat: 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Research Site status: NOT_YET_RECRUITING city: Żywiec zip: 34-300 country: Poland lat: 49.68529 lon: 19.19243 facility: Research Site status: NOT_YET_RECRUITING city: Bucharest zip: 014461 country: Romania lat: 44.43225 lon: 26.10626 facility: Research Site status: NOT_YET_RECRUITING city: Bucharest zip: 022328 country: Romania lat: 44.43225 lon: 26.10626 facility: Research Site status: NOT_YET_RECRUITING city: Bucharest zip: 040883 country: Romania lat: 44.43225 lon: 26.10626 facility: Research Site status: NOT_YET_RECRUITING city: Bucuresti zip: 010731 country: Romania lat: 44.42802 lon: 26.09665 facility: Research Site status: NOT_YET_RECRUITING city: Cluj Napoca zip: 400349 country: Romania lat: 46.76667 lon: 23.6 facility: Research Site status: NOT_YET_RECRUITING city: Iasi zip: 700503 country: Romania lat: 47.16667 lon: 27.6 facility: Research Site status: NOT_YET_RECRUITING city: Targu Mures zip: 540136 country: Romania lat: 46.54245 lon: 24.55747 facility: Research Site status: 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city: Nitra zip: 949 11 country: Slovakia lat: 48.30763 lon: 18.08453 facility: Research Site status: NOT_YET_RECRUITING city: Presov zip: 080 01 country: Slovakia lat: 48.99839 lon: 21.23393 facility: Research Site status: NOT_YET_RECRUITING city: Puchov zip: 020 01 country: Slovakia lat: 49.12494 lon: 18.32597 facility: Research Site status: NOT_YET_RECRUITING city: Rožňava zip: 048 01 country: Slovakia lat: 48.66009 lon: 20.53758 facility: Research Site status: NOT_YET_RECRUITING city: Trnava zip: 91708 country: Slovakia lat: 48.37741 lon: 17.58723 facility: Research Site status: NOT_YET_RECRUITING city: Zilina zip: 010 01 country: Slovakia lat: 49.22315 lon: 18.73941 facility: Research Site status: NOT_YET_RECRUITING city: Benoni zip: 1501 country: South Africa lat: -26.18848 lon: 28.32078 facility: Research Site status: NOT_YET_RECRUITING city: Bloemfontein zip: 9301 country: South Africa lat: -29.12107 lon: 26.214 facility: Research Site status: NOT_YET_RECRUITING city: Cape Town 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lat: 36.83814 lon: -2.45974 facility: Research Site status: NOT_YET_RECRUITING city: Badalona zip: 08916 country: Spain lat: 41.45004 lon: 2.24741 facility: Research Site status: NOT_YET_RECRUITING city: L'Hospitalet de Llobregat zip: 08907 country: Spain lat: 41.35967 lon: 2.10028 facility: Research Site status: NOT_YET_RECRUITING city: La Coruna zip: 15006 country: Spain lat: 43.37135 lon: -8.396 facility: Research Site status: NOT_YET_RECRUITING city: Lugo zip: 27004 country: Spain lat: 43.00992 lon: -7.55602 facility: Research Site status: NOT_YET_RECRUITING city: Madrid zip: 28040 country: Spain lat: 40.4165 lon: -3.70256 facility: Research Site status: NOT_YET_RECRUITING city: Malaga zip: 29010 country: Spain lat: 36.72016 lon: -4.42034 facility: Research Site status: NOT_YET_RECRUITING city: Málaga zip: 29010 country: Spain lat: 36.72016 lon: -4.42034 facility: Research Site status: NOT_YET_RECRUITING city: Palma deMallorca zip: 07010 country: Spain lat: 39.56939 lon: 2.65024 facility: Research Site status: NOT_YET_RECRUITING city: Pamplona zip: 31008 country: Spain lat: 42.81687 lon: -1.64323 facility: Research Site status: NOT_YET_RECRUITING city: Sevilla zip: 41950 country: Spain lat: 37.38283 lon: -5.97317 facility: Research Site status: NOT_YET_RECRUITING city: Valencia zip: 46010 country: Spain lat: 39.46975 lon: -0.37739 facility: Research Site status: NOT_YET_RECRUITING city: Danderyd zip: 182 57 country: Sweden lat: 59.3987 lon: 18.02942 facility: Research Site status: NOT_YET_RECRUITING city: Gavle zip: 80188 country: Sweden lat: 60.67452 lon: 17.14174 facility: Research Site status: NOT_YET_RECRUITING city: Göteborg zip: 413 46 country: Sweden lat: 57.70716 lon: 11.96679 facility: Research Site status: NOT_YET_RECRUITING city: Linkoping zip: 58185 country: Sweden lat: 58.41086 lon: 15.62157 facility: Research Site status: NOT_YET_RECRUITING city: Rättvik zip: 79530 country: Sweden lat: 60.88632 lon: 15.11787 facility: Research Site status: NOT_YET_RECRUITING city: Stockholm zip: 141 86 country: Sweden lat: 59.33258 lon: 18.0649 facility: Research Site status: NOT_YET_RECRUITING city: Uppsala zip: 751 85 country: Sweden lat: 59.85882 lon: 17.63889 facility: Research Site status: NOT_YET_RECRUITING city: Varberg zip: 43281 country: Sweden lat: 57.10557 lon: 12.25078 facility: Research Site status: NOT_YET_RECRUITING city: Kaohsiung City zip: 80756 country: Taiwan lat: 22.61626 lon: 120.31333 facility: Research Site status: NOT_YET_RECRUITING city: Kaohsiung zip: 81362 country: Taiwan lat: 22.61626 lon: 120.31333 facility: Research Site status: NOT_YET_RECRUITING city: Taichung zip: 402 country: Taiwan lat: 24.1469 lon: 120.6839 facility: Research Site status: NOT_YET_RECRUITING city: Taichung zip: 40447 country: Taiwan lat: 24.1469 lon: 120.6839 facility: Research Site status: NOT_YET_RECRUITING city: Taipei City zip: 110 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Research Site status: NOT_YET_RECRUITING city: Taipei zip: 10002 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Research Site status: NOT_YET_RECRUITING city: Taipei zip: 112 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Research Site status: NOT_YET_RECRUITING city: Yung Kang City zip: 71044 country: Taiwan facility: Research Site status: NOT_YET_RECRUITING city: Bangkok zip: 10330 country: Thailand lat: 13.75398 lon: 100.50144 facility: Research Site status: NOT_YET_RECRUITING city: Bangkok zip: 10700 country: Thailand lat: 13.75398 lon: 100.50144 facility: Research Site status: NOT_YET_RECRUITING city: Chiang Mai zip: 50200 country: Thailand lat: 18.79038 lon: 98.98468 facility: Research Site status: NOT_YET_RECRUITING city: Hat Yai zip: 90110 country: Thailand lat: 7.00836 lon: 100.47668 facility: Research Site status: NOT_YET_RECRUITING city: Muang zip: 34000 country: Thailand facility: Research Site status: NOT_YET_RECRUITING city: Muang zip: 40002 country: Thailand facility: Research Site status: NOT_YET_RECRUITING city: Phutthamonthon zip: 73170 country: Thailand facility: Research Site status: NOT_YET_RECRUITING city: Ratchathewi zip: 10400 country: Thailand lat: 13.759 lon: 100.53358 facility: Research Site status: NOT_YET_RECRUITING city: Adana zip: 01060 country: Turkey lat: 37.00167 lon: 35.32889 facility: Research Site status: NOT_YET_RECRUITING city: Adapazarı zip: 54100 country: Turkey lat: 40.78056 lon: 30.40333 facility: Research Site status: NOT_YET_RECRUITING city: Afyonkarahisar zip: 03030 country: Turkey lat: 38.75667 lon: 30.54333 facility: Research Site status: NOT_YET_RECRUITING city: Ankara zip: 06230 country: Turkey lat: 39.91987 lon: 32.85427 facility: Research Site status: NOT_YET_RECRUITING city: Antalya zip: 07059 country: Turkey lat: 36.90812 lon: 30.69556 facility: Research Site status: NOT_YET_RECRUITING city: Bursa zip: 16059 country: Turkey lat: 40.19559 lon: 29.06013 facility: Research Site status: NOT_YET_RECRUITING city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 facility: Research Site status: NOT_YET_RECRUITING city: Kahramanmaras zip: 46100 country: Turkey lat: 37.5847 lon: 36.92641 facility: Research Site status: NOT_YET_RECRUITING city: Kayseri zip: 38039 country: Turkey lat: 38.73222 lon: 35.48528 facility: Research Site status: NOT_YET_RECRUITING city: Kocaeli zip: 41380 country: Turkey lat: 39.62497 lon: 27.51145 facility: Research Site status: NOT_YET_RECRUITING city: Chernivtsі zip: 58002 country: Ukraine facility: Research Site status: NOT_YET_RECRUITING city: Ivano-Frankivsk zip: 76000 country: Ukraine lat: 48.9215 lon: 24.70972 facility: Research Site status: NOT_YET_RECRUITING city: Kyiv zip: 02081 country: Ukraine lat: 50.45466 lon: 30.5238 facility: Research Site status: NOT_YET_RECRUITING city: Kyiv zip: 02125 country: Ukraine lat: 50.45466 lon: 30.5238 facility: Research Site status: NOT_YET_RECRUITING city: Kyiv zip: 03037 country: Ukraine lat: 50.45466 lon: 30.5238 facility: Research Site status: NOT_YET_RECRUITING city: Kyiv zip: 03057 country: Ukraine lat: 50.45466 lon: 30.5238 facility: Research Site status: NOT_YET_RECRUITING city: Kyiv zip: 04050 country: Ukraine lat: 50.45466 lon: 30.5238 facility: Research Site status: NOT_YET_RECRUITING city: Ternopil zip: 46000 country: Ukraine lat: 49.55589 lon: 25.60556 facility: Research Site status: NOT_YET_RECRUITING city: Ternopil zip: 46001 country: Ukraine lat: 49.55589 lon: 25.60556 facility: Research Site status: NOT_YET_RECRUITING city: Uzhhorod zip: 88018 country: Ukraine lat: 48.61667 lon: 22.3 facility: Research Site status: NOT_YET_RECRUITING city: Vinnytsia zip: 21009 country: Ukraine lat: 49.23278 lon: 28.48097 facility: Research Site status: NOT_YET_RECRUITING city: Vinnytsia zip: 21018 country: Ukraine lat: 49.23278 lon: 28.48097 facility: Research Site status: NOT_YET_RECRUITING city: Vinnytsia zip: 21029 country: Ukraine lat: 49.23278 lon: 28.48097 facility: Research Site status: NOT_YET_RECRUITING city: Vinnytsya zip: 21001 country: Ukraine lat: 49.23278 lon: 28.48097 facility: Research Site status: NOT_YET_RECRUITING city: Bristol zip: BS105NB country: United Kingdom lat: 51.45523 lon: -2.59665 facility: Research Site status: NOT_YET_RECRUITING city: Cambridge zip: CB2 0XY country: United Kingdom lat: 52.2 lon: 0.11667 facility: Research Site status: NOT_YET_RECRUITING city: Harrow zip: HA3 7LT country: United Kingdom lat: 51.57142 lon: -0.33371 facility: Research Site status: NOT_YET_RECRUITING city: Leicester zip: LE1 5WW country: United Kingdom lat: 52.6386 lon: -1.13169 facility: Research Site status: NOT_YET_RECRUITING city: Liverpool zip: L9 7AL country: United Kingdom lat: 53.41058 lon: -2.97794 facility: Research Site status: NOT_YET_RECRUITING city: London zip: EC1A 2BE country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Research Site status: NOT_YET_RECRUITING city: London zip: SE5 9RJ country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Research Site status: NOT_YET_RECRUITING city: Newcastle-Under-Lyme zip: ST4 6QG country: United Kingdom lat: 53.0 lon: -2.23333 facility: Research Site status: NOT_YET_RECRUITING city: Nottingham zip: NG5 1PB country: United Kingdom lat: 52.9536 lon: -1.15047 facility: Research Site status: NOT_YET_RECRUITING city: Wolverhampton zip: WV10 0QP country: United Kingdom lat: 52.58547 lon: -2.12296 facility: Research Site status: NOT_YET_RECRUITING city: Bien Hoa zip: 810000 country: Vietnam lat: 10.94469 lon: 106.82432 facility: Research Site status: NOT_YET_RECRUITING city: Da Nang zip: 550000 country: Vietnam lat: 16.06778 lon: 108.22083 facility: Research Site status: WITHDRAWN city: Ha Noi zip: 100000 country: Vietnam lat: 20.47366 lon: 106.02292 facility: Research Site status: NOT_YET_RECRUITING city: Ho Chi Minh zip: 700000 country: Vietnam lat: 10.82302 lon: 106.62965 facility: Research Site status: NOT_YET_RECRUITING city: Hochiminh city zip: 700000 country: Vietnam lat: 10.82302 lon: 106.62965 hasResults: False

 nctId: NCT06268860 id: 20220015 briefTitle: A Study to Assess Bioavailability of Rocatinlimab (AMG 451) Vial and Prefilled Syringe in Healthy Participants overallStatus: RECRUITING date: 2024-02-15 date: 2024-08-29 date: 2024-08-29 date: 2024-02-20 date: 2024-04-12 name: Amgen class: INDUSTRY briefSummary: The primary objective of the study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) dose in a vial compared to a prefilled syringe in healthy participants. conditions: Atopic Dermatitis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 230 type: ESTIMATED name: Rocatinlimab vial injection name: Rocatinlimab prefilled syringe measure: Maximum Observed Serum Concentration (Cmax) of Rocatinlimab measure: Area Under the Serum Concentration-time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rocatinlimab measure: AUC From Time Zero to Infinity (AUCinf) of Rocatinlimab measure: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE) measure: Number of Participants Experiencing Serious Adverse Events (SAE) measure: Number of Participants Positive to Anti-rocatinlimab Antibody sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fortrea Clinical Research Unit - Daytona Beach status: RECRUITING city: Daytona Beach state: Florida zip: 32117-5116 country: United States lat: 29.21081 lon: -81.02283 facility: Fortrea Clinical Research Unit - Dallas status: RECRUITING city: Dallas state: Texas zip: 75247-4968 country: United States lat: 32.78306 lon: -96.80667 facility: Fortrea Clinical Research Unit Limited - Leeds status: RECRUITING city: Leeds state: LDS zip: LS2 9LH country: United Kingdom lat: 53.79648 lon: -1.54785 hasResults: False

 nctId: NCT06268847 id: DERMATIDYSS briefTitle: Efficacy of Marine By-product Hydrolysate on the Reduction of Atopic Dermatitis Symptoms overallStatus: RECRUITING date: 2024-01-09 date: 2024-06-18 date: 2024-06-18 date: 2024-02-20 date: 2024-02-20 name: Abyss Ingredients class: INDUSTRY name: Eurofins briefSummary: This interventional, double-blind, randomized, placebo-controlled study aims to evaluate the effect of a marine by-product hydrolysate supplementation on the reduction of atopic dermatitis symptoms. conditions: Atopic Dermatitis conditions: Eczema studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 108 type: ESTIMATED name: Placebo name: ACT01 name: ACT02 measure: SCORAD (SCORing Atopic Dermatitis) measure: EASI (Eczema Area and Severity Index) measure: Investigator Global Assessment scale measure: Corneometer measure: Tewameter measure: Quality of Life Index - Perceived Stress measure: Participant's Satisfaction sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Eurofins status: RECRUITING city: Barcelona zip: 08013 country: Spain name: Jessica Zumaquero role: CONTACT phone: +34 932 85 14 46 phoneExt: 1110 email: JessicaZumaquero@eurofins.com lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06268834 id: ZonulinPPI briefTitle: Is Long-Term Proton Pump Inhibitor Use a Cause of Leaky Gut Syndrome overallStatus: COMPLETED date: 2023-10-04 date: 2023-12-31 date: 2023-12-31 date: 2024-02-20 date: 2024-02-20 name: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital class: OTHER briefSummary: Our study aims to investigate the effect of bacterial overgrowth induced by long-term PPI use on zonulin levels. conditions: Proton Pump Inhibitor Adverse Reaction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment primaryPurpose: PREVENTION masking: NONE count: 75 type: ACTUAL name: Blood for zonulin level was drawn from the group. measure: Zonulin levels in long-term proton pump inhibitor users sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06268821 id: ADC-UK-PMS-23059 briefTitle: Effect on HbA1c of the Initiation of CGM in Adults With Type 2 Diabetes Treated With Basal Insulin in Finland overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-01 date: 2025-01 date: 2024-02-20 date: 2024-02-20 name: Abbott Diabetes Care class: INDUSTRY briefSummary: The goal of this clinical study is to determine the impact of starting the use of the FreeStyle Libre 2 glucose monitoring system, over a three month period, on HbA1c in adults with type 2 diabetes treated with a basal insulin regimen. conditions: Type 2 Diabetes Treated With Insulin studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 82 type: ESTIMATED name: FreeStyle Libre 2 Flash Glucose Monitoring System measure: HbA1c measure: Time in range (TIR) measure: Time above range (TAR) measure: Time below range (TBR) measure: Frequency of hypoglycaemia events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pihlajalinna Jämsä, Välikatu 1, city: Jämsä zip: 42100 country: Finland name: Henri Honka, MD, PhD role: CONTACT lat: 61.8642 lon: 25.19002 facility: Pihlajalinna Koskiklinikka, Hatanpäänvaltatie 1, city: Tampere zip: 33100 country: Finland name: Elina Pimiä, MD role: CONTACT lat: 61.49911 lon: 23.78712 hasResults: False

 nctId: NCT06268808 id: ADC-UK-PMS-23058 briefTitle: Initiation of Continuous Glucose Monitoring in Adults With Type 2 Diabetes Treated With Basal Insulin, in Italy overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-12 date: 2024-12 date: 2024-02-20 date: 2024-02-20 name: Abbott Diabetes Care class: INDUSTRY briefSummary: The goal of this clinical study is to determine the impact of starting the use of the FreeStyle Libre 2 glucose monitoring system, over a three month period, on HbA1c in adults with type 2 diabetes treated with a basal insulin regimen. conditions: Type 2 Diabetes Treated With Insulin studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 82 type: ESTIMATED name: FreeStyle Libre 2 Flash Glucose Monitoring System measure: HbA1c measure: Time in range (TIR) measure: Time above range (TAR) measure: Time below range (TBR) measure: Frequency of hypoglycaemia events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari city: Bari country: Italy name: Francesco Giorgino role: CONTACT lat: 41.11148 lon: 16.8554 facility: Università degli Studi di Catania, Ospedale Garibaldi-Nesima, U.O. Endocrinologia city: Catania country: Italy name: Lucia Frittitta role: CONTACT lat: 37.49223 lon: 15.07041 facility: Università degli Studi di Catania, Ospedale Garibaldi-Nesima, U.O.C. Medicina Interna city: Catania country: Italy name: Salvatore Piro role: CONTACT lat: 37.49223 lon: 15.07041 facility: Azienda Ospedaliera - Università di Padova city: Padova country: Italy name: Gian Paolo Fadini role: CONTACT lat: 45.40797 lon: 11.88586 facility: Azienda Ospedaliero-Universitaria di Parma city: Parma country: Italy name: Riccardo Bonadonna role: CONTACT lat: 44.79935 lon: 10.32618 facility: La Sapienza Università di Roma, AOU Policlinico Umberto I city: Rome country: Italy name: Raffaella Buzzetti role: CONTACT lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06268795 id: BASE briefTitle: A Diagnostic Test Accuracy Study Comparing Biopsy to Aspiration in Shoulder and Elbow Arthroplasty Revision Surgery (BASE Study) overallStatus: RECRUITING date: 2024-03-20 date: 2028-09-01 date: 2028-09-01 date: 2024-02-20 date: 2024-04-24 name: Wrightington, Wigan and Leigh NHS Foundation Trust class: OTHER briefSummary: The aim of this study is to compare the diagnostic accuracy of percutaneous aspiration against open biopsy, using microbiological and histological methods, for the detection of shoulder and elbow periprosthetic joint infection (PJI). This is to establish the utility of pre-operative joint aspiration in the treatment pathway for shoulder and elbow PJI. conditions: Periprosthetic Joint Infection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 244 type: ESTIMATED measure: Comparison of diagnostic accuracy measure: Culture analysis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wrightington Wigan & Leigh Teaching Hospitals NHS Foundation Trust status: RECRUITING city: Wigan state: Lancashire zip: WN6 9EP country: United Kingdom name: Zaid Z Hamoodi role: CONTACT email: zaid.hamoodi@nhs.net lat: 53.54295 lon: -2.63705 hasResults: False

 nctId: NCT06268782 id: 1204202118 briefTitle: The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women overallStatus: COMPLETED date: 2021-09-21 date: 2023-01-24 date: 2023-09-19 date: 2024-02-20 date: 2024-02-22 name: University of Turku class: OTHER name: Finnish Cultural Foundation briefSummary: The aim of this quasi-experimental study was to assess the effectiveness of a 6-week online exercise program on self-assessed quality of life (QoL), physical activity (PA), and dysfunctions of pelvic floor muscles of postpartum women immediately and 6 months after the online intervention. The data were collected with e-questionnaires. The data collection started in September 2021 and ended in September 2023. conditions: Quality of Life conditions: Physical Activity conditions: Urinary Incontinence conditions: Pelvic Organ Prolapse studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 308 type: ACTUAL name: Rehabilitate your core measure: Quality of Life measure: Physical activity measure: Urinary incontinence measure: Pelvic organ prolapse sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Nursing Science, Faculty of Medicine, University of Turku city: Turku zip: 20014 country: Finland lat: 60.45148 lon: 22.26869 hasResults: False

 nctId: NCT06268769 id: TaC:Drop id: 2023-503531-18-00 type: OTHER domain: EUCT Number briefTitle: Tacrolimus C:D Ratio Measured in Renal Transplant Recipients Treated With Once-daily Prolonged-release Drugs acronym: TaC:Drop overallStatus: RECRUITING date: 2024-03-09 date: 2026-12 date: 2029-09 date: 2024-02-20 date: 2024-04-08 name: Edward Geissler class: OTHER name: Chiesi Pharmaceuticals GmbH briefSummary: The goal of this clinical trial is to compare the bioavailability and practicability of two different formulations of tacrolimus in kidney transplant recipients. The main objective is to demonstrate that Envarsus® (test drug) has superior (higher) oral bioavailability compared with Advagraf™ (comparator drug) at 12 weeks after kidney transplantation. The trial also aims to compare the practicability (handling) of the two drugs using a series of pharmacokinetic parameters and to explore the relationship between drug bioavailability and long-term clinical outcomes, with a special focus on dose-dependent adverse reactions, measured until 3 years post-transplantation. The trial incorporates a pharmacokinetic sub-study designed to profile the peak tacrolimus blood concentration up to 6 hours after drug intake on the day of the 12-week study visit. conditions: Immunosuppression studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A dynamic allocation technique assigns participants in a 1:1 ratio to one of two treatment arms: Envarsus tablets (test IMP) or Advagraf capsules (comparator IMP). Randomisation is stratified by two factors: a) trial site, in order to minimise systematic treatment bias at the level of the trial centre and reduce the influence of inter-centre variability, and b) participation in the optional pharmacokinetic sub-study, in order to ensure an equal representation of Envarsus- and Advagraf-treated patients in the sub-study. primaryPurpose: PREVENTION masking: NONE count: 300 type: ESTIMATED name: Tacrolimus Pill name: Tacrolimus capsule measure: Dose-normalised blood trough level of tacrolimus (concentration/dose ratio) measure: Time to reach the first trough level in target range measure: Proportion of patients with trough levels lower, within, or higher than the target range measure: Mean tacrolimus trough level and inter-patient variability (range) of tacrolimus trough levels measure: Mean daily dose of tacrolimus and inter-patient variability (range) of tacrolimus daily dose measure: Tacrolimus concentration/dose (C/D) ratio measure: Intra-patient variability of C/D ratio and daily dose measure: Treatment failure rate measure: Time to treatment failure after transplantation measure: Incidence rate, severity and time to clinically-confirmed biopsy-proven acute rejection measure: Incidence rate of graft failure measure: Mortality rate measure: Graft function measured by eGFR (estimated glomerular filtration rate) measure: Incidence rate of for-cause biopsies measure: Incidence rate of acute rejection episodes requiring treatment measure: Incidence rate of steroid-resistant episodes of biopsy-proven acute rejection measure: Incidence rate of delayed graft function measure: Incidence rate of primary non-function of the renal allograft measure: Incidence of hepatotoxicity measure: Incidence of CMV and BKV infection (including organ manifestation, if relevant) measure: Incidence, type, severity and seriousness of adverse reactions (ARs) measure: Blood pressure measure: Incidence of de novo tremor measure: Incidence of gastrointestinal disorders requiring diagnostic investigation measure: Incidence of new onset diabetes mellitus after transplantation (NODAT) measure: Recurrence of primary kidney disease measure: Incidence of de novo DSA measure: Patient-reported health-related quality-of-life measured using the Kidney Transplant Questionnaire-34 (KTQ-34) measure: Doses and duration of glucocorticosteroid treatment measure: Dose of mycophenolate measure: Incidence and time to study treatment discontinuation measure: Incidence, time to and reason for patient withdrawal from study sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Charité Universitätsmedizin, Department of Nephrology and Medical Intensive Care status: NOT_YET_RECRUITING city: Berlin zip: 10117 country: Germany name: Klemens Budde, Prof. Dr. role: CONTACT lat: 52.52437 lon: 13.41053 facility: University Hospital Dresden, Division of Nephrology status: RECRUITING city: Dresden zip: 01307 country: Germany name: Christian Hugo, Prof. Dr. role: CONTACT lat: 51.05089 lon: 13.73832 facility: University Medical Center Hamburg-Eppendorf, Internal Medicine III (Nephrology, Rheumatology, Endocrinology) status: NOT_YET_RECRUITING city: Hamburg zip: 20251 country: Germany name: Malte A. Kluger, PD Dr. role: CONTACT lat: 53.57532 lon: 10.01534 facility: University Medical Center of the Johannes Gutenberg University Mainz, Medical Clinic I. (Nephrology) status: NOT_YET_RECRUITING city: Mainz zip: 55131 country: Germany name: Julia Weinmann-Menke, Prof. Dr. role: CONTACT lat: 49.98419 lon: 8.2791 facility: University Hospital Regensburg, Department of Nephrology status: RECRUITING city: Regensburg zip: 93053 country: Germany name: Edward K. Geissler, PhD role: CONTACT phone: +49 941 944 phoneExt: 6961 email: edward.geissler@ukr.de name: Bernhard Banas, MD, PhD role: CONTACT phone: +49 941 944 phoneExt: 7301 email: bernhard.banas@ukr.de lat: 49.01513 lon: 12.10161 hasResults: False

 nctId: NCT06268756 id: 2023_RIPH_020_RESANXIEST briefTitle: Fear of Other's Judgment, Self-esteem and Use of Social Networks Among Students acronym: RESANXIEST overallStatus: RECRUITING date: 2024-02-07 date: 2024-04-07 date: 2024-06-07 date: 2024-02-20 date: 2024-02-20 name: Université de Reims Champagne-Ardenne class: OTHER briefSummary: Fear of being judged negatively by others can lead to avoidance of social situations or even social isolation. If the intensity of this fear is excessive and results in significant impairment of functioning or significant suffering, the subject may suffer from social anxiety.

The considerable growth of social networks in a decade has led to the emergence of new behaviors among young people. Individuals spend on average 2 hours and 27 minutes per day with differences in usage: time spent, social network used, function sought. The use of these networks may be reasonable and moderate but may also be excessive and abusive (Amnon, 2014). Some authors even talk about addiction or dependence on social networks (Perales and Billieux, 2020) even if the existence of this disorder is not consensus.

People who fear being judged negatively by others may be more at risk of misuse of social networks. Indeed, the use of social networks would compensate for their existing problems (Kardefelt-Winther, 2014) and would thus be a new emotional management strategy. It would also reduce dreaded social situations such as face-to-face exchanges (Weidman and Rodebaugh, 2012; Yen and Ko, 2012). Self-esteem is defined as a subjective judgment of oneself in relation to one's values and vision of the real and ideal self (Rosenberg. 1979). The greater the gap between the vision of the real self and the ideal self, the lower the self-esteem. conditions: Self-esteem studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 500 type: ESTIMATED name: Data collection measure: Rosenberg Self-esteem Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ufr Medecine Urca status: RECRUITING city: Reims zip: 51100 country: France name: Coralie Barbe role: CONTACT phone: 326913665 phoneExt: +33 email: coralie.barbe1@univ-reims.fr lat: 49.25 lon: 4.03333 facility: Université de Reims Champagne Ardenne status: RECRUITING city: Reims zip: 51100 country: France name: CURRS CURRS role: CONTACT phone: 0326918822 email: currs@univ-reims.fr lat: 49.25 lon: 4.03333 hasResults: False

 nctId: NCT06268743 id: 2023-114 briefTitle: Effects of a Combined Exercise Intervention on the Gut Microbiome of People With Type 2 Diabetes acronym: GUTFIT overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-08 date: 2026-08 date: 2024-02-20 date: 2024-03-01 name: University of New Brunswick class: OTHER name: Laval University briefSummary: The goal of this experimental trial is to learn about the changes in bacterial diversity in individuals with type 2 diabetes who perform endurance and strength training at different intensities.

Participants with type 2 diabetes will be randomly assigned to 16 weeks of either moderate-intensity endurance and strength training or high-intensity endurance and strength training.

Researchers will compare the moderate-intensity and high-intensity exercise groups for differences in glycemia and bacterial diversity. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel group, single blinded, randomized trial primaryPurpose: PREVENTION masking: SINGLE whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: High intensity name: Moderate intensity measure: Glycemic control through glycated hemoglobin measure: Gut microbiome diversity through 16S ribosomal RNA genes sex: ALL minimumAge: 19 Years maximumAge: 64 Years stdAges: ADULT hasResults: False

 nctId: NCT06268730 id: 23-2437 briefTitle: Effects of SinuSonic on Psychological and Physical Well-Being overallStatus: RECRUITING date: 2024-03-28 date: 2024-07 date: 2024-07 date: 2024-02-20 date: 2024-03-29 name: University of North Carolina, Chapel Hill class: OTHER name: Healthy Humming, LLC briefSummary: The goal of this clinical trial is to evaluate the effects of using the SinuSonic on psychological and physical well-being in adults who have nasal/sinus congestion.

The study aims are:

* Aim #1: to evaluate the effect of the SinuSonic on physical and psychological well-being in individuals with chronic nasal congestion;
* Aim #2: to evaluate the relationship between autonomic reactivity and psychological well-being (i.e., anxiety and depression) in individuals with chronic nasal congestion;
* Exploratory Aim: to evaluate the impact of adverse experiences on physical and psychological well-being in individuals who experience chronic nasal congestion.

Participants will be asked to complete self-report measures of physical health, mental health and autonomic regulation before using SinuSonic (i.e., baseline research session) and after 5 weeks of directed use (post-intervention). Demographic information and adverse experiences will be documented during the baseline research session. Participants will be asked to document (weekly) current nasal symptoms and SinuSonic usage. conditions: Nasal Congestion and Inflammations conditions: Sinus Congestion Chronic studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All participants will follow the same procedures. primaryPurpose: BASIC_SCIENCE masking: NONE count: 50 type: ESTIMATED name: SinuSonic measure: Change in the Anxiety Subscale of the Hospital Anxiety and Depression Scale measure: Change in the Depression Subscale of the Hospital Anxiety and Depression Scale measure: Change in the Body Perception Questionnaire measure: Change in the Total Nasal Symptom Score measure: Change in the Patient Global Impression of Change measure: Adverse Traumatic Experiences Survey at Baseline measure: Short Form Health Survey (SF-20) at Baseline sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of North Carolina at Chapel Hill status: RECRUITING city: Chapel Hill state: North Carolina zip: 27599-7160 country: United States name: Keri J Heilman, PhD role: CONTACT email: keri_heilman@med.unc.edu name: Keri J Heilman, PhD role: PRINCIPAL_INVESTIGATOR lat: 35.9132 lon: -79.05584 hasResults: False

 nctId: NCT06268717 id: 23-0316 briefTitle: GI Alpha-Gal Study overallStatus: RECRUITING date: 2023-10-17 date: 2024-10-17 date: 2025-10-17 date: 2024-02-20 date: 2024-02-20 name: University of North Carolina, Chapel Hill class: OTHER name: Revivicor, Inc briefSummary: This is a double-blind, crossover food challenge study using pork with and without α-gal in patients with a clinical diagnosis of gastrointestinal (GI)- α-gal allergy, and to investigate the pathophysiology underlying their symptoms. conditions: Alpha-Gal Syndrome conditions: Irritable Bowel Syndrome conditions: Diarrhea conditions: Abdominal Pain conditions: Vomiting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Double-blind crossover. Each participant will be randomized to undergo two double-blind food challenges with at least a 10-day washout period between the challenges. One food challenge will contain pork meat containing alpha-gal sugar; one challenge will contain pork meat without alpha-gal sugar. primaryPurpose: OTHER masking: QUADRUPLE maskingDescription: The principal investigator and clinical research coordinators will be blinded to the challenges during the course of the study. The metabolic kitchen and a delegated research staff member will be unblinded. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Ground pork containing alpha-gal name: Pork meat not containing alpha-gal measure: Allergic reaction (food challenge positive) measure: No allergic reaction (food challenge negative) measure: Lactulose excretion measure: C13 mannitol excretion measure: Basophil activation threshold response at timepoint 0 measure: Basophil activation threshold response at 2 hours measure: Basophil activation threshold response at 4 hours measure: Basophil activation threshold response at 6 hours measure: Serum tryptase at timepoint 0 measure: Serum tryptase at 2 hours measure: Serum tryptase at 4 hours measure: Serum tryptase at 6 hours measure: Mast cell count on stomach biopsies (per high powered field (hpf)) measure: Mast cell count on small bowel biopsies (per high powered field (hpf)) measure: Eosinophil cell count on stomach biopsies (per high powered field (hpf)) measure: Eosinophil cell count on small bowel biopsies (per high powered field (hpf)) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of North Carolina at Chapel Hill status: RECRUITING city: Chapel Hill state: North Carolina zip: 27599 country: United States name: Sarah McGill, MD role: CONTACT phone: 919-966-7047 email: mcgills@email.unc.edu name: Sarah McGill, MD role: PRINCIPAL_INVESTIGATOR lat: 35.9132 lon: -79.05584 hasResults: False

 nctId: NCT06268704 id: UNM HRRC #23-503 briefTitle: Particulate vs. Non-Particulate Steroid for Sacroiliac Joint Injection overallStatus: RECRUITING date: 2024-03-27 date: 2025-01-01 date: 2025-05-01 date: 2024-02-20 date: 2024-03-29 name: University of New Mexico class: OTHER briefSummary: This study will compare two different corticosteroids (dexamethasone and methylprednisolone) for use in sacroiliac joint injections to treat SI joint pain. conditions: Sacroiliac Joint Dysfunction conditions: Sacro-Iliac Spondylosis studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 230 type: ESTIMATED name: Dexamethasone name: Methylprednisolone name: 2% Lidocaine HCl Injection measure: Pain using Numeric Pain Rating Score sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of New Mexico Hospital status: RECRUITING city: Albuquerque state: New Mexico zip: 87131 country: United States name: Mark W Shilling, BS role: CONTACT phone: 505-925-7599 email: mwshilling@salud.unm.edu lat: 35.08449 lon: -106.65114 hasResults: False

 nctId: NCT06268691 id: ProjectCOLOMBIA-ZMG.U-Freiburg briefTitle: Sustainable Reduction of Dengue in Colombia: Vector Breeding Site Intervention With an Insecticidal Coating overallStatus: COMPLETED date: 2019-02-04 date: 2019-09-02 date: 2023-07-31 date: 2024-02-20 date: 2024-02-20 name: Rocio Cardenas Sanchez class: OTHER name: Göteborg University name: Instituto Nacional de Salud, Colombia name: Instituto Departamental de Salud de Norte de Santander name: Universidad Francisco de Paula de Santander briefSummary: Effective control of Aedes aegypti mosquitoes in breeding sites with high reproductive rates could have a major impact on reducing arbovirosis in endemic communities. The application of a safe, effective, low cost and sustained insecticide coating (IC) could be an affordable response to dengue for local health services. Therefore, a cluster randomised trial for the application of a new vector control tool (insecticidal coating of water containers) was conducted in the metropolitan area of Cúcuta, Colombia. The IC is an aqueous solution containing polymeric microcapsules of insecticides and insect growth regulators (pyriproxyfen-PPF (0.063%) and alphacypermertrin-ACM (0.07%) in suspension, without interaction between them, development by INESFLY®, Spain.

The main questions it aims to answer are:

Whether the control of the main breeding sites of Aedes mosquitoes, through the application of insecticide coating, in clusters of dwellings, could reduce dengue transmission in a sustainable way, compared to untreated clusters, in Cúcuta, Colombia.

Whether the control of the main breeding sites of Aedes mosquitoes through the application of insecticide coating, in clusters of dwellings, could reduce the Aedes Indices in a sustainable way, compared to untreated clusters. The initial preparation phases: i) socialization ii) A safety evaluation to determine the health risks of IC in domestic water containers; iii) The determination of the effects and efficacy of IC on Aedes aegypti.

The Baseline study to characterise the study clusters from entomological, epidemiological and socio-economic approaches was carried out in 2019-2020. The IC application phase in the intervention arm was carried out between Nov-2021 and Jan-2022, with the respective monitoring of the safety of IC use. This was followed by entomological monitoring. Finally, the 9-month post-intervention evaluation. Epidemiological data were obtained from the National Public Health Surveillance System - SIVIGILA.

The study was conducted in 20 clusters of 2000 dwellings each, where 10 clusters were randomly assigned to the control arm and 10 clusters to the intervention arm.

In order to determine the effect of IC application in household tanks, the dengue incidence and entomological indices are compared in the study clusters. The data are analysed under the difference in difference approach. Additionally, the acceptance of IC in the intervened communities and local health services is determined. conditions: Dengue conditions: Vector Borne Diseases conditions: Arbovirus Infections conditions: Zika conditions: Chikungunya Fever studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A cluster randomised trial for the application of a new vector control tool (insecticide coating of water containers) was conducted in the metropolitan area of Cúcuta, Colombia. Each cluster comprising approximately 2,000 dwellings. primaryPurpose: PREVENTION masking: NONE count: 35000 type: ACTUAL name: Insecticide Coating INESFLY measure: Change of dengue incidence for 12 months measure: Change of vector densities estimated through larval and pupal indices. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Instituto Departamental de Salud de Norte de Santander city: Cúcuta state: Norte De Santander zip: 540001 country: Colombia lat: 7.89391 lon: -72.50782 facility: Centre for Medicine and Society city: Freiburg state: Baden-Württemberg zip: 79098 country: Germany lat: 47.9959 lon: 7.85222 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2019-03-11 uploadDate: 2024-02-12T15:19 filename: Prot_000.pdf size: 2263350 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2019-03-11 uploadDate: 2024-02-12T15:19 filename: SAP_001.pdf size: 768947 hasResults: False

 nctId: NCT06268678 id: 4539513 briefTitle: The Effect of Menstrual Cycle Phase on Muscle Protein Synthesis overallStatus: RECRUITING date: 2023-12-08 date: 2025-01-30 date: 2025-01-30 date: 2024-02-20 date: 2024-02-20 name: University of Exeter class: OTHER name: Pvolve briefSummary: The combination of dietary protein ingestion and resistance exercise are essential to increase muscle protein synthesis. The vast majority of studies assessing protein intake following resistance exercise in young adults has been conducted exclusively in men or in studies where both men and women are assessed. The increase in muscle mass is thought to be impacted by sex hormones that fluctuate across different phases of the menstrual cycle. However, the effect of menstrual cycle phase on muscle protein synthesis following exercise is not known. conditions: Menstrual Cycle Phase conditions: Muscle Protein Synthesis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomised cross-over design. primaryPurpose: BASIC_SCIENCE masking: NONE count: 15 type: ESTIMATED name: Phase of the menstrual cycle measure: Muscle protein synthesis measure: Plasma amino acid kinetics measure: Serum insulin concentrations measure: Sex hormone concentrations measure: Energy expenditure sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: University of Exeter status: RECRUITING city: Exeter state: Devon zip: EX1 2LT country: United Kingdom name: Marianna Apicella role: CONTACT lat: 50.7236 lon: -3.52751 hasResults: False

 nctId: NCT06268665 id: UCDCC307 briefTitle: Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy overallStatus: NOT_YET_RECRUITING date: 2024-02-28 date: 2027-02 date: 2027-06 date: 2024-02-20 date: 2024-02-20 name: Eve Rodler class: OTHER briefSummary: This is a single institution phase II randomized study evaluating the potential benefits of a supplement, tart cherry juice at high- versus low-doses, to prevent taxane induced peripheral neuropathy in breast and ovarian cancer patients undergoing paclitaxel chemotherapy.

Eligible participants enrolled onto the study will be block randomized in a 1:1 allocation to either the tart cherry juice high-dose group (Arm 1) or the tart cherry juice low-dose group (Arm 2). conditions: Breast Cancer conditions: Breast Cancer Stage I conditions: Breast Cancer Stage II conditions: Breast Cancer Stage III conditions: Breast Cancer Stage IV conditions: Invasive Breast Cancer conditions: Ovarian Cancer conditions: Ovarian Cancer Stage 1 conditions: Ovarian Cancer Stage II conditions: Ovarian Cancer Stage III conditions: Ovarian Cancer Stage IV conditions: Ovarian Cancer Stage IA conditions: Ovarian Cancer Stage IB conditions: Ovarian Cancer Stage IC conditions: Ovarian Cancer Stage 2 conditions: Ovarian Cancer Stage 3 conditions: Ovarian Cancer Stage IIIb conditions: Ovarian Cancer Stage IIIC conditions: Breast Cancer Stage IIIA conditions: Breast Cancer Invasive conditions: Breast Cancer, Stage IA conditions: Breast Cancer, Stage IB conditions: Breast Cancer Stage IIA conditions: Breast Cancer Stage IIB conditions: Breast Cancer Stage IIIB conditions: Breast Cancer Stage IIIc conditions: Cancer, Breast conditions: Tumors, Breast conditions: Mammary Cancer conditions: Mammary Carcinoma conditions: Breast Carcinoma conditions: Breast Neoplasm conditions: Malignant Breast Neoplasm conditions: Malignant Tumor of Breast conditions: Cancer of Ovary conditions: Ovary Cancer conditions: Ovary Neoplasm studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 86 type: ESTIMATED name: Tart Cherry Juice measure: Efficacy of tart cherry juice supplementation in the prevention of paclitaxel-induced peripheral neuropathy (PIPN) in breast and ovarian cancer patients undergoing treatment with paclitaxel-based chemotherapy. measure: Compare the effectiveness of high- dose and low-dose tart cherry juice supplement in reducing the severity of PIPN in breast and ovarian cancer patients undergoing treatment with paclitaxel-based chemotherapy. measure: Assess the impact of tart cherry juice on dose delivery of taxane chemotherapy. measure: Tolerability of daily intake of high-dose and low-dose tart cherry juice. measure: Safety profile of daily intake of high-dose and low-dose tart cherry juice. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California Davis Comprehensive Cancer Center city: Sacramento state: California zip: 95827 country: United States name: Eve Rodler, MD role: CONTACT phone: 916-734-5409 email: erodler@ucdavis.edu name: Eve Rodler, MD role: PRINCIPAL_INVESTIGATOR lat: 38.58157 lon: -121.4944 hasResults: False

 nctId: NCT06268652 id: B2023-686-01 briefTitle: Patient Derived Organoid-guided Personalized Treatment Versus Treatment of Physician's Choice in Breast Cancer overallStatus: RECRUITING date: 2024-01-15 date: 2026-02-15 date: 2028-01-15 date: 2024-02-20 date: 2024-02-20 name: Sun Yat-sen University class: OTHER briefSummary: This multicenter, open-label, randomized phase III trial is designed to study the efficacy and safety of organoid-guided personalized treatment （OGPT）versus treatment of physician's choice (TPC) in previously treated refractory breast cancer. conditions: Breast Cancer conditions: Refractory Breast Carcinoma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 302 type: ESTIMATED name: Organoid-guided personalized treatment name: Gemcitabine name: Capecitabine name: Vinorelbine name: Eribulin measure: Progression-free survival (PFS) measure: Overall Survival (OS) measure: Objective Response Rate (ORR) measure: Duration of Response (DOR) measure: Disease Control Rate (DCR) measure: Incidence of Treatment-related Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yanxia Shi status: RECRUITING city: Guangzhou state: None Selected zip: 510060 country: China name: Yanxia Shi role: CONTACT phone: 020-87343368 email: shiyx@sysucc.org.cn lat: 23.11667 lon: 113.25 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-12-12 uploadDate: 2024-01-23T03:33 filename: Prot_000.pdf size: 469389 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-12-12 uploadDate: 2024-01-23T02:42 filename: ICF_001.pdf size: 330483 hasResults: False

 nctId: NCT06268639 id: ECM#2024-216 id: RGP1/347/44 type: OTHER_GRANT domain: King Khalid University briefTitle: Evaluation of Bone Density Before and After Placement of Implant Using Osseodensification Technique acronym: BIDOS overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-04-30 date: 2024-06-30 date: 2024-02-20 date: 2024-03-15 name: King Khalid University class: OTHER briefSummary: The study investigates the impact of osseodensification drills on bone density changes surrounding dental implants. Osseodensification, a novel technique, is hypothesized to enhance primary stability of implants by densifying bone rather than removing it during osteotomy. Participants undergo pre-operative and post-operative DentaScan CT analyses to measure bone density in Hounsfield units at apical, mesial, and distal positions around the implant sites. This intervention-based research aims to quantify the benefits of osseodensification in improving bone quality and implant success. Data from 32 sites, analyzed via the Radiant DICOM software, undergo statistical examination using SPSS to ascertain significant differences in bone density pre- and post-surgery. The outcome could redefine surgical approaches in implantology, emphasizing osseodensification's role in achieving superior bone-implant integration. conditions: Evaluation of Osseointegration and Stability of Dental Implants in Bone Density Enhanced by Osseodensification Technique studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The study employs a single-group, interventional model to examine the impact of osseodensification on bone density at dental implant sites. It involves a sequential process starting from pre-operative bone density assessment using DentaScan CT, followed by surgical intervention using osseodensification drills, and concluding with a post-operative bone density evaluation to compare changes. This approach aims to determine if osseodensification can significantly enhance bone density and stability around implant sites, thereby potentially improving the success rates of dental implants. The methodology includes detailed pre-operative and post-operative assessments, with statistical analysis conducted to evaluate the effectiveness of the intervention. primaryPurpose: TREATMENT masking: NONE maskingDescription: The study employs an open-label design, where no masking is applied. This means that the participants, care providers, investigators, and outcomes assessors are all aware of the intervention being administered. Given the nature of the intervention-osseodensification technique used in dental implant surgery-it is not feasible to blind the study participants or the clinical staff involved in the procedure and assessment to the intervention being studied. The open-label approach allows for direct observation of the intervention's effects on bone density without the complexity of blinding, which is often the case in surgical and procedural interventions where the treatment administered is evident. count: 32 type: ESTIMATED name: Osseodensification measure: Increase in Bone Density at Implant Sites Using Osseodensification Technique sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT hasResults: False

 nctId: NCT06268626 id: H22-02426 id: F22-01302 type: OTHER_GRANT domain: Canadian Institutes of Health Research (CIHR) id: F21-03695 type: OTHER_GRANT domain: Canadian Institutes of Health Research (CIHR) briefTitle: Detection of Endometrial Cancer Through Risk Modelling acronym: DETECTR overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-01 date: 2027-01 date: 2024-02-20 date: 2024-02-20 name: University of British Columbia class: OTHER name: Canadian Institutes of Health Research (CIHR) briefSummary: The goal of this study is to combine information on risk factors from health questionnaires with minimally invasive biological tests (vaginal DNA and microbiome swabs, pH, hormones) to predict the risk of endometrial cancer (EC), better understand progression of the disease, and identify opportunities for intervention.

This study will recruit patients who are already scheduled to undergo diagnostic evaluation for abnormal uterine bleeding via endometrial biopsy. In Part A, consented participants will be asked to fill out an online risk factor questionnaire. Samples will be collected by the gynecologist at the biopsy appointment. After biopsy results are obtained, all samples from participants diagnosed with EC or precursors, plus a random subset with benign results, will be selected to be sequenced and analyzed.

In Part B, that subset of selected non-malignant participants, based on biopsy, will be invited to take part in lifestyle tracking using a Fitbit, questionnaires, and to provide another round of at-home vaginal samples to identify any persistent genetic mutations or microbiome alterations 6-8 months later. conditions: Endometrial Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED measure: Association Between Risk Factor Data and Endometrial Cancer and It's Precursors. measure: Change in Risk Prediction of Endometrial Cancer When Mutation and Microbiome Data Is Combined With Traditional Risk Factors, Compared to Traditional Risk Factors Alone. measure: Persistence of Mutations and Microbiome Alterations in Participants With Endometrial Hyperplasia. sex: FEMALE minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: VGH Research Pavilion city: Vancouver state: British Columbia zip: V5Z 1M9 country: Canada name: Aline Talhouk, PhD role: CONTACT phone: +1 (604) 875-4111 phoneExt: 21365 email: a.talhouk@ubc.ca name: Elise Abi Khalil, PhD role: CONTACT phone: +1 (604) 875-4111 phoneExt: 21369 email: elise.abikhalil@ubc.ca name: Aline Talhouk, PhD role: PRINCIPAL_INVESTIGATOR lat: 49.24966 lon: -123.11934 hasResults: False

 nctId: NCT06268613 id: SB27-1005 briefTitle: A Study to Compare the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Pembrolizumab (SB27, EU Sourced Keytruda, and US Sourced Keytruda) in Subjects With Stage II-IIIA NSCLC Following Complete Resection and Adjuvant Platinum-based Chemotherapy overallStatus: RECRUITING date: 2024-01-16 date: 2025-05 date: 2025-12 date: 2024-02-20 date: 2024-04-19 name: Samsung Bioepis Co., Ltd. class: INDUSTRY briefSummary: The goal of this clinical trial is to compare the amount of study drug in patients' blood to confirm that SB27 works in the same way as EU and US sourced Keytruda in early or locally advanced non-small cell lung cancer (NSCLC) patients who underwent surgery and adjuvant chemotherapy. The main question it aims to answer is:

• What the body does to the study drug, which is called "pharmacokinetic"

Participants will receive investigational product (IP) administration every 3 weeks, maximum 18 cycles over about 51 weeks and blood sample will be collected.

Researchers will compare 3 medicines (SB27, EU sourced Keytruda, and US sourced Keytruda) to see if SB27 works in the same way as EU and US sourced Keytruda. conditions: Non-small Cell Lung Cancer Stage II conditions: Non-small Cell Lung Cancer Stage IIIA studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 135 type: ESTIMATED name: SB27 name: EU sourced Keytruda name: US sourced Keytruda measure: Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 1 measure: Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 6 measure: Disease-free Survival measure: Overall Survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SB Investigative Site status: RECRUITING city: Busan country: Korea, Republic of lat: 35.10278 lon: 129.04028 facility: SB Investigative Site status: RECRUITING city: Daegu country: Korea, Republic of lat: 35.87028 lon: 128.59111 facility: SB Investigative Site status: RECRUITING city: Hwasun country: Korea, Republic of lat: 35.06125 lon: 126.98746 facility: SB Investigative Site status: RECRUITING city: Jinju country: Korea, Republic of lat: 35.19278 lon: 128.08472 facility: SB Investigative Site status: RECRUITING city: Seongnam country: Korea, Republic of lat: 37.43861 lon: 127.13778 facility: SB Investigative Site status: RECRUITING city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: SB Investigative Site status: RECRUITING city: Suwon country: Korea, Republic of lat: 37.29111 lon: 127.00889 facility: SB Investigative Site status: RECRUITING city: Szczecin country: Poland lat: 53.42894 lon: 14.55302 facility: SB Investigative Site status: RECRUITING city: Leganés state: Madrid country: Spain lat: 40.32718 lon: -3.7635 facility: SB Investigative Site status: RECRUITING city: A Coruña state: Santiago De Compostela country: Spain lat: 43.37135 lon: -8.396 facility: SB Investigative Site status: RECRUITING city: Jaén country: Spain lat: 37.76922 lon: -3.79028 facility: SB Investigative Site status: RECRUITING city: Málaga country: Spain lat: 36.72016 lon: -4.42034 hasResults: False

 nctId: NCT06268600 id: NPC-Thyroid function briefTitle: The Protection of Thyroid Function in IMRT for Nasopharyngeal Carcinoma overallStatus: RECRUITING date: 2019-01-01 date: 2024-11-30 date: 2025-11-30 date: 2024-02-20 date: 2024-04-11 name: Jiangxi Provincial Cancer Hospital class: OTHER briefSummary: This study aimed to reduce radiation-induced thyroid injury without compromising control of the cervical region by optimizing the delineation of the cervical lymph node drainage area. conditions: Nasopharyngeal Carcinoma conditions: Nasopharyngeal Cancer conditions: Hypothyroidism studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: NONE count: 320 type: ESTIMATED name: Modified neck target volume delineation measure: Regional Recurrence-free Survival measure: Radiation-induced hypothyroidism measure: Overall Survival measure: Progression-free Survival sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Nasopharyngeal Carcinoma, Jiangxi Cancer Hospital status: RECRUITING city: Nanchang state: None Selected zip: 330029 country: China name: Tianzhu Lu role: CONTACT phone: 8615270186250 email: lutianzhu2008@163.com role: CONTACT phoneExt: Li email: lijingao@hotmail.com name: Jingao Li, PhD role: PRINCIPAL_INVESTIGATOR name: Xiaochang Gong, PhD role: SUB_INVESTIGATOR lat: 28.68396 lon: 115.85306 hasResults: False

 nctId: NCT06268587 id: 2023/80 briefTitle: A Before and After Study Studying the Impact of an Analgesia Protocol After Discharge From Outpatient Surgery overallStatus: COMPLETED date: 2019-09-01 date: 2022-02-28 date: 2022-02-28 date: 2024-02-20 date: 2024-02-20 name: Centre Hospitalier Universitaire de Liege class: OTHER briefSummary: The goal of this before and after study is to measure the effectiveness of a home analgesia protocol after outpatient surgery in a tertiary hospital. The main question it aims to answer is:

- Measure the impact of the protocol on the proportion of patients with a VAS greater than 3/10 on day one and who did not take the analgesics.

The participants are divided into two groups. The control group leaves the hospital with instructions and prescriptions. The experimental group leaves the hospital with instructions, analgesics for a maximum of two days with detailed dosages and an explanatory booklet on postoperative pain. conditions: Postoperative Pain conditions: Outpatient Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1423 type: ACTUAL name: Measure the impact of the home analgesia protocol on the proportion of patients with a VAS &amp;gt; 3/10 on day one and who did not take analgesics. measure: Measure the impact of the protocol on the proportion of patients with a pain greater than 3/10 on a Visual Analogue Scale at day one and who did not take the analgesics. measure: Measure the adequacy of post-op analgesics by measuring the proportion of patients with a Visual Analogue Scale < or = 3/10 on day one for each group measure: Measure the impact of the protocol on the occurrence of nausea and vomiting on day one measure: Measure the impact of the protocol on general satisfaction of stay in outpatient surgery on day 7 with a Visual Analogue Scale Satisfaction sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Liège city: Liège state: Wallonie zip: 4000 country: Belgium lat: 50.63373 lon: 5.56749 hasResults: False

 nctId: NCT06268574 id: RIVER-52 briefTitle: Safety and Efficacy of RVU120 for Treatment of Relapsed/Refractory AML acronym: RIVER-52 overallStatus: RECRUITING date: 2024-01-23 date: 2026-02 date: 2026-09 date: 2024-02-20 date: 2024-02-20 name: Ryvu Therapeutics SA class: INDUSTRY briefSummary: The goal of this study is to assess the safety, tolerability, anti-tumor activity (efficacy), pharmacokinetics (PK), and pharmacodynamics (PD) of the agent RVU120 when administered to adult patients with relapsed or refractory acute myeloid leukemia (AML) or relapsed or progressing high-risk myelodysplastic syndrome (HR-MDS) and who have no alternative therapies available. The study consists of two parts. Part 1 will assess the safety and tolerability of the dosages given and the level of anti-tumor activity or clinical response. Based on the results from part 1 the study will continue to enrol patient into Part 2 which will continue to evaluate safety and tolerability and anti-tumor activity in a larger number of patients. conditions: Acute Myeloid Leukemia (AML) conditions: High-risk Myelodysplastic Syndrome studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single Group Assignment primaryPurpose: TREATMENT masking: NONE count: 94 type: ESTIMATED name: RVU120 measure: Complete Remission (CR), with and without measurable residual disease (MRD) measure: Overall response rate measure: Duration of response measure: Progression-free survival measure: Overall survival measure: Incidence of Adverse Events (Safety and Tolerability) measure: Percentage of participants bridged to hematopoietic stem cell transplantation measure: Maximum Plasma Concentration (Cmax) measure: Maximum Plasma Concentration (Tmax) measure: Area Under the Concentration Time-Curve (AUC) measure: Impact of treatment on hematological malignancy patient-reported outcomes (HM-PRO) measure: Impact of treatment on health-related quality of life (QOL-E) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MTZ Clinical Research status: RECRUITING city: Warszawa state: Mazowieckie Województwo zip: 02-172 country: Poland name: Krzysztof Mądry role: CONTACT phone: +48 22 572 59 59 email: info@pratia.com name: Krzysztof Mądry, MD role: PRINCIPAL_INVESTIGATOR lat: 52.22977 lon: 21.01178 facility: MICS Centrum Medyczne Toruń status: RECRUITING city: Toruń zip: 87-100 country: Poland name: Dominik Chraniuk role: CONTACT phone: +48 56 300 43 email: d.chraniuk@naszlekarz.pl name: Dominik Chraniuk, MD role: PRINCIPAL_INVESTIGATOR lat: 53.01375 lon: 18.59814 hasResults: False

 nctId: NCT06268561 id: IRBN852023/CHUSTE briefTitle: Ozurdex Endophtamitis Cohort, Prognostic Assessment at 12 Months overallStatus: RECRUITING date: 2023-06-05 date: 2024-06 date: 2024-06 date: 2024-02-20 date: 2024-02-20 name: Centre Hospitalier Universitaire de Saint Etienne class: OTHER briefSummary: OZURDEX endophthalmitis is a rare and potentially very serious pathology. Different treatments can be carried out early and change the functional prognosis of the patient. conditions: Endophthalmitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 8 type: ESTIMATED name: Visual acuity analysis name: Intraocular pressure analysis name: Analysis of optical coherence tomography (OCT) images name: Analysis of retinograms measure: Visual acuity measure: IOP measured in mmHg by tonometer and confirmed with Goldman Applanation measure: Tomography measure: Resumption of intravitreal therapy sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Saint Etienne status: RECRUITING city: Saint-Étienne zip: 42000 country: France name: Thibaud GARCIN, MD PhD role: CONTACT phone: (0)477829662 phoneExt: +33 email: thibaud.garcin@chu-st-etienne.fr name: Thibaud GARCIN, MD PhD role: PRINCIPAL_INVESTIGATOR name: Henri PITEAU, resident role: SUB_INVESTIGATOR lat: 45.43389 lon: 4.39 hasResults: False

 nctId: NCT06268548 id: P.T.REC/012/004790 briefTitle: Effect of Manual Diaphragmatic Activation on Diaphragm Function in Patients With Gastroesophageal Reflux Disease overallStatus: RECRUITING date: 2023-09-15 date: 2024-02-20 date: 2024-02-27 date: 2024-02-20 date: 2024-02-20 name: Cairo University class: OTHER briefSummary: This study was conducted to investigate Effect of manual diaphragmatic activation on diaphragm function in patients with gastroesophageal reflux disease conditions: Diaphragm Dysfunction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Manual diaphragmatic activation measure: Diaphragm Excursion sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: Faculty of physical therapy status: RECRUITING city: Giza zip: 12613 country: Egypt name: Nesreen Ghareb Mohamed, Professor role: CONTACT phone: 01002227242 email: nesreen.elnahas@pt.cu.edu.eg lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06268535 id: CaenUH_DL_1 briefTitle: Identification of Anticancer Drugs Associated With Heart Failure: a WHO Pharmacovigilance Database Analysis overallStatus: COMPLETED date: 2022-04-01 date: 2022-05-31 date: 2022-05-31 date: 2024-02-20 date: 2024-02-20 name: University Hospital, Caen class: OTHER briefSummary: Therapeutic advances have significantly improved the survival of patients with cancer. However, these novel therapies are associated with a concomitant increase in the prevalence of toxicity, including cardiovascular complications of cancer therapy.

Among these adverse drug reactions, heart failure and, more generally, cancer therapy-related cardiac dysfunction are the most concerning cardiovascular complications of cancer therapy, carrying a high morbidity burden and an elevated risk of death.

Patients with both heart failure and cancer have a worse prognosis when compared with heart failure patients with no history of cancer. It is therefore crucial to enhance the identification of patients at a higher risk of cancer therapy-related cardiac dysfunction both before and during treatment, especially when utilizing cancer therapies with known potential cardiovascular adverse drug reactions.

The explosion of new anticancer drugs has led to the potential association of these therapies with cardiac dysfunction.

Using VigiBase, the World Health Organization's (WHO) global pharmacovigilance database, the investigators aimed to assess the relationship between cancer therapy-related cardiac dysfunction and the administration of anti-cancer drugs. conditions: Heart Failure conditions: Cancer, Therapy-Related studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3406383 type: ACTUAL name: Cancer therapy with FDA and/or EMA approval on the 31st March 2022 measure: Disproportionality individual case data analysis between heart failure of cardiac dysfunction and cancer therapies measure: Description of the population of patients having a heart failure of cardiac dysfunction event with cancer therapies measure: Description of the pathologies (cancer) for which the incriminated drugs have been prescribed measure: Description of the drug-drug interactions associated with adverse events sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Caen University Hospital city: Caen country: France lat: 49.18585 lon: -0.35912 hasResults: False

 nctId: NCT06268522 id: 2023P001582 briefTitle: Adjunctive Mindfulness During Opioid Tapering for patientS With Chronic Pain (The AMOS Study) overallStatus: RECRUITING date: 2024-02 date: 2024-06 date: 2024-06 date: 2024-02-20 date: 2024-02-20 name: Brigham and Women's Hospital class: OTHER briefSummary: This study is a Randomized Controlled Trial exploring the effects of a Mindfulness interventions in reducing pain interference and opioid dose in patients with Chronic Low Back Pain. A total of 200 opioid-using patients with chronic pain, male and female participants will be enrolled, with a need for 160 completers. Patient will be randomly assigned into the Mindfulness-Oriented Recovery Enhancement or the Psychoeducation comparison control group. conditions: Low Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Behavioral primaryPurpose: TREATMENT masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Mindfulness-Oriented Recovery Enhancement: (MORE) group name: Psychoeducation measure: Pain Interference measure: Opioid Dose measure: Pain Intensity measure: Opioid Misuse measure: Opioid Withdrawal measure: Opioid Craving sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital status: RECRUITING city: Chestnut Hill state: Massachusetts zip: 02467 country: United States name: Marie Curiel role: CONTACT phone: 617-732-9578 email: MCURIEL@mgh.harvard.edu name: Asimina Lazaridou, PhD role: PRINCIPAL_INVESTIGATOR name: Robert Edwards, PhD role: SUB_INVESTIGATOR lat: 42.33065 lon: -71.16616 hasResults: False

 nctId: NCT06268509 id: MONAS briefTitle: Nutrition Optimalization Among Pregnant Women to Improve Maternal and Neonatal Outcome in DKI Jakarta acronym: MONAS overallStatus: RECRUITING date: 2023-04-01 date: 2024-06 date: 2024-08 date: 2024-02-20 date: 2024-02-20 name: Dr Cipto Mangunkusumo General Hospital class: OTHER name: Dinas Kesehatan DKI Jakarta name: Fakultas Kedokteran Universitas Indonesia briefSummary: The goal of this MONAS Study is to learn about comprehensive monitoring and nutritional intervention among pregnant women in order to improve maternal and neonatal outcomes. The main questions it aims to answer are:

1. Are comprehensive monitoring and nutritional intervention among pregnant women can improve maternal outcomes (maternal death, preterm labour, preeclampsia, intrauterine infection, and bleeding during pregnancy and delivery) compared to standard maternal health services?
2. Are comprehensive monitoring and nutritional intervention among pregnant women can improve neonatal outcomes (neonatal death, low birth weight, intrauterine growth restriction, and neonatal asphyxia) compared to standard maternal health services?

Participants in the intervention group will receive:

* Fetomaternal ultrasound examination each trimester
* Complete laboratory examination for nutritional panel (complete blood count with reticulocyte profile and iron profile, vitamin D level, zinc level, fatty acid profile, electrophoresis for Thalassemia) as an addition to standard maternal routine laboratory examination
* Supplements: multivitamin, minerals, vitamin D, fatty acid
* Intervention regarding any abnormal results of nutritional panel
* All standard maternal health services according to Indonesian Ministry of Health protocol

Participants in the control group will receive:

- All standard maternal health services according to Indonesian Ministry of Health protocol conditions: Pregnancy Complications conditions: Maternal Death conditions: Preeclampsia conditions: Intrauterine Infection conditions: Pregnancy Hemorrhage conditions: Preterm Birth conditions: Neonatal Death conditions: Low; Birthweight, Extremely (999 Grams or Less) conditions: Asphyxia Neonatorum conditions: IUGR studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 245 type: ESTIMATED name: Nutritional panel laboratory examination name: Pregnancy supplements (other than provided by Ministry of Health) name: Fetomaternal ultrasound measure: Composite of poor maternal outcomes measure: Composite of poor neonatal outcomes sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Jakarta Primary Care Health Facility (Puskesmas) under Jakarta Health Office status: RECRUITING city: Jakarta country: Indonesia name: Risal, M.D., M.Sc. role: CONTACT email: dinkes@jakarta.go.id lat: -6.21462 lon: 106.84513 hasResults: False

 nctId: NCT06268496 id: LRP23021-A serum briefTitle: Efficacy and Tolerability of the Tested Formula After 3 Months in Treatment of Facial Hyperpigmentation of 3 Origins overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-02-20 date: 2024-03-05 name: Cosmetique Active International class: INDUSTRY briefSummary: The objective of this study is to evaluate the efficacy, cosmetic acceptability and improvement of the stigmatization of the tested product (2039125 03) used bis in die (BID) for 3 months in adult patients suffering from mild to moderate melasma, or mild to moderate acne induced post-inflammatory hyperpigmentation, or solar lentigo. conditions: Hyperpigmentation studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 60 type: ESTIMATED name: serum formula 2039125 03 measure: IGA score for patients with melasma or acne induced post-inflammatory hyperpigmentation (PIHP) measure: modified Melasma Area and Severity Index (mMASI) for patients with melasma measure: Post-Acne Hyperpigmentation Index (PAHPI) measure: solar lentigo pigmentation scale measure: colorimetry measurements sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medcin Instituto da Pele Ltda city: Osasco country: Brazil lat: -23.5325 lon: -46.79167 hasResults: False

 nctId: NCT06268483 id: JalUrol id: Policlinico type: OTHER domain: IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico briefTitle: Effect of Hyaluronic Acid Oral Supplementation on Sexual and Urinary Symptoms of Women With Recurrent Urinary Tract Infections acronym: JalUrol overallStatus: COMPLETED date: 2022-03-01 date: 2023-03-28 date: 2023-03-28 date: 2024-02-20 date: 2024-02-20 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: Uncomplicated urinary tract infections (UTI) are one of the most common bacterial infections globally, causing a significant proportion of medical consultations in primary and outpatient settings. Recurrent UTI (rUTI) have a detrimental impact on the patient's quality of life, causing a negative effect on women's social relationships, self-esteem, as well as irritability and tiredness. Moreover, several real-life studies have shown that reproductive-aged women with rUTI more frequently experience sexual dysfunction as compared to controls without infections. The glycosaminoglycan layer of the bladder urothelium, mainly composed by chondroitin sulfate (CS) and hyaluronic acid (HA), provides a protective barrier against the penetration of bacteria. A deficiency of this layer facilitates bacterial adherence, leading to recurrent infection. Treatment to restore this layer with intravesical instillation of HA has been proven to reduce the incidence of rUTI episodes. Furthermore, intravesical instillation with HA has been associates with sexual function improvement in women with rUTI and painful bladder . Therefore, in conditions where the glycosaminoglycan layer of the bladder is impaired, such as rUTIs, treatment with HA to restore it appears to have a beneficial effect on urinary and sexual symptoms.

Recently, a randomized control trial has demonstrated that an oral formulation of HA, CS, quercetin and curcumin was effective in improving urinary symptoms in women undergoing intravesical chemotherapy for bladder cancer. However, there are no studies investigating the impact of the oral administration of HA and CS on the sexual and urinary symptoms of women with rUTI. Since rUTI are highly prevalent in sexually active women and exert a detrimental impact on women's quality of life, sexual and urinary symptoms, the identification of oral treatments that could alleviate these bothersome consequences is of primary clinical importance.

Therefore we will conduct this randomized, cross-over trial to evaluate the efficacy of an oral preparation of HA, CS, N-Acetylglucosamine and vitamin C in improving sexual and urinary symptoms in a cohort of reproductive-aged women with rUTI.

Methods:

Pre-menopausal, sexually active women referred to our center for symptomatic rUTIs. At the time of enrollment, participants were randomized with a 1:1 allocation ratio by means of a computer-generated random list in two groups: intervention (I) and control (C) (Figure 1).

Inclusion and exclusion criteria We included sexually active, reproductive-aged women with symptomatic rUTIs. Exclusion criteria: younger than 18, if they had used combined hormonal contraception during the previous 6 months; pregnant, breastfeeding or trying to conceive, if they had symptoms of upper UTI, a history of urinary tract anomalies/vesicoureteral reflux, stress urinary incontinence, interstitial cystitis, diabetes, urinary tract stones, neurologic conditions, clinical depression or depressive symptoms.

All women will be assessed with a thorough medical and sexual history. To psychometrically quantify sexual function impairment all participants completed The Female Sexual Function Index (FSFI) questionnaire at baseline and at each follow up assessment.

Treatment Protocol Group I: an oral preparation (capsule) of HA 100 mg, CS 400 mg, N-Acetylglucosamine 200 mg and vitamin C 80 mg once a day in the morning plus an oral preparation of cranberry, D-mannose, propolis extract, tumeric and Boswellia twice a day for three months.

Group C: an oral preparation of cranberry, D-mannose, propolis extract, tumeric and Boswellia twice a day for three months.

After three months of treatment (follow up 1) all women were evaluated with medical and sexual history. Participants also completed the FSFI and IPSS questionnaires. At this point the treatment was reversed (crossover scheme) for additional three months.

At 6 months follow up (follow up 2) participants were again investigated with medical and sexual history and the IPSS and FSFI were completed. Figure 2 report the complete study design. Monthly phone calls were performed to check for adherence to treatment.

Statistics: The sample size consisted of 25 participants in each group, calculated by using the two-sample t-test analysis. Baseline clinical and psychometric scores will be compared between I and C groups. Second, potential differences in FSFI values at 3-6 months follow-up assessment will be evaluated between and within groups. Potential predictors of FSFI improvement will be evaluated. conditions: Urinary Tract Infections, Recurrent studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: randomized, crossover primaryPurpose: TREATMENT masking: NONE count: 50 type: ACTUAL name: HA 100 mg, CS 400 mg, N-Acetylglucosamine 200 mg and vitamin C 80 mg + cranberry, D-mannose, propolis extract, tumeric and Boswellia name: cranberry, D-mannose, propolis extract, tumeric and Boswellia measure: Improvement in sexual symptoms measure: Improvement in urinary symptoms sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico city: Milan state: MI zip: 20122 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06268470 id: Chula-ARC 001/18 briefTitle: Antiplatelet Therapy in Chronic Urticaria overallStatus: ACTIVE_NOT_RECRUITING date: 2018-06-01 date: 2024-03-01 date: 2024-05-01 date: 2024-02-20 date: 2024-02-21 name: Chulalongkorn University class: OTHER briefSummary: This study compares the combination of antiplatelets and antihistamine versus antihistamine alone for the treatment of chronic spontaneous urticaria conditions: Chronic Urticaria studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients diagnosed with chronic urticaria will be assigned to 2 treatment arms. 1. high dose antihistamine with antiplatelets; and 2. high dose antihistamine alone. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Identical capsules whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 12 type: ESTIMATED name: Desloratadine plus cilostazol and dipyridamole name: Desloratadine measure: Weekly urticaria activity score measure: D-dimer levels sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Medicine, Chulalongkorn University city: Bangkok zip: 10330 country: Thailand lat: 13.75398 lon: 100.50144 hasResults: False

 nctId: NCT06268457 id: CE-AVEC 789/2023/Oss/IOR briefTitle: Arterial Chemoembolization for the Treatment of Desmoid Fibromatosis acronym: Embodesmo overallStatus: RECRUITING date: 2024-02-20 date: 2027-02-01 date: 2028-02-01 date: 2024-02-20 date: 2024-03-20 name: Istituto Ortopedico Rizzoli class: OTHER briefSummary: Desmoid fibromatoses are rare (1-2 cases/million per year) and locally aggressive mesenchymal tumors. For asymptomatic disease, current guidelines suggest an initial period of active surveillance.

The current scientific evidence regarding the efficacy and safety of the treatment of desmoid fibromatosis by arterial embolization is constituted by several retrospective and prospective studies. Embolization of desmoid tumors alone, without chemotherapy, on the contrary, has been shown to be inefficient. Using Doxorubicin in desmoid fibromatosis is effective but associated with systemic toxicity. Consequently, this drug is reserved for symptomatic, nonresponsive, rapidly growing or life-threatening tumors. The intrinsic hypervascularity of desmoid tissue can be exploited as a conduit to achieve local distribution of Doxorubicin by navigation of a catheter endovascular. conditions: Desmoid studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Chemoembolization with Doxorubicin measure: Volume reduction in cm measure: Reduction of pain (VAS score) measure: Reduction of antalgic therapy (mg) measure: Improvement in quality of life (EORTC QLQ-C15-PAL questionnaire) measure: Improvement in quality of life (EORTC QLQ - BM22) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Ortopedico Rizzoli status: RECRUITING city: Bologna state: Emilia Romagna zip: 40136 country: Italy name: Giancarlo Facchini, MD role: CONTACT phone: +39 333 650 0944 email: giancarlo.facchini@ior.it lat: 44.49381 lon: 11.33875 hasResults: False

 nctId: NCT06268444 id: PI2023_843_0077 briefTitle: Infant Sleep and Exposure to Mixture of Chemical Environmental Pollutants acronym: SOLANGE overallStatus: RECRUITING date: 2024-02-07 date: 2026-02 date: 2026-02 date: 2024-02-20 date: 2024-02-20 name: Centre Hospitalier Universitaire, Amiens class: OTHER briefSummary: During their first year of life, children spend more than half their time sleeping, a function essential to their neurodevelopment. This period of maturation and development of the future adult is considered extremely vulnerable to environmental exposure. During this period, the child\&#39;s diet is mainly provided by breastfeeding, where persistent chemical substances have been found. A cocktail of 19 mostly persistent substances (POPs) present in breast milk has recently been identified as the main contributor to neurodevelopmental risk. However, the reality of their impact on neurophysiological development, in particular on infant sleep, has yet to be assessed.

In this project, the sleep of children under 6 months of age will be studied using an actimetry watch worn for 7 days by the child, accompanied by a sleep diary. Exposure to environmental pollutants will be assessed by measuring their presence in the infant\&#39;s milk (breastfeeding) and wearing a silicone bracelet to collect air pollutants. A questionnaire on exposure will complement this evaluation. conditions: Newborn conditions: Chemical Pollutants Exposure conditions: Sleep studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 60 type: ESTIMATED name: 7-day actimetry sleep recording name: Determination of environmental pollutants in breast milk name: Measurements of environmental pollutants in indoor air deposited on the bracelet worn by the child name: Continuous recording of the child&#39;s temperature for 7 days name: Use of a sleep diary for 7 days name: Parental questionnaire of environmental exposure measure: total sleep time per day in infants using actimetry measure: Concentration of various substances in breast milk measure: concentration of chemical polluants on newborn bracelets measure: Child Temperature level (°C) sex: ALL maximumAge: 6 Months stdAges: CHILD facility: CHRU Amiens status: RECRUITING city: Amiens zip: 80054 country: France name: Karen CHARDON, Pr role: CONTACT phone: 03.22.82.78. 65 email: Karen.chardon@u-picardie.fr name: Elodie HARAUX, HARAUX role: PRINCIPAL_INVESTIGATOR name: Pierre TOURNEUX, Pr role: SUB_INVESTIGATOR lat: 49.9 lon: 2.3 hasResults: False

 nctId: NCT06268431 id: 43084 briefTitle: Oxytocin Rest to Reduce Cesarean Delivery acronym: ORCA overallStatus: RECRUITING date: 2024-02-15 date: 2026-02-15 date: 2026-03-15 date: 2024-02-20 date: 2024-02-20 name: Christiana Care Health Services class: OTHER briefSummary: Prolonged labor is usually managed with continuous oxytocin infusion. "Oxytocin rest" has been proposed as a strategy to resolve protracted labor in patients who have received continuous oxytocin without progress. This strategy involves discontinuing oxytocin then restarting infusion after a period of time, under the theory that washout of the oxytocin receptor will strengthen uterine contractions to improve labor progress. "Oxytocin rest" is performed on labor and delivery units across the United States. Yet, there is no randomized or prospective data to support the practice.

The purpose of this study is to assess whether oxytocin rest of 60 minutes in patients with prolonged labor reduces risk for cesarean delivery. conditions: Prolonged Labor conditions: Failed Induction conditions: Labor Dystocia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 350 type: ESTIMATED name: Oxytocin rest measure: Cesarean rate measure: Time to delivery (hours) measure: Time to vaginal delivery (hours) measure: Time to active labor (hours) measure: Duration of active labor (hours) measure: Composite maternal adverse outcome measure: Composite neonatal adverse outcome measure: Labor Agentry Scale score measure: Rate of intraamniotic infection (IAI) measure: Rate of postpartum endometritis measure: Rate of postpartum hemorrhage sex: FEMALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: ChristianaCare Health System status: RECRUITING city: Newark state: Delaware zip: 19718 country: United States name: Teresa C Logue role: CONTACT phone: 302-733-6563 email: teresa.logue@christianacare.org lat: 39.68372 lon: -75.74966 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-01-21 uploadDate: 2024-02-11T17:37 filename: Prot_SAP_000.pdf size: 239099 hasResults: False

 nctId: NCT06268418 id: 2024PI020 briefTitle: Pre-therapeutic 68Ga-PSMA PET AI Based Dose Prediction for 177Lu-PSMA Targeted Radionuclide Therapy acronym: PADL overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2024-06-30 date: 2024-08-30 date: 2024-02-20 date: 2024-02-21 name: Central Hospital, Nancy, France class: OTHER briefSummary: Targeted Radionuclide Therapy (TRT) is a contemporary approach to radiation oncology, aiming to deliver the maximal destructive radiation dose via cancer-targeting radiopharmaceutical. Radioactive ligands for the prostate-specific membrane antigen (PSMA) have emerged for the treatment of metastatic castration-resistant prostate cancer (mCRPC).Normal organ and tumor dose can be assessed by a series of cross-sectional whole-body SPECT scans, however, these require a large amount imaging time and are often not feasible in routine clinical practice.

An alternative is to generate a 3D time integrated activity (TIA) map per patient based on the PBPK and the pre-therapy imaging conditions: Radionucleide Therapy studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 46 type: ESTIMATED name: Artificial intelligence measure: Evaluate the prediction of the absorbed dose by Deep Learning approaches for RLT with 177Lu-PSMA, from pre-treatment 68Ga-PSMA.PET/CT images measure: Automatically contour the total tumor metabolic volume on 68Ga-PSMA pretreatment PET images using Deep Learning approaches sex: MALE minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06268405 id: 22-5806 briefTitle: Positron Emission Mammography and Liquid Biopsy in Women With High-risk Breast Screenings overallStatus: RECRUITING date: 2023-09-21 date: 2024-09-21 date: 2024-09-21 date: 2024-02-20 date: 2024-02-20 name: University Health Network, Toronto class: OTHER briefSummary: The goal of this pilot research study is to compare two experimental tests, namely Liquid Biopsy and Positron Emission Mammography (PEM) in women at high risk of breast cancer. The plan for this study is to evaluate if findings from Liquid Biopsy can be matched to images obtained by PEM.

Liquid Biopsy is a blood test that can detect early tumours in patients with malignancies, while PEM is an imaging tool equipped with a high-resolution camera that uses an injected positron emitting isotope to locate breast tumours. Participation in this study entails a blood draw for Liquid Biopsy test and a PEM imaging exam before undergoing a magnetic resonance imaging (MRI) - guided biopsy for a suspicious breast lesion.

If correlations between paired samples are observed between imaging using PEM and the Liquid Biopsy data, further studies will be conducted to evaluate if these techniques can help refine screening investigations and ultimately reduce the unnecessary biopsies and anxiety in high-risk populations. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 30 type: ESTIMATED name: Liquid Biopsy name: Positron Emission Mammography (PEM) measure: Correlation of paired samples between Liquid Biopsy data and Positron Emission Mammography (PEM) images sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Health Network status: RECRUITING city: Toronto state: Ontario zip: M5G 2M9 country: Canada name: Samira Taeb, MSc role: CONTACT phone: 416-946-4501 phoneExt: 5853 email: samira.taeb2@uhn.ca name: Vivianne Freitas role: CONTACT phone: 416-946-2000 phoneExt: 5608 email: vivianne.freitas@uhn.ca name: Vivianne Freitas, MD role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06268392 id: CT-2023-11-20-001 briefTitle: A Comparative Study of AI Methods for Fetal Diagnostic Accuracy in Ultrasound overallStatus: NOT_YET_RECRUITING date: 2024-02-15 date: 2024-08-01 date: 2024-08-01 date: 2024-02-20 date: 2024-02-22 name: Copenhagen Academy for Medical Education and Simulation class: OTHER name: Slagelse Hospital name: Technical University of Denmark name: Rigshospitalet, Denmark briefSummary: This study serves as a supplemental investigation to the randomized controlled SCAN-AID study (NCT0632187). This study will evaluate and compare the fetal growth estimation outcomes of AI-supported groups, expert sonographers, and control groups using a secondary AI predictive model. conditions: Fetal Growth Retardation conditions: Fetal Macrosomia conditions: Fetal Growth studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 150 type: ESTIMATED measure: Fetal weight measure: Ultrasound fetal weight estimation sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06268379 id: #08-01-03-23 briefTitle: BMA and Dynamic Nomogram for Survival Prediction in Patients With CRC overallStatus: COMPLETED date: 2010-02-15 date: 2021-12-15 date: 2021-12-15 date: 2024-02-20 date: 2024-02-20 name: Cabrini Health class: OTHER briefSummary: This project will examine the outstanding statistical techniques for predicting the survival of patients with colorectal cancer (CRC) (colorectal neoplasia database). The motivating clinical question that led to proposing this project is based on the general assumption that: "Right-sided colorectal cancer (CRC) has worse survival than left-sided CRC." The question is, which aspects of the patient's characteristics are responsible for this difference? This led us to BMA model selection and provide a clinician-friendly online nomogram. conditions: Colon Cancer conditions: Model Disease studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 2475 type: ACTUAL name: Surgery measure: OS measure: RFS sex: ALL minimumAge: 22 Years maximumAge: 101 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cabrini Health city: Melbourne state: Victoria zip: 3144 country: Australia lat: -37.814 lon: 144.96332 hasResults: False

 nctId: NCT06268366 id: UEvansville briefTitle: Effects of Exercise-Based Interventions on Symmio Self-Movement Screen overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-08-01 date: 2025-03-01 date: 2024-02-20 date: 2024-02-29 name: University of Evansville class: OTHER briefSummary: Musculoskeletal screening for physical risk factors requires equipment and a trained healthcare or fitness professional to perform and interpret the scoring so that appropriate exercise interventions can be prescribed. However, barriers such as healthcare costs and accessibility, low perceived need to seek medical care, and previous unfavorable evaluation of seeking medical care are associated with healthcare avoidant behaviors. This research aims to explore the effectiveness of the Symmio Self-Screen application to generate specific exercise interventions to address an individual's associated physical risk factors. The ability of the Symmio application to prescribe a targeted exercise program which can reduce asymmetries, improve movement quality, and enhance overall function is unknown. Therefore, the purpose of this study is to determine the effectiveness of the Symmio application in designing individualized exercise interventions which target the unique movement limitations and asymmetries in adults. conditions: Movement Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The primary investigators and statisticians will be blinded to the group allocation whoMasked: OUTCOMES_ASSESSOR count: 180 type: ESTIMATED name: Exercise measure: Symmio Self-Movement Screen measure: Global Rating of Change sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06268353 id: 109324-1 briefTitle: Is the Plasma Concentration of CAPGDF15 Increased in Pregnancy? A Pilot Study acronym: CAP overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2026-03-15 date: 2026-03-15 date: 2024-02-20 date: 2024-02-26 name: University of Copenhagen class: OTHER name: Stanford University briefSummary: Background and Purpose During pregnancy, the hormone GDF15 rises between 100-200 times higher than before pregnancy. The significance of this dramatic increase is not clarified, but it has been shown that pregnant women with insufficient increase in GDF15 have a higher risk of spontaneous abortion. CAPGDF15 is a small peptide consisting of 12 amino acids recently found in plasma in both mice and humans, and this peptide is part of the prohormone from which GDF15 is synthesized. Therefore, the assumption is that CAPGDF15 is secreted simultaneously with GDF15. The significance of CAPGDF15 in the organism is completely unknown, except that injection into mice reduces food intake. Therefore, the investigators are interested in investigating whether there is a similar dramatic upregulation of CAPGDF15 as with GDF15 itself. The investigators will not set up a large-scale study without having some prior knowledge of whether this is indeed the case. Therefore, the investigators will conduct a pilot study on 3 pregnant women and 3 control women to examine whether there is any reason to proceed with an actual scientific experiment. Since the increase in GDF15 itself is very large at least100 fold, a pilot study involving only 3 pregnant women and 3 non-pregnant women will be sufficient to gain an impression of whether there is also a significant increase in CAPGDF15. The data will be used to assess whether an actual research project is worth establishing.

Purpose:

The purpose of conducting this pilot study is to investigate whether there is an upregulation of CAPGDF15 similar to that of the hormone GDF15 during pregnancy. By conducting a pilot study on 3 pregnant women and 3 control women, the investigators will see if this is actually the case before setting up an actual scientific experiment. conditions: Pregnancy Related studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: Non-pregnant controls and pregnant women primaryPurpose: BASIC_SCIENCE masking: NONE count: 6 type: ESTIMATED name: blood sampling measure: CAPGDF15 levels in plasma sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False

 nctId: NCT06268340 id: ABIntl-23-25 briefTitle: Hearing and Structure Preservation Via ECochG acronym: PRESERVE overallStatus: NOT_YET_RECRUITING date: 2024-02-29 date: 2026-06-30 date: 2026-06-30 date: 2024-02-20 date: 2024-02-20 name: Advanced Bionics AG class: INDUSTRY briefSummary: The goal of the study is to determine the benefit of using an ECochG-based corrective action guide during cochlear implant surgery compared to the traditional surgical approach without ECochG surveillance and guidance. conditions: Hearing Loss, Sensorineural conditions: Severe-to-profound Hearing Loss studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 102 type: ESTIMATED name: ECochG monitored CI surgery incl. corrective action guide name: Routine CI surgery without ECochG monitoring measure: Hearing Preservation measure: Structure Preservation measure: Speech perception measure: Surgeons' feedback sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitair Ziekenhuis Gent city: Gent zip: 9000 country: Belgium name: Lara Derycke, Ms role: CONTACT phone: +3293321246 email: Lara.derycke@ugent.be name: Ingeborg Dhooge, Dr role: PRINCIPAL_INVESTIGATOR name: Freya Swinnen, Dr role: PRINCIPAL_INVESTIGATOR lat: 51.05 lon: 3.71667 facility: Le Centre Hospitalier Régional Universitaire de Tours city: Tours zip: 37000 country: France name: Mme Nollet role: CONTACT email: promotions.externes@chu-tours.fr name: David Bakhos, Prof role: PRINCIPAL_INVESTIGATOR name: Mathieu Robier, Mr role: PRINCIPAL_INVESTIGATOR lat: 47.38333 lon: 0.68333 facility: Universitätsklinikum Freiburg Klinik city: Freiburg zip: 79106 country: Germany name: Claudia Greulich, Ms role: CONTACT email: claudia.greulich@uniklinik-freiburg.de name: Antje Aschendorff, Prof role: PRINCIPAL_INVESTIGATOR name: Thomas Wesarg, Dr role: PRINCIPAL_INVESTIGATOR lat: 47.9959 lon: 7.85222 facility: Ospedale Martini city: Torino state: TO zip: 10141 country: Italy name: Diego Di Lisi, Dr role: PRINCIPAL_INVESTIGATOR name: Patrizia Consolino, Dr role: PRINCIPAL_INVESTIGATOR lat: 45.07049 lon: 7.68682 facility: World Hearing Center city: Warsaw state: Nadarzyn zip: 05-830 country: Poland name: Iwona Tomaszewska-Hert, Ms role: CONTACT email: i.tomaszewska@csim.home.pl name: Piotr Skarżyński, Prof role: PRINCIPAL_INVESTIGATOR name: Adam Walkowiak, Dr role: PRINCIPAL_INVESTIGATOR lat: 52.22977 lon: 21.01178 facility: Cambridge University Hospitals NHS Foundation Trust city: Cambridge state: England zip: CB2 0QQ country: United Kingdom name: Sophie McKenny, Ms role: CONTACT phone: +441223586625 email: sophie.mckenny@nhs.net name: Matthew E Smith, Dr role: PRINCIPAL_INVESTIGATOR name: Patrick Axon, Dr role: PRINCIPAL_INVESTIGATOR lat: 52.2 lon: 0.11667 hasResults: False

 nctId: NCT06268327 id: Adjuvant treatment in BC briefTitle: Adding Adjuvant Cisplatin and Gemicitabine Versus Capecitabine in Triple-negative Breast Cancer Patients in Non pCR After Neoadjuvant Standard Chemotherapy overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2025-10-30 date: 2026-10-30 date: 2024-02-20 date: 2024-02-20 name: Assiut University class: OTHER briefSummary: In our study; investigator aim To show efficacy and toxicity of Adjuvant cisplatin and gemcitabine in triple-negative breast cancer patients with non pathologically complete response after neoadjuvant chemotherapy To compare outcome of adjuvant cisplatin and gemcitabine versus capecitabine conditions: Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Cisplatin injection and gemcitabine name: Capecitabine tablets measure: Adding adjuvant cisplatin and gemcitabine versus capecitabine in triple-negative Breast cancer patients with non pathologically complete response after neoadjuvant standard chemotherapy measure: Comparison of patients who receive cisplatin and gemcitabine versus capecitabine in Triple negative breast cancer sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06268314 id: hypoalbuminemia in pediatrics. briefTitle: Feeding Pattern and Hypoalbuminemia in Pediatrics With Chronic Kidney Disease. overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2026-06-01 date: 2024-02-20 date: 2024-03-05 name: Assiut University class: OTHER briefSummary: To determine the impact of feeding pattern on the development of hypoalbuminemia and out come of pediatric patients with chronic kidney disease. conditions: Chronic Kidney Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 70 type: ESTIMATED measure: Feeding Pattern and Hypoalbuminemia in Pediatrics With Chronic Kidney Disease. sex: ALL minimumAge: 2 Years maximumAge: 16 Years stdAges: CHILD hasResults: False

 nctId: NCT06268301 id: TAK-721-1003 briefTitle: A Study to Determine the Effect Food Has on TAK-721 (Budesonide Oral Suspension) in the Body of Healthy Adults overallStatus: COMPLETED date: 2023-02-06 date: 2023-02-17 date: 2023-02-20 date: 2024-02-20 date: 2024-02-20 name: Takeda class: INDUSTRY briefSummary: The main aim of this study is to check what the body of a healthy adult who either fasted or had eaten does to TAK-721 and how TAK-721 is distributed in and removed from the body. Other aims are to learn how safe the treatment with TAK-721 is and how suitable the TAK-721 is for healthy adults who either fasted or had eaten. All participants will receive TAK-721 but half will be assigned by chance to the participant group who are fasting first then getting the high-fat/high-calorie meal later or the group who gets meal first and fasts later. The group assignment will be switched once during the course of the study so that all participants will receive TAK-721 in both a fasted or fed condition. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 20 type: ACTUAL name: Budesonide measure: Maximum Observed Concentration (Cmax) measure: Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) measure: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC∞) measure: Number of Participants who Experience at Least one Treatment Emergent Adverse Event (TEAE) by Severity, Serious Adverse Events (SAE) and Death measure: Number of Participants With Clinically Significant Abnormal Vital Sign Values measure: Number of Participants With Clinically Significant Abnormal Clinical Laboratory Values measure: Area Under the Concentration-time Curve From Time 0 to 12 Hours (AUC0-12) measure: Area Under the Curve From the Last Quantifiable Concentration to Infinity Expressed as a Percentage of AUC∞ (AUCextrap%) measure: Time to First Occurrence of Cmax (tmax) measure: Lag Time to First Quantifiable Concentration (tlag) measure: Terminal Disposition Phase Half-life (t1/2z) measure: Terminal Disposition Phase Rate Constant (λz). measure: Apparent Clearance (CL/F) Calculated Using the Observed Value of the Last Quantifiable Concentration measure: Apparent Volume of Distribution During the Terminal Disposition Phase (Vz/F) Calculated Using the Observed Value of the Last Quantifiable Concentration sex: ALL minimumAge: 19 Years maximumAge: 55 Years stdAges: ADULT facility: Celerion city: Lincoln state: Nebraska zip: 68502 country: United States lat: 40.8 lon: -96.66696 hasResults: False

 nctId: NCT06268288 id: 22-011492 briefTitle: Non-invasive Vagal Neurostimulation (nVNS) in Adolescents With Postural Orthostatic Tachycardia Syndrome (POTS) overallStatus: NOT_YET_RECRUITING date: 2024-02-12 date: 2024-07-22 date: 2024-12-22 date: 2024-02-20 date: 2024-02-20 name: Mayo Clinic class: OTHER briefSummary: The purpose of this study is to determine if nVNS will decrease autonomic symptom intensity (COMPASS-31 and Child Functional Disability Inventory) in adolescent patients with postural orthostatic tachycardia syndrome (POTS) in comparison to standard recovery STEPS management. conditions: Postural Tachycardia Syndrome conditions: Autonomic Dysfunction conditions: Postural Orthostatic Tachycardia Syndrome conditions: POTS - Postural Orthostatic Tachycardia Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Half of the patient population will be randomized to standard management only. The other half of the population will be randomized to standard management plus use of the vagal nerve stimulator primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: GammaCore intervention name: STEPS management protocol measure: The change in COMPASS-31 scores between individuals in both arms of the study measure: The change in Child Functional Disability Inventory scores between individuals in both arms of the study measure: The change in heart rate increase in head up tilt table tests in individuals in both arms of the study measure: Does nVNS influence headache frequency in adolescent patients with POTS measure: Does nVNS influence ability to increase exercise duration in adolescent patients with POTS measure: Does use of nVNS influence degree of depression in adolescent patients with POTS sex: ALL minimumAge: 12 Years maximumAge: 19 Years stdAges: CHILD stdAges: ADULT facility: Mayo Clinic in Rochester city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06268275 id: HE651314 briefTitle: Comparison of Effects of Scalp Block and Intravenous Esmolol on Hemodynamic Response Following the Skull Pins Application for Elective Supratentorial Craniotomy overallStatus: COMPLETED date: 2022-09-19 date: 2024-02-01 date: 2024-02-13 date: 2024-02-20 date: 2024-02-20 name: Khon Kaen University class: OTHER briefSummary: The goal of this clinical trial is to compare hemodynamic response (MAP, SBP, DBP and HR) between scalp block and intravenous esmolol while skull pins application in patients undergoing elective supratentorial craniotomy under general anesthesia. conditions: Hemodynamic Instability studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: RCT primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 90 type: ACTUAL name: Scalp block name: Esmolol measure: MAP measure: SBP measure: DBP measure: HR measure: BIS measure: Cumulative postoperative opioids consumption measure: Postoperative adverse events sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Khon Kaen University city: Khon Kaen state: Naimuang, Muang zip: 40002 country: Thailand lat: 16.44671 lon: 102.833 hasResults: False

 nctId: NCT06268262 id: XYFY2023-KL045-01 briefTitle: Surgical-imaging Research on Obesity (SIRO) overallStatus: RECRUITING date: 2023-03-01 date: 2026-12 date: 2028-12 date: 2024-02-20 date: 2024-03-15 name: The Affiliated Hospital of Xuzhou Medical University class: OTHER briefSummary: The global obesity epidemic is well established, and is an important public health issue. The previous researches had applied the clues that obesity is a kind of systemic disease. The investigators hypothesized that a serious alteration of the body systems will occur after bariatric surgery, which may shed light on the mechanisms of obesity. Thus, the research aims to combine the imaging and surgery to investigate the alterations of the body that induced by obese and alterations after surgery. conditions: Overweight and Obesity studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Imaging parameters of obesity measure: Imaging parameters of obesity measure: Imaging parameters of obesity measure: Neurotransmitter, inflammatory factors and hormones related to obesity in blood sample measure: Neurotransmitter, inflammatory factors and hormones relating to obesity in blood sample measure: Neurotransmitter, inflammatory factors and hormones related to obesity in blood sample measure: Genetic information from venous blood sample, biopsied liver tissue, biopsied fat tissue, and gastric tissue sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Affiliated Hospital of Xuzhou Medical University status: RECRUITING city: Xuzhou state: Jiangsu zip: 221000 country: China name: Kai Liu, M.D/Ph.D role: CONTACT phone: +86-15920157720 email: liu-k@hotmail.com lat: 34.18045 lon: 117.15707 hasResults: False

 nctId: NCT06268249 id: TJ-IRB20231224 briefTitle: Ulinastatin Improves Post-Cardiac Surgery Cognitive Dysfunction overallStatus: COMPLETED date: 2015-01-01 date: 2022-12-30 date: 2023-12-30 date: 2024-02-20 date: 2024-02-20 name: Qin Zhang class: OTHER briefSummary: This study is a retrospective, observational study that aims to include patients undergoing cardiac surgery. 1. Evaluate the preventive effect of ursodeoxycholic acid on post-cardiac surgery cognitive dysfunction over the past eight years. 2. Utilize the pre-existing preoperative and postoperative 24-hour plasma samples from previous studies to measure the levels of glycocalyx and its related regulatory factors. 3. Assess the clinical correlation between the measured parameters and patient outcomes. conditions: Cardiac Complication studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 7065 type: ACTUAL name: Ulinastatin measure: POCD - Postoperative Cognitive Dysfunction measure: Survival time sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430030 country: China lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06268236 id: BF2023-252 briefTitle: Electro-acupuncture to Treat Disorder of Consciousness overallStatus: RECRUITING date: 2024-01-01 date: 2026-01-31 date: 2026-01-31 date: 2024-02-20 date: 2024-02-20 name: The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine class: OTHER briefSummary: With the rapid development of life support technology, more and more people can survive severe brain injury. Some survivors regain consciousness after a period of coma, however, many patients develop prolonged disorders of consciousness (DOC), which poses a therapeutic challenge for clinicians and a heavy burden for their families. The investigators design an Electro-acupuncture to treat disorder of consciousness (AcuDoc) trial with the aim of validating the clinical effect of electroacupuncture in treating DOC and exploring its therapeutic mechanisms by integrating EEG, neuroimaging, evoked potential tests, and behavioral assessments. conditions: Disorder of Consciousness conditions: Electroacupuncture studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Electroacupuncture name: Sham electroacupuncture measure: Coma Recovery Scale - Revised score measure: phase locking value measure: amplitude of low-frequency fluctuation measure: Amide proton transfer-weighted signal measure: f value measure: neurite density index measure: latency value of N20 measure: latency between III and V potentials measure: Glasgow Outcome Scale-Extended score measure: Glasgow Outcome Scale-Extended score measure: brain-computer interface accuracy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Guangzhou University of Chinese Medicine status: RECRUITING city: Guangzhou state: Guangdong zip: 510120 country: China name: Fang Yuan, PhD role: CONTACT phone: +86-20-81887233 email: plawlx@gzucm.edu.cn lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06268223 id: 2023/315 briefTitle: Home-Based Action Observation Training for Chewing and Swallowing Function overallStatus: RECRUITING date: 2023-10-13 date: 2024-05-01 date: 2024-07-01 date: 2024-02-20 date: 2024-02-20 name: Ondokuz Mayıs University class: OTHER name: Hacettepe University briefSummary: The goal of this clinical trial is to investigate the effects of home-based Action Observation Training (AOT) applied together with Functional Chewing Training (FuCT) on chewing and swallowing functions and feeding behavior in children with Cerebral Palsy (CP) who have chewing disorders. The main questions it aims to answer are:

* Is the application of Home-Based AOT together with FuCT effective on chewing function in children with CP?
* Is the application of Home-Based AOT together with FuCT effective on swallowing function in children with CP?
* Is the application of Home-Based AOT together with FuCT effective on feeding behavior in children with CP? Within the scope of the study, children with CP will be divided into two groups as the study group and the control group. All groups will implement FuCT routines, comprising 5 sets per day, 5 days a week, for 12 weeks. Additionally, the study group will be included in an AOT program, conducted via telerehabilitation, for 1 set per day, 3 days a week, for 12 weeks, with the guidance of a physiotherapist. All children with CP will be evaluated at the beginning, after 6 weeks, and at the end of the study. conditions: Cerebral Palsy conditions: Chewing Disease conditions: Action Obervation Training studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Chewing Exercise Training measure: Karaduman Chewing Performance Scale measure: Turkish version of the Mastication Observation and Evaluation Instrument measure: Test of Masticating and Swallowing Solids in Children measure: Nutrient consistency according toInternational Dysphagia Diet Standardisation Initiative measure: The Pediatric version of the Eating Assessment Tool measure: Dysphagia Disorder Survey measure: Behavioral Pediatrics Feeding Assessment Scale sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Seda Nur Kemer,PT, MSc,PhD Candidate, Lecturer status: RECRUITING city: Samsun state: Atakum zip: 55200 country: Turkey name: Seda Nur Kemer, 1 role: CONTACT phone: +9005467861866 email: sedakemer@gmail.com lat: 41.27976 lon: 36.3361 hasResults: False

 nctId: NCT06268210 id: 4-2023-1546 briefTitle: Neoadjuvant Lazertinib With or Without Chemotherapy for Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer acronym: NeoLazer overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-06 date: 2028-06 date: 2024-02-20 date: 2024-02-20 name: Yonsei University class: OTHER briefSummary: In the randomized, multicenter Phase II clinical trial, we aim to evaluate the efficacy and safety of Lazertinib monotherapy or the combination of Lazertinib and cytotoxic chemotherapy as neoadjuvant therapy in patients with resectable, treatment-naive EGFR-mutant (exon 19 deletion or exon 21 L858R) non-small cell lung cancer, ranging from clinical stage IB to IIIB. The study is designed to assess the impact on pathological response, as well as effectiveness and safety considerations. conditions: Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 160 type: ESTIMATED name: Lazertinib+Pemetrexed+Carboplatin name: Lazertinib measure: Primary pathological response measure: Surgical Resection Methods (Segmentectomy or Lobectomy) measure: Pathologic Complete Response measure: Objective Response Rate measure: Event-Free Survival measure: Disease-Free Survival measure: Overall Survival measure: Number of patients with Adverse events according to CTCAE v5.0 sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Severance hospital city: Seoul country: Korea, Republic of name: Hye Ryun Kim role: CONTACT phone: 82-2-2228-8125 email: nobelg@yuhs.ac lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06268197 id: IRB23-0329 briefTitle: Interoception-Based Yoga for Chronic Pain overallStatus: RECRUITING date: 2024-02-16 date: 2024-12-30 date: 2024-12-30 date: 2024-02-20 date: 2024-02-20 name: University of Illinois at Urbana-Champaign class: OTHER briefSummary: The purpose of this research is to examine the feasibility and acceptability of an interoception-based yoga program for chronic pain. Interoception involves your ability to feel sensations in your body (such as your heartbeat or muscle tension) as well as how you think about and interpret those sensations. Interoception may be an important component of chronic pain and the research team is studying whether yoga can change how you feel, think about, and interpret sensations in your body. conditions: Chronic Pain studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: Yoga Intervention measure: Feasibility measure: Acceptability measure: Interoceptive Sensibility measure: PROMIS Pain Interference measure: Interoceptive Accuracy measure: Mindfulness measure: PROMIS Pain Intensity measure: Quality of Life measure: Spiritual Wellbeing measure: Pain Impact sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: University of Illinois Urbana-Champaign status: RECRUITING city: Urbana state: Illinois zip: 61801 country: United States name: Project Coordinator role: CONTACT phone: 217-265-0741 email: svoss2@illinois.edu name: Neha P Gothe, PhD role: PRINCIPAL_INVESTIGATOR name: Steven Petruzzello, PhD role: SUB_INVESTIGATOR lat: 40.11059 lon: -88.20727 hasResults: False

 nctId: NCT06268184 id: omega3 in oxidative stress briefTitle: Effect of Omega 3 on Oxidative Stress and Nutritional Status of Children on Regular Dialysis overallStatus: RECRUITING date: 2021-10-04 date: 2024-03-01 date: 2024-04-01 date: 2024-02-20 date: 2024-02-20 name: Tanta University class: OTHER briefSummary: evaluaion the effects of oral omega-3 supplementation on nutritional status and oxidative stress in pediatric patients with end stage renal disease on regular hemodialysis conditions: Oxidative Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: group 1: 30 children with ESRD receive omega 3 supplementation group 2:15 children with ESRD receive lpacebo primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 45 type: ESTIMATED name: D3 LAB SYRUP name: placebo capsule measure: decrease oxidative stress measure: increase antioxidant activity measure: improvement of nutritional status assessed by anthropometric measurements. measure: mid upper arm circumference in centimeters measure: triceps skin fold thickness in millimeter's measure: improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA) measure: improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA) measure: improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA) measure: improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA) measure: improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA) measure: improvement of nutritional status assessed by laboratory investigations. measure: s. ionized calcium level measure: s.phosphorus level measure: alkaline phosphatase level measure: parathormone hormone level measure: 25(oh)vitamin D level sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Faculty of Medicine status: RECRUITING city: Tanta state: Gharbia country: Egypt name: Noha sayed ahmed, M.Sc role: CONTACT phone: 01016919217 phoneExt: 01097722167 email: noooooha1990@gmail.com name: rasha gamal elshafaay, MD role: CONTACT phone: 01227405988 phoneExt: 01114277784 email: rashagamal1978@gmail.com lat: 30.78847 lon: 31.00192 hasResults: False

 nctId: NCT06268171 id: 2023_0214 id: 2023-A02390-45 type: OTHER domain: ANSM briefTitle: Ultrasound Assessment of Rectus Femoris Cross-sectionnal Area Following Lung Transplantation acronym: EchoSS-TP overallStatus: NOT_YET_RECRUITING date: 2024-03-04 date: 2025-09-04 date: 2025-11-05 date: 2024-02-20 date: 2024-02-20 name: Hopital Foch class: OTHER briefSummary: In France, the profile of patients receiving lung transplants has changed in recent years, mainly due to the advent of treatment for cystic fibrosis. This progress has led to an evolution in the patient profile, with an increase in cases of pulmonary fibrosis or COPD, and an increase in the average age of patients. In these older patients, sarcopenia, a condition characterized by loss of muscle mass, is a major concern, as it exacerbates morbidity and mortality.

After transplantation, patients are at risk of developing neuromyopathy due to their hospitalization in intensive care. There is currently no effective preventive treatment for this condition, underlining the need for early rehabilitation strategies. The combination of sarcopenia and neuromyopathy diminishes their functional capabilities on discharge from the ICU.

Muscle ultrasound, a simple, non-invasive technique, is already used to assess muscle function in intensive care patients. This study aims to evaluate the use of ultrasound to measure muscle loss in lung transplant patients, in particular by examining the rectus femoris muscle. Objectives include observing variations in the surface area of the rectus femoris muscle before and after transplantation, identifying factors influencing this variation, and exploring its relationship with post-transplant morbidity.

In summary, this study seeks to better understand muscle loss in lung transplant patients using ultrasound, in order to identify risk factors and guide the development of post-transplant rehabilitation strategies. conditions: Lung Transplant conditions: Physiotherapy conditions: Sarcopenia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 42 type: ESTIMATED name: ultrasound measurement of the cross-sectional area of the rectus femoris measure: Evaluation of the change at D7 in the cross-sectional area of the rectus femoris following lung transplantation measure: Measure change in CSA-RF at D7 according to LT pattern measure: Evaluate the relationship between length of stay in intensive care unit and variation in CSA-RF at D7 measure: Determine the relationship between CSA-RF at D-1 and Body Mass Index sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06268158 id: 2023/45 briefTitle: The Effect of Eye Mask and Music on Sleep Quality and Delirium in Patients Monitored in Intensive Care Unit overallStatus: RECRUITING date: 2023-04-01 date: 2024-04-01 date: 2024-06-01 date: 2024-02-20 date: 2024-02-20 name: TC Erciyes University class: OTHER briefSummary: After abdominal surgery, most patients experience problems such as respiratory complications, surgical wound infection, cardiac problems, renal failure, delirium, and insomnia, along with surgical trauma and underlying comorbidities. Postoperative delirium (POD) is an adverse postoperative complication that can occur in patients of all ages, from children to the elderly. Effective non-pharmacological treatment approaches for delirium include using an orientation board, calendar, clock, ensuring hydration, improving sleep quality, therapeutic activities, providing companionship of family members, and building private rooms. This study will be conducted as a randomized controlled and experimental study to determine the effect of eye patch and music on sleep quality and delirium in patients followed after abdominal surgery in the surgical intensive care unit.

It was planned to include a total of 34 patients who underwent abdominal surgery, 17 in the experimental group and 17 in the control group.

During the data collection phase, the Patient Information Form, Richard-Campbell Sleep Scale, Nursing Delirium Screening Scale and Richmond Agitation-Sedation Scale, will be used. conditions: Abdominal Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 34 type: ESTIMATED name: Eye patch measure: Richard-Campbell Sleep Scale measure: Nursing Delirium Screening Scale measure: Richmond Agitation-Sedation Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erciyes University status: RECRUITING city: Kayseri state: Talas zip: 38080 country: Turkey name: Yeliz Sürme, PhD role: CONTACT phone: +0905532051130 email: yelizsurme@erciyes.edu.tr name: Tuğçe TOPAL role: CONTACT phone: +9005075698312 email: tugcetopal5@gmail.com name: Tuğçe TOPAL, Msn role: PRINCIPAL_INVESTIGATOR name: Yeliz SÜRME, PhD role: PRINCIPAL_INVESTIGATOR lat: 38.73222 lon: 35.48528 hasResults: False

 nctId: NCT06268145 id: EC0006 briefTitle: ECC5004 RBA FE Study in Healthy Participants overallStatus: RECRUITING date: 2024-02-06 date: 2024-03-30 date: 2024-03-30 date: 2024-02-20 date: 2024-02-20 name: Eccogene class: INDUSTRY briefSummary: This study is a Phase 1, open-label, randomized, single dose, fixed sequence, crossover study designed to compare the relative bioavailability of 50 mg ECC5004 current tablet formulation (F1) and 50 mg ECC5004 new tablet formulation (F2) under fasted and fed conditions in healthy participants conditions: Type 2 Diabetes Mellitus studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 14 type: ESTIMATED name: ECC5004 measure: ECC5004 PK parameters: AUC0-tlast measure: ECC5004 PK parameters: AUC0-inf measure: ECC5004 PK parameters: Cmax measure: ECC5004 PK parameters: tmax measure: Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations measure: ECC5004 PK parameters: AUC0-tau measure: ECC5004 PK parameters: AUC 0-24 measure: ECC5004 PK parameters: tlag measure: ECC5004 PK parameters: t1/2 measure: ECC5004 PK parameters: CL/F measure: ECC5004 PK parameters: AUC(extr) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Eccogene Investigational Site status: RECRUITING city: Anaheim state: California zip: 92801 country: United States name: Eccogene role: CONTACT lat: 33.83529 lon: -117.9145 hasResults: False

 nctId: NCT06268132 id: MLS90 briefTitle: Longevity in Russia overallStatus: RECRUITING date: 2019-12-25 date: 2024-12-31 date: 2025-12-31 date: 2024-02-20 date: 2024-02-22 name: Center for Strategic Planning, of the Federal Medical and Biological Agency class: OTHER name: Pirogov Russian National Research Medical University briefSummary: This is an observational cohort study of long-living adults (participants aged 90 and above) from the Central Federal District of Russia.

The study seeks to determine the genetic and cellular and molecular determinants of healthy longevity and to assess the impact of lifestyle and socioeconomic and environmental factors on healthy longevity.

The study is expected to result in the development of a panel of markers of healthy longevity and/or a model of healthy aging based on the analysis of all factors under consideration. conditions: LONGEVITY 1 conditions: Frailty conditions: Aging conditions: Age-related Cognitive Decline conditions: Aging Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 4000 type: ESTIMATED measure: Mortality among long-living adults measure: Morbidity among long-living adults measure: Aging phenotypes measure: Social, economic, and medical- history-related determinants measure: Genetic determinants measure: Epigenetic determinants measure: Metagenomic determinants sex: ALL minimumAge: 90 Years stdAges: OLDER_ADULT facility: RUSSIAN CLINICAL AND RESEARCH CENTER OF GERONTOLOGY, Pirogov Russian National Research Medical University of the Ministry of Healthcare of the Russian Federation status: RECRUITING city: Moscow zip: 129226 country: Russian Federation name: Irina D. Strazhesko, M.D., Ph.D role: CONTACT phone: +7 (499) 187-64-67 email: Istrazhesko@gmail.com lat: 55.75222 lon: 37.61556 hasResults: False

 nctId: NCT06268119 id: MustafaKU-SBF-GKS-01 briefTitle: Effectiveness of Delirium Care Protocol After Cardiac Surgery overallStatus: COMPLETED date: 2023-03-06 date: 2023-05-15 date: 2023-05-22 date: 2024-02-20 date: 2024-02-20 name: Gonul Kara Soylemez class: OTHER briefSummary: This study was conducted as a quasi-experimental study to determine the effectiveness of the postoperative delirium prevention, diagnosis and intervention protocol in patients monitored in the intensive care unit after cardiac surgery. conditions: Delirium, Postoperative studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The control group received standard care. The intervention group received care in line with postoperative delirium prevention, diagnosis, and intervention. primaryPurpose: PREVENTION masking: NONE count: 64 type: ACTUAL name: training nurses and caring for patients to prevent, diagnose, and intervene in postoperative delirium. measure: Confusion Assessment Scale in the Intensive Care Unit (CAM-ICU) measure: Glasgow Coma Scale (GCS) measure: Richmond Agitation-Sedation Scale (RASS) measure: Information Assessment Form for Postoperative Delirium (Pretest-Posttest) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Antalya Training and Research Hospital city: Antalya state: Center zip: 07000 country: Turkey lat: 36.90812 lon: 30.69556 hasResults: False

 nctId: NCT06268106 id: IRB N/A briefTitle: Graphic Novel for Patients Undergoing EUS-FNB overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-07-30 date: 2024-08-01 date: 2024-02-20 date: 2024-02-20 name: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies class: OTHER briefSummary: Endoscopy with endoscopic ultrasound (EUS) is a primary technique for diagnosing and treating severe pancreatic disorders. However, the procedure can cause fear and anxiety in patients, especially when a biopsy is involved. Graphic medicine, a form of visual storytelling that explores narratives of healthcare, is being used to alleviate this anxiety.

This is a prospective single-center interventional pilot study with the aim to evaluate the impact of a novel graphic on the stress and behaviors of patients with pancreatic lesions undergoing EUS-FNB. The study will run for six months with the aim to enroll patients to llok for differences in the anxiety and stress levels.

Enrolled patients will be randomly allocated to the test or control group, with the test group receiving a graphic novel to read while waiting for the procedure. Post-procedure, patients will complete the Beck Anxiety Inventory (BAI) and a modified version of the Depression Anxiety Stress Scales-21 (mDASS-21), now named mASS-14 (modified Anxiety Stress Scales-14), to assess anxiety and stress levels.

This study is conducted according to the principles of the Declaration of Helsinki regarding experimentation involving human subjects, and written informed consent will be obtained from all participants before enrollment. conditions: Anxiety conditions: Pancreatic Cancer conditions: Pancreatic Cystic Lesions conditions: Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Graphic novel will be visualized by interventional group before EUS-FNB primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: CARE_PROVIDER count: 50 type: ESTIMATED name: Graphic novel visualization measure: Anxiety and stress level according to BAI measure: Anxiety and stress level according to mASS-14 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Irccs - Ismett city: Palermo state: PA zip: 90127 country: Italy name: Giacomo Emanuele Maria Rizzo, MD role: CONTACT phoneExt: +393406602502 email: g.rizzo.gr@gmail.com name: Ilaria Tarantino, MD role: PRINCIPAL_INVESTIGATOR name: Giacomo Emanuele Maria Rizzo, MD role: PRINCIPAL_INVESTIGATOR name: Mario Traina, MD role: PRINCIPAL_INVESTIGATOR lat: 38.13205 lon: 13.33561 hasResults: False

 nctId: NCT06268093 id: XWTETS briefTitle: The Therapeutic Effect of Thalidomide in Syringomyelia overallStatus: RECRUITING date: 2024-02 date: 2027-02 date: 2028-02 date: 2024-02-20 date: 2024-02-20 name: Xuanwu Hospital, Beijing class: OTHER briefSummary: Purpose: This phase II clinical trial aims to evaluate the indications, therapeutic effects and side effects of thalidomide in refractory syringomyelia.

Primary outcome measure: The primary endpoint is the change of ASIA at week 12. The clinical efficacy is defined as ASIA increase ≥ 1 at week 12, as compared with that before thalidomide usage. conditions: Syringomyelia conditions: Thalidomide studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Thalidomide measure: ASIA Score measure: syringomyelia remission measure: The evoked electromyographic signal (eEMG) potential measure: Visual Analog Scale (VAS) measure: Klekamp and Sammi syringomyelia scale measure: modified Japanese Orthopaedic Association Scores (mJOA) measure: xuanwu syringomyelia scale measure: Incidence of complications sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fengzeng Jian status: RECRUITING city: Beijing state: Beijing City zip: 100032 country: China name: fengzeng jian, md role: CONTACT email: jianfengzeng@xwh.ccmu.edu.cn lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06268080 id: A+9317 briefTitle: Depth of Anesthesia on Postoperative Delirium and Cognitive After Surgery acronym: Balanced-2 overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2027-12-31 date: 2028-12-31 date: 2024-02-20 date: 2024-02-20 name: Auckland City Hospital class: OTHER_GOV briefSummary: The goal of this clinical trial (Balanced-2 study) is to compare light to deep general anesthesia using widely available brain monitors, to see if 'light' anesthesia could reduce rates of delirium, cognitive decline, and disability in older adults undergoing major surgery.

Delirium is the most common serious surgical complication, occurring in an estimated one in four older adults undergoing major surgery. Delirium causes significant distress to patients and family, and is associated with prolonged hospital stay, physical disability, progression to dementia-like illnesses, and discharge to long-term care. Between 10 - 30% of adults aged 70 years and above have surgery every year, and preserving brain health and wellbeing is an important priority during this time.

Older adults (aged ≥65 years, or Indigenous, Pasific patients aged ≥55 years) undergoing major surgery with general anesthesia (excluding heart and brain surgery) and able to provide consent will be able to participate. Participants will be randomized to two groups - a lighter general anesthesia group and a deeper general anesthesia group using processed electroencephalography (a brain monitor that provides information on depth of anesthesia using brain waves). The anesthesiologist will titrate anesthetic drugs according to the brain monitor. Participants will be followed up to determine if they experience delirium after surgery, and longer term impact of delirium such as cognitive and physical decline will also be measured.

If found to be effect, this simple, cheap, and widely available treatment could reduce disability, preserve brain health and wellbeing of many older adults undergoing surgery worldwide, and save millions in healthcare dollars. conditions: Delirium, Postoperative conditions: Anesthesia conditions: Surgery-Complications conditions: Cognition Disorder conditions: Delirium conditions: Cognitive Decline studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multicentre, prospective, randomized, active control, parallel group, intention to treat, safety and efficacy study. primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: Blinding of procedural anesthesiologist is not possible. Patients, surgeons, and all outcome assessors will be blinded. One unblinded research coordinator at each site will collect pEEG related data points. Other research coordinators will be blinded as to treatment allocation and will collect data relating to primary and secondary outcomes. Clinicians carrying out participant usual care will be able to unblind study allocation if necessary by viewing the patients anesthesia record via password protected, accessing clinician identity logged, Electronic Health Record (EHR). This record will be unavailable for access by other means. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 2766 type: ESTIMATED name: Depth of anesthesia titration using pEEG measure: Incidence of postoperative delirium (POD) measure: Incidence of severe delirium measure: Incidence of new mild and major postoperative neurocognitive disorders measure: Postoperative cognitive decline measure: Functional decline measure: All-cause mortality measure: Duration of delirium measure: Incidence of awareness measure: Adverse and serious adverse events sex: ALL minimumAge: 55 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06268067 id: Renal uptake at F18 FDG PET/CT briefTitle: Kidney Uptake at F-18 FDG PET/CT Studies and Renal Function Status overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-04-01 date: 2024-02-20 date: 2024-02-20 name: Assiut University class: OTHER briefSummary: Searching for a possible correlation between renal uptake at F-18-FDG PET/CT and renal functional parameters in both normal subjects and patients with CKD. conditions: Renal Uptake at F-18-FDG PET/CT studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 97 type: ESTIMATED name: PET/CT measure: significance of renal uptake at F18-FDG PET CT studies measure: Early detection of patients with CKD sex: ALL minimumAge: 19 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06268054 id: DEH113-III-0123 briefTitle: Efficacy and Safety of DEH113 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea acronym: LIBERTÀ overallStatus: NOT_YET_RECRUITING date: 2025-02 date: 2027-02 date: 2027-09 date: 2024-02-20 date: 2024-02-22 name: EMS class: INDUSTRY briefSummary: The purpose of this study if to evaluate the efficacy and safety of DEH113 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea. conditions: Primary Dysmenorrhea studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 78 type: ESTIMATED name: DEH113 name: Placebo Comparator measure: Sum of Total Pain Relief (TOTPAR) over 0-6 hours post-dose measure: Sum of Total Pain Relief (TOTPAR) over 0-4 and 0-8 hours post-dose measure: Sum of Pain Intensity Difference (SPID) over 4, 6 and 8 hours post-dose. measure: Use of rescue medication measure: Number of additional drug intake measure: Patients' Global Impression of Change (PGIC) measure: Incidence of Adverse Events Associated with DEH113 in the Treatment of Primary Dysmenorrhea sex: FEMALE minimumAge: 16 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06268041 id: 427659 id: R01HD093694 type: NIH link: https://reporter.nih.gov/quickSearch/R01HD093694 briefTitle: HIT-Stroke Trial 2 acronym: HST2 overallStatus: RECRUITING date: 2024-02-09 date: 2028-01 date: 2028-04 date: 2024-02-20 date: 2024-02-20 name: University of Cincinnati class: OTHER name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) name: University of Kansas Medical Center name: University of Delaware briefSummary: People who had a stroke at least 6 months prior and who still have difficulty with walking will each be randomly assigned to receive either moderate or vigorous intensity walking exercise. Both protocols will be performed individually with a physical therapist for 45 minutes, 3x/week for 12 weeks. Measures including walking function will be assessed at baseline (PRE), after 4, 8 and 12 weeks of training (12WK) and at 3-month follow up (3moPOST), by raters who are unaware of the participant randomization. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 156 type: ESTIMATED name: Moderate-Intensity Aerobic Training name: High-Intensity Interval Training measure: 6-Minute Walk Test Distance measure: 6-Minute Walk Test Distance measure: Self-Selected Gait Speed measure: Fastest Gait Speed measure: PROMIS-Fatigue Scale version 8a measure: Aerobic Capacity measure: EuroQol-5D-5L sex: ALL minimumAge: 30 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Delaware status: RECRUITING city: Newark state: Delaware zip: 19713 country: United States name: Jane Diehl role: CONTACT email: strokestudies@udel.edu name: Darcy Reisman, PT, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.68372 lon: -75.74966 facility: University of Kansas Medical Center status: RECRUITING city: Kansas City state: Kansas zip: 66160 country: United States name: Sasha Moores role: CONTACT phone: 913-588-2697 email: reachlab@kumc.edu name: Sandra Billinger, PT, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.11417 lon: -94.62746 hasResults: False

 nctId: NCT06268028 id: BELMA TA briefTitle: Discharge Training Given to Primiparous Mothers Who Had a Cesarean Delivery overallStatus: ENROLLING_BY_INVITATION date: 2024-01-10 date: 2024-06-10 date: 2024-11-10 date: 2024-02-20 date: 2024-02-21 name: Aydin Adnan Menderes University class: OTHER briefSummary: This study aimed to determine the effect of discharge training given to primiparous mothers who gave birth by cesarean section on the level of readiness for discharge.

The research is a pre-test-post-test, randomized controlled experimental study. conditions: Education studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 70 type: ESTIMATED name: Training measure: A pre-test will be applied to 70 women who constitute the sample of the research. measure: Apost-test will be applied to 70 women who constitute the sample of the research. sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Aydın Maternity and Child Health Hospital city: Aydın zip: 09010 country: Turkey lat: 37.84501 lon: 27.83963 hasResults: False

 nctId: NCT06268015 id: Pro00115311 briefTitle: Botensilimab and Balstilimab Optimization in Colorectal Cancer acronym: BBOpCo overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2028-07 date: 2028-07 date: 2024-02-20 date: 2024-02-22 name: Nicholas DeVito, MD class: OTHER name: Gateway for Cancer Research name: Agenus Inc. briefSummary: This is a single-arm, interventional, pilot clinical trial. Fifteen evaluable patients will have tumor-informed ctDNA testing at baseline and start botensilimab and balstilimab treatment. They will receive botensilimab and balstilimab in 6-week cycles until progression, after which mFOLFOX6 and bevacizumab or panitumumab will be added to the regimen. Subjects will have safety testing at baseline and every two weeks while on study drug. Study treatment with botensilimab and balstilimab, mFOLFOX6, and bevacizumab or panitumumab will be continued until radiographic or clinical progression, toxicity, or patient withdrawal. Subjects will have one safety follow up visit 30 days after the last treatment and will be followed for survival every 12 weeks for up to 2 years. conditions: Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Botensilimab name: Balstilimab name: Oxaliplatin name: Leucovorin name: Fluorouracil name: Bevacizumab name: Panitumumab measure: Disease control rate based on iRECIST at second restaging scan measure: Proportion of subjects with a best overall response of complete response or partial response according to iRECIST measure: Disease control rate based on RECIST v1.1 at second restaging scan measure: Proportion of subjects with a best overall response of complete response or partial response according to RECIST v1.1 measure: Months of overall survival measure: Months of progression-free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Duke University city: Durham state: North Carolina zip: 27710 country: United States name: Nicholas C. DeVito, MD role: PRINCIPAL_INVESTIGATOR lat: 35.99403 lon: -78.89862 hasResults: False

 nctId: NCT06268002 id: 5876557033 briefTitle: Effect of Vernonia Cinerea Lozenges as a Smoking Cessation Aid in Patients With Non-communicable Diseases overallStatus: COMPLETED date: 2017-09-01 date: 2021-09-30 date: 2021-12-31 date: 2024-02-20 date: 2024-02-28 name: Chulalongkorn University class: OTHER briefSummary: Vernonia cinerea is an herbal which has been recorded in many Thai herbal formulation and Thai traditional medicine has used this herbal for treating various diseases included hypertension, asthma, fever, hepatitis, kidney stone and smoking cessation. Now aday there are more interest for using Vernonia cinerea as a medication to aid smoker to quit smoking because it is cheaper than other current therapeutic medications. The objective of this study is to evaluate efficacy and safety of Vernonia cinerea lozenge for smoking cessation when compared to placebo. conditions: Smoking Cessation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study was a multicenter randomized, paralleled, double-blind, controlled trial at 5 hospitals and 2 community pharmacies in Thailand primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 93 type: ACTUAL name: Vernonia cinerea name: Placebo measure: continuous abstinence rate measure: continuous abstinence rate (CAR) and point prevalence rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Krittin Bunditanukul city: Bangkok zip: 10600 country: Thailand lat: 13.75398 lon: 100.50144 hasResults: False

 nctId: NCT06267989 id: Gothenburg University briefTitle: The Effectiveness of Early Intervention to Correct the Position of PDC:s acronym: PDC overallStatus: RECRUITING date: 2024-02-12 date: 2027-12-30 date: 2027-12-30 date: 2024-02-20 date: 2024-02-21 name: Region Örebro County class: OTHER briefSummary: Approximately 2-3% of children will have problems with one or both of their permanent or 'adult' canine teeth in the upper jaw. These canine teeth sometimes fail to erupt properly, because they are displaced into the roof of the mouth or palate. These are known as palatally displaced canines, PDC, (Brin et al., 1986, Ericson and Kurol, 1987). In addition to failing to erupt, displaced teeth can cause problems, such as damage to the roots or displacement of the neighbouring teeth (Ericson and Kurol, 1988a, Ericson and Kurol, 2000, Falahat et al., 2008).

It has been suggested that if the primary ('baby' or 'milk') canine is extracted at an appropriate time in a child with a suspected palatally displaced canine, then the displaced tooth might spontaneously correct its position (Ericson and Kurol, 1988b) and the extraction of the baby canine when a clinician suspects that the adult canine is displaced has become accepted clinical practice (Short, 2009). This appears to be on the basis of one report of a series of 35 children who received the intervention and no control group (Ericson and Kurol, 1988b). Two recent systematic reviews have examined the evidence for the effectiveness of removal of the primary canine with the aim of correcting the eruption path of a palatally displaced canine. A recent systematic review published in The Cochrane Library in 2021 (Benson et al., 2021) noted that the evidence for any intervention to correct the eruption path of a displaced permanent canine is weak and further research is required. Numerous problems with the reported studies were identified by both reviews.

Other authors have suggested that using a RME (Rapid Maxillary expansion) or headgrear (EOT) to create sufficient space within the dental arch for the permanent canine tooth will encourage the tooth to erupt (Baccetti et al., 2011). This approach might be less traumatic to a child who may have had no experience of dental treatment, other than routine check-ups. If either or both approaches are shown to be effective then their widespread use would be advantageous to both the child and the healthcare provider, because the need for an operation, under general anaesthetic, to uncover the tooth and extensive brace treatment to straighten the tooth will be avoided. conditions: Ectopic Tooth Eruption conditions: Palatal Expansion Technique conditions: Randomized Clinical Trial studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 318 type: ESTIMATED name: Extraction of the primary canine teeth name: Expansion measure: Succeful eruption of the palatally displaced canines into the dental arch measure: Cost effectiveness of the interventions measure: Prevalence and severity of damage to surrounding teeth either due to the unerupted tooth or orthodontic intervention. sex: ALL minimumAge: 10 Years maximumAge: 12 Years stdAges: CHILD facility: Gothenbrug University status: RECRUITING city: Gothenburg country: Sweden name: Farhan Bazargani, DDS, PhD role: CONTACT name: Björn Ludwig, DDS, PhD role: PRINCIPAL_INVESTIGATOR name: Martyn Coborune, DDS, PhD role: PRINCIPAL_INVESTIGATOR lat: 57.70716 lon: 11.96679 hasResults: False

 nctId: NCT06267976 id: REB23-1003 briefTitle: Validation of the ProSomnus® RPMO2 Device overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2024-05-31 date: 2024-06-30 date: 2024-02-20 date: 2024-04-02 name: ProSomnus Sleep Technologies class: INDUSTRY briefSummary: The purpose of the study is to:

1. Evaluate the SpO2 accuracy of the oximeter component of the ProSomnus RPMO2 Device during non-motion conditions over the range of 70-100% SaO2 by comparison to SaO2 values determined by arterial blood sample specimen analyzed by a CO-oximeter.
2. Evaluate the pulse rate performance simultaneously collected over the SpO2 range. conditions: Healthy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 15 type: ESTIMATED name: ProSomnus RPMO2 measure: SpO2 accuracy measure: Pulse rate accuracy sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: University of Calgary city: Calgary state: Alberta zip: T2N4N1 country: Canada name: Brad Hansen role: CONTACT phone: 403-210-8925 email: bhanse@ucalgary.ca lat: 51.05011 lon: -114.08529 hasResults: False

 nctId: NCT06267963 id: C4391010 id: 2023-507074-40-00 type: REGISTRY domain: CTIS (EU) briefTitle: A Study to Understand What the Body Does to the Study Medicine Called PF-07220060 When Taken by Healthy Adults overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-31 date: 2024-04-18 date: 2024-04-18 date: 2024-02-20 date: 2024-04-16 name: Pfizer class: INDUSTRY briefSummary: The purpose of this study is to learn about how much PF-07220060 will be taken up and processed by healthy male participants.

The study is seeking for participants who:

* are males aged 18 to 65 years and are healthy.
* have Body mass index (BMI) between 17.5 and 30.5 kilograms/meter2
* have a total body weight of at least 50 kilograms.

The study consists of two groups. In group 1, participants will take one amount of PF-07220060 by mouth. In group 2, participants will take one amount by mouth and one amount as an injection through a vein at the study clinic.

In group 1, participants will stay at the clinic site for up to 15 days. In group 2, the duration of participants' stay depends on the results of group 1.

During their stays, participants will have their blood, urine, and feces collected by the study doctors several times. We will measure the level of PF-07220060 in participants' blood, urine, and feces samples. This will help to know how much the study medicine is getting taken up by the body. At the end of the study, participants will be contacted by phone to check in. Participants will be involved in this study for about 9 weeks from the screening until the follow-up. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 12 type: ACTUAL name: Oral [14C]PF-07220060 name: Oral PF-07220060 name: IV [14C] PF-07220060 measure: Cumulative recovery (%) of radioactivity in urine and feces (adjusted for vomitus, if any), expressed as a percent of total oral radioactive dose administered. measure: Amount of metabolites of [14C]PF-07220060 in plasma, urine, and feces. measure: Dose normalized AUCinf of intravenous radiolabeled PF-07220060 in plasma (if data permit) measure: The absolute oral bioavailability (F) of PF-07220060 measure: The fraction of PF-07220060 dose absorbed (Fa) measure: Number of participants with treatment emergent clinically significant laboratory abnormalities measure: Number of participants with treatment emergent clinically significant abnormal ECG measurements measure: Number of participants with treatment emergent clinically significant abnormal vital measurements measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) measure: Number of participants with treatment emergent clinically significant abnormal physical examination sex: MALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: PRA Health Sciences city: Groningen zip: 9728 NZ country: Netherlands lat: 53.21917 lon: 6.56667 hasResults: False

 nctId: NCT06267950 id: PILUO-INFANT briefTitle: Effect of Oral Feeding in Infants With Pierre Robin Syndrome overallStatus: RECRUITING date: 2024-02-29 date: 2024-10 date: 2024-10 date: 2024-02-20 date: 2024-03-06 name: Zeng Changhao class: OTHER briefSummary: This was a randomized controlled study. The infants enrolled were randomly divided into the IOE group (with Intermittent Oro-Esophageal Tube Feeding) and the PNG group (with Nasogastric Tube Feeding), all receiving systemic therapy. Before and after 4-week treatment, pulmonary infection, swallowing function, nutritional status and body weight between the two group were compared. conditions: Pierre Robin Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: systematic therapy name: intermittent oro-esophageal tube feeding name: gastric tube feeding measure: Number of patients diagnosed as the pulmonary infection "Positive" measure: Nutritional status-total protein measure: Nutritional status-hemoglobin measure: Nutritional status-albumin measure: Body weight measure: The Functional Oral Intake Scale for Infants sex: ALL minimumAge: 1 Month maximumAge: 12 Months stdAges: CHILD facility: Hsinchu Rehabilitation Hospital status: RECRUITING city: Xinzhu country: Taiwan name: Haim Liu, Master role: CONTACT lat: 22.46205 lon: 120.47335 hasResults: False

 nctId: NCT06267937 id: 101 briefTitle: Hip Fractures in Chile: Implications for Public Health Policy and Healthcare Delivery overallStatus: COMPLETED date: 2023-03-10 date: 2023-03-10 date: 2024-01-30 date: 2024-02-20 date: 2024-02-20 name: University of Chile class: OTHER name: Instituto Sistemas Complejos de Ingeniería, Universidad de Chile, Santiago, Chile briefSummary: Hip fractures in individuals aged 60 and above pose significant challenges in terms of morbidity, mortality, and healthcare costs. While countries like the United Kingdom and Australia have optimized their healthcare systems for timely management of hip fractures, the situation in Chile presents distinct challenges due to its mixed healthcare system. This study aims to assess survival rates following hip fractures in Chile and identify associated risk factors using national databases from 2012 to 2018. A comprehensive analysis of 35,520 patients revealed that factors such as age, type of health insurance, access to surgery, and treatment in public hospitals significantly influence mortality rates after hip fractures. The study found that patients with hip fractures experience lower 5-year survival rates compared to the general population, particularly when affiliated with public insurance and treated in public institutions. Modifiable factors like delayed surgery and prolonged hospital stays contribute to increased mortality rates. The findings underscore the urgent need for optimized public health policies and healthcare delivery systems to enhance outcomes for hip fracture patients in Chile.Hip fractures in individuals aged 60 and above pose significant challenges in terms of morbidity, mortality, and healthcare costs. While countries like the United Kingdom and Australia have optimized their healthcare systems for timely management of hip fractures, the situation in Chile presents distinct challenges due to its mixed healthcare system. This study aims to assess survival rates following hip fractures in Chile and identify associated risk factors using national databases from 2012 to 2018. conditions: Hip Fractures studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 46380 type: ACTUAL name: Access to surgery name: type of intitution measure: survival after hip fracture sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: hospital Clinico Universidad de Chile city: Santiago state: Region Metropolitana zip: 8380456 country: Chile lat: -33.45694 lon: -70.64827 hasResults: False

 nctId: NCT06267924 id: Olith10703 briefTitle: SENSE-VM: Safety and Effectiveness of a Novel Medical Device for Symptom Ease in Vestibular Migraines overallStatus: ENROLLING_BY_INVITATION date: 2024-02-28 date: 2024-08-31 date: 2024-09-30 date: 2024-02-20 date: 2024-03-19 name: Otolith Labs class: INDUSTRY name: MCRA briefSummary: The goal of this virtual clinical trial is to compare the effectiveness of two study devices in providing temporary relief to adults aged 18-75 who suffer from symptoms of chronic Vestibular Migraines (VM), also known as Migraine Associated Vertigo.

Participants will be:

* Enrolled up to 50 days; enrollment, 14 days in Baseline Phase (no device), 7 days in Transition Phase, 28 days in Treatment Phase (study device)
* Randomized and stratified into groups based on the referring clinic to be assigned one study device
* Asked to use the study device as instructed by the study coordinator
* Asked to submit daily diaries reporting their symptoms and use of device, and to participate in tele-health visits with study coordinators
* Asked to provide their vertigo diagnosis from their physician
* Compensated for their participation

Researchers will compare the randomized groups to determine which group responds better to which device. conditions: Vestibular Migraine conditions: Migraine Associated Vertigo studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The proposed clinical trial for the study device will be a randomized, sham-controlled, double-blind study with two-parallel arms (active/sham device). primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 200 type: ESTIMATED name: Otoband Experimental name: Otoband Sham measure: DHI Change in Scores measure: Number of related adverse events measure: Change in number of vestibular migraine episodes weekly measure: Global Impression of Change (severity of episodes) measure: DHI change from transition to end of study measure: Device responder rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Otolith Labs city: Washington state: District of Columbia zip: 20001 country: United States lat: 38.89511 lon: -77.03637 hasResults: False

 nctId: NCT06267911 id: 202223-10 id: 160/U/2022 type: OTHER_GRANT domain: Fundació La Marató de TV3 briefTitle: Rehabilitation Gaming System for Intensive Care Units acronym: RGS-ICU overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-04 date: 2026-04 date: 2024-02-20 date: 2024-04-23 name: University of the Balearic Islands class: OTHER name: Corporacion Parc Tauli name: Hospital Son Llatzer name: Fundació La Marató de TV3 briefSummary: Admission to an Intensive Care Unit (ICU) is a potentially traumatic experience for a mentally vulnerable person. Beyond the stress and anxiety associated with the ICU environment and medical procedures, survivors of critical illness are at risk of developing cognitive and psychological sequelae related to Post-Intensive Care Syndrome (PICS). These disorders are associated with high economic, medical and personal costs.

This trial aims to evaluate the efficacy of an innovative neuropsychological e-health intervention for early cognitive stimulation and psychological support of people in critical care, i.e. the Rehabilitation Gaming System for Intensive Care Units (RGS-ICU) intervention, in improving comfort during ICU admission and cognition and mental health three and 12 months after ICU discharge. The RGS-ICU intervention, applied as an adjunct to standard ICU care, is based on non-immersive virtual reality techniques and has been specifically designed and developed to suit the needs of people in critical care and the characteristics of the ICU environment. To ensure the safety of the intervention, participants' physiological parameters will be automatically recorded by advanced continuous monitoring systems as part of standard ICU care.

The investigadors hypothesize that the cognitive stimulation and psychological support protocols of the RGS-ICU intervention, applied as an adjunct to standard ICU care, in addition to being safe for people in critical care units, will improve comfort during ICU admission and cognitive and mental health outcomes after ICU discharge, compared to receiving standard ICU care alone.

The findings derived from this trial may contribute to establish a novel and superior paradigm of human-centered ICU care to improve the comfort of people admitted to the ICU. This achievement could also have a relevant impact on medical and economic costs during ICU admission, and on functionality and health-related quality of life after ICU discharge associated with the reduction of cognitive and psychological sequelae linked to PICS.

The RGS-ICU intervention has been designed at Corporacion Parc Taulí with the collaboration of the University of the Balearic Islands and has been developed by Eodyne Systems S.L., a company dedicated to the development of science-based technological solutions for intervention, monitoring, diagnosis, and prognosis in stroke and other brain disorders. conditions: Critical Illness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Cognitive stimulation and psychological support (RGS-ICU) measure: Attention performance measure: Working memory performance measure: Learning/memory performance measure: Executive function performance measure: Processing speed performance measure: Incidence of Treatment-Emergent Adverse Events [Safety] measure: Dyspnea intensity measure: Pain intensity measure: Worry intensity measure: Sadness intensity measure: Comfort experienced measure: Anxiety symptoms measure: Symptoms of depression measure: Symptoms of post-traumatic stress disorder measure: Subjective cognition measure: Functionality measure: Health-related quality of life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of the Balearic Islands city: Palma De Mallorca state: Balearic Islands zip: 07122 country: Spain name: Guillem Navarra-Ventura, PhD role: CONTACT phone: +34971259888 email: g.navarra@uib.es lat: 39.56939 lon: 2.65024 facility: Hospital Universitari Son Llàtzer city: Palma De Mallorca state: Balearic Islands zip: 07198 country: Spain name: Gemma Rialp, MD, PhD role: CONTACT phone: +34871202000 email: grialp@ssib.es lat: 39.56939 lon: 2.65024 facility: Corporacion Parc Tauli city: Sabadell state: Catalonia zip: 08208 country: Spain name: Sol Fernández-Gonzalo, PhD role: CONTACT phone: +34937236673 email: msfernandez@tauli.cat lat: 41.54329 lon: 2.10942 hasResults: False

 nctId: NCT06267898 id: EBMT- 842205547 briefTitle: Non Interventional Study on Iron Toxicity After First Allo-transplant in MDS/CMML overallStatus: COMPLETED date: 2009-11-01 date: 2015-01-29 date: 2015-05-21 date: 2024-02-20 date: 2024-02-20 name: European Society for Blood and Marrow Transplantation class: NETWORK name: Novartis briefSummary: Stem cell transplantation and blood product transfusions are standard of care for Myelodysplastic Syndromes (MDS). Several studies have shown changes in serum ferritin and non-transferrin-bound iron (NTBI) in patients undergoing stem cell transplantation. A large proportion of MDS patients are at risk for organ damage from tissue siderosis, due to the development of iron overload.

Toxic effects of iron may play an important role in the complications associated with HSCT. Iron chelation therapy may reduce the acute and chronic treatment-related toxicity by removing excess of iron, iron radicals and reactive oxygen species (ROS).

There is little information about the efficacy and safety of iron chelation in MDS patients. This audit wants to evaluate the effect of iron toxicity on treatment-related mortality in untreated, adult MDS or CMML patients during and after treatment with myeloablative conditioning (MAC) and reduced intensity conditioning (RIC) allo-HSCT, by prospectively collecting data from 200 MDS or CMML patients from 2009 onwards. conditions: MDS conditions: CMML studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 222 type: ACTUAL measure: non-relapse mortality (treatment related mortality). measure: treatment-related toxic effects measure: relapse rate measure: event-free survival measure: overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Antwerp University Hospital (UZA) city: Antwerp zip: 2650 country: Belgium lat: 51.21989 lon: 4.40346 facility: University Hospital Gasthuisberg city: Leuven zip: 3000 country: Belgium lat: 50.87959 lon: 4.70093 facility: University of Liege city: Liege zip: 4000 country: Belgium lat: 50.63373 lon: 5.56749 facility: Charles University Hospital city: Pilsen zip: 304 60 country: Czechia lat: 49.74747 lon: 13.37759 facility: University Hospital city: Essen zip: 45122 country: Germany lat: 51.45657 lon: 7.01228 facility: University Hospital Leipzig city: Leipzig zip: 04103 country: Germany lat: 51.33962 lon: 12.37129 hasResults: False

 nctId: NCT06267885 id: Children NOF fracture fixation briefTitle: Fixation of Fracture Neck of Femur in Children overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-02 date: 2026-03 date: 2024-02-20 date: 2024-02-20 name: Assiut University class: OTHER briefSummary: Find the best way for fixation of fracture neck of femur in children either by cannulated screws or wagner's technique conditions: Fracture Neck of Femur studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 42 type: ESTIMATED name: Cannulated screws vs wagner's technique measure: The better method for fixation of fracture neck of femur sex: ALL minimumAge: 1 Year maximumAge: 14 Years stdAges: CHILD facility: Assiut university city: Assiut country: Egypt name: Mina Maged role: CONTACT lat: 27.18096 lon: 31.18368 hasResults: False

 nctId: NCT06267872 id: HVTN 309 briefTitle: A Clinical Trial in Adult Participants Without HIV and in Overall Good Health to Evaluate the Safety and Immunogenicity of CD4BS CH505M5 Pr-NP1 Followed by CH505 TF chTrimer Boost Both Adjuvanted With Either Lipid Nanoparticles (LNPs) or 3M-052-AF + Alum overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2025-12-12 date: 2026-07-11 date: 2024-02-20 date: 2024-02-20 name: National Institute of Allergy and Infectious Diseases (NIAID) class: NIH name: National Institutes of Health (NIH) name: Department of Health and Human Services name: Duke University name: Access to Advanced Health Institute (AAHI) briefSummary: This is a multicenter, open-label, phase 1 clinical trial to test two human immunodeficiency virus (HIV) vaccines with two adjuvants. An adjuvant is an ingredient used with some vaccines that may help people make an immune response. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS).

About 42 people will take part in the HVTN 309 clinical trial. This clinical trial will take place at multiple sites in the US and South Africa and the clinical trial is divided into 3 parts: Part A, Part B and Part C. About 3 people will participate in Part A of this study. After results from Part A are reviewed, it will be determined whether or not Part B and Part C of the clinical trial will proceed. conditions: HIV studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: PREVENTION masking: NONE count: 42 type: ESTIMATED name: CD4BS CH505M5 Pr-NP1 name: CH505TF chTrimer name: 3M-052-AF (labeled as AP 60-702) name: Aluminum Hydroxide Suspension (Alum) name: ACU-026-001-1 (labeled as empty LNP) measure: Frequency of local reactogenicity signs and symptoms after receipt of any study vaccine measure: Frequency of systemic reactogenicity signs and symptoms after receipt of any study vaccine measure: Number of serious adverse events (SAEs) leading to early participant withdrawal or permanent discontinuation measure: Number of medically attended adverse events (MAAEs) leading to early participant withdrawal or permanent discontinuation measure: Number of adverse events of special interest (AESIs) leading to early participant withdrawal or permanent discontinuation measure: Number of adverse events (AEs) leading to early participant withdrawal or permanent discontinuation measure: Part C only: Frequency of the CD4BS and CH505M5, G458Y, GNT1-specific, N280D KO IgG+ memory B cells, as assessed by flow cytometry measure: Part C only: Response rate of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by TZM-bl assay measure: Part C only: Magnitude of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by TZM-bl assay measure: Parts B and C: Response rate of serum IgG binding Abs to autologous and heterologous HIV Env stabilized trimers, as assessed by binding antibody multiplex assay (BAMA) measure: Parts B and C: Magnitude of serum IgG binding Abs to autologous and heterologous HIV Env stabilized trimers, as assessed by binding antibody multiplex assay (BAMA) measure: Part B only: Response rate of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by the TZM-bl assay measure: Part B only: Magnitude of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by the TZM-bl assay measure: Parts B and C: Response rate of differential serum Ab neutralization of precursor detection virus and corresponding epitope KO virus, as measured by TZM-bl assay measure: Parts B and C: Magnitude of differential serum Ab neutralization of precursor detection virus and corresponding epitope KO virus, as measured by TZM-bl assay measure: Parts B and C: Response rate of serum Ab neutralization of heterologous HIV-1 strains, as measured by TZM-bl assay measure: Parts B and C: Magnitude of serum Ab neutralization of heterologous HIV-1 strains, as measured by TZM-bl assay measure: Parts B and C: Response rate of CD4+ and CD8+ T-cell responses, as measured by flow cytometry measure: Parts B and C: Magnitude of CD4+ and CD8+ T-cell responses, as measured by flow cytometry measure: Part B only: Frequency of the CD4BS and CH505M5, G458Y, GNT1-specific, N280D KO IgG+ memory B cells, as assessed by flow cytometry sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Alabama CRS (Site ID: 31788) city: Birmingham state: Alabama zip: 35222 country: United States name: Heather Logan, A.N.P. role: CONTACT phone: 205-873-8686 email: heatherlogan@uabmc.edu lat: 33.52066 lon: -86.80249 facility: The Ponce de Leon Center CRS (Site ID: 5802) city: Atlanta state: Georgia zip: 30308 country: United States name: Ericka Patrick, M.S.N role: CONTACT phone: 404-616-6313 email: erpatri@emory.edu lat: 33.749 lon: -84.38798 facility: Vanderbilt Vaccine (VV) CRS (Site ID: 30352) city: Nashville state: Tennessee zip: 37232 country: United States name: Shonda E. Sumner, B.S.N. role: CONTACT phone: 615-343-6906 email: Shonda.sumner@vumc.org lat: 36.16589 lon: -86.78444 facility: Setshaba Research Centre CRS (Site ID: 31829) city: Soshanguve state: Gauteng zip: 0152 country: South Africa name: Magdeline K. Molapo role: CONTACT phone: 27-12-7992422 email: KMolapo@setshaba.org.za facility: Isipingo CRS (Site ID: 31635) city: Isipingo state: Kwa Zulu Natal zip: 4110 country: South Africa name: Girisha Kistnasami, B.Sc., D.P.M. role: CONTACT phone: 27-31-2423600 email: girisha.kistnasami@mrc.ac.za lat: -29.98639 lon: 30.91853 facility: Klerksdorp CRS (Site ID: 30325) city: Klerksdorp state: North West Province zip: 2571 country: South Africa name: Olebogeng Jonkane role: CONTACT phone: None Listed email: ojonkane@auruminstitute.org lat: -26.85213 lon: 26.66672 hasResults: False

 nctId: NCT06267859 id: No. 2 of 2023/11/7 briefTitle: Development of Methods for Effective Treatment and Improvement of Common Somatic Diseases in Children overallStatus: RECRUITING date: 2023-11-08 date: 2033-12-30 date: 2034-01-30 date: 2024-02-20 date: 2024-02-28 name: Tashkent Pediatric Medical Institute class: OTHER briefSummary: The goal of the clinical study is to clarify the course of common congenital, infectious, and non-infectious diseases in children living in Uzbekistan, and to develop methods for their treatment and rehabilitation.

The main questions it aims to answer:

* Analysis of common congenital diseases among children;
* Analysis of commonly diagnosed bronchopulmonary and cardiovascular diseases among children;
* Based on the results of the primary research, common diseases among children will be identified;
* Analysis of existing treatment methods and their effectiveness;
* Development of modern methods of treatment and rehabilitation of children. conditions: Respiratory Diseases conditions: Congenital Heart Defects studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: identification of children from the group of "frequently ill children" primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: working with children from the "frequently ill children" group whoMasked: PARTICIPANT count: 110 type: ESTIMATED name: The use of a combination of microelements and vitamins against the background of physiotherapy measure: Working with archival documentation. measure: Formation of a group of patients to study immunity and the antioxidant system in venous blood. measure: Clinical scientific research. measure: Clinical trial evaluation. sex: ALL minimumAge: 3 Days maximumAge: 15 Years stdAges: CHILD facility: Turdieva Shokhida Tolkunovna status: RECRUITING city: Tashkent state: Yunus-obad District zip: 100140 country: Uzbekistan name: Shokhida T Turdieva, M.D., D.Sc. role: CONTACT phone: +998935872570 email: Shohidahon69@mail.ru name: Kholida B Abdurashidova role: CONTACT phone: +998935092934 email: otdel.nayka@mail.ru name: Gulmira R Nasirova, Ph.D. role: SUB_INVESTIGATOR lat: 41.26465 lon: 69.21627 hasResults: False

 nctId: NCT06267846 id: NBI-1070770-MDD2029 briefTitle: A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive Disorder overallStatus: RECRUITING date: 2024-03-20 date: 2025-09 date: 2025-12 date: 2024-02-20 date: 2024-04-12 name: Neurocrine Biosciences class: INDUSTRY briefSummary: To evaluate the efficacy, safety, and tolerability of NBI-1070770 compared to placebo on improving symptoms of depression in participants with major depressive disorder (MDD). conditions: Major Depressive Disorder studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 72 type: ESTIMATED name: NBI-1070770 name: Placebo measure: Change in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score from Baseline to Day 5 measure: Change in Total MADRS Score from Baseline at Postbaseline Timepoints sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Neurocrine Clinical Site status: RECRUITING city: Little Rock state: Arkansas zip: 72211 country: United States lat: 34.74648 lon: -92.28959 facility: Neurocrine Clinical Site status: RECRUITING city: Rogers state: Arkansas zip: 72758 country: United States lat: 36.33202 lon: -94.11854 facility: Neurocrine Clinical Site status: RECRUITING city: Lemon Grove state: California zip: 91945 country: United States lat: 32.74255 lon: -117.03142 facility: Neurocrine Clinical Site status: RECRUITING city: Long Beach state: California zip: 90806 country: United States lat: 33.76696 lon: -118.18923 facility: Neurocrine Clinical Site status: RECRUITING city: Hollywood state: Florida zip: 33024 country: United States lat: 26.0112 lon: -80.14949 facility: Neurocrine Clinical Site status: RECRUITING city: Decatur state: Georgia zip: 30030 country: United States lat: 33.77483 lon: -84.29631 facility: Neurocrine Clinical Site status: RECRUITING city: Savannah state: Georgia zip: 31405 country: United States lat: 32.08354 lon: -81.09983 facility: Neurocrine Clinical Site status: RECRUITING city: Gaithersburg state: Maryland zip: 20877 country: United States lat: 39.14344 lon: -77.20137 facility: Neurocrine Clinical Site status: RECRUITING city: North Canton state: Ohio zip: 44730 country: United States lat: 40.87589 lon: -81.40234 facility: Neurocrine Clinical Site status: RECRUITING city: Houston state: Texas zip: 77008 country: United States lat: 29.76328 lon: -95.36327 hasResults: False

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

 nctId: NCT06267820 id: 2010 briefTitle: Postoperative Pain Control by Adding Ketorolac to Bupivacaine in Transversus Abdominis Plane Block in Children overallStatus: COMPLETED date: 2023-06-01 date: 2023-12-01 date: 2023-12-10 date: 2024-02-20 date: 2024-02-20 name: Sohag University class: OTHER briefSummary: Control of of pain in children is fundamental. TAP block is associated with less side effects compared with other neuraxial techniques especially when done under ultrasound guidance.

Ketorolac has analgesic effect comparable to morphine. Children were arranged randomly into two equal groups, forty-five children in each.

Group (K) (n= 45): received ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg) and ketorolac (0.5 mg/kg).

Group (T) (n =45): received ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg) conditions: Postoperative Pain, Acute studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ACTUAL name: Bupivacain name: Ketorolac measure: 1st analgesic requirement measure: Number of patients who requested analgesia measure: heart rate measure: Total rescue analgesia measure: Satisfaction of the parents regarding their children analgesia measure: Number of children in each group who required analgesia in the first 24 h postoperatively measure: blood pressure sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Fouad Ibrahim Soliman city: Sohag zip: 52514 country: Egypt lat: 26.55695 lon: 31.69478 hasResults: False

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

 nctId: NCT06267794 id: ODISEA Study briefTitle: Prolonged Release Pirfenidone Versus Placebo in Compensated Cirrhosis. acronym: ODISEA overallStatus: COMPLETED date: 2015-06-26 date: 2021-12-30 date: 2023-03-24 date: 2024-02-20 date: 2024-02-20 name: Jorge L Poo class: OTHER briefSummary: This will be a multicenter, double-blind clinical trial to evaluate the safety and efficacy of two doses of prolonged release pirfenidone, compared against placebo plus conventional therapy in patients with compensated liver cirrhosis. The study will be conducted in compliance with International Standard good clinical practices (GCPs) and the Declaration of Helsinki. The protocol is approved by a local Institutional Review Board and registered in clinical trials.gov. conditions: Liver Fibrosis conditions: Cirrhosis, Liver conditions: Chronic Liver Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double blind, placebo-controlled multicenter study primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Placebo will be identical to medication.

Methods to assign treatment:

Before assigning numbers to subjects, the researcher must confirm that the inclusion criteria have been met, that none of the exclusion criteria apply, that written and signed informed consent has been obtained, that the evaluations of the scrutiny (of admission) and that the required laboratory results are available and meet the admission criteria. To do this, the centers will be assisted with a check list format that contains all the selection criteria.

The person responsible for the medication at the research site will contact the Randomization center, where the treatment will be assigned to the patient. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 180 type: ACTUAL name: Pirfenidone 1200 mg name: Pirfenidone 1800 mg name: Placebo measure: Change in liver fibrosis measure: Clinical side effects measure: Improvement in Child Pugh score measure: Improvement in MELD score measure: Improvement in bilirrubin and albumin measure: Improvement in prothrombin time measure: Improvement in liver enzymes measure: Improvement in EuroQol Visual analog scales measure: Improvement in EuroQol five dimensions Scale measure: Improvement in modified fatigue impact scale (MFIS) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

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

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

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

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

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

 nctId: NCT06267716 id: 274-2023 briefTitle: Pericapsular Nerve Block and Iliopsoas Fascial Plane Block in Hip Surgery overallStatus: RECRUITING date: 2024-02-23 date: 2024-07-30 date: 2024-08-30 date: 2024-02-20 date: 2024-02-28 name: Haseki Training and Research Hospital class: OTHER briefSummary: This prospective randomized interventional study aims to compare the effects of two peripheral nerve blocks, the periencapsular nerve block (PENG) and iliopsoas block (IPB), on analgesia and motor function after hip surgery.

The main questions it aims to answer are the effectivity of postoperative pain management the preservation of motor movement.

Participants will receive standardized general anesthesia and postoperative PENG or IPB in either Group.

Researchers will compare the total amount of rescue analgesia and numeric rating scale with accompanying evaluating motor function at the same time intervals within 24 hour. conditions: Hip Fractures conditions: Peripheral Nerve Block studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: prospective randomized standardized triple-blind primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: The participants under general anaesthesia and the orthopaedic surgeon responsible for the study will be blinded to the study groups and the specific block procedures. This surgeon will serve as the sole evaluator of postoperative outcomes. Intraoperative results will be recorded by the anaesthesia technician, who is present in the operating room and unaware of the block procedures. Moreover, the data analysis will be conducted before the data are unblinded. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: PENG block name: IPB measure: postoperative motor block measure: pain scores measure: total analgesia, intraoperative measure: total rescue analgesia sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Haseki Training and Research Hospital status: RECRUITING city: Istanbul state: Sultangazi zip: 34000 country: Turkey name: Berna Caliskan role: CONTACT phone: +905067108770 email: caliskan.b@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False

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

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

 nctId: NCT06267677 id: 2007/3928 briefTitle: Efficacy of Liquid Versus Powder Protein Supplementation to Optimize Protein Intake After Bariatric Surgery overallStatus: COMPLETED date: 2008-01-02 date: 2008-04-18 date: 2009-03-06 date: 2024-02-20 date: 2024-02-20 name: Hospital Clinic of Barcelona class: OTHER briefSummary: The goal of this randomized control trial is to compare the effect of a liquid formula rich in nutrients and low in calories (supplement) with the progressive diet with conventional foods that we usually recommend in patients after surgery. The main question it aims to answer is if the addition of a high-protein, volume-controlled nutritional supplement as a fundamental part of the diet during the first two months after surgery will preserve the patient's nutritional status and prevent the appearance of nutritional deficits and associated complications.

Participants will be evaluated at the beginning, at 1 month and at the end of the study (2m) and the following determinations will be made:

* Analytical determination
* Nitrogen balance by determining urea N2 in 24-hour urine
* Anthropometric determinations
* Body composition determined by impedanciometry
* Resting energy expenditure and nutrient oxidation measured by indirect calorimetry.
* Energy, protein and hydration intake.
* Gastrointestinal tolerance through self-registration of symptoms. Researchers will compare the effect of a complete hypocaloric liquid formula group with the usual progressive diet group to see if they achieve the protein intake goal established for patients after obesity surgery, preservation of nutritional status and lean mass during the rapid phase of weight loss and the gastrointestinal tolerance during the first two months after surgery. conditions: Body Composition conditions: Obesity conditions: Protein Supplementation conditions: Bariatric Surgery Candidate conditions: Weight Loss studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 50 type: ACTUAL name: High protein liquid formula measure: protein intake measure: evaluate nutritional deficiencies measure: Tolerance sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06267664 id: PI-GR-23-3263 briefTitle: Real-world Effectiveness and Tolerability of Triptans-Ditans-Gepants (TRIDIGEP) acronym: TRIDIGEP overallStatus: RECRUITING date: 2023-12-04 date: 2024-09-30 date: 2024-12-01 date: 2024-02-20 date: 2024-02-21 name: Hospital Clínico Universitario de Valladolid class: OTHER briefSummary: Migraine is the third most prevalent disease and the leading reason of years lived with disability in the most productive years of the life. Migraine associated disability can be alleviated by acute and preventive treatment. The migraine landscape has changed recently, with the approval of novel acute treatments, including oral Calcitonin gene-related peptide antagonists, the gepants (Rimegepant, Ubrogepant, Zavegepant) and 5-HT-1F antagonists, the Ditans (Lasmiditan). These have joined Triptans as acute "migraine-specific" drugs.

The TRIDIGEP study will be an open-label, multiple attack, prospective cohort study.

This study aims to describe 1) the effectiveness of the acute treatments of migraine attacks in routine clinical practice, 2) the tolerability of the drugs, and 3) to explore potential response and tolerability predictors.

The endpoints recommended by the International Headache Society will be employed, including: 1) Pain freedom; 2) Absence of the most bothersome symptom; 3) Sustained pain freedom; 4) Total freedom from migraine; 5) Headache relief; 6) Duration of attacks; 7) Time lost due to an attack; 8) Need of rescue medication. The study endpoints will be assessed at 2, 8 and 24 hours after the acute drug use. Data will be collected by the patients themselves, with a validated data collection instrument within a RedCap questionnaire, using QR codes. conditions: Migraine conditions: Migraine Disorders conditions: Migraine With Aura conditions: Headache Disorders studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1500 type: ESTIMATED name: Patients with migraine treated with triptans, Lasmiditan or Gepants measure: Pain freedom at 2 hours measure: Absence of the most bothersome symptom measure: Pain freedom at 8 hours measure: Pain freedom at 24 hours measure: Sustained pain freedom measure: Total freedom from migraine at 2 hours measure: Total freedom from migraine at 8 hours measure: Total freedom from migraine at 24 hours measure: Headache relief at 2 hours measure: Headache relief at 8 hours measure: Headache relief at 24 hours measure: Time to meaningful relief measure: Time to pain freedom measure: Time to migraine freedom measure: Need of rescue medication at 2 hours measure: Need of rescue medication at 8 hours measure: Need of rescue medication at 24 hours measure: Tolerability of the drugs measure: Response predictors at 2 hours measure: Response predictors at 24 hours measure: Tolerability predictors measure: Time lost due to an attack sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Clínico Universitario de Valladolid status: RECRUITING city: Valladolid zip: 47010 country: Spain name: David Garcia Azorin, MD, PhD role: CONTACT phone: +34665872228 email: davilink@hotmail.com name: Yesica González Osorio role: CONTACT phone: 634330426 email: yesgonzalezosorio@outlook.com lat: 41.65518 lon: -4.72372 hasResults: False

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

 nctId: NCT06267638 id: Chomthong hospital, Thailand briefTitle: Comparison of Postoperative Pain Score Between Perioperative Intravenous Ketamine and Placebo in Patients Undergoing Unilateral Total Knee Arthroplasty Under General Anesthesia overallStatus: RECRUITING date: 2024-01-22 date: 2025-12-31 date: 2025-12-31 date: 2024-02-20 date: 2024-03-12 name: Ministry of Health, Thailand class: OTHER_GOV briefSummary: The goal of this clinical trial is to compare postoperative pain score between perioperative intravenous ketamine and placebo in patients undergoing unilateral total knee arthroplasty under general anesthesia. The main question\[s\] it aims to answer are:

* Can perioperative intravenous ketamine reduce postoperative pain score during rest and movement at 0, 2, 4, 8, 12, 18, 24 hours better than no administration of Ketamine in patients undergoing Unilateral total knee arthroplasty under general anesthesia?
* Can perioperative intravenous ketamine reduce morphine consumption in postoperative 24 hours, length of hospital stay, first time to receive opioid and side effect or complication from ketamine and opioid better than no administration of Ketamine in patients undergoing Unilateral total knee arthroplasty under general anesthesia? Participants will receive intravenous ketamine intraoperative TKA and comparison group will receive placebo that is normal saline. Researchers will compare perioperative intravenous ketamine and placebo to see postoperative pain score, morphine consumption in postoperative 24 hours, length of hospital stay, first time to receive opioid and side effect or complication from ketamine and opioid. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Ketamine group name: Placebo group measure: Postoperative pain score at rest and movement measure: First time to receive intravenous analgesic drug measure: Morphine consumption measure: Length of hospital stay measure: side effect and complication from ketamine and opioid sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chomthong hospital status: RECRUITING city: Chiangmai zip: 50160 country: Thailand name: Numphung Sukantarat, master role: CONTACT phone: 66855426519 email: phuang_007@yahoo.com lat: 18.79038 lon: 98.98468 hasResults: False

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

 nctId: NCT06267612 id: KY20231109-11 briefTitle: Corheart 6 LVAS Long-term Follow-up Study overallStatus: NOT_YET_RECRUITING date: 2024-02-10 date: 2030-06-30 date: 2030-06-30 date: 2024-02-20 date: 2024-02-20 name: Nanjing First Hospital, Nanjing Medical University class: OTHER briefSummary: The purpose of this clinical study is to explore the long-term efficacy and safety of the Corheart 6 Left Ventricular Assist System (LVAS) as a treatment for patients with advanced heart failure.

The study will be a single-arm, prospective, single-center, non-blinded, and non-randomized study with a follow-up duration of five years. conditions: Heart Failure studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Corheart 6 Left Ventricular Assist System measure: Device implantaion success rate at 24 months post-implantation measure: Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23) measure: Quality of Life as measured by the EuroQoL-5D-5L (EQ-5D-5L) questionnaire measure: Functional status as measured by the Six Minute Walk Test (6MWT) measure: Functional status as measured by the New York Heart Association (NYHA) Classification measure: Stroke severity as assessed with the National Institutes of Health Stroke Scale (NIHSS) score measure: Stroke severity as assessed by the modified Rankin Scale (mRS) score measure: Adverse events measure: Device-related re-operations measure: Device-related re-hospitalizations measure: Overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanjing First Hospital city: Nanjing state: Jiangsu country: China name: Zhibing Qiu role: CONTACT email: qiuzhibing2009@163.com lat: 32.06167 lon: 118.77778 hasResults: False

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

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

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

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

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

 nctId: NCT06267534 id: YCH briefTitle: Mindfulness-based Mobile Applications Program overallStatus: COMPLETED date: 2022-09-09 date: 2022-09-22 date: 2022-09-22 date: 2024-02-20 date: 2024-02-20 name: Yu-Chien Huang class: OTHER briefSummary: The goal of this type of study: quasi-experimental clinical trial . The purpose of this study is to explore the effects of applying mindfulness-based mobile applications program to maintaining mental health of emergency nurses during providing care to COVID-19 patients. The main question\[s\] it aims to answer are:

1. To explore the effect of mindfulness-based mobile device-assisted program on care stress of emergency nurses caring for COVID-19 patients.
2. To explore the impact of mindfulness-based mobile device-assisted programs on the psychological distress of emergency nurses caring for COVID-19 patients.
3. To explore the impact of a mindfulness-based mobile device-assisted program on compassion fatigue in emergency nurses caring for COVID-19 patients.

Participants will Mindfulness-based mobile device is provided to experimental group as assistance for 2 weeks. In the contrary, no intervention measure was assigned in the control group. Scale exam was performed before and after the program in both groups at the same time. conditions: COVID-19 conditions: Cell Phone Use conditions: Nurse conditions: Mental Health studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 102 type: ACTUAL name: mindfulness-based mobile applications program measure: The impact of mindfulness-based mobile device assistance program on the care stress of emergency nursing staff caring for COVID-19 patients measure: Effects of mindfulness-based mobile device assistance program on psychological distress among emergency nursing staff caring for COVID-19 patients measure: Effects of a mindfulness-based mobile device-assisted program on compassion fatigue among emergency nursing staff caring for COVID-19 patients sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yu-Chien Huang city: Taipei state: Zhongzheng District zip: 100 country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False

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

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

 nctId: NCT06267495 id: EOCXLFE briefTitle: Epithelium-on Cross-linking Versus Observation of Fellow Eyes of Patients With Unilateral Clinically Evident Keratoconus overallStatus: COMPLETED date: 2017-01-01 date: 2024-01-31 date: 2024-01-31 date: 2024-02-20 date: 2024-02-20 name: Assiut University class: OTHER briefSummary: Keratoconus (KC) is a bilateral asymmetric progressive corneal degenerative disease. The management of young patients, diagnosed with clinically evident KC in one eye and with no clinical signs of KC in the other eye, represents a real challenge for many ophthalmologists.

The aim of the current study is to investigate the effectiveness and safety of epithelium-on accelerated CXL to stabilize the eye with no clinical signs of KC, in young patients with unilateral clinically evident KC, compared with standard care and follow-up only. conditions: Keratoconus studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 40 type: ACTUAL name: Epithelium-on corneal cross-linking (epi-on CXL) measure: Steep keratometry value measure: Maximum keratometry value measure: Corrected distance visual acuity sex: ALL minimumAge: 12 Years maximumAge: 30 Years stdAges: CHILD stdAges: ADULT facility: Tiba Eye Center city: Assiut zip: 71516 country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False

 nctId: NCT06267482 id: 122311 briefTitle: Using ROSA for Challenging The TKA Standard of Care overallStatus: RECRUITING date: 2024-04-16 date: 2025-04 date: 2025-06 date: 2024-02-20 date: 2024-04-18 name: Lawson Health Research Institute class: OTHER name: Zimmer Biomet briefSummary: This is a prospective, randomized controlled trial using the cruciate retaining, MC Persona to comparing the conventional TKA to ROSA assisted TKA. Patients will be randomized to one of three study trial arms.

1. Standard of care medial parapetallar approach (Control)
2. ROSA PSA medial parapetallar approach
3. ROSA PSA medial subvastus approach Participants will be followed for 1 year post surgery with a combination of perioperative parameters, imaging, patient reported outcomes, functional outcomes, blood and tissue sampling for inflammatory information and activity levels. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 90 type: ESTIMATED name: ROSA PSA Parapatellar Approach name: ROSA PSA Subvastus Approach measure: Functional Outcome - Weight-bearing CT scan measure: Functional Outcome - 3D Ultrasound measure: Functional Outcome - Timed Up and Go test measure: Patient health status - Knee Society Score measure: Patient health status - EuroQuol Survey measure: Patient health status - Knee Injury and Osteoarthritis Outcome Score measure: Patient health status - Western Ontario and McMaster Universities Arthritis Index measure: Patient health status - Global Assessment measure: Health Ecominics sex: ALL minimumAge: 21 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital status: RECRUITING city: London state: Ontario country: Canada lat: 42.98339 lon: -81.23304 hasResults: False

 nctId: NCT06267469 id: Boutonniere deformity briefTitle: Boutonniere Deformity Effectiveness of Thermoplastic and Fabricated Orthoses overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2024-09-30 date: 2024-09-30 date: 2024-02-20 date: 2024-02-20 name: Magdalena Kolasińska class: OTHER name: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland briefSummary: The goal of this study is to present the author's thumb orthosis with a butonier deformity and its effect on hand function, strength, dexterity and pain levels in relation to patients wearing factory-made orthopedic supplies. It is planned to include about 60 people in the study (30 people each in the group with thermoplastic orthoses and 30 participants with factory-made orthoses)

The main questions it aims to answer are:

1. How much improvement in dexterity will the patient wearing the orthosis get? 2. By how much will the grip strength of the whole hand and pincer grip strength improve with the orthosis? 3. How will wearing the orthosis affect the pain associated with the disease? Participants will

1. measurement of grip strength of the right and left hands with a dynamometer in an orthosis and without an orthosis, at the time of the test conducted and at the appointed times.
2. measurement of pincer grip strength with a dynamometer in an orthosis and without an orthosis, at the time of the test conducted and at the designated times.

4. completion of the DASH questionnaire 6. assessment of the NRS pain scale in relation to the period of 6 months before the start of the study 7. Likert scale - evaluation of satisfaction with the use of the orthosis 8. the Kapandji scale Researchers will compare patients with thermoplastic orthosis and patients with fabric orthosis to see which is more functional. conditions: Orthotic Devices studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 60 type: ESTIMATED name: Thermoplastic orthosis measure: Grip strength measure: DASH -Disabilities of the Arm, Shoulder and Hand measure: Likert scale measure: Kapandji score measure: NRS - Numerical Rating Scale measure: pinch strength sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher city: Warsaw state: Mazowieckie zip: 02-637 country: Poland name: Magdalena Kolasińska, Msc role: CONTACT phone: +48609219822 email: magdalena.kolasinska@awf.edu.pl name: Teresa Sadura-Sieklucka, Phd role: CONTACT email: teresa.sadura@awf.edu.pl lat: 52.22977 lon: 21.01178 facility: Terapia Ręki Magda Kolasińska city: Warszawa state: Mazowieckie zip: 01-494 country: Poland name: Magdalena Kolasińska, Msc role: CONTACT phone: +48609219822 email: magdalena.kolasinska@awf.edu.pl lat: 52.22977 lon: 21.01178 hasResults: False

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

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

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

 nctId: NCT06267417 id: CCHE-AML-4/2023 briefTitle: Laser Therapy Effect as Preventive Measure for Oral Mucositis in Children With Hematological Malignancies overallStatus: RECRUITING date: 2023-04-10 date: 2024-04-01 date: 2024-12-31 date: 2024-02-20 date: 2024-02-20 name: Children's Cancer Hospital Egypt 57357 class: OTHER briefSummary: Introduction:

Among the most drastic complications of chemotherapy is oral mucositis(OM). It is a painful inflammatory, often ulcerative condition and may increase risk for systemic infections leading to prolonged hospital stays and interruptions of treatment protocol. Many treatment modalities have been introduced for the prevention and treatment of oral mucositis , of which low level laser therapy(LLLT) is gaining popularity. The use of LLLT as a prophylactic treatment for chemotherapy induced oral mucositis in pediatric cancer patients is still lacking robust evidence. Also, the parameters used have not been optimized and no standard method has yet been established. Based on this point, this study will compare photobiomodulation to the conventional preventive program of oral mucositis applied in 57357 children's cancer hospital foundation to determine which will be optimal for the prophylaxis of chemotherapy-induced OM.

Aim:

To assess the effectiveness of low level laser therapy in the prophylaxis of oral mucositis in pediatric patients diagnosed with Hematological cancers.

Methods:

This study is a randomized, prospective, double-blinded trial that will include acute Myeloid leukemia patients admitted to receive chemotherapy cycle between the age of 3 and 18years. These patients will be randomized into two groups: group 1 will receive low level laser therapy and group 2 will receive mock treatment. Patient will be followed to asses the development of oral mucositis on prespecified time points. conditions: Oral Mucositis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: The outcome evaluator will be a single personnel from the oncology team following up with the case whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 42 type: ESTIMATED name: Laser therapy name: Mock treatment measure: To measure incidence of oral mucositis in Laser arm versus Placebo arm. measure: To measure grade of oral mucositis in patients receiving laser arm placebo arm. sex: ALL minimumAge: 3 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Children Cancer Hospital 57357 status: RECRUITING city: Cairo zip: 11617 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06267404 id: IShamsi briefTitle: Effectiveness of Iliopsoas Positional Release Versus Conventional Exercises in the Management of Sub-acute Back Pain. overallStatus: RECRUITING date: 2024-02-21 date: 2025-02-15 date: 2025-02-25 date: 2024-02-20 date: 2024-02-22 name: University of Karachi class: OTHER name: Sindh Institute of Physical Medicine and Rehabilitation briefSummary: Recommended treatment for chronic non-specific LBP is exercise therapy, behavioral therapy including pain management, or a combination of these; There is not enough evidence to establish recommendations for which one is the most appropriate.

The primary objective of this study is to explore the effects of Ilio-psoas Release on Sub-acute back pain, ROM \& functional disability conditions: Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Iliopsoas Positional release therapy name: Conventional exercises measure: VAS Visual Analogue Scale VAS Visual Analogue Scale measure: Modified Schober's test measure: Roland-Morris Disability Questionnaire sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Sindh Institute of Physical Medicine and Rehabilitation status: RECRUITING city: Karachi state: Sindh country: Pakistan name: Iram I Shamsi, MPhil role: CONTACT name: Iram I Shamsi, MPhil role: PRINCIPAL_INVESTIGATOR lat: 24.8608 lon: 67.0104 hasResults: False

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

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

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

 nctId: NCT06267352 id: 230097 briefTitle: Epidemiology and Genomic Surveillance of Staphylococcus Aureus in ICU Neonatology acronym: NEOSAUR overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2026-06 date: 2024-02-20 date: 2024-02-20 name: University Hospital, Caen class: OTHER briefSummary: Newborns hospitalized in Neonatology are particularly vulnerable to infections, in particular healthcare associated infection (HAI). Staphylococcus aureus represents the 2nd microorganism responsible for sepsis, this infection is particularly serious and like any HAI, it increases the length of hospitalization of newborns and neonatal morbidity.

In September 2020, the CDC published recommendations for the prevention and control of Staphylococcus aureus infections in neonatal intensive care unit/ICU. They specify the indications for implementing a MSSA surveillance strategy as well as the screening and management methods.

Despite the absence of a defined strategy at the national level, our establishment chose to initiate management measures several years ago following serious infections and MSSA epidemics in neonatal intensive care unit/ICU.

With the aim of improving the efficiency of care and evaluating the strategy chosen at the establishment, it is necessary to describing

* the epidemiology of MSSA carriage and infections
* cross-transmission of MSSA strains between patients
* the success rate of decolonization
* the sensitivity of detection of digestive carriage by stool swabbing in order to limit the number of samples from newborns. conditions: the Aim of This Study is to Describe Genomic Epidemiology of MSSA in Neonatal ICU studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED measure: frequency of MSSA cross transmission as assessed by WGS sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

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

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

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

 nctId: NCT06267300 briefTitle: Treatment of Post-COVID-19 With Hyperbaric Oxygen Therapy: a Randomized, Controlled Trial overallStatus: NOT_YET_RECRUITING date: 2024-10-01 date: 2025-10-01 date: 2026-04-01 date: 2024-02-20 date: 2024-02-28 name: Erasmus Medical Center class: OTHER name: Da Vinci Clinic name: HGC Rijswijk briefSummary: The goal of this clinical try is to investigate the effect of hyperbaric oxygen therapy (HBOT) on symptoms, quality of life and absence of work through sickness in patients with post-COVID on short- and mid-term, as well as to identify biochemical mechanisms of action.

The main questions it aims to answer are:

* What is the clinical relevance of improvements of symptoms and quality of life after treatment with HBOT for post-COVID?
* What are the changes in absence from work after treatment with HBOT?
* What is the cost-effectiveness of treatment with HBOT?
* What are possible mechanisms of action of HBOT?

Participants will undergo 40 sessions of HBOT. Researchers will compare HBOT with standard care alone (control group). In case of a positive outcome, patients in the control group can cross-over to the HBOT group after 6 months. conditions: Post-COVID-19 Syndrome conditions: Post-COVID Syndrome conditions: Post COVID-19 Condition conditions: Post-COVID Condition conditions: Post COVID-19 Condition, Unspecified conditions: Long COVID conditions: Long Covid19 studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomized controlled trial comparing HBOT to standard care alone, with a cross-over from standard care to HBOT in case primary outcome is positive after 6 months follow-up. primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Hyperbaric oxygen measure: Physical and mental component scores of the 36-item Short Form Survey (SF-36) measure: Euroqol-5D (EQ-5D) measure: Activity tracking (through wrist band), monitoring heart rate, step count and sleep patterns measure: Biochemical parameters measure: Absence from work measure: Cost-effectiveness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Da Vinci Clinic city: Amersfoort country: Netherlands lat: 52.155 lon: 5.3875 facility: Da Vinci Clinic city: Geldrop country: Netherlands lat: 51.42167 lon: 5.55972 facility: Da Vinci Clinic city: Hoogeveen country: Netherlands lat: 52.7225 lon: 6.47639 facility: HGC Rijswijk city: Rijswijk country: Netherlands name: Rutger Lalieu, Dr. role: CONTACT lat: 52.03634 lon: 4.32501 facility: Da Vinci Clinic city: Rotterdam country: Netherlands name: Nina Lansdorp, Dr. role: CONTACT lat: 51.9225 lon: 4.47917 facility: Erasmus MC city: Rotterdam country: Netherlands name: Merel Hellemons, Dr. role: CONTACT lat: 51.9225 lon: 4.47917 facility: Da Vinci Clinic city: Waalwijk country: Netherlands name: Nina Lansdorp, Dr. role: CONTACT lat: 51.6825 lon: 5.07083 hasResults: False

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

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

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

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

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

 nctId: NCT06267222 id: SCATDCS23 briefTitle: Trans-spinal Electrical Stimulation in Individuals With Spinocerebellar Ataxia overallStatus: ENROLLING_BY_INVITATION date: 2024-03-04 date: 2024-06-30 date: 2024-07-31 date: 2024-02-20 date: 2024-02-20 name: Laura Alice Santos Oliveira class: OTHER name: Federal Institute of Rio de Janeiro briefSummary: The main goal of this pragmatic clinical trial is to investigate the effects of trans-spinal tDCS in individuals with spinocerebellar ataxia (SCA) over some parameters of gait and postural control in real-world conditions, reflecting daily clinical practice. The main questions it aims to answer are:

* If an extended number of tDCS sessions, beyond the typical 5 to 10 sessions described in scientific literature, applied concomitantly with exercises with progressive challenges, to yield positive outcomes over some parameters of gait and postural control in individuals with SCA and if there is retention of possible benefits one month later the end of this protocol.
* If there is specific characteristics (including balance, gait, mobility, severity of ataxia, DNA test characteristics and non-ataxic signs) in individuals with SCA that can predict their improvement in postural control and gait following the 20 tDCS sessions.

  * Participants will receive 20 tDCS sessions concomitantly with exercises for gait and postural control with progressive challenges.
  * Postural control and gait of the participants will be assessed in two big sessions before (#assessment 1) and after the 20 sessions (#assessment 5) and 3 small sessions after every 5 sessions (#assessments 2, 3 and 4). Also, as a follow-up, they will be assessed a month after the end of the intervention (#assessment 6). conditions: SCA conditions: Postural Balance conditions: Gait Ataxia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a pragmatic clinical trial that will be carried out using the CONSORT-Pragmatic Trials (Zwarenstein et al., 2008). primaryPurpose: TREATMENT masking: NONE maskingDescription: THE INVESTIGATOR NOT BE INFORMED ABOUT THE TREATMENT count: 40 type: ESTIMATED name: TRANSCRANIAL DIRECT CURRENT STIMULATION + exercises measure: Postural control measure: Mobility measure: Gait performance measure: The subjective experience of the participants regarding the protocol. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anna Fontes Baptista city: Rio de Janeiro state: RJ zip: 21032-060 country: Brazil lat: -22.90278 lon: -43.2075 hasResults: False

 nctId: NCT06267209 id: He-Modulation briefTitle: Conditioned Pain Modulation in Patients With Hemophilia overallStatus: NOT_YET_RECRUITING date: 2024-02-19 date: 2024-03-03 date: 2024-04-20 date: 2024-02-20 date: 2024-02-20 name: Investigación en Hemofilia y Fisioterapia class: NETWORK briefSummary: Introduction: Hemophilic arthropathy is characterized by functional alterations, disabling physical sequelae, and chronic pain. Conditioned pain modulation describes the net effect of endogenous pathways that enhance or diminish the effects of afferent noxious stimuli.

Objectives: To describe conditioned pain modulation in patients with hemophilia and identify the best predictive model of conditioned pain modulation in these patients Methods: Cross-sectional cohort study. 51 patients with hemophilic arthropathy will be recruited in 3 regions of Spain. The main study variable will be the conditional pain modulation (Conditioned Pain Modulation Index, using an ischemic technique of the arm using the pain pressure threshold as a test stimulus), with age being the dependent variable. The secondary variables, estimated as modifying or confounding variables, will be kinesiophobia (Tampa Scale for Kinesiophobia), catastrophizing (Pain Catstrophizing Scale), trait and state anxiety (State-Trait Anxiety Inventory) and the main clinical, anthropometric, and sociodemographic.

Expected results: Identify the degree of modulation conditioned by pain in patients with hemophilic arthropathy. Identify the best predictive model for conditioned pain modulation in these patients based on the study variables conditions: Hemophilia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 51 type: ESTIMATED name: Observational group measure: Assess the Conditioned Pain Modulation Index measure: Assess the kinesiophobia with Tampa Scale of Kinesiophofia measure: Assess the catastrophizing with Pain catastrophizing scale measure: Assess the catastrophizing with State-Trait Anxiety Inventory measure: Assess the joint damage with Haemophilia Joint Health Score measure: Assess the joint pain with visual analog scale measure: Assess the pressure pain threshold with pressure algometer measure: Assess the functional capacity with the 6-Minute Walking test sex: MALE minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Oviedo city: Oviedo state: Asturias zip: 33006 country: Spain name: Rubén Cuesta-Barriuso, PhD role: CONTACT lat: 43.36029 lon: -5.84476 hasResults: False

 nctId: NCT06267196 id: CemilTascıogluERHO-AYAN briefTitle: The Effect of the Stress Ball Used During Spinal Anesthesia on Pain and Anxiety acronym: stressball overallStatus: RECRUITING date: 2023-11-02 date: 2024-03-02 date: 2024-03-15 date: 2024-02-20 date: 2024-02-20 name: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization class: OTHER briefSummary: The aim is to determine the impact of the stress ball used during spinal anesthesia on pain and anxiety levels conditions: Pain conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 140 type: ESTIMATED name: The use of a stress ball measure: stress ball and anxiety measure: stress ball and pain measure: Stress ball and blood pressure measure: Stress ball and pulse measure: Stress ball and saturation sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Özge Sayın Ayan status: NOT_YET_RECRUITING city: Istanbul state: Eyup zip: 34065 country: Turkey name: özge sayın role: CONTACT phone: +905332965628 email: ozgesayinayan@gmail.com name: volkan özen role: CONTACT phone: +905309276094 email: vozen81@gmail.com lat: 41.01384 lon: 28.94966 facility: Prof.Dr.Cemil Tascioglu City Hospital status: RECRUITING city: Istanbul state: Şişli zip: 34360 country: Turkey name: özge sayın ayan role: CONTACT phone: +905332965628 email: ozgesayinayan@gmail.com name: volkan özen role: CONTACT phone: +905309276094 email: vozen81@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False

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

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

 nctId: NCT06267157 id: 2023/23 briefTitle: Breastfeeding Consultant Training in the Metvaverse Universe overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-05-20 date: 2024-07-02 date: 2024-02-20 date: 2024-02-20 name: Gulhane School of Medicine class: OTHER briefSummary: Although breastfeeding is an important and natural process in infant development, mothers may fail to manage the process. Nurses, who have an important place in helping to physically initiate and maintain breastfeeding, provide an in-depth knowledge of breast anatomy and breastfeeding physiology, practice and process breastfeeding techniques. Must have extensive management skills. Although the World Health Organization recommends that breastfeeding issues should be addressed in medical, nursing and midwifery schools, there is a lack of nurses' training curricula and breastfeeding training given in hospitals. Due to this deficiency, mothers have low self-confidence and insufficient knowledge about breastfeeding.

The aim of this project is to develop a breastfeeding counseling model in the metaverse universe and to determine the effect of this model on nursing students' breastfeeding counseling skills, knowledge level and empathy skills. Giving breastfeeding education with the metaverse application compared to the application on real patients includes much less risk for the patient and the ability to practice until the right skill is acquired. In the project, it is expected that the breastfeeding counseling education model (LactaVerse), which is structured on virtual reality developed in the metaverse universe, is compared to the existing deficient and non-standardized breastfeeding education practice, enabling nurses to practice more and without errors during the undergraduate education, and to gain more effective skills in breastfeeding counseling. In this context, the project will support the ability of multiple users in the metaverse universe to examine the anatomy of the breast and apply breastfeeding counseling to the mother by transmitting their voices and movements with virtual glasses.

In the preparation phase of the training to be developed in the virtual universe within the scope of the project, the breast anatomical modeling and the breastfeeding mother-baby duo project scenario will be developed and virtual glasses will be transferred. At this stage, expert opinions of the questionnaires to be used in the evaluation of educational effectiveness will be taken. Pre-application of data collection tools and LactaVerse training will be made. Experiment (n=40) and control (n=40) groups will be determined from the students by randomization. "Descriptive Characteristics Data Collection Form", "Breastfeeding Information Form", "Basic Empathy Level Scale", "Nursing Counseling Skill Scale" and "Presence Scale" will be applied to both groups. During the application phase, Lactaverse training method with virtual glasses will be applied to the experimental group, and a 2-hour theoretical classical training method will be applied to the control group. After 4 weeks of the training, the post-tests will be applied to the experimental group and the control group and they counseling will be given to the patient who plays the role of a nursing mother in the laboratory, and measurements will be made with the Breastfeeding Counseling Skill List and statistical analyzes will be applied.

With the training developed in connection with the project, it is expected that nurses will have a high level of empathy development and breastfeeding counseling skills in a complex healthcare environment such as breastfeeding counseling before they graduate. In this way, the professional knowledge, counseling skills and empathy skills of nurses, who have an important role in breastfeeding, will increase, helping our society to increase the breastfeeding rates to the desired level. conditions: Breast Feeding studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 22 type: ESTIMATED name: virtual reality training name: theoretical breastfeeding training measure: Introductory Features Data Collection Form measure: Breastfeeding Information Form measure: Basic Empathy Level Scale measure: Breastfeeding Teaching Skill Evaluation Form measure: Presence Scale sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Gulhane Faculty of Nursing city: Ankara country: Turkey name: Gulten Guvenc role: CONTACT email: gulten.guvenc@sbu.edu.tr lat: 39.91987 lon: 32.85427 hasResults: False

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

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

 nctId: NCT06267118 id: Treatment of Bronchiolitis briefTitle: Comparative Efficacy of Hypertonic Saline vs Adrenaline Nebulization in Acute Bronchiolitis acronym: children overallStatus: RECRUITING date: 2023-11-01 date: 2024-04-30 date: 2024-05-31 date: 2024-02-20 date: 2024-02-20 name: Combined Military Hospital, Pakistan class: OTHER briefSummary: The goal of this clinical trial is to compare the efficacy of hypertonic saline nebulization with adrenaline nebulization in the treatment of acute bronchiolitis in children. Main aim is to evaluate the following in both group of patients

1. Improvement in Wood-Downes clinical score (WDF score) in bronchiolitis
2. Length of Hospitalization conditions: Acute Bronchiolitis Due to Respiratory Syncytial Virus studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients with acute bronchiolitis after informed written consent will be divided into two groups randomly. Group I will be nebulized with adrenaline every 6 hours and group II will nebulized with hypertonic saline every 6 hours. After 24 hours and 48 hours of nebulization, WDF score will be recorded by measuring respiratory rate, heart rate, chest retractions, chest auscultation findings and SPO₂ levels. Researcher will record all data on a specified Performa. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Investigator will make all the protocol and research Performa. Drugs will already be prepared for nebulization and labelled by investigator. Researcher /care provider will nebulize the patients of both groups randomly and record the results accordingly. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 60 type: ESTIMATED name: Hypertonic Saline Solution, 1 Ml name: Adrenaline measure: Wood-Downes-Ferres clinical score calculation measure: total length of hospitalization sex: ALL minimumAge: 1 Month maximumAge: 2 Years stdAges: CHILD facility: Combined Military Hospital status: RECRUITING city: Nowshera state: KPK zip: 24110 country: Pakistan name: Syed Qamar Zaman role: CONTACT phone: 00923365307823 email: dr.qamarzaman@hotmail.com name: Shahid Mahmud role: CONTACT phone: 00923315301289 email: childspec@hotmail.com name: Syed Qamar Zaman role: PRINCIPAL_INVESTIGATOR hasResults: False

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

 nctId: NCT06267092 id: NN9838-4944 briefTitle: A Study of How CagriSema Works on Appetite in People With Excess Body Weight overallStatus: RECRUITING date: 2024-02-15 date: 2026-01-19 date: 2026-01-19 date: 2024-02-20 date: 2024-02-28 name: Novo Nordisk A/S class: INDUSTRY briefSummary: Part A: The study will look at participants appetite and energy intake and also look at the mechanisms of brain associated with appetite and food intake. Participants will not get any medicine and will be in a group that will be compared to another group receiving a weight-loss medicine. The study will last for about 6 months.

Part B: The study will look at how CagriSema works on participants appetite and energy intake and will be compared with a ''dummy'' medicine. The study will also look at how participants brain works when participants take the medicine. Participants will either get CagriSema or ''dummy'' medicine. conditions: Overweight conditions: Obesity studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Sponsor staff involved in the clinical trial is masked according to company standard procedures. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: No treatment given name: Cagrilintide and Semaglutide name: Placebo measure: Change in mean postprandial appetite score based on visual analogue scale (VAS) measure: Change in mean postprandial VAS ratings of: hunger, fullness, satiety and prospective food consumption measure: Change in average DAILY EATS questionnaire scores over one week for: average hunger, worst hunger, appetite, cravings, satiety and eating drivers index composite score measure: Change in control of eating questionnaire (COEQ), 4 domains: craving control score, positive mood score, craving for sweets score and craving for savoury food score measure: Change in power of food questionnaire for: food available score, food present score, food tasted score and composite score measure: Change in blood oxygen level dependant (BOLD) response to food cues in the brain reward areas measure: Relative change in total energy intake during ad libitum lunch, evening meal and snackbox measure: Change in percent energy intake of high fat, sweet food in total ad libitum energy intake in the evening snack box measure: Change in total energy intake during ad libitum lunch, evening meal and snackbox measure: Change in total amount of food consumed during ad libitum lunch, evening meal and snackbox measure: Change in body weight sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Charité Research Organisation GmbH status: RECRUITING city: Berlin zip: 10117 country: Germany lat: 52.52437 lon: 13.41053 hasResults: False

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

 nctId: NCT06267066 id: MD-232-2022 briefTitle: Fractional Carbon Dioxide Laser: A Novel Therapeutic Option for Lichen Simplex Chronicus overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-08-01 date: 2024-08-30 date: 2024-02-20 date: 2024-02-20 name: Cairo University class: OTHER briefSummary: The goal of this randomized control trial is to compare the use of fractional carbon dioxide (Co2) laser to topical corticosteroids to treat lichen simplex chronicus (LSC) patients presenting to Dermatology outpatient clinic, Faculty of Medicine, Cairo University.

Participants will:

* Be assessed clinically by doctor
* Biopsies will be taken from them by doctor
* Receive treatment as laser or topical steroids or both
* Fill in depression questionnaire.

Researchers will divide and compare groups as follows:

Sixty patients will be divided randomly through closed envelop technique into 2 groups (Group A and B) each of 30 patients. Group A will be subdivided into 2 groups (1 and 2). All LSC lesions will be treated in any patient having multiple lesions.

* Group 1 - A: Patients will receive 3 monthly laser sessions, in addition to the use of topical emollients only once daily in between the sessions.
* Group 2 - A: Patients will receive 3 monthly laser sessions, in addition to topical steroids twice daily and topical emollient once daily in between the sessions.
* Group B: Patients will be prescribed topical steroids twice daily and topical emollient once daily for 3 months.

to see if:

1. Pruritus severity scale.
2. Scaling, erythema, lichenification excoriation scores
3. Visual analogue scale.
4. Investigator's Global Assessment.
5. Itching mediators (Interleukin-31, Nerve Growth Factor and Substance P assays (itching mediators)
6. Depression

improve more in which group of patients after treatment. conditions: Lichen Simplex Chronicus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Sixty patients will be divided randomly through closed envelop technique into 2 groups (Group A and B) each of 30 patients. Group A will be subdivided into 2 groups (1 and 2) each of 15 patients. All LSC lesions will be treated in any patient having multiple lesions.

Group 1 - A: Patients will receive 3 monthly laser sessions, in addition to the use of topical emollients only once daily in between the sessions.

Group 2 - A: Patients will receive 3 monthly laser sessions, in addition to topical steroids twice daily and topical emollient once daily in between the sessions.

Group B: Patients will be prescribed topical steroids twice daily and topical emollient once daily for 3 months. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Experienced dermatologist blinded to the interventions done will assess the patients' at the end of the treatment period. whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Betamethasone Valerate 0.1% Cream name: SmartXide® fractional carbon dioxide laser name: Vaseline Topical Product measure: Comparison between 2 groups regarding change in Pruritus severity scale measure: Comparison between 2 groups regarding change in Visual analogue scale measure: Comparison between 2 groups regarding change in Investigator's Global Assessment. measure: Comparison between 2 groups regarding change in Scaling score measure: Comparison between 2 groups regarding change in Erythema score measure: Comparison between 2 groups regarding change in Lichenification score measure: Comparison between 2 groups regarding change in Excoriation score measure: change of depression score in both groups. measure: change of itching mediators' levels (IL-31, Nerve Growth Factor and substance) between 2 groups measure: Comparison of itching mediator's levels in lesional, non-lesional skin and healthy controls sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lobna Alieldin city: Cairo zip: 11562 country: Egypt name: Noha Asem, professor role: CONTACT phone: 01003657120 phoneExt: 20 email: kasralainirec@yahoo.com name: Lobna Alieldin, MSc role: CONTACT phone: 01002279968 phoneExt: 20 email: Lobnaalieldin@gmail.com name: Lobna Alieldin role: PRINCIPAL_INVESTIGATOR lat: 30.06263 lon: 31.24967 facility: Lobna Alieldin city: Cairo zip: 11562 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

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

 nctId: NCT06267040 id: 17 Al-KindyCM briefTitle: Linguistic and Clinical Validation of the Arabic Version of Acute Cystitis Symptom Score (ACCS) overallStatus: RECRUITING date: 2023-09-01 date: 2024-04-15 date: 2024-04-30 date: 2024-02-20 date: 2024-04-16 name: Al-Kindy College of Medicine class: OTHER briefSummary: The goal of this prospective observational study is to provide an Arabic translation of the Acute Cystitis Symptom Score (ACSS) and to test the linguistic validity and clinical reliability of the translated Arabic version of ACCS (Arabic-ACCS) in Arabic-speaking women older than 18 years of age diagnosed with uncomplicated cystitis.

The main questions it aims to answer are:

* Do the questions of the Arabic-ACSS have sufficient clarity?
* Can the Arabic-ACCS serve its purpose in identifying the presence of uncomplicated cystitis in Arabic-speaking women? The participant will be asked to fill out the Arabic-ACCS questionnaire at the time of diagnosis. The participants will be asked to fill out the second part of the Arabic-ACCS questionnaire 5-10 days later after receiving the appropriate treatment according to the local health policy as prescribed by the treating physician.

Researchers will compare the results from the patients who filled out the first part of the questionnaire with the results of a comparable group of women who were presented with complaints unrelated to the lower urinary tract. conditions: Cystitis Acute studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Linguistic validity measure: Clinical reliability sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Al-Elwiya Maternity Teaching Hospital status: RECRUITING city: Baghdad zip: 10064 country: Iraq name: Zahraa Muhmmed Jameel Al-Sattam, FICMS (Gyn.) role: PRINCIPAL_INVESTIGATOR name: Weqar Akram Hussein, FICMS (Gyn.) role: SUB_INVESTIGATOR lat: 33.34058 lon: 44.40088 facility: Alkindy Teaching Hospital status: RECRUITING city: Baghdad zip: 10064 country: Iraq name: Harth Mohamed Kamber, FICMS (Uro.) role: CONTACT phone: +9647706029071 email: harthkamber@kmc.uobaghdad.edu.iq name: Harth Mohamed Kamber, FICMS (Uro.) role: PRINCIPAL_INVESTIGATOR name: Ahmed Abed Marzook, FICMS role: SUB_INVESTIGATOR lat: 33.34058 lon: 44.40088 hasResults: False

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

 nctId: NCT06267014 id: 2023-A02163-42 briefTitle: Use of a Virtual Reality Cognitive Stimulation Programme for Breast Cancer Patients Wishing to Restart or Maintain a Professional Activity acronym: Cog-RV overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-06 date: 2025-06 date: 2024-02-20 date: 2024-02-20 name: Centre Francois Baclesse class: OTHER briefSummary: The study concerns patients who have been treated for breast cancer, have cognitive problems and are planning to return to work or are currently working and wish to begin cognitive rehabilitation.

Patients will follow the Virtual Reality program developed for the study, during the cognitive rehabilitation usually proposed in the establishment, at the rate of a weekly session of 10-15 minute for 6 weeks. conditions: Breast Cancer conditions: Cancer-related Cognitive Difficulties studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Patients will follow the Virtual Reality program developed for the study, during the cognitive rehabilitation sessions primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 23 type: ESTIMATED name: Virtual Reality sessions measure: Proportion of patients adhering to the Virtual Reality program sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre François Baclesse city: Caen country: France name: Adeline MOREL, MD role: CONTACT lat: 49.18585 lon: -0.35912 hasResults: False

 nctId: NCT06267001 id: GO45006 id: 2023-506696-10-00 type: REGISTRY domain: EU CT briefTitle: A Study of Tiragolumab Plus Atezolizumab Compared With Placebo Plus Atezolizumab in Participants With Completely Resected Non-small Cell Lung Cancer Who Have Received Adjuvant Platinum-based Chemotherapy acronym: SKYSCRAPER-15 overallStatus: RECRUITING date: 2024-03-21 date: 2034-03-31 date: 2039-06-30 date: 2024-02-20 date: 2024-04-26 name: Hoffmann-La Roche class: INDUSTRY briefSummary: The purpose of this study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab administered to participants with non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy. conditions: Non-small Cell Lung Cancer (NSCLC) studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1150 type: ESTIMATED name: Atezolizumab name: Tiragolumab name: Placebo measure: Disease-free Survival (DFS) measure: Percentage of Participants With Adverse Events (AEs) measure: Overall Survival (OS) measure: DFS Rate measure: Percentage of Participants Who Maintained or Meaningfully Improved from Baseline in Patient-reported Role, Emotional, and Physical Functioning and Global Health Status (GHS)/Quality of Life (QoL) measure: Serum Concentration of Tiragolumab measure: Serum Concentration of Atezolizumab measure: Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab measure: Percentage of Participants With ADAs to Atezolizumab sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Oncology Institute of Hope and Innovation; Cerritos status: RECRUITING city: Cerritos state: California zip: 90703 country: United States lat: 33.85835 lon: -118.06479 facility: University of California, San Francisco; Medical Center status: RECRUITING city: San Francisco state: California zip: 94158 country: United States lat: 37.77493 lon: -122.41942 facility: Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital status: RECRUITING city: Marietta state: Georgia zip: 30060 country: United States lat: 33.9526 lon: -84.54993 facility: Springfield Clinic status: RECRUITING city: Springfield state: Illinois zip: 62702 country: United States lat: 39.80172 lon: -89.64371 facility: UNM Lovelace status: RECRUITING city: Albuquerque state: New Mexico zip: 87102 country: United States lat: 35.08449 lon: -106.65114 facility: University of New Mexico Cancer Center status: RECRUITING city: Albuquerque state: New Mexico zip: 87106 country: United States lat: 35.08449 lon: -106.65114 facility: Asante Rogue Regional Medical Center status: RECRUITING city: Medford state: Oregon zip: 97504-8332 country: United States lat: 42.32652 lon: -122.87559 facility: Hospital Britanico; Oncologia status: RECRUITING city: Buenos Aires zip: C1280AEB country: Argentina lat: -34.61315 lon: -58.37723 facility: Centro Oncologico Korben; Oncology status: RECRUITING city: Ciudad Autonoma Buenos Aires zip: C1426AGE country: Argentina lat: -34.61315 lon: -58.37723 facility: CINME S.A. ? Centro de Investigaciones Metabolicas - Rx Trials LLC status: RECRUITING city: Ciudad Autonoma de Buenos Aires zip: C1027AAP country: Argentina lat: -34.61315 lon: -58.37723 facility: Sunshine Coast University Hospital; The Adem Crosby Centre status: RECRUITING city: Birtinya state: Queensland zip: 4575 country: Australia lat: -26.74322 lon: 153.11913 facility: Greenslopes Private Hospital; Gallipoli Research Centre status: RECRUITING city: Greenslopes state: Queensland zip: 4120 country: Australia lat: -27.50815 lon: 153.04951 facility: Cancer Research SA status: RECRUITING city: Adelaide state: South Australia zip: 5000 country: Australia lat: -34.92866 lon: 138.59863 facility: Monash Health status: RECRUITING city: Clayton state: Victoria zip: 3168 country: Australia lat: -37.91667 lon: 145.11667 facility: Hospital de Cancer de Barretos status: RECRUITING city: Barretos state: SP zip: 14784-400 country: Brazil lat: -20.55722 lon: -48.56778 facility: Hospital A. C. Camargo; Oncologia status: RECRUITING city: Sao Paulo state: SP zip: 01509-010 country: Brazil lat: -23.5475 lon: -46.63611 facility: Changzhou First People's Hospital; Oncology status: RECRUITING city: Changzhou zip: 213003 country: China lat: 31.77359 lon: 119.95401 facility: The First Affiliated Hospital of Sun Yat-sen University status: RECRUITING city: Guangzhou City zip: 510080 country: China facility: Guangdong General Hospital status: RECRUITING city: Guangzhou zip: 510080 country: China lat: 23.11667 lon: 113.25 facility: Shandong Cancer Hospital status: RECRUITING city: Jinan zip: 250117 country: China lat: 36.66833 lon: 116.99722 facility: Yunnan Cancer Hospital status: RECRUITING city: Kunming zip: 650118 country: China lat: 25.03889 lon: 102.71833 facility: The First Affiliated Hospital of Nanchang University status: RECRUITING city: Nanchang City zip: 330008 country: China facility: Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School status: RECRUITING city: Nanjing City zip: 210008 country: China facility: Ningbo No.2 Hospital status: RECRUITING city: Ningbo country: China lat: 29.87819 lon: 121.54945 facility: Zhongshan Hospital Fudan University status: RECRUITING city: Shanghai zip: 200032 country: China lat: 31.22222 lon: 121.45806 facility: Shanghai Pulmonary Hospital status: RECRUITING city: Shanghai zip: 200433 country: China lat: 31.22222 lon: 121.45806 facility: Liaoning Provincial Cancer Hospital status: RECRUITING city: Shengyang zip: 110042 country: China facility: Tianjin Cancer Hospital status: RECRUITING city: Tianjin zip: 300060 country: China lat: 39.14222 lon: 117.17667 facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Technology status: RECRUITING city: Wuhan City zip: 430030 country: China facility: The Affiliated Hospital of Xuzhou Medical University status: RECRUITING city: Xuzhou country: China lat: 34.18045 lon: 117.15707 facility: The First Affiliated Hospital of Zhengzhou University status: RECRUITING city: Zhengzhou zip: 450052 country: China lat: 34.75778 lon: 113.64861 facility: Kindai University Hospital status: RECRUITING city: Osaka zip: 589-8511 country: Japan lat: 34.69374 lon: 135.50218 facility: Pusan National University Hospital status: RECRUITING city: Busan zip: 602-739 country: Korea, Republic of lat: 35.10278 lon: 129.04028 facility: Chungbuk National University Hospital status: RECRUITING city: Cheongju si zip: 28644 country: Korea, Republic of lat: 36.63722 lon: 127.48972 facility: Kyungpook National University Chilgok Hospital status: RECRUITING city: Daegu zip: 41404 country: Korea, Republic of lat: 35.87028 lon: 128.59111 facility: St. Vincent's Hospital status: RECRUITING city: Gyeonggi-do zip: 16247 country: Korea, Republic of lat: 37.58944 lon: 126.76917 facility: Pusan National University Yangsan Hospital status: RECRUITING city: Gyeongsangnam-do zip: 50612 country: Korea, Republic of facility: Chonnam National University Hwasun Hospital status: RECRUITING city: Jeollanam-do zip: 58128 country: Korea, Republic of facility: Seoul National University Bundang Hospital status: RECRUITING city: Seongnam-si zip: 463-707 country: Korea, Republic of lat: 37.43861 lon: 127.13778 facility: Seoul National University Hospital status: RECRUITING city: Seoul zip: 03080 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Severance Hospital, Yonsei University Health System status: RECRUITING city: Seoul zip: 03722 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Asan Medical Center status: RECRUITING city: Seoul zip: 05505 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Samsung Medical Center status: RECRUITING city: Seoul zip: 06351 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Korea University Guro Hospital status: RECRUITING city: Seoul zip: 08308 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Ulsan University Hosiptal status: RECRUITING city: Ulsan zip: 44033 country: Korea, Republic of lat: 35.53722 lon: 129.31667 facility: Kaohsiung Medical Uni Chung-Ho Memorial Hospital; Dept of Internal Medicine status: RECRUITING city: Kaohsiung zip: 807 country: Taiwan lat: 22.61626 lon: 120.31333 facility: Taichung Veterans General Hospital; Dept of Internal Medicine status: RECRUITING city: Taichung zip: 407 country: Taiwan lat: 24.1469 lon: 120.6839 facility: Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology status: RECRUITING city: Taipei zip: 112 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Tri-Service General Hospital; Dept. of Internal Medicine status: RECRUITING city: Taipei zip: 114 country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False

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

 nctId: NCT06266975 id: CKD pts in CML briefTitle: Chronic Kidney Disease Patient in Chronic Myloied Leukemia overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2026-11 date: 2026-11 date: 2024-02-20 date: 2024-02-20 name: Sahar Mohammed Gad class: OTHER briefSummary: To study the Prevalence ,Characteristics and outcome of CKD in patiants with chronic myeloid leukemia . conditions: Chronic Myeloid Leukemia in Remission studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 40 type: ESTIMATED name: Biobsy from kidney measure: Chronic Kidney Disease Patient in Chronic Myloied Leukemia sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

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

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

 nctId: NCT06266936 id: EssaiClinique_SL2i-MSC briefTitle: Smart Life Smart Living Intercontinental - Medical Students' Cohort acronym: SL2i-MSC overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2044-09 date: 2044-12 date: 2024-02-20 date: 2024-04-17 name: University Hospital, Grenoble class: OTHER name: Université Grenoble-Alpes briefSummary: The question of the well-being, quality of life and mental health of care students is unanimously considered to be a central issue among young adults. According to the French Ministry of Higher Education and Research, there will be 194,752 care students in France in 2021-2022. The quality of life and well-being of health students can be affected at several levels. The first is mental health. In France, the mental health of these students has deteriorated considerably in recent years. According to a 2017 survey of 21,768 French medical students, 66% of them had an anxiety disorder and 27% a depressive syndrome. In addition, a number of risk factors have been identified for the mental health of health students.

The aim of the study is to carry out a longitudinal evaluation of the mental health status of care students during their university studies in France through anxiety, depression and perceived stress. conditions: Mental Health Issue conditions: Student Burnout studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1564 type: ESTIMATED name: No intervention measure: Synthetic score on standardized assessment scale of anxiety measure: Synthetic score on standardized assessment scale of mental health measure: Synthetic score on standardized assessment scale of stress sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

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

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

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

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

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

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

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

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

 nctId: NCT06266819 id: OU-HEM-LE-01 briefTitle: The Effect of Mint Flavored Chewing Gum on Hyperemesis Gravidarum Nausea Vomiting Severity, Coping With Stress and Anxiety Level in Pregnants With Hyperemesis Gravidarum overallStatus: RECRUITING date: 2024-01-15 date: 2024-06-01 date: 2024-07-01 date: 2024-02-20 date: 2024-02-20 name: T.C. ORDU ÜNİVERSİTESİ class: OTHER briefSummary: In the research planned as a randomized controlled study, the experimental groups will be administered routine hyperemesis gravidarum (HG) treatment as well as chewing mint-flavored gum, while the control group will only receive routine HG treatment and no intervention will be performed. This study aims to contribute to the literature by investigating the effect of chewing mint-flavored gum on the severity of nausea and vomiting, coping with stress, and anxiety levels due to hyperemesis gravidarum in pregnant women. conditions: Hyperemesis Gravidarum studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: two groups with chewing mint gum experimental group and a control group primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The study protocol in the research will be created using SPIRIT as a guide. Reporting of the trial will be structured according to the CONSORT checklist. Random distribution of pregnant women included in the study to the intervention and control groups will be made at www.randomizer.org. Which group will be the intervention or control group will be determined by drawing lots at the beginning of the study. Pregnant women in the intervention group will be given the practice of chewing mint-flavored gum.

Since the researcher knows which group the pregnant women are included in, the data collection phase of the study is single blind. To avoid selection bias in this study, pregnant women will be randomly assigned to the intervention and control groups by randomization method. To prevent reporting bias, the analysis of the research data will be carried out by an expert statistician. whoMasked: OUTCOMES_ASSESSOR count: 78 type: ESTIMATED name: chewing gum measure: Pregnancy-Specific Nausea and Vomiting Severity Scale (PUQE-24) measure: Visual Analog Scale (VAS) measure: Stress Coping Styles Scale (SCSS) measure: State-Trait Anxiety Inventory (STAI) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Özel Şar Hospital status: RECRUITING city: Rize zip: 53100 country: Turkey name: M.Akif KUMBUZOĞLU, Uzm. Dr. role: CONTACT phone: +90 464 212 11 03 email: info@sarhospital.com.tr lat: 41.02083 lon: 40.52194 hasResults: False

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

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

 nctId: NCT06266780 id: P1473-2023 briefTitle: Impact Evaluation of a Targeted mHealth Intervention to Improve Uptake of Postpartum Contraception in Kenya overallStatus: RECRUITING date: 2024-02-02 date: 2024-08-30 date: 2024-12-31 date: 2024-02-20 date: 2024-02-20 name: Jacaranda Health class: OTHER name: Harvard School of Public Health (HSPH) name: Jhpiego name: IPSOS briefSummary: The goal of this study is to explore approaches to improve postpartum contraceptive counseling, information, and uptake through a collaboration between the Harvard Chan School, Rutgers School of Public Health, Jacaranda Health, Jhpiego, and IPSOS, leveraging an existing mobile health platform for intervention delivery and Jacaranda's established partnership with the Kenyan Ministry of Health, county health offices and public maternity hospitals.

Jacaranda's PROMPTS mHealth platform has reached over two million pregnant women and new mothers, providing them with needed, tailored information about prenatal and postpartum health along with access to a mobile helpdesk to triage users' questions. Using a targeted human-centered-design process with early postpartum mothers, we developed targeted messaging around family planning and contraceptive method options, with the goal of integrating this new content into Jacaranda's PROMPTS platform. We will conduct a randomized controlled trial with pregnant women engaged with the PROMPTS platform to determine the impact of the intervention package on information and utilization of postpartum contraception. If proven effective, the results of this intervention will be integrated into Jacaranda's PROMPTS system at full scale. conditions: Postpartum Family Planning studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 4190 type: ESTIMATED name: PROMPTS Enhanced Family Planning Counselling measure: Use of postpartum family planning at 3 months measure: Use of postpartum family planning at 6 months measure: Knowledge of return to fertility measure: Knowledge of safe birth spacing measure: Knowledge of lactational amenorrhea (LAM) method measure: Intention to continue family planning method measure: Intended duration of continued family planning method use measure: Desired pregnancy spacing of two years or more measure: Short interpregnancy interval measure: Method satisfaction measure: Uptake of most effective family planning methods measure: Time to take-up of most effective methods measure: Discussion of FP at any prenatal visit measure: Discussion of FP at any postnatal visit measure: Reproductive empowerment: health care provider communication measure: Quality of helpdesk team in counselling on family planning measure: Quality of message flow on method selection sex: FEMALE minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Jacaranda Health status: RECRUITING city: Nairobi zip: 00000 country: Kenya name: Anneka Wickramanayake, Masters role: CONTACT phone: +254700164229 email: awickramanayake@jacarandahealth.org name: Jessica Cohen, Ph.D role: CONTACT phone: +16174327577 email: cohenj@hsph.harvard.edu lat: -1.28333 lon: 36.81667 hasResults: False

 nctId: NCT06266767 id: MRC-01-18-157 briefTitle: Programmed Intermittent Epidural Bolus (PIEB) Techniques for Labour Analgesia acronym: PIEB overallStatus: NOT_YET_RECRUITING date: 2024-02-20 date: 2024-04-20 date: 2024-04-30 date: 2024-02-20 date: 2024-02-20 name: Hamad Medical Corporation class: INDUSTRY briefSummary: Epidural Analgesia remains the most effective form of pain relief in labour. After initiating epidural analgesia, there are many epidural drug regimens that can be employed to maintain analgesia for the duration of labour using an epidural catheter. Due to recent advances in medical technology, new epidural pumps, which allow both patient controlled epidural analgesia boluses (PCEA, a common standard of care in many hospitals) and programmed intermittent epidural boluses (PIEB, automatic boluses given in addition to the PCEA bolus), are now available. In this randomized double-blind trial, we aim to evaluate the effects of different combinations of PIEB (epidural bolus volume) and PIEB (bolus volume and time interval) on labour patient-controlled epidural analgesia (PCEA) usage. In theory, the more effective the PIEB combination (the ideal drug volume and ideal time interval), the less PCEA boluses (extra epidural drug) will be used as well as less clinician boluses and less lower limb weakness (motor block) as assessed by the Bromage Score. conditions: Labor Pain conditions: Obstetric Pain conditions: Analgesia studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: We aim to use a pragmatic sequential optimization method as described by Sveticic et al. 2003. For the first round of recruitment, the research team will randomize women into 8 different groups of PIEB/PCEA regimens with six (n=6) women per group and set up the epidural pump for the maintenance of labor analgesia. This first round of recruitment will be called Complex #1. The PCEA bolus volume and lockout interval will stay the same for all groups.

There will be 8 combinations of PIEB/PCEA using an epidural mixture of 0.1% levobupivacaine + 2mcg/ml Fentanyl (n=48). We will exclude the 2 worst performing groups (as assessed by our composite primary outcome). Using sequential optimization, 2 new groups with different combinations of PIEB volume / interval will be added to the remaining 6 groups. Complex 2 therefore will consist of 8 groups of 48 patients (n=6 per group). We anticipate 3 to 4 rounds of recruitment until our statistician determines the 2 best performing groups. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: TRIPLE maskingDescription: This is a randomized double-blinded design. Patients and their attending physicians / clinical anaesthetists / data collection study member / midwives / nurses will be blinded to patient group allocation whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Levobupivacaine and Fentanyl measure: The volume of local anaesthetic mixture for breakthrough pain (PCEA + clinician bolus) + the Bromage Score measure: Pain score measure: Total local anesthetic consumption measure: Need for supplementary epidural analgesia measure: Bromage score (lower limb weakness score) measure: Type of delivery measure: Sensory block measure: Fetal Outcome sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Hamad Medical Corporation (HMC) city: Doha zip: 3050 country: Qatar lat: 25.28545 lon: 51.53096 hasResults: False

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

 nctId: NCT06266741 id: NCT093509350936 briefTitle: The Predictive Value of Lubricin in Patients With Infective Endocarditis overallStatus: ENROLLING_BY_INVITATION date: 2024-02-11 date: 2024-02-20 date: 2026-02-20 date: 2024-02-20 date: 2024-02-20 name: Aydin Adnan Menderes University class: OTHER briefSummary: The main goal of this study is to evaluate the predictability of the disease by measuring the serum lubricin levels in patients with infective endocarditis and in non-patients conditions: Infective Endocarditis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Lubricin measure: Valve damage indicative sign in infective endocarditis sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sevil Gulasti city: Aydın state: Zafer zip: 09010 country: Turkey lat: 37.84501 lon: 27.83963 hasResults: False

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

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

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

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

 nctId: NCT06266676 id: 202301775B1 briefTitle: Mobile Micro-course Impact on Perioperative RNs in Heart Surgery Nursing. overallStatus: RECRUITING date: 2024-02-01 date: 2024-04-10 date: 2024-12-31 date: 2024-02-20 date: 2024-02-20 name: Ting-Fang Yeh class: OTHER briefSummary: The goal of this clinical trialis to compare in learning effectiveness of nurses. The main questions it aims to answer are:

1. Can the "Micro-course" teaching enhance the awareness of cardiac surgery nursing among operating room nurses?
2. Can the "Micro-course" teaching boost the learning motivation and engagement of operating room nurses?
3. What is the satisfaction level of nurses regarding the use of "Micro-course" in cardiac surgery nursing?
4. What are the relevant factors influencing the effectiveness of the "Micro-course" teaching intervention?

Participants will be divided into two groups. The control group will receive online presentations, while the experimental group will engage in mobile learning combined with micro-courses. Both groups of participants will undergo instruction through asynchronous online courses. conditions: periOperative conditions: Cardiac Surgical Procedures studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 75 type: ESTIMATED name: micro-course name: slide presentation measure: Cognitive scale measure: motivation scale measure: Engagement Scale measure: learning satisfaction sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: ChangGungMH status: RECRUITING city: Taoyuan City zip: 33305 country: Taiwan name: Ting-Fang Yeh role: CONTACT phone: +88633281200 phoneExt: 2380 email: ytf812@cgmh.org.tw lat: 24.95233 lon: 121.20193 hasResults: False

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

 nctId: NCT06266650 id: 19485 briefTitle: Unilateral vs Bilateral Application of Muscle Energy Techniques in Pelvic Somatic Dysfunction acronym: PMEOMT overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-08-30 date: 2024-09-30 date: 2024-02-20 date: 2024-02-20 name: The Touro College and University System class: OTHER briefSummary: The goal of this clinical trial is to compare the efficacy of pelvic muscle energy technique online against the traditional full length osteopathic pelvic treatment protocol. The main question it aims to answer are

• Can one single pelvic muscle energy technique can correct all pelvic somatic dysfunctions (SD)?

Participants will

* be positioned by the physician into the area of treatment into a position of resistance, which is the restrictive barrier.
* be instructed to use the targeted muscles for 3-5 seconds in the direction of ease while the physician provides a counterforce.
* be instructed to stop contracting their muscles and evaluate the area for decreased tension, then repositions the patient into their new restrictive barrier.
* These steps are repeated three to five times and then the dysfunction is reevaluated.

Subjects diagnosed with pelvic SD will be divided into two groups. One group will be treated with traditional one and be compared with the pelvic muscle energy group. conditions: Pelvic Somatic Dysfunction studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Subjects diagnosed with pelvic SD will be divided into two groups. One group will be treated with traditional one-sided MET, the second group will be treated with combination MET. Results of post-treatment exams will be collected and statistically analyzed. primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Osteopathic Treatment Technique- Muscle Energy Treatment measure: Resolution of pelvic somatic dysfunction measure: Anterior anatomical landmarks assessment measure: Posterior anatomical landmarks assessment sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06266637 id: P.T.REC/012/004999 briefTitle: Effect of Scoliosis-Specific Exercise on Lower Limb Biomechanics overallStatus: ACTIVE_NOT_RECRUITING date: 2023-03-12 date: 2024-03-01 date: 2024-03-15 date: 2024-02-20 date: 2024-02-20 name: Delta University for Science and Technology class: OTHER name: Benha University briefSummary: PURPOSE: To examine the effect of Physiotherapeutic Scoliosis-Specific Exercise on limb biomechanical parameters in adolescents with idiopathic scoliosis. A randomised controlled trial

BACKGROUND:

Adolescent idiopathic scoliosis is one of the most common orthopaedic diseases affecting the spine during adolescence. The efficacy of exercise treatment is controversial. Although evidence suggests that PSSE, which include auto-correction in 3D, integration in daily life, stabilizing the corrected posture, and patient education, could improve some outcomes, effect of PSSE on related biomechanical alterations in lower limbs have not yet been examined.

HYPOTHESES:

Null hypothesis There are no statistically significant effect of Physiotherapeutic Scoliosis-Specific Exercise on lower limb biomechanics in scoliotic adolescents.

RESEARCH QUESTION:

What are the effect of Physiotherapeutic Scoliosis-Specific Exercise on lower limb biomechanics in scoliotic adolescents.? conditions: Scoliosis Idiopathic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 56 type: ACTUAL name: Conventional Physical Therapy Program name: Physiotherapeutic Scoliosis-Specific Exercise (Schroth) measure: Cobb's angle measure: Coronal balance measure: length of the the tibia and femur measure: tibiofemoral angle measure: knee joint line convergence angle measure: lower limb mechanical axis; and mechanical axis deviation sex: ALL minimumAge: 10 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Delta university for science and technology city: Gamasa state: Dakahleya zip: 7731168 country: Egypt lat: 31.44112 lon: 31.53675 hasResults: False

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

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

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

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

 nctId: NCT06266572 id: 1R43DA055182-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R43DA055182-01 briefTitle: Overcoming Stigma and Improving Outcomes for SUDs Through Education, Engagement, and Empowerment acronym: OASIS overallStatus: COMPLETED date: 2021-09-30 date: 2023-09-29 date: 2023-09-29 date: 2024-02-20 date: 2024-03-01 name: Center for Social Innovation, Massachusetts class: OTHER briefSummary: C4 Innovations (C4) and partners at Yale University (Yale) and the West Haven VA Medical Center (WHVA) proposed to develop and test OASIS (Overcoming and Addressing Stigma in Substance Use Disorders), a web-based educational platform for primary care clinicians and individuals with Opioid Use Disorder. The major aims of the study were to:

1. Develop a prototype of OASIS for patients with Opioid Use Disorder (OUD) and primary care clinicians; conduct usability testing.
2. Pilot OASIS with a small sample of individuals with untreated OUD and their clinicians to determine feasibility, acceptability, and preliminary product effectiveness for a Phase II effectiveness trial.

After development of the prototype, the C4-Yale-WHVA team planned to test OASIS with patients (N = 30) and clinicians (N = 5) using validated measures and qualitative interviews to assess usability, satisfaction, knowledge, empowerment, and stigma. conditions: Opioid Use Disorder studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 19 type: ACTUAL name: Overcoming and Addressing Stigma in Substance Use Disorders (OASIS) measure: Open Minds Scale for Health Care Providers measure: Brief Opioid Stigma Scale measure: Perceived Stigma of Addiction Scale measure: Knowledge Check measure: System Usability Scale measure: Internalized Stigma of Mental Illness Scale measure: Recovery Empowerment Scale measure: Mental Health Seeking Attitudes Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: West Haven VA Medical Center city: West Haven state: Connecticut zip: 06516 country: United States lat: 41.27065 lon: -72.94705 hasResults: False

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

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

 nctId: NCT06266533 id: Pro2023002473 briefTitle: Dismantling the U.S. Social Norm of the "Kids' Food" Archetype (REACH Project) overallStatus: RECRUITING date: 2024-02-21 date: 2024-07-01 date: 2024-07-01 date: 2024-02-20 date: 2024-03-08 name: Rutgers, The State University of New Jersey class: OTHER 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. conditions: Food Selection conditions: Environmental Exposure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomly assigned to a conventional nutrition education or an arts-based education group. primaryPurpose: PREVENTION masking: NONE count: 38 type: ESTIMATED name: Conventional Ultra-processed Food Nutrition Education name: Arts-based Ultra-processed Food Nutrition Education measure: Ultra-Processed Food Knowledge measure: Environmental assessment of ultra-processed food sex: FEMALE minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Leaguers Inc. Head Start status: RECRUITING city: Newark state: New Jersey zip: 07102 country: United States name: Aurthur Nabi role: CONTACT phone: 973-643-0300 email: "arthuarthur_nabi@theleaguers.org lat: 40.73566 lon: -74.17237 hasResults: False

 nctId: NCT06266520 id: DongyangH briefTitle: MNK Therapy in Releasing the Superficial Fascia for Patients With AAS: an Assessor-blinded, Randomised Controlled Trial overallStatus: RECRUITING date: 2023-01-01 date: 2025-06-01 date: 2025-06-01 date: 2024-02-20 date: 2024-02-20 name: Sen-wei Lu class: OTHER 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. conditions: Acute Ankle Sprain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: MNK therapy to release the superficial fascia name: acupuncture measure: Visual Analogue Scale (VAS) measure: Kofoed Ankle Score sex: ALL minimumAge: 16 Years maximumAge: 55 Years stdAges: CHILD stdAges: ADULT facility: The Affiliated Dongyang Hospital of Wenzhou Medical University, Dongyang, Zhejiang, China status: RECRUITING city: Dongyang state: Zhejiang zip: 322100 country: China name: Sen-wei Lu, Dr. role: CONTACT phone: +8613989441117 email: lswlsw1121@163.com lat: 29.26778 lon: 120.22528 hasResults: False

 nctId: NCT06266507 id: 169 briefTitle: Examining the Effect of Occupational Therapy-Based Parent Coaching on Feeding Problems in Children With a Preterm Birth overallStatus: NOT_YET_RECRUITING date: 2024-02-15 date: 2025-02-15 date: 2025-03-15 date: 2024-02-20 date: 2024-02-20 name: Ankara Medipol University class: OTHER 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. conditions: Feeding Behavior conditions: Mother-Child Relations conditions: Feeding and Eating Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 46 type: ESTIMATED name: Ergotherapy Based Parent Coaching name: Informative Brochure Distribution measure: Behavioral Pediatric Feeding Assessment Scale measure: Sensory Profile Questionnaire - Oral Sensory Processing Test measure: Feeding Strategies Quesstionnaire measure: Parental Self-Efficacy Scale sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Medipol University city: Ankara state: Ankara/ Altındağ zip: 06110 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06266494 id: 23-1349 id: CDMRP-DM220077 type: OTHER_GRANT domain: Department of Defense briefTitle: Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis acronym: Frostbite overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2026-05 date: 2026-08 date: 2024-02-20 date: 2024-02-20 name: University of Colorado, Denver class: OTHER name: Congressionally Directed Medical Research Programs 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. conditions: Frostbite studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Long-Acting silver dressings name: Aloe Vera name: Dalbavancin measure: The number of positive microbial wound cultures on admission measure: The number of positive microbial wound cultures on hospital day 4 measure: The number of positive microbial wound cultures on hospital day 8 measure: The number of positive microbial wound cultures on hospital day 12 measure: The number of positive microbial wound cultures on hospital day 16 measure: The number of positive microbial wound cultures on hospital day 20 measure: The number of positive microbial wound cultures on hospital day 24 measure: The number of positive microbial wound cultures on hospital day 28 measure: The number of positive microbial wound cultures on hospital day 32 measure: The number of positive microbial wound cultures on hospital day 36 measure: The number of positive microbial wound cultures on hospital day 40 measure: The number of positive microbial wound cultures on hospital day 44 measure: The number of positive microbial wound cultures on hospital day 48 measure: The number of positive microbial wound cultures on hospital day 52 measure: The number of positive microbial wound cultures on hospital day 56 measure: The number of positive microbial wound cultures on hospital day 60 measure: Number of gram positive cultures at admission measure: Number of gram positive cultures on hospital day 4 measure: Number of gram positive cultures on hospital day 8 measure: Number of gram positive cultures on hospital day 12 measure: Number of gram positive cultures on hospital day 16 measure: Number of gram positive cultures on hospital day 20 measure: Number of gram positive cultures on hospital day 24 measure: Number of gram positive cultures on hospital day 28 measure: Number of gram positive cultures on hospital day 32 measure: Number of gram positive cultures on hospital day 36 measure: Number of gram positive cultures on hospital day 40 measure: Number of gram positive cultures on hospital day 44 measure: Number of gram positive cultures on hospital day 48 measure: Number of gram positive cultures on hospital day 52 measure: Number of gram positive cultures on hospital day 56 measure: Number of gram positive cultures on hospital day 60 measure: Change in serum concentration of dalbavancin in plasma (mcg/ml) over time measure: Dalbavancin concentrations in subcutaneous tissue measure: Change in presence of Augmented Renal Clearance sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Colorado Denver Anschutz Medical Campus city: Aurora state: Colorado zip: 80045 country: United States name: Blaire Balstad role: CONTACT phone: 303-724-7803 email: blaire.balstad@cuanschutz.edu name: Tracey MacDermott role: CONTACT phone: 303-724-2757 email: tracey.macdermott@cuanschutz.edu lat: 39.72943 lon: -104.83192 hasResults: False

 nctId: NCT06266481 id: pua04202312313157 briefTitle: Topical Dexamethasone Versus Topical Lidocaine Spray to Reduce POST in Shoulder Arthroscopic Surgeries: A Comparative Study acronym: post overallStatus: RECRUITING date: 2024-03-01 date: 2024-04-30 date: 2024-05-30 date: 2024-02-20 date: 2024-02-20 name: Pharos University in Alexandria class: OTHER 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. conditions: Postoperative Sore Throat studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 100 type: ESTIMATED name: Topical dexamethasone name: 10% lidocaine was sprayed over the tube for the second group measure: Topical dexamethasone versus topical lidocaine spray to reduce post-intubation sore throat in shoulder arthroscopic surgeries: A comparative study sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Pharos University status: RECRUITING city: Alexandria zip: 21348 country: Egypt name: mona el. massoud, ph anesthesia role: CONTACT phone: 002+01005542232 email: mona.elsaid@pua.edu.eg name: hatem a. attalla, ph anaesthesia role: CONTACT phone: 002+1001445568 email: hatattalla@hotmail.com name: mona el. massoud, lecture role: PRINCIPAL_INVESTIGATOR lat: 31.21564 lon: 29.95527 hasResults: False

 nctId: NCT06266468 id: STUDY00149178 briefTitle: Nutricity: An mHealth Nutrition Intervention to Improve Diet Quality Among Latino Children overallStatus: NOT_YET_RECRUITING date: 2024-02-21 date: 2025-06-30 date: 2025-12-31 date: 2024-02-20 date: 2024-02-20 name: University of Kansas Medical Center class: OTHER 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. conditions: Diet Quality studyType: INTERVENTIONAL phases: NA 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 masking: NONE count: 80 type: ESTIMATED name: Nutricity measure: Change in Diet quality (Healthy Eating Index) (child) measure: Nutrition Literacy (parent) measure: Body Mass Index (child) measure: Skin Carotenoid measure: Feeding Behaviors of Parent and Children measure: Mediation of Children's Media Use measure: Parent Self-Efficacy measure: Parent Nutrition Attitudes sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06266455 id: Pro00000615 briefTitle: Individualized Nutrition to Optimize Preterm Infant Growth and Neurodevelopment acronym: THRIVE overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2034-01 date: 2034-01 date: 2024-02-20 date: 2024-02-28 name: Children's National Research Institute class: OTHER 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. conditions: Very Preterm Maturity of Infant conditions: Very Low Birth Weight Infant studyType: INTERVENTIONAL phases: NA 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 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 count: 150 type: ESTIMATED name: Standardized Fortification name: Adjustable Fortification name: Adjustable Fortification measure: Weight Gain Velocity measure: Length Growth Velocity measure: Head Circumference Growth Velocity measure: Total and Regional Brain Volumes measure: Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) measure: Mullen Scales of Early Learning (MSEL) measure: Mullen Scales of Early Learning (MSEL) measure: Wechsler Preschool and Primary Scale of Intelligence (4th edition) (WPPSI-IV) measure: Differential Abilities Scale (2nd edition)-(DAS-II) sex: ALL maximumAge: 4 Weeks stdAges: CHILD facility: Children's National Hospital city: Washington state: District of Columbia zip: 20010 country: United States name: Catherine Limperopoulos, Ph.D. role: CONTACT phone: 202-476-5293 email: CLimpero@childrensnational.org name: Katherine M. Ottolini, M.D. role: CONTACT phone: 202-476-8905 email: KOttolin@childrensnational.org name: Catherine Limperopoulos, Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 38.89511 lon: -77.03637 hasResults: False

 nctId: NCT06266442 id: Mav-WGS briefTitle: M. Avium WGS During Mav-PD Treatment overallStatus: RECRUITING date: 2024-02 date: 2026-09 date: 2026-09 date: 2024-02-20 date: 2024-02-20 name: University Health Network, Toronto class: OTHER name: Western University, Canada name: Public Health Ontario Laboratory, Canada 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. conditions: Mycobacterium Avium conditions: Mycobacterium Infections, Nontuberculous conditions: Mycobacterium Infections conditions: Nontuberculous Mycobacterial Lung Disease conditions: Respiratory Tract Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Whole genome sequencing testing measure: Proportion of patients with persistent culture-positive sputum despite antimicrobial therapy 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 measure: Whether there is a source of infection from the home water environment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Health Network status: RECRUITING city: Toronto state: Ontario zip: M5G country: Canada name: Matty Mehrabi, B.Sc. M. Ed role: CONTACT phone: 416-603-5726 email: matty.mehrabi@uhn.ca name: Theodore Marras, MD role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06266429 id: STUDY00001304 briefTitle: Metabolomic Profiling of Racial Disparity overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-12-31 date: 2026-12-31 date: 2024-02-20 date: 2024-02-20 name: Olubukola Nafiu class: OTHER 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. conditions: Adenoid Hypertrophy conditions: Tonsillar Hypertrophy conditions: Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Blood collection measure: Mean fold-change of metabolomics markers by race using untargeted reverse-phase liquid-chromatographic mass spectrometry measure: Highest pain score measure: Last pain score sex: ALL minimumAge: 4 Years maximumAge: 17 Years stdAges: CHILD hasResults: False

 nctId: NCT06266416 id: 115207 briefTitle: IMARA for Black Male Caregivers and Girls Empowerment (IMAGE) acronym: IMAGE overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2027-05-31 date: 2028-05-31 date: 2024-02-20 date: 2024-04-24 name: University of Illinois at Chicago class: OTHER name: University of Michigan 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. conditions: Sexually Transmitted Infections (Not HIV or Hepatitis) conditions: HIV Infections conditions: Sexual Behavior studyType: INTERVENTIONAL phases: NA 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 masking: SINGLE whoMasked: INVESTIGATOR count: 612 type: ESTIMATED name: IMARA for Black Male Caregivers and Girls Empowerment name: Time-matched control program measure: STI Incidence in Participants measure: Rate of STI History among Participants measure: Number of Participants Using Condoms measure: Number of Sexual Partners of Participants sex: ALL minimumAge: 14 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of Illinois Chicago city: Chicago state: Illinois zip: 60612 country: United States name: LIsa Sharp, PhD role: CONTACT phone: 312-966-1819 email: sharpl@uic.edu name: Sue Littau role: CONTACT phone: 312.996.3932 email: slittau@uic.edu lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06266403 id: STUDY00024154 briefTitle: Evaluating Verbal Communication in Structured Interactions: Theoretical and Clinical Implications overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2029-03 date: 2029-03 date: 2024-02-20 date: 2024-02-20 name: Penn State University class: OTHER 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. conditions: Amyotrophic Lateral Sclerosis studyType: INTERVENTIONAL phases: NA 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 masking: NONE count: 300 type: ESTIMATED name: Structured Communicative Interaction name: Clear Speech name: Unstructured communicative interaction name: Clear Speech Structured Communicative Interaction measure: Formant frequencies of speech sounds measure: Intelligibility of recorded speech measure: Syntactic properties measure: Pragmatic Properties measure: Duration of speech sounds sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06266390 id: 855007 briefTitle: Engaging sgACC With TMS for Depression overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2026-01-30 date: 2026-04 date: 2024-02-20 date: 2024-04-18 name: University of Pennsylvania class: OTHER name: National Institutes of Health (NIH) 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. conditions: Depression conditions: Major Depressive Disorder conditions: Persistent Depressive Disorder studyType: INTERVENTIONAL phases: PHASE1 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 masking: SINGLE maskingDescription: Participants will not be informed on which target they have been assigned to. whoMasked: PARTICIPANT count: 50 type: ESTIMATED name: Transcranial Magnetic Stimulation (TMS) measure: sgACC Blood Oxygen Level Dependent (BOLD) signal change following single-pulse fMRI-guided TMS (TMS On vs TMS Off) measure: Change in sgACC evoked response Pre/Post TMS treatment with positive and negative sgACC correlated targets sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Pennsylvania city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Almaris Figueroa-González role: CONTACT email: almaris.figuera-gonzalez@pennmedicine.upenn.edu name: Ethan Hammett role: CONTACT email: ethan.hammett@pennmedicine.upen.edu name: Desmond J Oathes, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06266377 id: 11122023 briefTitle: AUT-MENU: Improving Meal Experience of Subjects With Autism Spectrum Disorder overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2025-06-01 date: 2025-11-30 date: 2024-02-20 date: 2024-02-20 name: University of Pavia class: OTHER name: Consiglio per la ricerca in agricoltura e l'analisi dell'economia agraria (CREA) 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. conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA 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 masking: NONE count: 200 type: ESTIMATED name: Administration of menus of collective catering adapted to the sensory and nutritional needs of subjects with Autism Spectrum Disorder name: Nutrition education course aimed at caregivers of individuals with Autism Spectrum Disorder measure: Food acceptance of canteen menus by individuals enrolled in the study measure: Reduction in food selectivity as a result of the targeted nutrition education course sex: ALL minimumAge: 5 Years maximumAge: 19 Years stdAges: CHILD stdAges: ADULT facility: Milano Ristorazione S.p.A. city: Milano zip: 20139 country: Italy lat: 45.46427 lon: 9.18951 facility: Istituto I.P.S.E.O.A. "Tor Carbone - A. Narducci". city: Roma zip: 00178 country: Italy lat: 41.89193 lon: 12.51133 facility: Istituto Tecnico Agrario Statale "Giuseppe Garibaldi" city: Roma zip: 00178 country: Italy lat: 41.89193 lon: 12.51133 hasResults: False

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

 nctId: NCT06266351 id: LASIKIOP briefTitle: EVALUATION OF CATS TONOMETER PRISM IN LASIK SUBJECTS overallStatus: NOT_YET_RECRUITING date: 2024-02-12 date: 2024-06-01 date: 2024-08-01 date: 2024-02-20 date: 2024-02-20 name: Intuor Technologies, Inc. class: INDUSTRY 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. conditions: Glaucoma conditions: Ocular Hypertension conditions: Normal Tension Glaucoma studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: This is observational IOP measurement measure: IOP measurement difference between CATS and GAT in LASIK patients sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Arizona Eye Consultants city: Tucson state: Arizona zip: 85710 country: United States lat: 32.22174 lon: -110.92648 facility: Eye Specialty Group city: Memphis state: Tennessee zip: 38120 country: United States name: Sean Dodson role: CONTACT phone: 520-327-3487 email: sjmccafferty66@hotmail.com lat: 35.14953 lon: -90.04898 hasResults: False

 nctId: NCT06266338 id: STU-2023-1118 briefTitle: Study of Pembrolizumab and Lenvatinib in Metastatic and Recurrent Cervix Cancer (LenPem Cervix) overallStatus: RECRUITING date: 2024-03-11 date: 2025-10-31 date: 2026-10-31 date: 2024-02-20 date: 2024-03-13 name: University of Texas Southwestern Medical Center class: OTHER name: Merck Sharp & Dohme LLC 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. conditions: Cervix Cancer conditions: Cervical Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Pembrolizumab name: Lenvatinib measure: Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors v1.1 measure: Progression Free Survival (PFS) assessed by Response Evaluation Criteria in Solid Tumors v1.1 sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UT Southwestern Medical Center status: RECRUITING city: Dallas state: Texas zip: 75390 country: United States name: Annette Paulsen role: CONTACT phone: 214-648-7097 role: CONTACT email: annette.paulsen@utsouthwestern.edu lat: 32.78306 lon: -96.80667 hasResults: False

 nctId: NCT06266325 id: 6138 briefTitle: Development and Validation of a Dementia Life Expectancy Tool overallStatus: COMPLETED date: 2010-04-01 date: 2022-12-31 date: 2022-12-31 date: 2024-02-20 date: 2024-03-04 name: University of Toronto class: OTHER name: Sunnybrook Research Institute name: Ottawa Hospital Research Institute name: ICES 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. conditions: Dementia conditions: Death studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 202217 type: ACTUAL name: There is no intervention. Exposures are predictor variables of mortality. measure: Mortality sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06266312 id: Maastricht UMC+ briefTitle: Feasibility of a Preoperative, Multimodal Lifestyle Intervention in Patients With Breastcancer acronym: APRIORI overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-03-01 date: 2024-02-20 date: 2024-02-20 name: Maastricht University Medical Center class: OTHER name: Nationaal Fonds tegen Kanker 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. conditions: Breast Cancer conditions: Breast Neoplasms studyType: INTERVENTIONAL phases: NA 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 masking: NONE count: 11 type: ESTIMATED name: A multimodal prehabilitation programme measure: Recruitment rate (%) measure: Characteristics of included participants measure: Attendance rate for MIET sessions (%) measure: Adherence rate, exercise relative dose intensity (ExRDI) MIET (%) measure: Reasons for not having executed a training session as intended measure: Attendance rate HIIT + strength sessions (%) measure: Adherence rate, ExRDI HIIT training (%) measure: Adherence rate, ErXDI strength training (%) measure: Attendance rate for dietary consultations (%) measure: Percentage of use of the digital food diary 'Mijn Eetmeter'(%) measure: Percentage of days on which nutritional requirements were achieved (%) measure: Reasons for not achieving the nutritional requirements as intended measure: Drop-out rate (%) measure: Time point of drop-out measure: Reasons for drop-out measure: Serious adverse events (SAE) measure: Study related adverse events measure: Acceptance - Experiences with the multimodal lifestyle intervention measure: Acceptance - Suitability of the multimodal lifestyle intervention and study procedures measure: Acceptance - Barriers and enablers regarding participation in the study measure: Fatigue measure: Cardiorespiratory fitness measure: Muscle strength measure: Nutritional status measure: Weight (kg) measure: Height (cm) measure: Body Mass Index (BMI) measure: Energy and protein intake (absolute kcal and gr and gr/kg body weight per day) measure: Energy requirements (kcal) measure: Protein requirements measure: Circumference of upper arm and waist (cm) measure: Chemotherapy Relative Dose Intensity (RDI) measure: Treatment-related Side effects sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06266299 id: 2269-001 briefTitle: A Study of KK2269 in Adult Participants With Solid Tumors overallStatus: RECRUITING date: 2024-01-25 date: 2027-12 date: 2027-12 date: 2024-02-20 date: 2024-04-26 name: Kyowa Kirin, Inc. class: INDUSTRY 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. conditions: Advanced Solid Tumor conditions: Metastatic Solid Tumor conditions: Gastric Adenocarcinoma conditions: Gastroesophageal Junction Adenocarcinoma conditions: Esophageal Adenocarcinoma conditions: Non Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 71 type: ESTIMATED name: KK2269 name: Docetaxel measure: Number of Subjects Experiencing Dose-limiting Toxicity measure: Number of Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Center Hospital East status: RECRUITING city: Kashiwa City state: Chiba zip: 277-8577 country: Japan lat: 35.86224 lon: 139.97732 facility: National Cancer Center Hospital status: RECRUITING city: Chuo-ku state: Tokyo zip: 104-0045 country: Japan lat: 35.57779 lon: 139.71685 hasResults: False

 nctId: NCT06266286 id: 2022-A00233-40 briefTitle: EXOPULSE Mollii Suit & Cerebral Palsy acronym: EXOCEP overallStatus: RECRUITING date: 2023-09-13 date: 2025-06-30 date: 2025-10-30 date: 2024-02-20 date: 2024-02-20 name: Institut De La Colonne Vertebrale Et Des Neurosciences class: OTHER 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. conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA 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 masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 32 type: ESTIMATED name: EXOPULSE MOLLII SUIT (active) name: EXOPULSE MOLLII SUIT (sham) measure: Improvement in balance using the PBS (Pédiatric Balance Scale) before and after active and sham stimulation measure: Evaluation of the cumulative effects of EXOPULSE Mollii suit on balance using the PBS measure: Evaluation of the effects of EXOPULSE Mollii suit on spasticity using the Modified Ashworth Scale (MAS) measure: Evaluation of the effects of EXOPULSE Mollii suit on mobility using the Timed Up and Go test (TUG) measure: Quality of life will be measured using the EuroQol 5 dimensions quality of life questionnaire for youth (EQ-5D-Y) measure: Pain will be assessed using the Pain Scale Chart (PSC) measure: Evaluation of overall improvement using the Clinical Global Impression (CGI) sex: ALL minimumAge: 5 Years maximumAge: 12 Years stdAges: CHILD facility: Centre Hospitalier Intercommunal D'Aix Pertuis status: RECRUITING city: Aix-en-Provence country: France name: PASCAL GRANIER, MD role: PRINCIPAL_INVESTIGATOR name: HELENE RAUSCENT, MD role: SUB_INVESTIGATOR lat: 43.5283 lon: 5.44973 facility: Centre Medico Chirurgical de Readaptation Des Massues status: NOT_YET_RECRUITING city: Lyon country: France name: EMMANUELLE CHALEAT - VALAYER, MD role: PRINCIPAL_INVESTIGATOR name: Marie-Charlotte D'ANJOU, MD role: SUB_INVESTIGATOR lat: 45.74848 lon: 4.84669 facility: Centre de Sante Rossetti status: RECRUITING city: Nice country: France name: GAUTIER DE CHELLE, MD role: PRINCIPAL_INVESTIGATOR lat: 43.70313 lon: 7.26608 facility: Centre de Readaptation Pediatrique D'Oleron status: RECRUITING city: Saint-Trojan-les-Bains country: France name: SOLENE VIOT, MD role: PRINCIPAL_INVESTIGATOR lat: 45.84134 lon: -1.20728 hasResults: False

 nctId: NCT06266273 id: SBA 23/442 briefTitle: Investigating the Development, Validity, and Reliability of the Avoidance of Sports Activities Photo Scale overallStatus: RECRUITING date: 2024-01-01 date: 2024-06-30 date: 2024-08-30 date: 2024-02-20 date: 2024-02-20 name: Hacettepe University class: OTHER 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. conditions: Questionnaire conditions: Athletes conditions: Shoulder Pain studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 170 type: ESTIMATED name: No intervention measure: Investigating the Development, Validity, and Reliability of The Sports Activity Avoidance Photo Scale sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Elif Turgut status: RECRUITING city: Ankara zip: 06300 country: Turkey name: Elif Turgut, Assoc. Prof. role: CONTACT phone: +90 (544) 264 56 00 email: elif.turgut.pt@gmail.com name: Birgül DINGIRDAN, Master role: SUB_INVESTIGATOR name: Büşra PAKÖZ, Master role: SUB_INVESTIGATOR name: Kübra ÇAYLAN GÜRSES, Master role: SUB_INVESTIGATOR name: Pınar KUYULU HAKSAL, Master role: SUB_INVESTIGATOR lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06266260 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 overallStatus: RECRUITING date: 2023-09-11 date: 2025-04-01 date: 2026-04-01 date: 2024-02-20 date: 2024-02-20 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER 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. conditions: Portal Hypertension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: EUS PPG measurement 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) 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) measure: Markers of hemodynamic response measure: Markers of hemodynamic response measure: Markers of hemodynamic response sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Policlinico Gemelli IRCCS status: RECRUITING city: Roma zip: 00168 country: Italy name: Francesco Santopaolo, MD role: CONTACT phone: +393492754288 email: francesco.santopaolo@policlinicogemelli.it lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06266247 id: 06-2023/16 id: KMU-BAP type: OTHER domain: KMU briefTitle: How Sirtuin Levels Change During Behçet Disease overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-15 date: 2024-06-30 date: 2024-10-30 date: 2024-02-20 date: 2024-02-20 name: Karamanoğlu Mehmetbey University class: OTHER 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\&#39;s patients. Our secondary aim was to evaluate Sirtuin-1 in Behcet\&#39;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. conditions: Behçet Disease conditions: Inflammation conditions: Vasculitis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 60 type: ESTIMATED name: Take blood samples 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. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Karamanoğlu Mehmetbey University city: Karaman country: Turkey lat: 37.18111 lon: 33.215 hasResults: False

 nctId: NCT06266234 id: APHP230600 id: 10723253 Bis type: OTHER domain: CESREES briefTitle: Characterization by Automated System on Infantile Spasmes acronym: REASSESS overallStatus: RECRUITING date: 2024-02-01 date: 2026-01 date: 2026-01 date: 2024-02-20 date: 2024-03-13 name: Assistance Publique - Hôpitaux de Paris class: OTHER name: OSO-AI 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 spasms

As 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. conditions: Infantile Spasm studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 5000 type: ESTIMATED measure: Automated computer detection of the spasms > 95% measure: Automated computer detection of the non spasms > 95% sex: ALL maximumAge: 3 Years stdAges: CHILD facility: Department of paediatric neurological care and intensive care unity (PICU), Raymond Poincaré hospital - APHP status: RECRUITING city: Garches zip: 92380 country: France lat: 48.84226 lon: 2.18232 hasResults: False

 nctId: NCT06266221 id: APHP200073 id: 2022-000712-59 type: EUDRACT_NUMBER briefTitle: Severe Erythema Multiforme - CORTICO acronym: SEMCORTICO overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-06-01 date: 2027-11-01 date: 2024-02-20 date: 2024-02-20 name: Assistance Publique - Hôpitaux de Paris class: OTHER 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. conditions: Erythema Multiforme studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 96 type: ESTIMATED name: Prednisone 20 Mg name: Oral Placebo name: Methylprednisolone 120 Mg name: IV Placebo measure: Time to success measure: Evaluation of Pain measure: Food intake measure: Rescue therapy intake measure: Time to clear or almost clear healing of all sites measure: Time to fever resolution measure: Length of hospital stay measure: Number of days of consumption of level III analgesics measure: Evaluation of pain measure: Chopped or solid food intake resumption measure: Rate of patients in the two groups with need for a rescue therapy measure: Rate of sequelae measure: Rate of adverse events during the treatment and follow-up measure: Evaluation of the quality of life sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06266208 id: UCV/2021-2022/201 briefTitle: Utility of High-resolution Ultrasound to Evaluate Dorsal Osteophyte overallStatus: RECRUITING date: 2024-03-20 date: 2024-04-15 date: 2024-07-15 date: 2024-02-20 date: 2024-04-23 name: Fundación Universidad Católica de Valencia San Vicente Mártir class: OTHER 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. conditions: Exostosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: Exostectomy name: Cut fingernail measure: Nail-phalange distance measure: Nail Curvature Index measure: Thickness of the nail plate measure: Dorsal Osteophyte Height sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Enieto podologos status: RECRUITING city: Logroño state: La Rioja zip: 26003 country: Spain name: Eduardo Nieto-Garcia, Dr role: CONTACT phone: 941 25 55 66 email: clinica@enietopodologos.com name: eduardo Nieto-Garcia, Dr role: CONTACT phone: 941 25 55 66 email: eduardo.nieto@ucv.es name: Eduardo Nieto-Garcia, Dr role: SUB_INVESTIGATOR lat: 42.46667 lon: -2.45 facility: Centro podológico Valencia status: RECRUITING city: Valencia state: València zip: 46001 country: Spain name: Martín Redón role: CONTACT phone: 96 352 63 41 email: info@podologomartinredon.com name: Emma Guillem-escámez role: CONTACT phone: 96 352 63 41 email: em_chec@mail.ucv.es name: emma Guillem-Escamez role: PRINCIPAL_INVESTIGATOR lat: 39.46975 lon: -0.37739 facility: Clinicas UCV status: RECRUITING city: Valencia state: València zip: 46001 country: Spain name: Pablo Vera-Ivars, Dr. role: CONTACT phone: 963 92 06 24 email: clinicas.ucv@ucv.es name: Cristina Mico-Salcedo role: CONTACT phone: 963 92 06 24 email: clinicas.ucv@ucv.es name: Javier Ferrer-Torregrosa, Dr role: PRINCIPAL_INVESTIGATOR name: Juan Vicente-Mampel, Dr. role: PRINCIPAL_INVESTIGATOR lat: 39.46975 lon: -0.37739 facility: Clinica Pasito a pasito status: RECRUITING city: Valencia zip: 46008 country: Spain name: Javier Ferrer-Torregrosa, Dr role: CONTACT phone: 963855535 email: clinicaspasitoapasito@gmail.com name: Javier Ferrer-Torregrosa, Dr role: CONTACT phone: 644733882 email: javier.ferrer@ucv.es name: JAVIER Ferrer- TORREGROSA, Dr role: PRINCIPAL_INVESTIGATOR lat: 39.46975 lon: -0.37739 hasResults: False

 nctId: NCT06266195 id: 5452 briefTitle: Spectroscopic Profiling of Extracellular Vesicles By Resonant Gold Nanostructures in the Infrared acronym: PROVEIR_1 overallStatus: RECRUITING date: 2023-03-15 date: 2023-12-31 date: 2025-02-28 date: 2024-02-20 date: 2024-02-20 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER 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. conditions: Vesicle studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 64 type: ESTIMATED name: sierological test measure: primary endpoint sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: FPGemelliIRCCS status: RECRUITING city: Roma state: Lazio zip: 00168 country: Italy name: Fabrizio Pizzolante, MD PhD role: CONTACT phone: +390630151 email: fabrizio.pizzolante@policlinicogemelli.it name: Gabriele Ciasca, Professor role: CONTACT phone: +390630151 email: gabriele.ciasca@unicatt.it lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06266182 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 overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-12 date: 2026-04 date: 2024-02-20 date: 2024-02-22 name: University of Social Sciences and Humanities, Warsaw class: OTHER name: National Science Centre, Poland 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. conditions: Hematopoietic Cell Transplantation Recipient conditions: Acceptance and Commitment Therapy studyType: INTERVENTIONAL phases: NA 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 masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 192 type: ESTIMATED name: Acceptance and Commitment Therapy name: Education measure: Distress (Global Meaning Violation Scale; GMVS) measure: Illness perception (Brief-Illness Perception Questionnaire; B-IPQ) measure: Global meaning (Meaning in Life Questionnaire; MLQ) measure: Psychological flexibility (Comprehensive Assessment of Acceptance and Commitment Therapy Processes-9; CompACT-9) measure: Coping self-efficacy (Coping Self-Efficacy Scale; CSE - selected items) measure: Deliberate meaning-making (Core Beliefs Inventory; CBI) measure: Automatic meaning-making (Event-Related Rumination Inventory; ERRI - intrusive ruminations subscale) measure: Post-traumatic growth (the "current standing" Post-Traumatic Growth Inventory-Short Form; C-PTGI-SF ) measure: Meanings made (Meaning of Loss Codebook; MLC) measure: Anxiety and depressive symptoms (Patient Health Questionnaire-4; PHQ-4) measure: Loneliness (The Revised UCLA Loneliness Scale; R-UCLA - selected items) measure: Loneliness (the Community Life Survey) measure: Health-related quality of life (Quality of Life Questionnaire of the European Organization for Research and Treatment of Cancer; EORTC QLQ-C3) measure: Daily subjective health (Daily Subjective Health Scale) measure: Daily affect (Daily Positive and Negative Affect Scale) measure: Daily meaning-making (Event-Related Rumination Inventory-daily form; ERRI-daily form) measure: Daily meanings made (Meaning of Loss Codebook-daily form; MCL-daily form) measure: Daily psychological flexibility (Comprehensive Assessment of Acceptance and Commitment Therapy Processes-daily form; CompACT-daily form) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT 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 name: Małgorzata Sobczyk-Kruszelnicka, MD role: CONTACT phone: 011 48 322788520 email: malgorzata.sobczyk-kruszelnicka@gliwice.nio.gov.pl name: Małgorzata Sobczyk-Kruszelnicka, MD role: SUB_INVESTIGATOR lat: 50.29761 lon: 18.67658 hasResults: False

 nctId: NCT06266169 id: fpc-2023-ivf-01 briefTitle: Application of Spectral Methods to Assess Gametes, Embryos, and Human Reproductive Capabilities overallStatus: RECRUITING date: 2023-09-20 date: 2024-02-28 date: 2025-12-31 date: 2024-02-20 date: 2024-02-20 name: Family Planning Center of Women's Welfare Clinic #44 of Pushkin District class: OTHER_GOV 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. conditions: Infertility studyType: INTERVENTIONAL phases: NA 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 masking: SINGLE whoMasked: PARTICIPANT count: 1064 type: ESTIMATED name: making artificial intelligence based decisions of gamete, embryo and endometrial potential measure: Embryonic model performance measure: Gamete model performance measure: Endometrial model performance measure: Embryonic model clinical efficiency measure: Endometrial model clinical efficiency sex: ALL minimumAge: 20 Years maximumAge: 44 Years stdAges: ADULT facility: Family planning center status: RECRUITING city: Saint Petersburg state: Pushkin zip: 196608 country: Russian Federation name: Alexey Gryaznov role: CONTACT phone: +7(812)414-57-09 email: libra19831010@mail.ru lat: 59.93863 lon: 30.31413 hasResults: False

 nctId: NCT06266156 id: BMU-HTUNC-01 briefTitle: Evaluation of The Effect of Consecutive Dental Visits on Dental Anxiety of Paediatric Patients overallStatus: COMPLETED date: 2023-08-05 date: 2023-11-03 date: 2023-12-27 date: 2024-02-20 date: 2024-02-20 name: Burdur Mehmet Akif Ersoy University class: OTHER 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. conditions: Dental Anxiety studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 240 type: ACTUAL name: Score of anxiety questionnaire name: Heart rate name: Oxygen saturation measure: Determination of sample size. measure: Inviting participants to the study. measure: Determination of dental anxiety score of participants before dental treatment in first dental session measure: Heart rate measuring in first dental session. measure: Oxygen saturation measuring in first dental session. measure: Determination of dental anxiety score of participants after dental treatment in first dental session measure: Determination of dental anxiety score of participants before dental treatment in second dental session measure: Heart rate measuring in second dental session. measure: Oxygen saturation measuring in second dental session. measure: Determination of dental anxiety score of participants after dental treatment in second dental session sex: ALL minimumAge: 6 Years maximumAge: 9 Years stdAges: CHILD facility: Burdur Mehmet Akif Ersoy University Faculty of Dentistry city: Burdur state: Centrum zip: 15100 country: Turkey lat: 37.72028 lon: 30.29083 hasResults: False

 nctId: NCT06266143 id: Y101D03 briefTitle: A Trial of Y101D in Combination With Gemcitabine and Albumin Paclitaxel in Patients With Advanced Pancreatic Cancer overallStatus: ACTIVE_NOT_RECRUITING date: 2023-02-08 date: 2024-07-30 date: 2024-12-31 date: 2024-02-20 date: 2024-02-20 name: Wuhan YZY Biopharma Co., Ltd. class: INDUSTRY 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. conditions: Advanced Pancreatic Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 71 type: ACTUAL name: Y101D measure: Dose Limiting Toxicities (DLTs) measure: RP2D measure: Objective Response Rate (ORR) measure: Peak Serum Concentration (Cmax) measure: Trough Serum Concentration (Ctrough) measure: Area under the serum concentration versus time curve (AUC) during one treatment cycle (21 days) measure: The TGF-β concentration in serum measure: The CA19-9 concentration in serum measure: The positive rate of Anti-Drug Antibody (ADA) and Neutralizing antibody (Nab) measure: Disease control rate (DCR) measure: Duration of response (DOR) measure: Progression-free survival (PFS) measure: Overall survival (OS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430022 country: China lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06266130 id: EM-11-050087 briefTitle: Digital Bonding vs. Direct Bonding Study overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-08 date: 2026-08 date: 2024-02-20 date: 2024-02-20 name: 3M class: INDUSTRY 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. conditions: Orthodontic Brackets studyType: INTERVENTIONAL phases: NA 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 masking: NONE maskingDescription: Due to the nature of the devices, Investigator blinding is not feasible for the study. count: 178 type: ESTIMATED name: Treatment Group Digital Bonding Tray name: Control Group Direct Bonding measure: Prep-and-bonding time measure: Number of adjustment visits to complete treatment measure: Overall chair time sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06266117 id: SBF-HMS-GES-03 briefTitle: Pain, Anxiety, and Comfort Levels in Coronary Angiography overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2024-03-30 date: 2024-07-30 date: 2024-02-20 date: 2024-02-20 name: Abant Izzet Baysal University class: OTHER 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. conditions: Pain conditions: Anxiety conditions: Nursing Caries studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 216 type: ESTIMATED measure: Pain level measure: Anxiety measure: Comfort sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Abant Izzet Baysal University Faculty of Health Science city: Bolu state: Merkez zip: 14100 country: Turkey lat: 40.73583 lon: 31.60611 hasResults: False

 nctId: NCT06266104 id: Protocol V1.4_04012024 briefTitle: Image Enhanced Endoscopy IBD overallStatus: RECRUITING date: 2024-04-03 date: 2025-12-31 date: 2026-03-01 date: 2024-02-20 date: 2024-04-12 name: Royal Perth Hospital class: OTHER 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. conditions: Inflammatory Bowel Diseases conditions: Dysplasia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: INVESTIGATOR count: 270 type: ESTIMATED name: Image Enhanced Endoscopy Filters measure: Dysplasia Detection Rate measure: Withdrawal times measure: Characterisation of lesions sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Royal Perth Hosptial status: RECRUITING city: Perth state: Western Australia zip: 6000 country: Australia name: Sherman Picardo, MBBS role: CONTACT phone: 92242244 lat: -31.95224 lon: 115.8614 hasResults: False

 nctId: NCT06266091 id: M70102 briefTitle: Treat Malignant Ascites Caused by Gastrointestinal or Ovarian Cancer With M701 Bispecific Antibody overallStatus: ACTIVE_NOT_RECRUITING date: 2021-11-24 date: 2024-03-31 date: 2024-12-31 date: 2024-02-20 date: 2024-02-20 name: Wuhan YZY Biopharma Co., Ltd. class: INDUSTRY 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. conditions: Malignant Ascites studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: M701 name: paracentesis measure: Puncture-free survival, PuFS measure: objective response rate (ORR) of malignant ascites measure: Progression-free Survival, PFS measure: Overall survival, OS measure: Quality of Life, QoL measure: Safety profiles measure: Positive rate of ADA and Nab in serum measure: The EpCAM expression in ascites measure: Trough serum concentration (Ctrough) measure: Peak serum concentration (Cmax) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Medical Center of Chinese PLA General Hospital city: Beijing state: Beijing zip: 100141 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06266078 id: School of Nursing briefTitle: A Human Factors Simulation Study Protocol for the Assessment of Usability of Innovative Personal Protective Equipment overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-06-01 date: 2024-12-15 date: 2024-02-20 date: 2024-02-20 name: University of Campinas, Brazil class: OTHER 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. conditions: Personal Protective Equipment studyType: INTERVENTIONAL phases: NA 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 masking: NONE count: 9 type: ESTIMATED name: Innovative PPE name: Traditional PPE measure: Content Validity of the items included in the "Innovative PPE assessment tool" and in the "Simulation scenario script" measure: Errors during PPE assembly/preparation, donning and doffing measure: Communication impairments while using PPE measure: Self-contamination risk in the professional while using and doffing the PPE measure: Influence of PPE on individual performance measure: Influence of PPE on team performance and behavioral changes measure: Changes in mobility and comfort while using PPE measure: Thermal sensations measure: Perception regarding safety and satisfaction of the PPE user measure: Perceived workload measure: Usability measure: Complementary Content Analysis - qualitative data sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06266065 id: 8.1-23/260-2;02/013AG briefTitle: Impact of Coronary Sinus Flow Reducer on Coronary Microcirculation and Myocardial Ischemia overallStatus: RECRUITING date: 2024-02-27 date: 2026-06 date: 2026-06 date: 2024-02-20 date: 2024-03-06 name: Clinical Hospital Centre Zagreb class: OTHER 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. conditions: Coronary Artery Disease conditions: Angina Pectoris studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single-Center Prospective Study primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Coronary Sinus Reducer measure: Impact of Coronary Sinus Reducer on Coronary Microcirculation measure: Myocardial Ischemia assessment measure: Angina assessment measure: Functional capacity assessment sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Centre Zagreb status: RECRUITING city: Zagreb zip: 10000 country: Croatia name: Josko Bulum, MD, PhD role: CONTACT phone: +385981714090 email: jbulum@gmail.com name: Luka Percin, MD role: CONTACT phone: +385917917252 email: luka.percin555@gmail.com lat: 45.81444 lon: 15.97798 hasResults: False

 nctId: NCT06266052 id: 2019/04 briefTitle: Evaluation of the Effects of Four Different Flap Designs on Tissue Healing in Lower Third Molar Surgery overallStatus: ENROLLING_BY_INVITATION date: 2024-01-20 date: 2024-03-20 date: 2024-04-20 date: 2024-02-20 date: 2024-02-20 name: Recep Tayyip Erdogan University class: OTHER 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. conditions: Soft Tissue Injuries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Triangular Flap name: Berwick Flap name: Saurez Flap name: Heitz Flap measure: Eudema Amount measure: Pain Level measure: Trismus Level measure: Halitosis Amount measure: bone healing condition sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: RTEU Faculty of Dentistry city: Rize country: Turkey lat: 41.02083 lon: 40.52194 hasResults: False

 nctId: NCT06266039 id: 2022-0328-01 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 overallStatus: RECRUITING date: 2023-03-31 date: 2024-09-30 date: 2024-09-30 date: 2024-02-20 date: 2024-02-20 name: University of Bordeaux class: OTHER 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 comorbidities

Main 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. conditions: Addiction Opiate studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 223 type: ESTIMATED measure: The change in the composite score of the "Drug use" section from the Addiction Severity Index (ASI) at 6 months after treatment initiation measure: The change in addiction severity at 6 months after treatment initiation measure: The change in quality of life with EuroQoL-5 Dimensions-5 Levels (EQ-5DL-5L) at 6 months after treatment initiation measure: The change in quality of life with the 12-Item Short Form Survey (SF-12) at 6 months after treatment initiation 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 measure: The change in quality of life with assisted quality of life assessment chart (TEAQV) at 6 months after treatment initiation measure: The change in other use at 6 months after treatment initiation measure: The change in craving at 6 months after treatment initiation measure: The change in other domains of addiction severity at 6 months after treatment initiation measure: The change in Treatment Satisfaction Questionnaire for Medication (TSQM) at 6 months after treatment initiation measure: Cues - craving - use links and others factors variations measure with EMA after treatment initiation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Bordeaux status: RECRUITING city: Bordeaux state: Gironde zip: 33000 country: France name: Marc Auriacombe, Professor role: CONTACT phone: +33556561738 email: marc.auriacombe@u-bordeaux.fr lat: 44.84044 lon: -0.5805 hasResults: False

 nctId: NCT06266026 id: ThermoBreast briefTitle: ThermoBreast - Non-contact Breast Cancer Imaging Using AI-enhanced Thermography. acronym: ThermoBreast overallStatus: RECRUITING date: 2023-12-11 date: 2028-12 date: 2029-12 date: 2024-02-20 date: 2024-02-20 name: ThermoMind Ltd. class: INDUSTRY name: Assuta Medical Centers Ltd. name: Hospital of Lithuanian University of Health Sciences Kaunas Clinics name: Institut Gustav Roussy name: M.D. Anderson Cancer Center name: Sheba Medical Center name: The Holy Family Hospital Nazareth name: University College Cork name: Univerzitetni klinicni center Maribor name: Academisch Ziekenhuis Groningen name: Technical University of Munich name: Technion, Israel Institute of Technology name: Vrije Universiteit Brussel name: Cancer Patients Europe name: University Hospital Heidelberg 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. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 28000 type: ESTIMATED name: ThermoBreast - AI-based evaluation of dynamic breast thermography imaging measure: Sensitivity (true-positive rate) measure: Specificity (true-negative rate) measure: Cancer detection rate measure: Detection rate of ductal carcinoma in situ (DCIS) measure: Detection rate of tumor category pT1 measure: Recall rate measure: Sensitivity measure: Specificity measure: Positive-predictive value measure: Negative-predictive value measure: Diagnostic performance in the three trial cohorts measure: Proportion of breast quadrant localization measure: Proportion of correct histopathologic subtype identification measure: Proportion of correct tumorbiologic subtype identification measure: Proportion of correct axillary lymph node involvement identification measure: Effect of hormonal status on diagnostic performance measure: Effect of breast density on diagnostic performance measure: Effect of ethnicity on diagnostic performance measure: Timing of ThermoBreast measure: Screening time measure: Cost-effectiveness measure: Lived Experience sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Heidelberg University Hospital status: RECRUITING city: Heidelberg country: Germany name: André Pfob, MD role: CONTACT lat: 49.40768 lon: 8.69079 hasResults: False

 nctId: NCT06266013 id: 009 briefTitle: Influence of an Inspiratory Muscle Fatigue Protocol on Older Adults on Respiratory Muscle Strength, Muscle Oxygen Saturation, and Functional Capacity overallStatus: NOT_YET_RECRUITING date: 2024-02-14 date: 2024-02-19 date: 2024-03-10 date: 2024-02-20 date: 2024-02-20 name: Sierra Varona SL class: OTHER name: Universidad Europea de Madrid 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. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT 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 count: 18 type: ESTIMATED name: inspiratory muscle training measure: Muscle oxygen saturation (SmO2) measure: Functional mobility measure: Respiratory muscle strength measure: Diaphragmatic thickness and thickening fraction measure: Functional capacity measure: Diaphragm movement curve sex: ALL minimumAge: 60 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06266000 id: PROPAL briefTitle: Comparison of 2 Extracts of Saw Palmetto Versus Placebo on BPH Symptoms overallStatus: RECRUITING date: 2024-03-01 date: 2025-01-01 date: 2025-03-01 date: 2024-02-20 date: 2024-04-04 name: RDC Clinical Pty Ltd class: INDUSTRY 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. conditions: Benign Prostatic Hyperplasia studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 120 type: ESTIMATED name: Saw palmetto extract 320mg per day name: Commercial Saw palmetto extract 320mg per day name: Palm Oil capsule measure: International Prostate Symptom Score (IPSS) measure: Daily Urinary Frequency Diary measure: Brief Sexual Function Inventory (BSFI) measure: International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms Module (ICIQ-MLUTS) measure: Electrolytes (E/LFT) blood test measure: Liver Function (E/LFT) blood test measure: Inflammatory marker - JM27 measure: Blood pressure measure: Pulse rate measure: Adverse event frequency measure: Adverse event severity measure: Discontinuation due to adverse events sex: MALE minimumAge: 45 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RDC Clinical Pty Ltd status: RECRUITING city: Brisbane state: Queensland zip: 4006 country: Australia name: Amanda Rao, PhD role: CONTACT phone: +61 414 488 559 email: amanda@rdcglobal.com.au name: David Briskey, PhD role: CONTACT phone: +61 421 784 077 email: david@rdcglobal.com.au lat: -27.46794 lon: 153.02809 hasResults: False

 nctId: NCT06265987 id: ECHOQUALITY2 briefTitle: Maternal and Fetal Characteristics Influencing Image Quality in Prenatal Ultrasonography overallStatus: COMPLETED date: 2023-08-01 date: 2024-01-01 date: 2024-01-31 date: 2024-02-20 date: 2024-02-20 name: Poitiers University Hospital class: OTHER 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? conditions: Ultrasonography conditions: Obstetrics conditions: Fetus conditions: Pregnant Women studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 198 type: ACTUAL measure: Maternal and fetal characteristics can influence quality image in ultrasonography sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital La MILETRIE city: Poitiers zip: 86000 country: France lat: 46.58333 lon: 0.33333 hasResults: False

 nctId: NCT06265974 id: ECHOQUALITY briefTitle: Evaluation of Image Quality in Obstetrical Ultrasonography: Comparison Between Subjective Assessment and Contrast-to-noise Ratio overallStatus: COMPLETED date: 2023-08-01 date: 2024-01-01 date: 2024-01-31 date: 2024-02-20 date: 2024-02-20 name: Poitiers University Hospital class: OTHER 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 conditions: Ultrasonography conditions: Obstetrics studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 198 type: ACTUAL measure: The comparability between a subjective and objective assessment of the contrast to noise ratio of an obstetric ultrasound image sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital La MILETRIE city: Poitiers zip: 86000 country: France lat: 46.58333 lon: 0.33333 hasResults: False

 nctId: NCT06265961 id: 02.01.2024_39 briefTitle: Efficiency of the Bibliotherapy Method in Developing Cultural Intelligence and Competencies of Nurses overallStatus: ENROLLING_BY_INVITATION date: 2024-03-01 date: 2024-05-01 date: 2024-05-31 date: 2024-02-20 date: 2024-02-20 name: Eskisehir Osmangazi University class: OTHER 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 phase

1. 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. conditions: Cultural Competency studyType: INTERVENTIONAL phases: NA 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 masking: NONE count: 30 type: ESTIMATED name: Education name: Bibliotherapy measure: Cultural intelligence measure: Cultural competence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Eskisehir Osmangazi University city: Eskisehir state: Odunpazarı zip: 26040 country: Turkey lat: 39.77667 lon: 30.52056 hasResults: False

 nctId: NCT06265948 id: comparsion drugs in cancer briefTitle: Comparsion Between Intravenous Infusion of Ketofol and Inhalational Anasthetics in Abdominal Cancer Surgeries for Post Operative Analgesia overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-05 date: 2024-02-20 date: 2024-02-20 name: Assiut University class: OTHER briefSummary: ( post operative pain between intravenous infusion ketofol and standard inhalational general anesthesia in abdominal cancer surgeries ) conditions: Abdominal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED measure: post operative pain sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06265935 id: Ataturk Unıversıty - Neslihan briefTitle: Effect of Diaphragmatic Breathing Exercise on Fatigue and Quality of Life in Pregnant Women With Gestational Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-08-15 date: 2024-10-15 date: 2024-02-20 date: 2024-02-29 name: Ataturk University class: OTHER 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. conditions: Gestational Diabetes Mellitus in Pregnancy conditions: Pregnancy in Diabetic conditions: Fatigue conditions: Quality of Life studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomize primaryPurpose: SUPPORTIVE_CARE 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 count: 2 type: ESTIMATED name: Experimental Group measure: SF-36 Quality of Life Scale: measure: Visual Similarity Scale for Fatigue sex: FEMALE minimumAge: 19 Years maximumAge: 35 Years stdAges: ADULT hasResults: False

 nctId: NCT06265922 id: P.T.REC/012/003937 briefTitle: Cerebellar rTMS in Patients With Multiple Sclerosis overallStatus: NOT_YET_RECRUITING date: 2024-02-18 date: 2024-04-18 date: 2024-06-02 date: 2024-02-20 date: 2024-02-20 name: Cairo University class: OTHER briefSummary: To determine the efficacy of high frequency cerebellar repetitive transcranial magnetic stimulation on coordination in patients with multiple sclerosis. conditions: Patients With Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT 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 count: 40 type: ESTIMATED name: High frequency repetitive transcranial magnetic stimulation name: Sham repetitive transcranial magnetic stimulation measure: Biodex balance system measure: Berg balance scale measure: Nine-Hole Peg Test (9-HPT) measure: Four square step test (FSST) sex: ALL minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06265909 id: PRW001 briefTitle: Prospective Real World Study on Therapy Prediction Algorithm Training overallStatus: COMPLETED date: 2015-03-01 date: 2022-12-31 date: 2022-12-31 date: 2024-02-20 date: 2024-02-20 name: Mobio Interactive PTE LTD class: INDUSTRY 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. conditions: Stress conditions: Emotional Wellbeing studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 67 type: ACTUAL name: AmDTx measure: Objective Stress Level (OSL) measure: Self-Reported Stress (SRS) measure: Self-Reported Mood (SRM) sex: ALL minimumAge: 18 Years maximumAge: 66 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mobio Interactive Pte Ltd city: Singapore zip: 389637 country: Singapore lat: 1.28967 lon: 103.85007 hasResults: False

 nctId: NCT06265896 id: P.T.REC/012/004948 briefTitle: Effect of Kinesiotaping on Activation of Abdominal Muscles in Female Patients With Stress Urinary Incontinence overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-05-01 date: 2024-06-01 date: 2024-02-20 date: 2024-02-20 name: Cairo University class: OTHER 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. conditions: Stress Urinary Incontinence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Kinesio taping name: Pelvic floor exercise training measure: Pelvic floor impact questionnaire- short form 7 (PFIQ-7) measure: King's Health Questionnaire (KHQ) measure: Assessment of pelvic floor muscle strength sex: FEMALE minimumAge: 30 Years maximumAge: 50 Years stdAges: ADULT facility: Cairo University city: Giza country: Egypt name: Mai N. Mamdouh, M.Sc. Student role: CONTACT phone: 01014924808 email: G01014924808@gmail.com name: Dalia M. Kamel, Prof. role: CONTACT phone: 01273990045 email: dr-daliakamel@cu.edu.eg name: Ahmed S. Ebrahim, Prof. role: PRINCIPAL_INVESTIGATOR lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06265883 id: MIIR-16-Retro briefTitle: Lenvatinib Plus DEB-TACE With/Without FOLFOX-HAIC for Large HCC With PVTT overallStatus: COMPLETED date: 2019-07-01 date: 2022-12-31 date: 2022-12-31 date: 2024-02-20 date: 2024-02-20 name: Second Affiliated Hospital of Guangzhou Medical University class: OTHER name: Zhongshan People's Hospital, Guangdong, China name: Affiliate Hospital of Guangdong Medical University name: Jieyang People's Hospital name: Huizhou Municipal Central Hospital name: Guangzhou Development District Hospital name: Shenzhen Traditional Chinese Medicine Hospital name: First People's Hospital of Foshan 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. conditions: Hepatocellular Carcinoma Non-resectable studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 205 type: ACTUAL name: Len+DEB-TACE+HAIC name: Len+DEB-TACE measure: Time to progression (TTP) measure: objective response rate (ORR) measure: Disease control rate (DCR) measure: overall survival measure: treatment-related adverse events (TRAEs) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Guangzhou Medical University city: Guangzhou state: Guangdong zip: 510260 country: China lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06265870 id: Parasite in Eosinophilia briefTitle: Specific Versus Empirical Anthelminthic Treatment in Eosinophilia acronym: Eosinophilia overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2025-12-31 date: 2025-12-31 date: 2024-02-20 date: 2024-04-03 name: Prince of Songkla University class: OTHER 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. conditions: Eosinophilia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 700 type: ESTIMATED name: Albendazole name: Ivermectin or albendazole measure: Eosinophilia recovery sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06265857 id: IOE-naoxiaoxueguan briefTitle: Effect of Multifunctional Nutrition Tube on Cerebral Small Vessel Disease Patients overallStatus: RECRUITING date: 2024-02-28 date: 2024-06 date: 2024-06 date: 2024-02-20 date: 2024-03-06 name: Zeng Changhao class: OTHER 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. conditions: Cerebral Small Vessel Diseases conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 88 type: ESTIMATED name: Intermittent Oro-esophageal Tube Feeding name: Nasogastric Tube Feeding name: comprehensive rehabilitation therapy measure: Video Fluoroscopic Swallowing Study measure: Functional Oral Intake Scale measure: Body mass index measure: Serum albumin measure: Hemoglobin measure: Pneumonia measure: Activities of daily living measure: World Health Organization Quality of Life Assessment Instrument Brief Version sex: ALL minimumAge: 40 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Thai Rehabilitation Community Center status: RECRUITING city: Ban Phon Ko country: Thailand name: Cop Kun role: CONTACT hasResults: False

 nctId: NCT06265844 id: IOE-Biyanai briefTitle: Multifunctional Nutrition Tube in Dysphagia for Nasopharyngeal Carcinoma overallStatus: RECRUITING date: 2024-03-01 date: 2024-09-30 date: 2024-09-30 date: 2024-02-20 date: 2024-03-06 name: Zeng Changhao class: OTHER 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. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Intermittent Oral-esophageal Tube Feeding name: Nasogastric Tube Feeding name: comprehensive rehabilitation therapy measure: Hemoglobin measure: Serum albumin measure: Body Mass Index measure: Serum prealbumin measure: Depression measure: Functional Oral Intake Scale measure: Penetration-Aspiration Scale measure: Swallowing-Quality of Life questionnaire measure: Feeding amount sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Saint Martin Hospital status: RECRUITING city: Hong Kong country: Hong Kong name: Xi Maheen, Master role: CONTACT lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06265831 id: BU-FHS-NC-03 briefTitle: The Effect of Face Hand Fan Application on Dyspnea acronym: HandfanCOPD overallStatus: ACTIVE_NOT_RECRUITING date: 2023-04-01 date: 2023-11-30 date: 2024-03 date: 2024-02-20 date: 2024-02-20 name: Bartın Unıversity class: OTHER name: The Scientific and Technological Research Council of Turkey 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. conditions: COPD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel group: two groups, an intervention group and a control group, receiving complementary therapy. primaryPurpose: SUPPORTIVE_CARE 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 count: 61 type: ACTUAL name: Hand-fan application to the face measure: Modified Borg Scale measure: Saint George Respiratory Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Necmiye ÇÖMLEKÇİ city: Bartın zip: 74100 country: Turkey lat: 41.63583 lon: 32.3375 hasResults: False

 nctId: NCT06265818 id: 2024-KY-0126 briefTitle: The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder acronym: ABE-S overallStatus: RECRUITING date: 2024-03-01 date: 2024-05 date: 2024-05 date: 2024-02-20 date: 2024-03-06 name: Zeng Changhao class: OTHER 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. conditions: Respiratory Rhythm Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Rehabilitation training name: Active Breathing Exercises measure: The Penetration-Aspiration Scale measure: The Functional Oral Intake Scale measure: Yale Pharyngeal Residue Severity Rating Scale measure: Fiberoptic Endoscopic Dysphagia Severity Scale measure: Murray Secretion Scale measure: Swallowing Quality of Life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center Rehabilitation Hospital status: RECRUITING city: Seoul country: Korea, Republic of name: Wei Liu, Master role: CONTACT lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06265805 id: 2024-KY-0125-015 briefTitle: Effect of Different Feeding Modes on Psychological Condition and Experience in Stroke Patients acronym: IOE-Xinli overallStatus: RECRUITING date: 2024-02-28 date: 2024-12-30 date: 2024-12-30 date: 2024-02-20 date: 2024-03-06 name: Zeng Changhao class: OTHER 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. conditions: Ischemic Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: comprehensive rehabilitation therapy name: Intermittent Oro-esophageal Tube Feeding name: Nasogastric Tube Feeding measure: Generalized Anxiety Disorder 7 measure: Patient Health Questionnaire-9 measure: Self-made questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hsinchu Rehabilitation Hospital status: RECRUITING city: Xinzhu country: Taiwan name: Haim Liu, Master role: CONTACT lat: 22.46205 lon: 120.47335 hasResults: False

 nctId: NCT06265792 id: 2024-KY-0125 briefTitle: Efficacy of Stellate Ganglion Block in Obstructive Sleep Apnea acronym: OSA overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-01 date: 2024-12-15 date: 2024-02-20 date: 2024-03-06 name: Zeng Changhao class: OTHER 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. conditions: Obstructive Sleep Apnea studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: routine rehabilitation treatment name: Stellate ganglion block measure: Epworth Sleepiness Scale measure: Apnea-Hypopnea Index sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center Rehabilitation Hospital city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06265779 id: 2024-KY-0122 briefTitle: Transcranial Direct Current Stimulation Combined With Intermittent Oral to Esophageal Tube on Dysphagia acronym: IOE+JLCJ-S overallStatus: RECRUITING date: 2024-02-29 date: 2024-11-30 date: 2024-12-15 date: 2024-02-20 date: 2024-03-06 name: Zeng Changhao class: OTHER 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. conditions: Cerebral Infarction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 84 type: ESTIMATED name: Comprehensive rehabilitation therapy name: Intermittent Oro-esophageal Tube Feeding name: Transcranial direct current stimulation measure: Penetration Aspiration Scale measure: Functional Oral Intake Scale measure: Swallowing Quality of Life Questionnaire measure: Patient Health Questionnaire-9 measure: Body weight measure: Nutritional status-total protein measure: Nutritional status-albumin sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center Rehabilitation Hospital status: RECRUITING city: Seoul country: Korea, Republic of name: Wei Liu, Master role: CONTACT lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06265766 id: NL85511.041.24 id: 85511 type: OTHER domain: ABR number briefTitle: Brain STimulation for Arm Recovery After Stroke 2 acronym: B-STARS2 overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2029-03-31 date: 2029-12-31 date: 2024-02-20 date: 2024-02-20 name: Jord Vink class: OTHER 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 conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Sham cTBS treatment is delivered with a sham TMS-coil. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 454 type: ESTIMATED name: cTBS measure: Upper extremity section of the Fugl-Meyer Assessment measure: Upper extremity section of the Fugl-Meyer Assessment measure: Action Research Arm Test measure: modified Rankin Scale measure: Hand section of Stroke Impact Scale measure: Participation section of Stroke Impact Scale measure: EuroQol-5D measure: Nine Hole Peg Test measure: Ipsilesional corticospinal excitability measure: iMTA medical consumption and productivity cost questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Reade city: Amsterdam country: Netherlands name: Marijn Mulder-Kampen role: CONTACT lat: 52.37403 lon: 4.88969 facility: Revalidatie Friesland city: Beetsterzwaag country: Netherlands name: Wietske Rienstra role: CONTACT lat: 53.05914 lon: 6.07711 facility: Revant city: Breda country: Netherlands name: Marissa Riemens role: CONTACT lat: 51.58656 lon: 4.77596 facility: Tolbrug city: Den Bosch country: Netherlands name: Cynthia Klinkers role: CONTACT lat: 51.27 lon: 5.59167 facility: Basalt city: Den Haag country: Netherlands name: Kangdi Zhu role: CONTACT lat: 52.07667 lon: 4.29861 facility: MRC Aardenburg city: Doorn country: Netherlands name: Lisa Kruisheer role: CONTACT lat: 52.03343 lon: 5.34571 facility: Libra Blixembosch city: Eindhoven country: Netherlands name: Daphne Stranders role: CONTACT lat: 51.44083 lon: 5.47778 facility: University Medical Center Groningen city: Groesbeek country: Netherlands name: Henk Meulenbelt role: CONTACT lat: 51.77667 lon: 5.93611 facility: Merem city: Hilversum country: Netherlands name: Maijke van Bloemendaal role: CONTACT name: Karin Peek role: CONTACT lat: 52.22333 lon: 5.17639 facility: Adelante city: Hoensbroek country: Netherlands lat: 50.92387 lon: 5.92528 facility: Basalt city: Leiden country: Netherlands name: Annelies Mantje role: CONTACT lat: 52.15833 lon: 4.49306 facility: Sint Maartenskliniek city: Nijmegen country: Netherlands name: Nelleke Kooiman role: CONTACT lat: 51.8425 lon: 5.85278 facility: Libra Leijpark city: Tilburg country: Netherlands name: Iris Habets role: CONTACT lat: 51.55551 lon: 5.0913 facility: De Hoogstraat city: Utrecht country: Netherlands name: Mirjam Kouwenhoven role: CONTACT lat: 52.09083 lon: 5.12222 facility: Heliomare city: Wijk Aan Zee country: Netherlands name: Deborah Wit role: CONTACT lat: 52.4936 lon: 4.59409 facility: Vogellanden city: Zwolle country: Netherlands name: Bente Visser role: CONTACT lat: 52.5125 lon: 6.09444 hasResults: False

 nctId: NCT06265753 id: Gastrocimemius spasticity id: E-60116787-020-474196 type: REGISTRY domain: Pamukkale University Ethics Comitee briefTitle: Gastrocinemius Function Massage on Lower Extemity Spasticity acronym: Spasticity overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-23 date: 2024-06-01 date: 2024-09-01 date: 2024-02-20 date: 2024-02-20 name: Pamukkale University class: OTHER briefSummary: This study aimed to investigate gastrocinemius function massage on physical parameters of stroke patients. conditions: Stroke conditions: Stroke Ischemic studyType: INTERVENTIONAL phases: NA 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 masking: SINGLE whoMasked: PARTICIPANT count: 28 type: ESTIMATED name: Gastrocinemius Function Massage name: Sham application measure: Spasticity measure: Gait parameters and fall risk sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Address city: Denizli state: Muş Alparslan University zip: 20100 country: Turkey lat: 37.77417 lon: 29.0875 hasResults: False

 nctId: NCT06265740 id: RBHP 2023 GALLOT (PREMABIOTE) id: 2023-A02466-39 type: OTHER domain: 2023-A02466-39 briefTitle: Early Diagnosis of Premature Births by Analysis of the Vaginal Microbiota acronym: PREMABIOTE overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-11 date: 2025-11 date: 2024-02-20 date: 2024-02-20 name: University Hospital, Clermont-Ferrand class: OTHER 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). conditions: Premature Birth conditions: Vaginal Flora studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 150 type: ESTIMATED name: vaginal swab measure: Early diagnosis of preterm birth using vaginal microbiota analysis sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Clermont-Ferrand city: Clermont-Ferrand country: France name: Lise Laclautre role: CONTACT name: Denis Gallot role: PRINCIPAL_INVESTIGATOR lat: 45.77966 lon: 3.08628 hasResults: False

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

 nctId: NCT06265714 id: LB.02.01/VII/005/KEP005/2022 briefTitle: The IndONEsia ICCU Registry: a Multicenter Cohort of Intensive Cardiovascular Care Units Patients in Indonesia overallStatus: COMPLETED date: 2021-07-23 date: 2023-09-06 date: 2023-09-23 date: 2024-02-20 date: 2024-02-20 name: Indonesia University class: OTHER 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. 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 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 12950 type: ACTUAL measure: Alive measure: Death measure: Readmitted to ICCU measure: Rehospitalization sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prof. dr. I.G.N.G. Ngoerah General Hospital city: Denpasar state: Bali country: Indonesia lat: -8.65 lon: 115.21667 facility: Dr. Kariadi General Hospital city: Semarang state: Central Java country: Indonesia lat: -6.99306 lon: 110.42083 facility: Dr. Saiful Anwar General Hospital city: Malang state: East Java country: Indonesia lat: -7.9797 lon: 112.6304 facility: Dr. Iskak General Hospital city: Tulung Agung state: East Java country: Indonesia lat: -5.3578 lon: 105.04623 facility: Prof. Dr. R. D. Kandou Manado General Hospital city: Manado state: North Sulawesi country: Indonesia lat: 1.48218 lon: 124.84892 facility: Dr. Wahidin Sudirohusodo General Hospital city: Makassar state: South Sulawesi country: Indonesia lat: -5.14861 lon: 119.43194 facility: Dr. M. Djamil Padang General Hospital city: Padang state: West Sumatra country: Indonesia lat: -0.94924 lon: 100.35427 facility: National Cardiovacular Center Harapan Kita city: Jakarta country: Indonesia lat: -6.21462 lon: 106.84513 facility: Sardjito General Hospital city: Yogyakarta country: Indonesia lat: -7.80139 lon: 110.36472 hasResults: False

 nctId: NCT06265701 id: IRB0148200 briefTitle: Does a Novel Intervention Targeting Derailment Decrease Depressive Symptoms? overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-15 date: 2024-03-12 date: 2024-03-12 date: 2024-02-20 date: 2024-03-13 name: Cornell University class: OTHER 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. conditions: Depression conditions: Depressive Symptoms conditions: Derailment conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT 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 count: 116 type: ACTUAL name: Derailment-Focused Reflective Journaling name: Everyday Tasks Reflective Journaling measure: Change from Pre-Assessment in Depressive Symptoms on the Beck Depression Inventory II (BDI-II) at Week 2 (Session 6/Post-Assessment) measure: Change from Pre-Assessment in Levels of Derailment on the Derailment Scale at Session 5 measure: Change from Pre-Assessment in Anxiety Symptoms on the Generalized Anxiety Disorder - 7 (GAD-7) at Week 2 (Session 6/Post-Assessment) 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) measure: Change from Pre-Assessment in Levels of Perceived Stress on the Perceived Stress Scale (PSS) at Week 2 (Session 6/Post-Assessment) 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 sex: ALL minimumAge: 18 Years maximumAge: 29 Years stdAges: ADULT facility: Cornell University city: Ithaca state: New York zip: 14850 country: United States lat: 42.44063 lon: -76.49661 hasResults: False

 nctId: NCT06265688 id: CTMX-2051-101 briefTitle: First In Human Study of CX-2051 in Advanced Solid Tumors overallStatus: RECRUITING date: 2024-04-02 date: 2027-11-30 date: 2029-03-31 date: 2024-02-20 date: 2024-04-18 name: CytomX Therapeutics class: INDUSTRY 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. conditions: Solid Tumor, Adult studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 124 type: ESTIMATED name: CX-2051 measure: Safety and tolerability of CX-2051 measure: Determine the recommended Phase 2 dose (RP2D) measure: Objective response rate (ORR) measure: Duration of response (DOR) measure: Progression-free survival (PFS) measure: Disease control rate (DCR) measure: Duration of disease control (DODC) measure: Overall survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dana-Farber Cancer Institute status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02215 country: United States lat: 42.35843 lon: -71.05977 facility: Carolina BioOncology Institute, PLLC status: RECRUITING city: Huntersville state: North Carolina zip: 28078 country: United States lat: 35.41069 lon: -80.84285 facility: Sarah Cannon Research Institute, LLC status: RECRUITING city: Nashville state: Tennessee zip: 37203 country: United States lat: 36.16589 lon: -86.78444 hasResults: False

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

 nctId: NCT06265662 id: 66701100301 briefTitle: A Digital Health Program for Non-Communicable Disease Prevention in a Workplace Setting in Thailand overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-09 date: 2025-09 date: 2024-02-20 date: 2024-02-20 name: Chulalongkorn University class: OTHER 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. conditions: Chronic Disease conditions: Noncommunicable Diseases studyType: INTERVENTIONAL phases: NA 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 masking: NONE count: 150 type: ESTIMATED name: A Digital Health Program for Non-Communicable Disease Prevention in a Workplace Setting in Thailand measure: Weight measure: BMI measure: Total cholesterol measure: Triglycerides measure: HDL measure: LDL measure: HbA1c measure: Fasting plasma glucose measure: blood pressure measure: Feasibility (number of consented participants to all eligible participants ratio) measure: Acceptability sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06265649 id: NOM-ALCD briefTitle: Comparison of NOM for ACLD Between Medical and Surgical Ward overallStatus: RECRUITING date: 2024-01-01 date: 2024-03 date: 2024-03 date: 2024-02-20 date: 2024-02-20 name: Ospedali Riuniti Trieste class: OTHER 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. conditions: Diverticulitis conditions: Colon Disease conditions: Acute Diverticulitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 175 type: ESTIMATED name: NOM measure: Hospitalization length measure: Follow-up and recurrences sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Manuela Mastronardi status: RECRUITING city: Trieste state: TS zip: 34149 country: Italy name: Manuela Mastronardi, MD role: CONTACT phone: 0403994152 phoneExt: 0039 email: manuela.mastronardi@gmail.com name: Alan Biloslavo, MD role: PRINCIPAL_INVESTIGATOR name: Margherita Sandano, MD role: SUB_INVESTIGATOR name: Paola Germani, MD role: SUB_INVESTIGATOR name: Stefano Fracon, MD role: SUB_INVESTIGATOR name: Davide Cosola, MD role: SUB_INVESTIGATOR name: Selene Bogoni, MD role: SUB_INVESTIGATOR name: Nicolò de Manzini, MD role: PRINCIPAL_INVESTIGATOR name: Marina Troian, MD role: SUB_INVESTIGATOR name: Nicola Artusi, MD role: SUB_INVESTIGATOR lat: 45.64953 lon: 13.77679 hasResults: False

 nctId: NCT06265636 id: 2006202325523 briefTitle: Electrical Stimulation of the Mandibular Nerve for Pain and Function Management in Temporomandibular Disorders acronym: Origenkine overallStatus: NOT_YET_RECRUITING date: 2024-02-17 date: 2024-12-20 date: 2026-05-15 date: 2024-02-20 date: 2024-02-20 name: OrigenKinesis fisioterapia class: OTHER name: Universidad Rey Juan Carlos 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. conditions: Temporomandibular Disorder studyType: INTERVENTIONAL phases: NA 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 masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Percutaneous nerve stimulation name: Manual therapy name: exercise measure: pain intensity measure: Pressure pain thresholds (PPT) measure: Pain-free mandibular opening range of motion measure: Self-reported quality of life (SF-12) measure: Electromyographic activation rate of the masseter muscle. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT 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 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

 nctId: NCT06265623 id: UKE-IKPT 2024/01 briefTitle: Intermittent Hypoxemia, Lung Function Decline, Morbidity, and Mortality in COPD (PROSA Study). acronym: PROSA overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2028-09-30 date: 2029-09-30 date: 2024-02-20 date: 2024-02-20 name: Universitätsklinikum Hamburg-Eppendorf class: OTHER 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. conditions: Chronic Obstructive Pulmonary Disease (COPD) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 148 type: ESTIMATED name: No active intervention, but observational follow-up measure: Difference in FEV1(% of LLN) between baseline and end-of-follow-up measure: Difference in all-cause mortality during follow-up between groups measure: Difference in COPD-related mortality during follow-up between groups measure: Difference in frequency of hospital admissions for exacerbation of COPD during follow-up between groups measure: Difference in frequency of hospital admissions for causes other than exacerbation of COPD during follow-up between groups measure: Sensitivity of plasma biomarkers (spec. ADMA and SDMA) to predict the prevalence of exertional desaturation in COPD patients 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 measure: Sensitivity and specificity of plasma biomarkers at baseline to prospectively predict the mortality rate in COPD patients 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 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 sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Medical Center Hamburg-Eppendorf, Institute of Clinical Pharmacology and Toxicology city: Hamburg zip: 20246 country: Germany name: Rainer Böger, MD role: CONTACT email: boeger@uke.de name: Juliane Hannemann, PhD role: CONTACT email: j.hannemann@uke.de lat: 53.57532 lon: 10.01534 hasResults: False

 nctId: NCT06265610 id: 2022/186 briefTitle: A Comparison Of The Effect Of Target-Controlled Infusion Anesthesia And Inhalation Anesthesia overallStatus: COMPLETED date: 2022-03-01 date: 2023-09-01 date: 2023-10-01 date: 2024-02-20 date: 2024-02-20 name: TC Erciyes University class: OTHER 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. conditions: Pediatric Patients conditions: Cardiology studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 70 type: ACTUAL name: TIVA/TCI measure: intraoperative period measure: postoperative period measure: hemodynamic parameters measure: Modified Aldrete Recovery Score sex: ALL minimumAge: 3 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Sibel Seçkin Pehlivan city: Kayseri state: Talas zip: 38039 country: Turkey lat: 38.73222 lon: 35.48528 hasResults: False

 nctId: NCT06265597 id: EU-SBE-DŞ-01 briefTitle: The Effect of Healthy Nutrition and Yoga Program on Obese Children overallStatus: ENROLLING_BY_INVITATION date: 2022-09-14 date: 2024-08-02 date: 2024-12-02 date: 2024-02-20 date: 2024-02-20 name: TC Erciyes University class: OTHER 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. conditions: Obesity, Childhood studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: There is a control and intervention group. primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Healthy Nutrition and Yoga Program measure: Anthropometric Measurements and Child Follow-up Form measure: Family Nutrition and Physical Activity Scale measure: Adolescent Identification Form sex: ALL minimumAge: 10 Years maximumAge: 14 Years stdAges: CHILD facility: Karaman Provincial Directorate of National Education city: Karaman zip: 70200 country: Turkey lat: 37.18111 lon: 33.215 hasResults: False

 nctId: NCT06265584 id: IRB-300011730 (UAB2370) briefTitle: Trial of 2 Step ATG for Prevention of Acute GVHD Post Allogeneic Stem Cell Transplant overallStatus: NOT_YET_RECRUITING date: 2024-06-28 date: 2028-02 date: 2028-05 date: 2024-02-20 date: 2024-04-03 name: University of Alabama at Birmingham class: OTHER 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. conditions: Acute Leukemia conditions: Myelodysplastic Syndrome conditions: Myeloproliferative Disorders studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 56 type: ESTIMATED name: ATG dosing platform when combined with standard tacrolimus and mini methotrexate measure: Rate of GRFS (graft versus host disease GVHD, relapse free survival) at one year post transplant. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama at Birmingham city: Birmingham state: Alabama zip: 35294 country: United States name: Zaid Al Kadhimi, MD role: PRINCIPAL_INVESTIGATOR name: Manuel Espinoza-Gutarra, MD role: SUB_INVESTIGATOR name: Donna Salzman, MD role: SUB_INVESTIGATOR name: Antonio Di Stasi, MD role: SUB_INVESTIGATOR name: Lauren Shea, MD role: SUB_INVESTIGATOR name: Omar Jamy, MD role: SUB_INVESTIGATOR lat: 33.52066 lon: -86.80249 hasResults: False

 nctId: NCT06265571 id: EskisehirUO briefTitle: Postoperative Pain in Shoulder Surgery overallStatus: COMPLETED date: 2020-11-15 date: 2021-06-15 date: 2021-07-15 date: 2024-02-20 date: 2024-02-20 name: Eskisehir Osmangazi University class: OTHER 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. conditions: Pain, Postoperative studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 40 type: ACTUAL name: perineural injection measure: rescue analgesia measure: difference between the analgesic methods sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ferda YAMAN city: Eskişehir state: Odunpazarı zip: 26040 country: Turkey lat: 39.77667 lon: 30.52056 hasResults: False

 nctId: NCT06265558 id: PROICM 2023-08 TPN briefTitle: Prevention of Postoperative Complications by Negative Pressure Therapy After Complex Breast Cancer Surgery acronym: TPN-SEIN overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-02 date: 2027-02 date: 2024-02-20 date: 2024-04-04 name: Institut du Cancer de Montpellier - Val d'Aurelle class: OTHER 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. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 254 type: ESTIMATED name: Negative pressure therapy (NPT) name: Dressing measure: Rate of patients with post-operative scarring trouble measure: Rate of patients with a surgical site infection measure: Surgical revision rate measure: Rate of patients with at least one rehospitalization measure: Surgical complication rate by Clavien-Dindo classification measure: Time to initiation of adjuvant therapy measure: Quality of life evaluated by questionnaire QLQ-C30 (Version 3) measure: Quality of life evaluated by questionnaire QLQ-BReast cancer (BR23) measure: Patient satisfaction about cosmetic result evaluated using the BR23 questionnaire measure: Medical cost of post-surgery care sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier de Nîmes city: Nîmes state: Gard zip: 30900 country: France name: Fanny BECHARD, MD role: CONTACT email: fanny.bechard@hotmail.fr name: Fanny BECHARD, MD role: PRINCIPAL_INVESTIGATOR lat: 43.83333 lon: 4.35 facility: Centre Hospitalier de Montpellier city: Montpellier state: Hérault zip: 34090 country: France name: Martha DURAES, MD role: CONTACT email: m-duraes@chu-montpellier.fr name: Martha DURAES, MD role: PRINCIPAL_INVESTIGATOR lat: 43.61092 lon: 3.87723 facility: Institut régional du Cancer de Montpellier city: Montpellier state: Hérault zip: 34298 country: France name: Mathias NERON, MD role: CONTACT phone: 467614813 phoneExt: +33 email: mathias.neron@icm.unicancer.fr name: Mathias NERON, MD role: PRINCIPAL_INVESTIGATOR lat: 43.61092 lon: 3.87723 hasResults: False

 nctId: NCT06265545 id: RR-AML-2023 briefTitle: Multicenter, Platform-type Clinical Study of Refractory/Recurrent Acute Myeloid Leukemia overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2026-01-30 date: 2026-06-30 date: 2024-02-20 date: 2024-04-16 name: Institute of Hematology & Blood Diseases Hospital, China class: OTHER 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. conditions: AML conditions: Refractory conditions: Relapsed studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Ivosidenib,Venetoclax,gilteritinib,Selinexor measure: Complex response (CRc) rate (including CR and CRi) measure: mortality associated with salvage treatment (30 days, 60 days) measure: MRD-negative complete response rate measure: Overall survival measure: Event-free survival measure: Relapse-free survival sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Blood Hospital city: Tianjin zip: 300020 country: China name: hui wei, MD role: CONTACT phone: 86-13132507161 email: weihui@ihcams.ac.cn lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06265532 id: Pro00060157 id: R33HL158540 type: NIH link: https://reporter.nih.gov/quickSearch/R33HL158540 briefTitle: Collagen-targeted Positron Emission Tomography (PET) Imaging for Assessment of EGCG Effect overallStatus: RECRUITING date: 2024-02-07 date: 2025-05-31 date: 2025-05-31 date: 2024-02-20 date: 2024-02-20 name: Hal Chapman class: OTHER name: Cornell University name: Massachusetts General Hospital name: University of Michigan name: National Heart, Lung, and Blood Institute (NHLBI) 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. conditions: Idiopathic Pulmonary Fibrosis studyType: INTERVENTIONAL phases: PHASE1 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 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 count: 22 type: ESTIMATED name: EGCG 300 mg name: Placebo for EGCG 300 mg name: EGCG 600 mg name: Placebo for EGCG 600 mg measure: Change in collagen probe uptake over the entire lungs measure: Change in peak enhancement over the entire lungs measure: Change in the rate of contrast washin over the entire lungs measure: Change in the area under the curve at 60 seconds over the entire lungs measure: Change in the full width at half maximum over the entire lungs measure: Change in the rate of contrast washout over the entire lungs sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Massachusetts General Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02114 country: United States name: Sydney Montesi, MD role: CONTACT phone: 617-724-4030 email: SBMONTESI@PARTNERS.ORG name: Caroline Fromson role: CONTACT phone: 617-643-3260 email: CFROMSON@MGH.HARVARD.EDU name: Sydney Montesi, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06265519 id: MAR.UAD.008 briefTitle: Association of Urine BDNF and NGF With Lower Urinary System Parameters overallStatus: RECRUITING date: 2024-02-01 date: 2025-02-01 date: 2025-07-01 date: 2024-02-20 date: 2024-02-21 name: Marmara University class: OTHER 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. conditions: Benign Prostatic Hyperplasia With Outflow Obstruction conditions: Lower Urinary Tract Obstructive Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE maskingDescription: 0 count: 70 type: ESTIMATED name: Holmium laser enucleation of the prostate measure: Uroflowmetry measure: International prostate symptom score measure: Urodynamic sex: MALE minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Marmara University Hospital status: RECRUITING city: Istanbul country: Turkey name: Haydar Kamil Çam, Prof. role: CONTACT phone: +905323259547 email: kamilcam@hotmail.com name: Kader Ada Doğan, MD role: CONTACT phone: +905323845598 email: kader.dogan11@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06265506 id: 20320 id: R01AA031013 type: NIH link: https://reporter.nih.gov/quickSearch/R01AA031013 briefTitle: Virtual Incentive Treatment for Alcohol acronym: VITA overallStatus: NOT_YET_RECRUITING date: 2024-02-19 date: 2027-04-03 date: 2028-04-04 date: 2024-02-20 date: 2024-02-20 name: Washington State University class: OTHER name: The University of Texas Health Science Center at San Antonio name: Weill Medical College of Cornell University name: National Institute on Alcohol Abuse and Alcoholism (NIAAA) 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. conditions: Alcohol Use Disorder conditions: Alcohol Drinking conditions: Alcohol Abuse conditions: Alcohol Dependence studyType: INTERVENTIONAL phases: NA 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), or
2. CBT4CBT and reinforcement for PEth tests that are consistent with alcohol abstinence (CM Condition). primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: Contingency Management name: Computer Based Training for Cognitive Behavioral Therapy for AUD (CBT4CBT) measure: Aim 1) Alcohol Abstinence & Aim 3) Predictors: PEth-Defined Alcohol Abstinence During CM (Aim 1) and Follow-Up (Aim 3) measure: Aim 2) Alcohol-Related Harms: Addiction Severity Index (ASI) Lite measure: Aim 2) Alcohol-Related Harms: Patient Health Questionnaire-9 (PHQ-9) measure: Aim 2) Alcohol-Related Harms: Generalized Anxiety Disorder-7 (GAD-7) measure: Aim 2) Alcohol-Related Harms: Short Form Health Survey-12 (SF-12) measure: Aim 2) Alcohol-Related Harms & Aim 4) Cost Analysis: Non-study Medical and Other Services (NMOS) form measure: Aim 2) Alcohol Related Harms: Fagerstrom measure: Aim 2) Alcohol Related Harms: Urine Drug Tests measure: Aim 2) Alcohol Related Harms: Perceived Stress Scale (PSS-10) measure: Aim 3) Predictors: Demographics measure: Aim 3) Predictors: Addictions Neuroclinical Assessment (ANA) Questionnaire measure: Aim 3) Predictors: TestMyBrain measure: Aim 3) Predictors: Positive Negative Affect Schedule (PANAS) measure: Aim 3) Predictors: Situational Confidence Questionnaire-8 (SCQ-8) measure: Aim 3) Predictors: Alcohol Craving VAS measure: Aim 4) Cost Analysis: Drug Abuse Treatment Cost Analysis Program (DATCAP) measure: Aim 4) Cost Analysis: PROPr measure: Aim 1) Alcohol Abstinence: Regular excessive drinking measure: Aim 1) Alcohol Abstinence: uEtG-Defined Alcohol Abstinence measure: Aim 1) Alcohol Abstinence: Self-reported Alcohol Abstinence and Heavy Drinking measure: Additional Implementation Data: Attrition measure: Additional Implementation Data: CSQ-8 measure: Adverse Events measure: Computer Based Training for Cognitive Behavioral Health (CBT4CBT) Program Use sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Washington State University city: Spokane state: Washington zip: 99201 country: United States name: Michael McDonell, PhD role: CONTACT phone: 509-368-6967 email: mmcdonell@wsu.edu lat: 47.65966 lon: -117.42908 hasResults: False

 nctId: NCT06265493 id: PLAGH-AOC-L02 briefTitle: Postoperative Infectious Complications Calculator for Elderly Patients overallStatus: COMPLETED date: 2021-06-01 date: 2023-06-30 date: 2023-09-30 date: 2024-02-20 date: 2024-03-19 name: Weidong Mi class: OTHER 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. conditions: Postoperative Infection conditions: Geriatrics conditions: Prediction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 37230 type: ACTUAL measure: Postoperative Infectious Complications Calculator for Elderly Patients sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Depatment of Anesthesiology, The First Medical Center Affiliation: Chinese PLA General Hospital city: Beijing state: Beijing zip: 100853 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06265480 id: 2023-04577-01 briefTitle: FallFitness Fallprevention Program for Older Adults overallStatus: RECRUITING date: 2024-03-01 date: 2025-07-01 date: 2025-12-31 date: 2024-02-20 date: 2024-02-20 name: Dalarna University class: OTHER name: Sormland County Council, Sweden 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. conditions: Fall Injury conditions: Fall conditions: Self Efficacy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised Controlled Trial primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Study will be singled blinded (assessors) whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: FallFitness intervention group measure: Physical function by Short Physical Performance Battery measure: Self-efficacy (balance confidence) measure: Fear of Falling measure: EuroQoL-5 Dimension Questionnaire (EQ-5D) measure: Fallfrequency measure: Falling techniques measure: Handgrip strength sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Marina Arkkukangas status: RECRUITING city: Eskilstuna state: Sormland country: Sweden name: Marina Arkkukangas, PhD role: CONTACT phone: +46 (0)706468868 email: maau@du.se name: Michail Tonkonogi, Professor role: CONTACT phone: +46(0)708206435 email: mtn@du.se lat: 59.36661 lon: 16.5077 hasResults: False

 nctId: NCT06265467 id: 28909108800228 briefTitle: Evaluation of Two Different Techniques for Sinus Elevation, Open Versus Closed . overallStatus: COMPLETED date: 2022-01-01 date: 2023-02-01 date: 2023-07-01 date: 2024-02-20 date: 2024-02-20 name: Misr International University class: OTHER name: Suez Canal University 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. conditions: Alveolar Ridge Augmentation conditions: Sinus Floor Augmentation conditions: Maxillary Sinus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: it is a double blinded study, both the outcome assessor and statistician will be blinded whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ACTUAL name: Closed Sinus Elevation name: Open Sinus Elevation measure: Implant Stability measure: Radiographic bone gain sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Suez Canal University city: Ismailia zip: 41522 country: Egypt lat: 30.60427 lon: 32.27225 hasResults: False

 nctId: NCT06265454 id: LDAED IN MC briefTitle: Low Dose Atropine Eye Drops in Myopic Egyptian Children acronym: LAMP overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2025-12-30 date: 2026-03-30 date: 2024-02-20 date: 2024-02-20 name: Ain Shams University class: OTHER 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. conditions: Myopia Progression conditions: Axial Length, Eye conditions: Sclera Thickness studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 75 type: ESTIMATED name: low dose atropine eye drops name: Placebo measure: change in the average Choroidal Thickness over follow up period. sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Ain shams university city: Cairo state: Abbasia zip: 11517 country: Egypt name: Aya MA Abd El wahab, Masters role: CONTACT phone: 1009192526 phoneExt: +20 email: ayamah711@gmail.com name: Marwa M Abd al Karim, MD role: PRINCIPAL_INVESTIGATOR lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06265441 id: MS42/2024 briefTitle: Comparison of Pain Relief Post Knee Arthroscopy Using IPACK + Adductor Canal Block vs. Adductor Canal Block Alone overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-09-01 date: 2024-10-01 date: 2024-02-20 date: 2024-02-26 name: Ain Shams University class: OTHER 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. conditions: Postoperative Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED 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 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% 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. measure: Total analgesics consumption measure: The time till first analgesic requirement measure: The range of movement (ROM) measure: The number of steps sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Ain Shams University city: Cairo state: Abbassia zip: 00202 country: Egypt name: Mohamed Morsi, M.B.B.CH role: CONTACT phone: +201116618163 email: MohamedMorsi@med.asu.edu.eg name: Mohamed Morsi, M.B.B.CH role: PRINCIPAL_INVESTIGATOR lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06265428 id: DB-1303-O-3001 id: CTR20233403 type: OTHER domain: CENTER FOR DRUG EVALUATION, NMPA briefTitle: A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer overallStatus: RECRUITING date: 2024-01-29 date: 2026-02 date: 2026-02 date: 2024-02-20 date: 2024-02-20 name: DualityBio Inc. class: INDUSTRY name: BioNTech SE 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. conditions: HER2-positive Breast Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 224 type: ESTIMATED name: DB-1303/BNT323 name: T-DM1 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) measure: Overall Survival (OS) measure: Progression Free Survival (PFS) by Investigator assessment per RECIST 1.1 measure: Objective response rate (ORR) by BICR and investigator assessment per RECIST 1.1 measure: Duration of response (DoR) by BICR and investigator assessment per RECIST 1.1 measure: PK parameters: maximum observed concentration (Cmax) measure: PK parameters: time to maximum concentration (Tmax) measure: Adverse events (AEs) measure: Patient reported outcomes (PROs): European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) - C30 measure: Patient reported outcomes (PROs): EORTC QLQ-BR45 measure: Patient reported outcomes (PROs): European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L) measure: European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L) measure: Anti-drug antibodies (ADA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT 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 name: Zefei Jiang role: CONTACT lat: 39.9075 lon: 116.39723 facility: Fudan University Shanghai Cancer Center status: RECRUITING city: Shanghai state: Shanghai zip: 200032 country: China name: Jian Zhang role: CONTACT lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06265415 id: Soh-Med-24-01-07MS briefTitle: Comparative Study of Intravenous Labetalol Versus Intravenous Nitroglycerin Versus Sublingual Nifedipine overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2025-03-30 date: 2025-03-30 date: 2024-02-20 date: 2024-02-20 name: Sohag University class: OTHER 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 conditions: Severe Preeclampsia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Labetalol name: Nitroglycerine name: Nifedipine measure: duration of control blood pressure sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False

 nctId: NCT06265402 id: 36264 briefTitle: Retrolaminar Block Versus Tab Block in Abdomioasty overallStatus: RECRUITING date: 2024-01-15 date: 2025-10-15 date: 2025-12-15 date: 2024-02-20 date: 2024-02-20 name: Tanta University class: OTHER 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 conditions: Block studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Tab block versus retrolaminar block in abdominal plastic surgery measure: Total dose of morphine consumption in the first postoperative 24hours sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: TantaU U status: RECRUITING city: Tanta country: Egypt name: Hadeel Elsagheer, Master role: CONTACT lat: 30.78847 lon: 31.00192 hasResults: False

 nctId: NCT06265389 id: Pentoxifylline in pneumonia briefTitle: Pentoxifylline as an Adjuvant Therapy in the Treatment of Pediatric Pneumonia; A New Perspective of an Old Drug overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-08-31 date: 2024-10-30 date: 2024-02-20 date: 2024-02-20 name: Tanta University class: OTHER 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 conditions: Pentoxifylline as an Adjunct Therapy in the Treatment of Pneumonia studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: Pentoxifylline Oral Tablet measure: Respiratory distress measure: Temperature measure: Oxygen saturation measure: CRP measure: LDH measure: D-dimer measure: Interleukin 6 measure: Hospital stays measure: Pneumonia complications measure: Surgical intervention sex: ALL minimumAge: 2 Months maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06265376 id: IRB22-046 briefTitle: Do Patient Educational Videos Improve Pain and Recovery After Laparoscopic Hysterectomy? overallStatus: RECRUITING date: 2023-03-13 date: 2024-05-01 date: 2024-07-01 date: 2024-02-20 date: 2024-02-20 name: Benaroya Research Institute class: OTHER 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. conditions: Pain, Postoperative studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Educational Video measure: Overall satisfaction score (5 point Likert scale) with post operative pain control after laparoscopic hysterectomy measure: Pain score at the time of survey completion (0=no pain 10=worst pain measure: Average pain score for the first 7 days as perceived by the patients (likert scale) measure: Number of post-op phone calls received measure: Number of post-op emergency room visits measure: Number of readmissions measure: Number of patients with steri-strips still in place measure: Number opioids taken since surgery measure: Overall satisfaction with pre-operative education regarding surgery (5 point Likert scale) measure: ding surgery (5 point likert scale) Overall satisfaction with educations regarding what to expect post-operatively (5 point Likert scale) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Virginia Mason Medical Center status: RECRUITING city: Seattle state: Washington zip: 98101 country: United States name: Michelle Gruttadauria, MD role: CONTACT phone: 206-223-6191 email: Michelle.Gruttadauria@virginiamason.org lat: 47.60621 lon: -122.33207 hasResults: False

 nctId: NCT06265363 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 overallStatus: RECRUITING date: 2023-08-01 date: 2024-08-01 date: 2024-11-01 date: 2024-02-20 date: 2024-02-20 name: Baskent University Ankara Hospital class: OTHER name: Hacettepe University name: Gazi University name: Gaziosmanpasa Research and Education Hospital name: Celal Bayar University name: Selcuk University name: Recep Tayyip Erdogan University name: Karadeniz Technical University name: Istinye University name: Biruni University name: T.C. ORDU ÜNİVERSİTESİ name: Dr. Lutfi Kirdar Kartal Training and Research Hospital name: Pamukkale University name: Kanuni Sultan Suleyman Training and Research Hospital name: Konya City Hospital name: Kecioren Education and Training Hospital name: Ataturk University name: Meda Hospital name: Eskisehir Osmangazi University name: Necmettin Erbakan University name: Kırıkkale University name: Sisli Hamidiye Etfal Training and Research Hospital name: Acibadem Atakent University Hospital name: Balikesir Ataturk City Hospital name: Kocaeli University name: Acibadem Maslak Hospital name: Erzurum City Hospital name: Afyon Karahisar Hospital name: Ankara Koru Hospital name: University of Health Sciences Gulhane Hospital name: Bursa Yüksek İhtisas Education and Research Hospital name: Namik Kemal University name: Bursa City Hospital name: Kayseri City Hospital name: Ankara Etlik City Hospital name: Zonguldak Bulent Ecevit University name: Gazi Yasargil Training and Research Hospital name: Inonu University name: Dr. Behcet Uz Children's Hospital name: Ankara Training and Research Hospital name: Tepecik Training and Research Hospital name: Aydin Adnan Menderes University name: Dicle University name: Akdeniz University name: Umraniye Education and Research Hospital name: Ankara Bilkent City Hospital name: Afyonkarahisar University of Health Sciences Health Application and Research Center name: Harran University name: Sanliurfa Mehmet Akif Inan Education and Research Hospital name: Istanbul University - Cerrahpasa (IUC) name: Uludag University name: şanlıurfa training and research Hospital name: Dokuz Eylul University name: Bursa Doruk Yıldırım Hospital name: Malatya Turgut Ozal University name: Abant Izzet Baysal University name: Alanya Training and Research Hospital name: İstanbul Training and Research Hospital name: Baskent Univeristy Adana Hospital name: Kahramanmaras Sutcu Imam University name: Batman Training and Research Hospital name: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital name: Acıbadem Atunizade Hospital name: Adiyaman Training and Research Hospital name: Zeynep Kamil Maternity and Pediatric Research and Training Hospital name: Ondokuz Mayıs University name: Trakya University name: Trabzon Kanuni Education and Research Hospital name: Seyhan Hospital name: Esenyurt University Hospital name: Başakşehir Çam & Sakura City Hospital name: Sakarya University name: Mardin Training and Research Hospital name: Karabuk University name: Giresun Training and Research Hospital name: Koc University Hospital name: Tekirdağ City Hospital name: Medipol University Mega Hospital name: Adana City Training and Research Hospital name: Istanbul University name: Marmara University Pendik Training and Research Hospital name: Medikal Park Ankara Hospital name: Medipol University Bahcelievler Hospital name: Muğla Sıtkı Koçman University name: Yuzuncu Yıl University name: Sanko University name: Antalya Training and Research Hospital name: Firat University name: Ankara Güven Hospital name: Private Batman Hospital name: İstanbul Bağcılar Training and Research Hospital name: Istanbul Aydın University name: Mersin City Hospital 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. conditions: Retinopathy of Prematurity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED measure: Incidence of ROP measure: The role of being SGA in infants in the development of ROP measure: The role of sepsis in infants in the development of ROP measure: The role of mechanical ventilation in infants in the development of ROP measure: The role of chorioamnionitis in infants in the development of ROP measure: Laser photocoagulation treatment measure: Anti-VEGF treatment measure: Vitreoretinal surgery sex: ALL minimumAge: 28 Days stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Baskent University status: RECRUITING city: Ankara country: Turkey name: Sezin Unal role: CONTACT phone: 0090532 email: sezinunal@gmail.com name: Esin Koc, Prof role: PRINCIPAL_INVESTIGATOR name: Ahmet Y Bas, Prof role: PRINCIPAL_INVESTIGATOR name: İbrahim M Hirfanoğlu, Prof role: PRINCIPAL_INVESTIGATOR lat: 39.91987 lon: 32.85427 hasResults: False

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

 nctId: NCT06265337 id: LAMETA-OGTT briefTitle: Does Co-administration of Lactate to an Oral Glucose Tolerance Test Lower the Glucose Response? overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-01 date: 2025-01 date: 2024-02-20 date: 2024-02-20 name: University of Aarhus class: OTHER 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. conditions: PreDiabetes conditions: Metabolic Syndrome conditions: Insulin Resistance studyType: INTERVENTIONAL phases: NA 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 masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 12 type: ESTIMATED name: Lactate name: Placebo measure: Difference in integrated glucose concentrations between CTR and LAC following an OGTT measure: Difference in glucose absorption measure: Difference in insulin sensitivity measure: Difference in insulin secretion measure: Difference in free fatty acids concentration measure: Difference in ventricular emptying rate measure: Difference in subjective appetite sensation measure: Difference in integrated GLP-1 concentrations sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

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

 nctId: NCT06265311 id: 20221307-2 briefTitle: IDUS in CBD Stone Recurrence High Risk Patients overallStatus: RECRUITING date: 2021-11-02 date: 2024-01-31 date: 2024-06 date: 2024-02-20 date: 2024-04-19 name: Shanghai Municipal Hospital of Traditional Chinese Medicine class: OTHER 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. conditions: Choledocholithiasis conditions: Cholangiopancreatography, Endoscopic Retrograde conditions: Ultrasonography studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 80 type: ESTIMATED name: IDUS examination measure: recurrence of bile duct stone or cholangitis measure: need for a nasobiliary tube measure: need for stents measure: operation time measure: radiation time measure: hospitalization cost measure: Questionnaire of Symptoms and conditions after ERCP measure: White blood cell count measure: Red blood cell count measure: Platelet count measure: total bilirubin, direct bilirubin measure: Liver function test (ALT, AST) measure: albumin measure: total protein measure: Gamma-glutamyl transferase (GGT) test measure: An alkaline phosphatase (ALP) test measure: whether have a resection of gallbladder checklist sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shang General Hospital status: RECRUITING city: Shanghai zip: 200080 country: China name: Hang Zhao role: CONTACT phone: 18621186288 email: drzhaohang@163.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06265298 id: RECHMPL23_0099 briefTitle: Implementation of a Protocol for the Transdifferentiation of Buccal Mucosal Epithelium Into Corneal Epithelium acronym: TransBuCor overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-02 date: 2025-02 date: 2024-02-20 date: 2024-02-20 name: University Hospital, Montpellier class: OTHER name: Institute for Neuroscience Montpellier 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). conditions: Limbal Stem Cell Deficiency studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: transversal and fondamental study primaryPurpose: OTHER masking: NONE count: 4 type: ESTIMATED name: Conjunctival reconstruction measure: Successful Transdifferentiation measure: Successful Transdifferentiation measure: Successful Transdifferentiation measure: Successful Transdifferentiation measure: Successful Transdifferentiation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Gui de Chauliac - Service d'Ophtamologie city: Montpellier state: Occitanie zip: 34295 country: France name: Vincent DAIEN, Pr role: CONTACT email: v-daien@chu-montpellier.fr name: Vincent Daien, Pr role: PRINCIPAL_INVESTIGATOR lat: 43.61092 lon: 3.87723 hasResults: False

 nctId: NCT06265285 id: MC230716 id: NCI-2024-00637 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 23-009663 type: OTHER domain: Mayo Clinic Institutional Review Board 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 overallStatus: RECRUITING date: 2024-03-13 date: 2026-12-31 date: 2026-12-31 date: 2024-02-20 date: 2024-03-15 name: Mayo Clinic class: OTHER 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. 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 studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 50 type: ESTIMATED name: Home Health Encounter name: Nivolumab name: Patient Monitoring name: Questionnaire Administration measure: Change in patient-reported rating of Cancer CARE Cancer Connected Access and Remote Expertise (CARE) after 8 weeks measure: Patient preferred treatment location measure: Patient level of comfort with receiving injections at home measure: Patient-reported symptoms - PRO-CTCAE measure: Patient-reported function - EORTC QLQ-F17 measure: Patient-reported side effect impact - GP5 measure: Incidence of Adverse Events (AEs) measure: Emergency room visits and hospitalizations measure: Overall survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Florida status: RECRUITING city: Jacksonville state: Florida zip: 32224-9980 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Roxana S. Dronca, M.D. role: PRINCIPAL_INVESTIGATOR lat: 30.33218 lon: -81.65565 hasResults: False

 nctId: NCT06265272 id: 2022P002594 briefTitle: Value of [68Ga]Ga-PSMA-11 PET/MRI in the Assessment of Liver Cirrhosis overallStatus: RECRUITING date: 2023-12-10 date: 2026-12-19 date: 2026-12-19 date: 2024-02-20 date: 2024-02-20 name: Massachusetts General Hospital class: OTHER 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 conditions: Liver Cirrhosis conditions: Hepatic Cell Carcinoma conditions: Portal Hypertension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 45 type: ESTIMATED name: Injection of a gadolinium contrast agen name: Radiotracer Injection name: Imaging measure: Assessment of LI-RADS with Ga-PSMA-PET/MRI measure: Quantification of Macro- and Microperfusion in Cirrhotic Liver with Ga-PSMA-PET/MRI measure: Quantification of liver fibrosis with Ga-PSMA-PET/MRI vs. MRI and stand-alone PET measure: PET/MR protocol in liver cirrhosis sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT 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 name: Onforio Catalano, MD, Ph.D role: CONTACT phone: 617-724-4030 email: ocatalano@mgh.harvard.edu name: Diandrea Galloway role: CONTACT phone: 617-643-1407 email: dgalloway@mgh.harvard.edu lat: 42.37787 lon: -71.062 hasResults: False

 nctId: NCT06265259 id: 31-05-2023/25481 briefTitle: Efficacy of the Use of Vasopressin as a Primary Vasoconstrictor in Critically Ill Patients overallStatus: RECRUITING date: 2023-12-15 date: 2025-12-31 date: 2026-01-31 date: 2024-02-20 date: 2024-03-06 name: University of Thessaly class: OTHER 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. conditions: Circulatory Shock studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 145 type: ESTIMATED name: Initiation of vasopressine as a first vasoconstrictive drug name: Initiation of noradrenaline as a first vasoconstrictive drug measure: Multiorgan failure improvement assessment measure: Sepsis course measure: Sepsis course measure: Sepsis course measure: Duration of administration of vasoconstrictors measure: laboratory tests measure: laboratory tests measure: laboratory tests measure: laboratory tests measure: laboratory tests measure: laboratory tests measure: laboratory tests measure: laboratory tests measure: laboratory tests measure: laboratory tests measure: laboratory tests measure: Cardiac enzymes measure: Cardiac enzymes measure: renal function measure: renal function measure: renal function measure: Mechanical ventilation duration measure: length of ICU stay measure: 28 day mortality measure: ICU mortality measure: Adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: General University Hospital of Larissa, Intensive Care Unit status: RECRUITING city: Larissa state: Thessaly zip: 41110 country: Greece name: Vasiliki Tsolaki role: CONTACT phone: 00306972804419 email: vasotsolaki@yahoo.com name: Epaminondas Zakynthinos, Prof role: CONTACT phone: 00302413501280 email: ezakynth@yahoo.com name: Vasiliki TSOLAKI, MD, PhD role: SUB_INVESTIGATOR name: Asimina Valsamaki, MD, Msc role: SUB_INVESTIGATOR name: Epaminondas Zakynthinos, Prof role: PRINCIPAL_INVESTIGATOR lat: 39.63689 lon: 22.41761 hasResults: False

 nctId: NCT06265246 id: 104993 briefTitle: Impact of Milk and Yogurt Supplementation on Bone Health, Body Composition, and Gut Microbiota in Canadian Young Adults overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2028-05-15 date: 2024-02-20 date: 2024-02-20 name: University of Saskatchewan class: OTHER name: Dairy Farmers of Canada name: Agriculture and Agri-Food Canada 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. conditions: Osteoporosis conditions: Obesity studyType: INTERVENTIONAL phases: NA 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 masking: NONE count: 99 type: ESTIMATED name: Habitual Diet + Milk name: Habitual Diet + Yogurt measure: Femoral neck bone mineral density measure: Bone mineral density (total hip, lumbar spine, whole body) measure: Bone mineral content (total hip, femoral neck, lumbar spine, whole body) measure: Bone structure measure: Bone geometry measure: Serum bone alkaline phosphatase (biochemical indices of bone turnover) measure: Serum osteocalcin (biochemical indices of bone turnover) measure: Serum procollagen type 1 N-propeptide (biochemical indices of bone turnover) measure: Serum N-terminal telopeptide of type 1 collagen (biochemical indices of bone turnover) measure: Serum C-terminal telopeptide of type 1 collagen (biochemical indices of bone turnover) measure: Serum PTH (hormonal indices related to bone metabolism) measure: Serum 25(OH)D (hormonal indices related to bone metabolism) measure: Serum IGF-1 (hormonal indices related to bone metabolism) measure: Saliva IGF-1 (hormonal indices related to bone metabolism) measure: Fat mass and lean mass measure: Height measure: Weight measure: Gut microbiota via general lactobacillus and bifdobacterium measure: Dietary assessment measure: Physical activity sex: ALL minimumAge: 19 Years maximumAge: 30 Years stdAges: ADULT hasResults: False

 nctId: NCT06265233 id: 69668 briefTitle: ERP Plus Improv Group Therapy for OCD (IMPROVE Study) overallStatus: RECRUITING date: 2024-02-09 date: 2025-01 date: 2025-01 date: 2024-02-20 date: 2024-02-22 name: Stanford University class: OTHER briefSummary: The goal of this study is to pilot test a novel group therapy intervention for adults with OCD. conditions: Obsessive-Compulsive Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Group Improv sessions name: Group Exposure and Response Prevention (ERP) Therapy measure: Change in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS) measure: Change in Intolerance of Uncertainty Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: 401 Quarry status: RECRUITING city: Stanford state: California zip: 94304 country: United States name: Study Team role: CONTACT phone: 650-723-4095 email: ocdresearch@stanford.edu lat: 37.42411 lon: -122.16608 hasResults: False

 nctId: NCT06265220 id: AB-101-03 briefTitle: AB-101 in Combination With B-Cell Depleting mAb in Patients Who Failed Treatment for Class III or IV Lupus Nephritis overallStatus: RECRUITING date: 2024-02-24 date: 2026-10 date: 2026-10 date: 2024-02-20 date: 2024-02-20 name: Artiva Biotherapeutics, Inc. class: INDUSTRY briefSummary: AB-101 (also known as AlloNK) is an off-the shelf, allogeneic cell product made of "natural killer" cells, also called NK cells. White blood cells are part of the immune system and NK cells are a type of white blood cell that is known to enhance the effect of monoclonal antibody therapies.

This clinical trial will enroll adult patients with lupus nephritis Class III or IV either with or without the presence of Class V who relapsed or did not respond to previous standard of care treatment approaches.

The primary objective is to assess the safety, tolerability and preliminary activity of AB-101 plus rituximab after cyclophosphamide and fludarabine in adult subjects with relapsed/refractory lupus nephritis Class III or IV, with or without the presence of Class V.

Patients will be assigned to receive either AB-101 alone as monotherapy or in combination with rituximab. All patients will receive at least 1 treatment cycle of AB-101, followed by scheduled assessments of overall health and response status.

Patients may receive up to 2 cycles of treatment spaced 24 weeks apart. conditions: Lupus Nephritis - WHO Class III conditions: Lupus Nephritis - WHO Class IV studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: AB-101 name: Cyclophosphamide name: Fludarabine name: Rituximab measure: Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events measure: AB-101 Clinical Activity sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, San Diego status: RECRUITING city: San Diego state: California zip: 92121 country: United States name: Bosco Trinh role: CONTACT name: Bethany Karl, DO role: PRINCIPAL_INVESTIGATOR lat: 32.71533 lon: -117.15726 hasResults: False

 nctId: NCT06265207 id: ArdahanU-Simsekli-DS-02 briefTitle: The Effect of Virtual Reality on Pain, Anxiety and Satisfaction Level Before Mammography overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-03-15 date: 2025-04-15 date: 2024-02-20 date: 2024-02-20 name: Ardahan University class: OTHER name: Kafkas University briefSummary: In this study, it is planned to determine the effect of virtual reality applied to women before mammography on pain, anxiety and satisfaction levels. For this purpose, individuals applying for breast cancer screening will first be randomly divided into experimental and control groups. Pain, anxiety and satisfaction level evaluation forms will be applied to the experimental group before the mammography procedure. A relaxing video will be watched with virtual reality glasses and the mammography will be performed. At the end of the mammography, the relevant forms will be applied to the individuals again. The control group will not be subjected to any additional application that will continue with the applied routine. conditions: Mammography conditions: Early Diagnosis of Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Single Blind Parallel Group Randomized Controlled Trial primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Since the researcher will be conducting the research, blinding will not be possible, and separate consent forms were prepared for the experimental and control groups, without specifying which group they were in, and it was planned to blind the participants in this way. In addition, in order to prevent statistical bias, it is planned to prevent bias in data analysis by coding the data as first group and second group, rather than experimental and control group, when entering the data into SPSS, and by not giving information about which group is the experiment and which is the control group. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 78 type: ESTIMATED name: Virtual reality name: routine maintenance measure: Visual Comparison Scale measure: State Anxiety Inventory measure: Satisfaction Evaluation Scale sex: FEMALE minimumAge: 18 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06265194 id: ZAT2024 briefTitle: Effect of EMDR in the Treatment of Fibromyalgia acronym: EMDR overallStatus: COMPLETED date: 2015-01-01 date: 2018-01-01 date: 2018-03 date: 2024-02-20 date: 2024-02-20 name: Academy of Therapeutic Sciences, Turkey class: OTHER briefSummary: The goal of this randomized-controlled study is to investigate the impact of EMDR therapy on fibromyalgia symptoms, depression, sleep quality, and traumatic stress in fibromyalgia patients.

The main questions it aims to answer are:

* Does EMDR become useful in relieving pain and complaints in fibromyalgia patients?
* Is specific EMDR Fibromyalgia Protocol effective of fibromyalgia patients?
* Does EMDR therapy decrease depression, sleep quality and traumatic stress symptoms of individuals with fibromyalgia? conditions: Fibromyalgia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Eligible participants were randomized into two groups: one receiving TAU treatment (control group) and the other receiving both TAU and EMDR (experimental group). primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participants do not have the knowledge of group interventions. whoMasked: PARTICIPANT count: 79 type: ACTUAL name: EMDR name: TAU measure: Fibromyalgia Impact Questionnaire (FIQ) measure: Pittsburgh Sleep Quality Index (PSQI) measure: Trauma Symptom Checklist-40 (TSC-40) measure: Beck Depression Inventory (BDI) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06265181 id: AIBU-SBF-SK-04 briefTitle: The Effect of Diabetes Coaching on Distress and Diabetes Self-Management overallStatus: NOT_YET_RECRUITING date: 2024-03-27 date: 2026-12-31 date: 2027-12-31 date: 2024-02-20 date: 2024-02-20 name: Abant Izzet Baysal University class: OTHER briefSummary: This research is a randomized controlled, experimental study planned to evaluate the effect of diabetes coaching on diabetes self-management, glycosylated hemoglobin and diabetes distress levels in individuals with type 2 diabetes.

The research is planned to start on 01.01.2024. Participants will be divided into experimental and control groups using the block randomization method. Participants in the experimental group will first receive 8 sessions of diabetes coaching every 10 days after the chemistry interview. No intervention will be made to the control group. The preliminary implementation of the research will be carried out with 4 individuals with diabetes who voluntarily accept participation and meet the inclusion criteria. Data will be collected by face-to-face interview method. Data will be analyzed with IBM SPSS V23 program. conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Experimental and control group. primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: When the researcher evaluates the participant according to the inclusion criteria, written consent will be obtained from the participant and pre-evaluation forms will be applied when compliance with the criteria is achieved. Afterwards, the participant's group will be notified to the researcher by the independent researcher and randomization will be carried out. With this; Data entries will be made by an independent researcher as group A and group B, without writing the group names. Until the data analysis and reporting is completed, the statistician will be blinded to which group is the intervention and which group is the control. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 64 type: ESTIMATED name: Diabetes coaching measure: Type 2 Diabetes Self-Management Scale measure: Diabetes Distress Scale measure: HbA1c Monitoring Form measure: Introductory Features Form sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06265168 id: req-2023-01512; am23Sutter3 briefTitle: Comprehensive Observations and Multidisciplinary Approaches in the Management of Unconscious Patients acronym: COMA overallStatus: RECRUITING date: 2024-03-01 date: 2026-12-31 date: 2026-12-31 date: 2024-02-20 date: 2024-04-11 name: University Hospital, Basel, Switzerland class: OTHER briefSummary: This prospective observational high-fidelity simulation study aims to observe and better understand how physicians from different disciplines differentiate in the management of a comatose patient and how their diagnostic and treatment approaches adhere to current recommendations in a highly standardized simulated scenario. The results gained by this study will give more insight into the current quality of diagnostic procedures and treatment and help refine recommendations in this context. The investigators hypothesize that physicians do not strictly adhere (regarding diagnostic approach and treatment) to current guidelines/recommendations when confronted with a comatose patient. conditions: Coma studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Simulation measure: To reveal diagnostic and treatment approaches of physicians from different disciplines when confronted with a comatose patient. measure: Physicians' grade of adherence to current recommendations regarding diagnostic procedures and treatment of a comatose patient measure: Participants' self-evaluation of their performance in hindsight sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Basel status: RECRUITING city: Basel country: Switzerland name: Prof. Dr. Sutter role: CONTACT name: Liliane Nueesch role: CONTACT lat: 47.55839 lon: 7.57327 hasResults: False

 nctId: NCT06265155 id: SuzhouMHAnhui briefTitle: Triggers of Acute Ischemic Stroke Due to Large Vessel Occlusion overallStatus: RECRUITING date: 2024-02-01 date: 2025-06-30 date: 2025-12-31 date: 2024-02-20 date: 2024-03-28 name: Anzhi Li class: OTHER briefSummary: Acute ischemic stroke has a high incidence, ischemic stroke caused by large vessel occlusion is serious and has a poor prognosis, and its triggers in the short term before onset are not clear. The aim of this study was to evaluate the short-term risk of acute ischemic stroke caused by multiple triggers. In this trial, through a case-crossover study design, patients were asked about the exposure to each trigger in the previous year and the exposure during the preictal risk period (the exposure observed during the risk period) for each potential trigger of acute ischemic stroke caused by large vessel occlusion. To evaluate the relative risk of ischemic stroke resulting from exposure to triggers, comparing exposure during the dangerous period with the usual frequency of exposure. Relative risks and corresponding 95% CIs were estimated for past-year exposure and past-year mean exposure (assessed as chronic risk factors) and time to last exposure (assessed as triggers). Scientifically evaluate exposure to a range of potential triggers, including infection, mood, smoking, alcohol consumption, diarrhea and vomiting, extreme temperature changes, and several factors that increase blood pressure and their risk of developing acute ischemic stroke. conditions: Triggers of Acute Ischemic Stroke Due to Large Vessel Occlusion studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 302 type: ESTIMATED measure: RR values for exposure during the risk period versus exposure in the past year for each trigger sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Suzhou Hospital Anhui Medical University status: RECRUITING city: Suzhou state: Anhui zip: 234000 country: China name: Anzhi Li, B.S. role: CONTACT phone: +8615903860581 email: 365819805@qq.com name: Zhengfei Ma, M.D. role: CONTACT phone: 13866586362 email: Zhengfeima@126.com lat: 31.30408 lon: 120.59538 hasResults: False

 nctId: NCT06265142 id: MoH/CSR/23/26368 briefTitle: Clean Catch Urine Feasibility and Contamination Rate Compared to Bladder Catheterization Urine in Pre-Continent Children overallStatus: NOT_YET_RECRUITING date: 2024-02-15 date: 2024-09-01 date: 2024-12-01 date: 2024-02-20 date: 2024-02-20 name: Oman Medical Speciality Board class: OTHER_GOV briefSummary: Introduction: Urinary tract infections (UTIs) are a common source of infection in children, accounting for a significant proportion of visits every year. Diagnosing UTIs requires obtaining a urine specimen, which can be collected using four methods: invasive techniques, such as suprapubic aspiration and urethral bladder catheterization, and noninvasive techniques, such as sterile bag and clean catch. However, catheterization can be a painful and invasive procedure, particularly in young infants who are less cooperative, and sometimes tends to be rejected by parents.

Given the availability of alternative methods with comparable contamination rates, we aim to investigate the feasibility and contamination rate of clean catch urine compared to bladder catheterization, as well as secondary outcomes such as pain scores, parental satisfaction, and time required to collect urine for each technique.

Methods: To achieve this, we will conduct a randomized control trial in precontinent pediatric patients. A pilot study with 40 samples in each arm will be conducted since there is no prior information about contamination rates in our setting. A well-designed and labeled data collection sheets will be used for data collection, and the data will be entered using EPI-data software. Statistical analysis will be performed using IBM SPSS statistics.

Aim: The main aim of this study is to introduce clean catch urine (bladder massage technique) to our setting, and to compare its feasibility with the bladder catheterization which is the standard practice.

Patient Population: young infants from 0 to 6 months of age

Intervention: There will be two groups:

1. Group A (Experimental group):Urine samples will be collected using the clean catch urine method (bladder massage technique).
2. Group B (Control group): Urine samples will be collected using the standard bladder catheterization method.

Clinical Measurement: All collected urine samples will be labeled and sent to the laboratory. All results will be retrieved from the medical records. Direct measurement will be for the duration of the procedures in both experiment and control group (stopwatch will be used). Pain score (Neonatal Infant Pain Scale) and parental satisfaction survey will be filled at the time of the procedure.

Outcome: Contamination rate and feasibility of both urine sampling techniques conditions: Urinary Tract Infections studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patient will be assessed in triage and cases to be included in the study as per the inclusion criteria, after that patients will be randomized using computerized block randomization technique into two groups. Then, patients will be assigned to a bed, pulse oximetry to be applied, data collection sheet to be filled, confirm that infant had good feeding/ didn't pass urine over last 20 minutes and proper cleaning to be done. The next step will be, collecting urine sample according to randomization group. Group A patients (control group), urine to be collected by standardized catheterization technique while group B by standard CCU technique. Meanwhile, time of each procedure to be documented. Regarding group B , after collecting urine by CCU , we recommend to collect another sample by catheterization to guide the management and antibiotic choice. primaryPurpose: DIAGNOSTIC masking: SINGLE maskingDescription: The statistician who will analyze the data will be blinded. whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Bladder catheterization name: clean catch urine via bladder massage technique measure: Urine culture contamination rate measure: Parental satisfaction questionnaire measure: duration of the procedure measure: Pain score sex: ALL minimumAge: 1 Day maximumAge: 6 Months stdAges: CHILD typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-01-01 uploadDate: 2024-02-14T09:44 filename: Prot_000.pdf size: 662911 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-01-01 uploadDate: 2024-02-14T09:45 filename: ICF_001.pdf size: 128074 hasResults: False

 nctId: NCT06265129 id: R.23.12.2429 briefTitle: The Association Between Obstructive Sleep Apnea Severity and Red Blood Cells Indices overallStatus: COMPLETED date: 2023-03-20 date: 2023-10-20 date: 2023-12-20 date: 2024-02-20 date: 2024-02-20 name: Mansoura University class: OTHER briefSummary: Obstructive sleep apnea syndrome (OSAS) is characterized by recurrent episodes of obstructive events (apnea and hypopnea) and intermittent hypoxia, which in turn contributes to the systemic inflammation that underlies this disease and its consequences (Ryan et al 2009, Gileles-Hillel et al 2014). This systemic inflammation leads to endothelial dysfunction, which contributes to the pathogenesis of cardiovascular complications in OSAS, in addition to the exposure to risk factors, such as male gender, older age, obesity, and lack of exercise (Lorenzi Filho et al 2010). Some red blood cells (RBC) and platelets indices have emerged as inflammatory biomarkers in various diseases (Tertemiz et al 2016) The severity of OSA is significantly associated with increase hematocrit, even after controlling for possible confounding variables. However, nocturnal hypoxemia in OSA does not usually lead to clinical polycythemia (Choi et al 2006). In patients referred with a clinical diagnosis of OSAS, RDW may be a marker for the severity of the condition. As RDW is usually included in a complete blood count, it could provide an inexpensive tool for triaging OSAS patients for polysomnography evaluation (Sökücü et al 2012). The hematological indices white blood cell count (WBC), neutrophil count, lymphocyte count, mean platelet volume (MPV), platelet distribution width (PDW), and red blood cell distribution width (RDW) have been proposed as alternative markers to those normally used clinically, e.g., interleukin-6 (IL6) and C-reactive protein, to evaluate the burden of inflammation in OSAS (Wu et al 2018) conditions: Obstructive Sleep Apnea studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 30 type: ACTUAL name: Complete blood picture (done in the morning after the night of monitored sleep by PSG. With stress on red blood cell indices (RBC count, MCV, MCH, RDW) measure: Red Blood Cells Indices sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tamer Awad Elsayed city: Mansoura state: Dakhlia zip: 050 country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False

 nctId: NCT06265116 id: A0801024 CD briefTitle: One-Step Universal Adhesives: A 3-year Clinical Trial in Class II Composite Restorations overallStatus: RECRUITING date: 2024-01-23 date: 2027-01-23 date: 2027-01-30 date: 2024-02-20 date: 2024-02-20 name: Mansoura University class: OTHER briefSummary: to evaluate and compare the clinical performance and periodontal responses of four commercially available one-step universal adhesives with different formulations in Class II composite restorations over a three-year period. conditions: Dental Caries Class II conditions: Marginal Integrity of Composite Restorations With Universal Adhesives studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 48 type: ESTIMATED name: One-step universal adhesive measure: Percentage of functional and biological properties for each group sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Omar Abd El-Fattah Abd El-Maksoud status: RECRUITING city: Mansoura state: Dakahlia zip: 35516 country: Egypt name: Omar A Abd El-Maksoud role: CONTACT phone: 01024366555 email: omarabdelfata7.92@gmail.com lat: 31.03637 lon: 31.38069 hasResults: False

 nctId: NCT06265103 id: 20190407 briefTitle: Epilepsy Learning Healthcare System (ELHS) acronym: ELHS overallStatus: RECRUITING date: 2019-03-20 date: 2099-02-14 date: 2099-02-14 date: 2024-02-20 date: 2024-02-20 name: Epilepsy Foundation of America class: OTHER briefSummary: The Epilepsy Learning Health System (ELHS) is a quality improvement and research network to improve outcomes for people with epilepsy. The ELHS is designed as a model of value-based chronic care for epilepsy as envisioned by the National Academies of Medicine Committee in their landmark reports "The Learning Health System" and "Epilepsy Across the Spectrum: Promoting Health and Understanding".

The ELHS network is a collaboration among clinicians, patients and researchers that promotes the use of data for multiple purposes including one-on-one clinical care, population management, quality improvement and research. The ELHS Registry includes data on children and adults with epilepsy collected during the process of standard epilepsy care. These data are used to create population health reports and to track changes in outcomes over time. ELHS teams use quality improvement methods, such as Plan-Do-Study-Act (PDSA) cycles, to continuously learn how to improve care. conditions: Epilepsy conditions: Seizure Disorder conditions: Neurologic Disorder conditions: Rare Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 1000 type: ESTIMATED name: Clinical care and quality improvement measure: Seizure Frequency measure: Seizure Freedom measure: Quality of Life documentation sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Barrow Neurological Institute Comprehensive Epilepsy Center status: RECRUITING city: Phoenix state: Arizona zip: 85013 country: United States name: Malinda Brooks-Busch, MPH role: CONTACT phone: 602-406-3443 email: Malinda.Brooks-Busch@dignityhealth.org name: Sue Herman, MD role: PRINCIPAL_INVESTIGATOR lat: 33.44838 lon: -112.07404 facility: University of Southern California status: RECRUITING city: Los Angeles state: California zip: 90032 country: United States name: Alissa Maier, MPH role: CONTACT phone: 937-545-2627 email: Alissa.Maier@med.usc.edu name: Christi Heck, MD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 facility: Epilepsy Foundation status: RECRUITING city: Bowie state: Maryland zip: 20716 country: United States name: Kathleen Farrell, MB BCh BAO role: CONTACT phone: 732-832-5983 email: kfarrell@efa.org name: Saniya Griffin role: CONTACT email: elhs@efa.org name: Brandy Fureman, Ph.D role: PRINCIPAL_INVESTIGATOR lat: 38.94278 lon: -76.73028 facility: Partners - Massachusetts General Hospital Epilepsy Service (MGH)/ Partners - Brigham and Women's (BWH) status: RECRUITING city: Boston state: Massachusetts zip: 02114 country: United States name: Jason Raymond Smith role: CONTACT phone: 617-726-3311 email: JSMITH114@PARTNERS.ORG name: Daniel Hoch, MD, Ph.D role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Beth Israel Deaconess Medical Center's Comprehensive Epilepsy Program status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02215 country: United States name: Jennifer Sabbagh role: CONTACT phone: 617-975-8545 email: jsabbagh@bidmc.harvard.edu name: Bernard Chang, M.D., M.M.Sc. role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Cincinnati Children's Hospital Comprehensive Epilepsy Center (CCHMC) status: NOT_YET_RECRUITING city: Cincinnati state: Ohio zip: 45229 country: United States name: Naima Griffin role: CONTACT phone: 513-636-9933 email: naima.griffin@cchmc.org name: Katie Holland role: PRINCIPAL_INVESTIGATOR lat: 39.12713 lon: -84.51435 facility: University of Cincinnati Gardner Neuroscience Institute Epilepsy Center status: NOT_YET_RECRUITING city: Cincinnati state: Ohio zip: 45267 country: United States name: Lucy Mendoza, CCRP role: CONTACT phone: 513-558-3020 email: mendozlc@UCMAIL.UC.EDU name: David Ficker, MD role: PRINCIPAL_INVESTIGATOR lat: 39.12713 lon: -84.51435 facility: Penn State Hershey status: NOT_YET_RECRUITING city: Hershey state: Pennsylvania zip: 17033 country: United States name: Jessica Beiler, MPH,CCRC role: CONTACT phone: 717-531-5656 email: jbeiler@pennstatehealth.psu.edu name: William Trescher, MD role: PRINCIPAL_INVESTIGATOR lat: 40.28592 lon: -76.65025 facility: Children's Hospital of Philadelphia (CHOP) status: NOT_YET_RECRUITING city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Nicholas Abend role: CONTACT email: abend@email.chop.edu name: Nicholas Abend, MD, MSCE role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 facility: UT Southwestern Children's Dallas status: RECRUITING city: Dallas state: Texas zip: 75063 country: United States name: Bonnie Jenkins, LCSW role: CONTACT phone: 214-456-0614 email: bonnie.jenkins@childrens.com name: Deepa Sirsi, MD role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 hasResults: False

 nctId: NCT06265090 id: F.P.T 2307017 briefTitle: Effect of Lumbar Stabilization Exercises Combined With Ball and Balloon Exercise in Treatment of Chronic Non-specific Low Back Pain overallStatus: COMPLETED date: 2022-01-10 date: 2022-12-20 date: 2023-01-10 date: 2024-02-20 date: 2024-02-20 name: Delta University for Science and Technology class: OTHER briefSummary: \[Background\] Low back pain occurs when a poor lifestyle weakens the muscular strength of the waist and excessive loads on and tensions of the muscles create pain. Mediating muscle weakening to stabilize the trunk is an important aspect in the recovery of body function in patients with LBP \[Purpose\], this study was conducted to investigate the effect of core stability exercises combined with ball and balloon exercises on chronic non-specific low back pain. \[Subjects and Methods\] a sixty patient of chronic non-specific low back pain were randomly assigned into two groups, group (A) received core stability exercises combined with ball and balloon exercises and group (B) received core stability exercises, these exercises were performed for three times a week for four weeks. Pain was assessed by visual analogue scale (VAS). Spinal function was measured by Arabic Oswestery Disability Index (AODI) and pulmonary function was assessed by pulmonary function test including forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), FEV1/FVC, maximum voluntary ventilation (MVV) and peak expiratory flow (PEF) before and after the study.

Keywords: core stability exercises, ball and balloon exercises, chronic non-specific low back pain conditions: Chronic Mechanical Low Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This randomized controlled experimental trial was carried out at the outpatient clinic of faculty of physical therapy, Delta University for science and technology from April 2023 to October 2023. The aims of the study and the study protocol were explained for each patient before participation in the study. All patients signed an approved informed consent form for participation in this study. Before starting the treatment program, a complete history and physical examination will be taken for all patients.

Subjects:

Seventy male and female physiotherapy students have chronic non-specific low back pain will be chosen from faculty of physical therapy, delta university for science and technology.

The local ethics committee approved this study (Delta University for science and technology, faculty of Physical Therapy, Ethics committee F.P.T 2307017). primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: the participants were selected randomly without their knowledge about in experimental or control group the assessor was for assessment only and the therapist was for treatment only whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ACTUAL name: therapeutic exercises name: exercises measure: visual analogue score measure: forced expiratory volume in the first second (FEV1) in liters measure: forced vital capacity (FVC) in liters measure: FVC/FEV1 ratio measure: maximum voluntary ventilation (MVV) measure: peak expiratory flow (PEF) in liter/min measure: Arabic Oswestery Disability Index (AODI) for functional assessment measure: weight measure: age measure: height sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Delta University For Science and Technology city: Al Manşūrah state: Gamasah zip: 11152 country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False

 nctId: NCT06265077 id: 2023-199 briefTitle: Novel Preventive Approach Against Filgrastim-Induced Bone Pain in Cancer Patients overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-08 date: 2024-08 date: 2024-02-20 date: 2024-02-20 name: Noha Mansour class: OTHER briefSummary: No randomized controlled trial evaluated the safety and efficacy of double blockade on G-CSF induced bone pain. Therefore, this study aims to evaluate the efficacy and safety of double blockade on the incidence and severity of G-CSF induced bone pain. conditions: Breast Cancer conditions: Filgrastim Adverse Reaction studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 60 type: ESTIMATED name: Placebo name: famotidine and loratadine measure: The incidence of grade 2 or 3 bone pain in cycle 1 according to Common Terminology Criteria for Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06265064 id: KhonKaenUniversity briefTitle: STOP-Bang Score and Factors Predicting Difficult Intubation for Prediction of Difficult Mask Ventilation in Obese Patients overallStatus: COMPLETED date: 2022-07-11 date: 2023-10-31 date: 2023-10-31 date: 2024-02-20 date: 2024-02-20 name: Khon Kaen University class: OTHER briefSummary: The goal of this prospective observational study is to test combination of STOP-Bang score and factors predicting difficult intubation can improve accuracy of prediction difficult mask ventilation in obese patients that undergoing to elective surgery under general anesthesia.

The main question\[s\] it aims to answer are:

* Can combination of STOP-Bang score and factors predicting difficult intubation improve accuracy of prediction difficult mask ventilation in obese patients?
* Study about complication after endotracheal tube insertion in obese patients that undergoing to elective surgery under general anesthesia.

Participants who undergoing to elective surgery under general anesthesia will

* Routine preoperative evaluation and ask about STOP bang questions, evaluate neck circumference, Mallampati grade,Thyromental distance (That routine physical examination for anesthetic care pre-operation)
* In operation room, patients will be inducted anesthesia by anesthesiologist (step routine for general anesthesia),observe difficult mask ventilation grading before intubate endotracheal tube and complication after endotracheal tube insertion.

If there is a comparison group:

Researchers will compare obese patients with/without high STOP bang score \>=3 point plus factor predicting difficult intubation (Mallampati grade 3-4, Neck circumference \> 42 cm, Thyromental distance \< 6 cm)to prediction difficult mask ventilation conditions: Obesity conditions: OSA studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 278 type: ACTUAL name: STOP-Bang score >= 3 with factors predicting difficult intubation measure: Difficult mask ventilation measure: Resipiratory complication sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: KhonKaen University city: Nai Muang state: Khonkaen zip: +66 country: Thailand lat: 15.17901 lon: 100.1282 hasResults: False

 nctId: NCT06265051 id: 100939 briefTitle: Tirofiban After Successful MT Recanalization in AIS acronym: ATTRACTION overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-03-01 date: 2027-09-01 date: 2024-02-20 date: 2024-04-02 name: Xiang Luo class: OTHER name: Wuhan Central Hospital name: Wuhan University name: Renmin Hospital of Wuhan University name: Second Affiliated Hospital of Soochow University name: The First Affiliated Hospital of Zhengzhou University name: Wuhan Hospital of Traditional Chinese Medicine name: The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture name: Huangshi Central Hospital, China name: The First Affiliated Hospital of Yangtze University name: The Fifth Hospital of Wuhan name: Wuhan Puren Hospital name: Xiangyang No.1 People's Hospital name: Xianning Central Hospital name: Wuhan Hanyang Hospital name: Wuhan Third Hospital name: Yichang Central People's Hospital name: Affiliated Hospital of Chengde Medical University name: Beijing Tiantan Hospital name: Nanyang Central Hospital name: Jingzhou Central Hospital name: Taihe Hospital name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School briefSummary: Acute ischemic stroke with large vessel occlusion is a frequently occurring life-threatening condition. Although endovascular treatment can effectively open occluded vessels, the successful reperfusion rate exceeds 80%, but the rate of good prognosis is less than 50%. The current clinical focus is on how to improve futile recanalization. Tirofiban is widely used in the treatment of stroke, as it can effectively prevent vascular reocclusion and improve microcirculation perfusion. It has the potential to improve futile recanalization, but there is a lack of high-level evidence-based medical support. This multicenter, prospective, double-blind, randomized controlled trial was conducted to assess the effectiveness and safety of sequential tirofiban therapy following successful mechanical thrombectomy within 24 hours of onset. conditions: Acute Ischemic Stroke conditions: Vessel Occlusion studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1360 type: ESTIMATED name: Tirofiban name: Saline placebo measure: Proportion of patients functionally independent (mRS score 0 to 2) at 90 days measure: Number of participants with symptomatic intracranial hemorrhage measure: Modified ranking scale (mRS) measure: Proportion of patients non-disabled (mRS score 0 to 1) or return to pre-morbid mRS score at 90 days (for patients with mRS > 1) measure: Proportion of patients ambulatory or bodily needs-capable or better (mRS score 0 to 3) measure: Number of participants with improvement of neurological function measure: Health-related quality of life, assessed with the European Quality Five Dimensions Five Level scale (EQ-5D-5L) measure: All-cause mortality measure: Proportion of intracranial hemorrhage of any type sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06265038 id: SANAT-CAGE-2022 briefTitle: Confirmatory Investigation to Evaluate the Performance and Safety of ReSpace TiCell Cage Implants in TLIF overallStatus: RECRUITING date: 2024-02-01 date: 2026-02-01 date: 2026-10-01 date: 2024-02-20 date: 2024-02-21 name: Sanatmetal Orthopaedic and Traumatologic Equipment Manufacturer Ltd. class: INDUSTRY briefSummary: The primary objective of this study is to confirm superiority for the efficacy of the ReSpace Ticell Cage implants in Transforaminal Lumbar Interbody Fusion compared to state-of-the-art.

The secondary objective of the study is to evaluate further efficacy and safety of the ReSpace Ticell Cage implants in Transforaminal Lumbar Interbody Fusion with the following secondary efficacy and safety objectives:

* To evaluate if implantation causes significant reduction in patient's back, hip/buttock, and leg pain.
* To evaluate if implantation causes significant increase quality of life of the patients.
* To evaluate if using the device can be considered as safe overall. conditions: Degenerative Instability conditions: Spondylolisthesis conditions: Post-discectomy Syndrome conditions: Post-traumatic Instability studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, single-arm, open-label clinical trial. This clinical investigation addresses to collect data on clinical performance, effectiveness and safety of Sanatmetál's ReSpace TiCell Cage in human subjects following the good clinical practice according to the Medical Device Regulation (MDR) \& EN ISO 14155:2020. The study is conducted in Hungary at National Center for Spinal Disorders. primaryPurpose: OTHER masking: NONE count: 99 type: ESTIMATED name: ReSpace TiCell Cage measure: CT imaging_1 - cumulative fusion rate measure: CT imaging_2 - fusion status measure: Visual Analog Scale measure: Oswestry Disability Index (ODI) measure: AE and ADE measure: Complications measure: Surgical revisions sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Center for Spinal Disorders status: RECRUITING city: Budapest state: Pest zip: 1126 country: Hungary name: Aron Lazary, MD, PhD role: CONTACT phone: +36118877900 phoneExt: 5671 email: lazary.aron@gmail.com lat: 47.49801 lon: 19.03991 hasResults: False

 nctId: NCT06265025 id: GM103-CT-101 briefTitle: GM103 Intratumoral Injection in Patients With Locally Advanced, Unresectable, Refractory and/or Metastatic Solid Tumors overallStatus: RECRUITING date: 2024-02-20 date: 2025-05-30 date: 2028-10-30 date: 2024-02-20 date: 2024-03-21 name: GeneMedicine Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study is to measure safety, tolerability, and preliminary antitumor efficacy of GM103 administered alone and in combination with pembrolizumab in patients with locally advanced, unresectable, refractory and/or metastatic solid tumors (including but not limited to head and neck cancer, malignant melanoma, CRC, renal cell carcinoma, cervical cancer, and breast cancer). Study details include: conditions: Head and Neck Cancer conditions: Malignant Melanoma conditions: Colorectal Cancer conditions: Renal Cell Carcinoma conditions: Cervical Cancer conditions: Breast Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Dose escalation and dose expansion primaryPurpose: TREATMENT masking: NONE count: 125 type: ESTIMATED name: GM103 (Part A) name: GM103 (Part B) name: GM103 and Pembrolizumab (Part C) measure: Percentage of patients with DLTs by cohorts measure: Percentage of patients with DLTs measure: Incidence of AEs, AESIs, SAEs, AEs leading to discontinuation, and AEs resulting in death measure: ORR measure: DCR defined as the proportion of patients whose BOR was CR, PR and SD measure: Median PFS defined as the time from the date of the first administration of study drug to the date of disease progression or death measure: Incidence of GM103 detection measure: Changes in the level of anti-adenovirus antibodies(ADA) in blood compared to baseline (ADA in genome copies/mL using qPCR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Center status: NOT_YET_RECRUITING city: Goyang-si state: Gyeonggi-do zip: 10408 country: Korea, Republic of name: WY Choi role: CONTACT lat: 37.65639 lon: 126.835 facility: Korea University Anam Hospital status: NOT_YET_RECRUITING city: Seoul zip: 02841 country: Korea, Republic of name: SH Lee role: CONTACT lat: 37.566 lon: 126.9784 facility: Hanyang University Seoul Hospital status: NOT_YET_RECRUITING city: Seoul zip: 04763 country: Korea, Republic of name: MS Chung role: CONTACT lat: 37.566 lon: 126.9784 facility: Severance Hospital, Yonsei University Health System status: RECRUITING city: Seoul country: Korea, Republic of name: JY Lee role: CONTACT lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06265012 id: PHV01-C-101 briefTitle: Study to Evaluate the Recombinant Vesicular Stomatitis Virus (rVSV)-Marburg Virus Vaccine Candidate (PHV01) in Healthy Adult Subjects acronym: PHV01 overallStatus: RECRUITING date: 2024-02-05 date: 2024-04-17 date: 2024-09-16 date: 2024-02-20 date: 2024-02-22 name: Public Health Vaccines LLC class: INDUSTRY name: Biomedical Advanced Research and Development Authority briefSummary: This is a Phase 1 randomized, single-blind, placebo-controlled, ascending dose study to evaluate the safety and immunogenicity of rVSV∆G-MARV-GP \[Angola\] (PHV01, Marburg Virus glycoprotein \[MARV GP\] Vaccine) in healthy adults. PHV01 is a live, attenuated rVSV vaccine expressing the MARV GP. The main questions it aims to answer are:

* Which dose of PHV01 is safe to administer to, and well-tolerated by healthy adult subjects?
* What is the immunologic response (Marburg-specific Immunoglobulin G (IgG) ELISA antibody and neutralizing antibodies) to each dose level?

Participants will receive 1 intramuscular injection of PHV01 or placebo on Day 1 and will be followed for 181 days. conditions: Marburg Virus Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: Single-blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: PHV01 name: Placebo measure: Solicited Adverse Events (AEs) measure: Unsolicited AEs measure: Other AEs measure: Immunogenicity, Antibodies (Ab) measure: Immunogenicity, Neutralizing antibodies (NEUT) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: CenExel RCA status: RECRUITING city: Hollywood state: Florida zip: 33024 country: United States name: Terry Piedra role: CONTACT phone: 305-596-3125 email: t.piedra@cenexel.com name: Amanda Gonzalez role: CONTACT phone: 813-817-7984 email: amanda.gonzalez@cenexel.com name: Craig Shapiro, MD role: PRINCIPAL_INVESTIGATOR lat: 26.0112 lon: -80.14949 hasResults: False

 nctId: NCT06264999 id: 427976 briefTitle: Robotic Assisted Knee Arthroplasty - Retain the Anterior Cruciate Ligament or Not overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-04 date: 2026-04 date: 2024-02-20 date: 2024-02-23 name: St. Olavs Hospital class: OTHER name: Smith & Nephew, Inc. briefSummary: The goal of this clinical trial is to compare the function of the knee after retaining or sacrificing the anterior cruciate ligament in robotic assisted knee arthroplasty.

The main questions it aims to answer are:

Does retaining the anterior cruciate ligament improve postoperative gait? Participants will perform

* Gait analysis
* Stair performance test
* CT based Micromotion analysis of the implant micromovement conditions: Arthritis Knee conditions: Arthroplasty conditions: Gait Analysis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Journey II CR name: Journey II XR measure: Preferred walking speed (meter/minute) after surgery measure: CT-RSA measured maximum total point of motion(MTPM) measure: evaluation of max walking speed(m/minute) measure: stride length(cm) measure: step length in mid stance phase (cm) measure: single leg support time(s) measure: double-leg support time(s) measure: stair performance(s) measure: Rating pain using NRS (Numeric Rating Scale). measure: KOOS-PS (Knee Injury and Osteoarthritis Outcome score) measure: Clinical evaluation of range of motion . measure: Rating outcome using EQ-5D-5L(European quality of life index version 5D-5L), measure: IKSS (International Knee Society System knee and function score) measure: FJS-12 (Forgotten Joint score) measure: Clinical evaluation of Anteroposterior stability. measure: Clinical evaluation of Mediolateral stability. measure: A long leg X-Ray identifying outliers with Hip Knee Ankle angle Varus <-3 ºor Valgus >3 º measure: Presence of eminence fractures sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St.Olavs Hospital city: Trondheim state: Trøndelag zip: 7006 country: Norway name: Anders Sjøstrøm, MD role: CONTACT phone: +4772575241 email: anders.sjostrom@stolav.no name: Siri Bjørgen Winther, PhD role: SUB_INVESTIGATOR name: Sølvi Liabekk Selli role: SUB_INVESTIGATOR lat: 63.43049 lon: 10.39506 hasResults: False

 nctId: NCT06264986 id: 2023-09-02 briefTitle: The Effects of Ashwagandha (Withania Somnifera) Supplementation on Exercise Performance in Female Footballers overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-13 date: 2024-02-21 date: 2024-02-21 date: 2024-02-20 date: 2024-02-20 name: Blanca Roman-Viñas, MD class: OTHER briefSummary: The goal of this clinical trial is to evaluate the effects of short-term root extract ashwagandha supplementation on exercise performance in female footballers. The main question it aims to answer are:

Will short-term supplementation of root extract ashwagandha improve muscle strength markers in female footballers? Will short-term supplementation of root extract ashwagandha improve perception of recovery following high-intensity exercise in female footballers?

Participants will either supplement 600mg (5% withanolides) root extract ashwagandha or placebo once a day for 28 days. There will be three data points: baseline, 14 days and 28 days. Researchers will compare values of intervention against placebo to see if there is an effect on muscle strength or perception of recovery. conditions: Muscle Strength studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double-blind, placebo-controlled, randomised trial primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 30 type: ACTUAL name: Ashwagandha name: Placebo measure: Increased lower body muscle strength measure: Increased maximum voluntary muscle strength measure: Increased upper body muscle strength and explosiveness measure: Improved overall muscle strength measure: Improved perception of wellbeing measure: Improved perception of recovery sex: FEMALE minimumAge: 17 Years maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: Club Esportiu Seagull city: Badalona state: Barcelona zip: 08917 country: Spain lat: 41.45004 lon: 2.24741 hasResults: False

 nctId: NCT06264973 id: NL9318 briefTitle: Maternal and Fetal/Neonatal Pharmacokinetics and - Dynamics of Corticosteroids During Pregnancy acronym: MaDyCo overallStatus: RECRUITING date: 2021-01-01 date: 2025-06-01 date: 2025-12-01 date: 2024-02-20 date: 2024-02-20 name: Erasmus Medical Center class: OTHER briefSummary: Improving pregnancy outcome is essential in improving health of both parents and their offspring during the life course. Preterm birth (PTB) occurs in 10-15% of all pregnancies, is the leading cause of perinatal mortality and morbidity {Goldenberg, 2008}, has long-term adverse consequences for postnatal health {Huddy, 2001} and is a burden for health care expenditure. In order to improve neonatal outcome, antenatal corticosteroids (ACS) are routinely administered to women at risk for preterm delivery before 34 weeks of pregnancy. {Jobe, 2018;Roberts, 2017;Travers, 2018} However, the current, worldwide standard of care, for the use of ACS is still based on animal experiments performed in the 1970's. {Liggins, 1969} Although ACS treatment to improve neonatal outcome was clinically introduced in the 70's, still only two dosing regimens are used, neither of which have been investigated, re-evaluated or refined to determine the optimal doses or treatment interval. With the current health care approach of personalized medicine in mind, the same universal approach for everybody, independent of gestational age, number of fetus, maternal weight or comorbidity one dose does not fit all since it often has not the desired effect. Due to the lack of optimization of the above mentioned synthetic corticosteroid drug regimens {Kemp, 2019}, significant gaps in knowledge exist. An important aspect to set up, investigate and understand dosing and also dosing interval experiments, is knowledge of the maternal individual pharmacokinetics and pharmacogenetics of the drug of interest during pregnancy. conditions: Preterm Birth studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Pharmacokinetics of antenatal corticosteroids by investigation of betamethasone concentrations in serum measure: Maternal age measure: Fetal sex measure: Maternal weight/BMI measure: Number of fetus measure: Parity: the number of times a woman has given birth to a live neonate (any gestation) or at 24 weeks or more measure: PE by urine measurement of protein-creatinine ratio measure: Oestradiol concentration in serum measure: Cord blood and neonatal blood measure: CYP3A4 level sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erasmus Medical Center status: RECRUITING city: Rotterdam state: Zuid Holland zip: 3015GD country: Netherlands name: Sam Schoenmakers, MD, PhD role: CONTACT phone: +31107037439 email: s.schoenmakers@erasmusmc.nl name: Emma Ronde-Salminen, MD role: CONTACT phone: 0031683997312 email: e.ronde@erasmusmc.nl lat: 51.9225 lon: 4.47917 hasResults: False

 nctId: NCT06264960 id: E10208771 briefTitle: The Effect of Music Therapy and Breathing Exercise on Anxiety and Pain in Patients Undergoing Coronary Angiography overallStatus: COMPLETED date: 2022-09-15 date: 2023-05-30 date: 2023-10-02 date: 2024-02-20 date: 2024-02-20 name: Ulku Gunes class: OTHER briefSummary: Coronary angiography serves as the primary diagnostic technique for cardiovascular disease. However, this invasive procedure commonly triggers pain, anxiety, and fear in patients. The objective of this randomized controlled trial was to examine the impact of music and breathing exercises on anxiety and pain levels in individuals undergoing coronary angiography. The study, conducted as a single-blind, randomized controlled trial, involved a sample of 165 patients, with 55 in each group: the control group, the breathing exercise group, and the music therapy group. Patients in the music group listened to music during angiography, those in the breathing exercise group practiced exercises 30 minutes before the procedure, while the control group received standard treatment. Anxiety levels were assessed both before and after the procedure, and pain levels were measured post-procedure. The study strictly adhered to the CONSORT statement guidelines. conditions: Procedural Pain conditions: Procedural Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This single-center, single-blind, randomized controlled trial was conducted in Izmir, Turkey, from July 2021 to July 2022. Participants were randomly assigned to one of three groups: intervention 1 (music), intervention 2 (breathing exercises), or control (standard care), in a 1:1:1 ratio. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The nurse responsible for conducting all measurements, including pain and anxiety assessments using the Visual Analog Scale (VAS) and State-Trait Anxiety Inventory (STAI), was not part of the research team.

The nurse, being independent and not aware of the participants' group assignments, helps to ensure that the assessments are conducted impartially, without knowledge of which intervention each participant received. whoMasked: OUTCOMES_ASSESSOR count: 512 type: ACTUAL name: Music therapy name: Breathing exercise measure: State-Trait Anxiety Inventory measure: Visual Analog Scale sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ege University city: Bornova state: İzmir zip: 35100 country: Turkey lat: 38.47921 lon: 27.2399 facility: Ülkü Güneş city: Bornova state: İzmir zip: 35100 country: Turkey lat: 38.47921 lon: 27.2399 hasResults: False

 nctId: NCT06264947 id: CMUH112-REC2-141 briefTitle: Efficacy of Laser Acupuncture on Zanzhu (BL02) for Dry Age-related Macular Degeneration overallStatus: ENROLLING_BY_INVITATION date: 2024-01-26 date: 2024-11-01 date: 2024-11-01 date: 2024-02-20 date: 2024-02-20 name: China Medical University Hospital class: OTHER briefSummary: This study is to see if laser acupuncture is a better way to treat dry-AMD (Age-related Macular Degeneration) compared to sham laser acupuncture, in the aspect of visual acuity. Investigators planed to recruit participants who are diagnosed with dry-AMD, and not younger than 20 years old. Before the study, investigators will measure the participants' BCVA (Best Corrected Visual Acuity), and then practice laser acupuncture and sham-laser acupuncture on experiment group and control group respectively. After the 4-week study, investigators will measure the participants' BCVA again. conditions: Age-related Macular Degeneration studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: laser acupuncture name: sham laser acupuncture measure: BCVA (Best Corrected Visual Acuity) sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: China Medical University Hospital city: Taichung zip: 404 country: Taiwan lat: 24.1469 lon: 120.6839 hasResults: False

 nctId: NCT06264934 id: DiCECT briefTitle: An Investigation Into Dielectric Assessment of Permittivity and Cancer in Human Using a Novel Electrical Capacitance Tomography Scanner acronym: DiCECT overallStatus: RECRUITING date: 2024-01-25 date: 2024-12 date: 2024-12 date: 2024-02-20 date: 2024-02-23 name: Zedsen Limited class: INDUSTRY name: Imperial College Healthcare NHS Trust briefSummary: The goal of this observational study is to investigate the ability of a the Z-scanner to identify and differentiate cancer and benign lesions from healthy breast tissue based on permittivity. The main questions it aims to answer are:

1. Determine the permittivity values of the Z-scanner associated with healthy, benign, and malignant tissue in human breasts.
2. Determine the repeatability, reproducibility, inter-and intra-operator variability of the Z-scanner. conditions: Breast Cancer conditions: Benign Breast Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 90 type: ESTIMATED name: Breast scan using the Z-scanner name: Breast scan using the Z-scanner measure: Measurement of complex permittivity of breast tissue components measure: Permittivity target-to-background contrast ratios for targets of interest (e.g. malignant lesion, benign lesion) measure: Repeatability of the Z-scanner measure: Reproducibility of the Z-scanner sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Imperial College Healthcare NHS Trust status: RECRUITING city: London country: United Kingdom name: Lesley Honeyfield role: CONTACT name: Adrian Lim role: PRINCIPAL_INVESTIGATOR name: Deborah Cunningham role: SUB_INVESTIGATOR name: Sylvie Flais role: SUB_INVESTIGATOR lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06264921 id: NKT3447-101 briefTitle: A Study With NKT3447 for Adults With Advanced/Metastatic Solid Tumors overallStatus: RECRUITING date: 2024-02-23 date: 2025-03 date: 2025-05 date: 2024-02-20 date: 2024-04-12 name: NiKang Therapeutics, Inc. class: INDUSTRY briefSummary: The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) to determine the maximum tolerated dose (MTD) and/or preliminary recommended dose for expansion (RDE) of NKT3447 in adults with advanced or metastatic solid tumors. The goal of the Expansion phase of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and the preliminary antitumor activity of NKT3447 in adult subjects with cyclin E1 (CCNE1) amplified ovarian cancer at the RDEs selected in Dose Escalation and to determine the preliminary recommended phase 2 dose (RP2D). conditions: Solid Tumor conditions: Solid Tumor, Adult conditions: Advanced Solid Tumor conditions: Metastatic Tumor conditions: Ovarian Cancer conditions: Ovarian Neoplasms conditions: Ovarian Carcinoma conditions: Metastatic Ovarian Carcinoma conditions: Endometrial Cancer conditions: Endometrial Neoplasms conditions: Endometrial Diseases conditions: Metastatic Endometrial Cancer conditions: Metastatic Endometrial Carcinoma conditions: Advanced Endometrial Carcinoma conditions: Advanced Ovarian Carcinoma conditions: Gastric Cancer conditions: Advanced Gastric Carcinoma conditions: Metastatic Gastric Cancer conditions: Metastatic Gastric Carcinoma conditions: Small-cell Lung Cancer conditions: Small Cell Lung Carcinoma conditions: Triple Negative Breast Cancer conditions: Triple Negative Breast Neoplasms conditions: Platinum-resistant Ovarian Cancer conditions: Platinum-refractory Ovarian Carcinoma conditions: CCNE1 Amplification conditions: Hormone Receptor Negative Breast Carcinoma conditions: Human Epidermal Growth Factor 2 Negative Carcinoma of Breast conditions: Progesterone-receptor-positive Breast Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Dose Escalation and Dose Expansion primaryPurpose: TREATMENT masking: NONE maskingDescription: Randomized for the Expansion Phase count: 90 type: ESTIMATED name: NKT3447 measure: Number of Participants with Dose Limiting Toxicity (DLT) events measure: Objective Response Rate (ORR) measure: Progression-free survival (PFS) measure: Duration of Response (DOR) measure: Disease control rate measure: Overall Survival (OS) measure: Time to Response (TTR) measure: Number of Participants with Adverse Events measure: Maximum observed plasma concentration (Cmax) of NKT3447 measure: Time to maximum observed plasma concentration of NKT3447 (Tmax) measure: Observed trough concentration of NKT3447 (Ctrough) measure: Area under the plasma concentration-time curve (AUC0-t) of NKT3447 measure: Apparent clearance (CL/F) measure: Apparent volume of distribution (V/F) measure: Half-life (t1/2) measure: Accumulation ratio (AR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sarah Cannon Research Institute at HealthONE status: RECRUITING city: Denver state: Colorado zip: 80218 country: United States name: Kelly Mozzetta role: CONTACT name: Gerald Falchook, MD, MS role: PRINCIPAL_INVESTIGATOR lat: 39.73915 lon: -104.9847 facility: AdventHealth Cancer Institute status: RECRUITING city: Celebration state: Florida zip: 34747 country: United States name: Heather Osorio role: CONTACT email: Heather.Osorio@AdventHealth.com name: Karolina Kilowski, DO role: PRINCIPAL_INVESTIGATOR lat: 28.32529 lon: -81.53313 facility: The Gabrail Pharmacology Phase 1 Research Center status: RECRUITING city: Canton state: Ohio zip: 44718 country: United States name: Carrie Smith role: CONTACT email: csmith@gabrailcancercenter.com name: Nashat Y Gabrail, MD role: PRINCIPAL_INVESTIGATOR lat: 40.79895 lon: -81.37845 facility: Texas Oncology-Austin Midtown NEXT Oncology status: RECRUITING city: Austin state: Texas zip: 78758 country: United States name: Erica Torres role: CONTACT phone: 210-610-5205 email: etorres@nextoncology.com name: Andrae Vandross, MD role: PRINCIPAL_INVESTIGATOR lat: 30.26715 lon: -97.74306 facility: START Mountain Region status: RECRUITING city: West Valley City state: Utah zip: 84119 country: United States name: Marie Asay role: CONTACT phone: 801-907-4770 email: marie.asay@startthecure.com name: Justin A Call, MD role: PRINCIPAL_INVESTIGATOR lat: 40.69161 lon: -112.00105 hasResults: False

 nctId: NCT06264908 id: 20240125-010-000 briefTitle: An Integrated Self Management Programme to Improve Outcomes in Patients With Hand Osteoarthritis acronym: OASIS-H overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-12 date: 2028-04 date: 2024-02-20 date: 2024-02-20 name: Dr Iris Tang Yan Ki class: OTHER name: Hospital Authority, Hong Kong briefSummary: The goal of this trial is to evaluate the efficacy of an integrated self-management programme in improving clinical outcomes in patients with hand osteoarthritis (OA).

This is an open-labelled, randomized controlled trial with an objective to determine the efficacy of an integrated self-management programme versus routine clinical care for participants with symptomatic hand OA.

Participants will be randomized into early intervention group and routine clinical care groups in a 1:1 ratio. Patients who randomized into early intervention group will receive 8 week integrated self-management programme delivered by occupational therapists and rheumatology nurse on hand OA management. Patients who randomized into routine clinical care group will receive usual clinical care for OA for 26 weeks and then receive an identical 8 weeks integrated self-management programme. The primary outcome is the improvement in pain at 26 weeks between the two groups. conditions: Hand Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Patients will be randomized into early intervention and routine clinical care (control) group. Patients in control group will crossover to receive the intervention at week 26. primaryPurpose: TREATMENT masking: NONE count: 90 type: ESTIMATED name: Integrated self-management programme measure: Change in Pain visual analogue scale (VAS) measure: Change in pain Visual Analogue Scale (VAS) measure: Change in Functional index hand osteoarthritis (FIHOA) measure: Change in Quick Disabilities of the Arm, Shoulder, and Hand (DASH) score measure: Change in Australian/Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 measure: Change in Short-form 36 items health survey measure: Change in hand grip strength measure: Change in hand dexterity measurement measure: Radiographic changes measure: Adverse events measure: Use of rescue pain medication sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06264895 id: Trinity College Dublin 211202 briefTitle: Protocol for a Low Threshold Exercise Intervention for Women Experiencing Homelessness and Addiction. acronym: LEAP-W overallStatus: NOT_YET_RECRUITING date: 2024-02-26 date: 2024-07-31 date: 2024-07-31 date: 2024-02-20 date: 2024-02-20 name: University of Dublin, Trinity College class: OTHER briefSummary: Background: Frailty is a complex multi-dimensional state of increased vulnerability to adverse health outcomes and is usually associated with older age but there is growing evidence of accelerated ageing and frailty in non-geriatric populations, including those experiencing socio-economic deprivation and extreme social exclusion, such as people experiencing homelessness. Addiction, as a coping mechanism for prior trauma, is common among people who are homeless and can have a gendered dimension. Women experiencing homelessness and addiction have unique needs which require a gendered approach. The aim of this study is to explore the effectiveness of an exercise intervention to target the known physical functioning deficits and frailty which this population experiences.

Methods: This mixed-methods study will explore physical functioning deficits and frailty in women experiencing homelessness and addiction, using a bespoke test battery and an exercise intervention. Physical function (10m Walk Test, 2 Minute Walk Test, Single Leg Stance Test, Chair Stand Test, hand grip dynamometry), frailty (Clinical Frailty Scale and the SHARE-FI) and nutritional status (Mini-Nutritional Status), pain (Numerical Pain Rating Scale) and quality of life (SF 12-V2) will be evaluated. The intervention will involve a 3-times weekly exercise programme with protein supplementation for 10 weeks. Following this, qualitative interviews, which will be thematically analysed using Braun \& Clarke methodology, will be conducted. This study will be conducted in Dublin from February to July 2024.

Discussion: Little is kn own about frailty-focussed interventions in women experiencing homelessness and addiction. This proposed study will help to increase the knowledge base regarding the physical health burden and frailty experienced by this extremely vulnerable population and will deliver a targeted intervention with a gendered dimension to mitigate its affects. The findings of this research will help narrow this research gap and will guide clinicians and policy makers to implement unique gender-based treatment strategies for this population. conditions: Social Exclusion conditions: Chronic Disease conditions: Physical Disability conditions: Addiction studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: single -arm longitudinal cohort study primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Exercise measure: Recruitment measure: Retention measure: Adverse events measure: Hand grip dynamometry measure: Limb circumference measure: 10 Metre Walk Test measure: 2 Minute Walk Test measure: The Chair Stand Test measure: Single Leg Stance Test measure: Numerical Rating Scale (NRS) measure: Clinical Frailty Scale (CFS) measure: SHARE-Frailty Instrument (FI) measure: Mini Nutritional Assessment (MNA) measure: Short Form-12 V2 sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06264882 id: 23-1518 id: U54AG062319 type: NIH link: https://reporter.nih.gov/quickSearch/U54AG062319 briefTitle: Cardiometabolic Consequences of the Loss of Ovarian Function acronym: LILAC overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2028-05-31 date: 2028-08-31 date: 2024-02-20 date: 2024-02-20 name: University of Colorado, Denver class: OTHER name: National Institute on Aging (NIA) briefSummary: The menopause transition is associated with a decrease in artery health and an increased risk for weight gain in storing fat in the stomach area which may increase the risk for heart disease. The purpose of this research is to study how the decrease in estrogen at menopause changes artery health and fat gain, and risk of disease in women as they age. The first aim in this study will determine whether short term and long term low estrogen levels in premenopausal women decreases artery function and whether this is related to an increase in fat in the stomach area. The second aim will determine whether the changes in artery health and body fat are related to changes in a pathway that breaks down an important amino acid called tryptophan. This pathway is thought to play a role in regulating the aging process. Therefore, the investigators will determine whether the decrease in artery health and the increase in body fat in the stomach region with low estrogen is related to changes in this pathway in the blood, in vascular cells and fat tissue. Because estrogen levels fluctuate in premenopausal women, the investigators will use an approach (intervention) that controls estrogen levels to address these aims. The investigators will use a medication that is typically used to treat endometriosis or uterine fibroids to lower estrogen levels and an estrogen patch to increase estrogen in some women. Some women will receive a patch that has no estrogen (called a placebo patch). The intervention period will be 20 weeks. The study will provide us with new knowledge on how low estrogen with menopause affects artery health and fat gain estrogen. conditions: Menopause conditions: Estrogen Deficiency conditions: Aging conditions: Adiposity studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Degarelix name: Transdermal Estradiol Patch name: Transdermal Placebo Patch measure: Brachial artery flow mediated dilation (FMD) measure: Visceral fat area (VFA) measure: Subcutaneous fat area measure: Tryptophan-Kynurenine metabolites measure: Body composition - mass measure: Body composition - bone measure: Oxidized LDL measure: Total antioxidant status measure: Pro-inflammatory cytokines measure: Blood lipids and lipoproteins measure: Blood glucose measure: Insulin measure: Adipokines measure: Physical activity levels measure: Endothelial cell protein measures measure: Ex vivo serum exposure studies measure: Cerebrovascular function measure: Arterial Stiffness measure: Carotid artery stiffness measure: Blood pressure measure: Self reported sleep quality measure: Cognitive function sex: FEMALE minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT facility: University of Colorado Anschutz Medical Campus city: Aurora state: Colorado zip: 80045 country: United States lat: 39.72943 lon: -104.83192 hasResults: False

 nctId: NCT06264869 id: 141123 briefTitle: Interdental Guided Creeping Technique overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-11 date: 2024-11 date: 2024-02-20 date: 2024-02-20 name: October 6 University class: OTHER briefSummary: The aim of this randomized clinical trial is to treat interdental papillary deficiency with minimally invasive interdental guided creeping technique (IGCT) comparing collagen membrane versus connective tissue graft. conditions: Interdental Papilla Recession studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Interdental guided creeping technique (IGCT) and connective tissue graft (CTG) name: Interdental guided creeping technique (IGCT) and collagen membrane (CM) measure: Black triangle height measure: Percentage of interdental papillary fill measure: Papillary gain, black triangle reduction measure: Papillary height, attached gingiva width measure: Pocket depth, clinical attachment level, keratinized tissue thickness measure: Plaque index measure: Gingival index measure: Duration of surgery measure: Patient Reported Outcome measure: Patient Reported Outcome sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False

 nctId: NCT06264856 id: 202210096RIND briefTitle: Bronchoscopy for Thoracic Trauma Patients overallStatus: SUSPENDED date: 2024-12-01 date: 2025-12-31 date: 2025-12-31 date: 2024-02-20 date: 2024-02-20 name: National Taiwan University Hospital class: OTHER briefSummary: The study aims to evaluate the effectiveness of bronchoscopic sputum suction in patients with severe thoracic illness-induced respiratory failure. The study will compare the outcomes of patients who receive bronchoscopic sputum suction versus blind negative pressure aspiration for sputum removal. The study will measure baseline data, postoperative blood gas conditions, and clinical parameters, such as time of invasive ventilation, total time of ventilation, hospital stay, weaning success rate, reintubation rate, ventilator-associated pneumonia incidence, and fatality rate. The study aims to determine whether bronchoscopy-assisted sputum removal is superior to blind negative pressure aspiration in improving patient outcomes. conditions: Chest Trauma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: bronchoscopic sputum suction name: negative pressure aspiration suction measure: Rate of pneumonia measure: Intensive Care Unit admission interval measure: admission interval measure: tracheostomy rate measure: intubation rate sex: ALL minimumAge: 20 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Traumatology, National Taiwain University Hospital city: Taipei zip: 10002 country: Taiwan lat: 25.04776 lon: 121.53185 facility: NTUH Hsin-Chu Branch; NTUH Yun-Lin Branch city: Taipei zip: 100; 300; 640; 280 country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06264843 id: 724 briefTitle: Peripheral Bypass Trial for Completion Control acronym: PATENT overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-12 date: 2027-12 date: 2024-02-20 date: 2024-02-20 name: Medistim ASA class: INDUSTRY briefSummary: The goal of the study is to identify and validate flow measurement and ultrasound images in patients undergoing vein bypass surgery below-knee and above ankle conditions: Chronic Limb-Threatening Ischemia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 450 type: ESTIMATED name: Medistim MiraQ system with TTFM and L15 HFUS probes measure: Primary graft patency rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06264830 id: 202307103DIPC briefTitle: 3D Visualization System in Highly Myopic Cataract Operation acronym: 3D-HiMCO overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-12 date: 2024-12 date: 2024-02-20 date: 2024-04-16 name: National Taiwan University Hospital class: OTHER name: Alcon Research briefSummary: This study aims to investigate the impact of depth of field differences between the use of the 3D imaging system (NGENUITY® 3D Visualization System, Alcon, TX, USA) and conventional optical microscope in cataract surgery for highly myopic patients on intraoperative parameters and outcomes. conditions: Cataract conditions: High Myopia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Alcon-NGENUITY®(NG)-system name: Standard cataract operation measure: Number of times of Microscopic focus adjustment, measured by counting from the video recordings measure: Total moving distance in millimeter of microscope-lens-system relative to suspension arm, measured by ruler set on microscope measure: Distance of subjective focus change in millimeter between corneal surface and surface of posterior capsule, measured by ruler set on microscope measure: Total operation time measure: Cumulative dissipated energy (CDE) of phacoemulsification, that is automatically measured and demonstrated on the screen of phacoemulsification machine (Centurion) measure: Number of Participants with intraoperative complication measure: Best-corrected visual acuity of the operated eye of Participants at each postoperative follow-up within 3 month, measured with Snellen chart under standard condition (6 meters in distance and standard illumination of environment) measure: Number of Participants with post-operative complication measure: Intraocular pressure of the operated eye of participants at each postoperative follow-up within 3 month, measured with pneumatic tonometer sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Ophthalmology, National Taiwan University Hospital city: Taipei zip: 100 country: Taiwan name: Tzyy-Chang Ho, MD role: CONTACT phone: 886-2-23123456 phoneExt: 62579 email: hotc@ntuh.gov.tw name: Cheng-Yung Lee, MD role: CONTACT phone: 886-2-23123456 phoneExt: 65190 email: G05875@hch.gov.tw lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06264817 id: EC 48 LyberT briefTitle: Auto-Adjustable MOBIDERm Autofit Armsleeve in the Management of Upper Limb Lymphedema. acronym: LyberT overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-03-15 date: 2025-04-15 date: 2024-02-20 date: 2024-02-20 name: Thuasne class: INDUSTRY briefSummary: This study aims to assess Auto-Adjustable MOBIDERM® Autofit Armsleeve effect on upper limb volume excess compared to the compression bandages to manage the volume of upper limb lymphedema in patients with breast cancer related lymphedema conditions: Lymphedema of Upper Limb studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, multi-center, interventional, controlled-randomized, single blinded study primaryPurpose: TREATMENT masking: SINGLE maskingDescription: For the same patient, all measurements will be performed as far as possible by the same health professional who doesn't have the knowledge of patient's group. whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: MOBIDERM Autofit Armsleeve name: Compressive bandaging measure: Volume excess variation measure: Resource consumption measure: Resource consumption measure: Resource consumption measure: Lymphedema related Quality of life (QoL) measure: Doctors' opinion on improving the patient's health condition measure: Patient's opinion on Global Impression of Change measure: Satisfaction about the device measure: The safety measure: Compliance to treatment measure: General quality of life (QoL) measure: Skin elasticity measure: Ttissue induration sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pinar BORMAN city: Ankara country: Turkey name: Pinar BORMAN role: CONTACT lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06264804 id: [2023] No. 86 briefTitle: Risk Factors for Progressive Suction Loss in Corneal Refractive Surgery overallStatus: RECRUITING date: 2024-02-16 date: 2024-07-01 date: 2024-12-01 date: 2024-02-20 date: 2024-04-02 name: Yifeng Yu class: OTHER briefSummary: The goal of this Prospective observational studiesis to Characteristics of progressive suction loss. conditions: Refractive Surgery studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 800 type: ESTIMATED measure: Identify risk factors for progressive suction loss sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Yuyifeng status: RECRUITING city: Nanchang state: Jiangxi zip: 330008 country: China name: yifeng Yu, Doctorate role: CONTACT phone: +8613979180258 email: 171018170@qq.com lat: 28.68396 lon: 115.85306 hasResults: False

 nctId: NCT06264791 id: STUDY00018516 id: K99AA030591 type: NIH link: https://reporter.nih.gov/quickSearch/K99AA030591 briefTitle: Stress-motivated Alcohol Use as a Value-based Decision-making Process overallStatus: RECRUITING date: 2024-02-01 date: 2024-10-01 date: 2024-10-01 date: 2024-02-20 date: 2024-02-20 name: University of Washington class: OTHER name: National Institute on Alcohol Abuse and Alcoholism (NIAAA) briefSummary: The goal of this experimental study is to improve our understanding of the effects of stress on the decision to consume (more) alcohol in regular drinkers. The main question\[s\] it aims to answer are:

* Does psychological stress affect the decision to consume (more) alcohol?
* How does psychological stress affect the decision to consume (more) alcohol? Participants will be randomly assigned to one of four conditions (stress alcohol, stress no alcohol, no stress alcohol, no stress no alcohol) and complete a value-based decision-making task twice (once before and once after the manipulations). conditions: Psychological Stress conditions: Alcohol Intoxication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: BASIC_SCIENCE masking: NONE count: 160 type: ESTIMATED name: Stress name: Alcohol measure: Proportion of choices for alcoholic over non-alcoholic drinks. sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Washington status: RECRUITING city: Seattle state: Washington zip: 98105 country: United States name: Jonas Dora, PhD role: CONTACT phone: 206-741-6330 email: jdora@uw.edu lat: 47.60621 lon: -122.33207 hasResults: False

 nctId: NCT06264778 id: 2023013 briefTitle: Exploration of Fenestration Decompression Combined With Dalafenib in the Treatment of BRAF Mutant Ameloblastoma overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-11-01 date: 2025-12-31 date: 2024-02-20 date: 2024-02-20 name: Shandong University class: OTHER briefSummary: This pilot clinical trial plans to carry out dabrafenib adjuvant therapy combined with lesion curettage after fenestrated decompressive surgery for BRAF mutation-positive multicystic ameloblastoma to explore the effectiveness of this therapy in preventing tumor recurrence, reducing or even avoiding postoperative deformity and dysfunction. effect. Based on this, we plan to launch a prospective clinical study of dabrafenib in the treatment of BRAF V600E ameloblastoma, verify the feasibility of drug treatment or drug-assisted treatment of ameloblastoma, and provide patients with a safer Effective new treatment options will benefit more patients. conditions: Ameloblastoma studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This study is a single-arm study that does not involve randomization or blinding, nor does it establish a parallel control group and uses external control. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Dabrafenib measure: objective response rate measure: Relapse-free survival sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06264765 id: 22-12-23 briefTitle: Scalp Block -Craniotomi acronym: scalp block overallStatus: RECRUITING date: 2024-01-01 date: 2025-01-01 date: 2026-01-01 date: 2024-02-20 date: 2024-02-20 name: Aydin Adnan Menderes University class: OTHER briefSummary: Postoperative pain after craniotomy is an important clinical problem as it can lead to hypertension and increased intracranial pressure. Multimodal analgesia methods are performed by anesthesiologists in different ways depending on the anesthetist's preference.

In addition, both techniques have been shown in studies to provide intraoperative hemodynamic stabilization in addition to their effects on postoperative pain. Although there are many studies on both techniques, the number of studies comparing scalp block with infiltration technique is very limited. Therefore, postoperative use of scalp block and incisional infiltration for postoperative pain after craniotomy is recommended. conditions: Hemodynamic Instability studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: randomized double blinding primaryPurpose: OTHER masking: DOUBLE maskingDescription: Blind patients and postoperative follow-ups will not know which group the patient is in the study. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 62 type: ESTIMATED name: scalp block name: Incisional infiltration measure: opioid consumption measure: The Numeric Rating Scale (NRS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ferdi Gülaştı status: RECRUITING city: Aydın zip: 09020 country: Turkey name: Ferdi Gülaştı role: CONTACT email: ferdigulasti@gmail.com lat: 37.84501 lon: 27.83963 hasResults: False

 nctId: NCT06264752 id: STUDY20120008 id: R01DK121730 type: NIH link: https://reporter.nih.gov/quickSearch/R01DK121730 briefTitle: Multi-hospital Electronic Decision Support for Drug-associated Acute Kidney Injury acronym: MEnD-AKI overallStatus: ENROLLING_BY_INVITATION date: 2024-02-15 date: 2026-01 date: 2026-04 date: 2024-02-20 date: 2024-02-20 name: University of Pittsburgh class: OTHER name: University of Florida name: University of Pittsburgh Medical Center name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: This study is a randomized controlled trial at eight hospitals within the University of Pittsburgh Medical Center-UPMC system. The project will assess the efficacy of a clinical surveillance system augmented with real-time predictive analytics to support a pharmacist-led intervention delivered to attending physicians (primary service) to reduce the progression and complications of drug-associated acute kidney injury (D-AKI) in hospitalized (non-ICU) adults. conditions: Acute Kidney Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a prospective, randomized, interventional controlled trial at eight hospitals within the UPMC health-system. Researchers will randomize 39 hospital service clusters to receive either: 1) a Cerner electronic medical record (EMR)-based AKI passive alert which is standard of care at UPMC: this alert provides decision support within the EMR for the diagnosis and basic staging of AKI but without specific recommendations for management (Usual Care Arm); or 2) protocolized stage-based intervention delivered to the physician by a pharmacist for consideration and approval. Hospital service clusters will be allocated 1:1 to the intervention or usual care with a web-based system to maintain concealment using a randomized block design. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Statisticians performing the analysis will be blinded to the treatment allocation.

The investigators will randomize clusters to intervention and control within strata defined hospitals to adjust for inherent subgroup differences. The allocation sequence list will be maintained by the data management team (DMT) using a secure web-based system where assignments will be maintained and accessed by the CDSS. Pharmacists will only receive alerts for patients of physicians randomized to the intervention. whoMasked: OUTCOMES_ASSESSOR count: 625 type: ESTIMATED name: Level A name: Level B name: Passive Alert measure: Major Adverse Kidney Events within 30 days of randomization (MAKE30) measure: Progression of AKI from time of Level B intervention (first alert generated) to hospital discharge measure: AKI Intensity: Duration of AKI for all stages; Duration of AKI Stage 2; Duration of AKI stage 3 measure: Nephrotoxic burden sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UPMC Altoona city: Altoona state: Pennsylvania zip: 16601 country: United States lat: 40.51868 lon: -78.39474 facility: UPMC Horizon city: Farrell state: Pennsylvania zip: 16121 country: United States lat: 41.21228 lon: -80.49674 facility: UPMC McKeesport city: McKeesport state: Pennsylvania zip: 15132 country: United States lat: 40.34785 lon: -79.86422 facility: UPMC Jameson city: New Castle state: Pennsylvania zip: 16105 country: United States lat: 41.00367 lon: -80.34701 facility: UPMC Magee city: Pittsburgh state: Pennsylvania zip: 15213 country: United States lat: 40.44062 lon: -79.99589 facility: UPMC Presbyterian/Montefiore city: Pittsburgh state: Pennsylvania zip: 15213 country: United States lat: 40.44062 lon: -79.99589 facility: UPMC Shadyside city: Pittsburgh state: Pennsylvania zip: 15232 country: United States lat: 40.44062 lon: -79.99589 facility: UPMC Williamsport city: Williamsport state: Pennsylvania zip: 17701 country: United States lat: 41.24119 lon: -77.00108 hasResults: False

 nctId: NCT06264739 id: 22-12-23/2 briefTitle: Erector Spinae Block -Dexmedetomidine acronym: esp -dex overallStatus: RECRUITING date: 2024-01-01 date: 2025-01-01 date: 2026-01-01 date: 2024-02-20 date: 2024-02-20 name: Aydin Adnan Menderes University class: OTHER briefSummary: Postoperative pain is common after spinal surgeries, including lumbar disc surgery. Surgical anesthesia and perioperative analgesic regimen are aimed at complete intraoperative amnesia, deep analgesia, effective control of autonomic responses and rapid discharge from the hospital.

Although there are many studies on the use of these techniques for postoperative analgesia, the number of data comparing these techniques that can be used in meta-analyses is low. In our study, investigators aimed to compare the effects of remifentanil and dexmedetomidine accompanied by ESP block, which are different multimodal analgesia methods, on pain. conditions: Postoperative Acute Pain conditions: Opioid Consumption studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: randomized double blinding primaryPurpose: OTHER masking: DOUBLE maskingDescription: Blindness patients and those who follow up after surgery will not know which group is in the study. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 74 type: ESTIMATED name: esp Dexmedetomidine (dekstomid) name: esp remifentanyl (ultiva) measure: opioid consumption measure: The Numeric Rating Scale (NRS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ferdi Gülaştı status: RECRUITING city: Aydın zip: 09020 country: Turkey name: Ferdi Gülaştı role: CONTACT email: ferdigulasti@gmail.com lat: 37.84501 lon: 27.83963 hasResults: False

 nctId: NCT06264726 id: 23-0254 id: R01HL150909 type: NIH link: https://reporter.nih.gov/quickSearch/R01HL150909 briefTitle: CommunityRx-Cardiovascular Disease acronym: CRx-CVD overallStatus: RECRUITING date: 2024-03-12 date: 2025-03-12 date: 2025-03-12 date: 2024-02-20 date: 2024-04-12 name: University of North Carolina, Chapel Hill class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: The goal of this single arm pre-test post-test design study is to test the impact of providing patients with information about community-based resources to address health-related social needs and cardiometabolic health in rural African American patients. The main question it aims to answer is:

• What is the effectiveness of community resource information on patient self-efficacy to use community resources?

Participants will be given:

* A personalized "HealtheRx" resource with information about community resources related to food, housing, utility support, transportation, and crisis support. The HealtheRx is personalized for patients based on their age and zip code.
* Access to a community resource navigator for support with using the HealtheRx upon request
* 2 text messages with reminders about the HealtheRx and access to the community resource navigator conditions: Cardiovascular Diseases conditions: Self Efficacy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 325 type: ESTIMATED name: HealtheRx measure: Change in participant self-efficacy for finding community resources measure: Change in participant knowledge of community resources measure: Change in participant utilization of community resources sex: ALL minimumAge: 2 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: OIC Family Medical Center - Fairview status: RECRUITING city: Rocky Mount state: North Carolina zip: 27801 country: United States name: Jesslyn Pope role: CONTACT email: jpope@oicone.org lat: 35.93821 lon: -77.79053 facility: OIC Family Medical Center - Happy Hill status: RECRUITING city: Rocky Mount state: North Carolina zip: 27804 country: United States name: Jesslyn Pope role: CONTACT email: jpope@oicone.org lat: 35.93821 lon: -77.79053 hasResults: False

 nctId: NCT06264713 id: CE/2023_041 briefTitle: Immersive Virtual REality for Treatment of Unilateral Spatial NEglect Via Eye-tracking Biofeedback acronym: IRENE overallStatus: RECRUITING date: 2023-11-01 date: 2025-11-01 date: 2025-12-01 date: 2024-02-20 date: 2024-02-22 name: I.R.C.C.S. Fondazione Santa Lucia class: OTHER briefSummary: The purpose of this study is to evaluate the effects of a treatment using virtual reality on the recovery of unilateral spatial neglect. The investigators hypothesize that the experimental group underwent to a protocol of active exercises within the virtual environment will show an improvement in the exploratory functions of the left hemispace, investigated with specific scales and clinical tests. conditions: Neglect, Hemispatial conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised Clinical Trial primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Double blind randomisation. The patients and their families/caregivers are blinded with respect to the group allocation. The assessors are not informed about the group allocation for the entire period of the study. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: Immersive Virtual Reality name: Sham Immersive Virtual Reality measure: Changes in the Behavioural Inattention Test measure: Changes in the Copying drawings with or without programming elements measure: Changes in the Barrage Test measure: Changes in the Wundt Justrow area illusion test measure: Changes in the Kessler Foundation Neglect Assessment Process measure: Changes in the Stroke Specific Quality of Life Scale measure: Changes in the Fugl-Meyer Assessment scale measure: Changes in reaction time e time of fixation sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Santa Lucia Foundation status: RECRUITING city: Rome state: Lazio zip: 00142 country: Italy name: Valeria Verna, MSc role: CONTACT phone: 0651501907 name: Valeria Verna, MSc role: PRINCIPAL_INVESTIGATOR name: Marco Tramontano, PhD role: SUB_INVESTIGATOR name: Alex Martino Cinnera, PhD role: SUB_INVESTIGATOR name: Viviana Betti, PhD role: SUB_INVESTIGATOR name: Matteo Marucci, PhD role: SUB_INVESTIGATOR name: Luisa Magnotti, BSc role: SUB_INVESTIGATOR name: Alessandro Matano, MSc role: SUB_INVESTIGATOR name: Aurora Tavernese, MSc role: SUB_INVESTIGATOR name: Paolucci Stefano, MD role: SUB_INVESTIGATOR lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06264700 id: STUDY00003303 id: R44HL169085 type: NIH link: https://reporter.nih.gov/quickSearch/R44HL169085 briefTitle: Applying Directly Observed Therapy to Hydroxyurea to Realize Effectiveness acronym: ADHERE overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-12 date: 2025-12 date: 2024-02-20 date: 2024-02-20 name: Nationwide Children's Hospital class: OTHER name: Ann & Robert H Lurie Children's Hospital of Chicago name: Hasbro Children's Hospital name: National Institutes of Health (NIH) name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: This study is for caregivers of young children with sickle cell disease and adolescents with sickle cell disease who are currently prescribed hydroxyurea and are receiving care at one of the study sites. The study will assess retention and engagement during a pilot randomized control trial comparing video directly observed therapy (VDOT) to attention control. We also hope to understand more about patient and family preferences longer-term adherence monitoring and intervention.

Participants will use an electronic adherence monitor (provided by the study team) to measure how often they are taking their hydroxyurea. Participants will also be asked to complete questionnaires throughout the study period to provide information about their expectations for, experience with, and satisfaction with the study materials. conditions: Sickle Cell Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: After completing a one to three-month run-in period, participants will be randomized to receive six months of either VDOT or attention control. All participants will then complete six months of ongoing monitoring during which VDOT patients will receive intermittent communication to encourage adherence and both groups will continue to use their electronic adherence monitors. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The investigators will be blinded to prevent the possibility of any differential treatment that could affect the ability of the study team to evaluate the impact of VDOT on hydroxyurea adherence. As such, a statistician will create a randomization model and study staff will facilitate communication with participants as well as between participants and the VDOT team. whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Video Directly Observed Therapy (VDOT) name: Health Reminder Tip Alerts measure: Retention Rate measure: Sustained Engagement measure: Electronic Adherence measure: Pediatric SCD Medication Self-Management Questionnaire measure: Frequency of acute care visits (ACS and VOC), ICU admissions, and LOS for hospitalizations measure: Laboratory Studies (i.e. MCV, HbF) measure: Treatment Satisfaction measure: Participant Satisfaction sex: ALL minimumAge: 11 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Lurie Children's Hospital city: Chicago state: Illinois zip: 60611 country: United States name: Sherif Badawy, MD role: CONTACT phone: 312-227-4836 email: sbadawy@luriechildrens.org lat: 41.85003 lon: -87.65005 facility: Hasbro Children's Hospital city: Providence state: Rhode Island zip: 02903 country: United States name: Patrick McGann, MD, PhD role: CONTACT phone: 617-519-9555 email: patrick_mcgann@brown.edu lat: 41.82399 lon: -71.41283 hasResults: False

 nctId: NCT06264687 id: HepcidinIVIron briefTitle: Hepcidin After Intravenous Iron Treatment overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-05-31 date: 2024-05-31 date: 2024-02-20 date: 2024-02-20 name: Pierre-Alexandre Krayenbühl class: OTHER briefSummary: The aim of this study is to investigate the hepcidin hormone response after intravenous iron administration. conditions: Iron Deficiency (Without Anemia) studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 10 type: ESTIMATED measure: Serum Hepcidin Change sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False

 nctId: NCT06264674 id: CLI-05993AB6-03 id: 2023-503333-22-00 type: OTHER domain: EMA CTIS briefTitle: Comparison Between CHF5993 pMDI 200/6/12,5mg HFA-152a VS CHF5993 pMDI 200/6/12,5mg HFA-134a in Subjects With Asthma (Trecos) acronym: TRECOS overallStatus: RECRUITING date: 2023-11-27 date: 2024-08-25 date: 2025-09-18 date: 2024-02-20 date: 2024-02-20 name: Chiesi Farmaceutici S.p.A. class: INDUSTRY briefSummary: The CLI-05993AB6-03 Study is an interventional study designed to compare potential for bronchoconstriction, safety and tolerability profile using of HFA 152a propellant versus using to HFA 134a. conditions: Asthma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double-blind multicentre, randomised, active-controlled, 2-arm, parallel-group primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Double-blind multicentre, randomised, active-controlled, 2-arm, parallel-group whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 790 type: ESTIMATED name: CHF5993 200/6/12.5 μg pMDI HFA-152a name: Inhaler CHF5993 200/6/12.5 μg pMDI HFA-134a measure: Relative change from pre-dose Forced Expiratory Volume in one second with (FEV1) (Safety Assessment to evaluate of the potential bronchoconstriction of the study treatment) measure: To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (relative change from pre-dose FEV1) measure: To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (absolute change from pre-dose FEV1) measure: To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (number and percentage of subjects with a relative decrease from pre-dose in FEV1) measure: To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (Absolute and relative changes from baseline in pre-dose FEV1) measure: To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (Change from pre-dose in FEV1) measure: Peak expiratory flow (PEF) change from baseline at each inter-visit period over the entire treatment period measure: Percentage of days without intake of rescue medication. measure: Change in the average daily use of rescue medication. measure: Change on the average daily asthma symptoms. measure: Change from baseline in Asthma Control Questionnaire 7 (ACQ 7) score. measure: To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of Adverse Events (AEs) / Adverse Drug Reactions (ADRs). measure: To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of number of Adverse Events (AEs) of particular interest. measure: To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of incident rate of Adverse Events (AEs) of particular interest. measure: To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of rate ration of Adverse Events (AEs) of particular interest. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medicines Evaluation Unit, Langley Building, Wythenshawe Hospital status: RECRUITING city: Manchester zip: M23 9QZ country: United Kingdom name: Dave Singh, MD role: CONTACT lat: 53.48095 lon: -2.23743 hasResults: False

 nctId: NCT06264661 id: HJM 006/22-R briefTitle: Effect of Cognitive Behavioral Therapy and Phototherapy on Glycosylated Hemoglobin, CLOCK Genes and Quality of Life in Patients With Type 2 Diabetes Mellitus and Insomnia overallStatus: COMPLETED date: 2022-08-08 date: 2022-09-30 date: 2022-11-30 date: 2024-02-20 date: 2024-02-20 name: Centro Interdisciplinario de Ciencias de la Salud Unidad Santo Tomás class: OTHER briefSummary: Purpose: To analyze the efficiency of Cognitive Behavioral Intervention in combination with phototherapy to reduce insomnia and improve glycemic control, quality of life, and CLOCK genes expression in patients with type 2 diabetes mellitus. Methods: Clinical, quasi-experimental, pre-post, explanatory, non-probability sampling. Subjects were invited to participate in Hospital Juárez de México. They received eight sessions of Cognitive Behavioral Therapy in combination with phototherapy. The assessment was carried out with validated instruments for Mexican population and gene expression was evaluated by real-time PCR. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Clinical, quasi-experimental, pre-post, explanatory, non-probability sampling. Subjects were invited to participate in Hospital Juárez de México. They received eight sessions of Cognitive Behavioral Therapy in combination with phototherapy. The assessment was carried outwith validated instruments for Mexican population and gene expression was evaluated by real-time PCR. primaryPurpose: TREATMENT masking: NONE count: 23 type: ACTUAL name: Effect of Cognitive Behavioral Therapy with Phototherapy in glycated hemoglobin, CLOCK genes and quality of life in patients with type 2 diabetes mellitus and insomnia measure: Sleep quality measure: Glycosylated hemoglobin measure: Quality of life measure: Insomnia measure: Gene expression analysis of CLOCK measure: Gene expression analysis of BMAL1 measure: Gene expression analysis of PER1 measure: Gene expression analysis of PER2 sex: ALL minimumAge: 40 Years maximumAge: 60 Years stdAges: ADULT facility: Centro Interdisciplinario de Ciencias de la Salud Unidad Santo Tomás city: Cdmx state: México zip: 11360 country: Mexico hasResults: False

 nctId: NCT06264648 id: AIBU-FTR-OOP-04 briefTitle: Investigation of Palpation Pressure Sensitivity overallStatus: COMPLETED date: 2023-05-03 date: 2023-06-16 date: 2023-10-20 date: 2024-02-20 date: 2024-02-20 name: Abant Izzet Baysal University class: OTHER briefSummary: The study is planned for searching physiotherapists palpation abilities. There were 2 groups of physiotherapists. They were asked for to push target pressures. After making some exercise, the assesment was done again. conditions: Sensitivity Training Groups studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 2 groups of physiotherapists with different fields of experience were attended to study. primaryPurpose: OTHER masking: NONE count: 63 type: ACTUAL name: Pressure sensitivity education measure: Measurement Palpation Pressure with Digital Scale measure: Measurement Palpation Pressure with Digital Scale sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Health Sciences Bolu Abant İzzet Baysal University city: Bolu zip: 14300 country: Turkey lat: 40.73583 lon: 31.60611 hasResults: False

 nctId: NCT06264635 id: HS26227 briefTitle: Evaluating the Efficacy of Platelet-Rich-Plasma (PRP) for Erectile Dysfunction overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-03 date: 2024-02-20 date: 2024-03-08 name: University of Manitoba class: OTHER briefSummary: There is great interest in restorative therapies (platelet-rich plasma (PRP) injections, shockwave therapy and stem cell therapy) for ED given their non-invasive nature. However, data is still limited and requires further research prior to widespread adoption. Unfortunately, therapies such as PRP injections are being widely used without clinical evidence demonstrating its safety or effectiveness for the treatment of erectile dysfunction. 2-7 To date, there are no treatments that address the underlying cause of endothelial dysfunction, although low-intensity shockwave therapy for ED has shown promising results. Platelet-derived therapies targeting inflammation and promoting tissue/nerve regeneration and may represent a potential treatment option towards this direction. The investigators propose to perform Canada's first pilot RCT to evaluate and safety and efficacy of PRP for the treatment of ED. conditions: Erectile Dysfunction studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The provider and patient are both blinded to which treatment (PRP vs saline) the patient is receiving whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 60 type: ESTIMATED name: Platelet-Rich-Plasma name: Saline measure: International Index of Erectile Function (IIEF) measure: Adverse Events sex: MALE minimumAge: 30 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Men's Health Clinic city: Winnipeg state: Manitoba zip: R3K 1M3 country: Canada name: Premal Patel, MD role: CONTACT phone: 2042214476 email: ppatel5@hsc.mb.ca name: Jainik Shah, BFSc role: CONTACT phone: 6477721737 email: shahj4@myumanitoba.ca lat: 49.8844 lon: -97.14704 hasResults: False

 nctId: NCT06264622 id: CEIC-2996 briefTitle: ABG+/GarlACE Effects on Cardiovascular Risk Factors in Subjects With Grade I Hypertension acronym: GARDOSE overallStatus: RECRUITING date: 2024-02-26 date: 2024-10-31 date: 2024-12-31 date: 2024-02-20 date: 2024-02-20 name: Universitat de Lleida class: OTHER name: Pharmactive Biotech Products S.L.U briefSummary: The goal of this clinical trial is to evaluate the dose response effect on cardiovascular disease risk factors of a Black Garlic Extract in subjects with Grade I Hypertension. The main questions it aims to answer are:

* If the reduction in blood pressure (systolic and diastolic) is in a dose-response manner
* If the changes in lipid profile are in a dose-response manner

Participants will be randomly assign to a low dose (250 mg/day), high dose (600 mg/day) or placebo of a standardized Garlic Extract (ABG+/GarlACE) during 12 weeks conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 180 type: ESTIMATED name: Low dose name: High dose name: Placebo measure: Blood Pressure measure: Blood Lipid Profile sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Lleida status: RECRUITING city: Lleida zip: 25198 country: Spain name: Jose Serrano, PhD role: CONTACT phone: 973702408 email: josecarlos.serrano@udl.cat name: Manuel Portero, PhD role: CONTACT phone: 973702408 email: manuel.portero@udl.cat lat: 41.61674 lon: 0.62218 hasResults: False

 nctId: NCT06264609 id: 91026 briefTitle: Precision Medicine Approach for Osteoporosis - Follow Up Study overallStatus: ENROLLING_BY_INVITATION date: 2024-02-01 date: 2029-12-31 date: 2029-12-31 date: 2024-02-20 date: 2024-02-20 name: Hartmut Malluche, MD class: OTHER briefSummary: Osteoporosis is a health problem of major proportions. It affects more than 40 million Americans and results in more than 2 million fractures annually among Medicare patients alone. Hospital admissions for osteoporotic fractures exceed those of heart attacks, strokes and breast cancer combined. Osteoporosis is commonly considered a disease associated with menopause. This estrogen deficiency related bone loss is characterized by high bone turnover with increased resorption without commensurate changes in bone formation. It is in contrast to age-related bone loss, which starts as early as in the fourth decade of life and continues with increasing age. Age-related bone loss is usually associated with lower bone turnover and decreased bone formation is the main abnormality.

Current therapies do not address age-related bone loss and the special needs of the age-related osteoporosis population is currently ignored. This is to a great degree due to difficulties associated with the bone biopsy necessary for unequivocal determination of bone turnover status. Thus, the current standard of care relies on starting with an antiresorber, which is of limited effectiveness in age-related osteoporosis, and in fact impedes the effectiveness of the appropriate anabolic medication. In a current ongoing study - Novel precision medicine approach to treatment of osteoporosis based on bone turnover. EIRB#70781; efforts are focused on addressing this particular problem.

Our follow-up study seeks to achieve one specific aim: to compare effectiveness of Alendronate vs Teriparatide after participants have been switched at the end of treatment at year one, to the other drug at year two for the same duration of treatment. conditions: Osteoporosis studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Alendronate name: Teriparatide name: Alendronate measure: Percent change in bone loss measure: Percent change in Bone Mass Density at the hip measure: Trabecular bone score (TBS) sex: FEMALE minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Kentucky city: Lexington state: Kentucky zip: 40536 country: United States lat: 37.98869 lon: -84.47772 hasResults: False

 nctId: NCT06264596 id: 2310-72 briefTitle: Epinephrine in Irrigation Fluid for Visualization During Ankle Surgery overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2026-04 date: 2024-02-20 date: 2024-02-22 name: The Guthrie Clinic class: OTHER briefSummary: The purpose of this study is to evaluate the effect of epinephrine in irrigation fluid for visual clarity in ankle arthroscopic surgery. conditions: Intraoperative Bleeding studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Concealed irrigation bags whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 78 type: ESTIMATED name: Epinephrine name: Normal Saline irrigation fluid measure: visual clarity during ankle arthroscopic surgery, which will be evaluated by visual analog scale measure: surgeon's discomfort related to bleeding, measured by visual numeric rating scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Robert Packer Hospital city: Sayre state: Pennsylvania zip: 18840 country: United States name: Wonyong Lee, MD role: CONTACT phone: 570-887-4882 email: Wonyong.Lee@guthrie.org name: Wonyong Lee role: PRINCIPAL_INVESTIGATOR lat: 41.97896 lon: -76.5155 hasResults: False

 nctId: NCT06264583 id: IN-DE-980-6998 briefTitle: HDV-Europe: Prevalence and Outcome of HDV in HIV/HBV Coinfection overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-07-31 date: 2024-12-31 date: 2024-02-20 date: 2024-02-20 name: University Hospital, Bonn class: OTHER name: Swiss HIV Cohort Study name: ICONA Cohort name: Amsterdam UMC name: Royal Free Hospital NHS Foundation Trust name: King's College London name: University Hospital of Cologne name: Goethe University name: Heinrich-Heine University, Duesseldorf name: University Hospital, Essen name: ICH Hamburg name: Praxiszentrum Hohenstaufenring Köln name: Sorbonne University name: Henri Mondor University Hospital name: Hospital Universitario Infanta Leonor name: Hospital General Universitario Gregorio Marañon name: GEPCOI (Portuguese Group of Coinfection) briefSummary: The aim of this project is to set up a cross-sectional cohort study (France, Germany, The Netherlands, Poland, Spain, Switzerland, Italy, United Kingdom and Portugal) to assess the implementation of EACS guidelines for HDV-testing among PLWH with positive HbsAg and thereby evaluate the prevalence of HDV infection among HIV/HBV-coinfected in 2023, as well as corresponding risk factors. In addition to the testing itself, this study will also set up a cohort and databasee for future HDV studies among PLWH, including clinical, virological und laboratory parameters.

1. Analyze the rate of HDV-testing and evaluate the prevalence of HDV-infection by testing.

   1. Evaluation of former screening of HDV by assessing existing data at study sites.
   2. Determination of the HDV prevalence in European PLWH and HBV coinfection.
2. Setting up a database of all PLWH with HBV/HDV coinfection

   1. Analysis of transmission risk factors for HDV coinfection
   2. Asses the rate of HDV positive patients with ongoing HDV replication.
   3. Define the liver disease state by APRI score, fibroscan, ultrasound and routine laboratory test results. conditions: Hepatitis D studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 8000 type: ESTIMATED name: HDV screening measure: HDV prevalence in HIV/HBV coinfection measure: Degree of liver disease in pateints with HIV/HBV/HDV triple infection sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Bonn city: Bonn state: NRW zip: 53127 country: Germany name: Jürgen Rockstroh role: CONTACT phone: +491716575969 email: juergen.rockstroh@ukbonn.de lat: 50.73438 lon: 7.09549 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-10-31 uploadDate: 2024-02-09T03:56 filename: Prot_000.pdf size: 798649 hasResults: False

 nctId: NCT06264570 id: SW007 briefTitle: Evaluation of a Genetically Determined Personalized Approach in Prescribing Biologically Active Substances in Patients With Elevated Blood Homocysteine Levels. acronym: PERBIO-HC overallStatus: RECRUITING date: 2023-10-23 date: 2024-05-15 date: 2024-11-30 date: 2024-02-20 date: 2024-03-13 name: S.LAB (SOLOWAYS) class: OTHER name: Center of New Medical Technologies briefSummary: The clinical trial assesses the effectiveness and safety of a genetically-determined personalized approach to prescribing bioactive substances in patients with elevated blood homocysteine levels. Hyperhomocysteinemia (HHcy) is a risk factor for cardiovascular diseases (CVD), potentially exacerbating the effects of arterial hypertension and high cholesterol levels, increasing the risks of heart disease, stroke, and venous thrombosis. The trial aims to reduce plasma homocysteine levels to normal values (\<15 µmol/L) through a pilot, single-center, prospective, double-blind, placebo-controlled study. The study will involve a 6-month observation period with visits at 1, 3, and 6 months, assessing the efficacy of two composite bioactive substances not considered medicinal drugs. The primary endpoint is the reduction of homocysteine levels in patients with elevated levels, while secondary endpoints include lowering very low-density lipoprotein levels, absence of anxiety and depression (using the Spielberg Anxiety Scale), and the occurrence of major cardiovascular events. The sample size is planned for 111 patients across three groups, with a 1:1:2 distribution, considering a 40% reduction in homocysteine levels in the treated group and 5% in the control group, aiming for an 80% power and a 0.05 alpha. Inclusion criteria include adults aged 18-80 with elevated homocysteine (\>15 µmol/L) and LDL cholesterol levels (≥1.4 mmol/L), without taking any substances that could influence homocysteine levels for at least one month prior. The trial will also conduct an interim analysis after enrolling 55 patients, using statistical analysis to evaluate the results. conditions: Hyperhomocysteinemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 111 type: ESTIMATED name: B-TMG supplementation name: B-SAM supplementation name: B-TMG placebo name: B-SAM placebo measure: Change in homocysteine levels in patients with elevated homocysteine levels in the blood evaluated by 15 µmol/l. measure: change in the level of very low density lipoproteins measure: change of anxiety when using dietary supplements accessed by the Spielberg scale measure: change of depression when using dietary supplements by the Becks scale measure: occurrence of major cardiovascular events during follow-up sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center of New Medical Technologies status: RECRUITING city: Novosibirsk state: Novosibisk Region zip: 630090 country: Russian Federation name: Andrei AV Ponomarenko, MD role: CONTACT phone: +79628316017 email: dayshadoff@gmail.com name: Elena EI Krykova role: CONTACT phone: +79133825952 email: krukova_ei@cnmt.ru name: Eugene EA Pokushalov, PhD role: PRINCIPAL_INVESTIGATOR name: Andrei AV Ponomarenko, MD role: SUB_INVESTIGATOR lat: 55.0415 lon: 82.9346 hasResults: False

 nctId: NCT06264557 id: RW-MCI-01 id: ROWAN type: OTHER domain: ROWAN briefTitle: Cognitive Therapy Software for Improving Cognitive Function for Patients With Mild Cognitive Impairment acronym: SB-DEX overallStatus: RECRUITING date: 2024-01-17 date: 2024-05-31 date: 2025-05-01 date: 2024-02-20 date: 2024-02-20 name: Rowan class: INDUSTRY briefSummary: Cognitive therapy software for improving cognitive function for patients with mild cognitive impairment conditions: Mild Cognitive Impairment conditions: MCI studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 126 type: ESTIMATED name: SB-100 name: Educational book measure: K-RBANS measure: K-RBANS measure: K-MMSE-2 measure: CDR-SB measure: K-IADL measure: PRMQ measure: GDS-15 measure: QOL-AD measure: ADAS-Cog14 sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hanyang University Guri Hospital status: RECRUITING city: Guri-si state: Gyeonggi-do zip: 11923 country: Korea, Republic of name: Hojin Choi, PI role: CONTACT lat: 37.5986 lon: 127.1394 facility: Inje University Haeundae Paik Hospital status: RECRUITING city: Busan country: Korea, Republic of name: Jinse Park, PI role: CONTACT lat: 35.10278 lon: 129.04028 facility: Inha University Hospital status: RECRUITING city: Incheon zip: 22332 country: Korea, Republic of name: Hyewon Yoon, PI role: CONTACT lat: 37.45646 lon: 126.70515 facility: Gachon University Gil Medical Center status: RECRUITING city: Incheon country: Korea, Republic of name: Kee Hyung Park, PI role: CONTACT lat: 37.45646 lon: 126.70515 facility: Chonnam National University Hospital status: RECRUITING city: Kwangju country: Korea, Republic of name: Soo Hyun Cho, PI role: CONTACT lat: 36.9122 lon: 127.1279 facility: Ewha Womans University Seoul Hospital status: RECRUITING city: Seoul country: Korea, Republic of name: Ji Young Yun, PI role: CONTACT lat: 37.566 lon: 126.9784 facility: Hanyang University Seoul Hospital status: RECRUITING city: Seoul country: Korea, Republic of name: Jin Seok Park, PI role: CONTACT lat: 37.566 lon: 126.9784 facility: Koera University Guro Hospital status: RECRUITING city: Seoul country: Korea, Republic of name: Chi Kyung Kim, PI role: CONTACT lat: 37.566 lon: 126.9784 facility: Korea University Anam Hospital status: RECRUITING city: Seoul country: Korea, Republic of name: Chan Nyoung Leee, PI role: CONTACT lat: 37.566 lon: 126.9784 facility: The Catholic University of Korea, Seoul St. Mary's Hospital status: RECRUITING city: Seoul country: Korea, Republic of name: Dong Woo Kang, PI role: CONTACT lat: 37.566 lon: 126.9784 facility: Ajou University Hospital status: RECRUITING city: Suwon country: Korea, Republic of name: Sun Min Lee, PI role: CONTACT lat: 37.29111 lon: 127.00889 facility: The Catholic University of Korea, St. Vincent's Hospital status: RECRUITING city: Suwon country: Korea, Republic of name: Yoo Hyun Um, PI role: CONTACT lat: 37.29111 lon: 127.00889 hasResults: False

 nctId: NCT06264544 id: SW006 briefTitle: Trial to Evaluate the Efficacy of a Zinc, Selenium, and L-Tyrosine Supplement in the Prevention of Thyrotoxicosis in Subjects With r25191G/A SEPP1 Polymorphism acronym: ZEST-PREP overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2024-10-15 date: 2024-12-30 date: 2024-02-20 date: 2024-02-20 name: S.LAB (SOLOWAYS) class: OTHER name: Center of New Medical Technologies briefSummary: This randomized, double-blind, placebo-controlled trial evaluates the efficacy of a zinc, selenium, and L-tyrosine supplement in preventing thyrotoxicosis among adults aged 18-85 with elevated TPOAb levels and the r25191G/A SEPP1 polymorphism. The study excludes those with thyroid disease, pregnant/breastfeeding women, and individuals allergic to the supplement. Key endpoints include changes in thyroid antibodies and hormones over a 6-month period. With an estimated sample size of 150 participants per group, accounting for a 20% dropout rate, the trial seeks to demonstrate the supplement's potential in reducing thyrotoxicosis risk through a genetically-informed approach. conditions: Thyrotoxicosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 150 type: ESTIMATED name: zinc, selenium, and L-tyrosine in SEPP1 name: Placebo measure: Percent change of Thyroid Peroxidase Antibodies (TPOAb) in subjects with r25191 SEPP1 polymorphism measure: Percent change in Thyroglobulin Antibodies (TgAb) in subjects with r25191 SEPP1 polymorphism measure: Free Thyroxine (Free T4) change in subjects with r25191 SEPP1 polymorphism measure: Free Triiodothyronine (Free T3) change in subjects with r25191 SEPP1 polymorphism measure: Thyroid Receptor Antibodies (TRAb) change in subjects with r25191 SEPP1 polymorphism measure: TSH Receptor Antibodies (TSHR-Ab) change in subjects with r25191 SEPP1 polymorphism sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center of New Medical Technologies city: Novosibirsk state: Novosibisk Region zip: 630090 country: Russian Federation lat: 55.0415 lon: 82.9346 hasResults: False

 nctId: NCT06264531 id: JDS_2023_12 briefTitle: Efficacy and Safety of Anti-angiogenic Therapy With IV Bevacizumab in Patients With Symptomatic Cerebral Arteriovenous Malformations acronym: BevacizuMAV overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-12 date: 2027-06 date: 2024-02-20 date: 2024-02-22 name: Fondation Ophtalmologique Adolphe de Rothschild class: NETWORK briefSummary: Brain arteriovenous malformations (AVMs) are responsible for hemorrhagic strokes, particularly in children and young adults. They can also be responsible for chronic neurological disorders: motor or sensory deficits, disturbances of higher functions, epilepsy or disabling headaches. The management of brain AVMs is complex and requires a multidisciplinary approach in an expert center. Available therapies include endovascular embolization, neurosurgical resection and/or radiosurgery. These procedures carry a risk of neurological complications, and are reserved for small AVMs located at a distance from highly functional cerebral structures. To date, no drug therapy is recommended if interventional treatment is not possible.

Several studies on resected brain AVM tissue have demonstrated that these malformations are the site of significant evolutionary inflammatory and neo-angiogenesis processes. Other studies have specifically shown that VEGF (vascular endothelial growth factor) levels are increased in AVMs. More recently, a pre-clinical study showed that anti-angiogenic treatment with Bevacizumab reduced vascular proliferation within AVMs in mice. Finally, a Phase II clinical trial in patients with Rendu-Osler disease (a genetic vascular disorder characterized by recurrent epistaxis, cutaneous telangiectasia and the presence of visceral AVMs) showed a clinical benefit of IV Bevacizumab on the symptomatology of these vascular malformations, with a reduction in the risk of hemorrhage and the extent of hepatic arteriovenous shunts. A randomized Phase III trial is currently underway (NCT03227263) to assess the efficacy of IV Bevacizumab in Rendu-Osler disease.

The aim of our study is to assess the efficacy of IV Bevacizumab on the disabling symptoms associated with symptomatic brain AVMs. conditions: Cerebral AV Malformation studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 54 type: ESTIMATED name: Bevacizumab name: Placebo measure: Proportion of patients showing at least one of the following improvements : cognition, neurological symptoms, epilepsy symptoms, headaches. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06264518 id: 56168915 briefTitle: An Observational Exploration of Clinical Trials Targeting Traumatic Brain Injury overallStatus: NOT_YET_RECRUITING date: 2025-03 date: 2026-03 date: 2027-03 date: 2024-02-20 date: 2024-02-20 name: Power Life Sciences Inc. class: INDUSTRY briefSummary: Clinical study participation has historically been heavily biased toward specific demographics.

Several people will be invited to enroll in this study so that it may collect a variety of data about traumatic brain injury clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal.

People with traumatic brain injury who are invited to take part in medical research will benefit from the analysis of the data. conditions: Traumatic Brain Injury studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 500 type: ESTIMATED measure: Number of patients who decide to enroll in a traumatic brain injury clinical trial measure: Rate of patients who remain in traumatic brain injury clinical trial to trial completion sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Power Life Sciences city: San Francisco state: California zip: 94107 country: United States name: Michael B Gill role: CONTACT phone: 415-900-4227 email: https://www.withpower.com/contact-us@withpower.com lat: 37.77493 lon: -122.41942 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-09 uploadDate: 2024-02-09T11:16 filename: ICF_000.pdf size: 79118 hasResults: False

 nctId: NCT06264505 id: 55955210 briefTitle: Investigative Analysis of Soft Tissue Sarcoma Clinical Trials: An Observational Study overallStatus: NOT_YET_RECRUITING date: 2025-03 date: 2026-03 date: 2027-03 date: 2024-02-20 date: 2024-02-28 name: Power Life Sciences Inc. class: INDUSTRY briefSummary: Generally, specific demographic cohorts exhibit higher participation rates in medical research, yet there exists a scarcity of research elucidating the trial attributes impacting the engagement of these particular demographics.

The primary objective of this study is to gather extensive data on the clinical trial experiences of individuals diagnosed with soft tissue sarcoma, with the aim of identifying factors hindering patient enrollment or trial completion. conditions: Soft Tissue Sarcoma studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 500 type: ESTIMATED measure: Rate of patients in soft tissue sarcoma clinical research measure: Number of soft tissue sarcoma study participants who maintain involvement until study finish sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Power Life Sciences city: San Francisco state: California zip: 94107 country: United States name: Michael B Gill role: CONTACT phone: 415-900-4227 email: https://www.withpower.com/contact-us@withpower.com lat: 37.77493 lon: -122.41942 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-09 uploadDate: 2024-02-09T10:34 filename: ICF_000.pdf size: 80606 hasResults: False

 nctId: NCT06264492 id: 55777205 briefTitle: Delving Into Participation Trends of Scleroderma Clinical Trials overallStatus: NOT_YET_RECRUITING date: 2025-03 date: 2026-03 date: 2027-03 date: 2024-02-20 date: 2024-02-28 name: Power Life Sciences Inc. class: INDUSTRY briefSummary: Typically, specific demographic subsets tend to exhibit greater engagement in medical research. Nonetheless, there is insufficient research elucidating the trial characteristics influencing the participation of these particular demographics.

The study will analyze data from diverse demographic viewpoints to uncover recurring trends that could provide valuable insights for future patients with scleroderma. conditions: Scleroderma studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 500 type: ESTIMATED measure: Rate of patients in clinical research for scleroderma measure: Number of scleroderma study participants who stay committed until clinical study wraps up sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Power Life Sciences city: San Francisco state: California zip: 94107 country: United States name: Michael B Gill role: CONTACT phone: 415-900-4227 email: https://www.withpower.com/contact-us@withpower.com lat: 37.77493 lon: -122.41942 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-09 uploadDate: 2024-02-09T10:51 filename: ICF_000.pdf size: 71611 hasResults: False

 nctId: NCT06264479 id: PEAR-TREE2 briefTitle: Prospective Evaluation of AI R&D Tool for Patient Stratification: a Trial for Renal Immuno-oncology Model Experimental Evaluation 2 acronym: PEAR-TREE2 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-09-30 date: 2029-03-31 date: 2024-02-20 date: 2024-04-02 name: Ourotech, Inc. class: INDUSTRY name: Royal Free Hospital NHS Foundation Trust name: Cambridge University Hospitals NHS Trust name: East & North Herts NHS Trust name: Imperial College Healthcare NHS Trust briefSummary: Pear Bio has developed a predictive biomarker technology that combines 3D cell culture, microscopy and computer vision to measure the response of an individual patient's tumor sample to different systemic therapy regimens that are tested simultaneously ex vivo.

This study will recruit patients with advanced or metastatic kidney cancer who are due to start a clinically-indicated new line of therapy.

The oncologist will be blinded to the response on the Pear Bio test (the test will be run in parallel with the patient's treatment). The primary objective of this study is to establish the sensitivity and specificity of Pear Bio's test results against patient outcomes (objective response, progression-free survival, depth and duration of response, overall survival). conditions: Kidney Cancer conditions: Renal Cell Cancer Metastatic studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Biopsy measure: Objective Response Rate correlation accuracy (sensitivity & specificity) measure: Complete Response rate correlation accuracy (sensitivity & specificity) measure: Deep Response rate correlation accuracy (sensitivity & specificity) measure: Durable Response rate correlation accuracy (sensitivity & specificity) measure: PFS prediction accuracy measure: Culture success rate measure: Hazard ratio by biomarker group measure: OS prediction accuracy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Addenbrooke's Hospital city: Cambridge state: Cambridgeshire zip: CB2 0QQ country: United Kingdom name: Kate Fife role: CONTACT lat: 52.2 lon: 0.11667 facility: Mount Vernon Cancer Centre city: London zip: HA6 2RN country: United Kingdom name: Anand Sharma role: CONTACT lat: 51.50853 lon: -0.12574 facility: Imperial College Healthcare NHS Trust city: London zip: W6 8RF country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Royal Free NHS Foundation Trust city: London country: United Kingdom name: Ekaterini Boleti, MD PhD MRCP role: CONTACT phone: 020 7830 2396 phoneExt: 34476 lat: 51.50853 lon: -0.12574 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-07-28 uploadDate: 2023-07-28T07:18 filename: Prot_SAP_000.pdf size: 424039 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-07-28 uploadDate: 2023-07-28T07:19 filename: ICF_001.pdf size: 197013 hasResults: False

 nctId: NCT06264466 id: IECED-010112023 briefTitle: Safety and Efficacy of a Novel Flexible Bipolar in POEM overallStatus: RECRUITING date: 2023-12-01 date: 2024-12-01 date: 2025-01-15 date: 2024-02-20 date: 2024-02-20 name: Instituto Ecuatoriano de Enfermedades Digestivas class: OTHER briefSummary: Per-oral endoscopic myotomy (POEM) is a minimally invasive therapy for achalasia. The procedure has demonstrated high technical and clinical success with lower adverse events. Different types of knives have been used for cutting and coagulation during the procedure; however, exchanging accessories is sometimes needed to perform all the stages of POEM.

To overcome this disadvantage, the investigators aim to evaluate a single device that integrates in its tip bipolar radiofrequency and microwave, the Speedboat Ultraslim (Creo Medical, UK) for cutting and coagulation during POEM procedure. Some of the promise's advantages derived from its use are: (1) less inflammation, (2) clear differentiation between layers, (3) the use of a single device for the procedure.

This single-center, prospective, interventional study will include patients with achalasia submitted to POEM procedure, with or without fundoplication (POEM-F). All stages (mucosal incision, submucosal tunneling, myotomy) of POEM will be performed using the Speedboat ultraslim flexible catheter. Technical and clinical success, along with safety will be the primary endpoints; while, post-procedure reflux symptoms and quality of life will be assessed as secondary outcomes with reflux severity index (RSI) and the Northwestern Esophageal Quality of Life (NEQOL), respectively. conditions: Esophageal Achalasia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: interventional trial primaryPurpose: TREATMENT masking: NONE count: 73 type: ESTIMATED name: POEM with Speedboat Ultraslim measure: Technical success of procedure measure: Clinical success of procedure measure: Frequency of adverse events attributable to the procedure measure: Rate of Gastroesophageal reflux disease measure: Assessment of Gastroesophageal reflux disease severity measure: Change in health-related quality of life after POEM sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Instituto Ecuatoriano de Enfermedades Digestivas (IECED) status: RECRUITING city: Guayaquil state: Guayas zip: 090505 country: Ecuador name: Carlos Robles-Medranda, MD FASGE role: CONTACT phone: +593989158865 email: carlosoakm@yahoo.es role: CONTACT email: carlosoakm@yahoo.es name: Carlos Robles-Medranda, MD role: PRINCIPAL_INVESTIGATOR name: Michel Kahaleh, MD role: SUB_INVESTIGATOR name: Eduardo Albeniz, MD role: SUB_INVESTIGATOR name: Juan Alcivar-Vasquez, MD role: SUB_INVESTIGATOR name: Maria Egas-Izquierdo, MD role: SUB_INVESTIGATOR name: Jorge Baquerizo-Burgos, MD role: SUB_INVESTIGATOR name: Domenica Cunto, MD role: SUB_INVESTIGATOR name: Miguel Puga-Tejada, MD role: SUB_INVESTIGATOR name: Martha Arevalo-Mora, MD role: SUB_INVESTIGATOR name: Raquel Del Valle, MD role: SUB_INVESTIGATOR name: Hannah Pitanga-Lukashok, MD role: SUB_INVESTIGATOR lat: -2.20584 lon: -79.90795 hasResults: False

 nctId: NCT06264453 id: KH-001-D201 briefTitle: A Study to Evaluate the Efficacy and Safety of KH001 in Patients With Dentin Hypersensitivity overallStatus: NOT_YET_RECRUITING date: 2024-03-11 date: 2024-08-23 date: 2024-08-30 date: 2024-02-20 date: 2024-02-21 name: HysensBio Co., Ltd class: INDUSTRY briefSummary: The purpose of this study is to evaluate the efficacy and safety of KH001 in patients with dentin hypersensitivity. conditions: Dentin Hypersensitivity studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 171 type: ESTIMATED name: KH001 name: Placebo measure: Change from baseline in Schiff sensitivity score measure: Change from baseline in a Schiff sensitivity score measure: Change from baseline in a Tactile threshold measure: Change from baseline in Visual Analogue Scale sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06264440 id: 283HV104 briefTitle: A Study to Assess the Potential for Gastric-pH Dependent Drug-Drug Interactions of BIIB122 With a Proton Pump Inhibitor in Healthy Participants overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-12 date: 2024-05-07 date: 2024-05-07 date: 2024-02-20 date: 2024-03-25 name: Biogen class: INDUSTRY briefSummary: The primary objective of the study is to evaluate the effects of a proton pump inhibitor (PPI) \[rabeprazole\] on BIIB122 pharmacokinetics (PK) after a single dose in healthy participants. The secondary objective of the study is to evaluate the safety and tolerability of BIIB122, with and without a PPI (rabeprazole), after a single dose in healthy participants. conditions: Healthy Volunteer studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 18 type: ACTUAL name: BIIB122 name: Rabeprazole measure: Maximum Observed Concentration (Cmax) of BIIB122 measure: Area Under the Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUClast) of BIIB122 measure: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of BIIB122 measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) sex: ALL minimumAge: 30 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: PPD Development, LP city: Austin state: Texas zip: 78744 country: United States lat: 30.26715 lon: -97.74306 hasResults: False

 nctId: NCT06264427 id: KVUG - 2022 - 10 briefTitle: Phenotypic and Genotypic Characterization of Patients With Dysmetabolism in Greenland overallStatus: RECRUITING date: 2022-07-15 date: 2025-12-31 date: 2026-12-31 date: 2024-02-20 date: 2024-02-20 name: Steno Diabetes Center Greenland class: OTHER name: Zealand University Hospital name: University of Copenhagen briefSummary: The goal of this clinical trial is to perform a detailed description of the feno- and genotype of people living with type 2 diabetes and severe obesity who are linked to care at Steno Diabetes Center Greenland.

The main questions it aims to answer are:

* Are monogenetic diabetes variants associated with the same risk of developing late diabetic complications as other types of diabetes?
* Can genotyping and thereby personalized medicine be implemented in Greenland, and can personalized medicine lead to improved treatment?
* What is the prevalence of sleep apnea among high-risk individuals in Greenland?
* Is it possible to develop and implement a simple algorithm for the identification of sleep apnea in Greenland that can ensure treatment of severe sleep apnea?

Participants will:

* Answer WHO-5 and FOSQ-10 questionnaires regarding quality of life and functional outcomes of sleepiness
* Perform VAGUS examinations for Cardiovasculare Autonomic Neuropathy
* Clinical examination of height, weight, circumference of hip, waist and neck, Friedman tonsil and tongue score, nasal air flow, nasal septal deviation
* Blood samples for full genome sequencing conditions: Diabetes Mellitus, Type 2 conditions: Obesity, Morbid conditions: Obstructive Sleep Apnea conditions: MODY conditions: Diabetic Retinopathy conditions: Diabetic Neuropathies studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Participants will be examined with whole genom sequencing, and diabetes treatment will be accommodated their diabetic fenotype.

'For the intervention, participants will be screened for obstructive sleep apnea (OSA). Participants with signs of OSA will be offered treatment with Continuos Positive Airway Pressure. primaryPurpose: TREATMENT masking: NONE count: 1000 type: ESTIMATED name: Whole genome sequencing name: VAGUS name: NightOwl name: CPAP measure: Number of participants with MODY diabetes and their complication status measure: Number of participants with diabetic complication measure: Number of participants with obstructive sleep apnea measure: CPAP compliance in Greenlandic patients measure: CPAP treatment effect on quality of life measured with the World Health Organization Well-being Index (WHO-5). measure: CPAP treatment effect on daytime sleepiness measured with the functional outcome of sleep questionnaire (FOSQ-10). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Steno Diabetes Center Greenland, Queen Ingrids Hospital status: RECRUITING city: Nuuk state: Sermersooq zip: 3900 country: Greenland name: Mads Mose Jensen, MD. role: CONTACT phone: +299 34 46 23 email: MMSN@peqqik.gl name: Marit Eika Jørgensen, Md. Ph.d role: CONTACT phone: 34 43 24 email: MAEJ@peqqik.gl lat: 64.18347 lon: -51.72157 hasResults: False

 nctId: NCT06264414 id: DTT106-III-0123 briefTitle: Efficacy and Safety of the DTT106 in the Treatment of Erectile Dysfunction Associated With Benign Prostatic Hyperplasia acronym: AUSTRÁLIA overallStatus: NOT_YET_RECRUITING date: 2025-02 date: 2026-06 date: 2027-07 date: 2024-02-20 date: 2024-02-20 name: EMS class: INDUSTRY briefSummary: The purpose of this study is to assess the safety and efficacy of the DTT106 in the treatment of erectile dysfunction associated with benign prostatic hyperplasia conditions: Prostatic Hyperplasia, Benign conditions: Erectile Dysfunction studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 262 type: ESTIMATED name: DTT106 name: Dutasteride-Tamsulosin measure: Change in the Erectile Function domain score of the International Index of Erectile Function (IIEF-EF) at the end of treatment, from baseline. measure: Change in maximum urinary flow rate (Qmax) measure: Decrease in post-void residual volume (PVR) measure: Improvement in urinary symptoms. measure: Improvement in urinary emptying symptoms measure: Improvement in urinary storage symptoms. measure: Improvement in the participant's quality of life in relation to their urinary condition measure: Improvement in the participant's sexual function measure: Improvement in the participant's orgasmic function. measure: Effectiveness of the treatment in improving the participant's sexual desire measure: Effectiveness in improving the participant's satisfaction with sexual relations measure: Overall satisfaction of the participant regarding their sex life. sex: MALE minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: EMS city: Hortolândia state: São Paulo country: Brazil lat: -22.85833 lon: -47.22 hasResults: False

 nctId: NCT06264401 id: menopausal with osteoporsis briefTitle: Treatment Exercises With Core Stability and Dynamic Resistance Exercise for Postmenopausal Women With Osteoporosis overallStatus: NOT_YET_RECRUITING date: 2024-02-22 date: 2024-12-31 date: 2024-12-31 date: 2024-02-20 date: 2024-02-21 name: Cairo University class: OTHER briefSummary: osteoporosis is a common disease that affect most of postmenopausal women. various treatment procedures are used to avoid future complain among postmenopausal population. conditions: Postmenopausal Osteoporosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: intervention: medication the experimental and control groups received (Alendronate) 70 mg 1 tab every week for 4 months.

treatment exercises the experimental group performed core stability and dynamic resistance exercises, a 45-min lumbar-pelvic/core strength and stability exercise program which include 5 min warming up and 5 min cooling down at the end of the session each exercise was executed for three sets of 15 seconds, which gradually upgraded to three sets of 45-second at the fourth month and 10 sec rest between each set and dynamic resistance exercise performed by each woman for 2 sets for 8-12 repetitions gradually along the study of 90 sec rest between each set for a duration of 60 min including 10 min warming up and 10 min cooling down in form of stretching. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Alendronate name: treatment exercises measure: Dual-energy x-ray absorptiometry measure: Oswestry Disability Index sex: FEMALE minimumAge: 50 Years maximumAge: 60 Years stdAges: ADULT facility: faculty of physical therapy, Cairo university city: Giza zip: 12662 country: Egypt name: Nermeen Abd El Aziem, phd role: CONTACT phone: 01025016087 email: nermeenshaaban93o@yahoo.com lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06264388 id: 20231234 id: R21CA282543 type: NIH link: https://reporter.nih.gov/quickSearch/R21CA282543 briefTitle: DB107-Retroviral Replicating Vector (RRV) Combined With DB107-Flucytosine (FC) in Patients With Recurrent Glioblastoma or Anaplastic Astrocytoma overallStatus: RECRUITING date: 2024-05-01 date: 2034-05-01 date: 2034-05-01 date: 2024-02-20 date: 2024-04-26 name: Ashish Shah class: OTHER name: Denovo Biopharma LLC name: National Cancer Institute (NCI) briefSummary: The purpose of this study is to determine if the investigational products, DB107-RRV and DB107-FC, as a combination treatment will shrink high-grade glioma (HGG) in patients with recurrent/progressive, resectable or unresectable disease and increase the time that disease is controlled. conditions: High Grade Glioma conditions: Anaplastic Astrocytoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 33 type: ESTIMATED name: DB107-RRV name: DB107-FC measure: Progression Free Survival measure: Overall Survival measure: Assessment of Tumor Status Measured by Response Assessment in Neuro-oncology (RANO) Criteria measure: Number of Treatment Related Toxicities measure: Durable Response Rate (DRR) measure: Durable Clinical Benefit Rate (DCBR) measure: Duration of Durable Response Rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Miami Hospital status: RECRUITING city: Miami state: Florida zip: 33136 country: United States name: Leonela Wright, MSN, RN role: CONTACT phone: 305-243-0864 email: lxw612@med.miami.edu name: Ashish Shah, MD role: CONTACT phone: 305-243-6946 email: ashah@med.miami.edu name: Ashish Shah, MD role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 hasResults: False

 nctId: NCT06264375 id: E-SPORT briefTitle: Effect of a Specific and General Physical Exercise Intervention on Gaming and E-Sport Performance acronym: E-SPORT overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-19 date: 2024-04-19 date: 2024-09-30 date: 2024-02-20 date: 2024-04-23 name: Universitaet Innsbruck class: OTHER briefSummary: The goal of this randomized control intervention study is to test the effect of i) a specific physical training for e-sport and ii) a general physical training on e-sport performance, compared to iii) not training physically at all.

Participants are gamers and e-athletes who play at least \>2hours peer week. The main questions it aims to answer are:

* Does physical training have an effect on e-sport related abilities (hand grip strength, reaction, anticipation)
* Does the training of specific elements, which aim at these abilities "out-game", transfer on the actual skills needed using a keyboard and mouse

Participants will be randomly - but mediated by hours of playing per week - distributed in 1 of 3 groups.

* Group 1 will 3 times per week for 30 minutes perform a specific physical training with focus on abilities needed in e-sport (grip strength, reaction, anticipation) over a timespan of 8 weeks.
* Group 2 will perform a similar physical training (load, intensity) to Group 1, but without specific elements.
* Group 3 will serve as control group without any training.

Researchers will compare Group 1, Group 2 and Groups 3 to see if the different trainings (Group 1 and Group 2) have different effect on e-sport performance and if no training (Group 3) differs in e-sport performance development. conditions: Physical Activity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 8 weeks of intervention, where Group 1 does a specific physical training, Group 2 a general physical training and Group 3 who does not train. primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: Data is collected and afterwards anonymized during the pre- and post measurement and during the intervention using a weekly questionnaire (activity level, gaming time) count: 28 type: ACTUAL name: Physical exercise measure: Grip Strength (Out-Game) measure: Reaction Time (Out-Game) measure: Anticipation (Out-Game) measure: Whole Body Fitness measure: Gaming Performance - Accuracy/Speed and Anticipation measure: Well-being after training sex: ALL minimumAge: 10 Years maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: Department of Sport Science city: Innsbruck state: Tyrol zip: 6020 country: Austria lat: 47.26266 lon: 11.39454 hasResults: False

 nctId: NCT06264362 id: K23AG081547 type: NIH link: https://reporter.nih.gov/quickSearch/K23AG081547 id: 1K23AG081547-01 type: NIH link: https://reporter.nih.gov/quickSearch/1K23AG081547-01 briefTitle: Developing a Nonpharmacological Pain Intervention for Community-dwelling Older Adults With Dementia overallStatus: RECRUITING date: 2023-10-09 date: 2027-05-01 date: 2027-05-01 date: 2024-02-20 date: 2024-04-17 name: Drexel University class: OTHER name: National Institute on Aging (NIA) briefSummary: The purpose of this study is to develop an exercise treatment program for knee osteoarthritis that works well for people with memory problems. This study will include two parts. Participants can choose to participate in either or both parts.

In Part 1 - The investigators are inviting the following people to participate in an interview:

1. Individuals aged 60 years or older who do not live in a nursing home and have both memory issues and knee pain.
2. Care partners of people with knee pain and memory issues. A care partner can be a family member or friend who helps regularly.
3. Clinicians (exercise physiologists or rehabilitation therapists like physical and occupational therapists) who have worked with older adults with memory issues and knee pain.

The goal of these interviews is to learn from the experiences of people with memory issues and knee pain and those who care for them. From these interviews, the investigators hope to design a non-drug, tailored physical activity program that will be interesting and helpful in managing knee pain for older adults with memory problems.

For people with memory problems and knee pain and their care partners: The investigators will ask some questions to determine eligibility to participate in the study.

Those who qualify for the study will be invited to participate in an interview that could be completed online or in person (Philadelphia, PA). The interview could last up to 90 minutes (1 and a half hours) and can be completed as one or multiple sessions.

For clinicians: Participants will engage in a 90-minute focus group with other clinicians where lunch will be served if in person. Those participating in an online focus group will receive a gift card equal to the value of lunch.

In Part 2 - The program developed in Part 1 will be tested. The program will be physical activity-based. Specific program details for part 2 will be provided as they emerge. Participants can choose to sign up for either or both parts. Signing up for Part 1 does not mean participants have to sign up for Part 2.

Please contact us for any questions. conditions: Pain, Chronic conditions: Dementia, Mild conditions: Mobility Limitation conditions: Physical Disability conditions: Osteo Arthritis Knee conditions: Mild Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: In Phase 1, 15 dyads and 15 clinicians will be interviewed (a dyad equals one person living with mild to very mild dementia and their care partner) to inform design of the intervention. In Phase 2, 20 people living with mild to very mild dementia will be treated with the new intervention. Their care partners may be involved in treatment. primaryPurpose: TREATMENT masking: NONE count: 85 type: ESTIMATED name: Tailored Physical Activity Program measure: Program parameters measure: Program parameters measure: Feasibility of Intervention Measure measure: Perception of program measure: Numeric Pain Score measure: Zarit Burden Interview-Short Form sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Drexel University status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Annalisa Na, PT, PhD role: CONTACT phone: 267-359-5889 email: an838@drexel.edu name: Ben Senderling, MS role: CONTACT phone: 2679800425 email: bms422@drexel.edu lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06264349 id: 05102023 briefTitle: Women and Maternity: Development of a Nutritional Education Project acronym: MATER overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-05-15 date: 2025-11-30 date: 2024-02-16 date: 2024-02-16 name: University of Pavia class: OTHER briefSummary: The "first 1000 days of life", from conception to 2 years of life, are crucial for promoting the health of both mother and baby. During this period, a woman's diet and lifestyle play a significant role in determining the future health of the child. The perinatal period is an ideal time for regular contact with healthcare providers who can institute an intervention to encourage pregnant women to make nutritional changes to improve their health and that of their babies.

Therefore, an educational program on an appropriate lifestyle during the "first 1000 days" can represent a crucial primary prevention strategy in reducing the risk of developing obesity and non-communicable diseases (NCDs) during childhood and later adulthood. conditions: Pregnancy conditions: Lactation studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Quasi-experimental - controlled, non-randomized pilot study primaryPurpose: PREVENTION masking: NONE count: 100 type: ESTIMATED name: Lifestyle Educational Intervention measure: Gestational weight gain management measure: Nutritional aspects evaluation during pregnancy and lactation measure: Physical activity evaluation during pregnancy and lactation measure: Smoking habits during pregnancy and lactation measure: Maternal attitude towards infant feeding. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06264336 id: UIC AHS Pilot 2024 briefTitle: Effects of High-intensity Gait Training on Fatigue, Gait, and Neuroplasticity in People With Multiple Sclerosis overallStatus: RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-16 date: 2024-02-28 name: University of Illinois at Chicago class: OTHER briefSummary: Nearly 1 million individuals in the United States have multiple sclerosis, which causes fatigue and problems with walking. Fatigue and walking problems are poorly treated, but exercise training, particularly high-intensity walking exercise, may help. This provide insight into whether high-intensity walking exercise can improve fatigue and walking problems in people with multiple sclerosis, which could improve quality of life and reduce economic burden. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: treadmill training measure: Symptomatic fatigue measure: Walking speed measure: Corticomotor excitability measure: Fatigue impact measure: Walking endurance measure: Aerobic capacity measure: Visual processing speed measure: Verbal learning and memory measure: Spatial walking symmetry measure: Temporal walking symmetry measure: Community ambulation measure: Interhemispheric inhibition sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Illinois Chicago status: RECRUITING city: Chicago state: Illinois zip: 60612 country: United States name: Brice T Cleland, PhD role: CONTACT phone: 312-996-9056 email: bcleland@uic.edu lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06264323 id: UI-5487 briefTitle: Incidence of Acute Injuries in Boxing overallStatus: COMPLETED date: 2017-09-01 date: 2018-05-30 date: 2018-11-30 date: 2024-02-16 date: 2024-02-16 name: University of Iceland class: OTHER briefSummary: A prospective cohort study with 9 months follow up was carried out in 2017-2018. Boxers of both sexes 18 years and older from all 7 boxing clubs in Iceland were invited to participate in the study. Participants filled out a questionnaire on previous injuries during boxing training and competition and were evaluated on the Sport Concussion Assessment Tool 3rd edition (SCAT3). Exposure at training and competition was measured and any injuries sustained during the study period were recorded via text messages and phone calls every 2 weeks. conditions: Injuries studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 74 type: ACTUAL measure: Questionnaire measure: Sport Concussion Assessment Tool 3rd Edition (SCAT3) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Iceland city: Reykjavík zip: 102 country: Iceland lat: 64.13548 lon: -21.89541 hasResults: False

 nctId: NCT06264310 id: R2R01-WHF-201 briefTitle: To Evaluate the Safety, Tolerability and Efficacy of R2R01 Combined With SOC as Compared to SOC Alone in Outpatients With Worsening Heart Failure (WHF) overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-01 date: 2025-03 date: 2024-02-16 date: 2024-02-20 name: River 2 Renal Corp. class: INDUSTRY name: International HealthCare, LLC briefSummary: This Study Aims to Evaluate the Safety, Tolerability and Efficacy of R2R01 Combined With SOC as Compared to SOC Alone in Outpatients With Worsening Heart Failure (WHF) conditions: Heart Failure conditions: Worsening Heart Failure (WHF) studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients will be randomly assigned to one of four cohorts. Three groups will receive R2R01, and one group will receive placebo. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Treatment of all cohorts will be double-blind (all patients, study staff, investigators and Sponsor). Site pharmacist is unblinded. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 32 type: ESTIMATED name: Placebo name: R2R01 measure: Number and rate of patients with one or more TEAEs (treatment emergent AE's) and/or serious TEAEs as assessed by CTCAE v5.0. measure: Number and rate of patients with one or more TEAEs (treatment emergent AE's) and/or serious TEAEs as assessed by CTCAE v5.0. measure: Change from Baseline on NT-pro-BNP using descriptive and summary statistics by dose level at Day 7 and Day 30. measure: Change from baseline on Cystatin C and creatinine clearance using descriptive and summary statistics by dose level at Day 7 and Day 30. measure: Number of patients requiring dose adjustment of oral diuretics during the 30-day follow-up. measure: Number of patients with an event of: WHF-induced SDAC or other outpatient clinic visits requiring additional intensification of the therapy/IV loop diuretics using descriptive and summary statistics for change from baseline by dose level at Day 30. measure: Number of cardiovascular hospitalizations among patients using descriptive and summary statistics for change from baseline by dose level at Day 30. measure: Number of all-cause hospitalizations among patients using descriptive and summary statistics for change from baseline by dose level at Day 30. measure: Number of patients with CV mortality using descriptive and summary statistics for change from baseline by dose level at Day 30. measure: Number of patients with all-cause mortality using descriptive and summary statistics for change from baseline by dose level at Day 30. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Eastern Shore Research Institute city: Fairhope state: Alabama zip: 36532 country: United States lat: 30.52297 lon: -87.90333 facility: C&R Research Services USA, Inc. city: Cape Coral state: Florida zip: 33904 country: United States lat: 26.56285 lon: -81.94953 facility: Nature Coast Clinical Research city: Inverness state: Florida zip: 34452 country: United States lat: 28.83582 lon: -82.33037 facility: Jacksonville Center for Clinical Research city: Jacksonville state: Florida zip: 32216 country: United States lat: 30.33218 lon: -81.65565 facility: Amavita Research Services, LLC city: Miami state: Florida zip: 33137 country: United States lat: 25.77427 lon: -80.19366 hasResults: False

 nctId: NCT06264297 id: 01-22-270-111 briefTitle: High-Voltage Pulsed Radiofrequency of the Lumbar Dorsal Root Ganglion for the Treatment of Chronic Lumbar Radicular and Neuropathic Pain; A Prospective, Doble-blinded and Randomized Controlled Trial acronym: Radiofrequency overallStatus: RECRUITING date: 2023-02-20 date: 2027-01 date: 2027-12 date: 2024-02-16 date: 2024-02-16 name: Consorci Sanitari de Terrassa class: OTHER briefSummary: The management of chronic lumbar radicular and neuropathic pain is complex and the treatment success rates are low. Pulsed radiofrequency (PRF) has been described in these cases. In order to determine whether high-voltage PRF show better results than PRF a prospective, doble-blinded and randomized study is conducted in patients with chronic lumbar radicular and neuropathic pain. conditions: Pulsed Radiofrequency conditions: Lumbar Radiculopathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 98 type: ESTIMATED name: Radiofrequency measure: OSWESTRY LOW BACK DISABILITY QUESTIONNAIRE measure: DN4 - QUESTIONNAIRE measure: Visual Numeric Scale measure: Categorical scale measure: patient global impression of improvement (pgi-i) score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Consorci Sanitari de Terrassa status: RECRUITING city: Terrassa state: Barcelona zip: 08227 country: Spain name: Maria Martinez Garcia role: CONTACT phone: +34650528215 email: mariamartinezgarcia@gmail.com role: CONTACT email: mariamartinezgarcia@gmail.com name: maria Martinez Garcia role: PRINCIPAL_INVESTIGATOR lat: 41.56667 lon: 2.01667 hasResults: False

 nctId: NCT06264284 id: 2023PI163 briefTitle: Emergency (Red Code) Cesarean Section : Maternal and Fetal Prognosis Depending on Anesthetic Modalities in a Level 3 Maternity Ward overallStatus: COMPLETED date: 2018-07-19 date: 2023-07-19 date: 2023-07-19 date: 2024-02-16 date: 2024-02-16 name: Central Hospital, Nancy, France class: OTHER briefSummary: We try to evaluate whether the type of anesthesia used influences the occurrence of perioperative maternal complications as well as neonatal outcome on emergency (Red Code) Cesarean Section.

This study occurred in a Level 3 Maternity Ward. conditions: Anesthesia Complication studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 150 type: ACTUAL name: epidural anesthesia name: general anesthesia measure: To evaluate whether the type of anesthesia used influences the occurrence of perioperative maternal complications as well as neonatal outcome sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Stanowski city: Nancy zip: 54000 country: France lat: 48.68439 lon: 6.18496 hasResults: False

 nctId: NCT06264271 id: GIP-22-NL-06-203 briefTitle: The Effect of Nutrition Education on Glycemic Control in Patients With Type 1 Diabetes overallStatus: COMPLETED date: 2022-02-01 date: 2023-12-31 date: 2024-02-01 date: 2024-02-16 date: 2024-02-20 name: Charles University, Czech Republic class: OTHER name: General University Hospital, Prague briefSummary: The study aims to elucidate whether patients with T1D initiating sensor monitoring experience greater improvement in glycemic control (HbA1c) when provided with structured nutrition education compared to those initiating sensor monitoring without such education. conditions: Diabetes Mellitus, Type 1 studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 329 type: ACTUAL name: structured nutrition intervention measure: difference in HbA1c measure: differences in time in range measure: differences in time below range measure: differences in time above range measure: differences in coefficient of variation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Charles University city: Prague zip: 12808 country: Czechia lat: 50.08804 lon: 14.42076 hasResults: False

 nctId: NCT06264258 id: STUDY2023_00000285 briefTitle: Game-based Pediatric Diabetes Education acronym: DVx-T1D overallStatus: RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2025-06-30 date: 2024-02-16 date: 2024-02-20 name: Carnegie Mellon University class: OTHER name: University of Pittsburgh briefSummary: The goal of this study is to evaluate the impact of a mobile app video game called Digital Vaccine for Type 1 Diabetes (DVx-T1D)™, proposed as a low-risk, non-invasive, digital therapeutic candidate for behavior change in children 6 to 12 years of age with Type 1 Diabetes (T1D).

The investigators hypothesize that adoption of DVx-T1D™ by T1D patients will positively influence healthy dietary and physical activity behaviors by providing nutrition and lifestyle education through a playful, Artificial Intelligence (AI)-based, cartoon-style medium of mobile gaming, and result in improvements in their T1D control. The investigators propose to conduct a longitudinal randomized controlled trial (RCT) over a 3-month period with a study population of 80 T1D participants (40 each in two arms of the trial) of 6-12 years old. The investigators will quantify the impact of the mobile game app plus standard care vs. standard care (with no exposure to the app) on T1D control (assessed by glycosylated hemoglobin or HbA1c measured during clinic visits and continuous glucose monitoring (CGM) parameters measured at home), physical activity levels and food choices of children (measured using food logs and surveys). Game telemetry, food logs, clinical, anthropometric, demographic, and survey data will be collected to obtain adequately powered, theory-driven evidence of the value of game-based approaches delivered via mobile apps. conditions: Diabetes Mellitus, Type 1 conditions: Behavior, Health studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The investigators propose to conduct a longitudinal randomized controlled trial (RCT) over a 3-month period with a study population of 80 participants (40 in each arm) of 6-12 years old youth with type 1 diabetes (T1D).The investigators will quantify the impact of the mobile game app vs. standard care on T1D control (assessed by glycosylated hemoglobin or HbA1c measured during clinic visits and continuous glucose monitoring (CGM) parameters), physical activity levels and food choices of children (measured using food logs and surveys).

The study will also assess changes in children's knowledge about the measured outcomes and investigate the feasibility and acceptability of game adoption and the barriers and challenges faced by patients, families and clinicians. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 80 type: ESTIMATED name: DVx-T1D™ app measure: Change in HbA1c values and and insulin dose adjusted HbA1c before and after the intervention measure: Change in glucose average and variability measure: Changes in the quality of food consumption measure: Change in game play patterns over time sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: UPMC Children's Hospital of Pittsburgh status: RECRUITING city: Pittsburgh state: Pennsylvania zip: 15224 country: United States name: Neha Sudhir role: CONTACT email: sudhirn2@upmc.edu name: Ingrid Libman, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 hasResults: False

 nctId: NCT06264245 id: 2022-126 id: 2023-A00985-40 type: OTHER domain: ID RCB briefTitle: Users of Remote Conferencing and Compression of Sound Dynamics : Auditory Effects acronym: COMPRESSED overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-01-15 date: 2025-01-15 date: 2024-02-16 date: 2024-03-06 name: Institut Pasteur class: INDUSTRY name: Institut de l'Audition briefSummary: The COMPRESSED project is a descriptive, bi-centric and non-invasive study carried out by the CERIAH - IDA - Institut Pasteur and the Haute École Léonard de Vinci in Brussels on volunteer participants identified in two groups :

* be subject to high exposure to compressed sound, as defined by professional participation in events on broadcast platforms using sound signal processing systems, over the last 3 years,
* be subject to moderate or limited exposure to compressed and manipulated sound, equivalent to that of a student following certain distance learning courses. on a videoconferencing platform, alternating with other face-to-face courses, with the ability to listen during breaks, which have been taught for a maximum of 2 years.

The main objective of the COMPRESSED study is to evaluate the auditory effects of exposure to manipulated sounds (compression, filtering, equalisation, accentuation, etc.) from sound distribution platforms on the auditory system of participants who are regularly exposed to these sounds as a result of their professional activity. conditions: Auditory Perception studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Audiological profile name: Hearing self-assessments name: Objective and subjective audiological tests name: Self-assessment of exposure sound quality measure: Hearing assessments of participants exposed to manipulated sounds after and before exposure measure: Audiometric thresholds in pure tone from 125 to 8000 Hz in the subject's exposed ear before and approximately one hour after exposure, measure: Difference between the threshold of the protective reflex of the auditory pathways (middle ear muscles) measured by impedancemetry in the exposed ear when a contralateral noise is presented for a few seconds. measure: Levels of otoemissions in acoustic distortion products in the exposed ear in response to pure tone sound stimuli measure: Tinnitus or auditory distortion (hyperacusis) reported by participants before and after exposure. measure: Effectiveness of the protective auditory reflexes (or acoustic reflexes), obtained by impedancemetry and derived from the reading of the otoemissions for each participant. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Haute Ecole Léonard De Vinci city: Bruxelles country: Belgium name: Patrick Vereheyden, MD role: CONTACT phone: + 32 2 793 41 43 email: Patrick.Verheyden@vinci.be lat: 50.85045 lon: 4.34878 facility: CEntre de Recherche et d'Innovation en Audiologie Humaine city: Paris zip: 75015 country: France name: Paul Avan, MD role: CONTACT lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06264232 id: AT ELANA 841P-BER-302-19 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-02-16 date: 2024-02-20 name: [Redacted] hasResults: False

 nctId: NCT06264219 id: H-24002284 briefTitle: Restoration of the Gut Microbiome After Cesarean Section acronym: RestoreGut overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-11-30 date: 2026-11-30 date: 2024-02-16 date: 2024-02-16 name: Professor Klaus Bønnelykke class: OTHER briefSummary: This study aims to develop a therapy for restoring the gut microbiome in infants born via CS. We will conduct a randomized, placebo-controlled feasibility trial to assess the ability of microbiome restoration by FMT and FVT in infants born by cesarean section. conditions: Microbial Colonization studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Microbiome restoration - FMT name: Microbiome restoration - FVT name: Placebo name: Vaginal birth, untreated control measure: Microbial development trajectory measure: Microbial development trajectory sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Copsac, DBAC city: Gentofte state: Copenhagen zip: 2820 country: Denmark lat: 55.74903 lon: 12.54601 facility: Rigshospitalet city: Copenhagen zip: 2100 country: Denmark name: Hanne Hegaard, Professor role: CONTACT phone: +45 27583632 email: Hanne.Kristine.Hegaard@regionh.dk lat: 55.67594 lon: 12.56553 hasResults: False

 nctId: NCT06264206 id: CALLA_IVF_KIR briefTitle: Effect of Immunomodulatory Treatment on IVF (in Vitro Fertilization) Outcomes in Patients With KIR AA Genotype overallStatus: COMPLETED date: 2022-01-01 date: 2022-12-31 date: 2023-12-31 date: 2024-02-16 date: 2024-02-16 name: Calla IVF Center class: OTHER briefSummary: The aim of the study is to investigate the immune cause of recurrent implantation failure (RIF) and the role of immunomodulatory treatment in IVF (in vitro fertilization) patients that have a KIR AA genotype. We compared pregnancy rates in Group KIR AA without immunomodulatory treatment, and pregnancy rates in Group KIR AA with immunomodulatory treatment. conditions: Immunomodulatory Drugs conditions: Killer-cell Immunoglobulin-like Receptors (KIRs) conditions: KIR Alleles (KIR AA) studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 65 type: ACTUAL name: Killer-cell immunoglobulin-like receptors (KIRs) testing measure: the incidence of immune cause of recurrent implantation failure measure: the efficiency of immnomodulatory treatment on pregnancy rate in patients with KIR AA measure: comparation between the pregnancy rates in KIR AA group and KIR Bx group sex: FEMALE minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: Calla Ivf Center city: Oradea state: Bihior zip: 410103 country: Romania lat: 47.0458 lon: 21.91833 hasResults: False

 nctId: NCT06264193 id: Rowers briefTitle: The Impact of Hypoxia on the Biochemical and Morphological Parameters of Blood in Rowers. acronym: IHOBMPBR overallStatus: COMPLETED date: 2014-11-30 date: 2014-12-21 date: 2014-12-21 date: 2024-02-16 date: 2024-02-16 name: Poznan University of Physical Education class: OTHER briefSummary: The response to hypoxia is very individual and epending on many aspects, such as the type of training, duration, intensity, or hypoxic stimulus, hypoxia affects the athlete in various ways. The results of this study have shown that 18 days of the LH-TL method does not significantly increase the level of EPO and VEGF in rowers. However, reticulocytes, immature red blood cells, have shown significant differences after 18-d LH-TL between groups. Further research should be carried out to investigate an optimal hypoxic dose and time, which will raise EPO, VEGF, and morphology variables. conditions: Hypoxia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The hypoxic group included rowers participating in sports training and the LH-TL method, hypoxic rooms (FiO2=14.5%, corresponds to an altitude of 3000 meters). And the control group participating only in sports training and living in normoxic rooms, at the same sports camp. primaryPurpose: DIAGNOSTIC masking: NONE count: 13 type: ACTUAL name: hypoxia measure: Erythropoietin (EPO) mlU/ml measure: vascular endothelial growth factor (VEGF) mlU/ml measure: creatine kinase (CK) ng/ml measure: Hs C-Reactive Protein (hsCRP) mg/L measure: hemoglobin (Hb)g/dL measure: hematocrit (Htc)% measure: red blood cells (RBC)mln/mm3 measure: white blood cells (WBC)10 3/µL measure: reticulocytes (Ret)‰ measure: SpO2 - oxygen saturation (%) measure: bpm - beats per minute(%) sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06264180 id: RP1-104 briefTitle: VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs (IGNYTE-3) overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2029-01-01 date: 2034-08-31 date: 2024-02-16 date: 2024-02-16 name: Replimune Inc. class: INDUSTRY briefSummary: This is a randomized, controlled, multicenter, open-label Phase 3 clinical study comparing VO in combination with nivolumab versus Physician's Choice treatment for patients with unresectable Stage IIIb-IV cutaneous melanoma whose disease progressed on an anti PD-1 and an anti-CTLA-4 containing regimen (administered either as a combination regimen or in sequence) or who are not candidates for treatment with an anti-CTLA-4 therapy. conditions: Advanced Melanoma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 400 type: ESTIMATED name: Vusolimogene Oderparepvec name: Nivolumab name: Nivolumab + Relatlimab name: Pembrolizumab name: Single-agent chemotherapy measure: Overall Survival (OS) measure: Progression Free Survival (PFS) measure: Objective Response Rate (ORR) sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06264167 id: NODE briefTitle: NODE (groiN ultrasOunD cancEr) acronym: NODE overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-03-31 date: 2028-03-31 date: 2024-02-16 date: 2024-02-16 name: Queensland Centre for Gynaecological Cancer class: OTHER_GOV name: Royal Brisbane and Women's Hospital briefSummary: This study is an open label, prospective, experimental, randomised clinical trial. The primary aim of this study is to determine whether it is feasible to randomise vulvar cancer patients into one of two treatment arms:1) surgical groin node dissection (as delivered though either a sentinel node biopsy or inguinofemoral lymph node dissection (IFL), or 2) serial high-resolution bilateral groin ultrasound surveillance and clinical examination every 2 months. conditions: Vulvar Cancer Stage Ib conditions: Vulvar Cancer Stage II conditions: Lymph Node Metastasis conditions: Groin Node conditions: Ultrasound Therapy; Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Feasibility trial, open label, three-group, randomised clinical trial

30 eligible females aged 18 or older with clinically stage 1b or 2 vulvar cancer will receive a bilateral groin node ultrasound up to 30 days prior to planned surgery:

Participants with normal/negative baseline groin ultrasounds will be randomly assigned to two groups (2:1 randomisation): one group undergoing radical procedures (groin lymph nodes are not removed) with bilateral groin ultrasound surveillance in conjunction with clinical examinations every 2 months, and the other group undergoing upfront full groin LND or sentinel node biopsy (SNB) based on clinician choice (according to local clinical practice management guidelines).

Participants with suspicious/indeterminate baseline groin ultrasound (third group) will receive an upfront full groin LND or SNB, consistent with the current standard treatment, according to local clinical practice management guidelines. primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: High-resolution bilateral groin ultrasound surveillance measure: Feasibility of randomisation: The percentage of patients willing to be randomised to either surgical groin node dissection or serial high-resolution bilateral groin ultrasound surveillance in conjunction with clinical examination every 2 months. measure: Utility of tumour mutations to determine positive lymph node metastasis. measure: Utility of circulating tumour DNA to determine positive lymph node metastasis. measure: Utility of plasma to determine positive lymph node metastasis. measure: Utility of serum to determine positive lymph node metastasis. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St Andrew's War Memorial Hospital city: Brisbane state: Queensland zip: 4000 country: Australia name: Sara Baniahmadi role: CONTACT phone: 07 3346 5073 email: s.baniahmadi@uq.edu.au name: Andreas Obermair, Prof role: PRINCIPAL_INVESTIGATOR lat: -27.46794 lon: 153.02809 facility: Royal Brisbane and Women's Hospital city: Brisbane state: Queensland zip: 4029 country: Australia name: Sara Baniahmadi role: CONTACT phone: 07 3346 5073 email: s.baniahmadi@uq.edu.au name: Avalon Knott role: CONTACT phone: 07 3346 5073 email: a.knott@uq.edu.au name: Andrea Garrett, Dr role: PRINCIPAL_INVESTIGATOR lat: -27.46794 lon: 153.02809 hasResults: False

 nctId: NCT06264154 id: 854051 id: R01CA287474-01 type: NIH link: https://reporter.nih.gov/quickSearch/R01CA287474-01 briefTitle: The Role of Flavor in the Substitutability of E-cigarettes for Combustible Cigarettes Among Persistent Smokers overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-06 date: 2027-12 date: 2024-02-16 date: 2024-02-16 name: University of Pennsylvania class: OTHER name: National Cancer Institute (NCI) briefSummary: This between-subjects study aims to evaluate the effect of flavor on initial and sustained switching from combustible cigarettes to e-cigarettes among 210 cigarette smokers. After measuring baseline cigarette smoking rate, participants will be randomized to a six-week regimen of fruit-flavored, tobacco-flavored, or menthol-flavored e-cigarettes and be instructed to switch (versus smoking cigarettes) over a 6-week period. Flavor-associated subjective reward and the reinforcing value of flavored e-cigarettes relative to combustible cigarettes will be assessed as mechanisms. conditions: Smoking conditions: Tobacco Use conditions: Cigarette Smoking conditions: E-Cig Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 210 type: ESTIMATED name: E-cigarettes measure: Cigarette Consumption measure: Cigarette Smoking Behavior sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06264141 id: NONS-RARS-01 briefTitle: Evaluation of Nitric Oxide Nasal Spray (NONS) for Treatment of Recurrent Acute Rhinosinusitis acronym: NONS-RARS-01 overallStatus: RECRUITING date: 2024-01-16 date: 2024-06 date: 2024-09 date: 2024-02-16 date: 2024-02-16 name: Sanotize Research and Development corp. class: INDUSTRY briefSummary: A two-week therapy of nitric oxide nasal spray (NONS) vs Placebo (saline nasal spray) initiated immediately after the onset of a new Recurrent Acute Rhinosinusitis (RARS) episode to assess the acceleration to clinical success (cured/much improved symptoms), lack of use of intranasal corticosteroids (INCS) (Day 5, or thereafter) and rescue oral antibiotics (ATBs) (Day 8, or thereafter) after initiation of nitric oxide releasing solution (NORS) platform therapy. conditions: Recurrent Acute Rhinosinusitis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A two-week therapy of NONS vs Placebo (saline nasal spray) initiated immediately after the onset of a new RARS episode to assess the acceleration to clinical success (cured/much-improved symptoms), lack of use of INCS (Day 5, or thereafter) and rescue oral antibiotics (ATBs) (Day 8, or thereafter) after initiation of nitric oxide-releasing solution (NORS) platform therapy. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: A blinded participant number will be assigned to each randomized participant. Site staff/ physician will then dispense a kit labelled with the authorization number generated during randomization to the individual participant. No study investigators, associates performing assessments or participants will be aware of the study medication in the assigned treatments. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 186 type: ESTIMATED name: Nitric Oxide Releasing Solution name: Nasal spray with isotonic saline measure: Primary endpoint is the time to sinus symptoms resolution measure: Time (days) to full recovery from sinusitis (participant reported) measure: Time (days) to sinus symptoms resolution, i.e., being cured or much improved (participant reported clinical success) measure: Time (days) to the initiation of rescue oral ATB(s), i.e., treatment failure i.e., treatment failure measure: Time (days) to initiation of INCS measure: Proportion of participants requiring INCS measure: Proportion of participants requiring rescue oral ATBs measure: Proportion of participants recovered from sinusitis measure: Proportion of participants with rapidly worsening symptoms requiring the use of INCS and oral ATBs measure: Proportion of participants achieving at least a 9-point improvement change from baseline in Sinonasal Outcome Test (SNOT)-22 measure: Tolerability and safety of NONS measure: Proportion of participants with clinically significant changes from baseline in vital signs measure: Proportion of participants with clinically significant changes from baseline in laboratory parameters measure: Number of participants with clinically significant changes from Baseline in physical examinations measure: Number of ATB courses required as a rescue treatment measure: Time (days) to the initiation of NSAIDs measure: Proportion of participants requiring NSAIDs measure: Time (days) to each symptom being cured or much improved measure: Proportion of participants being cured or much improved for each symptom measure: Proportion of participants achieving at least a 50% reduction in sinusitis symptoms (by MRSS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Okanegan Clinical Trials status: RECRUITING city: Kelowna state: British Columbia zip: V1Y 1Z9 country: Canada name: Cora Withers role: CONTACT phone: 250-862-8141 email: cora@oktrials.ca name: Colleen Maytham, MD role: PRINCIPAL_INVESTIGATOR lat: 49.88307 lon: -119.48568 facility: Richmond Clinical Trials (Okanagan Clinical Trials Satelite Site) status: RECRUITING city: Richmond state: British Columbia zip: V6V 2L1 country: Canada role: CONTACT phone: 604-373-4954 name: Colleen Maytham, MD role: PRINCIPAL_INVESTIGATOR lat: 49.17003 lon: -123.13683 facility: Cliantha Research status: RECRUITING city: Mississauga state: Ontario zip: L4W 1V7 country: Canada name: Patricia Couroux, MD role: PRINCIPAL_INVESTIGATOR lat: 43.5789 lon: -79.6583 facility: Clinical Research of Ontario status: NOT_YET_RECRUITING city: Scarborough state: Ontario zip: M1S 4T7 country: Canada name: Jemilat Smith role: CONTACT phone: 18002474525 phoneExt: 1 email: jemilatsmith@gmail.com lat: 43.77223 lon: -79.25666 facility: Intermed Groupe Santé status: RECRUITING city: Chicoutimi state: Quebec zip: G7H 7Y8 country: Canada name: Nancu Lavoie role: CONTACT phone: 418-602-6620 email: n.lavoie@intermedgs.ca name: Doria Grimard, MD role: PRINCIPAL_INVESTIGATOR lat: 48.41963 lon: -71.06369 facility: Alpha Recherche Clinique LeBourneuf status: RECRUITING city: Québec City state: Quebec zip: G2J 0C4 country: Canada name: Amélie Boulay role: CONTACT phone: 418.704.1112 email: aboulay@alpha-recherche.ca name: Anne-Marie Beaulieu, MD role: PRINCIPAL_INVESTIGATOR lat: 46.81228 lon: -71.21454 facility: Alpha Recherche Clinique Val-Belair status: RECRUITING city: Québec City state: Quebec zip: G3K 2P8 country: Canada name: Jessica M. M. Petit role: CONTACT phone: 418.847.1112 email: jpetit@alpha-recherche.ca name: Melanie Gauvin role: CONTACT email: mgauvin@alpha-recherche.ca name: Camille Walsh, MD role: PRINCIPAL_INVESTIGATOR lat: 46.81228 lon: -71.21454 hasResults: False

 nctId: NCT06264128 id: TheraPAP Comfort briefTitle: TPAP for Comfort in OSA overallStatus: RECRUITING date: 2024-03-08 date: 2024-05-31 date: 2024-06-30 date: 2024-02-16 date: 2024-03-18 name: SleepRes Inc. class: INDUSTRY briefSummary: TheraPAP is a prototype device (with full documented electrical and isolation safety) being developed by SleepRes for the treatment of obstructive sleep apnea (OSA) that can deliver either standard CPAP at a set pressure or what is called TPAP . TPAP is a pressure control algorithm that lowers the pressure from the set pressure at the beginning of inspiration and does not return the pressure to the full set level until about halfway through expiration. The present study, TheraPAP Comfort, aims at assessing whether TPAP improves patient comfort vs. CPAP during supine wakefulness. conditions: Obstructive Sleep Apnea studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All participants will undergo the same therapy combinations. CPAP (Continuous Positive Airway Pressure) and 2 level of TPAP (TheraPAP - novel CPAP approach pressure is reduced below therapy pressure from inspiration through mid exhalation specifically for comfort) will be assessed against each other in a round robin both backward and forward (6 total binary comparisons) for 2 levels of baseline pressure. primaryPurpose: TREATMENT masking: NONE maskingDescription: There is no specific intent to mask although participants will be naive to CPAP-type therapy, but they will be able to feel the difference. count: 80 type: ESTIMATED name: TPAP name: CPAP measure: CPAP v TPAP Patient Preference via Visual Analog Scale measure: TPAP 1 v TPAP 2 Patient Preference via Visual Analog Scale sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SleepCenters of Middle Tennessee status: RECRUITING city: Murfreesboro state: Tennessee zip: 37129 country: United States name: Craig Salazar role: CONTACT phone: 615-893-4896 email: csalazar@sleepcenterinfo.com name: WIlliam H Noah, MD role: PRINCIPAL_INVESTIGATOR lat: 35.84562 lon: -86.39027 hasResults: False

 nctId: NCT06264115 id: Soh-Med-24-01-05MS briefTitle: Outcomes of Three Ports Versus Four Ports Laparoscopic Cholecystectomy, Sohag General Surgery Department Experience overallStatus: ENROLLING_BY_INVITATION date: 2024-01-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-16 date: 2024-02-20 name: Sohag University class: OTHER briefSummary: To compare the outcomes of three ports and four ports Laparoscopic Cholecystectomy conditions: Cholecystitis, Chronic studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Laparoscopic Cholecystectomy measure: Postoperative pain score measure: Operative time measure: length of hospital stay measure: Total postoperative morphine consumption measure: Time of first analgesic sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sohag university city: Sohag country: Egypt lat: 26.55695 lon: 31.69478 hasResults: False

 nctId: NCT06264102 id: 2024/1/1 briefTitle: Influence of Dalcroze Eurhythmics on Pains in Older Women overallStatus: COMPLETED date: 2019-01-11 date: 2019-03-08 date: 2019-07-15 date: 2024-02-16 date: 2024-02-16 name: Poznan University of Physical Education class: OTHER briefSummary: In this study, we attempted to answer the question of whether participation in a 12-week rhythmic exercise program using the Dalcroze method affects the level of intensity of pain experienced by women over the age of 65. The level of pain was determined on a numerical scale from 1 to 10 and involved headaches, back pain and leg pain. conditions: Back Pain conditions: Headache conditions: Leg Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 61 type: ACTUAL name: Physical exercise program measure: Pain levels before exercise program measure: Results of pain levels after exercise program sex: FEMALE minimumAge: 65 Years stdAges: OLDER_ADULT facility: Poznan University of Physical Education city: Poznań state: Wielkopolska zip: 61-871 country: Poland lat: 52.40692 lon: 16.92993 hasResults: False

 nctId: NCT06264089 id: 202015 briefTitle: Effects of Preservation Rhinoplasty Nasal Valve Angle and Area overallStatus: COMPLETED date: 2020-08-06 date: 2023-08-30 date: 2023-08-30 date: 2024-02-16 date: 2024-02-16 name: Yuzuncu Yıl University class: OTHER briefSummary: The study planned to compare the internal nasal valve angle measurements of patients who underwent preservation rhinoplasty before and after surgery. conditions: Nasal Obstruction, Bilateral studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ACTUAL name: Preservation Rhinoplasty Nasal Valve Angle and Area measure: Nasal Obstruction Symptom Evaluation Scale (NOSE) measure: Reformatted coronal Computed tomography sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yaser Said Cetin city: Van zip: 65080 country: Turkey lat: 38.49457 lon: 43.38323 hasResults: False

 nctId: NCT06264076 id: 686340 id: CIV-NO-23-09-043976 type: OTHER domain: Eudamed CIV ID briefTitle: Ligament Balancing in Total Knee Arthroplasty acronym: BLIS-TKA overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-12-31 date: 2025-12-31 date: 2024-02-16 date: 2024-02-16 name: Oslo University Hospital class: OTHER name: Vestre Viken Hospital Trust briefSummary: The goal of this interventional pilot study is to evaluate if performing ligament balancing on the medial collateral ligament (MCL) in a more systematical manner with a novel instrument can produce more objective and repeatable ligament lengthening in Total Knee Arthroplasty. The main questions it aim to answer are:

1. Is it feasible to perform systematic ligament balancing on the MCL using a novel instrument?
2. Can a novel instrument for ligament balancing acquire more objective and repeatable results, without risk of injury?

Participants must consent prior to the surgery, but inclusion is only done once ligament balancing is indicated during surgery. Patients will be follow-up as standard protocol for Total Knee Arthroplasty patients at the hospital. conditions: Ligament; Laxity, Knee conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, single-group, non-blind, interventional study primaryPurpose: TREATMENT masking: NONE maskingDescription: Non-blind count: 20 type: ESTIMATED name: A novel instrument for ligament balancing in total knee arthroplasty measure: Is it feasible to perform systematic ligament balancing on the MCL using a novel instrument? measure: MCL-lengthening in millimeters after ligament balancing using the novel instrument measure: Demographic information - height (cm) - and how this parameters affects ligament balancing. measure: Demographic information - weight (kg) - and how this parameters affects ligament balancing. measure: Demographic information - age (years) - and how this parameters affects ligament balancing. measure: Demographic information - sex (biologic, male/ female) - and how this parameters affects ligament balancing. measure: Demographic information - co-morbidities (disease state) - and how this parameters affect ligament balancing. measure: Patient reported outcome measures (PROM) using EQ-5D-5L measure: Patient reported outcome measures (PROM) using FJS-12 measure: Patient reported outcome measures (PROM) using KOOS-12 sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Baerum Hospital, Vestre Viken Hospital Trust city: Bærums Verk state: Viken zip: 1346 country: Norway name: Jarle Vik, MD role: CONTACT phone: 004793844926 email: jarle.vik@vestreviken.no lat: 59.94148 lon: 10.50273 facility: Oslo University Hospital, Ullevaal city: Oslo zip: 0450 country: Norway name: Lars HW Engseth, MD role: CONTACT phone: 004741254136 email: laengs@ous-hf.no lat: 59.91273 lon: 10.74609 hasResults: False

 nctId: NCT06264063 id: D-DIST briefTitle: Study of Behavioral Dysfunctions and Related Neuronal Correlates in Patients With Dystonia acronym: D-DIST overallStatus: RECRUITING date: 2024-01-10 date: 2024-03-10 date: 2025-10-10 date: 2024-02-16 date: 2024-02-16 name: IRCCS Centro Neurolesi "Bonino-Pulejo" class: OTHER briefSummary: Dystonias represent hyperkinetic movement disorders characterized by protracted muscle contractions, such as to cause torsional movements and anomalous postures in different parts of the body. Although they occur more often in a focal form (blepharospasm, oromandibular dystonia, cervical dystonia, laryngeal dystonia, attitudinal cramps of the limbs) than segmental (involvement of several contiguous muscle groups, e.g. facial muscles and neck muscles), they are nevertheless capable of significantly influencing the quality of life, with consequent social and health costs. Although described as a predominantly motor disorder, the presence of non-motor symptoms in dystonias associated with alteration of the fronto-striatal circuits is increasingly recognized. Neuroimaging studies have highlighted that the striatum and, more specifically, striatal dopamine, is involved in high cognitive processes such as attention, reward-based learning and decision making. Clinical conditions associated with cortico-striatal circuit dysfunction and abnormal meso-striatal or meso-cortical dopamine transmission also appear to influence temporal estimation, delay discounting, showing an impulsive preference for immediate rewards over delayed gratification.

Based on these premises, the present project aims to evaluate the cognitive and affective aspects of dystonias, in line with neuroimaging research documenting structural and functional dysfunctions in the respective brain regions. conditions: Dystonia conditions: Neurologic Disorder conditions: NEUROSCIENCE studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: SINGLE whoMasked: PARTICIPANT count: 102 type: ESTIMATED name: control group name: experimental group name: EEG power in alpha band measure: montreal cognitive assessment measure: Beck depression inventory measure: EEG power in alpha band sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: IRCCS Centro Neurolesi Bonino Pulejo status: RECRUITING city: Messina zip: 98124 country: Italy name: Caterina Formica, PhD, PSY role: CONTACT phone: +3909060128185 email: katia.formica@irccsme.it lat: 38.19394 lon: 15.55256 hasResults: False

 nctId: NCT06264050 id: 2023.04 briefTitle: Psychological Support Group and Its Effects on Mood, Anxiety and Coping acronym: SUPPORT overallStatus: ACTIVE_NOT_RECRUITING date: 2004-01-08 date: 2024-09-08 date: 2025-03-15 date: 2024-02-16 date: 2024-02-16 name: IRCCS San Camillo, Venezia, Italy class: OTHER briefSummary: The aim of this study is to verify the influence that participation in a Psychological Support Group has on anxiety, depression and coping skills in patients admitted to the IRCCS San Camillo Hospital.

It is therefore an observational study with a pre-post design on a cohort of patients hospitalized at San Camillo IRCCS who attend the Psychological Support Group.

The study consists of verifying whether the therapeutic activity of the Psychological Support Group (GSP) has an influence on the levels of anxiety, mood and coping skills in the patients who attend it. These purposes will be pursued through the administration to each patient at the beginning (pre) and at the end (post) of the period of attendance at the GSP, of validated scales: Stay Y2 (anxiety), BDI II(depressive symptoms), COPE NVD 25 (coping strategies) and the CORE-OM (outcomes of psychological activity). conditions: Coping Strategies conditions: Anxiety conditions: Nurse-Patient Relations conditions: Psychological conditions: Mood Depressed conditions: Rehabilitation conditions: Neurologic Manifestations studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: pre post study on a single cohort primaryPurpose: DIAGNOSTIC masking: NONE count: 19 type: ACTUAL name: evalutaion scales measure: The State-Trait Anxiety Inventory (STAI) Y2 measure: The Beck Depression Inventory II (BDI-II) measure: The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) measure: The Coping Orientations to Problem Experienced NVI - 25 sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06264037 id: 2023.03 id: Studio 1574 /IRCCS San Camillo type: OTHER domain: CESC di Venezia e IRCSS San Camillo briefTitle: The Experience in Neurorehabilitation Setting: a Qualitative Study acronym: NURSEXPERIENCE overallStatus: RECRUITING date: 2023-03-15 date: 2024-12-08 date: 2025-03-15 date: 2024-02-16 date: 2024-02-16 name: IRCCS San Camillo, Venezia, Italy class: OTHER briefSummary: In this exploratory qualitative study with a hermeneutic phenomenological approach, we will describe and understand the experience of treatment and hospitalization in hospitalized people suffering from stroke, multiple sclerosis, Parkinson\&#39;s disease and patients post-neurosurgery for oncological causes. Patients will be interviewed in a semi-structured manner and sampling will take place for each of the pathology groups according to the saturation method. conditions: Rehabilitation conditions: Neurologic Disorder conditions: Stroke conditions: Parkinson Disease conditions: Multiple Sclerosis conditions: Neurosurgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: semi structured interview measure: narrative contents sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Alberto Camuccio status: RECRUITING city: Venezia zip: 30126 country: Italy name: Alberto Camuccio, doctor role: CONTACT phone: +39412207516 email: alberto.camuccio@hsancamillo.it name: Enrico Dal Pozzo, doctor role: CONTACT phone: +39412207111 email: enrico.dalpozzo@hsancamillo.it lat: 45.43713 lon: 12.33265 facility: IRCCS San Camillo Department of Neurorehabilitation, Venezia status: RECRUITING city: Venezia zip: 30126 country: Italy name: Alberto Camuccio, doctor role: CONTACT phone: +39412207516 email: alberto.camuccio@hsancamillo.it name: Enrico Dal Pozzo, doctor role: CONTACT phone: +39412207111 email: enrico.dalpozzo@hsancamillo.it lat: 45.43713 lon: 12.33265 facility: IRCCS San Camillo Venezia status: RECRUITING city: Venezia zip: 30126 country: Italy name: Alberto Camuccio, doctor role: CONTACT phone: +39412207516 email: alberto.camuccio@hsancamillo.it name: Enrico Dal Pozzo, doctor role: CONTACT phone: +39412207111 email: enrico.dalpozzo@hsancamillo.it lat: 45.43713 lon: 12.33265 hasResults: False

 nctId: NCT06264024 id: 519516 briefTitle: Simultaneous pHototherapeutic Keratectomy and corneAl Collagen cRosslinking in Eyes With Keratoconus: a Randomized Trial (SHARK) overallStatus: RECRUITING date: 2024-02-12 date: 2025-05-01 date: 2034-02-01 date: 2024-02-16 date: 2024-02-16 name: Oslo University Hospital class: OTHER briefSummary: The goal of this clinical trial is to compare CXL with combined treatment with CXL and t-PTK.

The main questions it aims to answer are whether combined treatment can give better visual acuity and if the treatments are equally safe. conditions: Keratoconus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 81 type: ESTIMATED name: Corneal collagen cross linking (CXL) name: Transepithelial phototherapeutic keratectomy (t-PTK) measure: Visual acuity measure: Risk of progression measure: Visual acuity measure: Visual acuity measure: Visual acuity measure: Visual acuity measure: Visual acuity measure: Risk of progression measure: Risk of progression measure: Risk of progression measure: Risk of progression measure: Risk of progression measure: Depth of demarcation line (OCT) measure: Depth of demarcation line (confocal microscopy) measure: Patient reported outcome measure (PROMs) measure: Patient reported outcome measure (PROMs) measure: Patient reported outcome measure (PROMs) measure: Patient reported pain after surgery sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Ophhtalmology, University of Oslo status: RECRUITING city: Oslo country: Norway name: Olav Kristianslund, MD, PhD role: CONTACT email: olakri@ous-hf.no name: Bjarne L Thorbjørnsen, MD role: CONTACT email: uxtbja@ous-hf.no lat: 59.91273 lon: 10.74609 hasResults: False

 nctId: NCT06264011 id: 2023B0044 briefTitle: Discrimination and Religious Experiences of Adult Muslimahs in Salaat acronym: DREAMS overallStatus: RECRUITING date: 2023-07-13 date: 2024-06 date: 2024-06 date: 2024-02-16 date: 2024-04-26 name: Ohio State University class: OTHER briefSummary: This goal of this clinical trial is to examine the effects of the Muslim prayer (salaat) on physiological arousal among Muslim women. This study aims to measure EEG and HRV during the salaat performance among Muslim women. Using EEG as a measure of physiological relaxation, HRV will be utilized as a measure of stress experienced by Muslim women whose prayer have been understudied in research on the salaat. Thus, the main questions it aims to answer are 1) whether salaat performed by Muslim women influences physiological relaxation similar to what is seen by men, and 2) Evaluate health-related correlates of perceived discrimination among Muslim women.

Participants will complete 15 questionnaires. Participants will be connected to a Heart Rate Variability (HRV) monitor as well as a 32-electrode EEG cap. After the baseline data are obtained, all participants will complete both conditions (salaat and counting) but the order of participation in conditions will be randomly assigned. The resting period will again occur between conditions and at the end of the second condition.

All participants will pray the Duha prayer, an optional superogatory prayer that typically occurs in the early morning, to control for differences in timing and duration of prayer. The Duha is completed between the dawn and noon prayers and consists of four cycles of prayer as well as Qur'an recitation and supplication throughout the four positions. The salaat condition includes four cycles with four different positions during each cycle (standing with bowing at a 90-degree angle with both hands covering the knees, standing again briefly with arms at the sides, prostrating with forehead, hands, knees, and feet touching the ground, followed by sitting with knees bent under the torso, prostrating, and sitting again). The counting condition will include the same physical component as the salaat condition. This will include 4 cycles of movement through the four different positions (i.e., standing, bowing at a 90-degree angle with both hands covering the knees, standing again briefly with arms at the sides, prostrating with forehead, hands, knees, and feet touching the ground, followed by sitting with knees bent under the torso, prostrating, and a final sitting position in cycles two and four (see Figure 2)). Apart from not including the final sitting position, cycles one and three are identical to cycles two and four (see Figure 2). The counting condition will include replacing Qur'anic recitation and subsequent supplications throughout the prayer by counting "one one-thousand, two one-thousand, three one-thousand, etc." throughout the duration of time typically required to perform the full salaat. During the standing position, counting can last for approximately 30-60 seconds in line with the previous study by Doufesh and colleagues (2012). Thus, the first three cycles of prayer will require approximately 77 seconds each while the final cycle will require around 97 seconds based on the estimates by Doufesh and colleagues (2012), for a total of approximately five and a half minutes. To ensure that participant duration during the counting condition is, on average, equivalent to the salaat condition, an audio recording will be provided with counting aloud during each position. The duration of the counting in the audio recording will be an average of the duration of each position as found in Doufesh and colleagues (2012). A bell sound will be used to indicate when participants should change to the next position. After performance of each condition, participants will return to a comfortable seated position. Participants will complete a questionnaire to rate their mental focus in the condition. Blood pressure will be measured at the end of each condition. While at rest, assessment of blood pressure, HRV, and EEG will be obtained from participants for 5 minutes between each condition and at the end of the study. conditions: Stress, Psychological conditions: Control studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: There is one intervention (i.e., the prayer condition) and one control condition (i.e., the counting condition). primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: This study uses a cross-sectional, repeated measures, crossover design. All participants will complete both conditions of the study but will be randomized to start in either the salaat or counting conditions. whoMasked: INVESTIGATOR count: 45 type: ESTIMATED name: Salaat name: Sham comparator measure: Relative power alpha measure: High frequency heart rate variability (HF-HRV) measure: The Body Perception Questionnaire Body Awareness Very Short Form (BPQ-VSF) measure: The SF 36-Item Health Survey (SF-36) measure: Modified International Physical Activity Questionnaire - Short Form (IPAQ-SF) measure: Health Care Discrimination Scale (HCDS; Martin, 2015) measure: Perceived Religious Discrimination Scale (PRDS; Rippy & Newman, 2008) measure: The Internalized Islamophobia Scale measure: Muslim Identification Scale (MIS; Verkuyten, 2007) measure: Brief Religious COPE measure: Salaat Frequency Scale measure: The Salaat Index measure: Hijab Frequency Scale sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: The Ohio State University status: RECRUITING city: Columbus state: Ohio zip: 43016 country: United States name: Ihsan Rodriguez, MS role: CONTACT phone: 505-463-5297 email: Rodriguez.919@osu.edu name: Charles Emery, PhD role: CONTACT phone: 43210 email: emery.33@osu.edu name: Charles Emery, PhD role: PRINCIPAL_INVESTIGATOR name: Ihsan Rodriguez, MS role: SUB_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False

 nctId: NCT06263998 id: HUC1-394 briefTitle: Clinical Study for the Evaluation of Safety and Tolerability of NCP112 Eye Drops overallStatus: NOT_YET_RECRUITING date: 2024-06-03 date: 2025-11-28 date: 2026-01-30 date: 2024-02-16 date: 2024-02-16 name: Huons Co., Ltd. class: INDUSTRY briefSummary: The objective is to evaluate the safety, local tolerability, and pharmacokinetics of NCP112 eye drops through single and multiple dose-escalation ocular administrations in healthy adults. conditions: Xerophthalmia studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: NCP112 name: NCP112 Placebo measure: Treatment-Emergent Adverse Events measure: Evaluation of pharmacokinetic profile measure: Evaluation of pharmacokinetic profile sex: ALL minimumAge: 19 Years maximumAge: 50 Years stdAges: ADULT hasResults: False

 nctId: NCT06263985 id: 20214133 briefTitle: Axis(TM) Solvent-dehydrate Dermal Allograft in the Treatment of Pelvic Organ Prolapse. overallStatus: ACTIVE_NOT_RECRUITING date: 2021-11-02 date: 2025-05-30 date: 2025-05-30 date: 2024-02-16 date: 2024-02-16 name: Michigan Institution of Women's Health PC class: OTHER name: Coloplast A/S briefSummary: The goal of this study is to assess improvement in subjects who have undergone Axis Dermis, biologic mesh for pelvic organ prolapse repair. \[describe participant population/health conditions\]. The main question\[s\] it aims to answer are:

* Is the leading edge of the prolapse above the hymen
* Does subject notice a bulge Participants will undergo Axis Dermis pelvic organ prolapse repair procedure. conditions: Pelvic Organ Prolapse studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Subjects undergoing the treatment for pelvic organ prolapse with Axis Dermis biologic mesh. primaryPurpose: TREATMENT masking: NONE count: 50 type: ACTUAL name: Axis Dermis biologic mesh repair for pelvic organ prolapse measure: Improvement in function measure: Improvement in Anatomy measure: Assess complications or untoward side effects. sex: FEMALE minimumAge: 21 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Advanced Urogynecology of Michigan city: Dearborn state: Michigan zip: 48124 country: United States lat: 42.32226 lon: -83.17631 hasResults: False

 nctId: NCT06263972 id: 0168-21EMC briefTitle: Comparison of the Efficacy of Transcranial Direct Current Stimulation (tDCS) of the Primary Motor Cortex (M1) or the Prefrontal Cortex Combined With Aerobic Activity for Alleviation of Fibromyalgia Symptoms. overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2026-07 date: 2024-02-16 date: 2024-02-16 name: HaEmek Medical Center, Israel class: OTHER name: Technion, Israel Institute of Technology name: Rambam Health Care Campus briefSummary: The goal of this study is to demonstrate the effectiveness of treating fibromyalgia using combination of electrical stimulation with aerobic activity.

Participants will be randomly assigned to stimulation in a ratio of 1:1:1. 120 participants (40 in each group). The therapeutic course will include moderate aerobic physical activity (at 60% of the target heart rate adjusted for age) 3 times a week for 4 weeks (a week of adjustment, and 3 weeks of treatment), along with low current electrical stimulation for 3 weeks. conditions: Fibromyalgia conditions: Electric Shock studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 120 type: ESTIMATED name: Direct Stimulation Prefrontal Cortex name: Shame cortex stimulation name: Direct Stimulation to Motor Cortex name: erobic physical activity measure: Study objectives: • Comparing the effectiveness of direct electric current stimulation between the two stimulus areas Numeric pain rating scale. measure: Study objectives: • Comparing the effectiveness of direct electric current stimulation (tDCS) between the two stimulus areas and in relation Adult sensory profile test Raw score. measure: Study objectives: • Comparing the effectiveness of direct electric current stimulation between the two stimulus areas and in relation to The Montreal Cognitive Assessment (MoCA) score. measure: Study objectives: • Comparing the effectiveness of direct electric current stimulation between the two stimulus areas and in relation to Generalized Anxiety Disorder 7-Item Scale sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06263959 id: GST-HG131-II-01 briefTitle: A Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Study to Evaluate the Safety and Efficacy of GST-HG131 Tablets in Patients With Chronic Hepatitis B overallStatus: RECRUITING date: 2023-12-29 date: 2024-09-01 date: 2024-11-01 date: 2024-02-16 date: 2024-02-16 name: Fujian Akeylink Biotechnology Co., Ltd. class: INDUSTRY briefSummary: A randomized, double-blind, placebo-controlled Phase IIa clinical study to evaluate the safety and efficacy of GST-HG131 tablets in patients with chronic hepatitis B conditions: Chronic Hepatitis B studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 45 type: ESTIMATED name: GST-HG131 name: Placebo to match GST-HG131 measure: Change from Baseline in HBsAg levels measure: Number of participants with adverse events (AEs), serious adverse events (SAEs), and withdrawals due to AEs sex: ALL minimumAge: 35 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Fifth Medical Center of Chinese PLA General Hospital status: RECRUITING city: Beijing country: China name: Tang Yanan role: CONTACT phone: +8613585734994 email: annie_tyn@163.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06263946 id: WS10337 briefTitle: Essilor® Stellest® Lenses Multicentre European Study (SLOMES) acronym: SLOMES overallStatus: RECRUITING date: 2024-03-22 date: 2026-09-30 date: 2026-12-30 date: 2024-02-16 date: 2024-04-03 name: Essilor International class: INDUSTRY briefSummary: The goal of this post-market clinical follow up Study is to demonstrate the efficacy, safety, acceptability, and quality of life implications of Essilor® Stellest® spectacle lenses in slowing myopia progression in European children and adolescents. Participants will receive Essilor® Stellest® at inclusion visit and will be asked for a full time wear (\>12 hours daily) for 24 months. The primary endpoints are the change in axial length and cycloplegic autorefraction from baseline to 24 months compared to expected change based on axial length and refraction centile positions at baseline. conditions: Myopia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: multicentre, European, prospective primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: Essilor® Stellest® spectacle lenses measure: Change in cycloplegic axial length measure: Change in cycloplegic autorefraction measure: Change in refraction progression centile measure: Change in cycloplegic axial length measure: Change in cycloplegic autorefraction measure: Change in refraction measure: Change in axial length measure: Change in choroidal thickness measure: Change in refraction measure: Change in axial length vs atropine measure: Change in choroidal thickness measure: Change in Paediatric Refractive Error Profile (PREP-2) score sex: ALL minimumAge: 6 Years maximumAge: 16 Years stdAges: CHILD facility: Hôpital Fondation Adolphe de Rothschild - Ophthalmology Department status: RECRUITING city: Paris zip: 75019 country: France name: Ramin Tadayoni, Professor role: CONTACT email: rtadayoni@for.paris name: Ramin Tadayoni role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Centre for Eye Research Ireland (CERI) - TU DUBLIN status: RECRUITING city: Dublin zip: D07 H6K8 country: Ireland name: Ian Flitcroft, Professor role: CONTACT email: ian.flitcroft@tudublin.ie name: James LOUGHMAN, Professor role: CONTACT phone: +353868589593 email: james.loughman@tudublin.ie name: Ian Flitcroft, Pr. role: PRINCIPAL_INVESTIGATOR name: James Loughman, Pr. role: SUB_INVESTIGATOR lat: 53.33306 lon: -6.24889 facility: Erasmus Medical Center status: NOT_YET_RECRUITING city: Rotterdam zip: 3015 country: Netherlands name: Caroline Klaver, Professor role: CONTACT email: c.c.w.klaver@erasmusmc.nl name: Jan Roelof Polling role: CONTACT phone: 010-7040704 email: j.polling@erasmusmc.nl name: Caroline Klaver role: PRINCIPAL_INVESTIGATOR name: Jan Roelof Polling role: SUB_INVESTIGATOR lat: 51.9225 lon: 4.47917 hasResults: False

 nctId: NCT06263933 id: 2023-A01804-41 briefTitle: Effect of Experience Sharing and Mutual Assistance on Insight and Recovery During the First Psychotic Episode acronym: DIPEM overallStatus: RECRUITING date: 2023-11-13 date: 2024-11-13 date: 2025-11-13 date: 2024-02-16 date: 2024-02-16 name: Centre hospitalier de Ville-Evrard, France class: OTHER briefSummary: Controlled, prospective, qualitative and quantitative trial. The goal of this trial is to evaluate the mutual assistance early intervention device efficacy and its impact on insight and personal recovery of participants living with a first psychotic episode. This intervention lasts 5 days with 1 session per day of 1 hour 30 minutes. Three evaluations, before the intervention, after intervention and 1 month after the hospitalization's end. conditions: Psychotic Episode studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A control group and a intervention group primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 50 type: ESTIMATED name: Insight Scale name: Semi-directional interviews name: routine care name: session of mutual assistance with a mediator psychologist measure: The level of the increasing of The INSIGHT scale measure: The increase of Recovery Scale measure: The semi-structured interview sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Etablissement Public de Santé de Ville-Evrard status: RECRUITING city: Neuilly-sur-Marne zip: 93330 country: France name: Rusheenthira Thavaseelan role: CONTACT phone: 0143093232 phoneExt: 033 email: r.thavaseelan@epsve.fr name: Dominique Januel role: CONTACT phone: 0143093232 phoneExt: 033 email: d.januel@epsve.fr name: Dominique Januel, Pr role: PRINCIPAL_INVESTIGATOR name: Ilona Arcomano, PhD role: SUB_INVESTIGATOR lat: 48.85373 lon: 2.54903 hasResults: False

 nctId: NCT06263920 id: 288703 briefTitle: Neurofrailty: A Study of Late-onset Epilepsy and Its Associations overallStatus: RECRUITING date: 2022-05-05 date: 2027-01-12 date: 2027-01-12 date: 2024-02-16 date: 2024-02-16 name: Lancashire Teaching Hospitals NHS Foundation Trust class: OTHER briefSummary: We don't know a great deal about why some people develop seizures in adulthood, but some researchers think that it might tell us something about the brain. A small number of people with first seizure in adulthood go on to experience problems like stroke or dementia later in life. However, stroke and dementia are common diseases, so we don't know whether there is a real association between these conditions. When people develop their first seizure in adult life, this is sometimes called Late-Onset Epilepsy. Through the NeuroFrailty study, we will observe 'brain health' over the years following the onset of a seizure, and I hope that it might give us more information about people with these kinds of seizures.

The NeuroFrailty study involves observing people from the time of diagnosis of first seizure. At this time, we will look at investigations such as blood tests, blood pressure, brain scans, alongside other diagnoses which might tell us whether there are differences compared to people without seizures. For some people, we will also look in greater depth at lifestyle including exercise, driving, family planning, and memory assessments.

Over the following years, we will look at how things change: for example whether there are changes in memory, new diagnoses, medication changes and how lifestyle has changed. Because there is so little research in this area, it is very difficult to predict what might happen. For example, some people can experience worse memory because of medication side effects; on the other hand, good seizure control following a diagnosis can sometimes lead to improved memory. Over years, it may become clear that some diseases are more likely in people with late-onset epilepsy than in people without such a diagnosis. You will receive a yearly newsletter to keep you updated on everything we learn about late-onset epilepsy.

Purpose and Background

Most of the time, we do not know why an adult develops epilepsy. Some researchers think there may be a connection between epilepsy which starts in adulthood, and increased risk of stroke or dementia in the future. However, there is very little research or evidence in this area, so we cannot say whether this is true.

What does taking part involve?

This study is an observational study, which means that the management of participants' seizure disorder will not be affected if they choose to take part in this study. The purpose of this study is to watch participants over the course of several years, to find out more about seizures which start in adulthood.

Participants can choose the level of involvement that is right for them.

1. LOW involvement. A researcher will check hospital and General Practice (GP records) once or twice per year, for the LIMITED AND SPECIFIC purpose of checking: medications, any new diagnoses, investigations associated with stroke risk (such as cholesterol, blood pressure, heart trace) and any brain scans that have been performed. I will not have access to more detailed information, such as conversations between a participant and their GP.
2. HIGH involvement. This involves being contacted by telephone once per year for 15-30 minutes to ask questions assessing memory and enquiring about lifestyle, such as exercise, smoking and alcohol use.
3. VERY HIGH involvement. These participants will be contacted for a longer telephone conversation 30-45 minutes once per year about their experience of how epilepsy has affected home life, work and medications.

If someone decides in the future that they don't want to be involved, they can withdraw from the study. However, once the study is completely finished, the information will be completely anonymous, which means that I won't be able to find individual's information in order to delete it.

Glossary Seizure disorder = any disorder which involved having experienced at least one seizure. First seizure and epilepsy both can be classed as a form of seizure disorder.

Neurofrailty = A condition whereby a person is at risk of stroke or dementia. conditions: Late Onset Epilepsy conditions: Stroke conditions: Dementia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 360 type: ESTIMATED measure: At the time of onset, do people with late-onset epilepsy have higher prevalence of cerebrovascular disease risk factors compared to a control population? measure: Quality of Life - how of chronic illness is mediated measure: What is the absolute and relative incidence of stroke and dementia in people after the onset of LOE compared to the background population? measure: Which anti-epileptic drugs are used in current practice in LOE, and how are they tolerated? sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lancashire Teaching Hospitals NHS status: RECRUITING city: Preston state: Lancashire zip: PR2 9HT country: United Kingdom name: Kina Bennett role: CONTACT phone: (+44) 01772 522031 email: kina.bennett@lthtr.nhs.uk name: Research Access role: CONTACT email: research.access@lthtr.nhs.uk name: Jasmine Wall role: PRINCIPAL_INVESTIGATOR lat: 53.76282 lon: -2.70452 hasResults: False

 nctId: NCT06263907 id: stellate ganglion block briefTitle: Stellate Ganglion Block for Prevention of Post Mastectomy Depression acronym: SGB overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2025-04-30 date: 2024-02-16 date: 2024-02-28 name: Mansoura University class: OTHER briefSummary: Complications after mastectomy include chronic pain and depression. conditions: Mastectomy conditions: Pain, Acute conditions: Pain, Chronic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients will be randomization into two equal groups using computer-generated random numbers prior to surgery of 70 each; Group S: will receive ipsilateral stellate gangalion block and Group C: will receive no block. primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: The anesthesiologist, who will be responsible for opening the envelope and do the block or not according to the group besides, evaluation of its success and covering the skin over the site of ipsilateral stellate gangalion with sterile dressing in both groups, will not be involved in data collection. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 140 type: ESTIMATED name: Stellate gangalion block measure: incidence of postmastectomy depression measure: incidence of postmastectomy depression measure: the need for postoperative antidepressant measure: acute postoperative pain at the incision site (breast and the axilla) measure: chronic postmastectomy pain at the incision site measure: incidence of nausea and vomiting measure: Functional pain in the ipsilateral shoulder measure: Any complications related to stellate ganglion injection sex: FEMALE minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06263894 id: MarmaraU-Ebe-ZDY-01 briefTitle: Alexander Technique on Labor Pain and Anxiety overallStatus: RECRUITING date: 2024-02-05 date: 2024-06-01 date: 2024-07-02 date: 2024-02-16 date: 2024-02-20 name: Marmara University class: OTHER name: The Scientific and Technological Research Council of Turkey briefSummary: This study will examine the effect of the Alexander Technique on labor pain and anxiety during labor. This study is designed as a randomized controlled experimental study. The population of the study consists of primiparous pregnant women who applied to Istanbul Provincial Health Directorate Başakşehir Çam and Sakura City Hospital, D-Block Maternity Hospital between November 2023 and May 2024. In calculating the sample size, G\*Power (3.1.9.6) program was used to calculate the sample size with an error of 0.05, effect level of 0.5, power of 95%, and the required sample size for 2 groups was calculated as 34 people for each group with a total of 68 people. conditions: Labor Pain conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: One experimental group and one conventional (control) group primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: In order to reduce selection bias in determining the experimental and control groups, a computer-assisted randomization program (https://www.randomizer.org) will be used for pregnant women who meet the inclusion criteria. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 68 type: ESTIMATED name: Experimental group measure: Decreasing labor pain measure: Decreasing anxiety sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Başakşehir Çam and Sakura City Hospital status: RECRUITING city: Istanbul country: Turkey name: Ayşen Özgür role: CONTACT phone: +905393806296 email: aysenozgurr@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06263881 id: MMH-407-009 briefTitle: Clinical Trial of the Efficacy and Safety of Raphamin in Combined Treatment of Community-acquired Pneumonia overallStatus: RECRUITING date: 2023-12-01 date: 2026-12-31 date: 2026-12-31 date: 2024-02-16 date: 2024-04-19 name: Materia Medica Holding class: INDUSTRY briefSummary: Multicenter double-blind placebo-controlled randomized in parallel groups clinical trial. conditions: Community-acquired Pneumonia conditions: Pneumonia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 370 type: ESTIMATED name: Raphamin name: Placebo measure: Percentage of patients with clinical cure at the test of cure (TOC) visit measure: Average duration of antibacterial therapy measure: Proportions of patients with a positive response to the initial course of antibiotic therapy after 48-72 hours measure: Proportion of patients who discontinue antibiotic therapy after 7 days of treatment (based on physician assessment of clinical symptoms). measure: Proportion of patients who required a change in antibiotic 48-72 hours after initiation of therapy. measure: Time until a persistent decrease in body temperature ≤37.2ºС (according to the patient's diary). measure: Proportion of patients who required a second course of antibiotic therapy. measure: Proportion of patients who required hospitalization during 15 days of follow-up. measure: Number of antipyretic drug doses taken during 7 days of the initial course of antibacterial therapy (per patient). measure: Proportion of patients without infiltration on x-ray/CT 14 days after randomization. measure: The Presence of Adverse Events (AEs). measure: Changes in Vital Signs (Blood Pressure measured in mm Hg) measure: Changes in Vital Signs (Pulse Rate (Heart Rate) measured in beats per minute) measure: Changes in Vital Signs (Respiratory Rate (Breathing Rate) measured in breaths per minute) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northern Medical Clinical Center named after N.A. Semashko Federal Medical and Biological Agency status: RECRUITING city: Arkhangelsk zip: 163000 country: Russian Federation name: Vadim Arkhipovsky, PhD, MD role: CONTACT name: Vadim Arkhipovsky, PhD, MD role: PRINCIPAL_INVESTIGATOR lat: 64.5401 lon: 40.5433 facility: Regional Clinical Hospital # 3 status: WITHDRAWN city: Chelyabinsk zip: 454018 country: Russian Federation lat: 55.15402 lon: 61.42915 facility: Ivanovo Clinical Hospital named after Kuvayevs status: RECRUITING city: Ivanovo zip: 153025 country: Russian Federation name: Svetlana Ushakova, PhD, MD role: CONTACT name: Svetlana Ushakova, PhD, MD role: PRINCIPAL_INVESTIGATOR lat: 56.99719 lon: 40.97139 facility: Central City Clinical Hospital status: RECRUITING city: Kaliningrad zip: 236005 country: Russian Federation name: Vladimir Rafalsky, Prof. role: CONTACT name: Vladimir Rafalsky, Prof. role: PRINCIPAL_INVESTIGATOR lat: 54.70649 lon: 20.51095 facility: Kazan State Medical University/Department of Infectious Diseases status: RECRUITING city: Kazan zip: 420012 country: Russian Federation name: Irina Kravchenko, MD, PhD role: CONTACT name: Irina Kravchenko, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.78874 lon: 49.12214 facility: Kuban State Medical University/Department of Infectious Diseases and Phthisiopulmonology status: RECRUITING city: Krasnodar zip: 350063 country: Russian Federation name: Marina Avdeeva, Prof. role: CONTACT name: Marina Avdeeva, Prof. role: PRINCIPAL_INVESTIGATOR lat: 45.04484 lon: 38.97603 facility: Lomonosov Interdistrict Hospital named after. I.N. Yudchenko status: RECRUITING city: Lomonosov zip: 188531 country: Russian Federation name: Svetlana Mosolova, MD role: CONTACT name: Svetlana Mosolova, MD role: PRINCIPAL_INVESTIGATOR lat: 59.90612 lon: 29.77253 facility: Central Research Institute of Epidemiology status: RECRUITING city: Moscow zip: 111123 country: Russian Federation name: Antonina Ploskireva, PhD, MD role: CONTACT name: Antonina Ploskireva, PhD, MD role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: Moscow Regional Research Clinical Institute named after. M.F. Vladimirsky status: RECRUITING city: Moscow zip: 129110 country: Russian Federation name: Svetlana Erofeeva, MD, PhD role: CONTACT name: Svetlana Erofeeva, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko status: RECRUITING city: Nizhny Novgorod zip: 603093 country: Russian Federation name: Vladimir Nosov, MD, PhD role: CONTACT name: Vladimir Nosov, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 56.32867 lon: 44.00205 facility: LLC "Persona group of companies" status: RECRUITING city: Nizhny Novgorod zip: 603155 country: Russian Federation name: Natalya Eremina, MD, PhD role: CONTACT name: Natalya Eremina, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 56.32867 lon: 44.00205 facility: LLC "Professor's clinic" status: RECRUITING city: Perm zip: 614070 country: Russian Federation name: Svetlana Teplykh, MD, PhD role: CONTACT name: Svetlana Teplykh, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 58.01046 lon: 56.25017 facility: LLC "4D Ultrasound Clinic" status: RECRUITING city: Pyatigorsk zip: 357502 country: Russian Federation name: Daria Saenko, MD role: CONTACT name: MD role: CONTACT name: Daria Saenko role: PRINCIPAL_INVESTIGATOR lat: 44.04861 lon: 43.05944 facility: St. Petersburg Research Institute of Phthisiopulmonology status: RECRUITING city: Saint Petersburg zip: 191036 country: Russian Federation name: Yana Startseva, MD role: CONTACT name: Yana Startseva, MD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: LLC "Energy of Health" status: RECRUITING city: Saint Petersburg zip: 194156 country: Russian Federation name: Natalya Egorova, MD role: CONTACT name: Natalya Egorova, MD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: City Multidisciplinary Hospital # 2 status: WITHDRAWN city: Saint Petersburg zip: 194354 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: LLC "Medical Clinic" status: RECRUITING city: Saint Petersburg zip: 194356 country: Russian Federation name: Maxim Bushara, MD role: CONTACT name: Maxim Bushara, MD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: LLC "Research Center Eco-Safety" status: WITHDRAWN city: Saint Petersburg zip: 196143 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: LLC "Zvezdnaya Clinic" status: RECRUITING city: Saint Petersburg zip: 196158 country: Russian Federation name: Artem Sergeenko, MD role: CONTACT name: Artem Sergeenko, MD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: City Pokrovskaya Hospital status: RECRUITING city: Saint Petersburg zip: 199106 country: Russian Federation name: Oleg Khmelnitsky, PhD, MD role: CONTACT name: Oleg Khmelnitsky, PhD, MD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: LLC "Meili" status: RECRUITING city: Saint Petersburg zip: 199406 country: Russian Federation name: Irina Nesterovich, PhD, MD role: CONTACT name: Irina Nesterovich, PhD, MD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: Samara State Medical University/Department of General and Clinical Microbiology, Immunology and Allergology status: RECRUITING city: Samara zip: 443099 country: Russian Federation name: Alexander Zhestkov, Prof. role: CONTACT name: Alexander Zhestkov, Prof. role: PRINCIPAL_INVESTIGATOR lat: 53.20007 lon: 50.15 facility: Smolensk State Medical University status: RECRUITING city: Smolensk zip: 214019 country: Russian Federation name: Roman Kozlov, Prof. role: CONTACT name: Roman Kozlov, Prof. role: PRINCIPAL_INVESTIGATOR lat: 54.7818 lon: 32.0401 facility: LLC "Scientific Medical Center of General Therapy and Pharmacology" status: RECRUITING city: Stavropol zip: 355000 country: Russian Federation name: Olga Ukhanova, Prof. role: CONTACT name: Olga Ukhanova, Prof. role: PRINCIPAL_INVESTIGATOR lat: 45.0428 lon: 41.9734 facility: Bashkir State Medical University/Department of Internal Medicine status: RECRUITING city: Ufa zip: 450008 country: Russian Federation name: Khalida Gantseva, Prof. role: CONTACT name: Khalida Gantseva, Prof. role: PRINCIPAL_INVESTIGATOR lat: 54.74306 lon: 55.96779 facility: Regional Clinic Hospital status: RECRUITING city: Vladimir zip: 600023 country: Russian Federation name: Mikhail Smirnov, MD role: CONTACT name: Mikhail Smirnov, MD role: PRINCIPAL_INVESTIGATOR lat: 56.13655 lon: 40.39658 facility: Voronezh Regional Clinical Hospital # 1 status: RECRUITING city: Voronezh zip: 394066 country: Russian Federation name: Natalya Kostina, PhD, MD role: CONTACT name: Natalya Kostina, PhD, MD role: PRINCIPAL_INVESTIGATOR lat: 51.67204 lon: 39.1843 facility: Clinical Hospital # 2 status: RECRUITING city: Yaroslavl zip: 150030 country: Russian Federation name: Andrey Arshinov, Prof. role: CONTACT name: Andrey Arshinov, Prof. role: PRINCIPAL_INVESTIGATOR lat: 57.62987 lon: 39.87368 facility: LLC "Medical Center for Diagnostics and Prevention Plus" status: RECRUITING city: Yaroslavl zip: 150040 country: Russian Federation name: Ekaterina Melnikova, MD, PhD role: CONTACT name: Ekaterina Melnikova, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 57.62987 lon: 39.87368 hasResults: False

 nctId: NCT06263868 id: 69HCL23_1090 id: 2023-A02313-42 type: OTHER domain: ID-RCB briefTitle: First Observatory of Precocious Puberty. acronym: PAPPEL overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2028-03-01 date: 2028-03-01 date: 2024-02-16 date: 2024-02-20 name: Hospices Civils de Lyon class: OTHER briefSummary: The age of puberty has fluctuated throughout history. Recent data shows an increase in the age of onset of puberty signs, in the United States but also in Europe. A recent Public Health France study published in 2018 reports an increase in the incidence of precocious puberty with geographical heterogeneity. The consequences of these appearances include the early onset of menarche, short adult height and the psychological impact.

Due to a lack of studies and additional data, the reasons for this development are difficult to understand. Among current hypotheses, the entanglement with the evolution of our environment is at the forefront: the action of environmental endocrine disruptors and nutritional factors could play a role in the process of early appearance of pubertal signs.

The establishment of a national observatory for early and advanced puberty in collaboration with pediatric endocrinologists (on the front line) would allow a reliable and precise field approach, capable of supplementing epidemiological data, which are currently insufficient.

The investigators hypothesize that the establishment of an observatory of pubertal advances (early puberty and advanced puberty) in private medicine is possible, with inclusion of at least 75% of eligible patients, and collection of at least 80% of data. conditions: Puberty, Precocious studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 3360 type: ESTIMATED measure: Number of recruited patients with at least 80% of the main data collected measure: Missing data rate measure: At least 75% of patients included sex: ALL maximumAge: 11 Years stdAges: CHILD facility: Clinique du Val d'Ouest city: Ecully state: Auvergne-Rhône-Alpes zip: 69130 country: France name: Emilie Doye, MD role: CONTACT phone: 0472118890 phoneExt: 33 email: emilie.doye@chu-lyon.fr name: Emilie Doye, MD role: PRINCIPAL_INVESTIGATOR lat: 45.77726 lon: 4.77481 facility: Clinique du Val d'Ouest city: Ecully state: Auvergne-Rhône-Alpes zip: 69130 country: France name: Emilie Beaufils, MD role: CONTACT phone: 0658187556 phoneExt: 33 email: pediatre.beaufils@gmail.com name: Emilie Beaufils, MD role: PRINCIPAL_INVESTIGATOR lat: 45.77726 lon: 4.77481 facility: Clinique du Val d'Ouest city: Ecully state: Auvergne-Rhône-Alpes zip: 69130 country: France name: Mélanie Daval Cote, MD role: CONTACT phone: 0472193310 phoneExt: 33 email: drdavalcote@yahoo.fr name: Mélanie Daval Cote, MD role: PRINCIPAL_INVESTIGATOR lat: 45.77726 lon: 4.77481 facility: Pediatric practice city: Lyon state: Auvergne-Rhône-Alpes zip: 69006 country: France name: Prisca DEALBERTI, MD role: CONTACT phone: 04 72 83 50 01 phoneExt: 33 email: dr.dealberti@gmail.com name: Prisca DEALBERTI, MD role: PRINCIPAL_INVESTIGATOR lat: 45.74848 lon: 4.84669 facility: Clinique Saint jean city: Lyon state: Auvergne-Rhône-Alpes zip: 69008 country: France name: Aude Mariani Ecochard, MD role: CONTACT phone: 0681560894 phoneExt: 33 email: docteurmariani@yahoo.com name: Aude Mariani Ecochard, MD role: PRINCIPAL_INVESTIGATOR lat: 45.74848 lon: 4.84669 facility: Pediatric practice city: Rennes state: Bretagne zip: 35200 country: France name: Livie CHATELAIS, MD role: CONTACT phone: 02 99 86 77 57 phoneExt: 33 email: lchatelais@yahoo.fr name: Livie CHATELAIS, MD role: PRINCIPAL_INVESTIGATOR lat: 48.11198 lon: -1.67429 facility: Pediatric practice city: Chambray-lès-Tours state: Centre-Val De Loire zip: 37170 country: France name: Caroline HASSELMAN, MD role: CONTACT phone: 02 46 65 07 45 phoneExt: 33 email: chasselmann@mac.com name: Caroline HASSELMAN, MD role: PRINCIPAL_INVESTIGATOR lat: 47.33537 lon: 0.70286 facility: Pediatric practice city: Essey-lès-Nancy state: Grand Est zip: 54270 country: France name: Julie AUGER, MD role: CONTACT phone: 03 83 21 01 11 phoneExt: 33 email: dr.augerjulie@gmail.com name: Julie AUGER, MD role: PRINCIPAL_INVESTIGATOR lat: 48.70179 lon: 6.22425 facility: Pediatric practice city: Levallois-Perret state: Hauts-de-Seine zip: 92300 country: France name: Delphine ZENATY, MD role: CONTACT phone: 01 70 83 61 23 phoneExt: 33 email: delphine.revco@gmail.com name: Delphine ZENATY, MD role: PRINCIPAL_INVESTIGATOR lat: 48.89389 lon: 2.28864 facility: Pediatric practice city: Paris state: Ile-de-France zip: 75116 country: France name: Mélanie AMOUYAL, MD role: CONTACT phone: 01 45 25 70 11 phoneExt: 33 email: dramouyal.endocrinoped@gmail.com name: Mélanie AMOUYAL, MD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Pediatric practice city: Fondettes state: Indre-et-Loire zip: 37230 country: France name: Myriam BOUILLO, MD role: CONTACT phone: 02 47 66 45 52 phoneExt: 33 email: myriam.bouillo@orange.fr name: Myriam BOUILLO, MD role: PRINCIPAL_INVESTIGATOR lat: 47.4035 lon: 0.59686 facility: Polyclinique Bordeaux rive droite city: Lormont state: Nouvelle-Aquitaine zip: 33310 country: France name: Aurélie LACOSTE RODRIGUE, MD role: CONTACT email: dr.aurelielacoste@free.fr name: Aurélie LACOSTE RODRIGUE, MD role: PRINCIPAL_INVESTIGATOR lat: 44.87495 lon: -0.51782 facility: Pediatric practice city: Pau state: Nouvelle-Aquitaine zip: 64000 country: France name: Catie CESSANS, MD role: CONTACT phone: 06 15 82 62 59 phoneExt: 33 email: pediatre.cessans@gmail.com name: Catie CESSANS, MD role: PRINCIPAL_INVESTIGATOR lat: 43.3 lon: -0.36667 facility: Pediatric Practice city: Pessac state: Nouvelle-Aquitaine zip: 33600 country: France name: Olivier PUEL, MD role: CONTACT phone: 0556453585 phoneExt: 33 email: opuel@free.fr name: Olivier PUEL, MD role: PRINCIPAL_INVESTIGATOR lat: 44.81011 lon: -0.64129 facility: Clinique rive gauche city: Toulouse state: Occitanie zip: 31300 country: France name: Adelaïde DURAND, MD role: CONTACT phone: 05 67 77 51 31 phoneExt: 33 email: dr.durand@cliniquerivegauche.fr name: Adelaïde DURAND, MD role: PRINCIPAL_INVESTIGATOR lat: 43.60426 lon: 1.44367 facility: Pediatric practice city: Saint-Nazaire state: Pays De La Loire zip: 44600 country: France name: Isabelle GUEMAS, MD role: CONTACT phone: 02 40 53 88 91 phoneExt: 33 email: isabelleguemas@gmail.com name: Isabelle GUEMAS, MD role: PRINCIPAL_INVESTIGATOR lat: 47.28333 lon: -2.2 facility: Pediatric practice city: Trélazé state: Pays De La Loire zip: 49800 country: France name: Julie CHEIGNON, MD role: CONTACT phone: 02 41 79 08 09 phoneExt: 33 email: julie.cheignon@wanadoo.fr name: Julie CHEIGNON, MD role: PRINCIPAL_INVESTIGATOR lat: 47.44565 lon: -0.4654 facility: Pediatric practice city: Aix-en-Provence state: Provence-Alpes-Côte d'Azur zip: 13090 country: France name: Céline CASTAINGS-CARLIOZ, MD role: CONTACT phone: 06 20 70 02 99 phoneExt: 33 email: celine.carlioz@yahoo.fr name: Céline CASTAINGS-CARLIOZ, MD role: PRINCIPAL_INVESTIGATOR lat: 43.5283 lon: 5.44973 facility: Pediatric practice city: Marseille state: Provence-Alpes-Côte d'Azur zip: 13008 country: France name: Hélène Bellon, MD role: CONTACT phone: 04 86 97 40 13 phoneExt: 33 email: h.bellon@sfr.fr name: Hélène Bellon, MD role: PRINCIPAL_INVESTIGATOR lat: 43.29551 lon: 5.38958 facility: Pediatric practice city: Nice state: Provence-Alpes-Côte d'Azur zip: 06000 country: France name: Frédérique GASTAUD, MD role: CONTACT phone: 04 93 13 85 17 phoneExt: 33 email: docteurgastaud.frederique@orange.fr name: Frédérique GASTAUD, MD role: PRINCIPAL_INVESTIGATOR lat: 43.70313 lon: 7.26608 facility: Pediatric practice city: Marseille state: Provence-Alpes-Côte-d'Azur zip: 13012 country: France name: Catherine BRUE FABRE role: CONTACT phone: 04 91 49 29 35 phoneExt: 33 email: catherine.brue@gmail.com name: Catherine BRUE FABRE, MD role: PRINCIPAL_INVESTIGATOR lat: 43.29551 lon: 5.38958 facility: Hôpital Femme Mère Enfant, Hospices civils de Lyon city: Bron zip: 69677 country: France name: Emilie Doye, MD role: CONTACT phone: 0472118890 email: emilie.doye@chu-lyon.fr name: Emilie Doye, MD role: PRINCIPAL_INVESTIGATOR lat: 45.73333 lon: 4.91667 facility: Pediatric practice city: Paris state: Île-De-France zip: 75010 country: France name: Capucine VIGNON SAVOYE, MD role: CONTACT phone: 09 80 46 71 19 phoneExt: 33 email: capucinevignon@free.fr name: Capucine VIGNON SAVOYE, MD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Pediatric practice city: Paris state: Île-De-France zip: 75011 country: France name: Isabelle FLECHTNER, MD role: CONTACT phone: 01 43 55 17 17 phoneExt: 33 email: drflechtner@gmail.com name: Isabelle FLECHTNER, MD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Pediatric practice city: Paris state: Île-De-France zip: 75017 country: France name: Maxime GERARD, MD role: CONTACT phone: 06 37 63 83 07 phoneExt: 33 email: m.gerard.endocped@gmail.com name: Maxime GERARD, MD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06263855 id: 24-000352 briefTitle: Effect of Large Language Model in Assisting Discharge Summary Notes Writing for Hospitalized Patients overallStatus: ENROLLING_BY_INVITATION date: 2024-07-01 date: 2024-12-31 date: 2025-04-01 date: 2024-02-16 date: 2024-04-05 name: Mayo Clinic class: OTHER briefSummary: This pilot study aims to assess the feasibility of carrying out a full-scale pragmatic, cluster-randomized controlled trial which will investigate whether discharge summary writing assisted by a large language model (LLM), called CURE (Checker for Unvalidated Response Errors), improves care delivery without adversely impacting patient outcomes. conditions: Large Language Model studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 1015 type: ESTIMATED name: CURE measure: Rate of patient accrual sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06263842 id: KFSIRB200-132 briefTitle: Elamrousy Novel Approach of Socket Shield Technique overallStatus: RECRUITING date: 2024-02-10 date: 2025-02-10 date: 2025-02-20 date: 2024-02-16 date: 2024-03-12 name: Kafrelsheikh University class: OTHER briefSummary: The current trial aim was to evaluate clinically and radiographically the changes around dental implants inserted immediately in maxillary anterior esthetic zone using a novel combination of autogenous whole tooth graft (AWTG) with socket shield approach (SSA) and compared this approach to socket shield technique with xenograft.

The present study included 63 patients, aged 20 to 45, with teeth that needed to be extracted. After Kafrelsheikh University research ethics committee approval, patients were randomized into 3 groups: group I patients underwent immediate implantation using socket shield protocol, while group II patients underwent the same procedure, but the shield/fixture jumping gap was grafted by xenograft. finally group III was grafted by AWTG that was created using the decoronated crown and the extracted palatal portion of the tooth; and then placed in the peri-implant gap defect. conditions: Implant Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The present study included 63 participants, aged 20 to 45, with teeth that needed to be extracted. After Kafrelsheikh University research ethics committee approval, patients were randomized into 3 groups: group I patients underwent immediate implantation using SSA protocol without grafting, while group II was grafted by xenograft, but group II was grafted with AWTG was created using the decoronated crown and the extracted palatal portion of the tooth; and then placed in the peri-implant gap defect. Clinically, pink aesthetic score (PES), midfacial mucosal alterations (MFMA), stability quotient of dental implants (SQDI) were observed at baseline, six and twelve months after implantation. Moreover, baseline, 6- and 12-months alterations of radiographic horizontal buccolingual ridge width (HBLRW), facial marginal bone level (FMBL), peri-implant Density of bone (PIDB) and peri-implant vertical bone defect depth (PIVBDD) changes were assessed using cone beam computed tomography (CBCT). primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: neither participant nor the outcome assessor know the group distribution whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 63 type: ESTIMATED name: modified Elamrousy approach for socket shield technique name: conventional socket shield name: combined socket shild with xenograft measure: Stability Quotient of dental implant (SQDI) measure: pink esthetic score (PES) measure: Midfacial Mucosal Alterations measure: facial marginal bone level (FMBL) sex: ALL minimumAge: 25 Years maximumAge: 40 Years stdAges: ADULT facility: Walid Elamrousy status: RECRUITING city: Kafr Ash Shaykh zip: 76130 country: Egypt name: walid elamrousy, phd role: CONTACT phone: +201005724781 email: Waled_Hammed@den.kfs.edu.eg name: mostafa fayed, bachelor role: CONTACT phone: +201063376252 lat: 31.11174 lon: 30.93991 hasResults: False

 nctId: NCT06263829 id: 2023-1580 briefTitle: HCV Tappt Adherence Study overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-01-01 date: 2025-07-01 date: 2024-02-16 date: 2024-02-16 name: University of Illinois at Chicago class: OTHER name: Synchronyx name: American Society of Health-System Pharmacists briefSummary: The goal of this non-inferiority clinical trial is to evaluate the efficacy of Tappt, a novel digital medication companion solution, among individuals with hepatitis C virus (HCV) who are starting a daily oral medication regimen following standard of care in a clinical pharmacy setting.

* The primary aim is to assess the non-inferiority of Tappt with medication adherence, treatment completion, sustained virologic response (SVR) assessment, and SVR achievement rates.
* The secondary aim is to assess the efficacy of Tappt at enabling pharmacists to personalize treatment and management decision based on participants' reported barriers to adherence, care, and SVR achievement.

Participants will download and utilize the Tappt app to record adherence to oral medication. For the purposes of this study, adherence for participants in the intervention arm will be measured using a modified medication possession ratio (MPR) measure called medication tag scan ratio (MTSR). MTSR is defined as a percentage of the number of times participants scanned their passive tags versus the total of expected tag scans based on that participant's medication regimen and treatment period.

Upon study completion, a retrospective matched control will be established for the intervention group. Historic data for the matched control's adherence, treatment completion, SVR assessment, and SVR rates will be compared to the intervention arm. conditions: Hepatitis C studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: Use of Tappt App measure: Medication adherence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06263816 id: CARVECIR briefTitle: Effect of Long-term Carvedilol to Prevent Decompensation or Death in Patients With Asymptomatic Child-Pugh A5 to B8 Cirrhosis and Clinically Significant Portal Hypertension: a Multicenter Double-blind Randomized Control Trial acronym: CARVECIR overallStatus: NOT_YET_RECRUITING date: 2024-11-15 date: 2029-10-15 date: 2030-06-15 date: 2024-02-16 date: 2024-02-20 name: University Hospital, Tours class: OTHER name: Centre Hospitalier Universitaire Amiens Picardie name: Centre Hospitalier Universitaire Angers name: Assistance Publique Hopitaux Paris BEAUJON name: Centre Hospitalier Universitaire Caen name: Centre Hospitalier intercommunal de Créteil name: Hospices Civils de Lyon name: Centre Hospitalier Universitaire Grenoble name: Centre Hospitalier Universitaire Haut Lévêque name: Centre Hospitalier Régional Universitaire Lille name: Centre Hospitalier Universitaire Jean Minjoz name: Assistance Publique Hopitaux Paris AVICENNE name: Centre Hospitalier Universitaire Clermont Ferrand name: Assistance Publique Hopitaux Paris LA PITIE SALPETRIERE name: Centre Hospitalier Universitaire Pontchaillou name: Assistance Publique Hopitaux Paris ST ANTOINE name: Assistance Publique Hopitaux Paris PAUL BROUSSE name: University Hospital, Montpellier name: Assistance Publique Hopitaux Paris HENRI MONDOR name: Centre Hospitaliser Départemental de Vendée name: Nantes University Hospital name: Centre Hospitalier Universitaire Dijon name: CHU de Reims name: Hôpitaux Universitaires de Strasbourg name: University Hospital, Toulouse briefSummary: Decompensation of cirrhosis is a turning point in cirrhosis course, as associated with a marked decrease in life expectancy. Thus, prevention of decompensation is crucial.

The usefulness of carvedilol to prevent decompensation of cirrhosis in patients with TE-LSM ≥ 25 kPa as a surrogate marker for clinically significant portal hypertension, has never been evaluated in a clinical trial. conditions: Asymptomatic Cirrhosis conditions: Clinically Significant Portal Hypertension studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study will be a national multicentric, phase III, superiority double-blinded randomized controlled trial with two parallel arms: carvedilol versus placebo. The primary end-point will be assessed by the local investigator (hepatologist), blinded of the randomization arm primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 290 type: ESTIMATED name: Experimental group: Patients will be treated with carvedilol. name: Control group: Patients will receive a placebo. measure: To evaluate the effect of low dose carvedilol (<=12.5 mg per day) versus placebo on the occurrence of decompensation of cirrhosis or liver-related death at 36 months sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Amiens Picardie city: Amiens country: France name: NGUYEN KHAC Eric, Dr role: CONTACT email: nguyen-khac.eric@chu-amiens.fr lat: 49.9 lon: 2.3 facility: CHU Angers city: Angers country: France name: OBERTI FREDERIC role: CONTACT email: froberti@chu-angers.fr lat: 47.46667 lon: -0.55 facility: CHU Beaujon city: Assistance Publique Hôpitaux De Paris country: France name: RAUTOU PIERRE EMMANUEL, Dr role: CONTACT email: pierre-emmanuel.rautou@aphp.fr facility: CHU Jean Minjoz city: Besançon country: France name: WEIL DELPHINE, Dr role: CONTACT email: dweil@chu-besancon.fr lat: 47.24878 lon: 6.01815 facility: CHU Haut Lévêque city: Bordeaux country: France name: DE LEDINGHEN VICTOR, Dr role: CONTACT email: victor.deledinghen@chu-bordeaux.fr lat: 44.84044 lon: -0.5805 facility: CHU Caen city: Caen country: France name: OLLIVIER-HOURMAND Isabelle, Dr role: CONTACT email: ollivierhourmand-i@chu-Caen.fr lat: 49.18585 lon: -0.35912 facility: CH intercommunal de Créteil city: CH Intercommunal De Créteil country: France name: ROSA ISABELLE, dR role: CONTACT email: isabelle.rosa@chi-creteil.fr facility: CHU Clermont Ferrand city: Clermont Ferrand country: France name: ABERGEL ARMAND, Dr role: CONTACT email: aabergel@chu-clermontferrand.fr lat: 45.77966 lon: 3.08628 facility: Hôpital Henri Mondor city: Créteil country: France name: LEROY Vincent, Dr role: CONTACT email: vincent.leroy2@aphp.fr lat: 48.78333 lon: 2.46667 facility: Hôpital Francois Mitterrand city: Dijon country: France name: MINELLO Anne, Dr role: CONTACT email: anne.minello@chu-dijon.fr lat: 47.31667 lon: 5.01667 facility: CHU Grenoble city: Grenoble country: France name: HILLERET Marie-Noelle, Dr role: CONTACT email: mnhilleret@chu-grenoble.fr lat: 45.16667 lon: 5.71667 facility: Centre Hospitalier départemental de Vendée city: La Roche-sur-Yon country: France name: LAGIN Ludovic, Dr role: CONTACT email: ludovic.lagin@ght85.fr lat: 46.66667 lon: -1.43333 facility: Hôpital Huriez city: Lille country: France name: LOUVET ALEXANDRE, Dr role: CONTACT email: alexandre.louvet@chru-lille.fr lat: 50.63297 lon: 3.05858 facility: CHU la Croix Rousse city: Lyon country: France name: LEBOSSE FANNY, Dr role: CONTACT email: fanny.lebosse@chu-lyon.fr lat: 45.74848 lon: 4.84669 facility: CHU de Montpellier city: Montpellier country: France name: URSIC Jose, Dr role: CONTACT email: jose.ursicbedoya@chu-montpellier.fr lat: 43.61092 lon: 3.87723 facility: CHU Hôtel Dieu city: Nantes country: France name: ARCHAMBEAUD Isabelle, Dr role: CONTACT email: isabelle.archambeaud@chu-nantes.fr lat: 47.21725 lon: -1.55336 facility: CHU Avicenne city: Paris country: France name: BLAISE LORAINE, Dr role: CONTACT email: lorraine.blaise@aphp.fr lat: 48.85341 lon: 2.3488 facility: CHU Pitié-Salpêtrière city: Paris country: France name: THABUT DOMINIQUE, Dr role: CONTACT email: dominique.thabut@aphp.fr lat: 48.85341 lon: 2.3488 facility: CHU Saint-Antoin city: Paris country: France name: OZENNE Violaine, Dr role: CONTACT email: violaine.ozenne@aphp.fr lat: 48.85341 lon: 2.3488 facility: CHU de Reims city: Reims country: France name: BERNARD CHABERT Brigitte, Dr role: CONTACT email: bbernard-chabert@chu-reims.fr lat: 49.25 lon: 4.03333 facility: CHU Pontchaillou city: Rennes country: France name: JEZEQUIEL Caroline, Dr role: CONTACT email: caroline.jezequiel@chu-rennes.fr lat: 48.11198 lon: -1.67429 facility: Hôpitaux Universitaires de Strasbourg city: Strasbourg country: France name: TRIPON Simona, Dr role: CONTACT email: simona.tripon@chru-strasbourg.fr lat: 48.58392 lon: 7.74553 facility: CHU de Toulouse city: Toulouse country: France name: BUREAU Christophe, Dr role: CONTACT email: bureau.c@chu-toulouse.fr lat: 43.60426 lon: 1.44367 facility: Hôpital Paul Brousse city: Villejuif country: France name: KOUNIS Ilias, Dr role: CONTACT email: ilias.kounis@aphp.fr lat: 48.7939 lon: 2.35992 hasResults: False

 nctId: NCT06263803 id: Karataymusic briefTitle: The Effect of Listening to Music on Chronic Low Back Pain overallStatus: RECRUITING date: 2024-02-01 date: 2024-04-01 date: 2024-04-15 date: 2024-02-16 date: 2024-02-16 name: KTO Karatay University class: OTHER briefSummary: The effects of passive music listening on pain, anxiety and quality of life in patients with chronic low back pain in addition to physical therapy will be examined. conditions: Pain, Chronic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: single whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Music listening, classic physical therapy measure: Beck anxiety inventory measure: Visual Analogue Scale measure: Short From-36 sex: ALL minimumAge: 30 Years maximumAge: 50 Years stdAges: ADULT facility: Mustafa Savaş Torlak status: RECRUITING city: Karatay state: Eyalet/Yerleşke zip: 42000 country: Turkey name: Mustafa S Torlak role: CONTACT phone: +905373660138 email: mustafa.savas.torlak@karatay.edu.tr lat: 37.86726 lon: 32.52863 hasResults: False

 nctId: NCT06263790 id: NEOUNIPD1(2024) briefTitle: Intubating Laryngeal Mask vs Direct Laryngoscopy: a Crossover Randomized Controlled Preterm Manikin Trial overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-03 date: 2024-03 date: 2024-02-16 date: 2024-02-16 name: University Hospital Padova class: OTHER briefSummary: The study aims to compare the success and time of intubation through an intubating laryngeal mask vs. direct laryngoscopy in a manikin simulating a term infant. In addition, we will assess the operator's opinion on the procedure.

This is an unblinded, randomized, controlled, crossover (AB/BA) pilot trial of intubation procedure through intubating laryngeal mask vs direct laryngoscopy in a manikin simulating a term newborn. conditions: Neonatal Disease conditions: Intubation; Difficult or Failed studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Intubating laryngeal mask name: Direct laryngoscopy measure: Success at the first attempt measure: Time of device positioning measure: Participant's opinion on difficulty of the procedure sex: ALL minimumAge: 25 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06263777 id: P.T.REC/012/004142 briefTitle: Early Detection of Children With Developmental Disabilities in Assiut Governorate overallStatus: COMPLETED date: 2021-01-01 date: 2021-03-15 date: 2021-09-30 date: 2024-02-16 date: 2024-02-16 name: Beni-Suef University class: OTHER briefSummary: The study aimed to determine the effectiveness of a designed training program for nurses toward early detection of developmental disabilities among children (0-3 years). conditions: Developmental Disability conditions: Development Delay conditions: Motor Delay conditions: Down Syndrome conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 21 type: ACTUAL name: Nurses training program on early detection of disability measure: Questionnaire of Screening and referral knowledge measure: Questionnaire of Disability Perception measure: questionnaire about Monitoring Practices measure: Follow up sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Tayseer Saber Abdeldayem city: Banī Suwayf state: Beni-Suef zip: 62521 country: Egypt lat: 29.07441 lon: 31.09785 hasResults: False

 nctId: NCT06263764 id: 23-11-1954 briefTitle: The Effect of Listening to Qur'an Recital on Quality of Life in Systemic Lupus Erythematosus Patients overallStatus: RECRUITING date: 2024-02-12 date: 2024-06-30 date: 2024-07-31 date: 2024-02-16 date: 2024-02-16 name: Indonesia University class: OTHER briefSummary: The goal of this quasi-experimental study is to evaluate the effect of listening to the Qur'an recital on quality of life among systemic lupus erythematosus patients. There will be intervention and control groups. Before the intervention, the quality of life of participants will be assessed using the Lupus-QoL questionnaire. After the baseline assessment, participants in the intervention group will be asked to listen to a Qur'an recital by Surah Ar-Rahman using an MP3 player twice a day for a minimum of 15 minutes each for 40 days. The control group will not receive any specific intervention and will continue with their usual routine. After the 40-day intervention period, the quality of life of participants in both groups will be assessed using the Lupus-QoL questionnaire. The results will be analyzed to determine if there is a significant improvement in quality of life. Besides, potential confounding factors such as SLE clinical manifestations, disease activity, pharmacologic treatment regimen, anxiety/depression, comorbidities, age, and economic status will also be collected before and after intervention to evaluate its effect on the quality of life. conditions: Quality of Life studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 70 type: ESTIMATED name: Listening to Qur'an Recital measure: Difference in Quality of Life Pre and Post Intervention sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Medicine Universitas Indonesia -Cipto Mangunkusumo Hospital, Jakarta, Indonesia status: RECRUITING city: Jakarta zip: 10430 country: Indonesia name: Alvina Widhani, PhD role: CONTACT phone: +6281905910034 email: alvina.widhani@gmail.com name: Karina Wijayanti, MD role: CONTACT phone: +6285226207270 email: karinawija@gmail.com lat: -6.21462 lon: 106.84513 hasResults: False

 nctId: NCT06263751 id: 202401096 id: 24FIM1268045 type: OTHER_GRANT domain: American Heart Association briefTitle: Comparing the Effectiveness of Two Produce Prescription Approaches On Fruit and Vegetable Intake and Food Security, While Exploring Implementation Outcomes Such as Reach, Implementation, Sustainability, and Cost acronym: NutriConnect overallStatus: RECRUITING date: 2024-03-25 date: 2025-03 date: 2025-06 date: 2024-02-16 date: 2024-03-27 name: Washington University School of Medicine class: OTHER name: Schnuck Markets, Inc. name: BJC HealthCare briefSummary: The produce prescription program is one type of food is medicine (FIM) programs, where healthcare providers "prescribe" fruits and vegetables (F\&V) to patients with low household incomes, experience food insecurity, and one or more diet-related diseases. NutriConnect seeks to compare the effectiveness of two produce prescription approaches on F\&V intake and food security: credit to Rewards account (NutriConnect Credit) vs. produce box delivery (NutriConnect Delivery), while exploring implementation outcomes such as reach, sustainability, implementation, and cost. conditions: Food Insecurity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 240 patients will be randomized to three arms: "usual care," NutriConnect Credit, and NutriConnect Delivery with equivalent monetary value to credit. The interventions will last 6 months. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: Due to the open study design, the NutriConnect team will not be able to have either patient or research coordinator/Schnucks intervention delivers blinded on group assignment. However, the assignment will be hidden from research faculty, the study biostatistician, and study analyst. whoMasked: OUTCOMES_ASSESSOR count: 240 type: ESTIMATED name: Product prescription program- NutriConnect Credit name: Product prescription program- NutriConnect Delivery measure: change in F&V intake measure: Household food insecurity measure: Self-reported health status sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Barnes Jewish Hospital status: RECRUITING city: Saint Louis state: Missouri zip: 63110 country: United States name: Jing Li, MD, DrPH, MS role: CONTACT phone: 314-273-9386 email: l.jing@wustl.edu name: Adam Hively, MPH role: CONTACT phone: 6142021540 email: adamh@wustl.edu lat: 38.62727 lon: -90.19789 hasResults: False

 nctId: NCT06263738 id: 2024-248 briefTitle: Cold and Heat Investigation to Lower Levels of Depression acronym: CHILL'D overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-04-01 date: 2027-04-01 date: 2024-02-16 date: 2024-03-28 name: Vail Health Behavioral Health class: OTHER name: Steadman Philippon Research Institute briefSummary: This study will recruit 112 medically healthy adults (aged 18-65) currently experiencing depressive symptoms to be randomized to receive either a single Whole Body Hyperthermia (heat therapy) treatment or a Whole Body Hyperthermia treatment followed by a cold water plunge. Participants will complete a baseline assessment of their depressive symptoms as well as 1-week and 2-week post-treatment followup assessments. conditions: Depression conditions: Mood Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants who meet inclusion/exclusion criteria will be stratified by use of antidepressant medication and randomized with a 1-to-1 allocation to receive a single session of WBH or a single session of WBH followed immediately by cold plunge (WBH+cold). primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The primary outcome data will be collected by trained raters blinded to participant group assignment and study visit number. The randomization list will be prepared by an unblinded study statistician and administered by study personnel with no other involvement in study activities. The participant will be blinded to their treatment assignment until the end of the WBH treatment, at which point they will be directed to either complete a cool-down period in the sauna device or proceed to the cold plunge. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 112 type: ESTIMATED name: Whole Body Hyperthermia name: Cold Water Plunge measure: Montgomery-Åsberg Depression Rating Scale (MADRS) measure: Warwick Edinburgh Mental Well-Being Scale (WEMWBS) measure: Patient Reported Outcome Measure Information System (PROMIS) 8A - Anxiety measure: Sheehan Disability Scale (SDS) measure: Quality of Life Enjoyment & Satisfaction Questionnaire Short Form (Q-LES-Q SF) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vail Health Behavioral Health Innovation Center city: Edwards state: Colorado zip: 81632 country: United States name: Study Coordinator role: CONTACT phone: 970-445-2489 email: BHIC@vailhealth.org name: Barry Sandler, DO role: PRINCIPAL_INVESTIGATOR lat: 39.64499 lon: -106.5942 hasResults: False

 nctId: NCT06263725 id: ALyster briefTitle: Protein Restriction (PR) for Weight Loss acronym: PR overallStatus: COMPLETED date: 2021-10-01 date: 2023-12-31 date: 2023-12-31 date: 2024-02-16 date: 2024-02-16 name: University of Copenhagen class: OTHER briefSummary: Prolonged dietary protein restriction has been shown to increase energy expenditure in mice simultaneously with an increase in plasma FGF21 levels. In overfeeding studies, a protein-restricted diet reduces weight gain in both mice and humans compared with normal and high-protein diets. Further, in energy balance studies, when lean men are provided with a protein-restricted diet for five weeks, an increase in energy intake was necessary to obtain their body weight. However, whether the effect of a protein-restricted diet is the same when consumed by overweight to obese men has divergent results in both mice and humans. conditions: Diet, Healthy, Body Weight studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 15 type: ACTUAL name: Restricted dietary protein name: Habitual diet measure: Body weight measure: FGF21 sex: MALE minimumAge: 25 Years maximumAge: 45 Years stdAges: ADULT facility: University of Copenhagen city: Copenhagen zip: 2100 country: Denmark lat: 55.67594 lon: 12.56553 hasResults: False

 nctId: NCT06263712 id: 2021-02504 (Project 2) briefTitle: Differences Between Suicide Attempters and Suicide Ideators. Influence of the Brief Therapy Attempted Suicide Short Intervention Program (ASSIP) on Neuropsychological Correlates and Psychological Process Factors - Project 2 acronym: NePsyAssip HT overallStatus: RECRUITING date: 2024-03-25 date: 2026-12 date: 2026-12 date: 2024-02-16 date: 2024-03-27 name: University of Bern class: OTHER briefSummary: The present study consists of 3 projects in total and aims to investigate the (neuro-) psychological patterns from suicidal ideation to suicidal behavior as well as the effects and feasibility of ASSIP Home Treatment.

The overall aim of project 2 is to investigate how the (neuro-) psychological patterns are modulated by the Attempted Suicide Short Intervention Program (ASSIP). Therefore, suicide attempters participating in this project 2 will be randomly assigned to either the intervention group ASSIP or a standard care plus resource interview (STAR) group. The ASSIP and STAR interventions take place at the University Hospital of Psychiatry and Psychotherapy Bern (Switzerland).

At the end of the assessment in project 1 participants who reported a history of past suicide attempt (SUAT) will be informed about project 2.

Only if participants agreed to take part in project 2 and have signed the informed consent, they are randomized into two conditions: The ASSIP intervention (ASSIP) versus standard of care plus resource interview (STAR). Participants of both groups will be assessed again 4 weeks and 12 months after their first baseline assessment of project 1. conditions: Inhibitory Control conditions: Self Efficacy conditions: Suicide Ideation conditions: Suicide, Attempted conditions: Locus of Control conditions: Process Factors conditions: Movement Synchrony studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 156 type: ESTIMATED name: Attempted Suicide Short Intervention Program (ASSIP) name: Standard of care plus resource interview group (STAR) measure: Differences in Inhibitory Control measure: Differences in Inhibitory Control measure: Differences in Inhibitory Control measure: Movement analyses measure: Selective Attention and Interference Control measure: General Sense of Self-Efficacy measure: Locus of control measure: Psychological Pain measure: Suicidal ideation and behavior measure: Suicidal ideation measure: Mental abilities like attention, working memory and visuomotor speed as well as mental flexibility measure: Sociodemographic data measure: Diagnostic and Statistical Manual 5 (DSM-V) and International Classification of Diseases 10 (ICD-10) psychiatric disorders measure: Depressive symptoms measure: Loneliness measure: Therapeutic Alliance measure: Therapeutic change measure: Therapeutic outcomes measure: Adherence and Competence measure: Physiologically Experienced Emotional Distress and Arousal measure: Ecological Momentary Assesment measure: Attention and Concentration Abilities measure: Dissociative Experience measure: Motivational Incongruence measure: Motivational Goals measure: Suicide-Related Coping sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital of Psychiatry and Psychotherapy, University of Bern status: RECRUITING city: Bern zip: 3008 country: Switzerland name: Anja C Gysin-Maillart, Ph.D. role: CONTACT phone: 0041 31 632 88 11 email: anja.gysin-maillart@unibe.ch name: Anja C Gysin-Maillart, Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 46.94809 lon: 7.44744 hasResults: False

 nctId: NCT06263699 id: S68225 briefTitle: Goniometry and Goniometric Measurement on Standardised Images in Dupuytren's Disease acronym: Goniometry overallStatus: RECRUITING date: 2024-01-29 date: 2025-01-01 date: 2025-01-01 date: 2024-02-16 date: 2024-02-21 name: Universitaire Ziekenhuizen KU Leuven class: OTHER briefSummary: Measuring range of motion (ROM) is essential in detecting musculoskeletal deficits, monitoring the effects of treatment and progression of the disease. In Dupuytren's disease the active and passive extension deficits (AED, PED) of digits 4 and 5 are usually clinically measured using a universal, short arm goniometer which is considered the standard of care. Using the goniometer can be time consuming. Measuring the extension deficit on a standardised picture could improve follow up, since it is a faster and easier process to take a picture and upload it to the patients files. Though this gives rise to the question whether this kind of measurement would be equally accurate and reliable in comparison to regular clinical measurement using a goniometer. conditions: Dupuytren's Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 59 type: ESTIMATED name: ROM measurement of the MCP and PIP joints in digits 4 and 5 measure: Active Extension Deficits (AED) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitaire Ziekenhuizen KU Leuven status: RECRUITING city: Leuven state: Vlaams-Brabant zip: 3000 country: Belgium name: Ilse Degreef, Prof. Dr. role: CONTACT phone: +32 16 33 88 43 email: ilse.degreef@uzleuven.be name: Anna Tarasiuk role: CONTACT phone: +32 16 33 88 18 email: orthopedie.research@uzleuven.be name: Ilse Degreef, Prof. Dr. role: PRINCIPAL_INVESTIGATOR lat: 50.87959 lon: 4.70093 hasResults: False

 nctId: NCT06263686 id: DAN056 briefTitle: Evaluation of the Effects of Routine Intake of Fresh vs- Pasteurized Yoghurt on the Immune System in Healthy Adults acronym: YASI-03 overallStatus: COMPLETED date: 2016-06-01 date: 2016-11-01 date: 2016-12-31 date: 2024-02-16 date: 2024-02-16 name: University of Valladolid class: OTHER name: Danone Institute International name: University of Seville briefSummary: In this study, the purpose was to describe and compare the modulator effects on the immune system of the routine ingestion of fresh vs. pasteurized yoghurt. A unicentral, prospective, randomized, double-blind, parallel group nutritional study for 8 weeks was carried out comparing the ingestion of 125 g (three times a day) of the products in healthy adults. A complete battery of in vitro tests on the activity of immune system, processes and phenomena was performed. conditions: Immune System conditions: Innate Inflammatory Response studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: CARE_PROVIDER count: 125 type: ACTUAL name: Pasteurised yoghurt name: Fresh yoghurt name: Sterilised yoghurt measure: T-cells measure: IFN-gamma induction measure: IgG sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06263673 id: 23-008183 briefTitle: Anti-Diabetic Medications to Fight PD and LBD overallStatus: RECRUITING date: 2024-04-17 date: 2024-06-30 date: 2024-06-30 date: 2024-02-16 date: 2024-04-17 name: Mayo Clinic class: OTHER briefSummary: The purpose of this study is to test the hypothesis that DPP4 inhibitors and SGLT2 inhibitors are well tolerated and have beneficial neurological effects, specifically for Parkinson's disease and Lewy body dementia. conditions: Lewy Body Dementia conditions: Parkinson Disease studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 12 type: ESTIMATED name: Sitagliptin name: Dapagliflozin name: Placebo measure: Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) measure: Change in Mini Mental State Examination measure: Glucose measure: Supine blood pressure measure: Standing blood pressure sex: ALL minimumAge: 45 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic Florida status: RECRUITING city: Jacksonville state: Florida zip: 32224 country: United States name: Zoe A Parrales, BS role: CONTACT phone: 904-953-3381 email: parrales.zoe@mayo.edu lat: 30.33218 lon: -81.65565 hasResults: False

 nctId: NCT06263660 id: 2022-007 briefTitle: Evaluation of a Keto-Like Supplement on Brain Responses to Emotional Stimuli in Depression overallStatus: RECRUITING date: 2024-01-09 date: 2026-01 date: 2026-01 date: 2024-02-16 date: 2024-02-20 name: Laureate Institute for Brain Research, Inc. class: OTHER briefSummary: This study aims to determine whether a keto-like supplement relative to placebo results in functional brain changes during fMRI tasks evaluating positive and negative valence in individuals with moderate to severe depression. In this double-blind randomized placebo-controlled trial, 75 individuals with a Patient Health Questionnaire (PHQ-9) scale score ≥ 10 (MDD) will be enrolled to participate in an 8-week treatment study to obtain 60 completers. Participants will be randomized with a 1-1 ratio to receive the keto-like supplement (n= 30 completers) or placebo (n=30 completers) taken orally three times per day for 8 weeks. Participants will undergo a 10.5-hour screening/baseline evaluation visit split over 2 days at week 0 including questionnaires, neuroimaging before and after supplement or placebo administration and blood draws, office visits at week 2 (1.5 hours), week 4 (3 hours), week 6 (0.5 hours), week 8 (6 hours), a follow-up visit at week 10 (1.5 hours) and two phone calls between visits (weeks 1 and 3) during which a brief clinical assessment will be obtained (10 minutes each). The total time involved in the study is approximately 23.5 hours. conditions: Depression studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 75 type: ESTIMATED name: Keto-like supplement name: Placebo measure: BOLD response during Monetary Incentive Delay Task measure: BOLD response during Adjective Task sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Laureate Institute for Brain Research status: RECRUITING city: Tulsa state: Oklahoma zip: 74136 country: United States name: Teresa Victor, PhD role: CONTACT phone: 918-502-5108 email: tvictor@laureateinstitute.org name: Colleen McCallum role: CONTACT phone: 918-502-5180 lat: 36.15398 lon: -95.99277 hasResults: False

 nctId: NCT06263647 id: HSC-MS-23-0904 id: UG3NR021232 type: NIH link: https://reporter.nih.gov/quickSearch/UG3NR021232 briefTitle: Incorporation of a Health Equity Approach to Hospital Violence Intervention Programs: The Integration of a Community and Hospital Based Initiatives to Reduce Gun Violence in a Large Metropolitan Area overallStatus: NOT_YET_RECRUITING date: 2025-06-01 date: 2028-02-01 date: 2028-05-01 date: 2024-02-16 date: 2024-02-16 name: The University of Texas Health Science Center, Houston class: OTHER name: National Institute of Nursing Research (NINR) briefSummary: The purpose of this study is to evaluate the effectiveness of Houston-Hospital Violence Intervention Programs (HVIP) in reducing the occurrence of repeat violent events among adults receiving care at Memorial Hermann Hospital in Houston, to determine the impact of the community-engaged Houston-HVIP program on violent re-injury and mental and behavioral health, assess the impact of the Houston-HVIP program on racial and ethnic disparities in those impacted by firearm violence injury and to identify the predictors of implementation success, including dosage, reach, fidelity, and acceptability from the perspective of gun violence victims, health care providers, and community violence intervention specialists conditions: Firearm Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Participants will be partially blinded in that they will know some information about the intervention but will not be exposed to the details of the intervention or the intervention manual. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: Houston-HVIP treatment name: Enhanced Case Management measure: Repeat violent victimization as assessed by the number of participants who return to the hospital system for a violent injury measure: Repeat violent victimization as assessed by the number of participants who are exposed to repeat violence but not admitted to the hospital captured using the Computer-assisted self-interviewing (CASI) instrument measure: Change in post-traumatic stress as assessed by the post-Traumatic Stress Disorder Checklist Version 5(PCL-5) measure: Change in aggression as assessed by the Buss-Perry Aggression Questionnaire (BPAQ) measure: Change in general health as assessed by the 12-item Short Form Health Survey (SF-12) sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: The University of Texas Health Science Center at Houston city: Houston state: Texas zip: 77030 country: United States name: Sandra McKay, MD role: CONTACT phone: 713-500-5666 email: Sandra.McKay@uth.tmc.edu name: Alexander Testa, PhD role: CONTACT phone: (210) 276-9000 email: Alexander.Testa@uth.tmc.edu lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06263634 id: 2022-206 briefTitle: Hand Exercises in Psoriatic Arthritis overallStatus: RECRUITING date: 2023-04-05 date: 2024-04-05 date: 2024-05-05 date: 2024-02-16 date: 2024-02-28 name: Akdeniz University class: OTHER briefSummary: This study is a randomized controlled study examining the effects of 8-week hand home exercises on grip strength, functionality, disease activity and quality of life in patients with PsA. Individuals participating in the study will be randomly divided into 2 groups. Individuals in the intervention group will perform home exercises consisting of stretching, mobility and strengthening, 4 days a week for 8 weeks, and the patients' compliance with the exercise will be monitored by phone call once a week. Individuals in the control group are on the waiting list and the same home exercise program will be taught to the patients at the end of the study. conditions: Psoriatic Arthritis conditions: Hand Rheumatism studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial primaryPurpose: TREATMENT masking: NONE count: 34 type: ESTIMATED name: Hand exercises measure: Psoriatic Arthritis Disease Activity Score (DAPSA) measure: Hand grip strength measurement measure: Hand fine grip strength measurement: measure: Nine-Hole Peg Test measure: Duruöz Hand Index measure: Michigan Hand Outcome Questionnaire (MHQ) measure: Hand Functional Index (HFI) measure: Psoriatic Arthritis Quality of Life Questionnaire (PsAQoL) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Akdeniz University status: RECRUITING city: Antalya country: Turkey name: Ayse Ayan, MD role: CONTACT phone: +90 242 249 44 00 email: drayseayan@yahoo.com.tr lat: 36.90812 lon: 30.69556 hasResults: False

 nctId: NCT06263621 id: 855090 briefTitle: Changing Portion Size Descriptions in a Cafeteria overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-11 date: 2024-05-29 date: 2024-05-29 date: 2024-02-16 date: 2024-02-26 name: University of Pennsylvania class: OTHER name: Restaurant Associates briefSummary: The goal of this this intervention is to test the degree to which a portion size labeling intervention influences consumer selection of smaller portions at two large cafés. The main question it aims to answer is: Do consumers order fewer calories when the portion size label for the smaller entree is called "standard" instead of "small"?

Participants will order lunch as usual in the two cafes (one intervention, one control) for 5.5 months, and all order items will be recorded in the check-out system. One cafe will receive the labeling intervention, while the other will not. Researchers will compare the average calories per order between the two cafes to see if there are differences. conditions: Food Selection conditions: Obesity conditions: Weight Gain conditions: Food Preferences studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Entrees are offered in two different portion sizes at two cafes. The cafes were randomized to either receive the "Standard" portion label for the smaller size (Intervention) or the "Small" portion label for the smaller size (Control). The larger portion was labeled "Large." Daily lunch transaction data will be provided by the cafes. primaryPurpose: PREVENTION masking: NONE count: 12000 type: ESTIMATED name: Intervention "Standard" measure: Average kcal per entree sold measure: Number of entrée units purchased measure: Total kcal per transaction measure: Weekly gross sales sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Courtyard Cafe city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 facility: Elements Cafe city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06263608 id: BUN B3002023000204 briefTitle: Structured Testing and Treatment for Obstructive Sleep Apnea in Patients With Atrial Fibrillation acronym: STAROSA overallStatus: RECRUITING date: 2024-02-23 date: 2028-02 date: 2028-02 date: 2024-02-16 date: 2024-03-06 name: University Hospital, Antwerp class: OTHER name: Jessa Hospital name: Hasselt University name: Universiteit Antwerpen briefSummary: The main goal of this prospective pre-post implementation study is to investigate how a structured testing and treatment program for obstructive sleep apnea using the NOX T3s device and a Fitbit smartwatch with the FibriCheck algorithm impacts the proportion of atrial fibrillation (AF) in an AF population.

Participants will wear the NOX T3s respiratory polygraphy device for one night at home. In case of a positive obstructive sleep apnea diagnosis, patients will be referred to the sleep clinic for a polysomnography examination. Patients positively diagnosed with polygraph will be monitored semi-continuously with the Fitbit smartwatch for three months. After the polysomnography examination, the positively diagnosed patients will be monitored semi-continuously for another three months after initiation of treatment (mostly continuous positive airway pressure (CPAP) treatment). Additionally, patients will be administered satisfaction and symptom burden questionnaires twice: right after the polysomnography examination and after the 3-month treatment. conditions: Atrial Fibrillation conditions: Obstructive Sleep Apnea studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 209 type: ESTIMATED name: (Cardio)Respiratory polygraphy (NOX T3s) name: Polysomnography name: Devices to deliver Continuous Positive Airway Pressure (CPAP), Bilevel Positive Airway Pressure (BiPAP) or Adaptive support ventilation (ASV) name: Fitbit smartwatch measure: AF burden before and after CPAP treatment measure: Obstructive sleep apnea severity agreement between polygraphy and polysomnography measure: False positive rate of polygraphy measure: Total sleep apnea burden measure: CPAP/BiPAP/ASV compliance measure: Sleep score measure: Patients' AF-related symptom burden, assessed by the Leuven ARrhythmia Questionnaire (LARQ) measure: Patients' obstructive sleep apnea-related symptom burden, assessed by the Berlin Questionnaire (BQ) measure: Patients' obstructive sleep apnea-related symptom burden, assessed by the Epworth Sleepiness Scale (ESS) measure: Polygraphy negative patients measure: User-friendliness of the NOX T3s polygraphy device measure: User-friendliness of the Fitbit-based FibriCheck monitoring measure: Uptake rate of the advice to patients to undergo a polysomnography examination measure: Protocol adherence to smartphone heart rhythm measurements measure: The quality of the FibriCheck measurements measure: Number of technical issues sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital of Antwerp status: RECRUITING city: Edegem country: Belgium name: Lien Desteghe, MSc PhD role: CONTACT email: lien.desteghe@uza.be lat: 51.15662 lon: 4.44504 facility: Jessa Hospital status: RECRUITING city: Hasselt country: Belgium name: Lien Desteghe, MSc PhD role: CONTACT email: lien.desteghe@jessazh.be lat: 50.93106 lon: 5.33781 hasResults: False

 nctId: NCT06263595 id: REB23-1754 briefTitle: Semaglutide and Preoperative Residual Gastric Volumes overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-16 date: 2024-02-16 name: University of Calgary class: OTHER name: Alberta Health services briefSummary: Given the pharmacodynamic and pharmacokinetic properties of glucagon-like peptide-1 (GLP-1) agonists, the Canadian Anesthesiologists' Society has recognized that patients on GLP-1 agonists may have an increased aspiration risk due to a 'full stomach,' even after following preoperative fasting guidelines. In other words, safe fasting timelines are not known in individuals taking GLP-1 agonists, as demonstrated by recent case reports of patients who either retained or regurgitated stomach contents despite being adequately fasted.

To address this gap, we plan to measure preoperative residual gastric volumes with point-of-care ultrasound (POCUS) in patients taking this medication. The priority is to first gather data to identify which patient populations need risk stratification and to then use this data to support the development of specific guidelines that reduce anesthetic complications, such as aspiration pneumonia.

Our primary objective is to use POCUS preoperatively to assess gastric volumes of fasted patients to demonstrate if there is a clinically significant increase in residual gastric volumes in patients on semaglutide. conditions: Pulmonary Aspiration studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 90 type: ESTIMATED name: gastric antral sonography measure: Number of participants presenting with a full stomach measure: Number of occurrences requiring change in anesthetic management plan measure: Relationship between dose, duration and timing of GLP-1 receptor agonist and gastric volume measure: Relationship between gastric emptying and purpose of GLP-1 receptor agonist administration sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: South Health Campus city: Calgary state: Alberta zip: T3M 1M4 country: Canada name: Joanna J Moser, MD, PhD role: CONTACT phone: 403-956-3883 email: joanna.moser@ahs.ca lat: 51.05011 lon: -114.08529 hasResults: False

 nctId: NCT06263582 id: IGHID12333 briefTitle: Pharmacokinetics of Intravaginal, Self-administered Artesunate Vaginal Pessaries Among Women in Kenya overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-02 date: 2025-02 date: 2024-02-16 date: 2024-02-20 name: UNC Lineberger Comprehensive Cancer Center class: OTHER briefSummary: This study investigates the pharmacokinetics of Artesunate (AS) and dihydroartemisinin (DHA), the active metabolite of Artesunate, following intravaginal use at the dosing and frequency being studied for cervical precancer treatment. A secondary objective is to investigate safety among study participants. conditions: Cervix Cancer conditions: Cervix Intraepithelial Neoplasia Grade 3 conditions: Cervix; Intraepithelial Neoplasia, Grade I conditions: Cervix; Intraepithelial Neoplasia, Grade II studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 16 type: ESTIMATED name: Artesunate pessary name: blood draws for pharmacokinetics of the study drug measure: To determine the area under the plasma concentration versus time curve (AUC) of dihydroartemisinin measure: To determine the area under the plasma concentration versus time curve (AUC) of Artesunate (AS) measure: To determine the maximum concentration of Artesunate (AS) measure: To determine the maximum concentration of dihydroartemisinin (DHA) (Cmax) measure: To determine the time to maximum concentration (Tmax) of Artesunate (AS) following five consecutive days measure: To determine the time to maximum concentration (Tmax) of dihydroartemisinin (DHA measure: To determine the half-life (t1/2) of Artesunate (AS) measure: To determine the half-life (t1/2) of dihydroartemisinin (DHA) measure: To determine the apparent clearance (CL/F) of Artesunate (AS) measure: To determine the apparent clearance (CL/F) of dihydroartemisinin (DHA) measure: To determine the volume of distribution (V/F) of Artesunate (AS) measure: To determine the volume of distribution (V/F) of dihydroartemisinin (DHA) measure: Type, frequency, severity, and duration of adverse events sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lumumba Sub-County Hospital city: Kisumu country: Kenya lat: -0.10221 lon: 34.76171 hasResults: False

 nctId: NCT06263569 id: SDB 2023-002 briefTitle: Effectiveness of Total Hip Arthroplasty for Patients With Osteoarthritis, a Target Trial Emulation Study acronym: EAGLE overallStatus: COMPLETED date: 2023-05-24 date: 2023-05-24 date: 2023-05-24 date: 2024-02-16 date: 2024-02-16 name: JointResearch class: OTHER briefSummary: The aim of this study is to assess the effect of total hip arthroplasty on hip disability and pain compared to non-surgery in patients with hip osteoarthritis, using target trial emulation to emulate a randomized controlled trial. conditions: Hip Osteoarthritis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 156 type: ACTUAL name: Total hip arthroplasty measure: Hip disability and Osteoarthritis Outcome Score Physical function Short form (HOOS-PS), change score from baseline measure: Numerical Rating Scale (NRS) pain during weight bearing, change score from baseline sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: OLVG city: Amsterdam state: Noord Holland zip: 1090 HM country: Netherlands lat: 52.37403 lon: 4.88969 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-05-17 uploadDate: 2024-02-08T10:36 filename: Prot_SAP_000.pdf size: 949604 hasResults: False

 nctId: NCT06263556 id: 2023/389 briefTitle: Effectiveness of TTNS in MS Patients With Lower Urinary Track Symptoms overallStatus: RECRUITING date: 2024-01-17 date: 2024-11-05 date: 2024-12-05 date: 2024-02-16 date: 2024-02-16 name: Bakirkoy Dr. Sadi Konuk Research and Training Hospital class: OTHER_GOV briefSummary: Multiple sclerosis (MS) is the most common inflammatory disease of the central nervous system. It is characterized with demyelinated plaques affecting subcortical, brain stem, and spinal cord nerve fibers. During the course of the disease, with the affection myelinated nerve tracks, lower urinary track symptoms may occur. 50-90% of the MS patients experience lower urinary track symptoms (LUTS) such as urinary incontinence, urgency, nocturia and/or urinary frequency during the at one point of their life.

Aim of this study is to determine the effects of transcutaneous tibial nerve stimulation (TTNS) on symptoms and quality of life in MS patients with LUTS. conditions: Multiple Sclerosis conditions: Lower Urinary Tract Symptoms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients will be randomized and assigned to either group. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 64 type: ESTIMATED name: Pelvic floor exercises name: Transcutaneous posterior tibial nerve stimulation name: Sham stimulation measure: Incontinence Quality of Life (I-QOL) measure: Post-void residue (PVR) measure: Bladder diary measure: International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Bakirkoy Dr. Sadi Konuk Research and Training Hospital status: RECRUITING city: Istanbul country: Turkey name: Sibel CAGLAR role: CONTACT phone: +905333365651 email: dr.sibelcaglar@gmail.com name: Arda Can KASAP role: CONTACT phone: +905384590119 email: drardakasap@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06263543 id: 2023-MAH-001 briefTitle: Sequencing Antibody Drug Conjugates in ER+/HER2 LOW MBC acronym: SERIES overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-10 date: 2024-02-16 date: 2024-02-16 name: Reshma L. Mahtani, D.O. class: OTHER name: Gilead Sciences briefSummary: The purpose of this research study is to see if the medication sacituzumab govitecan (SG) is effective at the currently approved dose and schedule in people who have previously received trastuzumab deruxtecan (T-DXd) for the treatment of metastatic, hormone receptor positive (HR+)/human epidermal growth factor 2 low (HER2 low) breast cancer. Although SG is approved to treat metastatic HR+/HER2 negative breast cancer, the aim of this study is to determine if SG is still effective specifically in people who have already received T-DXd. conditions: Breast Cancer conditions: Metastatic Breast Cancer conditions: Advanced Breast Cancer conditions: Hormone-receptor-positive Breast Cancer conditions: Human Epidermal Growth Factor 2 Low Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 75 type: ESTIMATED name: Sacituzumab govitecan measure: Overall response rate (ORR) measure: Clinical benefit rate (CBR) measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Duration of response (DOR) measure: Global Quality of Life measure: Treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Laboratory and Vital Sign Abnormalities measure: Growth Factor Support sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UCLA Jonsson Comprehensive Cancer Center city: Los Angeles state: California zip: 90404 country: United States name: Aditya Bardia, M.D. role: CONTACT phone: 310-586-2093 email: ABardia@mednet.ucla.edu lat: 34.05223 lon: -118.24368 facility: Miami Cancer Institute at Baptist Health, Inc. city: Miami state: Florida zip: 33176 country: United States name: Reshma L Mahtani, D.O. role: CONTACT phone: 786-596-2000 email: rmahtani@baptisthealth.net name: Krystal Fernandez role: CONTACT phone: (786) 596-2000 email: krystal.fernandez@baptisthealth.net lat: 25.77427 lon: -80.19366 facility: Winship Cancer Institute at Emory University city: Atlanta state: Georgia zip: 30322 country: United States name: Kevin Kalinsky, M.D., M.S. role: CONTACT phone: 404-778-0519 email: kkalins@emory.edu lat: 33.749 lon: -84.38798 hasResults: False

 nctId: NCT06263530 id: NU22-03-00182 briefTitle: Prognostic Significance of ctDNA in HL overallStatus: RECRUITING date: 2022-01-02 date: 2023-12-31 date: 2027-12-31 date: 2024-02-16 date: 2024-02-16 name: Interni hematologicka klinika FNKV class: NETWORK name: Charles University, Czech Republic name: General University Hospital, Prague name: University Hospital Olomouc name: University Hospital Hradec Kralove name: University Hospital, Motol briefSummary: Specific somatic mutations using ctDNA will be analyzed in predefined subgroups of cHL (e.g., age \<60 and ≥ 60 years, EBV). These mutations will be correlated with response to the treatment in the first line, in the relapse, during brentuximab vedotin and/or nivolumab treatment. Circulating tumor DNA will be correlated with the extent of tumor mass and chemo/radiotherapy. conditions: Prognostic Cancer Model studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 500 type: ESTIMATED measure: Identification of tumor specific mutation profiles at dg. of HL based on ctDNA measure: Quantitative analysis of ctDNA level during the first-line chemotherapy measure: Identification of tumor specific mutation profiles at relapse of classical HL measure: In vitro functional characterization of identified DNA variants and/or mutations sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Hradec Kralove status: RECRUITING city: Hradec Kralove zip: 50005 country: Czechia name: Alice Sykorova, M.D., Ph.D. role: CONTACT phone: +420495 832 866 email: alice.sykorova@fnhk.cz lat: 50.20923 lon: 15.83277 facility: University Hospital Olomouc status: RECRUITING city: Olomouc zip: 77520 country: Czechia name: Vit Prochazka, prof. M.D. role: CONTACT phone: +420588 442 878 email: prochazv@fnol.cz lat: 49.59552 lon: 17.25175 facility: University Hospital Kralovske Vinohrady status: RECRUITING city: Praha zip: 10034 country: Czechia name: Heidi Mocikova, M.D., Ph.D. role: CONTACT phone: +420267163554 email: heidi.mocikova@fnkv.cz name: Katerina Klaskova, Ing. role: CONTACT phone: +420267162880 email: katerina.klaskova@fnkv.cz lat: 50.08804 lon: 14.42076 facility: Charles University status: ACTIVE_NOT_RECRUITING city: Praha zip: 12108 country: Czechia lat: 50.08804 lon: 14.42076 facility: General University Hospital status: RECRUITING city: Praha zip: 12808 country: Czechia name: Jan Koren, M.D. role: CONTACT phone: +420224962541 email: jan.koren@vfn.cz lat: 50.08804 lon: 14.42076 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-11-30 uploadDate: 2024-02-07T11:30 filename: Prot_SAP_000.pdf size: 329948 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-11-30 uploadDate: 2024-02-07T11:43 filename: ICF_001.pdf size: 82316 hasResults: False

 nctId: NCT06263517 id: SPA-S-899-01-21 id: 2021-003124-33 type: EUDRACT_NUMBER briefTitle: Clinical Trial to Assess Efficacy, Tolerability of Rising Doses of Clodronate in Painful Knee Osteoarthritis Patients overallStatus: RECRUITING date: 2023-10-12 date: 2025-07 date: 2025-10 date: 2024-02-16 date: 2024-02-16 name: SPA Società Prodotti Antibiotici S.p.A. class: INDUSTRY name: Pharmaceutical Development and Services briefSummary: The goal of this clinical trial is to to clarify which is the best dose of administration, to select a dose and to confirm the therapeutic efficacy of clodronate in patients with painful knee osteoarthritis (OA). The clinical trial will be divided in two parts.

The main questions it aims to answer are:

* in Phase II, to assess the safety and tolerability of different escalating doses of intra articular (IA) clodronate
* in Phase II, to set a defined therapeutic dose (DTD) to be used in Phase III
* in Phase III, to assess the safety and tolerability of different escalating doses of IA clodronate to confirm and extensively evaluate the therapeutic efficacy and safety of the clodronate DTD in patients with knee OA conditions: Osteoarthritis of Knee studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Adaptative, multicenter, randomized, double-blind, parallel-group, placebo controlled primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Randomization list will be performed with Proc Plan procedure by SAS ® Software (release 9.4 or later) software using the block randomization method with block size of 4.

Subjects eligible at Baseline will be randomly allocated to receive 2, 5, 10 /2ml or placebo according to the balanced randomization list. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 296 type: ESTIMATED name: Clodronate name: Clodronate name: Clodronate name: Placebo measure: Efficacy: VAS Reduction measure: VAS mean changes measure: VAS mean changes observed 120 minutes after IA measure: Lequesne Algofunctional Index mean changes measure: WOMAC mean changes measure: Range of motion mean changes measure: Paracetamol consumption measure: SAE Reporting measure: AE Reporting measure: Clinical signs of intolerance Recording sex: ALL minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituti Clinici Maugeri status: RECRUITING city: Castel Goffredo state: Mantova zip: 46042 country: Italy name: Lul Abdi-Ali role: CONTACT lat: 45.29403 lon: 10.473 facility: Ospedale San Pellegrino status: RECRUITING city: Castiglione delle Stiviere state: Mantova zip: 46043 country: Italy name: Paolo Roberto Ferrari role: CONTACT lat: 45.3902 lon: 10.48619 facility: Ospedale Civile Servizio di Riabilitazione Funzionale status: RECRUITING city: Volta Mantovana state: Mantova zip: 46049 country: Italy name: Luisa Selletti role: CONTACT lat: 45.32192 lon: 10.65891 facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga status: NOT_YET_RECRUITING city: Orbassano state: Torino zip: 10043 country: Italy name: Filippo Castoldi role: CONTACT lat: 45.00547 lon: 7.53813 facility: Centro Riabilitativo Polifunzionale Teresio Borsalino status: RECRUITING city: Alessandria zip: 15122 country: Italy name: Marco Invernizzi role: CONTACT lat: 44.90924 lon: 8.61007 facility: IRCCS Ospedale Policlinico San Martino status: RECRUITING city: Genova zip: 16132 country: Italy name: Matteo Formica role: CONTACT lat: 44.40478 lon: 8.94438 facility: Ospedale Israelitico status: RECRUITING city: Roma zip: 00148 country: Italy name: Maria Chiara Meloni role: CONTACT lat: 41.89193 lon: 12.51133 facility: Ospedale San Pietro status: RECRUITING city: Rome zip: 00189 country: Italy name: Alberto Migliore role: CONTACT lat: 41.89193 lon: 12.51133 facility: Ospedale San Paolo status: NOT_YET_RECRUITING city: Savona zip: 17100 country: Italy name: Danilo Chiapale role: CONTACT lat: 44.30905 lon: 8.47715 facility: Azienda Ospedaliero Universitaria Senese status: RECRUITING city: Siena zip: 53100 country: Italy name: Bruno Frediani role: CONTACT lat: 43.31822 lon: 11.33064 facility: Ospedale Policlinico "G.B. Rossi" Borgo Roma status: RECRUITING city: Verona zip: 37134 country: Italy name: Luca Dalle Carbonare role: CONTACT lat: 45.4299 lon: 10.98444 hasResults: False

 nctId: NCT06263504 id: DM001 briefTitle: The Influence of Complex Correction of Dental and Musculoskeletal Systems on the Frequency of Relapses of Functional Disorders in Patients With Dental Pathologies. overallStatus: NOT_YET_RECRUITING date: 2024-03-10 date: 2025-06-15 date: 2025-10-15 date: 2024-02-16 date: 2024-02-26 name: NMSI DENTMASTER class: OTHER briefSummary: In influence of complex correction of dental and musculoskeletal systems on the frequency of relapses of functional disorders in patients with somatic pathologies: a randomized pilot study there will be two groups: Group 1 (control group): Patients in this group will receive standard treatment aimed solely at correcting malocclusions or restoring the integrity of the dentition without interfering with the musculoskeletal system.

Group 2 (experimental group): Patients will receive comprehensive treatment, including not only dental correction of bite or restoration of the integrity of the dentition, but also correction of disorders of the musculoskeletal system.

The endpoints will be :

Primary endpoint:

• Frequency of relapses and repeated requests for correction of disorders bite or restoration of the integrity of the dentition within 12 months after treatment.

Secondary endpoints:

* Change in pain intensity measured by visual analog scale (VAS).
* Improvement of functional indicators of the temporomandibular joint, including range of motion.
* Improved quality of life, assessed using the OHRQoL (Oral Health Related Quality) scale All endpoints will be evaluated within 12 months. conditions: Malocclusion conditions: Musculoskeletal Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: at correcting malocclusions or restoring the integrity of the dentition name: comprehensive treatment, including not only dental correction of bite or restoration of the integrity of the dentition, but also correction of disorders of the musculoskeletal system. measure: Frequency of relapses and repeated requests for correction of disorders bite or restoration of the integrity of the dentition. measure: Change in pain intensity measured by visual analog scale (VAS). measure: Changes in functional parameters of the temporomandibular joint, including range of motion. joint, including range of motion. measure: Improved quality of life, assessed using the OHRQoL (Oral Health Related Quality) scale sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Nmsi Dentmaster city: Novosibirsk state: Novosibirsk Region zip: 630090 country: Russian Federation name: Tatiana A Gatilova role: CONTACT phone: 952939919 phoneExt: +7 email: gatilova@dentservice.ru name: Anastasia V Semivolova role: PRINCIPAL_INVESTIGATOR lat: 55.0415 lon: 82.9346 hasResults: False

 nctId: NCT06263491 id: 2023-0413 id: NCI-2024-01325 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients overallStatus: NOT_YET_RECRUITING date: 2024-08-31 date: 2025-03-01 date: 2027-03-01 date: 2024-02-16 date: 2024-03-01 name: M.D. Anderson Cancer Center class: OTHER briefSummary: To learn if the chemotherapy-free combination of pirtobrutinib (also called LOXO-305) and rituximab can help provide long term remission in low and intermediate risk MCL. conditions: Mantle Cell Lymphoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Rituximab name: Pirtobrutinib measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Preetesh Jain, MBBS, MD, DM, PhD role: CONTACT phone: (713) 563-8786 email: pjain@mdanderson.org name: Preetesh Jain, MBBS, MD, DM, PhD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06263478 id: INCA34176-358 briefTitle: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Axatilimab Monotherapy in Japanese Participants With Recurrent or Refractory Active Chronic Graft-Versus-Host Disease overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2025-12-31 date: 2025-12-31 date: 2024-02-16 date: 2024-02-16 name: Incyte Biosciences Japan GK class: INDUSTRY briefSummary: This study will be conducted to determine the clinical efficacy of axatilimab in Japanese participants with chronic graft-versus-host disease (cGVHD). conditions: Chronic Graft-versus-host-disease studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: INCA034176 measure: Overall Response Rate in the First 6 Cycles measure: Proportion of participants with a ≥ 7-point improvement in modified Lee symptom scale (mLSS) score measure: Overall Response Rate measure: Duration of Response measure: Organ-specific Response Rate measure: Percent reduction in average daily dose (or equivalent) of corticosteroids measure: Proportion of participants who discontinue corticosteroid use measure: Number of participants with Treatment-emergent Adverse Events (TEAEs) measure: Change from baseline in Karnofsky/Lansky performance status measure: Axatilimab pharmacokinetic (PK) in Plasma measure: Number of Participants with Anti-Drug Antibody (ADA) sex: ALL minimumAge: 6 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06263465 id: CALM briefTitle: Precision Vaginal Microbiome Transplantation in Women With Bacterial Vaginosis overallStatus: RECRUITING date: 2024-03-11 date: 2025-07-01 date: 2025-12-31 date: 2024-02-16 date: 2024-03-13 name: Zhujiang Hospital class: OTHER name: ZhuHai Hospital briefSummary: The aim of this study was to explore the efficacy and safety of a new vaginal microbiome transplantation technique, using Lactobacillus cispatus from healthy donors as a treatment of bacterial vaginosis. conditions: Bacterial Vaginosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 120 type: ESTIMATED name: Lactobacillus cispatus name: placebo measure: BV recurrence rate measure: vaginal secretions 16s rRNA gene sequencing measure: BV recurrence rate sex: FEMALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Zhuhai People'S Hospital status: RECRUITING city: Zhuhai state: Guangdong zip: 519050 country: China name: Jingya WU, Doctor role: CONTACT phone: +8615902057821 lat: 22.27694 lon: 113.56778 hasResults: False

 nctId: NCT06263452 id: 23-2768 id: 1R01HL157422-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01HL157422-01 briefTitle: Beta-Blocker Influences on Inflammatory and Neural Responses to Stress overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2026-03 date: 2024-02-16 date: 2024-03-06 name: University of North Carolina, Chapel Hill class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) name: University of California, Los Angeles name: Dartmouth College briefSummary: The purpose of this study is to map the neural and molecular mechanisms underlying psychological stress-induced changes in inflammation which could reveal new targets for intervention to reduce the risk of cardiovascular disease. conditions: Cardiovascular Disease studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Subjects (n = 60 per condition, N = 120) will either take a one-time, 40mg dose of propranolol or an encapsulated placebo. primaryPurpose: BASIC_SCIENCE masking: TRIPLE maskingDescription: This is a double blind, randomized, placebo-controlled mechanistic clinical trial. The Investigational Drug Service will randomly assign patients to the experimental group (propranolol) or the placebo group. Research staff who have direct contact with the participant will be blind to their condition. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 120 type: ESTIMATED name: Propranolol name: Placebo measure: Change in levels of pro-inflammatory cytokine interleukin-6 in response to social stress measure: Change in levels of inflammatory gene expression in response to social stress sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Social Neuroscience and Health Laboratory city: Chapel Hill state: North Carolina zip: 27514 country: United States name: Keely A Muscatell, PhD role: CONTACT phone: 916-495-7661 email: kmuscatell@unc.edu name: Jessica R Cohen, PhD role: SUB_INVESTIGATOR name: Kristen A Lindquist, PhD role: SUB_INVESTIGATOR name: Samantha E Meltzer-Brody, MD, MPH role: SUB_INVESTIGATOR lat: 35.9132 lon: -79.05584 hasResults: False

 nctId: NCT06263439 id: RNI 2023 MIRAND id: 2023-A00585-40 type: OTHER domain: ANSM briefTitle: Surveillance of HFMD in Pediatric Outpatients acronym: PMB overallStatus: RECRUITING date: 2023-06-20 date: 2028-06-20 date: 2028-06-20 date: 2024-02-16 date: 2024-02-16 name: University Hospital, Clermont-Ferrand class: OTHER briefSummary: The aims of this prospective multicentric study is to determine the types of enteroviruses (EVs) responsible for hand, foot and mouth disease (HFMD) or herpangina in children seen within an ambulatory setting :

* to detect an EV-A71 epidemic or another type associated with atypical forms of the disease at an early stage
* to describe and compare the epidemiological, demographic, clinical and virological characteristics of these infections between the different types of EV. conditions: Hand, Foot and Mouth Disease conditions: Herpangina conditions: Enterovirus Infections studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3000 type: ESTIMATED name: Throat/buccal swab sample measure: Prevalence of different types of Enteroviruses measure: Clinical characteristics of HFMD/Herpangina according to the different types of enteroviruses sex: ALL maximumAge: 10 Years stdAges: CHILD facility: CHU de Clermont-Ferrand status: RECRUITING city: Clermont-Ferrand zip: 63000 country: France name: Lise Laclautre role: CONTACT email: promo_interne_drci@chu-clermontferrand.fr name: Audrey Mirand role: PRINCIPAL_INVESTIGATOR lat: 45.77966 lon: 3.08628 hasResults: False

 nctId: NCT06263426 id: IRB00387066 id: U01AI177211 type: NIH link: https://reporter.nih.gov/quickSearch/U01AI177211 briefTitle: Kidney Transplantation From Donors With HIV: Impact on Rejection and Long-Term Outcomes (Expanding HOPE Kidney) overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-09 date: 2029-09 date: 2024-02-16 date: 2024-02-16 name: Johns Hopkins University class: OTHER name: National Institute of Allergy and Infectious Diseases (NIAID) briefSummary: This research is being done to better understand rejection in transplant recipients with HIV who receive kidneys from donors with vs without HIV. conditions: Hiv studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: HIV D+/R+ name: HIV D-/R+ measure: Cumulative incidence of death and allograft rejection. measure: Participant survival measure: Graft survival measure: Type and severity of graft rejection measure: Time to first rejection measure: Rate of rejection events over time measure: Graft function over time measured by eGFR trajectory measure: Incidence of HIV viremia post-transplant measure: Incidence of new antiretroviral drug resistance and/or X4 tropic virus posttransplant measure: Incidence of bacterial, fungal, viral, and other opportunistic infections posttransplant measure: Incidence of surgical and vascular transplant complications post-transplant measure: Incidence and causes of chronic kidney disease post-transplant measure: Incidence of post-transplant malignancies measure: Incidence of de novo donor specific antibody (DSA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama at Birmingham city: Birmingham state: Alabama zip: 35294 country: United States name: Shikha Mehta, MD role: CONTACT email: smehta@uabmc.edu name: Shikha Mehta, MD role: PRINCIPAL_INVESTIGATOR lat: 33.52066 lon: -86.80249 facility: University of California, Los Angeles city: Los Angeles state: California zip: 90095 country: United States name: Joanna Schaenman, MD, PhD role: CONTACT email: JSchaenman@mednet.ucla.edu name: Joanna Schaenman, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 facility: University of California, San Diego city: San Diego state: California zip: 92037 country: United States name: Saima Aslam, MBBS role: CONTACT email: saslam@ucsd.edu name: Saima Aslam, MBBS role: PRINCIPAL_INVESTIGATOR lat: 32.71533 lon: -117.15726 facility: University of California, San Francisco city: San Francisco state: California zip: 94143 country: United States name: Garrett Roll, MD role: CONTACT email: Garrett.Roll@ucsf.edu name: Garrett Roll, MD role: PRINCIPAL_INVESTIGATOR lat: 37.77493 lon: -122.41942 facility: Yale School of Medicine city: New Haven state: Connecticut zip: 06510 country: United States name: Maricar Malinis, MD role: CONTACT email: maricar.malinis@yale.edu name: Maricar Malinis, MD role: PRINCIPAL_INVESTIGATOR lat: 41.30815 lon: -72.92816 facility: Rush University Medical Center city: Chicago state: Illinois zip: 60612 country: United States name: Carlos Santos, MD role: CONTACT email: Carlos_A_Santos@rush.edu name: Carlos Santos, MD role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 facility: Ochsner Clinic Foundation city: New Orleans state: Louisiana zip: 70121 country: United States name: Jonathan Hand, MD role: CONTACT email: jonathan.hand@ochsner.org name: Jonathan Hand, MD role: PRINCIPAL_INVESTIGATOR lat: 29.95465 lon: -90.07507 facility: Johns Hopkins University city: Baltimore state: Maryland zip: 21205 country: United States name: Christine Durand, MD role: CONTACT email: cdurand2@jhmi.edu name: Christine Durand, MD role: PRINCIPAL_INVESTIGATOR lat: 39.29038 lon: -76.61219 facility: Massachusetts General Hospital city: Boston state: Massachusetts zip: 02114 country: United States name: Nahel Elias, MD role: CONTACT email: elias.nahel@mgh.harvard.edu name: Nahel Elias, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: New York University city: New York state: New York zip: 10016 country: United States name: Sapna Mehta, MD role: CONTACT email: Sapna.mehta@nyumc.org name: Sapna Mehta, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: Icahn School of Medicine at Mt. Sinai city: New York state: New York zip: 10029 country: United States name: Sander Florman, MD role: CONTACT email: Sander.florman@mountsinai.org name: Sander Florman, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: Columbia University city: New York state: New York zip: 10032 country: United States name: Marcus Pereira, MD role: CONTACT name: Marcus Pereira, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: Weill Cornell Medical Center city: New York state: New York zip: 10065 country: United States name: Catherine Small, MD role: CONTACT email: Cbs9003@med.cornell.edu name: Catherine Small, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: University of Pittsburgh Medical Center city: Pittsburgh state: Pennsylvania zip: 15213 country: United States name: Ghady Haidar, MD role: CONTACT email: haidarg@upmc.edu name: Ghady Haidar, MD role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 hasResults: False

 nctId: NCT06263413 id: 24.12.2266-GHM briefTitle: Clinical Workflow Optimization Using Artificial Intelligence for Dermatological Conditions acronym: IDEI_2023 overallStatus: RECRUITING date: 2024-01-15 date: 2024-06-30 date: 2024-09-30 date: 2024-02-16 date: 2024-03-19 name: AI Labs Group S.L class: INDUSTRY name: Instituto de Dermatología Integral (IDEI) briefSummary: Artificial intelligence (AI) based on imaging holds tremendous potential to enhance visual diagnostic accuracy in the medical field. Amid the COVID-19 pandemic, limited access to in-person healthcare services drove shifts in medical care, hastening the adoption of telemedicine. In this context, AI usage for triage and decision support may be crucial for professionals to manage workload and improve performance. In dermatology, pigmented lesions, acne, and alopecia are three recurring pathology groups with high demand in dermatological centers. Both triage, clinical evaluation, and patient follow-up require in-person resources and specialist dedication. Employing tools like AI can benefit these professionals in reducing such processes and optimizing workload.

Advancements in image recognition and interpretation, as well as in artificial intelligence, have spurred innovations in diagnosing various pathologies, including skin conditions. Computer-Aided Diagnosis (CAD) systems and other algorithm-based technologies have demonstrated the ability to classify lesion images with a competency comparable to that of an expert physician.

In this study, the Legit.Health tool, developed by AI LABS GROUP S.L., which utilizes artificial intelligence to optimize clinical flow and patient care processes for skin conditions, will be evaluated. The purpose of this tool is to automatically prioritize patients with greater urgency, assign the type of consultation (dermatological or aesthetic), enhance diagnostic capability and detection of malignant pigmented lesions in auxiliary staff, and provide a visual record (photograph) of the condition for later review by external experts.

Thus, the main objective of this study is to validate that Legit.Health, based on Artificial Intelligence, improves efficiency in clinical flow and patient care processes, thereby reducing time and cost of patient care through enhanced diagnostic accuracy and severity determination.

The secondary objectives focus on measuring the diagnostic performance of Legit.Health:

Demonstrate that Legit.Health enhances healthcare professionals\&#39; ability to detect malignant or suspicious pigmented lesions.

Demonstrate that Legit.Health improves healthcare professionals\&#39; ability and precision in measuring the degree of involvement in patients with female androgenetic alopecia.

Demonstrate that Legit.Health improves healthcare professionals\&#39; ability and precision in measuring the degree of involvement in patients with acne.

Additionally, the study aims to assess the utility of this tool:

Automate the triage/initial assessment process in patients presenting with pigmented lesions.

Evaluate the reduction in healthcare resources usage by the center by reducing the number of triage consultations and directing the patient directly to the appropriate consultation (esthetic or dermatological).

Evaluate Legit.Health\&#39;s usability by the patient. Demonstrate that Legit.Health increases specialist satisfaction. Evaluate the reduction in healthcare resources usage by reducing the number of triage consultations and directing the patient directly to the appropriate consultation, whether in aesthetic or dermatological settings.

Methodology Study Design Type This is an observational study, both prospective with a longitudinal character and retrospective case series.

Study Period This study estimates a recruitment period of 3 months. The total study duration is estimated at 6 months, including the previous time for retrospective analysis and the necessary time after recruiting the last subject for database closure and editing, data analysis, and preparation of the final study report.

The total study duration for each participant with pigmented lesions will be 1-3 months. The duration for patients with acne and alopecia will be 1 day.

Study Population Adult patients (≥ 18 years) with skin pathologies treated at the Dermatology Unit of IDEI. conditions: Acne conditions: Acne Vulgaris conditions: Alopecia, Androgenetic conditions: Pigmented Lesions conditions: Pigmented Skin Lesion studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 150 type: ESTIMATED measure: Concordance between the physician's diagnosis and that of the tool. measure: Agreement of detected malignancy between the dermatologist and Legit.Health tool measure: Acne severity measure: Severity of alopecia sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IDEI Hospital status: RECRUITING city: Madrid zip: 28009 country: Spain name: Miguel Sánchez-Viera, PhD role: CONTACT phone: +34 915740990 email: sanchez.viera@ideidermatologia.com name: Miguel Sánchez-Viera, PhD role: PRINCIPAL_INVESTIGATOR name: Concetta Alessandro, MD role: SUB_INVESTIGATOR name: Alejandra Capote, MD role: SUB_INVESTIGATOR name: Pablo López-Andina, MD role: SUB_INVESTIGATOR name: Allison Marie Bell-Smythe Sorg, MD role: SUB_INVESTIGATOR name: Alejandra Vallejos, MD role: SUB_INVESTIGATOR name: Isabel del Campo, MD role: SUB_INVESTIGATOR name: Juliana Machado, MD role: SUB_INVESTIGATOR name: Raúl Lucas-Escobar, MD role: SUB_INVESTIGATOR name: Beatriz Torres role: SUB_INVESTIGATOR name: Alfonso Medela, MsC role: SUB_INVESTIGATOR name: Taig Mac Carthy, MsC role: SUB_INVESTIGATOR lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06263400 id: randomized trial briefTitle: Recovery Levels of Depression Patients and Caregiver Psychoeducation overallStatus: RECRUITING date: 2022-09-01 date: 2024-12-30 date: 2024-12-30 date: 2024-02-16 date: 2024-02-16 name: Aydin Adnan Menderes University class: OTHER briefSummary: To determine the effect of psychoeducation given to patients and caregivers on patients' depression and recovery levels, caregivers' emotional expression and family burden levels. conditions: Psychoeducation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In randomization, among the patients who volunteered to participate in the study, the odd number of patients and their caregivers in the list made according to the order of hospitalization constituted the study group, and the even number of patients and their caregivers formed the control group. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 92 type: ESTIMATED name: psychoeducation and follow-up study measure: to patients before training measure: pre-training caregivers measure: after training measure: after training sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AydınAdnan Menderes University, Faculy of Nursing, Division Public Health Nursing status: RECRUITING city: Aydın state: Aydın/Turkey zip: 09000 country: Turkey name: şerife öztaban, MsC role: CONTACT phone: +905557130105 email: serifeoztaban@gmail.com name: Filiz ADANA, Phd role: SUB_INVESTIGATOR lat: 37.84501 lon: 27.83963 hasResults: False

 nctId: NCT06263387 id: FILObsLAM_VENAZA briefTitle: Results From a French Temporary Utilization Authorization of First-line Acute Myeloid Leukemia (AML) Patients Ineligible for Intensive Chemotherapy (IC), Treated With Venetoclax Azacitidine acronym: VENAZA overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2024-11-30 date: 2025-03-30 date: 2024-02-16 date: 2024-04-18 name: French Innovative Leukemia Organisation class: OTHER name: Acute Leukemia French Association briefSummary: Following the results of the phase 1b and the phase 3 studies, Venetoclax/Azacitidine (VEN/AZA) was available in France for newly diagnosed AML patients ineligible-IC patients through the early access program the so-called ATU program.

Venetoclax (VEN) has been available in France through the ATU since Feb 2021 and through the current post-ATU schema from the point of marketing authorization approval and up to the pending publication of reimbursement and price. Between February 15, 2021, and June 30, 2021, 285 requests for ATU were made to the pharmaceutical company (Abbvie) and led to the initiation of treatment of more than 230 patients. At the end of ATU period, all these 230 ATU patients continued to be treated by VEN/AZA as part of the current post-ATU period. Healthcare professionals and health care decision makers need real world data to better understand the benefit/risk profile of treatment. Early access to treatment in France is close to real-life setting condition. conditions: AML, Adult studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 230 type: ESTIMATED measure: characterize the overall response rate, in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life cohort measure: characterize the overal survival (OS) in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life cohort measure: characterize the event free survival (EFS) in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life cohort measure: characterize the incidence and relatedness of serious adverse events (SAE), in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life measure: describe the management of Venetoclax/Azacitidine (VEN/AZA) in a real -life cohort of patient. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Amiens CHU city: Amiens country: France lat: 49.9 lon: 2.3 facility: Angers CHU city: Angers country: France lat: 47.46667 lon: -0.55 facility: Avignon CH city: Avignon country: France lat: 43.94834 lon: 4.80892 facility: Bayonne CH city: Bayonne country: France lat: 43.48333 lon: -1.48333 facility: Besançon CHU city: Besançon country: France lat: 47.24878 lon: 6.01815 facility: Brest CHU city: Brest country: France lat: 48.3903 lon: -4.48628 facility: Caen CHU city: Caen country: France lat: 49.18585 lon: -0.35912 facility: CERGY PONTOISE - CH René Dubos city: Cergy-Pontoise country: France lat: 49.03894 lon: 2.07805 facility: Hôpital d'Instruction des Armées PERCY city: Clamart country: France lat: 48.80299 lon: 2.26692 facility: CHU Estaing city: Clermont-Ferrand country: France lat: 45.77966 lon: 3.08628 facility: Corbeil-Essonnes - Ch Sud Francilien city: Corbeil-Essonnes country: France lat: 48.60603 lon: 2.48757 facility: Créteil CHU HENRI MONDOR city: Créteil country: France lat: 48.78333 lon: 2.46667 facility: Dijon CHU city: Dijon country: France lat: 47.31667 lon: 5.01667 facility: Grenoble CHU city: Grenoble country: France lat: 45.16667 lon: 5.71667 facility: Le Mans CH city: Le Mans country: France lat: 48.0 lon: 0.2 facility: CHU Lille city: Lille country: France lat: 50.63297 lon: 3.05858 facility: Limoges CHU city: Limoges country: France lat: 45.83153 lon: 1.25781 facility: Lyon sud CHU city: Lyon country: France lat: 45.74848 lon: 4.84669 facility: Marseille IPC city: Marseille country: France lat: 43.29551 lon: 5.38958 facility: Meaux CH de l'Est francilien city: Meaux country: France lat: 48.96014 lon: 2.87885 facility: METZ-THIONVILLE CHR- Hôpital de Mercy city: Metz country: France lat: 49.11911 lon: 6.17269 facility: Montpellier - Chu Saint Eloi city: Montpellier country: France lat: 43.61092 lon: 3.87723 facility: Nantes CHU city: Nantes country: France lat: 47.21725 lon: -1.55336 facility: Nice CHU city: Nice country: France lat: 43.70313 lon: 7.26608 facility: Nimes CHU city: Nîmes country: France lat: 43.83333 lon: 4.35 facility: Paris La Pitié salpetrière city: Paris country: France lat: 48.85341 lon: 2.3488 facility: Paris Necker city: Paris country: France lat: 48.85341 lon: 2.3488 facility: Paris Saint Louis city: Paris country: France lat: 48.85341 lon: 2.3488 facility: Bordeaux CHU city: Pessac country: France lat: 44.81011 lon: -0.64129 facility: Reims CHU city: Reims country: France lat: 49.25 lon: 4.03333 facility: Rennes CHU city: Rennes country: France lat: 48.11198 lon: -1.67429 facility: roubaix CH city: Roubaix country: France lat: 50.69421 lon: 3.17456 facility: Centre de Lutte Contre le Cancer H. Becquerel city: Rouen country: France lat: 49.44313 lon: 1.09932 facility: Institut de Cancérologie Lucien Neuwirth city: Saint-Priest-en-Jarez country: France lat: 45.47501 lon: 4.37614 facility: Saint Quentin CH city: Saint-Quentin country: France lat: 49.84889 lon: 3.28757 facility: ICANS - Institut de cancérologie de strasbourg europe city: Strasbourg country: France lat: 48.58392 lon: 7.74553 facility: Toulouse - IUCT Oncopole - Service d'Hématologie city: Toulouse country: France lat: 43.60426 lon: 1.44367 facility: Tours CHU city: Tours country: France lat: 47.38333 lon: 0.68333 facility: Troyes CH city: Troyes country: France lat: 48.3 lon: 4.08333 facility: Nancy CHU city: vandoeuvre les Nancy country: France lat: 48.65 lon: 6.18333 facility: Versailles CH city: Versailles country: France lat: 48.8 lon: 2.13333 facility: Villejuif IGR city: Villejuif country: France lat: 48.7939 lon: 2.35992 hasResults: False

 nctId: NCT06263374 id: 69HCL21_0355 briefTitle: Maxillofacial Rehabilitation Using Motor Imagery vs Sham After Orthognathic Surgery acronym: MAXIMAND overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2027-09-30 date: 2028-03-31 date: 2024-02-16 date: 2024-02-16 name: Hospices Civils de Lyon class: OTHER briefSummary: Dento-maxillary dysmorphoses are defined as an anomaly in the relative growth of the maxilla and/or mandible. They lead to functional disorders (i.e., disturbances in chewing or oral communication) and aesthetic issues with psychological repercussions on self-esteem, affecting the quality of life of these patients. The multidisciplinary treatment involves orthodontics (duration = 18-24 months), orthognathic surgery involving the maxillary and/or mandibular bone (at 12 months), immediately followed by physiotherapy (duration = 3 months). One main goal after surgery is the recovery of month opening to restore an appropriate orofacial function. Motor imagery (mental rehearsal of a movement without actually moving) is effectively used in athletes and in rehabilitation mainly neurological but so far has not been investigated in maxillofacial rehabilitation. Considering that the effectiveness of rehabilitation is increased when physical and mental practices are combined, this leads to propose this study aiming to investigate whether the addition of motor imagery of the maxillofacial region to maxillofacial physiotherapy (based on a practice of physical therapeutic exercises) modifies the recovery of maximum mouth opening, other ranges of motion, jaw function, and quality of life in patients after orthognathic surgery compared to the addition of a control cognitive task \[watching a non-emotional content film or filling out a crossword or Sudoku grid\] to maxillofacial physiotherapy. conditions: Maxillofacial Abnormalities studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multi-centric randomized controlled trial primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: A randomization list will be centrally generated by an independent methodologist for each center and integrated into the electronic case report form. The physiotherapist will disclose the allocation to the participant during the inclusion visit, following clear, transparent, and appropriate information, and obtaining the participant's consent to participate in the study. This disclosure occurs after all measurements have been completed. The inclusion visit is scheduled 30 days ± 8 before the surgery. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Motor imagery of the jaw name: Control task (Sudoku or Crossword puzzle) measure: Maximal mouth opening measured in millimeters using a caliper measure: Active maximum mouth opening in millimeter using a vernier caliper measure: Active jaw range of motion (ROM) other than maximal opening measure: Maxillofacial pain measure: Body weight mass (kilograms) measure: Orthodontic associated treatment measure: Compliance with physiotherapy and intervention measure: Orofacial function measure: Maxillofacial quality of life measure: Level of achievement of the goals set by the patient before surgery measure: Motor imagery capability sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cabinet Bataille city: Lyon zip: 69003 country: France name: Guillaume Nainani role: CONTACT phone: 0478011908 phoneExt: +33 email: guillaume.nainani@gmail.com lat: 45.74848 lon: 4.84669 facility: Cabinet de kinésithérapie Saint Alexandre city: Lyon zip: 69005 country: France name: Caroline Alvarado-Faysse role: CONTACT phone: 0437410332 phoneExt: +33 email: c.alvarado.faysse@gmail.com lat: 45.74848 lon: 4.84669 facility: Hôpital Henry Gabrielle city: Saint-Genis-Laval zip: 69230 country: France name: Sébastien Matéo role: CONTACT phone: 0478865066 phoneExt: +33 email: sebastien.mateo@chu-lyon.fr lat: 45.69558 lon: 4.7934 hasResults: False

 nctId: NCT06263361 id: NCH02-2021 briefTitle: Improving Safety and Accuracy of Stereotactic Brain Biopsies in Primary Central Nervous System Lymphoma. overallStatus: RECRUITING date: 2021-10-01 date: 2026-12-31 date: 2026-12-31 date: 2024-02-16 date: 2024-02-16 name: IRCCS San Raffaele class: OTHER briefSummary: Primary central nervous system lymphoma (PCNSL) is an aggressive extranodal non- Hodgkin lymphoma exclusively localized into the nervous system. The aim of this study is to evaluate the MRI imaging characteristics of the peritumoral area (PTA) and to correlate this information to pathological findings. conditions: Cerebral Lymphoma studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 15 type: ESTIMATED name: MRI imaging name: Cerebral biopsy measure: MRI imaging measure: MRI imaging measure: MRI imaging measure: MRI imaging measure: Define immunopathological features measure: Accuracy of fluoresceine guided stereotactic biopsy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS San Raffaele Scientific Institute status: RECRUITING city: Milan zip: 20132 country: Italy name: Laura Sincinelli role: CONTACT phone: 003926435568 email: sincinelli.laura@hsr.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06263348 id: HMM0601 briefTitle: A Post-Marketing Safety Study of Dorzagliatin in Patients With Type 2 Diabetes overallStatus: RECRUITING date: 2023-12-20 date: 2026-04-30 date: 2026-04-30 date: 2024-02-16 date: 2024-02-16 name: Hua Medicine Limited class: INDUSTRY name: Shanghai Branch, KunTuo Medical Research and Development (Beijing) Co., Ltd. briefSummary: The primary objective of this study is to evaluate the long-term safety of Dorzagliatin in a larger population of type 2 diabetes mellitus patients by collecting the post-marketing clinical safety data of Dorzagliatin. conditions: Type2diabetes studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The marketed product - Dorzagliatin tablet (HuaTangNing®) is used as the study drug. During this study, the dosage and administration of Dorzagliatin tablets will be completely in accordance with the investigator's judgment based on the package insert and the patient's condition. primaryPurpose: TREATMENT masking: NONE count: 2000 type: ESTIMATED name: Dorzagliatin tablets measure: Incidences of ADRs and SAEs measure: Blood glucose indicators measure: Response rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: China-Japan Friendship Hospital status: RECRUITING city: Beijing state: Beijing zip: 100029 country: China name: Wenying Yang, MD,PhD role: CONTACT lat: 39.9075 lon: 116.39723 facility: China-Japan Friendship Hospital status: RECRUITING city: Beijing state: Beijing zip: 100029 country: China name: Bo Zhang, MD,PhD role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06263335 id: Fatima Jinnah Women University briefTitle: MBI for Psychological Distress, SI and NSSI Among Young Adults overallStatus: COMPLETED date: 2022-02-28 date: 2022-05-28 date: 2022-05-28 date: 2024-02-16 date: 2024-02-16 name: Fatima Jinnah Women University class: OTHER briefSummary: Designed to measure the impact of Mindfulness Based Intervention on depression, anxiety, stress, psychological distress, Suicidal Ideation, Non-Suicidal Self Injury urge and Mindfulness in young adults. Those individuals who agree to participate in the trial and identified with high levels of psychological distress and Suicidal Ideation, randomly divided into interventional (n=30) and control (n=30) groups. The Mindfulness Based Stress Reduction intervention then administered to the interventional group for eight weeks and pre and post intervention assessment done for both the groups. conditions: Psychological Distress conditions: Suicidal Ideation conditions: Non-Suicidal Self Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ACTUAL name: Mindfulness Based Stress Reduction Intervention measure: Psychological Distress measure: Suicidal Ideation measure: Non-Suicidal Self-Injury (NSSI) sex: ALL minimumAge: 18 Years maximumAge: 24 Years stdAges: ADULT facility: Fatima Jinnah Women University city: Rawalpindi state: Punjab zip: 46000 country: Pakistan lat: 33.6007 lon: 73.0679 hasResults: False

 nctId: NCT06263322 id: IRB202200419 id: R21AG073769 type: NIH link: https://reporter.nih.gov/quickSearch/R21AG073769 briefTitle: The ROAMM-EHR Study acronym: ROAMM-EHR overallStatus: RECRUITING date: 2023-11-16 date: 2026-10-17 date: 2026-10-17 date: 2024-02-16 date: 2024-02-16 name: University of Florida class: OTHER name: National Institute on Aging (NIA) briefSummary: In recent years, mobile health (mHealth) apps have promised improved monitoring of health conditions to improve clinical outcomes. The objective of this study is to conduct a pilot randomized clinical trial (RCT) to evaluate the impact of using remotely collected patient generated health data (PGHD) from older patients undergoing bypass surgery due to chronic limb threatening ischemia. The hypothesis is that integrating PGHD with an EHR system will help providers manage post-surgical symptoms and thus improve post-operative mobility and quality of life health outcomes. conditions: Peripheral Arterial Disease conditions: Chronic Limb-Threatening Ischemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Randomized Clinical trial. Comparison study to test the feasibility of patient generated health data compared to standard of care post-surgical observation. primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE maskingDescription: Participants are masked to whether their PGHD are being sent to their care provider. Care providers are masked to who receives standard of care. Investigators (except for one who will be the point person for randomization) will be masked to intervention assignments. Staff assessors will be masked to whether PGHD are being sent to their care provider. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Actionable remotely generated health data name: Non-Actionable remotely generated health data measure: 6-min walk distance measure: self-reported quality of life sex: ALL minimumAge: 60 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Aging status: RECRUITING city: Gainesville state: Florida zip: 32611 country: United States name: Institute_of_Aging role: CONTACT phone: 352-273-5919 email: recruit@aging.ufl.edu name: HOBI_Department role: CONTACT phone: 352.627.9467 email: hobi@health.ufl.edu lat: 29.65163 lon: -82.32483 hasResults: False

 nctId: NCT06263309 id: Femoralneckfracture briefTitle: Mid-Term Radiological Outcomes of Femoral Neck Fractures Treated With Osteosynthesis: A Comparative Analysis overallStatus: COMPLETED date: 2022-06-01 date: 2023-06-01 date: 2023-09-01 date: 2024-02-16 date: 2024-02-16 name: Istanbul University class: OTHER briefSummary: OBJECTIVES: This study assesses the efficacy of dynamic hip screw (DHS) versus cannulated screws for femoral neck fractures, focusing on femoral neck shortening, avascular necrosis (AVN) incidence, and functional outcomes.

METHODS:

Design: Retrospective cohort study. Setting: Academic Level I Trauma Center. Patient Selection Criteria: Included were patients with femoral neck fractures treated with DHS or cannulated screws, with follow-up data available.

Outcome Measures and Comparisons: Main outcomes were femoral neck shortening, incidence of AVN, and Harris Hip Score (HHS) for functional assessment. conditions: Femoral Neck Fractures conditions: Femoral Neck Shortening studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 10 type: ACTUAL name: Femoral neck shortening measurement measure: Harris Hip score sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University city: İstanbul zip: 34093 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06263296 id: UW 24-055 briefTitle: Smartphone Assisted Self-management Education for Adult Burn Patient at Aftercare overallStatus: NOT_YET_RECRUITING date: 2024-03-11 date: 2025-06-28 date: 2025-09-30 date: 2024-02-16 date: 2024-03-05 name: Queen Mary Hospital, Hong Kong class: OTHER briefSummary: Burn rehabilitation management is dependent on the patients themselves, non-treatment adherence may delay the optimal timing of burn rehabilitation and it may not be regained easily. The inevitable sequelae of increasing joint stiffness and tethered soft-tissue glide become more devastating over time. It has a major impact on clinical outcomes such as scarring, deformity and dysfunction, which result in lower quality of life compared to general population

There is a growing body of research on patient-centered interventions including the concept of self-management. Such phenomenon is consistent with burn patients' needs at aftercare. The proposed smartphone self-management program is to change the paradigm from paternalistic to collaborative relationship. Self-management is to build up patient equipping ability in problem solving, decision making, and appropriate use of resources and has led to improved patient engagement, adherence, and better quality of care.

The investigators hypothesize that, upon intervention completion and compared with the control group, burn patients in the intervention group will report:

1. Higher level of health-related quality of life,
2. Higher level of self-efficacy
3. Higher level of score in Burn Rehabilitation Knowledge
4. Lower pain level, as measured by Numeric Pain Rating Scale; and
5. Lower level of itchiness

The desired smart phone assisted self-management intervention will be carried out by principal investigator to selected adult burn patients before discharge and post discharge period. Before discharge, ward nurses will provide discharge pamphlet and individual face to face education to both groups as usual care. After discharge, instant messaging supportive enquiry service will be provided to both groups via smartphone apps.

For intervention group, principal investigator will assess subject health care needs prior to intervention. Two extra sessions, 20 minutes, face to face, individual self-management education with aid of computer, track log sheet will be provided to intervention group. Concept of motivational interviewing will be incorporated as complement teaching strategy to facilitate self-management learning. Principal investigator will be responsible to deliver burn self-management education upon discharge. Intervention group will receive "Rehabilitation Booklet for Burn Patients" upon discharge. After discharge, only intervention group subject receives two sessions, 10 minutes, telephone follow up calls and five personalized chat-based messaging follow up will be provided. Besides that, self-management education information will be delivered to intervention group via instant messaging service as well. Ad-hoc instant messaging support will be provided to both groups if required. conditions: Burns conditions: Self Efficacy conditions: Burn Second Degree conditions: Burns Third Degree conditions: Quality of Life conditions: Adherence, Treatment conditions: Burn Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Pilot Randomized Controlled Trial primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Only subject will be single blinded to the intervention provided whoMasked: PARTICIPANT count: 50 type: ESTIMATED name: Self Management Education measure: Change from Baseline in the Disease Specific Quality of life at Week 4 & Week 12 measure: Change from Baseline in the Generic Quality of life at Week 4 & Week 12 measure: Change from Baseline in the Burn Rehabilitation Knowledge Questionnaire measure: Change from Baseline in the Self efficacy at Week 4 & Week 12 measure: Change from Baseline in the Itchiness of life at Week 4 & Week 12 measure: Change from Baseline in the Pain level at Week 4 & Week 12 measure: Percentage in the Burn related out-patient clinic attendance sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: LIU Siu Kwong city: Hong Kong country: China name: Siu Kwong LIU, ANC role: CONTACT phone: 852 22557610 email: onceliu@yahoo.com.hk lat: 22.39407 lon: 114.13737 hasResults: False

 nctId: NCT06263283 id: PROICM 2023-04 KYO briefTitle: Impact of an Educational Physiotherapy-Yoga Intervention on Perceived Stress in Women Treated With Brachytherapy for Cervical Cancer acronym: KYOCOL overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2026-03 date: 2024-02-16 date: 2024-02-16 name: Institut du Cancer de Montpellier - Val d'Aurelle class: OTHER briefSummary: Every year in France, nearly 3,000 women develop a cervical cancer. The average age of women diagnosed is 51. Uterovaginal brachytherapy is one of the reference treatments.

To allow this treatment, an applicator is first placed under general anaesthesia in the vaginal zone. Then, the pulsed Dose Rate (PDR) or high dose rate (HDR) uterovaginal brachytherapy requires 2-5 days hospitalization in an isolated room. Uterovaginal brachytherapy requires strict bed rest without movements allowed for the pelvic area until the applicator is removed.

Prolonged immobilization, the context of the illness and the intimacy of the area to be treated are all recognized sources of anxiety. According to a study, 40% of patients have post-traumatic stress at 3 months of treatment. A Danish team highlights the significant decrease in physical capacity during and after treatment.

Thus, as a recent literature review concludes, there is a real need to develop Non-Pharmacological-Interventions (NPI) to limit the aftereffects. It also seems important to provide support for self-management of symptoms.

Among NPI of interest, Yoga is a mind-body practice that can decrease perceived stress. A systematic review confirms that yoga can reduce stress during cancer treatment. This underlines the importance of proposing this practice for patients treated for all types of cancers and further evaluations on the effects of respiratory and meditation exercises. Another team showed the feasibility of respiratory exercise intervention in patients undergoing chemotherapy while also talking about mental health benefits. Finally, a reduction in perceived stress was achieved in women treated with radiotherapy for breast cancer through yoga intervention. A lot of work has been done with promising results without the result of a consensus applicable to all care situations.

Moreover, educational requirements are high in women treated to gynecological cancer.

Meeting these needs helps to improve quality of life, pain management and drug use.

Integrating Patient Educational Project (PEP) therefore seems relevant as an additional tool in patient empowerment. In addition, the fact that a combined Physiotherapy-Yoga-PEP intervention is feasible in women treated for breast cancer allows us to offer adjusted version in patients with brachytherapy.

The literature review thus invites us to propose the educational intervention Kine-Yoga-PEP in the very particular context of brachytherapy. conditions: Cervical Cancer conditions: Brachytherapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Control Group: Standard care according to the modalities of each center (concomitant treatment prescription, psychological support, physiotherapy or dietetic are supports that can be proposed if needed) Experimental Group: Standard support with Daily realization of a session of Kine-Yoga supervised by a physiotherapist at J2, J3 and J4 of uterovaginal brachytherapy. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 80 type: ESTIMATED name: session of Kine-Yoga measure: Evaluation of the Kine-Yoga-PEP intervention to standard care during the uterovaginal brachytherapy on perceived stress at 15 days of treatment initiation in patients treated for cervical cancer. measure: assessment in the experimental group: safety and patient compliance at the Kine-Yoga-PEP intervention measure: Evaluation of the immediate effect of the Kine-Yoga-PEP intervention in the experimental group on perceived stress, pain (overall and due to immobility) and the evolution of these parameters during brachytherapy. measure: Evaluation of the evolution of fatigue during uterovaginal brachytherapy measure: assessment of the psychological distress at inclusion and 15 days after the uterovaginal brachytherapy measure: Description of the use of anxiolytics by group (experimental vs control) measure: Description of the experiences of patients treated for cervical cancer during uterovaginal brachytherapy receiving a Kine-Yoga-PEP intervention (approximately 20 patients in the experimental group sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06263270 id: 12-2023-01 briefTitle: Evaluation of CYT-108, a Recombinant Protease Inhibitor, for Treatment of Mild to Moderate Primary Osteoarthritis of the Knee overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-16 date: 2024-04-16 name: Cytonics Corporation class: INDUSTRY name: Southern Star Research Pty Ltd. briefSummary: The goal of this Phase 1 study is to investigate the safety of CYT-108, our experimental recombinant protease inhibitor drug candidate for osteoarthritis, in a population of patients suffering from osteoarthritis of the knee. The main questions this study aims to answer are:

1. are two doses of CYT-108, delivered 12 weeks apart, safe when injected directly into the joint?
2. does administration of CYT-108 result in a reduction in pain, stiffness, and improvement in daily physical function?

Participants will either receive a placebo (Phosphate Buffer Saline, PBS) or CYT-108, and will be asked to report their pain/stiffness at weeks 1, 4, 8, 12, 16, and 26 (in a physician's office) after the initial injection, using a questionnaire to be provided by the physician. In addition to reporting the magnitude of pain, participants will also be asked about the onset of pain reduction. Researchers will compare the pain/stiffness scores between the CYT-108-treated to placebo-treated groups along the 26 week duration of the study. Participants will also receive blood draws along the course of the study, and researchers will analyze this blood for the presence of cartilage degradation product in attempt to identify "disease modification" (i.e., a reduction in cartilage degradation) in response to CYT-108 treatment. conditions: Osteoarthritis, Knee conditions: Osteoarthritis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The Phase 1a trial will be a multicenter, double-blind, randomized, placebo-controlled clinical study to evaluate the safety of two doses of CYT-108 (given at Day 1 and Day 85) in participants with mild to moderate primary OA of the knee, followed out to 26 weeks. A Screening Visit will be performed between twenty-eight days to two days before the first dose, (i.e., Days -28 to -2), and if eligible, participants will attend baseline evaluation on Day 1 to confirm eligibility before randomisation to treatment. The first and second doses will be administered on Day 1 and Day 85 (12 weeks post-first dose, with six follow-up visits on Days 8, 29, 57, 85, 113, and 183; Weeks 1, 4, 8, 12, 16, and 26 weeks post-first dose respectively). primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: This study is double-blind, placebo-controlled. Neither the investigator, care providers, patients, nor study sponsor have knowledge of the interventions assigned to each participant. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 22 type: ESTIMATED name: CYT-108, a recombinant protease inhibitor name: Phosphate Buffered Saline (PBS) measure: Adverse Events measure: Blood Pressure measure: Heart Rate measure: Respiratory Rate measure: Body Temperature measure: Titer of Human Anti-Drug Antibody measure: Change in WOMAC Scores (Pain, Stiffness, and Difficulty Performing Daily Activities) measure: Time of Onset measure: Concentration of Cartilage Degradation Fragments in Blood Plasma sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Emeritus Research city: Camberwell state: Victoria zip: 3124 country: Australia name: Stuart Game, MD role: CONTACT phone: +61 3 9509 6166 email: stuartgame@emeritusresearch.com lat: -37.84205 lon: 145.0694 hasResults: False

 nctId: NCT06263257 id: 2023-631 briefTitle: The Effect of Mandala Therapy on Anxiety and Comfort in Kidney Transplant Recipients overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2024-10 date: 2025-04 date: 2024-02-16 date: 2024-04-16 name: Busra Nur Temur class: OTHER briefSummary: The aim of this study is to evaluate the impact of mandala art therapy on the anxiety and comfort levels of living kidney transplant recipients. While kidney transplantation improves the recipients' quality of life, it may also expose them to psychological, physical, and social challenges post-transplant. This situation can increase recipients' levels of anxiety, making them cope with psychiatric issues and affecting their comfort levels. Feeling psychologically and physiologically comfortable is a crucial component of a successful recovery process for recipients.

Mandala art therapy is known as an effective method that supports the mental health, physical functioning, and social and emotional well-being of individuals with health issues. Mandalas can contribute to comfort by promoting inner peace, focusing attention, and encouraging creative expression. This study aims to investigate the impact of mandala art therapy on anxiety and comfort levels in kidney transplant recipients. To achieve this goal, a mixed-methods study using a randomized controlled and nested experimental design is planned.

The results of this study will provide valuable insights to healthcare providers by elucidating the impact of mandala art therapy on comfort and anxiety levels in living kidney transplant recipients. This information may guide healthcare professionals in enhancing kidney transplant recipients' psychological and emotional well-being, reducing stress, and promoting higher levels of comfort through mandala art therapy.

H0a: There is no effect of Mandala Art Therapy on the perceived anxiety level in living kidney transplant recipients.

H0b: There is no effect of Mandala Art Therapy on the comfort level of living kidney transplant recipients. conditions: Anxiety conditions: Transplant;Failure,Kidney conditions: Transplant Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: For the intervention group, the first measurement (afternoon of the day before surgery) will include State-Trait Anxiety Inventory and General Comfort Questionaire, the second measurement (Postoperative Day 5 - discharge day) will include State Anxiety Inventory and General Comfort Questionaire. The sessions of the Mandala Art Therapy training program for the intervention group will be conducted as follows: Session 1 on Postoperative Day 5 - discharge day (after the scales), Session 2 on 1st Control (1 week after surgery), Session 3 on 2nd Control (2 weeks after surgery), and the third measurement at 3rd Control (1 month after surgery). For the Control Group, the third measurement (1 month after surgery) will be collected through self-reporting for State Anxiety Inventory and General Comfort Questionaire. This stage aims to conduct a randomized controlled study. primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE maskingDescription: Blinding In this study, blinding of participants and the statistician is planned. Blinding of the researcher implementing the intervention will not be possible. Since participants will not know to which group they are assigned, participant blinding is considered feasible. Data related to the scales (post-test) will be coded as 'A' and 'B' without indicating whether they belong to the intervention or control group. The coded data will be analyzed by a statistician, without knowledge of group allocation. After the statistical analyses are completed, the coding for the intervention and control groups will be revealed. This blinding technique is intended to minimize statistical bias. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 72 type: ESTIMATED name: Mandala Art Therapy measure: Reduction in anxiety levels measure: Increasing comfort level sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06263244 id: NL83403.018.22 briefTitle: Specifying the Anti-inflammatory Effects of Ziltivekimab acronym: SPIDER overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-03-01 date: 2025-04-01 date: 2024-02-16 date: 2024-03-25 name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) class: OTHER briefSummary: The goal of this randomized, double blind, placebo controlled trial is to study whether ziltivekimab therapy reduces arterial wall inflammation as assessed by imaging, and reduces the systemic inflammatory tone as assessed by circulating monocytes, inflammatory biomarkers and proteomics. conditions: Atherosclerosis conditions: Inflammation studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized, double blind, placebo-controlled trial primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: After informed consent has been obtained, patients will be randomized via computer randomization to either 15 mg ziltivekimab (n=20) or placebo (n=20). On the eCRFs or other documents subjects will be identified by subject ID and randomization number only. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Ziltivekimab name: Placebo measure: TBRmax coronary arteries measure: monocyte activation marker protein expression measure: delta PCAT measure: Correlation delta TBRmax and CCTA derived plaque characteristics measure: delta SUVmax bone marrow measure: delta TBRmax ascending aorta measure: changes monocyte phenotype measure: changes in hsCRP measure: changes plasma cytokine and chemokine levels (pg/mL) measure: changes plasma cytokine and chemokine levels (ng/mL) sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06263231 id: IT-03 briefTitle: A Study to Investigate Efficacy & Safety of INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3) acronym: INVINCIBLE-3 overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-12 date: 2028-12 date: 2024-02-16 date: 2024-02-16 name: Intensity Therapeutics, Inc. class: INDUSTRY name: Premier Research Group plc briefSummary: To compare Overall Survival (OS) for INT230-6 vs United States (US) Standard of Care (SOC) in participants with unresectable or metastatic liposarcoma, undifferentiated pleomorphic sarcoma or leiomyosarcoma who have disease progression prior to study enrollment following no more than 2 standard therapies, which must have included an anthracycline-based regimen, unless contraindicated, and then a maximum of 1 additional regimen. conditions: Sarcoma,Soft Tissue studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 333 type: ESTIMATED name: INT230-6 name: Eribulin name: Trabectedin name: Pazopanib measure: Overall Survival (OS) measure: Overall Survival (OS) For INT230-6 Compared to OS for Standard of Care (SOC) for Participants with leiomyosarcoma measure: Overall Survival (OS) For INT230-6 Compared to OS for Standard of Care (SOC) for Participants with liposarcoma sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06263218 id: CCR-2023-200344 briefTitle: Real-world CMV Outcomes Among Kidney Transplant Recipients in Brazil overallStatus: ENROLLING_BY_INVITATION date: 2023-10-01 date: 2024-07-30 date: 2024-12-29 date: 2024-02-16 date: 2024-02-22 name: Hospital do Rim e Hipertensão class: OTHER briefSummary: This is a single-center, non-interventional, retrospective study of data, at the level of the individual without identification, extracted from medical records of adult patients undergoing a kidney transplant procedure after 1st from January 2018 until reaching the sample size enrollment (around 500 individuals); this refers to the period of verification of individuals' eligibility for entry into the study. Individuals under strategy preemptive patients who developed CMV infection/disease within 12 months after transplantation. The data will be collected from date of transplant (including pre-transplant clinical history) until completion of at least 12 months after transplantation, or until graft loss, or recipient death or loss to follow-up, when/if applicable. conditions: CMV Infection conditions: CMV Viremia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 500 type: ESTIMATED measure: Incidence of infection, CMV disease, and tissue invasive disease. measure: Incidence recurrent CMV infection/disease measure: Incidence of refractory CMV infection/disease sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital do Rim city: São Paulo zip: 04038-002 country: Brazil lat: -23.5475 lon: -46.63611 hasResults: False

 nctId: NCT06263205 id: Dressing briefTitle: Wound Management Following Gl Tumor Surgery: Comparing Outcomes of Dressing Changes Versus Non-Dressing Techniques acronym: Dressing overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-01-24 date: 2026-12-24 date: 2024-02-16 date: 2024-04-02 name: Fudan University class: OTHER name: Shanghai Changzheng Hospital name: Changhai Hospital name: Shanghai East Hospital briefSummary: The goal of this clinical trial is to assess the effectiveness and safety of non-dressing (exposed wound) versus dressing techniques in postoperative wound management for patients with gastrointestinal tumors. The main questions it aims to answer are:

1. Does non-dressing of postoperative wounds in gastrointestinal tumor surgery provide equivalent or better wound healing compared to traditional dressing techniques?
2. Can non-dressing of postoperative wounds reduce patient pain and healthcare costs? Participants in this study, who are diagnosed with gastrointestinal tumors and undergoing surgery, will be randomly assigned to either the non-dressing group or the dressing group. The non-dressing group will have their surgical wounds left exposed after initial postoperative care, while the dressing group will receive regular wound dressing changes every 48-72 hours. Researchers will compare these two groups to see if there are differences in the rate of wound complications, pain levels, and overall healthcare costs.

This study aims to provide evidence-based recommendations for postoperative wound care in gastrointestinal tumor surgeries, potentially improving patient outcomes and reducing medical expenses. conditions: Gastrointestinal Tumors conditions: Surgical Wound Infection conditions: Pain, Postoperative studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 816 type: ESTIMATED name: Non-Dressing of Surgical Wound name: Regular Dressing Change of Surgical Wound measure: Rate of Postoperative Wound Healing Complications measure: Patient Pain Levels measure: Medical Costs Associated with Wound Care sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University Shanghai Cancer Center city: Shanghai state: Shanghai zip: 2000000 country: China name: Dazhi Xu, MD,PHD role: CONTACT phone: 021-64175590 email: xudzh@shca.org.cn lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06263192 id: AMH-IUI briefTitle: Pregnancy Prediction Using Anti-Müllerian Hormone in Intrauterine Insemination Cycles overallStatus: COMPLETED date: 2020-10-01 date: 2022-12-01 date: 2023-05-01 date: 2024-02-16 date: 2024-02-16 name: Jose Antonio Moreno class: OTHER name: Universitat Autonoma de Barcelona briefSummary: The goal of this study is to compare the cumulative pregnancy rates after 4 artificial inseminations with donor (IAD) in non-sterile women with plasma AMH levels \> and \< 1.1 ng/mL. conditions: Infertility, Female conditions: Anti-Mullerian Hormone Deficiency studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 342 type: ACTUAL name: Intrauterine insemination measure: Cummulative pregnancy rate sex: FEMALE minimumAge: 25 Years maximumAge: 39 Years stdAges: ADULT facility: Fertty International city: Barcelona zip: 08010 country: Spain lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06263179 id: STUDY00007706 id: UL1TR001412 type: NIH link: https://reporter.nih.gov/quickSearch/UL1TR001412 briefTitle: Feasibility of Aerobic Exercise for Recovery From Work-related Concussion overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-14 date: 2024-12-30 date: 2024-02-16 date: 2024-04-08 name: State University of New York at Buffalo class: OTHER name: National Center for Advancing Translational Sciences (NCATS) briefSummary: There is a lot of research on how to treat people with sport-related concussion. There has not been a lot of research on the treatment of injured workers with concussion. An exercise program has been developed for people with sport-related concussion. It is suspected that this program may be helpful for injured workers with concussion too. This study will test the effect of this exercise in injured workers with concussion. conditions: Concussion, Brain studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Target Heartrate Aerobic Exercise primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Target Heartrate Aerobic Exercise measure: Adherence to Target Heartrate Aerobic Exercise (THRAE) program as measured by counting the number and duration of exercise sessions completed. measure: Change in post-concussive symptom burden as measured by the Post-Concussion Symptom Scale measure: Change in Patient Health Questionnaire-9 (PHQ-9) measure: Change in Generalized Anxiety Disorder-7 (GAD-7) measure: Primary Care Post Traumatic Stress Disorder (PTSD) Screen for DSM-5 (PC-PTSD-5) measure: Change in Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-10) measure: Work Climate Questionnaire - 6-Item Version measure: Change in Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS) measure: Time to return to work measured in days measure: Rate of adverse Events as assessed by questioning the participant sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-01-26 uploadDate: 2024-01-29T12:18 filename: ICF_000.pdf size: 252809 hasResults: False

 nctId: NCT06263166 id: 5535 briefTitle: The Effect of Using a Stress Ball During Vaginal Examination on Anxiety and Pain Levels: A Randomized Controlled Study overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-08 date: 2024-12 date: 2024-02-16 date: 2024-02-16 name: Ondokuz Mayıs University class: OTHER briefSummary: Women who will undergo vaginal examinations randomly assigned to intervention (n = 44) and control (n = 44) groups at a public hospital in Turkey will participate in the study. Stress ball application before vaginal examination will be explained to women in the intervention group. These women will be asked to tighten and loosen the stress ball given to them during the vaginal examination and continue this process until the examination is completed. Data regarding pain and anxiety outcomes will be collected before and after the examination.

The main questions it aims to answer are:

* question 1: What is the effect of stress ball application on women's anxiety level during vaginal examination?
* question 2: What is the effect of stress ball application on women's pain level during vaginal examination? conditions: Anxiety State conditions: Pain conditions: Exanimation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 88 type: ESTIMATED name: Stress ball intervention measure: Anxiety change measure: Pain level sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06263153 id: OSU-23329 id: NCI-2024-00002 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) briefTitle: Futibatinib in Combination With Durvalumab Prior to Cystectomy for the Treatment of Muscle-Invasive Bladder Cancer Patients Who Are Ineligible for Cisplatin-based Therapy overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-31 date: 2025-12-31 date: 2024-02-16 date: 2024-03-13 name: Yuanquan Yang class: OTHER name: Gateway for Cancer Research briefSummary: This phase II trial tests how well the combination of futibatinib and durvalumab given before cystectomy works in treating patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based therapy. Cisplatin-based therapy is the standard of care for patients with MIBC. However, many patients cannot receive standard therapy due to poor renal function, peripheral neuropathy, poor functional status, or clinically significant heart failure. Futibatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Radical cystectomy is a surgery to remove all of the bladder as well as nearby tissues and organs. Giving futibatinib in combination with durvalumab before surgery may be an effective treatment option for patients with MIBC who are ineligible for cisplatin-based therapy. conditions: Bladder Urothelial Carcinoma conditions: Muscle Invasive Bladder Carcinoma conditions: Stage II Bladder Cancer AJCC v8 conditions: Stage IIIA Bladder Cancer AJCC v8 studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Biospecimen Collection name: Computed Tomography name: Durvalumab name: Futibatinib name: Magnetic Resonance Imaging name: Radical Cystectomy measure: Complete pathologic response rate measure: Incidence of adverse events (AEs) measure: Pathologic down-staging rate to non-muscle invasive disease measure: Overall survival measure: Progression free survival measure: Frequency and severity of adverse events, including delay in cystectomy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ohio State University Comprehensive Cancer Center city: Columbus state: Ohio zip: 43210 country: United States name: Yuanquan Yang, MD, PhD role: CONTACT phone: 614-366-2485 email: Yuanquan.Yang@osumc.edu name: Yuanquan Yang, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False

 nctId: NCT06263140 id: Chula-ARC 001/21 briefTitle: Vitamin D Levels in Non-immediate Drug Hypersensitivity Case-control Study overallStatus: COMPLETED date: 2021-05-30 date: 2022-01-15 date: 2022-02-01 date: 2024-02-16 date: 2024-02-16 name: Chulalongkorn University class: OTHER briefSummary: Serum vitamin D levels in drug-induced non-immediate reactions conditions: Stevens-Johnson Syndrome conditions: Drug Reaction With Eosinophilia and Systemic Symptom conditions: Maculopapular Exanthem conditions: Vitamin D Deficiency conditions: Drug-Induced Rash studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 120 type: ACTUAL measure: Serum vitamin D levels sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Medicine, Chulalongkorn University city: Bangkok zip: 10330 country: Thailand lat: 13.75398 lon: 100.50144 hasResults: False

 nctId: NCT06263127 id: CMUH112-REC2-104 briefTitle: Sensory Motor Interventions on Preterm Infants overallStatus: NOT_YET_RECRUITING date: 2024-02-20 date: 2026-01-10 date: 2026-01-10 date: 2024-02-16 date: 2024-02-16 name: China Medical University Hospital class: OTHER briefSummary: Preterm infants experiencing bottle feeding difficulties will be included in this study. Two distinct interventions, oral stimulation (OS) and infant massage (IM), will be administered in this study. The objective of this clinical trial is to compare the effectiveness of these two approaches, either individually or in combination, in improving the feeding performance and development of participants. conditions: Preterm Infants studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: oral stimulation name: infants massage measure: Oral intake measure: Transition time of oral feeding measure: weight gain measure: Hospital stay measure: Neonatal Neurobehavioral Examination-Chinese Version(NNE-C) measure: Infant/Toddler Sensory Profile-Chinese Version(ITSP-C) measure: Premature Bottle Feeding Questionnaire(PBFQ) sex: ALL maximumAge: 34 Weeks stdAges: CHILD facility: China Medical University Hospital city: Taichung zip: 404 country: Taiwan name: Yu-Rou Chiang, Bachelor role: CONTACT phone: 0910-897-089 email: y198473@gmail.com name: Pei-Yu Yang, Master role: CONTACT phone: 0975-681-610 email: Yangpy888@gmail.com name: Pei-Yu Yang, Master role: PRINCIPAL_INVESTIGATOR name: Yea-Shwu Hwang, ScD role: SUB_INVESTIGATOR lat: 24.1469 lon: 120.6839 hasResults: False

 nctId: NCT06263114 id: 00002826 briefTitle: Correlation of Blood Gene Expression (TruGraf Liver) With Liver Biopsy in Pediatric Liver Transplant Recipients overallStatus: RECRUITING date: 2024-01-01 date: 2026-01-01 date: 2027-01-01 date: 2024-02-16 date: 2024-02-16 name: Children's Mercy Hospital Kansas City class: OTHER name: Eurofins briefSummary: Liver transplant rejection is when the body's immune system attacks and damages the liver of a transplant recipient. Currently the best way to see if that is happening is with a liver biopsy. The purpose of this research study is to see if a simple blood test can diagnose if a transplanted liver is being rejected. conditions: Liver Transplant; Complications conditions: Liver Failure, Acute studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 25 type: ESTIMATED name: TruGraf® Liver gene expression panel (GEP) measure: Correlation of the TruGraf® Liver GEP with rejection activity index (RAI) on surveillance and for-cause biopsy. measure: Comparison of the GEP to non-rejection injury found on biopsy measure: Utility of the GEP for monitoring liver injury sex: ALL minimumAge: 1 Year maximumAge: 17 Years stdAges: CHILD facility: Children's Mercy Hospitals and Clinics status: RECRUITING city: Kansas City state: Missouri zip: 64108 country: United States name: Corey Schurman, MA role: CONTACT phone: 816-802-1167 email: crschurman@cmh.edu name: Amber Bagherian, MD role: CONTACT phone: 816-234-3016 name: Ryan Fischer, MD role: PRINCIPAL_INVESTIGATOR lat: 39.09973 lon: -94.57857 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-01-03 uploadDate: 2024-01-08T15:14 filename: Prot_000.pdf size: 353012 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-10-23 uploadDate: 2024-02-14T12:08 filename: ICF_001.pdf size: 244224 hasResults: False

 nctId: NCT06263101 id: ChaoyangHospital briefTitle: Drainage Fluid Biomarkers and Postoperative Gastrointestinal Dysfunction in Laparoscopic Colorectal Surgery overallStatus: RECRUITING date: 2024-02-21 date: 2024-10-01 date: 2024-10-01 date: 2024-02-16 date: 2024-04-10 name: Chaoyang Hospital of China Medical University class: OTHER_GOV briefSummary: Postoperative gastrointestinal dysfunction (POGD), often referred to as postoperative ileus (POI) after colorectal surgery, is characterized by symptoms such as nausea, vomiting, abdominal distension, and delayed bowel movements. The incidence of this issue varies among medical institutions, impacting patient nutrition, prolonging hospital stays, and increasing healthcare costs.

The complex pathogenesis of POGD involves a brief neurogenic phase (within 3 hours) and a more prolonged inflammatory phase (beginning at 3-4 hours and lasting for days). The inflammatory phase is crucial and is recognized as initiated by mast cells and damage-associated molecular patterns that activate macrophages in the intestinal muscle layer. Subsequently, it triggers a series of cascading inflammation reactions through the release of inflammatory factors and recruitment of inflammatory cells, which contributes to the development and exacerbation of POGD. Studies have demonstrated changes in inflammatory cells and factors in the abdominal fluid following abdominal surgery, emphasizing the clinical significance of analyzing drainage fluid to predict postoperative gastrointestinal function.

This study analyzes inflammatory markers in drainage fluid following laparoscopic colorectal cancer surgery. The aim is to enhance the accuracy of predicting gastrointestinal recovery outcomes and contribute to the evolving field of Enhanced Recovery After Surgery (ERAS). conditions: Postoperative Gastrointestinal Dysfunction (POGD) studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 63 type: ESTIMATED name: Biochemical testing of abdominal drainage fluid name: Cytological examination of abdominal drainage fluid name: Peripheral blood cytology tests measure: Measurement of drainage fluid LDH and neutrophil to lymphocyte ratio (NLR) on postoperative day 1 measure: Measurement of drainage fluid LDH and neutrophil to lymphocyte ratio (NLR) on postoperative day 3 measure: Measurement of drainage fluid albumin, adenosine deaminase (ADA), lymphocyte-monocyte ratio (LMR), prognostic nutritional index (PNI) on postoperative day 1 measure: Measurement of drainage fluid albumin, adenosine deaminase (ADA), lymphocyte-monocyte ratio (LMR), prognostic nutritional index (PNI) on postoperative day 3 measure: Measurement of blood serum neutrophil-lymphocyte ratio (NLR), lymphocyte-monocyte ratio (LMR), platelet-lymphocyte ratio (PLR), systemic immune-inflammatory index (SII) on postoperative day 1. measure: Measurement of blood serum neutrophil-lymphocyte ratio (NLR), lymphocyte-monocyte ratio (LMR), platelet-lymphocyte ratio (PLR), systemic immune-inflammatory index (SII) on postoperative day 3. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chaoyang Central Hospital of China Medical University status: RECRUITING city: Chaoyang state: Liaoning country: China name: Xinao Fu role: CONTACT phone: +8618238692250 email: ailun10211@163.com lat: 41.57028 lon: 120.45861 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-01-08 uploadDate: 2024-02-12T01:53 filename: Prot_000.pdf size: 182027 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2024-01-08 uploadDate: 2024-02-12T01:52 filename: SAP_001.pdf size: 154895 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-01-08 uploadDate: 2024-02-12T01:37 filename: ICF_002.pdf size: 277845 hasResults: False

 nctId: NCT06263088 id: CASE15223 briefTitle: EQUITY GI: A Prospective Study to Enhance Quality, Inclusivity, and Trial Participation in Black Patients With Gastrointestinal Cancer. overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2026-06-30 date: 2026-06-30 date: 2024-02-16 date: 2024-02-20 name: Case Comprehensive Cancer Center class: OTHER briefSummary: This research study is being conducted to improve the quality of care of participants who have a diagnosis of gastrointestinal cancer (anal, colon, rectal, esophageal, stomach, small bowel, appendix, pancreas, gall bladder, liver, neuroendocrine tumor of gastrointestinal origin).

This study has 3 components as follows-

1. Ensuring appropriate biomarker testing and evidence-based care: Biomarkers are molecules in the tumor or blood that indicate normal or abnormal processes in participant's body and may indicate an underlying condition or disease. Various molecules, such as DNA (genes), proteins, or hormones, can serve as biomarkers since they all indicate something about participant's health. Biomarker testing can also help choose participant's treatment. Additionally, a tumor board will be conducted periodically to provide treatment recommendations to participant's treating physician. Participants will receive standard-of-care treatment if participant enroll in this study. Participant will not receive any experimental treatment.
2. Assistance with clinical trial enrollment. The study team will help participants enroll in a clinical trial appropriate for participant's condition. However, enrolling in a clinical trial is totally up to the participant.
3. Health literacy: The study team will provide information relevant to participant's diagnosis to enrich participant's understanding of participant's condition and treatment. Investigator will provide questionnaires to assess participant's understanding before and after participant's have been provided with educational/informational material appropriate for participant's diagnosis. conditions: Gastrointestinal Cancer conditions: Colon Cancer conditions: Rectal Cancer conditions: Anal Cancer conditions: Esophageal Cancer conditions: Stomach Cancer conditions: Appendix Cancer conditions: Pancreas Cancer conditions: Liver Cancer conditions: Neuroendocrine Tumors studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single arm study to address the existing disparities faced by Black participants with gastrointestinal (GI) cancer in accessing crucial biomarker testing, receiving evidence-based care, and participating in clinical trials. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 200 type: ESTIMATED name: EQUITY GI measure: Biomarker testing rate of Black participants diagnosed with GI cancer measure: Clinical trial enrollment rate among black participants diagnosed with GI cancer measure: Change in Health literacy test among black participants diagnosed with GI cancer measure: Change in Health literacy score among black participants diagnosed with GI cancer sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center city: Cleveland state: Ohio zip: 44106 country: United States name: Sakti Chakrabarti, MD role: CONTACT phone: 216-844-3951 email: sakti.chakrabarti@uhhospitals.org lat: 41.4995 lon: -81.69541 hasResults: False

 nctId: NCT06263075 id: 717/2023/Oss/AOUBo id: 6822 type: OTHER domain: SirER (Emilia-Romagna Research Information System) platform briefTitle: Hemodynamic Monitoring During Craniosynostosis Surgery: Comparing Traditional and Newer Technology Monitors (CRASY-PRAM) acronym: CRASY-PRAM overallStatus: RECRUITING date: 2023-12-13 date: 2025-12 date: 2026-06 date: 2024-02-16 date: 2024-02-16 name: IRCCS Azienda Ospedaliero-Universitaria di Bologna class: OTHER briefSummary: Hemodynamic evaluation during pediatric anesthesia is essential to care management. Intraoperative cardiovascular instability is frequent in major surgeries, and appropriate monitoring is necessary to ensure safe anesthetic conduction and promptly detect changes in blood pressure, cardiac output, blood volume, and organ perfusion. In this context, advanced hemodynamic monitoring, continuous measuring, and estimating various parameters can allow a more specific hemodynamic profile and help identify the causal mechanisms of its variability. Moreover, the reference ranges of hemodynamic values in different pediatric ages and how to best monitor hemodynamic status in pediatrics are still debated.

Surgical treatment of craniosynostosis is usually performed at an early age, between 3 and 8 months of age. The operation is burdened by a high risk of hemodynamic instability related mainly, but not only, to potential substantial hemorrhagic losses.

This study aims to characterize the hemodynamic events occurring during corrective craniosynostosis surgery, recorded simultaneously with standard monitoring and Pressure Recording Analytic Method (PRAM), and to analyze the paired measurements. conditions: Craniosynostoses conditions: Hypovolemia conditions: Hemorrhage conditions: Hemodynamic Instability studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Intraoperative monitoring measure: Hemodynamic events occurring during surgery measure: Evaluation of changes in volemic status measure: Evaluation of changes in volemic status measure: Evaluation of changes in systemic vascular resistance measure: Evaluation of changes in cardiac function measure: Evaluation of changes in cardiac function sex: ALL minimumAge: 3 Months maximumAge: 8 Months stdAges: CHILD facility: IRCCS AOU of Bologna Policlinico Sant'Orsola status: RECRUITING city: Bologna state: BO zip: 40138 country: Italy name: Luigia Scudeller, MD role: CONTACT phone: 051 2141402 phoneExt: +39 email: luigia.scudeller@aosp.bo.it name: Barbara Lotito, MD role: CONTACT phone: 051 2141296 phoneExt: +39 email: barbara.lotito@aosp.bo.it name: Lorena Pasini, MD role: SUB_INVESTIGATOR name: Fabio Caramelli, MD role: SUB_INVESTIGATOR name: Rosario Ruga, Student role: SUB_INVESTIGATOR name: Andrea La Placa, MD role: SUB_INVESTIGATOR lat: 44.49381 lon: 11.33875 hasResults: False

 nctId: NCT06263062 id: women undergoing colposcopy briefTitle: Management With Fear of Cancer in Women Undergoing Colposcopy: Randomized Controlled Study overallStatus: RECRUITING date: 2021-01-07 date: 2024-06-15 date: 2024-06-15 date: 2024-02-16 date: 2024-02-16 name: Alanya Alaaddin Keykubat University class: OTHER briefSummary: Cervical cancer is the fourth most common cancer in women worldwide. Due to advances in early diagnosis and treatment, the number of survivors of cancer has increased over the past 50 years. Therefore, the current standard of care for the detection of cervical neoplasm, a Papanicolaou smear and then a colposcopic biopsy, requires a high degree of diagnostic accuracy. In particular, the fear of developing cancer after cancer screening tests is becoming an increasingly significant problem, with an impact on psychosocial health in individuals. For people who are afraid of cancer, meditation and awareness training can make it easier for emotions to self-regulate in times of distress and pain. This study aim to conducted to determine the impact of the Awareness-Based Initiation Program on cancer fear and level of awareness in women undergoing colonoscopy. conditions: Cancer Fear conditions: Cervical Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Awareness-Based Coping with Fear of Cancer Programme measure: The Cancer Worry Scale measure: Philadelphia Mindfulness Scale sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alanya Alaaddin Keykubat University status: RECRUITING city: Alanya zip: 7400 country: Turkey name: fatma ozlem uner, MSc role: CONTACT phone: +905062972749 email: fatma.uner@alanya.edu.tr lat: 36.54375 lon: 31.99982 hasResults: False

 nctId: NCT06263049 id: ejaculation post TURP briefTitle: Is Ejaculation Preservation TURis the Natural Evolution of the "Gold Standard". overallStatus: COMPLETED date: 2023-05-01 date: 2024-01-01 date: 2024-02-01 date: 2024-02-16 date: 2024-04-24 name: Ain Shams University class: OTHER briefSummary: evaluation of the impact of apical urethral mucosa sparring with the urethra around the verumontanum on the ejaculatory function and early postoperative urinary incontinence conditions: Benign Prostatic Hyperplasia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 106 type: ACTUAL name: transurethral resection of prostate measure: post operative antegrade ejaculation measure: post operative urine continence sex: MALE minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ain shams university city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06263036 id: Bilgen S briefTitle: Morphometric Examination of the Larynx overallStatus: COMPLETED date: 2013-01-10 date: 2013-06-10 date: 2013-06-10 date: 2024-02-16 date: 2024-02-16 name: Acibadem University class: OTHER briefSummary: Objective: To measure laryngeal dimensions in a sample of Turkish cadavers including males and females of various ages and heights.

Patients and Methods: Morphological measurement was performed on 102 laryngeal specimens. Laryngeal cartilages were collected from human cadavers. All dimensions of the cartilages were measured using a thread and vernier calipers. Age, sex, and height were recorded. Results for men and women were compared. conditions: Laryngeal Dimensions in Males and Females studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 102 type: ACTUAL name: Men name: Women measure: To measure laryngeal dimensions in cadavers sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06263023 id: 34L-CP-02-009 briefTitle: A Central Preservation and Assessment Service to Optimize Donor Kidney Allocation acronym: OPTIMAL overallStatus: RECRUITING date: 2024-04-19 date: 2025-03 date: 2025-09 date: 2024-02-16 date: 2024-04-24 name: 34 Lives, PBC class: INDUSTRY name: Indiana University Health name: University of Miami name: MOUNT SINAI HOSPITAL name: University of Wisconsin, Madison briefSummary: This is a study to collect information to assess if transporting hard-to-place (HTP) donor kidneys to a central preservation and assessment facility with dedicated organ assessment capabilities increases allocation success to transplant hospitals. conditions: Organ Preservation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Sub-Normothermic Machine Preservation and Assessment measure: Transplant Allocation Success measure: 7-Day Delayed Graft Function (DGF) measure: Graft Survival measure: Patient Survival measure: Serum Creatinine (sCr) measure: eGFR measure: Long term data collection- Graft Survival measure: Long term data collection- Patient Survival measure: Long term data collection- Serum Creatinine measure: Long term data collection- eGFR sex: ALL minimumAge: 16 Years maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Miami Transplant Institute, University of Miami Miller School of Medicine status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33136 country: United States name: Giselle Guerra, MD role: CONTACT name: Giselle Guerra, MD role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 facility: Indiana University Health status: RECRUITING city: Indianapolis state: Indiana zip: 46202 country: United States name: William Goggins, MD role: CONTACT name: William Goggins, MD role: PRINCIPAL_INVESTIGATOR lat: 39.76838 lon: -86.15804 facility: The Mount Sinai Hospital status: RECRUITING city: New York state: New York zip: 10029 country: United States name: Matthew Holzner, MD role: CONTACT name: Matthew Holzner, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: University of Wisconsin School of Medicine and Public Health status: NOT_YET_RECRUITING city: Madison state: Wisconsin zip: 53792 country: United States name: Jacqueline Garonzik Wang, MD role: CONTACT name: Jacqueline Garonzik Wang, MD role: PRINCIPAL_INVESTIGATOR lat: 43.07305 lon: -89.40123 hasResults: False

 nctId: NCT06263010 id: CIBS-2023-01 briefTitle: Allopregnanolone as a Regenerative Treatment for Parkinson's Disease acronym: Allo-PD overallStatus: RECRUITING date: 2024-01-12 date: 2024-09 date: 2024-12 date: 2024-02-16 date: 2024-02-20 name: Roberta Brinton class: OTHER briefSummary: The goal of this open-label, pilot clinical trial is to test allopregnanolone as a regenerative treatment in patients with Parkinson's disease (PD). The main questions this study aims to answer are:

1. Is a large-scale clinical trial testing how well it works in patients with PD feasible?
2. Is allopregnanolone safe and well-tolerated in patients with PD.
3. Can we see any signals of changes in imaging and clinical scales?

Participants will receive a weekly infusion in their vein of allopregnanolone for a total of 12 weeks. There is no placebo so everyone receives allopregnanolone and "Open-label" means the study is not blinded so both the participant and investigators know the assigned treatment. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Allopregnanolone measure: Study completion measure: Adverse Events measure: Infusion Reactions measure: Pharmacokinetics: Peak Plasma Concentration (Cmax) measure: Pharmacokinetics: Time of peak concentration (tmax) measure: Pharmacokinetics: Half-life (t1/2) measure: Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) measure: Dopamine transporter (DaT) SPECT imaging measure: MRI: Regional brain volumes measure: MRI: Fractional Anisotropy measure: MRI: Quantitative anisotropy measure: MRI: Functional connectivity measure: Mean rate of change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score part I (non-motor EDL) measure: Mean rate of change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score part II (motor EDL) measure: Mean rate of change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score part III (motor examination) measure: Mean rate of change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score part IV (motor complications) measure: Mean rate of change in the Unified Dyskinesia Rating Scale (UDysRS) total score measure: Change from baseline in Montreal Cognitive Assessment (MoCA) score measure: Change from baseline in Parkinson's disease Questionnaire (PDQ-39). measure: Change from baseline in Hamilton Depression Rating Scale (HAM-D) measure: Cambridge Cognition's Paired Associates Learning (PAL) Test measure: Cambridge Cognition's Motor Screening Task (MOT) measure: Cambridge Cognition's One Touch Stockings of Cambridge (OTS) sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Arizona Clinical & Translational Science Research Center status: RECRUITING city: Tucson state: Arizona zip: 85721 country: United States name: Dakota Darby role: CONTACT email: dakotadarby@arizona.edu lat: 32.22174 lon: -110.92648 hasResults: False

 nctId: NCT06262997 id: TU-FTR-AMUTLU-2 briefTitle: Effectiveness of Pilates and Taping in Office Workers With Neck Pain overallStatus: RECRUITING date: 2024-02-15 date: 2025-02-15 date: 2025-02-15 date: 2024-02-16 date: 2024-02-23 name: Tarsus University class: OTHER briefSummary: The aim of this study is to investigate the effectiveness of pilates and kinesiotape applications in office workers with neck pain. In this direction, neck pain and disability, pain threshold, muscle strength, range of motion, core endurance, postural awareness and quality of life will be evaluated. conditions: Neck Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: One group will receive only pilates training. Other group participants will receive kinesiobant application in addition to pilates training. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The researcher who will do the pilates training and taping and the other researcher who will do the pre-test and post-test are blinded. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 42 type: ESTIMATED name: Pilates name: Pilates and Kinesiotape measure: Neck Disability Index measure: Pain PressureThreshold measure: Muscle Strength measure: Range of Motion measure: Prone Bridge Test measure: Sits Up Test: measure: Postural Habits and Awareness Scale measure: Short Form 36 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tarsus University status: RECRUITING city: Mersin country: Turkey name: Ali Mutlu role: CONTACT name: Ali MUTLU role: PRINCIPAL_INVESTIGATOR lat: 36.79526 lon: 34.61792 hasResults: False

 nctId: NCT06262984 id: 2023/21-754 briefTitle: Therapeutic Play Before Nasopharyngeal Swabbing in Children overallStatus: COMPLETED date: 2024-02-19 date: 2024-03-13 date: 2024-03-13 date: 2024-02-16 date: 2024-03-15 name: Maltepe University class: OTHER briefSummary: The study will be conducted with the randomized controlled experimental method. Children who apply to the Child Health and Diseases Polyclinic and Child Health and Diseases Service and who will have nasopharyngeal swab applied will be divided into two groups by drawing lots. After the randomization children in the therapeutic play group the nasal swab will be shown on the doll to the child by the researcher before being taken. The child is then allowed to play with the doll accompanied by the researcher. No intervention will be performed on children in the control group. The parents will also be found next to their children in both groups during the procedure. conditions: Behavior, Coping studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 68 type: ACTUAL name: Therapeutic Play measure: Children's emotional manifestation sex: ALL minimumAge: 3 Years maximumAge: 6 Years stdAges: CHILD facility: Maltepe University city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06262971 id: PCI-LM-Registry-2018 briefTitle: Left Main Percutaneous Coronary Intervention Registry in Istanbul Medipol University Hospital overallStatus: COMPLETED date: 2018-06-01 date: 2022-12-31 date: 2023-12-31 date: 2024-02-16 date: 2024-02-16 name: Medipol University class: OTHER briefSummary: This hospital-based registry study at Istanbul Medipol University Hospital focuses on documenting and analyzing the clinical and demographic characteristics, procedural-related aspects, and both short and long-term outcomes of patients undergoing left main coronary artery percutaneous coronary intervention (PCI). The study aims to identify predictors for adverse clinical outcomes in patients treated for left main coronary artery disease. conditions: Coronary Artery Disease conditions: Left Main Coronary Artery Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3620 type: ACTUAL name: Percutaneous coronary intervention measure: Incidence of Major Adverse Cardiac Events (MACE) within One Year Following Left Main Coronary Artery PCI measure: Ischemia-Driven Target Vessel Revascularization (ID-TVR) Ischemia-Driven Target Vessel Revascularization (ID-TVR) measure: Procedure-Related Complications Within 30 Days of PCI measure: Health-Related Quality of Life (HRQoL) Scores One Year After PCI measure: Rate of stent thrombosis sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul Medipol University city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06262958 id: KUH5703459 briefTitle: Recognition and Early Intervention for Alcohol and Substance Abuse in Adolescence in Adolescent acronym: REAL-SMART overallStatus: RECRUITING date: 2017-08-07 date: 2030-06-01 date: 2030-06-01 date: 2024-02-16 date: 2024-02-16 name: Kuopio University Hospital class: OTHER briefSummary: ASSIST mini-intervention is applied in an electric form in adolescent outpatients to see if it conditions: Alcoholism conditions: Substance Abuse conditions: Alcohol Dependence conditions: Alcohol-Related Disorders conditions: Substance Use Disorders conditions: Adolescent Behavior conditions: Adolescent Problem Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Clients are randomized into two groups: 1) those receiving TAU and 2) those receiving a mini-intervention for substance and alcohol use an add-on treatment. primaryPurpose: TREATMENT masking: NONE count: 800 type: ESTIMATED name: ASSIST name: Treatment as usual measure: Decreased consumption of alcohol, tobacco or substances measure: BDI scores measure: GAD scores sex: ALL minimumAge: 14 Years maximumAge: 19 Years stdAges: CHILD stdAges: ADULT facility: Kuopio University Hospital status: RECRUITING city: Kuopio zip: 70110 country: Finland name: Sanna Voutilainen, Res. nurse role: CONTACT phone: +358447175351 email: sanna.voutilainen@kuh.fi lat: 62.89238 lon: 27.67703 hasResults: False

 nctId: NCT06262945 id: YDU/2024/120-1808 briefTitle: Comperasion the Postoperative Effect of Low Laser Therapy and Platelet Rich Fibrin on Mandibular Third Molar Surgery. overallStatus: COMPLETED date: 2024-01-02 date: 2024-02-06 date: 2024-02-07 date: 2024-02-16 date: 2024-02-16 name: Beste Erismen class: OTHER briefSummary: The aim of this study was investigate the comparison of postoperative effects of low laser treatment and platelet-rich fibrin application on mandibular impacted third molar tooth extraction. The study included a total of 60 patients with impacted mandibular third molar. Patients were evaluated in 4 randomly separated groups. In group 1, PRF was applied to the tooth socket. In group 2, PRF was applied to the tooth socket combined with Low Laser Treatment extraorally to the extraction area for three days within surgery day In group 3, Low Laser Treatment was applied to the extraorally to the extraction area for three days within surgery day. In group 4 (control group), tradional osteomy was made. The outcome variables were pain, swelling, the number of analgesics taken, and trismus. These variables were also assessed based on first, second, third, and seventh days following the operation. All of the 4 groups patients were prescribed an 875/125 mg amoxicillin/clavulanic acid tablet twice daily for five days. conditions: Impacted Third Molar Tooth studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 60 type: ACTUAL name: Diagnoses name: traditional osteotomies name: platelet rich fibrin name: Antibiotics, Penicillin name: low laser therapy, bicure laser name: Analgesic measure: Visual analogue scale (VAS) measure: Visual analogue scale (VAS) measure: Visual analogue scale (VAS) measure: Visual analogue scale (VAS) measure: Trismus measure: Trismus measure: Trismus measure: Trismus measure: Swelling measure: Swelling measure: Swelling measure: Swelling measure: the number of analgesic tablets measure: the number of analgesic tablets measure: the number of analgesic tablets measure: the number of analgesic tablets sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Near East University city: Nicosia state: Lefkosa zip: 99138 country: Cyprus lat: 35.17531 lon: 33.3642 hasResults: False

 nctId: NCT06262932 id: RADS regimen briefTitle: Effectiveness of Repeated Amiodarone Dosing Regimen Versus Standard Dosing Regimen in Atrial Fibrillation Patient With Rapid Ventricular Response overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-16 date: 2024-04-08 name: Police General Hospital, Thailand class: OTHER briefSummary: The goal of this clinical trial is to compare in atrial fibrillation patient with rapid ventricular response. The main question it aims to answer are Effectiveness of Repeated Amiodarone dosing regimen versus standard dosing regimen in Atrial fibrillation patient with rapid ventricular response Participants will receive Amiodarone iv treatment with different regimen

* Repeated dosing regimen
* Standard dosing regimen conditions: Atrial Fibrillation studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: Amiodarone measure: Heart rate measure: Normal sinus rhythm at 24 hours measure: Heart rate measure: Major adverse cardiovascular events measure: Phlebitis measure: Changed in heart rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06262919 id: CDRB436I1401 briefTitle: Special Drug Use-results Surveillance of Tafinlar/Mekinist overallStatus: RECRUITING date: 2024-02-09 date: 2031-12-31 date: 2031-12-31 date: 2024-02-16 date: 2024-03-22 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: This is a prospective, multicenter, single-arm, non-interventional and observational J-PMS conducted by the central registration system and operated in Electronic data capture. conditions: BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 90 type: ESTIMATED name: Tafinlar/Mekinist measure: [Pediatric patients] Number of patients and incidence of adverse events/adverse reactions with respect to skeletal and sexual maturation measure: [Adult patients] overall response rate (ORR) measure: [Pediatric patients] Incidence proportion of ORR measure: [Pediatric and adult patients] Incidence proportion of PFS measure: [Pediatric patients] Number of patients with changes in height and body weight and sexual maturation sex: ALL minimumAge: 6 Years maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Novartis Investigative Site status: RECRUITING city: Kobe state: Hyogo zip: 650-0011 country: Japan lat: 34.6913 lon: 135.183 facility: Novartis Investigative Site status: RECRUITING city: Akita zip: 010-8543 country: Japan lat: 39.71667 lon: 140.10826 facility: Novartis Investigative Site status: RECRUITING city: Osaka zip: 534-0021 country: Japan lat: 34.69374 lon: 135.50218 facility: Novartis Investigative Site status: RECRUITING city: Osaka zip: 550-0015 country: Japan lat: 34.69374 lon: 135.50218 hasResults: False

 nctId: NCT06262906 id: BA-VCAP-01 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-02-16 date: 2024-04-25 name: [Redacted] hasResults: False

 nctId: NCT06262893 id: Shoulder nerve blocks briefTitle: Effect of Dexamethasone Adjuvant in Combined Supraclavicular Block and Suprascapular Block Versus Interscalene Block in Patients Undergoing Shoulder Arthroscopy overallStatus: NOT_YET_RECRUITING date: 2024-02-25 date: 2025-12 date: 2026-01 date: 2024-02-16 date: 2024-02-16 name: Assiut University class: OTHER briefSummary: In this study the investigators aim to compare the effect of the suprascapular- supraclavicular nerve block in association with dexamethasone to that of the interscalene brachial plexus block on analgesic effect during arthroscopic shoulder surgery, as postoperative pain scores ,postoperative consumption of analgesic rescue medications and diaphragmatic excursion assessment. conditions: Shoulder Arthroscopy Blocks conditions: Dexamethasone studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Shoulder arthroscopy blocks measure: Postoperative analgesia by visual analog scale (VAS). measure: Diaphragmatic excursion sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Assiut University city: Assiut country: Egypt name: Assiut University role: CONTACT lat: 27.18096 lon: 31.18368 hasResults: False

 nctId: NCT06262880 id: BIO-2305 briefTitle: Dietary Supplementation on Gastrointestinal Barrier Function overallStatus: RECRUITING date: 2024-02-06 date: 2024-12-20 date: 2025-02-06 date: 2024-02-16 date: 2024-03-08 name: Brightseed class: INDUSTRY briefSummary: The purpose of the current study is to examine the effects of a dietary supplement containing plant derived phenolics at two different dose levels on parameters of gastrointestinal (GI) health in otherwise generally healthy adults with risk factors (high BMI and waist circumference) for increased GI permeability. The primary hypothesis is that supplementation with plant derived phenolics will improve gut health compared to placebo. conditions: Intestinal Permeability studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 126 type: ESTIMATED name: plant derived phenolics name: Microcrystaline cellulose (MCC) measure: 0-2 h urine 13C Mannitol excretion measure: 2 to 8 h urine 13C Mannitol measure: 0 to 2 h urine LMR measure: 2 to 8 h urine LMR measure: Blood Biomarkers measure: Blood Biomarkers measure: Blood Biomarkers measure: Fecal Biomarkers measure: Fecal Biomarkers measure: Inflammatory Biomarkers (Blood) measure: Inflammatory Biomarkers (Blood) measure: Inflammatory Biomarkers (Blood) measure: Inflammatory Biomarkers (Blood) measure: 7-day recall of gastrointestinal symptoms measure: 7-day recall of gastrointestinal symptoms measure: Stool frequency measure: Stool consistency measure: Body Weight sex: ALL minimumAge: 30 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Biofortis status: RECRUITING city: Addison state: Illinois zip: 60101 country: United States name: Chad Cook role: CONTACT lat: 41.9317 lon: -87.98896 hasResults: False

 nctId: NCT06262867 id: ReadySetFood briefTitle: Early Allergen System Experience acronym: EASE overallStatus: NOT_YET_RECRUITING date: 2024-03-07 date: 2026-09-01 date: 2026-09-01 date: 2024-02-16 date: 2024-02-20 name: Prollergy dba Ready Set Food class: OTHER name: ObvioHealth briefSummary: Multiple clinical trials have demonstrated that early allergen introduction, feeding babies common food allergens before six months, decreases children's risk of developing a food allergy. Despite successful food allergy introduction trials showing that food allergies can be prevented, early introduction in the required amount can be challenging for parents. In some studies, less than 20% of parents introduce peanuts before their child is six months old, and few feed them regularly after introduction. Ready. Set. Food! is a direct-to-consumer product that offers a convenient supplement with a daily dose regimen that can be added to breastmilk, formula, or food to make early allergen introduction easy. The formulation includes cow's milk, egg, and peanut, representing the majority of childhood food allergies, and the protein levels are based on doses found to be effective in clinical trials. Over 200,000 infants have used Ready. Set. Food!.

This study investigates the effectiveness of introducing common allergens to infants with the goal of preventing food allergies. The study will enroll 1,100 infants stratified by their risk of developing a food allergy who are assigned to either receive Ready. Set. Food! supplements or follow standard allergen introduction practices recommended by their pediatrician.

The goal of this study is to assess how Ready. Set. Food! allergen introduction supplements improve the experience of parents introducing allergens, decrease healthcare costs related to food allergies, and decrease food allergy prevalence. conditions: Food Allergy in Infants studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 1110 type: ESTIMATED name: Ready. Set. Food! Stage 1 Mix ins measure: The proportion of caregivers who are adherent with the evidence-based guidance for cow's milk, egg, and peanut during the 6 - month period measure: Frequency of caregiver-reported allergy or food introduction-related adverse events (AEs) after introduction of cow's milk, egg, and peanut measure: Frequency of caregiver-reported serious adverse events (SAEs) after introduction of cow's milk, egg, and peanut measure: Frequency of caregiver-reported special interest adverse events (FPIES and anaphylaxis) after introduction to cow's milk, egg, and peanut by 12 months of age measure: The proportion of caregivers who are satisfied with introduction of egg, cow's milk, and peanut measure: The total allergy-related healthcare costs measure: The proportion of participants with food allergy to cow's milk, egg, or peanut measure: The proportion of participants with a suspected food allergy sex: ALL minimumAge: 2 Months maximumAge: 5 Months stdAges: CHILD hasResults: False

 nctId: NCT06262854 id: AOU Careggi Firenze briefTitle: Efficacy and Safety of Stimulan® for the Treatment of Diabetic Foot Osteomyelitis. The BIG D-FOOT Study acronym: BIG D-FOOT overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-05-31 date: 2024-02-16 date: 2024-02-16 name: Azienda Ospedaliero-Universitaria Careggi class: OTHER briefSummary: This study is designed as a double-blind, placebo-controlled, parallel series randomized trial aimed at verifying the effiicacy and safety of a local calcium-sulphate bio-absorbable antibiotic delivery (tobramicina+vancomicina) versus placebo (calcium-sulphate matrix without antibiotics) in patients with diabetic foot osteomyelitis treated with surgical procedures. conditions: Diabete Mellitus conditions: Foot Ulcer conditions: Osteomyelitis - Foot conditions: Surgical Procedure, Unspecified studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Granules of calcium sulphate with and without antibiotics are identical and undistinguishable. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Calcium-sulphate granules with tobramicina+vancomicina measure: The composite primary endpoint of this study will be the incidence osteomyelitis recurrence or new osteomyelitis in adjacent sites or tissue infection at the site of osteomyelitis. measure: Proportion of healed patients measure: Proportion of osteomyelitis recurrence measure: Proportion of post-surgical tissue infection measure: Proportion of wound recurrence measure: Proportion of patients undergoing major amputation measure: Proportion of patients undergoing new surgical intervention measure: Ulcer time-to-healing measure: Osteomyelitis time-to-recurrence measure: Any serious adverse events measure: Any non serious adverse events measure: Proportion of post-surgical dehiscence measure: Direct medical costs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06262841 id: Murat Kaan Erdem briefTitle: Post-Surgical Morbidity and Bone Healing of Impacted Lower Third Molars: Piezosurgery vs. Conventional Instruments overallStatus: COMPLETED date: 2022-11-01 date: 2023-04-01 date: 2023-04-01 date: 2024-02-16 date: 2024-02-16 name: Ankara University class: OTHER briefSummary: The aim of this study is to compare piezosurgery and conventional surgery in impacted third molar surgery and to determine its effect on postoperative outcomes and quality of life. conditions: Impacted Third Molar Tooth studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 21 type: ACTUAL name: Piezosurgery name: Conventional burs measure: Change in Oral Health-related Quality of Life measure: Change in pain measure: Change in Mouth opening measure: Operation time measure: Change in facial swelling sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Ankara University Faculty of Dentistry city: Ankara state: Çankaya zip: 06510 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06262828 id: UW 24-064 briefTitle: HEARTWISE - P-CARDIAC for Chinese: Population-based Study acronym: HEARTWISE overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2027-01-31 date: 2027-04-30 date: 2024-02-16 date: 2024-02-16 name: The University of Hong Kong class: OTHER briefSummary: Cardiovascular disease (CVD) is one of the prominent diseases that affect many people. One cost-effective solution is to identify people at higher risk of CVD by CVD risk prediction model. China-PAR, TRS-2P, and SMART2 are common risk prediction models for prevention. However, these risk scores were mostly based on the routinely self-check health information and multivariable regression without time-varying consideration. Investigators developed a Machine Learning (ML) based risk prediction model, Personalized CARdiovascular DIsease risk Assessment for Chinese (P-CARDIAC) among a predominantly Chinese population in Hong Kong to estimates the 10 years of secondary recurrent CVD risk for the high-risk individuals. The study objective is to evaluate the accuracy of the P-CARDIAC performance in practice among a large-scale Hong Kong population in medicine specialist outpatient clinic (SOPC) and cardiac clinic. The results will reassure cardiologists that the P-CARDIAC risk score is sensitive to the heart disease symptoms. Investigators anticipate that the results may help to facilitate P-CARDIAC in clinical setting and provide more practical information with the development of P-CARDIAC. conditions: Cardiovascular Diseases conditions: CVD studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 800 type: ESTIMATED measure: The relationship between P-CARDIAC risk score and heart disease related symptoms measure: P-CARDIAC risk thresholds determination sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: School of Nursing, The University of Hong Kong city: Hong Kong country: Hong Kong name: Sze Ling Celine Chui, PhD role: CONTACT phone: (852) 3917 6629 email: cslchui@hku.hk lat: 22.27832 lon: 114.17469 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-10-31 uploadDate: 2024-01-31T01:00 filename: Prot_SAP_000.pdf size: 294821 hasResults: False

 nctId: NCT06262815 id: 2023-06806-01 briefTitle: The Utility of Treatment With Nasogastric Tube Placement for Small Bowel Obstruction acronym: NGTUBE-OBS overallStatus: RECRUITING date: 2024-01-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-16 date: 2024-02-16 name: Daniel Wilhelms class: OTHER name: Linkoeping University briefSummary: Small bowel obstruction (SBO) occurs when the normal movements of the small bowel is obstructed, most commonly due to adhesion related to previous abdominal surgery. This may cause strangulation of the small bowel with reduced blood flow which is a surgical emergency requiring prompt treatment in the operating room. If there are no signs of strangulation or ischemia of the bowel at the time of diagnosis, international guidelines recommend initial treatment with intravenous fluids and nasogastric tube placement. However, there is emerging debate regarding non-selective treatment with nasogastric tube placement in patients with SBO. This management started around 1930 as a means to reduce pain in patients with SBO, in conjunction with other additions to management, like intravenous fluids. However the effect and utility of routine nasogastric tube placement have not been prospectively evaluated. There are a total of three retrospective observational studies in the past decade with a total of 759 patients where 292 (36%) were managed without a nasogastric tube. There was no difference in the rates of conservative treatment failure (requiring surgery), complications (vomiting, pneumonia) or mortality between patients receiving a nasogastric tube and those who didn't. However, the retrospective design of these studies limits their validity. Furthermore, nasogastric tube placement has been shown to be one of the more painful interventions patients may experience in-hospital. This calls into question the patient benefit of routine nasogastric tube placement in patients with SBO and further studies are needed to discern the utility of this intervention.

Definitive treatment for SBO is surgical adhesiolysis but there is debate regarding the timing of surgery, particularly in older adults. A large proportion of patients may be managed conservatively with oral contrast and repeated radiological evaluation and the obstruction will resolve in many patients within 24 to 48 hours. This timeframe is dependent on factors related to the disease itself as well as patient related factors like previous surgery and comorbidities. Older patients are at high risk for complications but current available data is insufficient to inform practice in this population. Frailty, a state of increased vulnerability and susceptibility to adverse events, has been shown to be an independent prognosticator in older adults in the Emergency Department(ED) and suggested as a potential measure to risk stratify older adults with SBO. However to the authors knowledge there is no available data on frailty in older adults with SBO and only one prospective observational trial looking at older adults with SBO. Despite SBO being one of the most common surgical emergencies in older adults.

To investigate the potential benefit of nasogastric tube placement in patients with SBO and the ability of frailty to prognosticate outcomes in older adults better evidence is needed. conditions: Small Bowel Obstruction conditions: Frailty conditions: Nasogastric Tube studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: Nasogastric tube placement name: Clinical Frailty Scale measure: Pain at Emergency Department discharge measure: Nausea at Emergency Department discharge measure: Hospital Length of Stay measure: Mortality measure: Admission for Small bowel obstruction measure: Emergency Surgery measure: Emergency Department Length of Stay sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sahlgrenska Universitetssjukhuset status: RECRUITING city: Göteborg country: Sweden name: Nina Bardhi, MD role: CONTACT lat: 57.70716 lon: 11.96679 facility: Östra sjukhuset status: RECRUITING city: Göteborg country: Sweden name: Mathias Jerkfelt, MD role: CONTACT lat: 57.70716 lon: 11.96679 facility: Skånes Universitetssjukhus status: ACTIVE_NOT_RECRUITING city: Lund country: Sweden lat: 55.70584 lon: 13.19321 facility: Skånes Universitetssjukhus status: ACTIVE_NOT_RECRUITING city: Malmö country: Sweden lat: 55.60587 lon: 13.00073 facility: Lasarett i Motala status: RECRUITING city: Motala country: Sweden name: Jens Wretborn, PhD role: CONTACT phone: +46101033000 email: jens.wretborn@regionostergotland.se lat: 58.53706 lon: 15.03649 facility: Vrinnevisjukhuset status: RECRUITING city: Norrköping country: Sweden name: Sigrid Wallden, MD role: CONTACT lat: 58.59419 lon: 16.1826 facility: Sundsvalls sjukhus status: RECRUITING city: Sundsvall country: Sweden name: Robert Schytzer, MD role: CONTACT lat: 62.39129 lon: 17.3063 facility: Akutmottagningen US Östergötland status: RECRUITING city: Linköping state: Östergötland zip: 58185 country: Sweden name: Jens Wretborn, PhD role: CONTACT phone: +46101033000 email: jens.wretborn@regionostergotland.se name: Alaa Hussein, MD role: CONTACT phone: +46101033000 email: alaa.hussein@regionostergotland.se lat: 58.41086 lon: 15.62157 hasResults: False

 nctId: NCT06262802 id: 123123 briefTitle: Volumetric Changes in Large Cystic Lesions Using Active Decompression and Distraction Sugosteogenesis vs Passive Decompression overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-09-01 date: 2025-03-01 date: 2024-02-16 date: 2024-02-16 name: Radwa Hydar Ragab class: OTHER briefSummary: Null hypothesis active decompression and distraction sugosteogenesis is not faster than passive decompression in volume reduction of large cystic lesions conditions: Odontogenic Cysts studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DEVICE_FEASIBILITY masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 10 type: ESTIMATED name: Active decompression measure: Volume change sex: ALL minimumAge: 12 Years maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06262789 id: 49RC23_0011 briefTitle: RAT-HEMATO : Return to Work After Malignant Hemopathy acronym: RAT-HEMATO overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2027-04-01 date: 2027-04-01 date: 2024-02-16 date: 2024-02-16 name: University Hospital, Angers class: OTHER_GOV briefSummary: Return to work (RTW) of patients after cancer treatment has been a topic of growing interest for the past two decades. Advances in cancer care have led to better patient survival, with some cancers considered as chronic or even cured diseases. The return of patients to their "pre-cancer life" can thus become an objective. Indeed, RTW after cancer is associated with improved quality of life for patients in several studies (improved financial status, improved social contacts, return of functional abilities and improved self-esteem). However, many difficulties can interfere with RTW. Many factors have been identified: disease, treatment, patient and occupational factors. The feeling of "return-to-work self-efficacy" is one of the main psychological determinants and its interest has been recently demonstrated in oncology. It corresponds to a cognitive mechanism based on expectations and/or beliefs of an individual about being able to carry out the actions required to achieve a goal, in this case RTW. The majority of studies on RTW concerns solid cancer and are retrospective. Very few studies have focused on hematological malignancies, whose prognosis was, until recently, worse. Moreover, very few interventional studies exist. There is therefore a significant need for prospective studies with appropriate methodological tools to reliably assess the benefit of interventional measures on RTW. The investigators propose to conduct a prospective, comparative, randomized, multicenter study evaluating the impact of an early RTW-consultation in patients who have been treated for a hematological malignancy. The investigators hypothesize that this consultation will improve patients' RTW rates and RTW quality. conditions: Leukemia conditions: Lymphoma conditions: Multiple Myeloma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 264 type: ESTIMATED name: "Return-to-work after cancer" consultation measure: Return-to-work rate at 1 year (percentage) measure: Cumulative incidence of return-to-work at 1 year measure: Change or not of the professional situation in the 2 arms measure: Factors influencing return to work measure: Quality of life (SF-12 score) evolution measure: Anxiety and depression (HAD scale) evolution measure: Return-to-work self-efficacy (RTW-SE-11 scale) evolution measure: Self-assessment of the benefit of the "return-to-work after cancer" consultation sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Angers University hospital city: Angers country: France name: PAILLASSA Jérome, MD role: CONTACT phone: 02.41.35.45.24 phoneExt: +33 email: jerome.paillassa@chu-angers.fr lat: 47.46667 lon: -0.55 facility: Brest University Hospital, Morvan Site city: Brest country: France name: Marie-Anne Couturier, MD role: CONTACT phone: 02.98.22.30.37 email: marie-anne.couturier@chu-brest.fr lat: 48.3903 lon: -4.48628 facility: Caen University hospital city: Caen country: France name: Ghandi Laurent DAMAJ, MD role: CONTACT phone: 02.31.27.21.40 phoneExt: +33 email: damaj-gl@chu-caen.fr lat: 49.18585 lon: -0.35912 facility: Rennes University Hospital, Pontchaillou site city: Rennes country: France name: Roch HOUOT, MD role: CONTACT phone: 02.99.28.42.91 phoneExt: +33 email: roch.houot@chu-rennes.fr lat: 48.11198 lon: -1.67429 facility: Centre Henri Becquerel city: Rouen country: France name: Stéphane LEPRETRE, MD role: CONTACT phone: 02.32.08.22.23 phoneExt: +33 email: stephane.lepretre@chb.unicancer.fr lat: 49.44313 lon: 1.09932 facility: Rouen University Hospital city: Rouen country: France name: Laetitia ROLLIN, MD role: CONTACT phone: 02.32.88.82.69 email: laetitia.rollin@chu-rouen.fr lat: 49.44313 lon: 1.09932 facility: Tours University Hospital, Bretonneau Site city: Tours country: France name: Emmanuel GYAN role: CONTACT phone: 02.47.47.38.11 email: e.gyan@chu-tours.fr lat: 47.38333 lon: 0.68333 hasResults: False

 nctId: NCT06262776 id: SIRZOSTER1.01 briefTitle: Safety and Immunogenicity of Recombinant Zoster Vaccine for Kidney Transplant Recipients acronym: SIR ZOSTER overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-06 date: 2026-11 date: 2024-02-16 date: 2024-02-16 name: Central Adelaide Local Health Network Incorporated class: OTHER_GOV name: National Health and Medical Research Council, Australia name: University of Adelaide name: Royal Prince Alfred Hospital, Sydney, Australia briefSummary: The goal of this clinical trial is to compare responses to Varicella Zoster vaccination between kidney transplant patients on different medication regimens, and their healthy co-habitants. The main questions it aims to answer are:

1. Are there differences in vaccination immunological responses in kidney transplant patients on different immunosuppression regimens?
2. Are there differences in vaccination immunological responses between kidney transplant patients and their healthy co-habitants? Participants will all receive a 2-dose course of SHINGRIX recombinant Zoster vaccination, and have immunological responses measured and compared at 5 timepoints between 1 week to 1 year post-vaccination. conditions: Immunosuppression conditions: Vaccine Response Impaired studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 120 type: ESTIMATED name: Recombinant zoster vaccine adjuvanted (SHINGRIX) measure: Functional T cell memory measure: Frequency of virus specific T cells measure: Magnitude of antibody response measure: Concentration of post-vaccination circulating cytokines measure: Frequency of polyfunctional T cells measure: Magnitude of vaccine-induced cross-protective antiviral responses measure: Frequency of virus-specific T stem cell memory compared to baseline measure: Incidence of shingles measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 measure: Tolerability of vaccination regimen as assessed by EQ-5D sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06262763 id: HILT for SIJP briefTitle: High-intensity Laser Therapy for Sacroiliac Joint Pain acronym: Girls overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-03 date: 2023-04-28 date: 2024-03-28 date: 2024-02-16 date: 2024-02-16 name: Kafrelsheikh University class: OTHER briefSummary: Effect of high intensity laser on sacroiliac joint pain conditions: Sacroiliac Joint Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ACTUAL name: Laser Therapy name: Traditional exercises name: Placebo laser measure: Pain intensity measure: Pressure pain threshold measure: Functional disability sex: FEMALE minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Kafr Al-Sheikh University city: Kafr Ash Shaykh country: Egypt lat: 31.11174 lon: 30.93991 hasResults: False

 nctId: NCT06262750 id: 00375/23 briefTitle: Evaluation of Safety and Efficacy of Anticoagulation Treatment in Patients With Splanchnic Vein Thrombosis: SAPIENT Study acronym: SAPIENT overallStatus: RECRUITING date: 2023-12-01 date: 2023-12-01 date: 2025-11-01 date: 2024-02-16 date: 2024-02-16 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Prospective single-centre, observational study with medical products. Patients with a medical history of SVT will be observed for at least 24 months after inclusion. The study will begin when the patient is referred to our centre for SVT and will end at the 24-month follow-up or at the occurrence of a study outcome event, or in case of Death OBJECTIVE: To prospectively define the incidence of recurrent thrombosis and bleeding events during anticoagulant therapy in patients with diagnosed SVT, regardless of whether they will be hospitalized or treated as outpatients conditions: Splanchnic Vein Thrombosis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 170 type: ESTIMATED measure: Incidenze of bleedings events measure: Incidence of venous and arterial thromboembolic events measure: Rate of progress /stable /regressive measure: incidence of liver related events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UOC Servizio e DH Ematologia status: RECRUITING city: Rome zip: 00168 country: Italy name: Valerio De Stefano role: CONTACT name: Rossella Talerico role: SUB_INVESTIGATOR name: Silvia Betti role: SUB_INVESTIGATOR name: Francesco Santopaolo role: SUB_INVESTIGATOR lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06262737 id: RBHP 2023 CHIAMBARETTA id: 2023-A01121-44 type: REGISTRY domain: ANSM briefTitle: Single-center Study Measuring OSDI Dry Eye Score in Patients Undergoing an Anti-VEGF Induction Protocol acronym: PISO overallStatus: RECRUITING date: 2023-09-30 date: 2024-10-01 date: 2025-10-01 date: 2024-02-16 date: 2024-02-16 name: University Hospital, Clermont-Ferrand class: OTHER briefSummary: The purpose of this study is to assess the sensation of ocular dry eye symptom after an intravitreal injection of anti-VEGF. conditions: Macular Degeneration conditions: Diabetic Macular Edema conditions: Retinal Vein Occlusion studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: OSDI measure: OSDI measure: HM measure: AM measure: NIBUT 1 measure: NIBUT 2 measure: Interferometry sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Clermont-Ferrand status: RECRUITING city: Clermont-Ferrand zip: 63000 country: France lat: 45.77966 lon: 3.08628 hasResults: False

 nctId: NCT06262724 id: Perforator Flaps briefTitle: Breast Reshaping Following Massive Weight Loss overallStatus: COMPLETED date: 2021-08-01 date: 2023-08-01 date: 2024-01-01 date: 2024-02-16 date: 2024-02-26 name: Ain Shams University class: OTHER briefSummary: Reliability of Chest Wall Perforator Flaps for Breast Reshaping following Massive Weight Loss conditions: Breast Ptosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All patients were subjected to the same intervention. primaryPurpose: TREATMENT masking: NONE count: 20 type: ACTUAL name: Breast auto-augmentation measure: Measurement of breast volume by sono-mammography measure: Sternal notch to nipple distance measure: Nipple to inframammary fold distance measure: Measure of nipple-to-nipple distance sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Faculty of Medicine, Ain Shams University city: Cairo state: Abbasia zip: 11591 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06262711 id: 321917 briefTitle: Effects of Vitamin C on Skeletal Muscle acronym: VICS overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-03 date: 2025-03 date: 2024-02-16 date: 2024-02-16 name: University of East Anglia class: OTHER name: The Norfolk and Norwich University Hospitals NHS Foundation Trust name: The Quadram Institute Clinical Research Facility briefSummary: As part of the ageing process muscles become weaker. One of the reasons for this is that mitochondria, the 'engines' that provide energy to fuel muscles, age and work less efficiently. Mitochondria are found in almost all cells in the human body. Mitochondria take in nutrients that are provided from food and break these down to create energy-rich compounds to fuel many different processes in the body. Muscles are loaded with mitochondria because they require a lot of energy. Mitochondria naturally produce small compounds called oxidants that can damage muscle cells and can cause inflammation. The cells in the body have a natural defence system to protect against oxidants, but when mitochondria age and become less efficient, the amount of oxidants that they produce can increase. These oxidants can damage muscles and the mitochondria themselves. Antioxidants, such as vitamin C, may help protect muscles from the damage caused by oxidants, and may help mitochondria work more efficiently. In this study, the investigators will explore whether vitamin C can help mitochondria work more efficiently, which may improve muscle strength, and help older people to remain mobile and independent for longer. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Crossover Assignment primaryPurpose: BASIC_SCIENCE masking: TRIPLE maskingDescription: Double blind masking whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 16 type: ESTIMATED name: Vitamin C name: Placebo measure: Difference in skeletal muscle mitochondrial function between vitamin C and placebo groups. measure: Difference in skeletal muscle phosphomonoester to phosphodiester ratio (PME/PDE) between vitamin C and placebo groups. measure: Difference in knee extension strength between vitamin C and placebo groups. measure: Difference in hand grip strength between vitamin C and placebo groups. measure: Difference in Short Physical Performance Battery (SPPB) score between vitamin C and placebo groups. measure: Difference in plasma vitamin C between vitamin C and placebo groups. measure: Difference in serum hs-CRP between vitamin C and placebo groups. measure: Difference in serum IL-6 between vitamin C and placebo groups. measure: Difference in serum TNF-α between vitamin C and placebo groups. measure: Difference in plasma P1NP between vitamin C and placebo groups. measure: Difference in plasma CTX between vitamin C and placebo groups. sex: FEMALE minimumAge: 65 Years stdAges: OLDER_ADULT facility: University of East Anglia city: Norwich state: Norfolk zip: NR4 7TJ country: United Kingdom lat: 52.62783 lon: 1.29834 hasResults: False

 nctId: NCT06262698 id: 81825902.903/148 briefTitle: The Effect of HBM-Based Education on Nursing Students acronym: HBM overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2024-12-31 date: 2025-06-30 date: 2024-02-16 date: 2024-02-16 name: Kafkas University class: OTHER briefSummary: The purpose of the study is to investigate the effect of HBM-based education on CAM knowledge, attitudes, and health beliefs related to medication use among nursing students through a randomized controlled trial.

Research hypotheses:

Hypothesis 01: There is no effect of HBM-based education on CAM knowledge level among nursing students.

Hypothesis 1: There is an effect of HBM-based education on CAM knowledge level among nursing students.

Hypothesis 02: There is no effect of HBM-based education on CAM attitude level among nursing students.

Hypothesis 2: There is an effect of HBM-based education on CAM attitude level among nursing students.

Hypothesis 03: There is no effect of HBM-based education on health beliefs related to medication use among nursing students.

Hypothesis 3: There is an effect of HBM-based education on health beliefs related to medication use among nursing students. conditions: Nursing conditions: Evidence-Based Nursing studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The experimental group will receive six weeks of HBM-based training. primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: Participants were assigned to groups using the "simple randomization method". Participants were not informed of which group they were in. Automated computer-based randomization resulted in the implementation of the experiment with the scheduling scenario and confidential allocation of participants to one of the four intervention branches. The researcher was blind to all conditions until the participants started the computer program and the intervention began. Participants were also unaware of whether the group they were assigned to was an experimental or a control condition. In addition, researchers coding and analyzing data will be blind to randomization and interventions. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Experiment group name: Pre-post test measure: The TCM Attitude Scale (CACMAS) The GETAT Attitude Scale (CACMAS): The scale, developed by McFadden et al. (2010), consists of 27 items rated on a 7-point Likert scale. Its Turkish validity and reliability were established by Köse et al. (2018). measure: The Medication Health Belief Scale sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Kafkas University Faculty of Health Sciences city: Kars zip: 36500 country: Turkey name: Gönül GÖKÇAY, Asist. Prof. role: CONTACT phone: 05447915549 email: gonul.gokcay@ogr.sakarya.edu.tr lat: 40.59825 lon: 43.08548 hasResults: False

 nctId: NCT06262685 id: 2023-509418-12-00 briefTitle: Efficacy, Safety and Cost-efficacy of a Pre-emptive Genotyping Strategy in Patients Receiving Statins acronym: PREVESTATGx overallStatus: NOT_YET_RECRUITING date: 2024-03-04 date: 2025-02-10 date: 2025-03-04 date: 2024-02-16 date: 2024-02-16 name: Instituto de Investigación Hospital Universitario La Paz class: OTHER name: Instituto de Salud Carlos III briefSummary: This is a Phase IV multicentre adaptive single-blinded randomized clinical trial if preemptively genotyping populations at risk of cardiovascular disease susceptible of receiving high or moderate doses of statin therapy is efficacious, cost-efficacious, and feasible within the Spanish National Health System when compared to the current standard of care. This trial is nested within the iPHARMGx master protocol conditions: Cardiovascular Diseases conditions: Dyslipidemias conditions: Statin Adverse Reaction conditions: Pharmacogenic Myopathy studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase IV, multicentre, controlled, randomized, parallel and single-blind adaptive clinical trial nested within the iPHARMGx master protocol study primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Subjects will remain blinded to arm assigned because pharmacogenetic phenotype and statin/dose-guidance will only be exclusively accesible to the attending physician whoMasked: PARTICIPANT count: 216 type: ESTIMATED name: Preemptive pharmacogenetic atorvastatin dose based on CPIC guidelines name: Preemptive pharmacogenetic simvastatin dose based on CPIC guidelines name: Preemptive pharmacogenetic pitavastatin dose based on CPIC guidelines name: Preemptive pharmacogenetic rosuvastatin dose based on CPIC guidelines name: Preemptive pharmacogenetic pravastatin dose based on CPIC guidelines name: Preemptive pharmacogenetic lovastatin dose based on CPIC guidelines name: Preemptive pharmacogenetic fluvastatin dose based on CPIC guidelines name: Standard of Care (SoC) dosing of atorvastatin name: Standard of Care (SoC) dosing of simvastatin name: Standard of Care (SoC) dosing of pitavastatin name: Standard of Care (SoC) dosing of rosuvastatin name: Standard of Care (SoC) dosing of prasavastatin name: Standard of Care (SoC) dosing of lovastatin name: Standard of Care (SoC) dosing of fluvastatin measure: Incidence of clinically relevant statin-associated musculoskeletal events measure: Low density lipoprotein cholesterol (LDLc) serum concentration baseline reduction rate measure: Baseline change in statin therapy prescription measure: Cost of a statin preemptive pharmacogenetic prescription scheme measure: Novel prognostic and predictive genetic biomarkers of statin-related adverse events and efficacy identification measure: Death from cardiovascular causes, nonfatal myocardial infarction or hospitalization for unstable angina or resuscitated cardiac arrest measure: Difference in percentage in the eight-item Morisky Medication Adherence Scale (MMAS-8) questionnaire score between intervention and control arm measure: SAMS intensity reduction of a statin preemptive pharmacogenetic prescription scheme sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital La Paz city: Madrid state: Comunidad De Madrid zip: 28046 country: Spain name: Stefan Mark Stewart Balbás, MD role: CONTACT lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06262672 id: PR0319R01 briefTitle: Evaluation of Some Parameters in University Students During the COVİD-19 Epidemic Process overallStatus: COMPLETED date: 2021-05-20 date: 2021-11-20 date: 2021-11-20 date: 2024-02-16 date: 2024-02-28 name: Kırklareli University class: OTHER briefSummary: The physical and mental effects of the COVID-19 pandemic have been examined by many researchers, but this study aims to evaluate in every aspect how university students who had to receive education with the distance education model due to the pandemic went through this process. Data regarding people's positive and negative habits from anthropometric characteristics and sleep quality, which is one of the sub-dimensions of healthy lifestyle behaviors, were evaluated, and the relationship between these parameters was examined in detail. conditions: Health Behavior conditions: Sleep conditions: Body Weight studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 236 type: ACTUAL name: Evaluation form measure: Health Promotion Life-Style Profile (HPLP-II) measure: Pittsburgh Sleep Quality Index (PSQI) measure: Anthropometric Measurements sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kirklareli University city: Kirklareli state: Kayalı zip: 39000 country: Turkey lat: 41.73508 lon: 27.22521 hasResults: False

 nctId: NCT06262659 id: 2023-142 briefTitle: The Effect of Ultrasonography on Blood Flow,Vessel Diameter,and Depth Measurements in Dialysis Patients With Fistula overallStatus: RECRUITING date: 2024-03-08 date: 2024-06-10 date: 2024-09-10 date: 2024-02-16 date: 2024-03-12 name: Kudret Atakan Tekin class: OTHER briefSummary: Arteriovenous fistulas (AVF) are considered essential and the primary vascular access for end-stage renal disease patients to receive hemodialysis (HD) treatment. The maturation failure rate of AVFs is approximately 23%. The aim of our study is to compare intraoperative fistula flow and measurements of vascular structures' diameters with postoperative fistula maturation, following the completion of the fistula operation, to reveal the relationship between them. Providing insights into the need for intraoperative intervention and/or postoperative fistula management based on these measurements is intended to contribute to the literature by offering predictions and perspectives. conditions: Arteriovenous Fistula studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 66 type: ESTIMATED name: Doppler Ultrasonography Assessment measure: intraoperative Arteriovenous Fistula Flow Measurement sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kudret Atakan Tekin status: RECRUITING city: Merkez state: Çorum country: Turkey name: Kudret Atakan Tekin role: CONTACT phone: 05424912184 email: dr.kudretatakantekin@gmail.com hasResults: False

 nctId: NCT06262646 id: NTEC-2023-677 briefTitle: Video-conferencing FACT for Young Children With Special Needs overallStatus: RECRUITING date: 2024-02-01 date: 2025-01-31 date: 2026-01-31 date: 2024-02-16 date: 2024-02-16 name: Chinese University of Hong Kong class: OTHER name: Hong Kong Christian Service name: Hong Kong Federation of Youth Groups name: Hong Kong Young Women's Christian Association name: Yang Memorial Methodist Social Service name: Hong Kong Sheng Kung Hui Welfare Council briefSummary: Objective: This RCT evaluates the efficacy of Focused Acceptance and Commitment Therapy (FACT) delivered via videoconferencing for parents of special needs children, targeting reducing parental stress (primary outcome), symptoms of depression and anxiety, as well as psychological flexibility.

Background: Parental caregiving for children with special needs is associated with significant stress, potentially impairing parental and familial functioning. Acceptance and Commitment Therapy (ACT) has shown promise in bolstering mental health across diverse populations. Preliminary findings from a feasibility trial (NCT05803252) suggest the potential of FACT in this context.

Methods: Expanding upon prior research, this definitive RCT compares FACT to standard parenting advice, correcting for earlier limitations through increased sample size and rigorous methodology. Assessments will be conducted at baseline, post-intervention (4-8 weeks), and 6-month follow-up.

Results: The study anticipates that FACT will demonstrate superior outcomes in promoting well-being among parents compared to parenting advice alone.

Conclusion: By leveraging videoconferencing for therapy delivery, the RCT aims to improve access to mental health interventions and emphasize the importance of psychological health among parents of special needs children. This could foster greater recognition and proactive management of mental health within this population. conditions: Autism Spectrum Disorder conditions: Attention Deficit Hyperactivity Disorder conditions: Specific Learning Disorder conditions: Communication Disorders conditions: Motor Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two-arm Randomised Controlled Trial (RCT) with a repeated-measures parallel-group design primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Eligible parents consenting to participate will be randomly assigned to either the FACT or Control Group in a 1:1 ratio, using the permuted block size of 6 through sequentially numbered, opaque and sealed envelopes with number cards (1=intervention, 2=control). A separate set of random numbers, concealed from the research team and RAs, will be generated by a statistician. Clerical staff uninvolved in the project will administer the randomisation. The research assistant (RA-1), blinded to subject selection, will open the envelopes only after informed consent and baseline assessments are completed. The research assistant (RA-2) is also blinded to group assignments and will conduct assessments/evaluations. whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 253 type: ESTIMATED name: Focused Acceptance and Commitment Therapy name: Control Group measure: Parenting stress measure: Parental depressive symptoms measure: Parental anxiety symptoms measure: Parental Psychological Flexibility measure: ACT Core Process Utilization sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Chinese University of Hong Kong status: RECRUITING city: Hong Kong country: Hong Kong name: Pui Tik YAU role: CONTACT phone: (852) 3943-9915 email: jamyau@cuhk.edu.hk lat: 22.27832 lon: 114.17469 hasResults: False

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

 nctId: NCT06262620 id: 2022-NHLHCRF-LX-01-0201-06 briefTitle: The Comparisonof Mediastinal/Hilar Lymph Node Biopsies by EBUS-TBNA, EBUS-TBCB, and EBUS-TBFB overallStatus: NOT_YET_RECRUITING date: 2024-02-18 date: 2026-02-18 date: 2026-02-18 date: 2024-02-16 date: 2024-02-16 name: China-Japan Friendship Hospital class: OTHER briefSummary: The goal of this prospective, multi-centre, randomised controlled clinical study is to compare the diagnostic efficacy and safety of the three biopsy techniques (EBUS-TBNA, EBUS-TBCB, and EBUS-TBFB) in mediastinal/hilar lymph node biopsies.

Participants will divided into EBUS-TBNA group, EBUS-TBCB group, and EBUS-TBFB group at a 1:1:1 ratio by using central, computerized random sequence, and then undertake EBUS-TBNA, EBUS-TBCB, or EBUS-TBFB according to the group.

Researchers will compare the adequacy of sampling by the three biopsy techniques, their sample quality, diagnostic rate, and incidence of each adverse events. conditions: Lymphadenopathy Hilar conditions: Lymphadenopathy Mediastinal studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 723 type: ESTIMATED name: EBUS-TBNA name: EBUS-TBCB name: EBUS-TBFB measure: Dignostic rate of EBUS-TBNA, EBUS-TBCB, and EBUS-TBFB measure: Incidence rate of adverse events measure: the adequacy of sample acquisition measure: the quality of sample acquisition sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

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

 nctId: NCT06262594 id: L'ÉTOILE briefTitle: Lemborexant Treatment of Insomnia Linked to Epilepsy acronym: L'ÉTOILE overallStatus: NOT_YET_RECRUITING date: 2024-02-08 date: 2025-02-08 date: 2026-02-08 date: 2024-02-16 date: 2024-02-16 name: University of Manitoba class: OTHER name: Duke University briefSummary: The goal of this clinical trial is to assess whether Lemborexant can improve sleep in patients with epilepsy. conditions: Epilepsy conditions: Sleep studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 26 type: ESTIMATED name: Lemborexant measure: WASO sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

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

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

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

 nctId: NCT06262542 id: 111016 briefTitle: Efficacy and Safety of Chinese Herb Medicine-Moxibustion Therapy on Chemotherapy-Induced Leukopenia overallStatus: RECRUITING date: 2024-03-13 date: 2024-12-31 date: 2024-12-31 date: 2024-02-16 date: 2024-04-12 name: Taichung Armed Forces General Hospital class: OTHER_GOV briefSummary: Cancer is the second leading cause of death globally, with an estimated 9.6 million deaths in 2018, accounting for one-sixth of total deaths. The economic burden of cancer continues to rise globally, causing significant physiological, psychological, and economic pressures on individuals, families, communities, and healthcare systems. The toxic effects of chemotherapy, such as nausea, vomiting, decreased blood cells, fatigue, etc., can impair patients' function, activities, and quality of life. Chemotherapy-induced leukopenia (CIL), particularly low white blood cell counts (48.9%), is a major concern for cancer patients.

Current conventional treatments primarily involve colony-stimulating factors (G-CSF and GM-CSF) to accelerate neutrophil recovery and regulate granulocyte production. However, G-CSF is costly and adds financial burden, and its use is restricted to cases meeting specific criteria. Additionally, rapid changes in patients' symptoms, weakness, and poor appetite may lead to swift deterioration of their condition, making it challenging to predict and prevent. Moreover, G-CSF has frequent side effects, including skin rash, liver function abnormalities, nausea, vomiting, fever, headache, fatigue, palpitations, and increased levels of ALP, LDH, and uric acid, with bone pain being the most common.

Traditional Chinese Medicine (TCM) has been a long-standing medical practice in Eastern societies and is a legally recognized healthcare option in Taiwan, covered by national health insurance. TCM includes acupuncture, moxibustion, and Chinese herbal medicine, all of which have been researched for their potential in addressing chemotherapy-induced leukopenia. conditions: Cancer, Chemotherapy-induced Leukopenia, Chinese Herb Medicine-moxibustion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: moxibustion and Chinese herbal medicine group measure: Track the number of white blood cells sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taichung Armed Force General Hospital status: RECRUITING city: Taichung state: Taiping zip: 411228 country: Taiwan name: ming huei cheng role: CONTACT phone: 0921059072 email: u9630091@cmu.edu.tw lat: 24.1469 lon: 120.6839 hasResults: False

 nctId: NCT06262529 id: 22-AOI-06 briefTitle: Neurocognitive Impairment After Ischemic Stroke acronym: COG-TRA-Y MRI overallStatus: RECRUITING date: 2024-02-09 date: 2025-02-09 date: 2027-02-09 date: 2024-02-16 date: 2024-02-16 name: Centre Hospitalier Universitaire de Nice class: OTHER briefSummary: Affecting more than 150,000 patients in France, stroke is a major public health issue and a leading cause of disability worldwide. In western countries, 80-85% of strokes are of ischemic subtype. This study will focus on young adults, aged 18-45, with a diagnosis of ischemic stroke.

Studies assessing post-stroke cognition in young patients reported an alarming prevalence of cognitive impairment, affecting about 60% of stroke survivors between 4 and 12 months after the acute event. However, longitudinal data on neurocognitive trajectories (i.e., the evolution of cognitive impairment over time) in young patients with ischemic stroke are lacking. Collecting such data requires an exhaustive neuropsychological assessment and several functional evaluations, at different times, for the same patient.

Repeated neurocognitive study of young patients with ischemic stroke will enable: a description of the prevalence of impaired global cognitive efficiency, an analysis of the specific neurocognitive domains affected, and the tracing of trajectories of recovery from cognitive impairment over time, in terms of global cognitive efficiency and as a function of specific neurocognitive domains (memory, executive, attentional, social cognition, instrumental functions, fatigability, etc.).

Up to date, the clinic-radiological predictors and associated factors of neurocognitive impairment after ischemic stroke in young patients have not been studied. Ischemic stroke causes acute brain lesions of the gray matter (GM) and white matter (WM). Numerous studies suggest that cognitive health may be more closely linked to the integrity of WM than to GM. Magnetic resonance imaging (MRI), and in particular diffusion tensor imaging (DTI) sequences, analyze WM bundles. By using fiber tracking algorithms image analysis enable the WM fiber bundle reconstruction and allow quantifying the volume of lesions (pre-existing and ischemic stroke-induced) in the WM tract.

The aim of this study is to study whether the extension of pre-existing and acute white matter lesions is associated with poorer cognitive recovery after ischemic stroke, both in terms of global cognitive performance and impairment in specific neurocognitive domains. conditions: Acute Ischemic Stroke studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 16 type: ESTIMATED name: Cerebral MRI measure: evolution of neurocognitive disorders (trajectories of global cognitive efficiency) over 1 year after stroke sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: cannes Hospital status: NOT_YET_RECRUITING city: Cannes zip: 06600 country: France name: sylvain LACHAUD role: CONTACT email: s.lachaud@ch-cannes.fr name: Sylvain Lachaud role: PRINCIPAL_INVESTIGATOR lat: 43.55135 lon: 7.01275 facility: Nice University Hospital status: RECRUITING city: Nice zip: 06000 country: France name: Marina Passalboni role: CONTACT phone: 04 92 03 27 90 email: passalboni.m@chu-nice.fr name: barbara CASOLLA role: PRINCIPAL_INVESTIGATOR lat: 43.70313 lon: 7.26608 hasResults: False

 nctId: NCT06262516 id: CASE2824 briefTitle: Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2027-01-01 date: 2029-01-01 date: 2024-02-16 date: 2024-02-16 name: Case Comprehensive Cancer Center class: OTHER briefSummary: The goal of this study is to conduct the first randomized-controlled trial to determine the oncologic efficacy of lymph node dissection in participants with upper tract urothelial cell carcinoma. The main questions it aims to answer are:

* To determine oncologic outcomes, specifically 2-year recurrence-free survival
* To determine other oncologic outcomes including treatment-free, cancer-specific and overall survival
* To determine time to recurrence and recurrence patterns
* To determine use of adjuvant therapies
* To determine perioperative complications

Participants will undergo nephroureterectomy with or without lymph node dissection. Researchers will compare these two groups to determine the oncologic efficacy of performing lymph node dissection. conditions: Urothelial Carcinoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is designed as a 1:1 two armed randomized-controlled trial. primaryPurpose: TREATMENT masking: NONE count: 94 type: ESTIMATED name: Nephroureterectomy name: Lymph Node Dissection measure: Recurrence-free survival measure: Treatment-free survival measure: Cancer-specific survival measure: Overall Survival measure: Time to recurrence measure: Use of adjuvant therapies measure: Perioperative complications sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cleveland Clinic Glickman Urological and Kidney Institute city: Cleveland state: Ohio zip: 44195 country: United States name: Mohamed Eltemamy, MD role: CONTACT phone: 216-444-5888 email: Eltemam@ccf.org lat: 41.4995 lon: -81.69541 hasResults: False

 nctId: NCT06262503 id: P.T.REC/012/004810 briefTitle: the Influence of Virtual Reality Approach on Phantom Pain in Trans Tibial Amputation overallStatus: ACTIVE_NOT_RECRUITING date: 2023-10-01 date: 2024-02 date: 2024-03 date: 2024-02-16 date: 2024-02-20 name: Cairo University class: OTHER briefSummary: 1. To investigate the effect of Virtual reality (VR) on phantom limb pain in trans tibial amputation.
2. To investigate the effect of Virtual reality (VR) on lower limb Function in trans tibial amputation.

A sample size of 60 will be randomly allocated to two groups(30 in each group) , by using computer-generated random number list method. Control group will receive conventional physiotherapy(TENS- Phantom exercises and mirroring exercise) for reducing phantom pain in trans -tibial amputation and the experimental group will receive conventional physiotherapy(TENS- Phantom exercises and mirroring exercise) and Virtual Reality for reducing phantom pain in trans -tibial amputation . conditions: Phantom Pain Following Amputation of Lower Limb studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Group1:conventional physiotherapy for phantom Pain Group2:conventional physiotherapy and Virtual Reality for phantom Pain primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 75 type: ESTIMATED name: Virtual Reality name: Transcutaneous Electrical Nerve Stimulation (TENS) name: Mirroring Therapy name: Phantom Exercises measure: Pain Intensity Level measure: Lower Extremity Functional sex: ALL minimumAge: 18 Months maximumAge: 75 Months stdAges: CHILD facility: Faculty of Physical therapy, Cairo university city: Giza zip: 12613 country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False

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

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

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

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

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

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

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

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

 nctId: NCT06262386 id: 202202172B0 briefTitle: Combined Relapse Prediction Model for Resectable Non-Small Cell Patients - a Prospective Clinical Feasibility Trial overallStatus: RECRUITING date: 2023-08-01 date: 2028-07-31 date: 2028-07-31 date: 2024-02-16 date: 2024-02-16 name: Chang Gung Memorial Hospital class: OTHER name: National Science and Technology Council briefSummary: For patients with lung cancer who have undergone tumor resection, early relapse significantly impacts survival. However, there are currently no reliable screening or imaging tools available to identify patients at risk of early relapse. To address this clinical challenge, many studies have focused on understanding the clinicopathologic characteristics associated with an increased risk of early relapse. Despite these efforts, we can identify patients at risk but cannot pinpoint which individuals will actually experience early relapse. Studies on adjuvant therapy have shown improved survival in cases of more advanced disease but have not demonstrated a reduction in early relapse rates.

In our preliminary analysis of previous study data, we observed that patients with a smaller reduction in circulating tumor cells (CTCs) within the first three days after surgery, followed by an increase on the third-day post-operation, are more likely to experience early relapse during regular monitoring. This pattern may be indicative of minimal residual disease. By combining trends in circulating tumor cell variations with pathologic characteristics, we aim to select patients for adjuvant therapy who are at high risk of developing early relapse.

The objective of our study is to employ screening based on circulating tumor cell dynamics and pathologic features to identify patients likely to experience early relapse and to assess the effectiveness of adjuvant therapy in these cases. conditions: Lung Cancer conditions: Relapse/Recurrence studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 358 type: ESTIMATED name: Cisplatin based chemottherapy measure: Accuracy of proposed relapse prediction model measure: early relapse rate measure: Overall surveival sex: ALL minimumAge: 20 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ching-Yang Wu status: RECRUITING city: Taoyuan City zip: 333 country: Taiwan name: Ching-Yang Wu role: CONTACT phone: +886975368204 email: wu.chingyang@gmail.com name: Jason CH Hsieh role: CONTACT phone: +886975366137 email: wisdom5000@gmail.com name: Jui-Ying Fu role: SUB_INVESTIGATOR name: Ching-Feng Wu role: SUB_INVESTIGATOR lat: 24.95233 lon: 121.20193 hasResults: False

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

 nctId: NCT06262360 id: P2023457 briefTitle: Changes in Pulmonary Ventilation Distribution Assessed by Electrical Impedance Tomography in Healthy Children Under General Anesthesia acronym: EIT_ped overallStatus: RECRUITING date: 2024-02-16 date: 2024-06-30 date: 2024-09-30 date: 2024-02-16 date: 2024-02-21 name: Queen Fabiola Children's University Hospital class: OTHER briefSummary: The incidence of atelectasis is high in patients undergoing general anesthesia. This may cause oxygenation impairment and further contribute to post-operative pulmonary complications. As important airway management devices for general anesthesia, few studies have compared the impact of laryngeal mask airway and spontaneous breathing on atelectasis. Through the study, the distribution of the pulmonary ventilation of children undergoing an elective and standard procedure in our center (H.U.D.E.R.F.) will be studied using electric impedance tomography.

Children from 1 year-old to 6-year-old, ASA physical status I or II who will undergo elective circumcisions under general anesthesia associated with regional anesthesia (Penile Block10) at the One Day Clinic of H.U.D.E.R.F. (Hôpital des Enfants Reine Fabiola - Brussels - Belgium).

Patients will be allocated to three different group in a ration of 1:1:1.

* Group 1: spontaneous mask ventilation (20 patients).
* Group 2: spontaneous laryngeal mask (LMA) ventilation (20 patients).
* Group 3: spontaneous-pressure support LMA ventilation (LMA SV-PS) (20 patients).
* Standard monitoring for the inductions of the anesthesia will include non-invasive blood pressure (NIBP), pulse oximetry (SpO2), Electrocardiogram (ECG), End-Tidal CO2 (EtCO2), End Tidal Sevoflurane concentration (EtSev %), inspired fraction of oxygen (FiO2), body temperature (rectal thermometer).

Induction is based as well on the local routine protocols using an inhalation induction of the patient with Sevoflurane (Fet of 6-8%) and a recommended FiO2 from 80-90% maximum until the stabilization of the induction. Then the FiO2 will be decreased at least under 40% and Sevoflurane adapted to the need of the deepness of the anesthesia (both at the discretion of the anesthesiologist in charge of the patient).

Depending on the randomization, the patient will undergo the surgery either with spontaneous face mask ventilation (group 1), LMA spontaneous ventilation (group 2), or LMA SV-PS (group 3) (during which the pressure support will be adapted at the discretion of the anesthesiologist but with a tidal volume included in the range of 6-10ml/kg).

Electrical impedance tomography measurements:

The effects of the spontaneous breathing (mask ventilation or LMA) or the pressure support ventilation (LMA SV-PS) on atelectasis formations and the distribution of the ventilation will be assessed using electrical impedance tomography.

The device used during the study will be the "PulmoVista 500"; it will be provided by Dräger (Lübeck, Germany) free of charge and without any obligation or results/conclusions requested by Dräger. The device is approved CE (European regulation) and will be used in the conditions for which it has been designed.

A reusable belt with 16 evenly spaced electrodes will be placed around the chest of each patient included in the study between the 4th and 6th ribs as recommended by Dräger.

The EIT measurements will be taken of 4 different moments:

T1: Before induction of the anesthesia in the preoperatory waiting room (and at least 30 min after the premedication).

T2: After the induction of anesthesia (GA and penile block), just before the beginning of the surgical procedure.

T3: After the end of the surgical procedure, just before discontinuing the general anesthesia.

T4: Before the discharge of the PACU. conditions: Anesthesia, Pediatric studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: General anesthesia with mask ventilation name: General anesthesia and spontaneous laryngeal mask ventilation name: General anesthesia with spontaneous laryngeal mask ventilation with pressure support measure: Variation of poorly ventilated pulmonary zones sex: ALL minimumAge: 1 Year maximumAge: 6 Years stdAges: CHILD facility: H.U.B - Hôpital Universitaire des Enfants Reine Fabiola status: RECRUITING city: Brussels zip: 1020 country: Belgium name: Denis Schmartz, MD role: CONTACT phone: +3225553919 email: denis.schmartz@hubruxelles.be lat: 50.85045 lon: 4.34878 hasResults: False

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

 nctId: NCT06262334 id: Pro00133917 id: K23MD016123 type: NIH link: https://reporter.nih.gov/quickSearch/K23MD016123 briefTitle: Evaluating the Fade to Fitness Program: A Barbershop-based Program for Black Men overallStatus: RECRUITING date: 2024-03-20 date: 2024-06-15 date: 2024-06-15 date: 2024-02-16 date: 2024-03-26 name: University of South Carolina class: OTHER name: National Institute on Minority Health and Health Disparities (NIMHD) briefSummary: The Fade to Fitness Program is a targeted intervention designed to improve the holistic health and quality of life among Black men. This comprehensive initiative focuses on four key health behaviors: Physical Activity, Healthy Eating, Stress Management, and Depression Management.

It is grounded in psychological and social theories like Self-Determination Theory, Motivational Interviewing, and Social Cognitive Theory. The program emphasizes the importance of making informed choices, feeling competent and connected, and learning through observation and modeling. Facilitators play a pivotal role, leading group discussions, providing support, and fostering an inclusive atmosphere.

The program is structured into weekly sessions that tackle each health behavior, interspersed with off weeks; for community engagement, especially in barbershops, to discuss health topics and promote a healthier lifestyle. conditions: Health Related Quality of Life studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 15 type: ESTIMATED name: The Fade to Fitness Program measure: Number of men who are eligible/eligible. measure: Length of time needed to enroll 15 men measure: Facilitator-assessed attendance in intervention measure: Number of men who express interest in the study measure: Attrition in intervention measure: Acceptability, appropriateness, demand, implementation, practicality, and integration of the intervention measure: Change in weight measure: Change in body mass index measure: Change in moderate-to-vigorous physical activity measure: Global Health - Mental 2a measure: Global Health - Physical 2a measure: Perceived Stress Scale measure: Emotional Distress - Depression - Short Form 4a measure: Healthy Eating Subscale of the Health Promotion Lifestyle Profile II measure: Instrumental Support- Short Form 4a measure: Informational Support - Short Form 4a measure: Emotional Support - Short Form 4a measure: Companionship - Short Form 4a measure: Motivation and Attitudes Towards Changing Health (MATCH) measure: NIH Self-Efficacy Measure measure: Subjective Social Norms of Health Behavior measure: Valuing Questionnaire measure: Diet sex: MALE minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of South Carolina status: RECRUITING city: Columbia state: South Carolina zip: 29208 country: United States name: Guillermo M Wippold, PhD role: CONTACT phone: 803-216-1051 email: wippold@mailbox.sc.edu name: Guillermo M Wippold, PhD role: PRINCIPAL_INVESTIGATOR lat: 34.00071 lon: -81.03481 hasResults: False

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

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

 nctId: NCT06262295 id: 2023-A02475-40 briefTitle: National, Observational Registry for Comprehensive Follow-up of All Implementations of the AVEIR VR LP Device in France (France LEADLESS) overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2027-09 date: 2027-09 date: 2024-02-16 date: 2024-02-16 name: French Cardiology Society class: OTHER name: Abbott briefSummary: Although the idea of a leadless pacemaker was first proposed in the 1970s to eliminate the probes, pockets and connectors required by conventional cardiac procedures and the associated complications, the first devices were not developed until the late 2010s. Leadless pacemakers can also improve patient comfort by replacing surgery with a percutaneous procedure, eliminating the mass and scar visible at the implantation site of a conventional pacemaker, and eliminating the need for activity restrictions to prevent dislodgement after implantation of a conventional lead.

The AVEIR VR LP leadless pacemaker was CE marked in July 2023 and will be implanted in patients in Europe.

The objective of this national registry is to evaluate the safety and performance of the AVEIR VR LP system in a population of patients indicated for implantation of a VVI(R) pacemaker in France. This registry will also allow the collection of patient characteristics and indications under normal conditions of use. conditions: Pacemaker studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED measure: To confirm the safety of the AVEIR VR LP device measure: To confirm the effectiveness of the AVEIR VR LP device measure: To collect patient characteristics and indications in normal conditions of use of the AVEIR VR LP device sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

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

 nctId: NCT06262269 id: Sportscol id: 2022-A00021-42 type: OTHER domain: Number IDRCB briefTitle: Interest of Adapted Physical Activity by Tele-rehabilitation in Chronic Pathology - Idiopathic Scoliosis in Adolescents overallStatus: RECRUITING date: 2022-09-21 date: 2025-06 date: 2025-12 date: 2024-02-16 date: 2024-03-08 name: Association des Paralysees de France (APF) class: OTHER name: Fondation de France briefSummary: This study is a randomised controlled trial designed to compare two adapted physical activity treatments for adolescent idiopathic scoliosis (AIS). The main hypotheses it aims to address are as follows:

* Treatment with a HIIT (High-Intensity Interval Training) type training program via tele-rehabilitation, supervised by an adapted physical activity teacher, is effective in AIS.
* A 12-week physical activity program maintains this efficacy over the long term. To test this hypothesis, Two groups of adolescents will be evaluated: a first group made up of non-athletic adolescents suffering from Idiopathic Scoliosis who will benefit from a tele-rehabilitation (physical activity sessions at home supervised by a teacher in adapted physical activities by video). A second group, control, also made up of non-athletic adolescents suffering from Idiopathic Scoliosis who will benefit from a self-program at home consisting of exercises specific to their scoliosis. conditions: Adolescent Idiopathic Scoliosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 70 type: ESTIMATED name: Home-based adapted physical activity program supervised by an APA teacher via individual video conference. name: First period of the home-based adapted physical activity program with an exercise booklet. name: Second period of the home-based adapted physical activity program with an exercise booklet. measure: Evaluation to overall physical performance on an ergometer-rowing machine measure: Evaluation of overall physical performance on an ergometer-rowing machine measure: Evaluation of perivertebral muscle performance (Plank) measure: Evaluation of perivertebral muscle performance (Rowing) measure: Indirect assessment of VO2 max measure: The Ratings Perceveid Exertion for Children during exercise (RPE-C) measure: Assessment of motivation to change measure: Evaluation of attendance at adapted physical activity sessions measure: Anthropometric evaluation (Height) measure: Anthropometric evaluation (weight) measure: Anthropometric evaluation (BMI) measure: Anthropometric evaluation by bioimpedance measurement measure: Analysis of the static vertical posture on a force platform SATEL® measure: Evaluation of the EOS radiograph of the total spine in front (Type) measure: Evaluation of the EOS radiograph of the total spine in front and in profile (Angle) measure: Evaluation of the EOS radiograph of the total spine in front (Frontal deviation) measure: Evaluation of the EOS radiograph of the total spine in front (Risser) measure: Photogrammetric morphostatic evaluation by surface topography measure: Measurement of the main gibbosity measure: Assessment of quality of life by the Scoliosis Research Society (SRS) scale : SRS-18 measure: Satisfaction questionnaires sex: FEMALE minimumAge: 13 Years maximumAge: 17 Years stdAges: CHILD facility: SSR Marc Sautelet status: RECRUITING city: Villeneuve-d'Ascq zip: 59650 country: France name: Jean-François Catanzariti, Médecin MPR role: CONTACT lat: 50.61669 lon: 3.16664 hasResults: False

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

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

 nctId: NCT06262230 id: OPCI on ASD Children briefTitle: Feasibility and Effectiveness of OPCI on ASD Children overallStatus: COMPLETED date: 2022-11-20 date: 2023-10-31 date: 2023-10-31 date: 2024-02-15 date: 2024-02-15 name: Peking University class: OTHER briefSummary: The goal of this interventional study was to explore the feasibility and effectiveness of online peer companion intervention (OPCI) on the social abilities and mental health of ASD children. The main questions it aims to answer are:

1. What is the acceptability and adherence of OPCI;
2. Whether OPCI is effective on the social abilities and mental health of ASD children;
3. What impact does OPCI have on ordinary children and parents of both children? conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: In this study, ordinary children will be paired with ASD children according to age, hobbies and other conditions primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 100 type: ACTUAL name: Online Inclusive Companionship Intervention measure: Social Behavior of ASD Children measure: Mental Health of ASD Children measure: Intervention Process Screen Recording Coding measure: Symptom Severity measure: Mental Health of Ordinary Children measure: Social Ability of Ordinary Children measure: Mental Health of Parents sex: ALL minimumAge: 7 Years maximumAge: 15 Years stdAges: CHILD facility: Peking University city: Beijing state: Beijing zip: 100871 country: China lat: 39.9075 lon: 116.39723 hasResults: False

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

 nctId: NCT06262204 id: Hallux Shark Screw(R) briefTitle: Hallux Valgus Correction Using the Metal Screw or the Human Allogeneic Cortical Bone Screw (Shark Screw). overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-02-28 date: 2026-02-28 date: 2024-02-15 date: 2024-04-05 name: Orthopedic Hospital Vienna Speising class: OTHER briefSummary: The goal of this clinical trial is to compare the treatment of Hallux Valgus using the conventional method (metal screw) with the new method (human allogeneic cortical bone screw (Shark Screw®) in adult patients with confirmed Hallux Valgus.

The main questions it aims to answer are:

Can the new method obtain comparable results as the conventional method in regard to union rate and time to union? Are the number of complications lower with the new method? Participants will be operated either with the metal screw or with the Shark Screw®. The assignment to the groups is randomized. conditions: Hallux Valgus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: does get the information only after 2 years at the end of teh study whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: Hallux Valgus Treatment with Shark Screw® name: Hallux Valgus Treatment with metal screw measure: clinical result of Hallux Valgus treatment measure: radiological (bony union)result of Hallux Valgus treatment measure: change in forefoot-American Orthopaedic Foot and Ankle Society (AOFAS) measure: Hallux-Valgus angle (HVA) change measure: gait analysis measure: Intermetatarsal angle (IMA) change sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Abteilung für Kinderorthopädie und Fußchirurgie Orthopädisches Spital Speising city: Vienna zip: 1130 country: Austria name: Florian Wenzel-Schwarz, MD role: CONTACT phone: +43180182 phoneExt: 3081 email: florian.wenzel-schwarz@oss.at name: Florian Wenzel-Schwarz, MD role: PRINCIPAL_INVESTIGATOR lat: 48.20849 lon: 16.37208 hasResults: False

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

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

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

 nctId: NCT06262152 id: 49187/2023 briefTitle: Sleep Profile of Patients With Septo-optic Dysplasia overallStatus: RECRUITING date: 2023-12-20 date: 2024-01-20 date: 2025-05-20 date: 2024-02-15 date: 2024-02-15 name: IRCCS National Neurological Institute "C. Mondino" Foundation class: OTHER briefSummary: The aim of this study is to evaluate sleep of patients with septo-optic dysplasia compared to patients with an isolated disorder of peripheral visual system and patients with corpus callosum agenesis since both visus defict and agenesis of corpus callosum might be present SOD but associated to other features / structural and functional anomalies.

Included patients and their caregivers will be asked to compile standardize sleep questionnaires and a sleep screening through an interview will be scheduled. Patients will be asked to wear an actigraph on their non-dominant hand wrist for 7 days. conditions: Septo-Optic Dysplasia conditions: Agenesis of Corpus Callosum conditions: Blindness studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 45 type: ESTIMATED name: Actigraphy, blood and salivary sample, and sleep evaluation measure: Sleep profile ( Sleep quality, sleep efficiency) of patients with SOD measure: melatonin profile of patients with SOD measure: Sleep EEG description of patients with SOD sex: ALL minimumAge: 3 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: IRCCS Casimiro Mondino Foundation status: RECRUITING city: Pavia state: PV zip: 27100 country: Italy name: Ludovica Pasca, MD role: CONTACT phone: 00393337201551 email: ludovica.pasca@mondino.it name: Valentina Franco, MD role: CONTACT lat: 45.19205 lon: 9.15917 hasResults: False

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

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

 nctId: NCT06262113 id: 2024P000392 id: AD-2022C2-24790 type: OTHER_GRANT domain: PCORI briefTitle: A Decentralized Clinical Trial to Promote Evidence-Based Care for Underserved Patients With Neurofibromatosis 1 overallStatus: NOT_YET_RECRUITING date: 2024-11 date: 2026-06 date: 2026-08 date: 2024-02-15 date: 2024-02-15 name: Massachusetts General Hospital class: OTHER name: Patient-Centered Outcomes Research Institute briefSummary: The goal of this fully decentralized, randomized controlled trial is to compare the efficacy of two educational interventions for individuals with Neurofibromatosis 1 (NF1). The primary objective of the study is to determine which intervention leads to higher rates of evidenced-based health screenings for NF1 patients in primary care settings.

Adults with NF1 and parents/guardians of children with NF1 from across the U.S. who do not go to a specialized NF clinic and who have an upcoming annual wellness visits scheduled with a primary care provider (PCP) are eligible to enroll in the study. conditions: Neurofibromatosis 1 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 360 type: ESTIMATED name: Letters about NF1 Care (Content Type 1) name: Letters about NF1 Care (Content Type 2) measure: Receipt of Recommended NF1 Health Screenings measure: Patient Activation Measure® measure: Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Clinician and Group Survey Version 4.0 (Beta): Rating of the Visit measure: Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Clinician and Group Survey Version 4.0 (Beta): How Well Providers Communicate With Patients Subscale measure: Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Clinician and Group Survey Version 4.0 (Beta): Providers' Use of Information to Coordinate Patient Care Subscale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Massachusetts General Hospital city: Boston state: Massachusetts zip: 02114 country: United States lat: 42.35843 lon: -71.05977 hasResults: False

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

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

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

 nctId: NCT06262061 id: PRO-TBI-FS briefTitle: Propranolol for the Treatment of Traumatic Brain Injury overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-04 date: 2025-09 date: 2024-02-15 date: 2024-02-15 name: London Health Sciences Centre class: OTHER briefSummary: Traumatic brain injury (TBI) is a leading cause of global disease and directly affects over 1.5 million Canadians, with 165 000 TBIs occurring yearly in Canada. Despite the burden of TBIs, there are limited treatment options available and current treatments generally focus on supportive care. The aim of TBI treatment is reduce inflammation and damage occurring after the TBI (secondary injury).

Beta- blockers (BBs) are medications commonly used to block the actions of endogenous catecholamines- hormones that are thought to contribute to secondary injury within brain tissue. This reduces metabolic demand in the vulnerable, injured brain. BBs have been studied in several retrospective trials and one single-center, non- blinded randomized controlled study. These results point towards a benefit to the use of BBs in TBI but need to be confirmed in a rigorous manner before they are widely adopted.

The current study aims to assess the feasibility of a single centre randomized controlled trial of BBs versus placebo to treat moderate to severe TBI. This feasibility trial will inform the planning of a large multi-center study powered to detect a difference in cognitive outcomes and mortality. It also will allow the investigators to gather biologic samples for measuring serum catecholamines and inflammatory mediators to better understand the basic science mechanisms of BBs in this patient population; and to assess the feasibility of using the Cambridge Battery to assess cognitive outcomes of trial participants. conditions: TBI (Traumatic Brain Injury) studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, single- center double- blinded randomized control trial comparing placebo to propranolol for the treatment of moderate- severe traumatic brain injury. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Patients will be randomized in a 1:1 allocation to either the propranolol or control group. Our hospital pharmacy will control the randomization procedure. The propranolol group will receive over-encapsulated whole marketed tablets comprised of 20mg oral propranolol \[USP grade\] filled with lactose monohydrate powder \[NF grade\] encapsulated with opaque gelatin capsules twice daily for 14 days (or until hospital discharge or death). The control group will receive an oral placebo comprised of lactose monohydrate powder \[NF grade\] encapsulated with indistinguishable opaque gelatin capsules. The pharmacy will have access to the randomization key. Nursing staff will remove the gelatin capsule casing and dissolve the trial drug \& placebo in sterile water prior to administering it enterally via a feeding tube to the participants. Aside from the nursing staff, the participants, research team, and remainder of the clinical care teams will all remain blinded to treatment allocation. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Propranolol name: Placebo measure: Hospital Mortality measure: Cognitive function measure: Catecholamines/Inflammatory markers sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

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

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

 nctId: NCT06262022 id: KaramanogluMehmetbeyUFGok briefTitle: The Effect of Cold Application on Pain Level, Edema and Drainage Amount overallStatus: RECRUITING date: 2024-01-15 date: 2024-04-30 date: 2024-04-30 date: 2024-02-15 date: 2024-02-15 name: Karamanoğlu Mehmetbey University class: OTHER name: Karaman Training and Research Hospital briefSummary: In this study, we aimed to investigate the effect of cold application applied for 20 minutes every hour for 8 hours on the first day, second and third days after total hip arthroplasty with gel pads, on the pain level, edema and drainage amount of total hip arthroplasty patients. The main question\[s\]it aims to answer are:

* Is there a difference between the pain levels of patients in the control and cold application arms?
* Is there a difference between the knee edema of patients in the control and cold application arms?
* Is there a difference between the amount of drainage of patients in the control and cold application arms? This study was planned as a prospective, parallel, two-arm (1:1) randomized controlled trial (RCT). conditions: Cold Therapy conditions: Pain, Postoperative studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study was planned as a prospective, parallel, two-arm (1:1) randomized controlled trial (RCT). primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 78 type: ESTIMATED name: cold therapy measure: pain level measure: edema measure: amount of drainage measure: Analgesic consumption sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Karamanoğlu Mehmet bey Üniversitesi status: RECRUITING city: Merkez state: Karaman zip: 70100 country: Turkey name: fatma gök role: CONTACT phone: 05544906142 email: fatmagok123@gmail.com hasResults: False

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

 nctId: NCT06261996 id: henanFSH briefTitle: Safety and Efficacy of Fospropofol vs Propofol During Invasive Mechanical Ventilation. overallStatus: NOT_YET_RECRUITING date: 2024-02-12 date: 2025-01-15 date: 2025-01-15 date: 2024-02-15 date: 2024-02-15 name: Henan Provincial People's Hospital class: OTHER briefSummary: The goal of this clinical trial is to compare the safety and efficacy of fospropofol and propofol during sedation in invasively mechanically ventilated patients in the Anesthesia Intensive Care Unit (AICU). Specific objectives include the following:

* Evaluate the sedative effects of fospropofol and propofol in invasively mechanically ventilated patients. Compare the sedative effects of the two medications using relevant clinical indicators and scoring tools, such as the Richmond Agitation-Sedation Scale (RASS).
* Compare the safety of fospropofol and propofol during sedation. Monitor medication-related adverse reactions, such as respiratory depression, hypotension, arrhythmias, headache, injection site pain, and assess the differences in adverse reaction incidence between the two medications.
* Compare the characteristics of recovery from sedation between PPD and propofol. Focus on the time from sedation to emergence from sedation and compare the differences in recovery time between the two medications.

Participants will be sedated with fospropofol or propofol during invasive mechanical ventilation. conditions: Invasive Mechanical Ventilation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Fospropofol measure: The patient's Richmond Agitation-Sedation Scale (RASS) score and the incidence of adverse reactions measure: Incidence of adverse reactions during the follow-up period measure: Extubation time sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

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

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

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

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

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

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

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

 nctId: NCT06261892 id: 2023-002 briefTitle: Non-invasive Biomarker Discovery for Pre-cervical or/and Cervical Cancer-HPV DNA and Other Biomarkers in Urine overallStatus: RECRUITING date: 2023-07-20 date: 2025-06 date: 2025-06 date: 2024-02-15 date: 2024-02-15 name: WomenX Biotech Limited class: INDUSTRY name: Hong Kong Science and Technology Parks Corporation briefSummary: The goal of this clinical trial is

1. To test the sensitivity and specificity of using HPV DNA from urine for the detection of pre-cervical or/and cervical cancer.
2. If HPV DNA is not a promising biomarker, other biomarkers will be explored.
3. To develop an effective and non-invasive detection method of the pre-cervical or/and cervical cancer. in Women with menstruation.

The main question it aims to answer is:

To validate whether HPV DNA from urine could be used as a non-invasive means for the detection of pre-cervical or cervical cancer

Participants will

1. Join the briefing session of the study
2. Sign the consent form and health questionnaire
3. Submit the cervical medical report(s) within 3 months or perform sponsored pap smear test
4. Collect the urine sample

If there is a comparison group: Researchers will compare The diseased group and the healthy group according to the medical reports they provided to see if HPV DNA from urine is a promising biomarker for the detection of pre-cervical or cervical cancer conditions: Cervical Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 300 type: ESTIMATED name: Collect HPV DNA from urine measure: HPV DNA from urine is a promising biomarkers for the detection of pre-cervical/ cervical cancer sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: WomenX Biotech Limited status: RECRUITING city: Hong Kong country: Hong Kong name: Alan LIU, Master role: CONTACT phone: +852 64786939 email: alanliu@womenx.net lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06261879 id: 2023-001 briefTitle: Non-invasive Biomarker Discovery for Pre-cervical or/and Cervical Cancer--ACTN4 and Other Biomarkers in Menstrual Blood overallStatus: RECRUITING date: 2023-07-20 date: 2025-06 date: 2025-06 date: 2024-02-15 date: 2024-02-15 name: WomenX Biotech Limited class: INDUSTRY briefSummary: The goal of this clinical trial is

1. To test the sensitivity and specificity of using ACTN4 from menstrual blood for the detection of pre-cervical or/and cervical cancer.
2. If ACTN4 is not a promising biomarker, other biomarkers will be explored.
3. To develop an effective and non-invasive detection method for pre-cervical or/and cervical cancer.

in Women with menstruation.

The main question it aims to answer is:

To validate whether menstrual blood could be used as a non-invasive means for the detection of pre-cervical or cervical cancer

Participants will

1. Join the briefing session of the study
2. Sign the consent form and health questionnaire
3. Submit the cervical medical report(s) within 3 months or perform sponsored pap smear test
4. Collect the menstrual blood sample

If there is a comparison group: Researchers will compare The diseased group and the healthy group according to the medical reports they provided to see if ACTN4 from menstrual blood is a promising biomarker for the detection of pre-cervical or cervical cancer conditions: Cervical Cancer conditions: CIN studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 300 type: ESTIMATED name: Special sanitary pad measure: ACTN4 is a promising biomarkers for the detection of pre-cervical/ cervical cancer sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: WomenX Biotech Limited status: RECRUITING city: Hong Kong country: Hong Kong name: Alan LIU, Master role: CONTACT phone: +852 64786939 email: alanliu@womenx.net lat: 22.27832 lon: 114.17469 hasResults: False

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

 nctId: NCT06261853 id: 2-081-23 briefTitle: The Impact of 3D-CBCT Imaging on Nerve Injuries During Wisdom Tooth Surgery acronym: IMPACTION overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-05 date: 2025-05 date: 2024-02-15 date: 2024-02-28 name: University of Aberdeen class: OTHER name: Zarqa University name: King's College London briefSummary: The investigators aim to investigate if the additional information available from a 3D scan of the wisdom tooth can reduce the risk of nerve injury during wisdom tooth surgery compared to conventional 2D images.

Wisdom tooth surgery is a common surgical procedures that a significant proportion of the population will undergo. As with any other surgical procedure, there are potential complications, of which, injury to the nerve supplying feeling to the lip, chin, and tongue is the most significant. This can lead to persistent pain, tingling, or numbness that may impact a patient's ability to eat and function.

The risk of nerve injury during wisdom tooth surgery is assessed using X-ray images, which show the position of the nerve and tooth in the jawbone. 2D and 3D scans are used, which have their own advantages and disadvantages such as reduced cost and radiation dose with 2D or more information from 3D images, but it remains unclear which is better at reducing the risk of nerve injuries. conditions: Inferior Alveolar Nerve Injuries conditions: Impacted Third Molar Tooth studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Pragmatic, two-arm, single-blinded, randomised controlled trial designed to investigate the differences between 3D cone-beam computerised tomography (CBCT) and 2D orthopantomography (OPG) in reducing inferior alveolar nerve injuries during wisdom tooth surgery. primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Double (Participant, Outcomes Assessor) A single-blinded methodology will be employed due to the nature of the image-based investigation where the surgeon is required to utilise one imaging modality during the surgery. In order to eliminate any influence or bias on the outcomes and data obtained for the primary objective, both the subject (patient) and the study member who will do the follow-up call will be blinded to the imaging techniques used on the day of surgery. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 1292 type: ESTIMATED name: 3D-CBCT name: 2D-OPG measure: The number of patients reporting altered sensation in their lip and/or chin on the side of wisdom tooth surgery measure: Surgical time measure: Planned surgical approach measure: Intraoperative complications measure: Postoperative Complications measure: Wisdom tooth impaction classification sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: King'S College Hospital Nhs Foundation Trust city: London state: England zip: SE5 9RS country: United Kingdom name: Nadine Khawaja, BDS PhD role: CONTACT email: nadine.khawaja@kcl.ac.uk name: Nadine Khawaja role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 facility: Aberdeen Dental Hospital city: Aberdeen state: Scotland zip: AB25 2ZR country: United Kingdom name: Anand Lalli, BDS PhD role: CONTACT phone: 01224553515 email: anand.lalli@nhs.scot name: Rahmeh Alhyari, BDS role: CONTACT email: r.alhyari.22@abdn.ac.uk name: Anand Lalli, Consultant in Oral Surgery role: PRINCIPAL_INVESTIGATOR lat: 57.14369 lon: -2.09814 hasResults: False

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

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

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

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

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

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

 nctId: NCT06261762 id: SDC-24-1 briefTitle: Hard and Soft Tissue Dimensional Change After Consecutive Extractions and Unassisted Socket Healing in the Esthetic Zone overallStatus: NOT_YET_RECRUITING date: 2024-02-29 date: 2026-06-30 date: 2026-06-30 date: 2024-02-15 date: 2024-02-15 name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University class: OTHER briefSummary: The goal of this observational study is to evaluate the post-extraction hard and soft tissue dimension changes in patients requiring consecutive extractions and unassisted socket healing in the anterior maxilla. The main questions it aims to answer are:

* Is significant alveolar ridge resorption observed at center sites after consecutive extractions
* Is significant alveolar ridge resorption observed at the interalveolar septum after consecutive extractions, are different extraction sites associated with significantly different bone resorption
* Is a thick or thin wall phenotype associated with the amount of bone resorption
* Is soft tissue thickness change associated with the corresponding location (extraction site or interalveolar septum) and post-extraction thickness of the bone
* Is the interdental papilla height significantly affected after extractions.

Participants will undergo consecutive (two) extractions and will be evaluated after subsequent unassisted socket healing for 8 weeks. conditions: Wound Heal studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED measure: Bone level change from baseline measure: Soft tissue change from baseline measure: Correlation between baseline facial bone thickness and dimensional soft tissue alterations during healing at the interalveolar septum. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

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

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

 nctId: NCT06261723 id: PI22/1009 briefTitle: Effect of Non-chirurgical Periodontal Treatment on the Immune System From a Gender Perspective overallStatus: RECRUITING date: 2024-02-15 date: 2025-09-01 date: 2025-12-31 date: 2024-02-15 date: 2024-04-16 name: Milagros Rocha Barajas class: OTHER name: Instituto de Salud Carlos III briefSummary: The goal of this observational study is to evaluate non-surgical periodontal treatment in women and men with periodontitis with and without obesity. The main questions it aims to answer are:

* If non-surgical periodontal treatment of patients with chronic periodontitis can modulate the innate and adaptive immune response taking into account patient gender and the coexistence of obesity
* If there are specific miRNAs that can regulate this immune response and can be considered as suitable biomarkers and therapeutic targets.

Obese or non-obese participants with periodontitis will receive non-surgical periodontal treatment, consisting of oral health guidance and mechanical periodontal debridement throughout the mouth using an ultrasonic device and manual curettes. Researchers will compare four groups: obese women, non-obese women, obese men, and non-obese men, to clarify the involment of immune response after treatment, considering the coexistence of obesity and potential gender differences. conditions: Periodontal Diseases studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED name: non-chirurgical periodontal treatment measure: Changes in inflammasome complex activation grade in patients with chronic periodontitis with and without obesity, before and after non-surgical periodontal treatment. measure: Changes in endothelial function in the study population. measure: Changes in endothelial function at molecular level in the study population. measure: Changes in the systemic inflammation status in the study population. measure: Changes in the expression of genes related to inflammatory pathways in PBMC in the study population. measure: Changes in the expression of genes related to oxidative stress levels in PBMC in the study population. measure: Changes in the expression of genes related to cellular respiration in PBMC in the study population. measure: Sequence miRNAs in biological fluids in patients with chronic periodontitis with and without obesity, before and after non-surgical periodontal treatment. measure: Evaluate the distribution and phenotype of different T lymphocyte and monocyte subpopulations in the study population. measure: Changes in the protein expression of autophagy markers in PBMC in the study population. measure: Evaluate autophagy flux in the study population. measure: Evaluate autophagosome formation in the study population. sex: ALL minimumAge: 18 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Dr Peset status: RECRUITING city: Valencia zip: 46017 country: Spain name: Milagros Rocha Barajas, PhD role: CONTACT phone: 0034 963 189 132 email: milagros.rocha@fisabio.es name: Milagros Rocha Barajas, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.46975 lon: -0.37739 facility: University Hospital Dr. Peset status: RECRUITING city: Valencia zip: 46017 country: Spain name: Milagros Rocha Barajas role: CONTACT phone: 963188875 email: milagros.rocha@fisabio.es lat: 39.46975 lon: -0.37739 hasResults: False

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

 nctId: NCT06261697 id: P.T.REC/012/004876 briefTitle: Relationship Between Smartphone Addiction and Temporomandibular Joint Disorders Among Adults in Egypt. overallStatus: NOT_YET_RECRUITING date: 2024-02-20 date: 2024-04 date: 2024-06 date: 2024-02-15 date: 2024-02-21 name: Cairo University class: OTHER briefSummary: Cross sectional study to investigate the relation between Smartphone addiction and temporomandibular disorders among youth population in Egypt. An online- based questionnaire study. A 296 participants who are Egyptians with age between18 and 35 years old without prior neck and upper extremity related diseases, orofacial trauma or surgeries, history of rheumatoid arthritis or congenital musculoskeletal problems. An online- based questionnaire will be sent through different social media platforms, it will include three screens, the first includes the consent form, the second includes the demographic data (year of birth, current educational status, gender and geographic information ), and the third page includes questionnaires

. conditions: Temporomandibular Disorders conditions: Smartphone Addiction studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 296 type: ESTIMATED name: A web based survey measure: Fonseca Anamnestic Index (FAI) questionnaire measure: Smartphone Addiction Scale-Short version (SAS-SV) questionnaire measure: Patient Health Questionnaire (PHQ) sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT hasResults: False

 nctId: NCT06261684 id: MS-259-2023 briefTitle: Intralesional Acyclovir Versus Cryotherapy in the Treatment of Plantar Warts. A Randomized Controlled Trial. overallStatus: RECRUITING date: 2023-10-01 date: 2024-10-01 date: 2024-10-01 date: 2024-02-15 date: 2024-02-15 name: Cairo University class: OTHER briefSummary: The goal of this prospective randomized controlled study is to study the safety and efficacy of intralesional acyclovir compared to cryotherapy in plantar warts. The main questions needed to be answered are:

1. Is Intralesional acyclovir safe for plantar warts?
2. Is Intralesional acyclovir more efficient in treating plantar warts compared to cryotherapy? conditions: Plantar Wart studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 92 type: ESTIMATED name: Intralesional Acyclovir name: Cryotherapy measure: Cure rate measure: Recurrence rate measure: Patient satisfaction score measure: Correlation of treatment with number of ipsilateral warts measure: Correlation of treatment with age measure: Correlation of treatment with gender measure: Correlation of treatment with size of the wart sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cairo University Hospital status: RECRUITING city: Cairo country: Egypt name: Basant Helal, MRCP role: CONTACT name: Shahira Ramadan, Professor role: PRINCIPAL_INVESTIGATOR name: Yousra Azzazi, Lecturer role: SUB_INVESTIGATOR lat: 30.06263 lon: 31.24967 hasResults: False

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

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

 nctId: NCT06261645 id: ROTOFUNK_2_2023 briefTitle: Rotofunc - Non-traumatic Shoulder Instability and Total Rotator Cuff Function acronym: ROTOFUNC overallStatus: RECRUITING date: 2023-05-01 date: 2025-12 date: 2026-12 date: 2024-02-15 date: 2024-03-08 name: Sahlgrenska University Hospital, Sweden class: OTHER briefSummary: The goal of this clinical trial is to test the effect of a novel assessment and treatment strategy for young adults with severely disabling non-traumatic shoulder instability. The main question it aims to answer is if this treatment will substantially change the patients shoulder function to a more stable and controllable state and thereby give a higher quality of life. Participants failure in active shoulder muscle function will be assessed and exercises will be selected individually. Patients will be asked to perform the exercises twice per day. At clinical visits to a specialized physiotherapist the exercises will be upgraded to restore full dynamic stability throughout shoulder movement range. The active treatment period will be 4 months. Researchers will compare two groups. One group will start directly after a baseline assessment is fulfilled. The other group will receive the treatment with a delay of 4 months to evaluate if the selected exercises can substantially change the shoulder stability compared to no treatment, the natural course of the condition. conditions: Shoulder Dislocation or Subluxation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: A 16 week exercise program with specific exercises to restore total rotator cuff function individually selected during clinical physiotherapy visits and performed 2 - 4 times daily.

In addition, the patient will receive education and guidance in the daily use of the arm to adjust to appropriate load on the shoulder. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Investigator: 6 physiotherapists are care providers, responsible for the Intervention . Two independent investigators does not know who is the actual care provider. However, all patients recieve the same intervention.

Outcome assessor: each participant is given a research code. The results from the assessments are entered in the data base by a research assistant, not involved in the study on any level.

Individuals are not identifiable. The outcome assessor are planning for all statistics used and is not in other ways involved in the study. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Early Physiotherapist selected active exercises name: Delayed Physiotherapist selected active exercises measure: Neuromuscular control measure: Clinical assessment - Active and passive range of motion measure: Pain at rest measure: Pain during motion measure: Apprehension of instability during motion measure: Patient reported quality-of-life in relation to shoulder function measure: Patient's satisfaction sex: ALL minimumAge: 16 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: Sahlgrenska University Hospital/Mölndal, Physiotherapy Dpt status: RECRUITING city: Gothenburg state: Mölndal zip: SE 43180 country: Sweden name: Ingrid K Hultenheim Klintberg, PhD role: CONTACT email: ingrid.hultenheim-klintberg@vgregion.se lat: 57.70716 lon: 11.96679 hasResults: False

 nctId: NCT06261632 id: Hemo-Blood briefTitle: Blood Flow Restriction in Improving Muscle Strength of Patients With Hemophilic Knee Arthropathy overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-19 date: 2024-07-28 date: 2024-11-01 date: 2024-02-15 date: 2024-02-20 name: Investigación en Hemofilia y Fisioterapia class: NETWORK briefSummary: Background. The main physical sequela of patients with hemophilia is the development of a progressive, degenerative intra-articular lesion, known as hemophilic arthropathy). This sequela is manifested by chronic pain, limited range of motion, axial abnormalities, and periarticular muscle atrophy.

Objective. To assess the safety and effectiveness of an intervention through blood flow restriction, regarding the frequency of bleeding and the improvement in muscle activation and strength, range of motion, functionality, joint pain, joint status and the perception of quality of life in patients with hemophilic arthropathy. knee and ankle.

Study design. Randomized, multicenter, single-blind clinical study. Method. 60 patients with hemophilia A and B will be recruited in this study. Patients will be recruited in 6 regions of Spain. The dependent variables will be: bleeding frequency (self-registration), pain (measured with the visual analog scale and pressure algometer), quality of life (SF-36 scale), joint status (Hemophilia Joint Health Score scale), strength (dynamometer) and muscle activation (surface electromyograph), range of motion (goniometer) and functionality (Timed up and go test). Three evaluations will be carried out: pre-treatment, post-treatment and after a follow-up period of 4 weeks.

Expected results. Observe the safety of blood flow restriction in hemophilia patients. To analyze the efficacy of blood flow restriction in improving muscle strength and activation, range of motion, chronic pain, functionality, and the perception of quality of life in patients with hemophilic knee and ankle arthropathy. conditions: Hemophilia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Blood flow restriction measure: Change from baseline hemarthrosis after treatment and at four weeks measure: Change from baseline pressure pain threshold after treatment and at four weeks measure: Change from baseline muscle strength after treatment and at four weeks measure: Change from baseline electrical activity of the muscles after treatment and at four weeks measure: Change from baseline range of motion after treatment and at four weeks measure: Change from baseline joint status after treatment and at four weeks measure: Change from baseline functionality after treatment and at four weeks sex: MALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: University of Oviedo city: Oviedo state: Asturias zip: 33006 country: Spain lat: 43.36029 lon: -5.84476 hasResults: False

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

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

 nctId: NCT06261593 id: Ankle-Blood briefTitle: Blood Flow Restriction in Improving Muscle Strength of Patients With Hemophilic Ankle Arthropathy overallStatus: RECRUITING date: 2024-04-06 date: 2024-07-03 date: 2024-09-20 date: 2024-02-15 date: 2024-02-20 name: Investigación en Hemofilia y Fisioterapia class: NETWORK briefSummary: Background. The main physical sequela of patients with hemophilia is the development of a progressive, degenerative intra-articular lesion, known as hemophilic arthropathy). This sequela is manifested by chronic pain, limited range of motion, axial abnormalities, and periarticular muscle atrophy.

Objective. To assess the safety and effectiveness of an intervention through blood flow restriction, regarding the frequency of bleeding and the improvement in muscle activation and strength, range of motion, stability, joint pain, joint status and the perception of quality of life in patients with hemophilic ankle arthropathy.

Study design. Randomized, multicenter, single-blind clinical study. Method. 32 patients with hemophilia A and B will be recruited in this study. Patients will be recruited in 4 regions of Spain. The dependent variables will be: bleeding frequency (self-registration), pain (measured with the visual analog scale and pressure algometer), quality of life (SF-36 scale), joint status (Hemophilia Joint Health Score scale), strength (dynamometer) and muscle activation (surface electromyograph), range of motion (goniometer) and stability (The Single Leg Stance Test). Three evaluations will be carried out: pre-treatment, post-treatment and after a follow-up period of 4 weeks.

Expected results. Observe the safety of blood flow restriction in hemophilia patients. To analyze the efficacy of blood flow restriction in improving muscle strength and activation, range of motion, chronic pain, stabilit, and the perception of quality of life in patients with hemophilic ankle arthropathy. conditions: Hemophilia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Blood flow restriction measure: Change from baseline hemarthrosis after treatment and at 4 weeks measure: Change from baseline pressure pain threshold after treatment and at 4 weeks measure: Change from baseline muscle strength after treatment and at 4 weeks measure: Change from baseline electrical activity of the muscles after treatment and at 4 weeks measure: Change from baseline joint status after treatment and at 4 weeks measure: Change from baseline range of motion after treatment and at four weeks measure: Change from baseline balance after treatment and at four weeks sex: MALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: University of Oviedo status: RECRUITING city: Oviedo state: Asturias zip: 33006 country: Spain name: Rubén Cuesta-Barriuso, PhD role: CONTACT lat: 43.36029 lon: -5.84476 hasResults: False

 nctId: NCT06261580 id: TP-CLN-100502 briefTitle: Normal Reference Range Study With the TEG6s Heparin Neutralization Cartridge in Healthy Volunteers overallStatus: COMPLETED date: 2021-07-28 date: 2021-10-25 date: 2021-10-25 date: 2024-02-15 date: 2024-02-15 name: Haemonetics Corporation class: INDUSTRY name: Machaon Diagnostics name: ClinStatDevice briefSummary: This trial holds minimal risk to the trial volunteers and consists of obtaining whole blood via venipuncture to perform coagulation parameter measurements to define a Normal Reference Range.

Written consent to participate in the study will be obtained prior to volunteer screening per site procedures. conditions: Healthy studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 181 type: ACTUAL name: TEG 6s Citrated K, KH, RTH, and FFH Cartridge name: Clauss Fibrinogen measure: CK-MA TEG Parameter measure: CK-R TEG Parameter measure: CKH-MA TEG Parameter measure: CKH-R TEG Parameter measure: CKH-LY30 TEG Parameter measure: CRTH-MA TEG Parameter measure: CFFH-MA TEG Parameter sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Machaon Diagnostics city: Oakland state: California zip: 94609 country: United States lat: 37.80437 lon: -122.2708 facility: Cardiovascular Research Institute - Loyola University Chicago Health Sciences city: Maywood state: Illinois zip: 60153 country: United States lat: 41.8792 lon: -87.84312 facility: Louisiana Coagulation / Machaon Division city: New Orleans state: Louisiana zip: 70118 country: United States lat: 29.95465 lon: -90.07507 hasResults: False

 nctId: NCT06261567 id: D2287R00189 briefTitle: A Retrospective Chart Review to Investigate Clinical Remission in Patients With Severe Asthma Treated With Biologics in the United Kingdom National Health Service acronym: REMISSION UK overallStatus: RECRUITING date: 2024-02-27 date: 2024-09-27 date: 2024-09-27 date: 2024-02-15 date: 2024-04-23 name: AstraZeneca class: INDUSTRY briefSummary: Asthma is a common lung condition that causes occasional breathing difficulties and affects around 5.4 million people in the UK of all ages. Common symptoms can include wheezing when breathing, breathlessness, a tight chest and coughing. However, these symptoms can get worse and lead to an asthma attack which can be fatal.

There is currently no cure for asthma but there are treatments that can help keep the symptoms under control. The main types of treatment include reliever inhalers used when needed quickly to reverse asthma symptoms for a short time, and preventer inhalers that are used everyday to prevent symptoms for starting. Unfortunately, not all patients are able to control their asthma on these treatments alone. Biologic treatments, also known as monoclonal antibodies, have been introduced to treat certain types of severe asthma over recent years. These specialist treatments use antibodies produced from cells in a laboratory to help reduce inflammation and might offer the possibility of higher levels of disease control including the reduction or absence of symptoms and normal lung function. This higher level of disease control is called remission.

This study aims to understand whether or not remission is possible in patients with severe asthmas treated with biologics in the NHS. This study will take place a 4 specialist asthma centres in the UK and seeks to include retrospective data from approximately 450 adult patients that were treated with biologics as part of routine care between 01 October 2021 and 30 September 2022. Data will be collected directly from medical records and entered into the study database in a pseudonymised format by members of the direct care team ready for analysis. conditions: Asthma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 425 type: ESTIMATED name: Biologic treatment measure: Proportion of patients in clinical remission measure: Number and proportion achieving specific criteria for clinical remission measure: Number and proportion of super-responders measure: Number and proportion of responders measure: Number and proportion of non-responders measure: Age at index measure: Sex measure: Ethnicity measure: Smoking status measure: BMI measure: IMD quintile measure: Comorbidities measure: COVID-19 vaccination status measure: Fractional Exhaled Nitric Oxide (FeNO) measure: Blood eosinophil count (EOS) measure: IgE measure: ACQ-6 measure: AQLQ measure: lung function (FEV1) measure: Rate of exacerbation in prior 12 months measure: Asthma treatments at 6 months measure: Asthma treatments at 12 months measure: Annualised exacerbation rate (AER) measure: mOCS use (proportion with 0 mg/day) measure: ACQ-6 score measure: AQLQ score measure: Lung function (FEV-1) measure: Respiratory infections measure: Annualised exacerbation rate (AER) measure: mOCS use (proportion with 0 mg/day) measure: ACQ-6 score measure: AQLQ score measure: Lung function (FEV-1) measure: Respiratory infections sex: ALL minimumAge: 18 Years maximumAge: 130 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site status: NOT_YET_RECRUITING city: Birmingham country: United Kingdom lat: 52.48142 lon: -1.89983 facility: Research Site status: RECRUITING city: London country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Research Site status: NOT_YET_RECRUITING city: Manchester country: United Kingdom lat: 53.48095 lon: -2.23743 facility: Research Site status: RECRUITING city: Southampton country: United Kingdom lat: 50.90395 lon: -1.40428 hasResults: False

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

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

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

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

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

 nctId: NCT06261489 id: REB23-1128 briefTitle: Cannabis (THC vs. CBD) in Multiple Sclerosis overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-09 date: 2025-12 date: 2024-02-15 date: 2024-02-15 name: University of Calgary class: OTHER name: Multiple Sclerosis Society of Canada briefSummary: The goal of this clinical trial is to examine the effect of Cannabis components, THC and CBD, on cognition and bladder symptoms in people with Multiple Sclerosis (MS).

Participants will complete questionnaires and cognitive tests. They will be randomly assigned to receive either CBD or THC oil and will take the study drug for 15 weeks. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: THC name: CBD measure: Cognitive outcome: The Differential Effect, if any, of THC and CBD in MS Cognition will be measured by Symbol Digit Modality Test (SDMT). measure: NLUTD outcome: The Differential Effect, if any, of THC and CBD on Neurogenic lower urinary tract dysfunction (NLUTD) symptoms will be measured by Neurogenic Bladder Symptom Score (NBSS). measure: Blinding feasibility: The ability to blind the administration of THC vs CBD in PwMS will be evaluated based on participants and investigators report. sex: ALL minimumAge: 18 Years maximumAge: 59 Years stdAges: ADULT hasResults: False

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

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

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

 nctId: NCT06261437 id: M-11053 id: MO230060 type: OTHER_GRANT domain: Military Operational Medicine Research Program (MOMRP) briefTitle: Effect of Ration Formulations on Warfighter Energy Balance and Physical Performance During a Field Training Exercise overallStatus: NOT_YET_RECRUITING date: 2024-02-22 date: 2024-03-04 date: 2024-03-04 date: 2024-02-15 date: 2024-02-15 name: United States Army Research Institute of Environmental Medicine class: FED briefSummary: The goal of this randomized clinical trial is to determine the effects of consuming the Close Combat Assault Ration (CCAR) compared to the First Strike Ration (FSR) during a 7-day strenuous military training on energy intake and energy balance in healthy, Active Duty Warfighters.

The main questions it aims to answer are:

* Will consuming the CCAR result in lower energy intake or energy balance compared to consumption of the FSR?
* Will consuming the CCAR result in lower lower body strength or anaerobic power compared to consuming the FSR?
* Will those consuming the CCAR report lower ration acceptability or greater gastrointestinal side effects compared to those consuming the FSR?

Participants will be asked to consume either the CCAR or FSR as the sole nutrition source during a 7-day field training exercise (FTX). The vertical jump test, running-based anaerobic sprint test, and lower-body strength pull will be conducted pre and post the 7-day FTX to assess physical performance. Energy expenditure and intake will be measured by the doubly-labelled water method and dietary logs, respectively. Surveys will be completed to assess ration acceptability and gastrointestinal symptoms.

Researchers will compare the CCAR and FSR groups to see if their consumption impacted energy intake, energy balance, physical performance, ration acceptance, or gastrointestinal side effects. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: CCAR name: FSR measure: Energy intake measure: Energy expenditure measure: Energy balance measure: Physical performance (vertical jump) measure: Physical performance (peak power) measure: Physical performance (Anaerobic capacity) measure: Physical performance (lower-body strength) measure: Food acceptance scale measure: Gastrointestinal Quality of Life Index measure: Hunger and Satiety Visual Analog Scales sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: U.S. Army Research Institute of Environmental Medicine city: Natick state: Massachusetts zip: 01760 country: United States name: USARIEM role: CONTACT phone: 508-206-2200 email: usarmy.natick.medcom-usariem.mbx.usariem-webmaster@health.mil name: Michael A Dawson, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.28343 lon: -71.3495 hasResults: False

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

 nctId: NCT06261411 id: 999430 id: FOU2024-00038 type: REGISTRY domain: Forskning och Utveckling (Region Uppsala) briefTitle: Lung Ultrasound as Alternative to Radiation in Thoracic Surgery acronym: LUS-ART overallStatus: ENROLLING_BY_INVITATION date: 2024-02-12 date: 2025-04-30 date: 2025-04-30 date: 2024-02-15 date: 2024-02-20 name: Uppsala University Hospital class: OTHER briefSummary: This projects aim is to study the effects of substitute conventional chest x-ray with lung ultrasound for patients undergoing thoracic surgery.

Participants in the study will be randomized to either ultrasound or routine chest x-ray as the primary method of diagnosis after having received surgery to their lungs. conditions: Thoracic Surgery conditions: Ultrasonography studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Case-Control primaryPurpose: DIAGNOSTIC masking: SINGLE maskingDescription: Inter-rater variability will be masked. whoMasked: OUTCOMES_ASSESSOR count: 110 type: ESTIMATED name: Lung Ultrasound measure: Reduction in chest x-ray measure: Re-insertion of chest tube measure: Delayed removal of chest tube measure: Time to chest tube removal measure: Patient Satisfaction measure: Missed Care measure: Inter-rater variability sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Uppsala Akademiska sjukhuset city: Uppsala state: Uppland zip: 751 85 country: Sweden lat: 59.85882 lon: 17.63889 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-02-02 uploadDate: 2024-02-07T05:12 filename: Prot_000.pdf size: 806384 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-02 uploadDate: 2024-02-07T05:12 filename: ICF_001.pdf size: 350352 hasResults: False

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

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

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

 nctId: NCT06261359 id: CEND1-202 briefTitle: A Study of CEND-1 With Chemotherapy as First-Line Therapy in Patients With Pancreatic Ductal Adenocarcinoma overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-04 date: 2026-10 date: 2024-02-15 date: 2024-02-15 name: Qilu Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study is to evaluate the efficacy and safety of CEND-1 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo as first-line treatment in patients with Locally Advanced Unresectable or Metastatic Pancreatic Ductal Adenocarcinoma. conditions: Pancreatic Ductal Adenocarcinoma (PDAC) studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: CEND-1 name: Gemcitabine name: Nab paclitaxel measure: Objective response rate (ORR) measure: Overall Survival (OS) measure: Progression Free Survival(PFS) measure: 6-month PFS rate measure: Duration Of Response (DOR) measure: Disease Control Rate (DCR) measure: Incidence of AEs, SAEs and treatment-emergent adverse events (TEAEs) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chinese People's Liberation Army (PLA) General Hospital city: Beijing state: Beijing zip: 100000 country: China lat: 39.9075 lon: 116.39723 hasResults: False

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

 nctId: NCT06261333 id: 23-11519-BO briefTitle: Quality of Life in Patients With Hemorrhagic Telangiectasia overallStatus: ENROLLING_BY_INVITATION date: 2024-01-22 date: 2024-12-31 date: 2025-12-31 date: 2024-02-15 date: 2024-02-15 name: University Hospital, Essen class: OTHER briefSummary: Hereditary Hemorrhagic Telangiectasia (HHT), also known as Osler's disease, is a genetic disorder that leads to abnormal blood vessel formations. It primarily affects blood vessels in the skin, mucous membranes, and internal organs. The disease can be clinically diagnosed using the Curaçao criteria (1. Positive family history of HHT, 2. Recurrent and spontaneous epistaxis, 3. Multiple typical telangiectasias, 4. Organ involvement with vascular malformations, especially in the liver, lungs, gastrointestinal tract, or brain); if a patient meets at least 3 criteria, the diagnosis of HHT can be established.

Patients with HHT often have telangiectasias on their faces. Additionally, many patients suffer from anemia, which can result in a pale and potentially tired appearance. Patients with HHT may be less satisfied with their appearance due to the aesthetic changes in their faces and may also experience psychosocial impairment. To further investigate this, various validated questionnaires (FACE-Q©, PROMIS-Profile-29+2, EQ5D), as well as routinely collected clinical data (e.g., laboratory values including hemoglobin levels, Curaçao criteria, smoking status, alcohol consumption, and the Epistaxis Severity Score (ESS)) will be used. conditions: Hereditary Hemorrhagic Telangiectasia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: Questionnaires measure: Quality of Life and Patient Satisfaction measured using the FACE-Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Departement of Otorhinolaryngology - Head and Neck Surgery University Hospital Essen city: Essen state: NRW zip: 45147 country: Germany lat: 51.45657 lon: 7.01228 hasResults: False

 nctId: NCT06261320 id: 2023-506950-18-00 briefTitle: Mesotherapy Treatment of Irritable Bowel Syndrome acronym: MESOCOLO overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-28 date: 2025-12-31 date: 2026-01-31 date: 2024-02-15 date: 2024-04-05 name: Polyclinique de l'Europe class: OTHER briefSummary: Irritable bowel syndrome (IBS) is a gastrointestinal transit disorder characterized by chronic abdominal pain and impaired transit in the absence of demonstrated organic disease. Considered a non-fatal disease, its effects relate more to quality of life, work production and health care systems.

Given the complexity of this disease, no treatment has been recognized as standard treatment. The treatment is rather focused on treating the symptoms caused (chronic pain or intestinal transit disorder). In general, therapy is considered individualized and includes lifestyle/diet modifications and pharmaceutical therapy.

Several published case studies evaluating the effect of mesotherapy on improving the severity of the disease have demonstrated an improvement in the symptoms of this syndrome. Due to the limited number of case studies and the insufficient level of evidence to conclude, our study will therefore be a before-and-after intervention study, to evaluate the effect of four mesotherapy sessions on the treatment of IBS symptoms. conditions: Inflammatory Bowel Diseases studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 27 type: ACTUAL name: Mesotherapy with mesocaine, thiocolchicoside, amitriptyline, magnesium pidolate measure: Irritable Bowel Syndrome Symptom Severity Scale(IBS-SSS) measure: Functional Digestive Disorders Quality of Life questionnaire (FDDQL) measure: Pain evaluation measure: Global satisfaction measure: Anxiety evaluation : Questionnaire "Hospital anxiety and depression scale" sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Polyclinique de l'Europe city: Saint-Nazaire zip: 44600 country: France lat: 47.28333 lon: -2.2 hasResults: False

 nctId: NCT06261307 id: 13462111 briefTitle: Language Development Deficits and Early Interactive Music Intervention acronym: BusyBaby overallStatus: RECRUITING date: 2024-03-11 date: 2026-03 date: 2027-03 date: 2024-02-15 date: 2024-04-05 name: University of Helsinki class: OTHER name: Folkhälsan Research Center name: Karolinska Institutet name: University of Turku name: University of Jyvaskyla name: Academy of Finland briefSummary: Investigators compare effects of 6-month music versus circus group interventions on language development in infants and toddlers with or without familial risk for dyslexia (anticipated total N=200). Effects of intervention timing, dyslexia risk and genetics, and social-emotional factors on the intervention outcomes are investigated. conditions: Dyslexia, Developmental conditions: Language Development Disorders conditions: Language Development studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The experimental arm will receive music training and the control arm will receive circus training. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: A dedicated member of the research team will be in charge of randomization of the participants to the two intervention arms, to ensure blindness of other team members. This member will not act as an outcomes assessor or a care provider.

The study will be presented to the caregivers as evaluating the effect of hobbies on language development. Therefore, the caregivers should not consider either intervention as the control arm. Both arms are expected to be potentially beneficial for the children's development.

Outcomes assessors will be unaware of the intervention arm and risk status (dyslexia risk vs no risk) of the children; caregivers will be reminded not to mention these to the researcher. Person in charge of randomization keeps track of violations of outcome assessor blindness. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Music intervention name: Circus intervention measure: Infant-Toddler Checklist (ITC) measure: MacArthur-Bates Communicative Development Inventory (MCDI) 8-16mo measure: Mismatch response (MMR) speech, amplitude measure: Mismatch response (MMR) speech, latency measure: Mismatch response (MMR) speech, laterality measure: Obligatory event-related potential (ERP) speech, amplitude measure: Obligatory event-related potential (ERP) speech, latency measure: Obligatory event-related potential (ERP) speech, laterality measure: Infant-Toddler Checklist (ITC) follow-up measure: MacArthur-Bates Communicative Development Inventory (MCDI) 16-30mo follow-up measure: Mismatch response (MMR) speech, amplitude follow-up measure: Mismatch response (MMR) speech, latency follow-up measure: Mismatch response (MMR) speech, laterality follow-up measure: Obligatory event-related potential (ERP) speech, amplitude follow-up measure: Obligatory event-related potential (ERP) speech, latency follow-up measure: Obligatory event-related potential (ERP) speech, laterality follow-up measure: Reynell Developmental Language Scales III (RDLS-III) measure: Infant Behavior Questionnaire Revised short form (IBQ-R-sf) measure: Early Childhood Behavior Questionnaire short form (ECBQ-sf) measure: Parenting Stress Index Short Form (PSI-sf) measure: Brief Infant-Toddler Social Emotional Assessment (BITSEA) measure: Parental dyslexia status (dyslexia - no dyslexia) measure: Allele groupings for dyslexia susceptibility genes measure: Gross and fine motor development measure: Bayley Scales III Motor scale measure: Mismatch response (MMR) music, amplitude measure: Mismatch response (MMR) music, latency measure: Mismatch response (MMR) music, laterality measure: Obligatory event-related potential (ERP) music, amplitude measure: Obligatory event-related potential (ERP) music, latency measure: Obligatory event-related potential (ERP) music, laterality measure: Music test scores (three parts of MMBB-MB) measure: Music-related activities measure: Musical background of parents measure: Home literacy measure: Multilingualism measure: Screen time sex: ALL minimumAge: 8 Months maximumAge: 12 Months stdAges: CHILD facility: University of Helsinki status: RECRUITING city: Helsinki zip: 00014 country: Finland name: Paula Virtala, PhD role: CONTACT phone: +358408446907 email: paula.virtala@helsinki.fi lat: 60.16952 lon: 24.93545 hasResults: False

 nctId: NCT06261294 id: CPIP-LUN-A001 briefTitle: OncoSweep Cancer Spotlight and Spectrum Product Line overallStatus: RECRUITING date: 2023-05-23 date: 2025-03-20 date: 2026-03-20 date: 2024-02-15 date: 2024-02-15 name: Pharus Taiwan, Inc. class: INDUSTRY briefSummary: CONQUER cancer study: To collect blood samples from cancer and non-cancer participants for development and validation of the 'OncoSweep Cancer Spotlight and Spectrum Product Line' conditions: Lung Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 800 type: ESTIMATED name: OncoSweep Lung Spotligh measure: To differentiate lung cancer signals from non-cancer signals based on analysis of OncoSweep Lung Spotlight. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mackay Memorial Hospital status: RECRUITING city: Taipei state: Zhongshan Dist zip: 104217 country: Taiwan name: Sheng-Hsiung Yang role: CONTACT phone: +886 2 2543-3535 email: lazatemax@gmail.com lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06261281 id: TBI cancel briefTitle: Effect of Intermittent Oro-esophageal Tube Feeding on Severe Traumatic Brain Injury Patient acronym: IOE-TBI overallStatus: WITHDRAWN date: 2024-02-10 date: 2024-07-10 date: 2024-07-10 date: 2024-02-15 date: 2024-03-06 name: Zeng Changhao class: OTHER briefSummary: This was a multicenter randomized controlled study of 98 severe Traumatic Brain Injury patients with tracheostomy. Patients enrolled were divided randomly into the observation group with Intermittent Oro-esophageal Tube Feeding or the control group with Nasogastric tube feeding for enteral nutrition support, respectively. Nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared. conditions: Traumatic Brain Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 0 type: ACTUAL name: Rehabilitation therapy name: Intermittent Oro-esophageal Tube Feeding name: Nasogastric tube feeding measure: Concentration of hemoglobin measure: Concentration of albumin measure: Concentration of prealbumin measure: Nutritional status-body mass index measure: Decannulation of tracheostomy tube-placement duration measure: Decannulation of tracheostomy tube-Successful removal measure: Level of consciousness measure: Feeding Amount sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zheng Da yi Yuan Hospital city: Zhengzhou state: Henan zip: 450000 country: China lat: 34.75778 lon: 113.64861 hasResults: False

 nctId: NCT06261268 id: Strip vs FGG briefTitle: Strip Graft w/ Xenogeneic Matrix vs Free Gingival Graft for the Augmentation of Peri-implant Keratinized Mucosa overallStatus: RECRUITING date: 2024-01-29 date: 2024-12-15 date: 2025-07-15 date: 2024-02-15 date: 2024-02-15 name: Universidad Complutense de Madrid class: OTHER briefSummary: The primary objective of this study is to compare changes in peri-implant keratinized mucosa (PIKM) following the application of apically repositioned flap (ARF) using a combination of a Strip graft and a Xenogeneic matrix, or with a free gingival graft (FGG), in implants in the second stage with \<2 mm of PIKM.

Additionally, as a secondary objective, the investigators compare postoperative blood supply in both recipient and donor sites based on the type of graft obtained. Meanwhile, the investigators evaluate differences between the two groups concerning microcirculation values (perfusion units, PU), soft tissue thickness (STT), volume change, vestibular depth, as well as clinical, aesthetic, and patient-reported outcome measures (PROMS). conditions: Peri-Implantational Loss conditions: Surgical Wound conditions: Healing Surgical Wounds conditions: Thin-gingiva studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomized controlled equivalence clinical trial will be performed, with two parallel groups, a 1:1 allocation ratio, and a 12-month follow-up. primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: Strip graft with Mucograft name: Free gingival graft measure: Changes in peri-implant keratinized mucosa width (mm) measure: Vascularization (in Laser Speckle perfusion units [LSPU]) measure: Changes in soft tissue thickness (STT) (mm) measure: Vestibule depth (VD) (mm) measure: Probing pocket depth (PPD) (mm) measure: Dehiscence (mm) measure: Full-mouth plaque score (FMPS) measure: Volumetric changes measure: Patient reported outcome measures (PROMS) measure: Esthetic analysis measure: Intra-surgical parameters measure: Intra-surgical time measure: Demographic data measure: Anamnesis data measure: Smoking habit measure: Full-mouth bleeding score (FMBS) (%) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Complutense University status: RECRUITING city: Madrid zip: 28040 country: Spain name: Mariano Sanz Alonso role: CONTACT phone: 913942021 email: marsan@ucm.es name: Andrea Dobos, DMD role: SUB_INVESTIGATOR name: David Palombo, DMD role: SUB_INVESTIGATOR lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06261255 id: ATT_CS briefTitle: Autotransplantation and Enamel Matrix Derivatives Case Series acronym: ATTCS overallStatus: COMPLETED date: 2020-06-01 date: 2023-09-01 date: 2023-12-01 date: 2024-02-15 date: 2024-02-15 name: Universidad Complutense de Madrid class: OTHER briefSummary: The goal of this prospective case series is to compare the adjunctive use of enamel matrix derivatives in the treatment of tooth autotransplantation in terms of clinical attachment level.

The main question it aims to answer is:

- What is the benefit, in terms of clinical attachment level, of using enamel matrix derivatives adjunctive to tooth autotransplantation?

Participants will be subjected to a digitally protocol of tooth autotransplantation.Only one group (test) is assessed. It will be supplemented with the application of enamel matrix derivatives before the placement of the transplanted tooth into the surgically produced alveolus. conditions: Tooth Loss studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This clinical investigation is a single-center, prospective case series study and is reported in compliance with the Preferred Reporting of Case Series in Surgery (PROCESS) guidelines. The study was conducted at the Department of Periodontology of the University Complutense of Madrid between March 2021 and September 2023. primaryPurpose: TREATMENT masking: NONE count: 14 type: ACTUAL name: ATT + EMD measure: Clinical attachment level (CAL) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universidad Complutense de Madrid city: Madrid zip: 28003 country: Spain lat: 40.4165 lon: -3.70256 facility: Universidad Complutense Madrid city: Madrid country: Spain lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06261242 id: TWM-C-2201 briefTitle: Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures Treatment overallStatus: RECRUITING date: 2023-06-16 date: 2025-02-28 date: 2025-07-31 date: 2024-02-15 date: 2024-02-16 name: National Cheng-Kung University Hospital class: OTHER briefSummary: This study is to evaluate the safety and effectiveness of the Tripod-Fix with Tecres Mendec® Spine HV System to treat subjects with osteoporotic vertebral compression fractures. conditions: Osteoporotic Vertebral Compression Fractures studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Tripod-Fix Vertebral Body Augmentation System (Tripod-Fix) measure: Proportion of participants with study success sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cheng Kung University Hospital Department of Orthopedics status: RECRUITING city: Tainan zip: 704 country: Taiwan name: Susan Guo role: CONTACT phone: +8666-2353535 phoneExt: 3690 name: Cheng-Li Lin role: PRINCIPAL_INVESTIGATOR lat: 22.99083 lon: 120.21333 hasResults: False

 nctId: NCT06261229 id: MURA2022/230 briefTitle: The Effectiveness of Intermittent Fasting and Behavioral Economics Intervention on Weight Control in Obese Patients overallStatus: ENROLLING_BY_INVITATION date: 2022-04-18 date: 2024-06-30 date: 2024-06-30 date: 2024-02-15 date: 2024-04-05 name: Mahidol University class: OTHER name: Health Systems Research Institute briefSummary: This study is a parallel randomized controlled trial (RCT). To determine the effect of intermittent fasting, intermittent fasting with behavioral economics, and intensive lifestyle modification on nutritional status; the differences between HOMA-IR, body weight change, and body composition in obese people.

Each participant will be randomized to receive the intervention (intermittent fasting, intermittent fasting with behavioral economics, or intensive lifestyle modification.

The study protocol will be explained to the eligible participant and informed written consent will be obtained.

The total sample size will be 123 participants. Blood and urine samples will be collected at baseline and each follow-up visit including 1-month, 2-months, 6-month, and 12-months, respectively for further study to find out the mechanisms of weight loss, weight regain, and the improvement in the metabolic disease. conditions: Intermittent Fasting conditions: Weight Loss conditions: Behavioral Economic conditions: Obese conditions: HOMA-IR studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 123 type: ESTIMATED name: Intermittent fasting name: Intermittent fasting + Behavioral economic name: Intensive Lifestyle Modification measure: HOMR-IR (index) measure: Body mass index (kg/m^2) measure: FBS (mg/dl) measure: HbA1C (%) measure: Albumin (g/L) measure: Creatinine (mg/dL) measure: Alanine transaminase (ALT) U/L measure: Aspartate transaminase (AST) U/L measure: Uric acid (mg/dL) measure: Total cholesterol (mg/dL) measure: HDL-C (mg/dL) measure: LDL-C (mg/dL) measure: Triglycerides (mg/dL) measure: Blood Urea Nitrogen (BUN) (mg/dL) measure: Urine albumin-creatinine ratio (UACR) (mg/g) measure: Energy from food (kilocalories) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mahidol University city: Ratchathewi state: Bangkok zip: 10400 country: Thailand lat: 13.759 lon: 100.53358 hasResults: False

 nctId: NCT06261216 id: 01/2023/LPA-wtATTR/NVNS briefTitle: Association Between Lifetime Physical Activity and Exercise and the Development of Wild-type Transthyretin Amyloid Cardiomyopathy overallStatus: RECRUITING date: 2024-02 date: 2025-02 date: 2025-02 date: 2024-02-15 date: 2024-02-15 name: Medical University of Graz class: OTHER name: Medical University Innsbruck briefSummary: The aim of this study is to investigate the association between increased lifetime physical activity and the development of wild-type transthyretin amyloid cardiomyopathy. conditions: Amyloid Cardiomyopathy conditions: Wild Type ATTR Amyloidosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 252 type: ESTIMATED name: Interview measure: Association between lifetime physical activity and disease development measure: Association between lifetime athletic activity and disease development sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of Graz status: RECRUITING city: Graz country: Austria name: PI role: CONTACT phone: 0043 316 385 30173 email: nicolas.verheyen@medunigraz.at name: Nicolas Verheyen, MD PhD role: PRINCIPAL_INVESTIGATOR name: Nora Schwegel, MD role: SUB_INVESTIGATOR lat: 47.06667 lon: 15.45 hasResults: False

 nctId: NCT06261203 id: Hany Hosny briefTitle: Low Dose Aspirin for Prevention of Early Pregnancy Loss overallStatus: RECRUITING date: 2023-07-01 date: 2025-07-01 date: 2025-07-15 date: 2024-02-15 date: 2024-02-15 name: Egymedicalpedia class: INDUSTRY briefSummary: Preeclampsia is a pregnancy-specific, multisystem disorder affecting 3% to 8% of pregnancies and remains a significant cause of maternal and neonatal morbidity and mortality worldwide.

The World Health Organization estimates that approximately 76,000 maternal deaths annually are attributed to preeclampsia, accounting for 16% of global maternal mortality, with the majority occurring in low- and middle-income countries conditions: Pre-Eclampsia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The The study's findings have the potential to clarify aspirin's role in preventing adverse pregnancy outcomes related to placental dysfunction and improve the management of women at risk of placental-mediated complications. primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 250 type: ESTIMATED name: Aspirin measure: Prevention of pregnancy loss sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Assuit University hospitals status: RECRUITING city: Asyūţ state: Assuit country: Egypt name: Mohamed Nagy, Lecturer role: CONTACT phone: 01096655458 email: drmnagy@aun.edu.eg name: Abdelrahman Mahmoud, Assist.Prof. role: PRINCIPAL_INVESTIGATOR lat: 27.18096 lon: 31.18368 hasResults: False

 nctId: NCT06261190 id: H-2308-182-1463 briefTitle: Active Surveillance for Low-risk Papillary Thyroid Carcinoma acronym: MAeSTroⅡ overallStatus: NOT_YET_RECRUITING date: 2024-03-04 date: 2029-12-31 date: 2032-12-31 date: 2024-02-15 date: 2024-02-26 name: National Cancer Center, Korea class: OTHER_GOV name: Seoul National University Bundang Hospital name: SMG-SNU Boramae Medical Center name: Seoul National University Hospital briefSummary: This study is an observational cohort study targeting patients with low-risk Papillary thyroid cancer who opted for active surveillance or immediate surgery based on a sufficient understanding of the treatment options. The primary objective of the study is to evaluate progression free survival of the patients with low-risk Papillary thyroid cancer who choose active surveillance, in other words, to observe the natural course of low-risk Papillary thyroid cancer. conditions: Thyroid Cancer conditions: Papillary Thyroid Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 499 type: ESTIMATED measure: Progression free survival of the patients with low-risk Papillary Thyroid Cancer who choose Active Surveillance measure: Disease progression measure: Rate of Participants in the Active Surveillance Group that change to surgery without disease progression measure: Comparison of Quality of Life between the Active Surveillance group and immediate surgery group measure: Measure of Anxiety and Depression measure: Measure of Satisfaction with the treatment measure: Factors influencing patients' decisions regarding disease management sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Center city: Goyang-si country: Korea, Republic of name: Eun Kyung Lee role: PRINCIPAL_INVESTIGATOR lat: 37.65639 lon: 126.835 facility: Seoul National University Bundang Hospital city: Seongnam country: Korea, Republic of name: Jae Hoon Moon role: PRINCIPAL_INVESTIGATOR lat: 37.43861 lon: 127.13778 facility: Seoul National University Hospital city: Seoul country: Korea, Republic of name: Young Joo Park role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: SMC-SNU Boramae Medical Center city: Seoul country: Korea, Republic of name: Ka Hi Lee role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06261177 id: 22-175 briefTitle: Take-home Functional Electrical Stimulation for MDD overallStatus: ACTIVE_NOT_RECRUITING date: 2023-12-04 date: 2024-12 date: 2025-03 date: 2024-02-15 date: 2024-02-15 name: Unity Health Toronto class: OTHER briefSummary: The purpose of this study is to learn whether Functional Electrical Stimulation (FES) of the facial muscles is effective in treating major depressive disorder (MDD) and to develop a model for take-home delivery. conditions: MDD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Double-blind whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ACTUAL name: Functional Electrical Stimulation (FES) name: Sham FES measure: Feasibility of the FES for MDD measure: Tolerability and safety of the FES for MDD measure: Improvement in symptoms of depression-17-item Hamilton Depression Rating Scale (HAM-D-17) measure: Improvement in symptoms of depression-16-Item Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR-16) measure: Improvement in symptoms of anxiety- General Anxiety Disorder (GAD-7) measure: Improvement in well-being-World Health Organization-5 Well-Being Index (WHO-5) measure: Improvement in sleep quality- Pittsburgh Sleep Quality Index (PSQI) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St. Michael's Hospital city: Toronto state: Ontario country: Canada lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06261164 id: 01-19-373- 2/23 briefTitle: Population Pharmacokinetic Model of Amikacin and Vancomycin in Critically Ill Patients overallStatus: RECRUITING date: 2024-01-31 date: 2024-12-31 date: 2025-01-31 date: 2024-02-15 date: 2024-02-15 name: University Clinical Centre of Republic of Srpska class: OTHER briefSummary: The object of the scientific research is the characterization of the pharmacokinetic profile and the investigation of factors of pharmacokinetic variability of amikacin and vacnomycin in critically ill patients with a diagnosis of sepsis-like condition (SIRS), hospital-acquired sepsis and/or septic shock and who are on extracorporeal therapy with Cytosorb® and Oxiris® adsorbents. conditions: Sepsis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Cytosorb® and Oxiris® adsorbents measure: Development of population pharmacokinetic model sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Medical Intensive Care Medicine status: RECRUITING city: Banja Luka zip: 78000 country: Bosnia and Herzegovina name: Nikolina Spiric, MPharm role: CONTACT phone: +38751342295 email: nikolina.spiric@kc-bl.com name: Pedja Kovacevic, Prof. role: SUB_INVESTIGATOR lat: 44.77842 lon: 17.19386 hasResults: False

 nctId: NCT06261151 id: Zhongshan-HHY-03 briefTitle: Preoperative Nutritional Status Associated With Delayed Discharge in Elderly Patients Undergoing Gastrectomy overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2025-03-31 date: 2024-02-15 date: 2024-02-15 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: Gastric cancer (GC) remains the 5th most common cancer worldwide and had the second- highest mortality rate in China. The population of elder patients with GC has been increasing because of the high prevalence of H. pylori infection and increasing life expectancy. Elderly GC patients face several challenges during treatment, such as comorbidities, organ dysfunction, immunosuppression, and delayed recovery. Advanced age is associated with a higher rate of postoperative complications shortly after surgical treatment, and lower 5-year overall survival as long-term outcome.

In China, the prevalence of malnutrition in hospitalized patients is around 12.6% to 46.19%. Malnutrition is one of the great risk factors of adverse clinical outcomes in elderly patients with GC. The nutritional status at the time of diagnosis was independently associated with postoperative complications, overall survival, and disease-free survival. The condition can be caused by mechanical obstruction of the digestive tract or anorexia-cachexia syndrome, leading to insufficient protein or energy intake and absorption disorder. Nutrition screening, assessment, and intervention are important steps in nutritional management.

Previous studies mostly focused on hospitalized internal medical patients. Only a few studies focused on surgical patients regardless of age. Therefore, in this retrospective study, we are going to investigate the nutritional status and perioperative nutritional support of geriatric surgical patients with GC, and provide a basis for implementing an effective nutritional intervention. conditions: Preoperative Nutritional Status and Risk Factors Associated With Elderly Patients Undergoing Gastrectomy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED name: Clinical data collection measure: The preoperative nutritional status of elderly patients underwent gastrectomy sex: ALL minimumAge: 60 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06261138 id: RSR-HCC-2019-001 briefTitle: Survival Analysis: TACE vs. Combination Therapy in HCC overallStatus: COMPLETED date: 2019-02-01 date: 2023-03-31 date: 2023-10-31 date: 2024-02-15 date: 2024-02-15 name: Zhejiang University class: OTHER briefSummary: This retrospective observational study aimed to assess potential improvements associated with systemic therapies in patients receiving transarterial chemoembolization (TACE) for initially unresectable HCC. conditions: Hepatocellular Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 279 type: ACTUAL name: Transarterial chemoembolization name: Systemic treatment measure: Progression Free Survival (PFS) per mRECIST measure: 12 months PFS rate measure: Overall survival (OS) measure: Objective Response Rate (ORR) per mRECIST measure: Disease Control Rate (DCR) per mRECIST measure: Adverse events (AEs) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: First Affiliated Hospital, Medical College of Zhejiang University city: Hangzhou state: Zhejiang zip: 310003 country: China lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06261125 id: SL-B2023-718 briefTitle: Combination of SBRT, PD-L1 Inhibitor, and Lenvatinib in Hepatocellular Carcinoma (HSBRT2401) acronym: HSBRT2401 overallStatus: RECRUITING date: 2024-03-10 date: 2026-06-30 date: 2028-06-30 date: 2024-02-15 date: 2024-03-12 name: Mian XI class: OTHER briefSummary: Abdominal lymph node metastasis (LNM) is one of the major modes of extrahepatic metastasis in hepatocellular carcinoma (HCC). Immunotherapy targeting the PD-1/PD-L1 checkpoints combined with targeted therapy is the standard treatment for HCC with abdominal LNM, but the outcome remains very poor, with an objective response rate of 5% to 30%. Previous studies have demonstrated that stereotactic body radiotherapy (SBRT) is an effective local treatment for HCC with abdominal LNM, with a high response rate of 60% to 80%. However, intrahepatic dissemination and distant metastasis remains the major recurrence pattern after SBRT in these patients, suggesting radiotherapy should be combined with systematic treatment. Recently, the combination of immunotherapy with SBRT has shown promising activity in HCC. The aim of this study was to investigate the efficacy and safety of SBRT followed by adebrelimab (an anti-PD-L1 antibody) and lenvatinib in HCC patients with portal abdominal LNM. conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Stereotactic body radiotherapy name: Adebrelimab name: Lenvatinib measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Overall response rate (ORR) measure: Disease control rate (DCR) measure: Duration of response (DOR) measure: Treatment-related adverse events measure: Correlation between serum cytokines and overall survival and immune-related adverse events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mian Xi status: RECRUITING city: Guangzhou state: Guangdong zip: 510060 country: China name: Mian Xi, MD role: CONTACT phone: +862087343385 email: ximian@sysucc.org.cn name: Mian Xi, MD role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06261112 id: B.30.2.ATA.01.11/285 briefTitle: The Effect of Using a Kaleidoscope on Fear and Pain in Children overallStatus: RECRUITING date: 2022-05-07 date: 2024-05-01 date: 2024-05-01 date: 2024-02-15 date: 2024-02-15 name: Mihriban Culha class: OTHER briefSummary: The research was conducted in randomized controlled experimental type between May 2022 and December2023. The universe of the research consisted of children and their parents who were diagnosed with a fracture, applied to the Orthopedic outpatient clinic and Emergency department of the Erzurum Ataturk University Health Research and Application Center and referred to the Orthopedic clinic, and decided to undergo a cast procedure for treatment. The sample of the research consisted of a total of 70 children and their parents, including 35 control groups and 35 kaleidoscope groups, who met the research criteria from this universe. The children in the kaleidoscope group were shown the kaleidoscope. No intervention other than routine application was applied to the control group. "Introductory Information Form", "Wong-Baker Facial Expressions Rating Scale and Child Fear Scale were used in the collection of data. conditions: Fracture; Complication Orthopedic Procedure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assigment primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: single /investigatör) whoMasked: INVESTIGATOR count: 70 type: ESTIMATED name: kaleidescope measure: Child Fear Scale (CFS) measure: Facial Expressions Rating Scale sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Ataturk University status: RECRUITING city: Erzurum zip: 25240 country: Turkey name: Mihriban ÇULHA role: CONTACT phone: 05070926243 email: mihriban2560@outlook.com lat: 39.90861 lon: 41.27694 hasResults: False

 nctId: NCT06261099 id: 037 briefTitle: Telerehabilitation-Based Early Upper Extremity Training in Stroke Patients overallStatus: RECRUITING date: 2024-02-08 date: 2025-02-27 date: 2025-11-27 date: 2024-02-15 date: 2024-02-15 name: Suleyman Demirel University class: OTHER briefSummary: Telerehabilitation method, which is an alternative to face-to-face rehabilitation practices for stroke patients who need intensive, regular and long-term rehabilitation in the early period, has been popularly used in recent years. Telerehabilitation is a practice in which the patient participates in the treatment via digital media without the need for the patient to come to the clinic. conditions: Stroke, Acute studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: prospective double-blind, randomized controlled trial primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Sealed envelopes will be prepared in advance for randomization and will be marked with numbers 1 and 2, indicating whether they are a study group or a control group. Randomization will be done by a third party unaware of the study content. Randomization order tracking will be done with sequentially numbered containers. Patients participating in the study will be blinded to which treatment group they will be included in. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: control + working group measure: Mini Mental Test measure: Fugl Meyer Motor Function Scale measure: Laser-pointer Assisted Angle Reproduction Test measure: Modified Barthel Index measure: Reaching Performance Scale sex: ALL minimumAge: 30 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Güler Ertuğrul status: RECRUITING city: Kocaeli state: İ̇zmi̇t country: Turkey name: GÜLER ERTUĞRUL role: CONTACT phone: +90 531 950 05 90 email: gertugrul004@gmail.com lat: 39.62497 lon: 27.51145 facility: Suleyman Demirel University status: RECRUITING city: Isparta state: Merkez country: Turkey name: MEHMET DURAY role: CONTACT phone: +90 506 473 11 65 email: mehmetduray@sdu.edu.tr lat: 37.76444 lon: 30.55222 hasResults: False

 nctId: NCT06261086 id: soh-med-24-01-06MS briefTitle: Evaluation of Pyroptosis-related Indicators in the Pathogenesis of Vitiligo:Across-sectional Comparative Study overallStatus: NOT_YET_RECRUITING date: 2024-02-24 date: 2024-08-24 date: 2024-08-24 date: 2024-02-15 date: 2024-02-15 name: Sohag University class: OTHER briefSummary: Vitiligo is an acquired pigmentary disorder on skin and/or mucosae, which is characterized by death of melanocytes (MCs), affecting 0.5%-2% of the population worldwide (1). It doesn't affect the health of patients but it has marked social pressure and greatly interfere with their quality of life (2,3). It presents with well circumscribed milky white patches that occur secondary to destruction of melanocyte, it may appear at any age and affect both sexes equally.

It can affect ethnic groups and people of all skin types with no predilection (4).

Clinically, several types of vitiligo are distinguished according to the distribution of the achromic lesions. One or more lesions in a dermatomal pattern are characteristic for segmental vitiligo (SV) while this segmental distribution is absent in non-segmental vitiligo (NSV). The latter variety includes both the focal type and the generalized type (5). Numerous previous studies tried to illustrate the pathogenesis behind the disease, but the exact pathophysiology is still not fully understood. It is a multifactorial disease. Factors include, neural theory, oxidative stress theory, autoimmune hypothesis, intrinsic theory, melanocytorrhagy hypothesis (6). Many theories tried to explain the mechanisms of MC destruction in vitiligo. Apoptosis is one of the most widely studied cell death pathways. In addition, the other two forms of cell death, conventional necrosis and autophagy seem to be involved in the death of vitiligo MCs under certain situations. Moreover, new types of regulated cell death including necroptosis, pyroptosis, and ferroptosis may also participate in the pathogenesis (7). Pyroptosis is a highly inflammatory form of necrosis cell death NCD regulated mainly by caspase-1, which is initiated following large supramolecular complex ermed inflammasome activation (8). The inflammasome-activated Caspases then cleave the pyroptosis-inducing protein Gasdermin D (GSDMD), which forms a pore in the plasma membrane and causes cell lysis as well as the secretion of IL-1β typically (9). Another study suggests that inflammasome activation could be a useful marker for assessing disease progression of vitiligo (10). However, the link between vitiligo and inflammasome activation is still unclear. The inflammasome regulates cell death and inflammation via activation of caspase-1 (11). The activation of caspase-1 promotes the secretion of proinflammatory cytokines IL-1β and IL-18, as well as the initiation of pyroptosis (12). So, evaluation of pyroptosis-related indicators (GASDM-D, IL 1β \& IL-18) may help understanding the obscure inflammasome pathway involvement in the pathogenesis of Vitiligo. conditions: Vitiligo studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 90 type: ESTIMATED name: evaluate serum levels pyroptosis-related indicators (GASDM-D, IL 1β & IL-18) measure: GASDM-D measure: IL 1β measure: IL-18 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06261073 id: Soh-Med-24-01-08MS briefTitle: Evaluation of Serum and Tissue Cathepsin L in Non-segmental Vitiligo Patients overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-03-01 date: 2025-03-01 date: 2024-02-15 date: 2024-02-15 name: Sohag University class: OTHER briefSummary: Introduction Vitiligo is an autoimmune disease of the skin that targets pigment producing melanocytes and results in patches of depigmentation that are visible as white spots (Frisoli et al., 2020) Vitiligo is a relatively common acquired pigmentation disorder that can cause significant psychological stress (Leung AKC et al., 2021). The disease affects both genders equally, it can appear at any age, and the average age of onset is somewhat variable in different geographic (Majumder et al, 1993), with an estimated prevalence of 0.5-2% of the population in both adults and children worldwide (Krüger et al, 2012).

Vitiligo results in white macules and patches on the body. Initial lesions occur most frequently on the hands, forearms, feet, and face, favoring a periocular or perioral distribution (Ahmed jan N et al., 2023). Vitiligo lesions are classified into 2 major categories: segmental vitiligo (SV) and non-segmental vitiligo (NSV) (Relke et al ., 2019). Segmental vitiligo is characterized by its early onset, rapid stabilization, and unilateral distribution (Van Geel et al., 2017). Non-segmental vitiligo comprises of generalized (vitiligo vulgaris), acrofacial, mucosal (multifocal), and universal vitiligo (Kovacevic et al., 2016). Non-segmental vitiligo (NSV) is the most common form of vitiligo (Benzekri et al., 2013). Multiple mechanisms are involved in melanocyte disappearance, namely genetic predisposition, environmental triggers, metabolic abnormalities, impaired renewal, and altered inflammatory and immune responses (Boniface K et al ., 2018).

The results of some studies indicate a frequent association of vitiligo with autoimmune diseases. A number of studies have established a higher prevalence of autoimmune endocrine diseases in women, as well as in non-segmental vitiligo patients and in cases of family history of vitiligo and/or other autoimmune diseases. In addition, it was shown that the prevalence of endocrine diseases increases with increasing area of depigmentation (Troshina EA et al., 2020). Autoimmunity in vitiligo is driven by the IFN-γ-CXCL10 cytokine signaling pathway. Activated melanocyte-specific CD8+ T cells secrete IFN-γ, which signals through the IFN-γ receptor (IFN-γR) to activate JAK1/2 and STAT1. This induces the production of CXCL9 and CXCL10, which signal through their receptor CXCR3 to recruit more auto-reactive T cells to the epidermis, resulting in widespread melanocyte destruction (Harris JE et al., 2017).

The lysosomal cysteine proteinases of the papain family are involved in lysosomal bulk proteolysis, major histocompatibility complex class II-mediated antigen presentation, pro-hormone processing, and extracellular matrix remodeling. conditions: Vitiligo studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 40 type: ESTIMATED name: blood sample and tissue biopsy measure: Cathepsin L sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False

 nctId: NCT06261060 id: 2023-0918 id: NCI-2024-01333 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Low-Dose Sirolimus to Increase Hematopoietic Function in Patients With RUNX1 Familial Platelet Disorder overallStatus: NOT_YET_RECRUITING date: 2024-08-31 date: 2026-06-11 date: 2028-06-11 date: 2024-02-15 date: 2024-03-07 name: M.D. Anderson Cancer Center class: OTHER briefSummary: To learn about the safety and effects of low-dose sirolimus in participants with RUNX1-FPD. conditions: Familial Platelet Disorder conditions: Hematopoietic studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: Sirolimus measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Courtney DiNardo, MD role: CONTACT phone: 713-794-1141 email: cdinardo@mdanderson.org name: Courtney DiNardo, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06261047 id: SDZLEC2023-389-02 briefTitle: Radiotherapy Delays Second-line Drug Therapy for Oligo Progressive Primary Liver Cancer overallStatus: RECRUITING date: 2024-01-01 date: 2026-01-01 date: 2026-01-01 date: 2024-02-15 date: 2024-02-15 name: Shandong Cancer Hospital and Institute class: OTHER briefSummary: Recent years have seen significant advancements in the treatment landscape of advanced hepatocellular carcinoma (HCC), with the emergence of targeted and immunotherapy strategies reshaping first-line therapy. Sorafenib, a multi-targeted tyrosine kinase inhibitor, initially set the standard, followed by approvals for lenvatinib, regorafenib, cabozantinib, and ramucirumab. Immunotherapy, particularly combinations like atezolizumab with bevacizumab, has shown superior efficacy over sorafenib. Despite these advances, second-line therapies offer limited progression-free survival (mPFS: 2-3 months), necessitating new approaches. Radiotherapy, bolstered by technological advancements, has shown promise. Techniques like stereotactic body radiotherapy (SBRT) combined with PD-1 inhibitors achieve significant response rates and survival benefits. Combining radiotherapy with targeted immunotherapy has also demonstrated improved outcomes. Radiotherapy, especially in oligometastatic HCC, is increasingly favored due to its ability to enhance local control without increasing toxicity. These developments underscore the evolving landscape of HCC treatment towards personalized and multimodal approaches. conditions: Hepatocellular Carcinoma conditions: Radiotherapy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 36 type: ESTIMATED name: radiotherapy measure: Progression free survival measure: Overall response rate measure: Overall survial measure: Disease control rate measure: Duration of control sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jinbo Yue status: RECRUITING city: Jinan state: Shandong zip: 250000 country: China name: jinbo yue role: CONTACT phone: +86053167626442 email: yuejinbo@hotmail.com lat: 36.66833 lon: 116.99722 hasResults: False

 nctId: NCT06261034 id: 23-008765 id: 8K12AR084222-15 type: NIH link: https://reporter.nih.gov/quickSearch/8K12AR084222-15 briefTitle: A Study of Sex Differences in Neurocirculatory Control overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-03 date: 2027-03 date: 2024-02-15 date: 2024-04-10 name: Mayo Clinic class: OTHER name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) briefSummary: The purpose of this study is to investigate potential sex differences in neurocirculatory control of blood pressure in patients with untreated obstructive sleep apnea (OSA). conditions: Obstructive Sleep Apnea studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED measure: Blood pressure measure: Arterial stiffness measure: Endothelial function measure: Sympathetic nerve burst frequency measure: Sympathetic nerve burst incidence measure: Sympathetic nerve burst amplitude (AU) measure: Total muscle sympathetic nerve activity (MSNA) measure: Cerebral autoregulation measure: Sympathetic action potentials per burst measure: Sympathetic action potential clusters per burst measure: Sympathetic action potential conduction latency of each cluster measure: Immune function measure: Urinary Extracellular Vesicle Presence and Content measure: Plasma Extracellular Vesicle Presence and Content sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester city: Rochester state: Minnesota zip: 55905 country: United States name: Joshua Bock, PhD role: CONTACT phone: 507-422-0768 email: bock.joshua@mayo.edu name: Ian Greenlund, PhD role: CONTACT phone: (507) 422-3411 email: Greenlund.Ian@mayo.edu name: Virend Somers, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06261021 id: INNO-6051 briefTitle: Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects With Discoid Lupus Erythematosus overallStatus: RECRUITING date: 2024-04-19 date: 2025-02 date: 2025-02 date: 2024-02-15 date: 2024-04-25 name: Innovaderm Research Inc. class: OTHER briefSummary: This study is a single-blind, intraindividual study to evaluate the efficacy of ruxolitinib 1.5 % cream in adult subjects with discoid lupus erythematosus. conditions: Discoid Lupus Erythematosus studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intra-individual primaryPurpose: TREATMENT masking: SINGLE maskingDescription: This study will be single-blinded. Only the efficacy assessor will be blinded in this study (for subjects with randomized areas). The assessor will only assess efficacy and will not have any other interactions with the subject. whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Ruxolitinib 1.5% cream name: Application without occlusion in Area 1 name: Application under occlusion at night in Area 2 name: Application under occlusion at night in Area 1 name: Application without occlusion in Area 2 measure: Change from baseline in target lesion CLASI-A score measure: Change from baseline in target lesion CLASI-A score measure: Proportion of subjects with an erythema score of 0 (absent) measure: Change from baseline in target lesion SADDLE-A measure: Proportion of subjects with a target lesion CLA-IGA score of 0 (clear) or 1 (almost clear) measure: Dermatology Life Quality Index (DLQI) measure: Cutaneous Lupus Erythematosus Quality of Life (CLEQol) measure: Numeric Rating Scale(NRS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Innovaderm Research Inc. status: RECRUITING city: Montréal state: Quebec zip: H2X 2V1 country: Canada name: Fareheen Chowdhury, MSc role: CONTACT phone: 514-521-4285 phoneExt: 341 email: fchowdhury@innovaderm.com name: Robert Bissonnette role: PRINCIPAL_INVESTIGATOR lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06261008 id: 2023.553 briefTitle: Interactive Telehealth Intervention to Increase Longitudinal Adherence to Repeat Faecal Immunochemical Test Screening overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-03-26 date: 2026-06-26 date: 2024-02-15 date: 2024-02-16 name: Chinese University of Hong Kong class: OTHER briefSummary: In Hong Kong, Colorectal cancer ranks second in both cancer incidence and mortality. The government-subsidized population-based CRC screening program (the Program) was launched for asymptomatic individuals aged 50-75 years to undergo biennial FIT screenings. A subsidized follow-up colonoscopy is offered to participants with positive FIT results. Participants are advised to repeat the FIT screening 2 years after receiving a negative result. An automated noninteractive short message service (SMS) text reminder, used by the Program as standard care (SC), is delivered to participants who are due for repeat FIT. According to unpublished data, despite SC, only 34% of participants adhere to biennial repeat FIT in the CRC screening program. Nonadherence to repeat FIT screening is caused by forgetfulness and is associated with an individual's psychological health behaviour. conditions: CRC, Colorectal Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patient will be randomized into either standard care or telehealth intervention group primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE maskingDescription: There will no masking count: 370 type: ESTIMATED name: TI group measure: adherence rate measure: the number of days to repeat FIT measure: costs incurred in each study arm measure: uptake rate in positive FIT measure: detection rate in positive FIT measure: qualitative factors associated with repeat FIT adherence sex: ALL minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre of Digestive Health, Prince of Wales Hospital city: Hong Kong country: Hong Kong lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06260995 id: Ref: 230603 briefTitle: The Role of Intermediaries in Connecting Individuals to Local Physical Activity - Study Protocol overallStatus: RECRUITING date: 2023-09-01 date: 2024-05-31 date: 2024-06-30 date: 2024-02-15 date: 2024-02-21 name: University of Dublin, Trinity College class: OTHER briefSummary: Intermediaries help people to connect to community-based services and supports, including physical activity and exercise groups (physical activities). They do this by acting as a link person. After receiving a referral or self-referral, they conduct an assessment, connect people to services in the community, and follow-up with people over time.

This project will investigate if connecting to physical activities through an intermediary can improve health and wellbeing. It will also investigate people's experiences of working with an intermediary. This project is a pilot feasibility study, which means the investigators are evaluating the measures used and the way the trial is designed to see if they are suitable for a larger study in the future. conditions: Physical Inactivity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Social Prescribing Link Worker Intermediary Intervention name: Local Sports Partnership Community Development Officer Intervention measure: International Physical Activity Questionnaire - Short Form measure: Self-Efficacy for Exercise Scale measure: Short Warwick Edinburgh Mental Well-being Scale measure: Demographics and Health Status measure: Semi-structured Interviews - Intervention Participants measure: Overall Acceptability of the Intervention measure: Gatekeeper Recruitment Logs measure: Semi-structured Interviews - Gatekeepers sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of Dublin, Trinity College Dublin status: RECRUITING city: Dublin 8 zip: D08 W9RT country: Ireland name: Megan O'Grady role: CONTACT phone: 018963613 email: ogradyme@tcd.ie lat: 53.33306 lon: -6.24889 hasResults: False

 nctId: NCT06260982 id: 2021PI148 briefTitle: Cognitive Disorders in Hereditary Spastic Paraplegia Type 4 acronym: SPG-TEP overallStatus: RECRUITING date: 2022-01-01 date: 2025-01 date: 2025-01-02 date: 2024-02-15 date: 2024-02-15 name: Central Hospital, Nancy, France class: OTHER briefSummary: Hereditary spastic paraplegia type 4 is the most frequent mutation of hereditary spastic paraplegias. It is commonly described as pure, with progressive weakness of the lower limbs, pyramidal syndrome and vesico-sphincter disorders. However, cognitive disorders have been reported for over 20 years, but remain poorly characterized. conditions: Spastic Paraplegia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: 18-FDG-PET measure: cognitive testing measure: Correlations between neuropsychological tests, clinical examination, PET and general data. measure: Genotype/Phenotype correlations sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Centre hospitalier régional universitaire status: RECRUITING city: Nancy zip: 54000 country: France name: Mathilde Renaud, MD, PhD role: CONTACT email: m.renaud2@chru-nancy.fr lat: 48.68439 lon: 6.18496 hasResults: False

 nctId: NCT06260969 id: TJHH-2023-WM13 briefTitle: Endovascular Treatment of Acute Ischemic Stroke With Underlying Intracranial Artery Stenosis overallStatus: RECRUITING date: 2022-09-01 date: 2025-09-30 date: 2025-09-30 date: 2024-02-15 date: 2024-02-15 name: Tianjin Huanhu Hospital class: OTHER briefSummary: The study is a prospective multicentre registry study. Patients admitted to 10 stroke centres nationwide from September 2022 to September 2025 with acute ischaemic stroke due to large vessel occlusion considering underlying ICAS and treated with emergency endovascular thrombolysis were included for analysis. Patients who met the general inclusion criteria underwent thrombectomy and the necessary remedial treatment. conditions: Large Vessel Occlusion conditions: Intracranial Artery Occlusion With Cerebral Infarction conditions: Endovascular Treatments conditions: Acute Ischemic Stroke studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 470 type: ESTIMATED name: balloon dilatation measure: Proportion of patients achieving a clinical prognosis of mRS 0-2 at 90 days measure: Proportion of patients with a good prognosis early after treatment measure: Change in final cerebral infarct volume relative to baseline at 24 (-2/+12) hours postoperatively on CT/MR measure: Vascular recanalization sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tianjin Huanhu Hospital status: RECRUITING city: Tianjin state: Tianjin country: China name: Ming Wei role: CONTACT phone: 13502182903 email: drweiming@163.com lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06260956 id: U01-ROC-001 id: 1U01AI173032 type: NIH link: https://reporter.nih.gov/quickSearch/1U01AI173032 briefTitle: Expecting Mother's Study of Consumption or Avoidance of Peanut and Egg acronym: ESCAPE overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-09 date: 2029-09 date: 2024-02-15 date: 2024-02-15 name: University of Rochester class: OTHER name: National Institute of Allergy and Infectious Diseases (NIAID) briefSummary: Peanut allergy is the most common cause of fatal and near-fatal food-allergic reactions and egg allergy is among the two most common causes of food-induced anaphylaxis. The proposed research will explore the development of sensitization to these food(s) in infants based on maternal consumption or avoidance during pregnancy and breastfeeding. conditions: Allergy and Immunology conditions: Peanut and Nut Allergy conditions: Egg Allergy conditions: Food Allergy in Infants conditions: Food Allergy Peanut studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: National, parallel, two arm (one-to-one allocation), single blinded, randomized controlled trial. primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: Due to the nature of the intervention, the subjects must know which arm they are assigned to, however, biostatistician and investigators will be blinded to study assignment. whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 400 type: ESTIMATED name: Avoidance name: Consumption measure: Egg sensitization measure: Peanut and egg specific IgG and IgG4 measure: Antibodies in maternal blood measure: Egg allergy measure: Antigen concentrations measure: Exploratory: Peanut sensitization measure: Exploratory: Symptoms measure: Exploratory: Peanut sensitization sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: University of Rochester city: Rochester state: New York zip: 14642 country: United States lat: 43.15478 lon: -77.61556 hasResults: False

 nctId: NCT06260943 id: 20221220 id: NCI-2024-00566 type: REGISTRY domain: NCI Clinical Trials Reporting Program (CTRP) briefTitle: Targeted Navigation in Hepatocellular Carcinoma (HCC) overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2026-10-31 date: 2026-10-31 date: 2024-02-15 date: 2024-02-15 name: University of Miami class: OTHER name: The V Foundation briefSummary: The investigators are trying to learn more about the personal perceptions and experiences regarding the needs of patients with liver cancer to help improve the care of all patients. The investigators would like to know whether there are needs that patients have or are aware of, especially those needs that the investigators have not been able to address. The investigators aim to develop a program that helps participants and participant's families to navigate the process of being diagnosed with liver cancer and receiving treatment. conditions: Hepatocellular Carcinoma conditions: Cholangiocarcinoma conditions: Hepatobiliary Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 50 type: ESTIMATED name: Target Navigation Pilot Program measure: Number of Days to First Contact measure: Number of Hours for Each Contact measure: Number of Days to First Appointment measure: Number of Days to First Treatment measure: Number of Months of Total Navigation measure: Number of Participants that Die Within One Year measure: Proportion of Participants Enrolled in Clinical Research sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Miami city: Miami state: Florida zip: 33136 country: United States name: Gloria Figueroa role: CONTACT phone: 305-243-0779 email: gef44@med.miami.edu name: Patricia Jones, MD role: CONTACT phone: (305) 243-0779 email: pdjones@med.miami.edu name: Patricia Jones, MD role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 hasResults: False

 nctId: NCT06260930 id: Value of chest ultrasonography briefTitle: Value of Chest Ultrasonography in ILD Screening overallStatus: COMPLETED date: 2017-01 date: 2019-09 date: 2019-12 date: 2024-02-15 date: 2024-02-15 name: Aswan University class: OTHER briefSummary: The main aim of this study is to detect the value of transthoracic ultrasonography in the diagnosis and assessment of ILDs in correlation to chest X- ray, blood gases, pulmonary function test and echocardiography and to compare it with high resolution CT (HRCT) as a golden diagnostic investigation. conditions: Interstitial Lung Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 80 type: ACTUAL measure: Sensitivity and specificity of the lung sonography for interstitial lung disease screening sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06260917 id: E2-23-4148 briefTitle: The Effect of Urinating Through the Zipper or by Pulling Down the Trousers on Uroflowmetry Parameters in LUTS overallStatus: COMPLETED date: 2023-11-01 date: 2023-12-31 date: 2023-12-31 date: 2024-02-15 date: 2024-02-15 name: Ankara City Hospital Bilkent class: OTHER briefSummary: There are many factors that affect uroflowmetry parameters. One of these is the urination position. Research has mostly focused on standing and sitting urination positions. However, those who prefer the standing position as a habit can urinate by opening the zipper or lowering the trousers. Although the effect of these two applications on uroflowmetry parameters in healthy men has been investigated in only one study, their effect on patients with lower urinary tract symptoms has not been examined. conditions: Benign Prostatic Hyperplasia conditions: Micturition Disorder conditions: Urinary Obstruction conditions: Urinary Tract Disease conditions: Urologic Diseases studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 80 type: ACTUAL name: position of urination measure: Qmax measure: PVR measure: Qave measure: Duration of voiding sex: MALE minimumAge: 45 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Bilkent City Hospital city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06260904 id: AIIMS BBSR/PGThesis/23-24/112 briefTitle: Efficacy and Safety of add-on Apremilast Versus add-on Methotrexate in Patients With Oral Lichen Planus overallStatus: NOT_YET_RECRUITING date: 2024-02-26 date: 2025-01-31 date: 2025-05-31 date: 2024-02-15 date: 2024-02-15 name: All India Institute of Medical Sciences, Bhubaneswar class: OTHER briefSummary: Lichen planus is an inflammatory disorder of unknown aetiology affecting the stratified squamous epithelia, with an estimated global prevalence of 0.22 to 0.5 %. Oral mucosa (Oral Lichen Planus; OLP) is the most commonly affected region. Corticosteroids are the primary treatment of choice. A prolonged treatment with steroids is required for clinical improvement, which increases the chances of long-term adverse effects. So, there is a need for newer, effective treatment modalities, such as retinoids, methotrexate, Janus kinase inhibitors, PDE4 inhibitors, etc.

Of these, methotrexate is a dihydrofolate reductase inhibitor that inhibits the replication and function of T and B lymphocytes. It has shown a good response to OLP (around 83%) in a study by Lajevardi et al. and can be considered a treatment option in patients with moderate to severe OLP. Apremilast is a drug with a novel immunomodulatory mechanism of action. It inhibits phosphodiesterase type IV, which increases levels of cyclic adenosine monophosphate (cAMP), thus activating protein kinase A and inhibiting various inflammatory mediators. Based on a pilot study by Paul et al., apremilast is associated with clinical improvement in lichen planus.

Among the various treatment options, there is a lack of head-on trials. Methotrexate is an immunosuppressant with various systemic adverse effects and requires close monitoring. Whereas apremilast is a non-immunosuppressive drug with a better safety profile, it does not show such adverse effects. These drugs can be used as an add-on to low-dose steroids in view of reducing the adverse effects associated with steroid therapy. To the best of our knowledge, there is no randomized controlled trial comparing these two drugs to date. Hence, the present study has been planned to evaluate the safety and efficacy of methotrexate versus apremilast as an add-on to the standard steroid therapy in OLP patients. conditions: Oral Lichen Planus studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized, add-on, active-controlled, open-label, parallel-design clinical trial primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: Prednisolone name: Apremilast name: Methotrexate measure: Pain by Visual Analogue Scale (VAS) score measure: Severity by Physician global assessment of disease (PGA) score measure: Severity and pain by oral mucosal disease severity score measure: serum IL 6 level measure: Quality of life by using oral health-related quality of life score (ORAL HEALTH IMPACT PROFILE - 14 ) measure: Incidence of treatment-emergent adverse events of both test and control group sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AIIMS Bhubaneswar city: Bhubaneswar state: Odisha zip: 751019 country: India name: Monalisa Jena, MD role: CONTACT phone: 09438884193 email: pharm_monalisa@aiimsbhubaneswar.edu.in name: Biswanath Behera, MD role: CONTACT phone: 07978351200 email: dermat_biswanath@aiimsbhubaneswar.edu.id name: Biswanath Behera role: SUB_INVESTIGATOR name: Madhusmita Sethy role: PRINCIPAL_INVESTIGATOR name: Mowdharani PS role: PRINCIPAL_INVESTIGATOR lat: 20.27241 lon: 85.83385 hasResults: False

 nctId: NCT06260891 id: ZnSCD briefTitle: Zinc Supplementation in Sickle Cell Disease acronym: ZnSCD overallStatus: NOT_YET_RECRUITING date: 2025-04-01 date: 2026-09-30 date: 2026-09-30 date: 2024-02-15 date: 2024-03-13 name: University of California, San Francisco class: OTHER name: American Society Hematology, Research Collaborative name: Children's Hospital of Philadelphia name: Johns Hopkins University name: Baylor College of Medicine name: Children's National Research Institute name: Children's Hospital Medical Center, Cincinnati name: Newark Beth Israel Medical Center name: University of Pennsylvania briefSummary: The goal of this short term prospective Phase II study is to compare the effects of two alternate daily doses of zinc (25 and 40 mg/day) in 34 randomly assigned homozygous Sickle Cell Disease (SCD-SS) patients aged 15-35 years old. The main question it aims to answer is: Which biomarkers are most responsive to zinc supplementation, and what is the maximum tolerated zinc dose that induces the desired changes in biomarkers of bone turnover? Participants will be recruited from 7 American Society Hematology Research Collaborative SCD Centers. Eligible SCD subjects will be invited to participate in the 16-week study, involving 2 baseline blood draws 4 weeks apart, followed by a 12-week zinc intervention. The findings from this study will be used to determine the dosage of zinc to be used in a larger, future study on the long term impact of zinc supplementation on bone health in SCD-SS. conditions: Sickle Cell Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a delayed start parallel design where all subjects will have a usual care period, 2 baseline samples 4 weeks apart, followed by a 12 week zinc intervention, with samples at 8 and 12 weeks. primaryPurpose: OTHER masking: QUADRUPLE maskingDescription: n/a the 2 zinc capsule dosages (25 and 40 mg) will be compounded to look identical whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 34 type: ESTIMATED name: 25 mg/day zinc name: 40 mg/day zinc measure: Biomarker of Bone Formation (PINP) measure: Biomarker of Bone Resorption (CTx) measure: Biomarker of Bone Formation (BSAP) measure: Biomarker of Bone Resorption (TRAP 5b) sex: ALL minimumAge: 15 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: UCSF Benioff Children's Hospital Oakland city: Oakland state: California zip: 94609 country: United States name: Ellen Fung, PhD role: CONTACT phone: 510-428-3885 phoneExt: 4939 email: ellen.fung@ucsf.edu name: Beth Anne Martin role: CONTACT email: beth.martin@ucsf.edu lat: 37.80437 lon: -122.2708 hasResults: False

 nctId: NCT06260878 id: REB23-0625 briefTitle: Short-term Intravenous Fluids for Prevention of Post-ERCP Pancreatitis acronym: STRIPE overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2027-12-31 date: 2028-06-30 date: 2024-02-15 date: 2024-02-15 name: University of Calgary class: OTHER briefSummary: This study will explore the efficacies of several practical short-term (peri-procedural) intravenous fluid regimens in the prevention of post- endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). PEP is the most common serious ERCP-related adverse event (AE), occurring in 5-15% of patients, and associated with significant morbidity, mortality, and healthcare utilization. Given the current lack of data on effectiveness of short-term fluid regimens in PEP prevention to inform practice, the results of the proposed study have the strong potential to impact ERCP practices worldwide, whether positive or negative. conditions: Post-ERCP Acute Pancreatitis studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 505 type: ESTIMATED name: Intravenous Ringer's lactate measure: Serum amylase measure: Pancreatitis measure: Bleeding measure: Cholangitis measure: Cardiorespiratory adverse event measure: Serum lipase measure: Electrolytes measure: Creatinine measure: Brain natriuretic peptide sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06260865 id: E-ETH-01K-CI02 briefTitle: A Confirmatory Trial of Multidisciplinary Digital Therapeutics for Patellofemoral Pain Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2024-07-31 date: 2024-08-30 date: 2024-02-15 date: 2024-02-15 name: EverEx Inc. class: INDUSTRY briefSummary: This randomized controlled confirmatory study will be evaluating an mobile application, MORA Cure (ETH-01K), owned by EverEx, Inc., to examine safety and effectiveness in individuals with patellofemoral pain syndrome. conditions: Patellofemoral Pain Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multicenter randomized controlled trial primaryPurpose: TREATMENT masking: NONE count: 216 type: ESTIMATED name: MORA Cure name: Treatment as Usual measure: Usual pain severity assessed by the Visual Analogue Scale (VAS) measure: Usual pain severity assessed by the Visual Analogue Scale (VAS) measure: Worst pain severity assessed by the Visual Analogue Scale (VAS) measure: Functional disability assessed by the Kujala Patellofemoral Scale measure: Health-related quality of life assessed by EuroQol five-dimensional (EQ-5D) measure: Assessment of mental health symptoms specific to depression as assessed by the Patient Health Questionnaire-9 (PHQ-9) measure: Assessment of catastrophic thinking measured by Pain Catastrophizing Scale (PCS) measure: Flexion and extension strength of knee measure: Treatment adherence sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Myongji Hospital city: Goyang-si state: Gyeonggi-do zip: 10475 country: Korea, Republic of lat: 37.65639 lon: 126.835 facility: Hanyang University Guri Hospital city: Guri-si state: Gyeonggi-do zip: 11923 country: Korea, Republic of lat: 37.5986 lon: 127.1394 facility: CHA Bundang Medical Center city: Seongnam-si state: Gyeonggi-do zip: 13496 country: Korea, Republic of lat: 37.43861 lon: 127.13778 facility: Inha University Hospital city: Junggu state: Incheon-si zip: 22332 country: Korea, Republic of lat: 37.69175 lon: 126.60024 facility: Chung-Ang University Hospital city: Dongjak state: Seoul zip: 06973 country: Korea, Republic of lat: 35.15713 lon: 126.8166 facility: Seoul Metropolitan Government-Seoul National University Boramae Medical Center city: Dongjak state: Seoul zip: 07061 country: Korea, Republic of lat: 35.15713 lon: 126.8166 facility: Kyung Hee University Hospital at Gangdong city: Gangdong state: Seoul zip: 05278 country: Korea, Republic of facility: The Catholic University of Korea Seoul St. Mary's Hospital city: Seocho state: Seoul zip: 06591 country: Korea, Republic of lat: 37.49056 lon: 127.02 facility: Seoul National University Bundang Hospital city: Gyeonggi-do zip: 13620 country: Korea, Republic of lat: 37.58944 lon: 126.76917 facility: Asan Medical Center city: Seoul zip: 05505 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06260852 id: ES20/Th8/23-11-2023 briefTitle: Identification of Minimum Focal Points in Vision Curve Formation overallStatus: RECRUITING date: 2024-02-01 date: 2024-08 date: 2024-08 date: 2024-02-15 date: 2024-03-07 name: Democritus University of Thrace class: OTHER briefSummary: The primary objective of this study is to identify how many focal points and at which distances are necessary for reliable visual curve formation and area of the curve (AoC) calculation using mathematical models and comparing the results to measurements acquired from participants that underwent uncomplicated pseudophakic presbyopia surgery. conditions: Presbyopia conditions: Pseudophakia conditions: Cataract conditions: Refractive Errors studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Diagnostic Test: Visual Acuity Assessment measure: Visual curves interpolation measure: Area of the curve (AOC) assessment measure: Visual acuity assessment sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Ophthalmology, University Hospital of Alexandroupolis status: RECRUITING city: Alexandroupolis state: Evros zip: 68100 country: Greece name: Georgios Labiris, MD, PhD role: CONTACT phone: 00302551030405 email: labiris@usa.net lat: 40.84995 lon: 25.87644 hasResults: False

 nctId: NCT06260839 id: KY20232442-F-1 briefTitle: the Effect of Minimally Invasive Technique Assisted by Magnetic Resonance Neurography overallStatus: RECRUITING date: 2024-02-16 date: 2024-12-01 date: 2024-12-31 date: 2024-02-15 date: 2024-02-26 name: He Xiang class: OTHER briefSummary: The goal of this clinical trial is to to compare the therapeutic effect of minimally invasive surgery guided by magnetic resonance neurography(MRN) compared with non-magnetic resonance assisted minimally invasive surgery in patients with moderate to severe gluteal muscle contracture(GMC). The main question it aims to answer are: magnetic resonance neurography can better help optimize the surgical path of minimally invasive surgery in the treatment of gluteal muscle contracture.

Participants will underwent preoperative magnetic resonance examination according to different groups, and then the experimental group designed individualized surgical approach and MRN-assisted minimally invasive release according to the imaging findings. In the control group, preoperative magnetic resonance examination was only used to assist in the diagnosis and evaluation of gluteal muscle contracture, and the magnetic resonance results were not used to assist in the design of surgical approach. In the control group, non-MRN-assisted minimally invasive release was performed. The researchers will compare the intraoperative surgery-related indicators and postoperative hip function scores and complications of patients in different groups to see if magnetic resonance-assisted surgery has a better postoperative effect. conditions: Orthopedic Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 44 type: ESTIMATED name: magnetic resonance neurography name: no magnetic resonance neurography measure: Hip joint outcome score(HOS) scale measure: Objective hip function scoring scale measure: Hip joint function of patients measure: Imaging data of patients with gluteal muscle contracture measure: Record the duration of the patient 's surgery measure: The record of the length of the surgical incision of the patient measure: Measurement of intraoperative blood loss measure: The first ambulation time after operation measure: postoperative pain score measure: Postoperative patients were satisfied with the appearance measure: The record of postoperative wound infection measure: The occurrence of postoperative wound fat liquefaction measure: Postoperative wound peripheral nerve vascular injury measure: Postoperative incision hematoma formation measure: Gluteal muscle contracture severity ZHAO 's classification measure: Demographic characteristics of patients sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xijing Hospital, the Fourth Military Medical University status: RECRUITING city: Xian state: Shaanxi zip: 710032 country: China name: Xiang He, MS role: CONTACT phone: 8684771013 email: caruya@163.com name: Long Bi, Prof. role: CONTACT phone: 8684771013 email: bilong@fmmu.edu.cn name: Long Bi, Prof. role: PRINCIPAL_INVESTIGATOR lat: 34.25833 lon: 108.92861 hasResults: False

 nctId: NCT06260826 id: 3977/QĐ-HVQY briefTitle: CPAP on Oxygenation and Pulmonary Function in Elderly Patients After Major Open Abdominal Surgery acronym: CPAP overallStatus: COMPLETED date: 2021-12-01 date: 2022-08-20 date: 2022-08-30 date: 2024-02-15 date: 2024-02-15 name: Nguyen Dang Thu class: OTHER briefSummary: Postoperative continuous positive airway pressure (CPAP) can improve lung function. The risk of pulmonary complications is high after major abdominal surgery but may be reduced by prophylactic postoperative noninvasive ventilation using CPAP. This study compared the effects of auto-CPAP via a nasal mask (JPAP) and constant-CPAP via a facial mask (O2-Max Trio) on oxygenation and pulmonary function in elderly patients after major open abdominal surgery. conditions: Continuous Positive Airway Pressure conditions: Pulmonary Function conditions: Older People studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients were randomly assigned in a 1:1 ratio to either the O2-Max Trio or JPAP group through a computer-generated randomization list . primaryPurpose: TREATMENT masking: NONE maskingDescription: the treatment allocation was unblinded to both the patient and the staffs count: 60 type: ACTUAL name: Auto CPAP via nasal mask (JPAP machine) name: Constant CPAP via facial mask (O2-Max Trio system) measure: The oxygenation-PaO2/FiO2 measure: The forced vital capacity (FVC) measure: The forced expiratory volume in the first second-FEV1 measure: The FEV1/FVC ratio measure: The peak expiratory flow-PEF sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: VietXo Friendship Hospital city: Hanoi zip: 12108 country: Vietnam lat: 21.0245 lon: 105.84117 hasResults: False

 nctId: NCT06260813 id: S66277 briefTitle: Biomechanical and Morphological Characterization of PTTD acronym: PTTD overallStatus: RECRUITING date: 2022-08-22 date: 2028-08-01 date: 2028-08-01 date: 2024-02-15 date: 2024-02-15 name: Universitaire Ziekenhuizen KU Leuven class: OTHER briefSummary: Posterior tibial tendon dysfunction (PTTD) is a progressive condition of the tendon of the tibialis posterior muscle with symptoms of tendinopathy or even rupture. Functionally, it is associated with the inability to lock the mid foot and thus manifests itself as a main contributor to adult acquired flatfoot deformity.

Concerning treatment, clinical decision making is currently based on a classification integrating various parameters as pain, flexibility of the foot joints, the condition of the posterior tibial tendon assessed through ultrasound imaging and radiographic assessment of arthritic changes. Surprisingly, this classification does not consider any morphologic characteristics (the shape of a bone or joint) or functional, biomechanical characteristics of the foot and ankle, i.e. based on kinematics (e.g. range of motion) and/or kinetics (center of pressure, angular velocity, moment, power absorption and power generation of a joint).

Detailed biomechanical characteristics of the foot and ankle can be reliably collected by instrumented gait analysis wherein a 3D camera system is combined with a force plate and plantar pressure platform. Kinematic studies in the field of PTTD typically considered the foot as a structure consisting of three segments: hind foot, forefoot and hallux. Consequently, the mid foot segment (the Chopart and Lisfranc joints) has been neglected, although it is this segment that is particularly affected in PTTD patients.

The aim of this research is to overcome the limitations of the current classification system and treatment of PTTD patients, by complementing the current standard-of-care clinical assessment with better insight in the pathologic changes that occur in PTTD patients. conditions: Posterior Tibial Tendon Dysfunction studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective interventional study that includes PTTD patients (PTTD I, II and III) and a healthy control group. primaryPurpose: DIAGNOSTIC masking: SINGLE maskingDescription: PTTD patients (PTTD I, II and III) and a healthy control group. whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: Radiography name: Ultrasound name: MRI name: CT-scan name: Gait analysis measure: Kinematic characteristics during Gait analysis measure: Center of pressure during Gait analysis measure: Angular velocity during Gait analysis measure: Moment during Gait analysis measure: Power absorption during Gait analysis measure: Power generation during Gait analysis measure: Bone morphology measure: American Orthopaedic Foot & Ankle Society (AOFAS) score measure: European Foot and Ankle Society (EFAS) score measure: 36-item Short Form Health Survey (SF36) measure: Visual Analogue Scale (VAS) pain measure: Visual Analogue Scale (VAS) satisfaction sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UZ Leuven status: RECRUITING city: Leuven state: Vlaams-Brabant zip: 3000 country: Belgium name: Sander Wuite role: CONTACT phone: +32 16 33 83 29 email: sander.wuite@uzleuven.be name: Kevin Deschamps role: CONTACT phone: +32 16 33 88 27 email: kevin.deschamps@uzleuven.be lat: 50.87959 lon: 4.70093 hasResults: False

 nctId: NCT06260800 id: PI 23-3405 briefTitle: Spanish Version of Credibility and Expectancy Questionnaire in Patients With Musculoskeletal Injuries overallStatus: RECRUITING date: 2024-01-08 date: 2024-07-01 date: 2024-11-30 date: 2024-02-15 date: 2024-02-15 name: University of Valladolid class: OTHER briefSummary: Physiotherapy treatment of musculoskeletal injuries should be performed following the main clinical guidelines of person-centered care. Patients' perception of the abilities and facilities provided by physiotherapists boost a convenient therapeutic relationship. This relation is linked with more satisfaction and adherence during the treatment, as well as credibility and expectancy of the patient related to the treatment. Thus, Credibility and Expectancy questionnaire is normally used to assess that point. CEQ presents good psychometric properties when used in Physisiotherapy interventions, but there is not a spanish version of this questionaire. conditions: Validation Study studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED name: Validation CEQ measure: Content validity measure: Construct validity measure: Reliability measure: Criterion validity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Silvia Lahuerta Martín status: RECRUITING city: Soria zip: 42004 country: Spain lat: 41.76401 lon: -2.46883 hasResults: False

 nctId: NCT06260787 id: OBGY-202401.01 briefTitle: Clinical Profiles And In Vitro Fertilization Success overallStatus: COMPLETED date: 2023-01-01 date: 2023-03-31 date: 2023-12-31 date: 2024-02-15 date: 2024-02-15 name: Universitas Padjadjaran class: OTHER briefSummary: This research was carried out to determine if the IVF patients' clinical profile were connected with how successful in their getting pregnant. This was a cross-sectional study which recruited all patients, performed at a major fertility clinic in Indonesia. Our data collection period spanned between January 2017 and December 2021. conditions: in Vitro Fertilisation studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 223 type: ACTUAL name: In Vitro Fertilisation measure: Pregnancy rate sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Obstetrics and Gynecology, Faculty of Medicine, Universitas Padjadjaran city: Bandung state: Jawa Barat zip: 40161 country: Indonesia lat: -6.92222 lon: 107.60694 hasResults: False

 nctId: NCT06260774 id: TTX-MC138-002 briefTitle: Study of TTX-MC138 in Subjects With Advanced Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-05-30 date: 2026-02-01 date: 2027-02-01 date: 2024-02-15 date: 2024-04-09 name: TransCode Therapeutics class: INDUSTRY briefSummary: A Phase 1/2 Multicenter, Open-Label, Dose-Escalation and Expansion Study of TTX MC138 in Subjects with Advanced Solid Tumors conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Dose Escalation Study Design primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: TTX-MC138 measure: Dose Escalation - Adverse Events measure: Dose Escalation - Overall Response Rate (ORR) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06260761 id: Dh3108103/64 briefTitle: MIPO Versus Conventional Approach in Volar Locking Plate for Close Fractures Distal End Radius Under WALANT overallStatus: COMPLETED date: 2021-10-05 date: 2023-02-05 date: 2023-02-05 date: 2024-02-15 date: 2024-02-15 name: Police General Hospital, Thailand class: OTHER briefSummary: The goal of this clinical trial is to compare the Minimally Invasive Plate Osteosynthesis (MIPO) approach with conventional methods in volar locking plate treatment for distal end radius fractures under the Wide Awake Local Anesthesia No Tourniquet (WALANT) technique. The main question it aims to answer is: Does the MIPO approach provide better pain control than the conventional approach of volar locking plate fixation in distal radius fractures under WALANT? Participants will be requested to record their pain on the Visual Analog Scale (VAS), assess their functional scores, and undergo postoperative radiographic evaluations. Researchers will compare the MIPO group and the conventional group to determine the postoperative pain VAS scores, shedding light on the comparative effectiveness of the two approaches. conditions: Radius; Fracture, Lower or Distal End studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: prospective, parallel group, assessor-blinded, randomized controlled trial. randomized with computer generator number and use block-of-four. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The data collector, an orthopedic resident unaware of the surgical technique used, obtained information after operation. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 68 type: ACTUAL name: MIPO name: Conventional measure: Pain Visual analogue scale measure: Quick Disabilities of the Arm, Shoulder and Hand measure: Grip strength measure: Pinch strength measure: Range of motion measure: Aesthetics measure: Satisfy measure: Volar tile measure: ulnar variance measure: radial inclination measure: operation time measure: skin incision measure: morphine IV use measure: complication sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Police general hospital city: Pathum Wan state: Bangkok zip: 10330 country: Thailand lat: 13.73649 lon: 100.5239 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2021-10-05 uploadDate: 2024-02-04T06:00 filename: Prot_SAP_000.pdf size: 1309374 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2021-10-05 uploadDate: 2024-02-04T06:05 filename: ICF_001.pdf size: 80882 hasResults: False

 nctId: NCT06260748 id: LBI-CDCA-001 id: 2023-505759-29-00 type: OTHER domain: EU Clinical Trials Register briefTitle: A Study of Chenodeoxycholic Acid (CDCA) in Newly Diagnosed Participants With Cerebrotendinous Xanthomatosis (CTX) overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-11-30 date: 2025-12-31 date: 2024-02-15 date: 2024-02-15 name: Leadiant Biosciences, Inc. class: INDUSTRY briefSummary: This study is designed to demonstrate the beneficial effect of CDCA in the treatment of CTX-associated diarrhea in approximately 10 participants aged 2-75 years old with newly diagnosed CTX or suspected CTX who have never received treatment with CDCA. conditions: Cerebrotendinous Xanthomatoses studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 10 type: ESTIMATED name: Chenodeoxycholic acid name: Chenodeoxycholic acid Placebo measure: Change from baseline at Week 4 in average number of stools with a BSS score of 6 or 7 per day measure: Change in plasma cholestanol levels from baseline to Week 12 measure: Change in urine and/or plasma bile alcohol levels from baseline to Week 12 measure: Incidence of, severity/intensity of, and relationship to study drug of AEs measure: Incidence of, severity/intensity of, and relationship to study drug of SAEs measure: Incidence of, severity/intensity of AESIs measure: Incidence of, severity/intensity of, and changes in laboratory values measure: Incidence of, severity/intensity of, and changes in physical examination measure: Incidence of, severity/intensity of, and changes in vital signs measure: Number of participants with discontinuations due to AEs sex: ALL minimumAge: 2 Years maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06260735 id: HS25897 (H2023:073) id: URGP#51472 type: OTHER_GRANT domain: University of Manitoba id: RGPIN-2015-05703 type: OTHER_GRANT domain: NSERC briefTitle: Non-invasive Spinal Cord Stimulation After Spinal Cord Injury acronym: SCI-ES-WALK overallStatus: RECRUITING date: 2023-06-15 date: 2024-08-15 date: 2024-11-15 date: 2024-02-15 date: 2024-02-15 name: University of Manitoba class: OTHER briefSummary: Spinal cord injury (SCI) is a central nervous system injury that often leads to motor dysfunction. Non-invasive electrical stimulation of the spinal cord has been recognized as a potential method of reactivating lost spinal neural networks to improve motor recovery and exercise response after SCI. Trans-spinal electrical stimulation (ts-ES) has been found to increase functional gains in people after SCI when applied in combination with other motor training protocols.

This project aims to evaluate the effects of non-invasive lumbar spinal cord electrical stimulation on the motor function of trunk and lower limbs in people with SCI after augmenting their locomotor training (treadmill stepping) with step-cycle-based electrical peripheral neural stimulation methods. conditions: Spinal Cord Injuries conditions: Spinal Cord Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Trans-spinal electrical stimulation name: Electrical muscle activation name: Treadmill walking measure: Neurophysiological markers or stepping measure: Electromyography (EMG) of ankle extensor muscles measure: Metabolic function testing measure: 6 Min Walk Test measure: SCIM-Spinal Cord Independence Measure- Mobility scores measure: Autonomic scores measure: Rate or Perceived Exertion (RPE) of Submaximal VO2 testing sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Manitoba status: RECRUITING city: Winnipeg state: Manitoba zip: R3E 0W2 country: Canada name: Katinka Stecina role: CONTACT phone: 204-789-3761 email: katinka.stecina@umanitoba.ca lat: 49.8844 lon: -97.14704 hasResults: False

 nctId: NCT06260722 id: 18805 id: J1I-MC-GZBZ type: OTHER domain: Eli Lilly and Company briefTitle: Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2) overallStatus: RECRUITING date: 2024-02-21 date: 2026-12-11 date: 2027-03-30 date: 2024-02-15 date: 2024-04-17 name: Eli Lilly and Company class: INDUSTRY briefSummary: The purpose of this study is to investigate the efficacy and safety of retatrutide compared with semaglutide in participants with Type 2 Diabetes and inadequate glycemic control with metformin with or without sodium-glucose cotransporter-2 inhibitor (SGLT2i). The study will last about 26 months and may include up to 24 visits. conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 1250 type: ESTIMATED name: Retatrutide name: Semaglutide measure: Change from Baseline in Hemoglobin A1c (HbA1c) (%) measure: Change from Baseline in HbA1c (%) measure: Percentage of Participants Who Achieve HbA1c ≤ 6.5% measure: Percentage of Participants Who Achieve HbA1c < 5.7% measure: Percent Change from Baseline in Body Weight measure: Change from Baseline in Body Weight measure: Percentage of Participants Who Achieve Weight Reduction of ≥ 5% measure: Percentage of Participants Who Achieve Weight Reduction of ≥ 10% measure: Percentage of Participants Who Achieve Weight Reduction of ≥ 15% measure: Percentage of Participants Who Achieve HbA1c ≤ 6.5% and ≥ 10% Weight Reduction measure: Percent Change from Baseline in Triglycerides measure: Percent Change from Baseline in Non- high-density lipoprotein (HDL) Cholesterol measure: Change from Baseline in Systolic Blood Pressure (SBP) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama - Department of Nutrition Sciences status: RECRUITING city: Birmingham state: Alabama zip: 35294 country: United States name: William Garvey role: PRINCIPAL_INVESTIGATOR lat: 33.52066 lon: -86.80249 facility: Neighborhood Healthcare Institute of Health status: RECRUITING city: Escondido state: California zip: 92025 country: United States name: James Schultz role: PRINCIPAL_INVESTIGATOR lat: 33.11921 lon: -117.08642 facility: Long Beach Research Institute status: RECRUITING city: Long Beach state: California zip: 90805 country: United States name: Ashley Duzik role: PRINCIPAL_INVESTIGATOR lat: 33.76696 lon: -118.18923 facility: Rancho Cucamonga Clinical Research status: RECRUITING city: Rancho Cucamonga state: California zip: 91730 country: United States name: Steven Barag role: PRINCIPAL_INVESTIGATOR lat: 34.1064 lon: -117.59311 facility: University of Colorado Anschutz Medical Campus status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: Neda Rasouli role: PRINCIPAL_INVESTIGATOR lat: 39.72943 lon: -104.83192 facility: Arrow Clinical Trials status: RECRUITING city: Daytona Beach state: Florida zip: 32117 country: United States name: David Billmeier role: PRINCIPAL_INVESTIGATOR lat: 29.21081 lon: -81.02283 facility: New Age Medical Research Corporation status: RECRUITING city: Miami state: Florida zip: 33186 country: United States name: Janet Gersten role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 facility: South Broward Research status: RECRUITING city: Miramar state: Florida zip: 33027 country: United States name: Kenneth Blaze role: PRINCIPAL_INVESTIGATOR lat: 25.98731 lon: -80.23227 facility: Clinical Research of Central Florida status: RECRUITING city: Winter Haven state: Florida zip: 33880 country: United States name: Eduardo Torres role: PRINCIPAL_INVESTIGATOR lat: 28.02224 lon: -81.73286 facility: Herman Clinical Research status: RECRUITING city: Suwanee state: Georgia zip: 30024 country: United States name: Lee Herman role: PRINCIPAL_INVESTIGATOR lat: 34.05149 lon: -84.0713 facility: Pacific Diabetes & Endocrine Center status: RECRUITING city: Honolulu state: Hawaii zip: 96813 country: United States name: ALAN PARSA role: PRINCIPAL_INVESTIGATOR lat: 21.30694 lon: -157.85833 facility: Rocky Mountain Clinical Research status: RECRUITING city: Idaho Falls state: Idaho zip: 83404 country: United States name: Kevin Prier role: PRINCIPAL_INVESTIGATOR lat: 43.46658 lon: -112.03414 facility: Deaconess Clinic - Gateway Health Center status: NOT_YET_RECRUITING city: Newburgh state: Indiana zip: 47630 country: United States name: Renee Galen role: PRINCIPAL_INVESTIGATOR lat: 37.94449 lon: -87.40529 facility: IMA Clinical Research Monroe - Armand status: RECRUITING city: Monroe state: Louisiana zip: 71201 country: United States name: Clinton Guillory role: PRINCIPAL_INVESTIGATOR lat: 32.50931 lon: -92.1193 facility: MedStar Health Research Institute (MedStar Physician Based Research Network) status: RECRUITING city: Hyattsville state: Maryland zip: 20782 country: United States name: Jean Park role: PRINCIPAL_INVESTIGATOR lat: 38.95594 lon: -76.94553 facility: Brigham and Women's Hospital Diabetes Program status: RECRUITING city: Boston state: Massachusetts zip: 02115 country: United States name: Vanita Aroda role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: NECCR PrimaCare Research status: RECRUITING city: Fall River state: Massachusetts zip: 02721 country: United States name: Ehab Sorial role: PRINCIPAL_INVESTIGATOR lat: 41.70149 lon: -71.15505 facility: Arcturus Healthcare , PLC, Troy Internal Medicine Research Division status: RECRUITING city: Troy state: Michigan zip: 48098 country: United States name: Neil Fraser role: PRINCIPAL_INVESTIGATOR lat: 42.60559 lon: -83.14993 facility: Palm Research Center Tenaya status: RECRUITING city: Las Vegas state: Nevada zip: 89128 country: United States name: Samer Nakhle role: PRINCIPAL_INVESTIGATOR lat: 36.17497 lon: -115.13722 facility: NYC Research INC status: RECRUITING city: Long Island City state: New York zip: 11106 country: United States name: Anastasios Manessis role: PRINCIPAL_INVESTIGATOR lat: 40.74482 lon: -73.94875 facility: Medication Management status: RECRUITING city: Greensboro state: North Carolina zip: 27405 country: United States name: James Franklin role: PRINCIPAL_INVESTIGATOR lat: 36.07264 lon: -79.79198 facility: Remington Davis Clinical Research status: RECRUITING city: Columbus state: Ohio zip: 43215 country: United States name: Elena Christofides role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 facility: Intend Research, LLC status: RECRUITING city: Norman state: Oklahoma zip: 73069 country: United States name: Lisa Connery role: PRINCIPAL_INVESTIGATOR lat: 35.22257 lon: -97.43948 facility: Central States Research status: RECRUITING city: Tulsa state: Oklahoma zip: 74136 country: United States name: Sarah Land role: PRINCIPAL_INVESTIGATOR lat: 36.15398 lon: -95.99277 facility: The Corvallis Clinic, P.C. status: RECRUITING city: Corvallis state: Oregon zip: 97330 country: United States name: Brian Curtis role: PRINCIPAL_INVESTIGATOR lat: 44.56457 lon: -123.26204 facility: Thomas Jefferson University Hospital status: NOT_YET_RECRUITING city: Philadelphia state: Pennsylvania zip: 19107 country: United States name: Serge Jabbour role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 facility: Dallas Diabetes Research Center status: RECRUITING city: Dallas state: Texas zip: 75230 country: United States name: Julio Rosenstock role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 facility: Valley Institute of Research - Fort Worth status: RECRUITING city: Fort Worth state: Texas zip: 76164 country: United States name: alex guevara role: PRINCIPAL_INVESTIGATOR lat: 32.72541 lon: -97.32085 facility: Juno Research status: RECRUITING city: Houston state: Texas zip: 77040 country: United States name: Damaris Vega role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 facility: Southern Endocrinology Associates status: RECRUITING city: Mesquite state: Texas zip: 75149 country: United States name: Sumana Gangi role: PRINCIPAL_INVESTIGATOR lat: 32.7668 lon: -96.59916 facility: Texas Valley Clinical Research status: RECRUITING city: Weslaco state: Texas zip: 78596 country: United States name: Eduardo Luna role: PRINCIPAL_INVESTIGATOR lat: 26.15952 lon: -97.99084 facility: Medrasa Clinical Research status: RECRUITING city: Wylie state: Texas zip: 75098 country: United States name: Tanvir Ahmad role: PRINCIPAL_INVESTIGATOR lat: 33.01512 lon: -96.53888 facility: Central Washington Health Services Association d/b/a Confluence Health status: RECRUITING city: Wenatchee state: Washington zip: 98801 country: United States name: Anton Grasch role: PRINCIPAL_INVESTIGATOR lat: 47.42346 lon: -120.31035 facility: Exemplar Research status: RECRUITING city: Morgantown state: West Virginia zip: 26505 country: United States name: WARD PAINE role: PRINCIPAL_INVESTIGATOR lat: 39.62953 lon: -79.9559 facility: CARE - Centro de Alergia y Enfermedades Respiratorias status: NOT_YET_RECRUITING city: Ciudad Autónoma de Buenos Aires state: Buenos Aires zip: 1414 country: Argentina name: Hernan Finkelstein role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: Stat Research S.A. status: NOT_YET_RECRUITING city: Buenos Aires state: Ciudad Autónoma De Buenos Aires zip: C1023AAB country: Argentina name: Lucas Gutnisky role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: CIPREC status: NOT_YET_RECRUITING city: Buenos Aires state: Ciudad Autónoma De Buenos Aires zip: C1061AAS country: Argentina name: Cesar Zaidman role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: Centro Médico Viamonte status: RECRUITING city: Buenos Aires state: Ciudad Autónoma De Buenos Aires zip: C1120AAC country: Argentina name: Diego Aizenberg role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: Mautalen Salud e Investigación status: NOT_YET_RECRUITING city: Buenos Aires state: Ciudad Autónoma De Buenos Aires zip: C1128AAF country: Argentina name: José Fretes role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: CEMEDIAB status: NOT_YET_RECRUITING city: C.a.b.a. state: Ciudad Autónoma De Buenos Aires zip: C1205AAO country: Argentina name: Alejandro Chertkoff role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: Instituto Centenario status: NOT_YET_RECRUITING city: Caba state: Ciudad Autónoma De Buenos Aires zip: 1204 country: Argentina name: SUSANA SALZBERG role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada status: NOT_YET_RECRUITING city: Ciudad Autonoma de Buenos Aires state: Ciudad Autónoma De Buenos Aires zip: C1425AGC country: Argentina name: Antonela Mainardi role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: Centro Medico Privado San Vicente Diabetes status: NOT_YET_RECRUITING city: Cordoba state: Córdoba zip: 5006 country: Argentina name: Cecilia Luquez role: PRINCIPAL_INVESTIGATOR lat: -31.4135 lon: -64.18105 facility: CIPADI - Centro Integral de Prevencion y Atencion en Diabetes status: RECRUITING city: Godoy Cruz state: Mendoza zip: 5501 country: Argentina name: Pedro Rosario Fabian Calella role: PRINCIPAL_INVESTIGATOR lat: -32.92863 lon: -68.8351 facility: Centro de Investigaciones Clínicas Baigorria status: RECRUITING city: Granadero Baigorria state: Santa Fe zip: 2152 country: Argentina name: Juan Escalante role: PRINCIPAL_INVESTIGATOR lat: -32.85683 lon: -60.71754 facility: Instituto de Investigaciones Clinicas Rosario status: NOT_YET_RECRUITING city: Rosario state: Santa Fe zip: S2000CVD country: Argentina name: Maximiliano Sicer role: PRINCIPAL_INVESTIGATOR lat: -32.94682 lon: -60.63932 facility: Fundación Respirar status: RECRUITING city: Buenos Aires zip: C1426ABP country: Argentina name: Maria De Salvo role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: Centro de Investigaciones Metabólicas (CINME) status: NOT_YET_RECRUITING city: Ciudad Autónoma de Buenos Aires zip: C1056ABJ country: Argentina name: Federico Perez Manghi role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: Centro Diabetológico Dr. Waitman status: NOT_YET_RECRUITING city: Córdoba zip: 5000 country: Argentina name: JOSE POZZI role: PRINCIPAL_INVESTIGATOR lat: -31.4135 lon: -64.18105 facility: University of Calgary - Clinical Trials Unit status: NOT_YET_RECRUITING city: Calgary state: Alberta zip: T2T 5C7 country: Canada name: Ronald Sigal role: PRINCIPAL_INVESTIGATOR lat: 51.05011 lon: -114.08529 facility: Alberta Diabetes Institute status: NOT_YET_RECRUITING city: Edmonton state: Alberta zip: T6G 2E1 country: Canada name: Peter Senior role: PRINCIPAL_INVESTIGATOR lat: 53.55014 lon: -113.46871 facility: Aggarwal and Associates Limited status: RECRUITING city: Brampton state: Ontario zip: L6T 0G1 country: Canada name: Naresh Aggarwal role: PRINCIPAL_INVESTIGATOR lat: 43.68341 lon: -79.76633 facility: Dr. Steven V. Zizzo Medicine Professional Corporation status: RECRUITING city: Hamilton state: Ontario zip: L8J 0B6 country: Canada name: Steven Zizzo role: PRINCIPAL_INVESTIGATOR lat: 43.25011 lon: -79.84963 facility: Wharton Medical Clinic status: NOT_YET_RECRUITING city: Hamilton state: Ontario zip: L8L 5G8 country: Canada name: Sean Wharton role: PRINCIPAL_INVESTIGATOR lat: 43.25011 lon: -79.84963 facility: Hamilton Medical Research Group status: RECRUITING city: Hamilton state: Ontario zip: L8M 1K7 country: Canada name: Richard Tytus role: PRINCIPAL_INVESTIGATOR lat: 43.25011 lon: -79.84963 facility: Bluewater Clinical Research Group Inc. status: NOT_YET_RECRUITING city: Sarnia state: Ontario zip: N7T 4X3 country: Canada name: John O'Mahony role: PRINCIPAL_INVESTIGATOR lat: 42.97866 lon: -82.40407 facility: Prime Health Clinical Research status: NOT_YET_RECRUITING city: Toronto state: Ontario zip: M4S 1Y2 country: Canada name: Iris Shasha Gorfinkel role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 facility: Maple Leaf Research status: RECRUITING city: Toronto state: Ontario zip: M5G 1K2 country: Canada name: Graham Smith role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 facility: Private Practice - Dr. Nigel Jagan status: RECRUITING city: Whitby state: Ontario zip: L1N 2L1 country: Canada name: Nigel Jagan role: PRINCIPAL_INVESTIGATOR lat: 43.88342 lon: -78.93287 facility: 9109-0126 Quebec Inc. status: RECRUITING city: Montreal state: Quebec zip: H4N 2W2 country: Canada name: Ronald Akhras role: PRINCIPAL_INVESTIGATOR lat: 45.50884 lon: -73.58781 facility: RM Pharma Specialists status: NOT_YET_RECRUITING city: Mexico City state: Distrito Federal zip: 03100 country: Mexico name: Mariana Crespo role: PRINCIPAL_INVESTIGATOR lat: 19.42847 lon: -99.12766 facility: Hospital de Jésus, I.A.P. status: NOT_YET_RECRUITING city: Mexico City state: Distrito Federal zip: 06090 country: Mexico name: Efrain Villeda Espinosa role: PRINCIPAL_INVESTIGATOR lat: 19.42847 lon: -99.12766 facility: Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares status: NOT_YET_RECRUITING city: Mexico City state: Distrito Federal zip: 11650 country: Mexico name: Melchor Alpizar Salazar role: PRINCIPAL_INVESTIGATOR lat: 19.42847 lon: -99.12766 facility: Diseno y Planeacion en Investigacion Medica status: NOT_YET_RECRUITING city: Guadalajara state: Jalisco zip: 44130 country: Mexico name: Cesar Calvo role: PRINCIPAL_INVESTIGATOR lat: 20.66682 lon: -103.39182 facility: Private Practice - Dr. Arechavaleta Granell Maria del Rosario status: NOT_YET_RECRUITING city: Guadalajara state: Jalisco zip: 44670 country: Mexico name: Maria Arechavaleta Granell role: PRINCIPAL_INVESTIGATOR lat: 20.66682 lon: -103.39182 facility: Instituto de Diabetes, Obesidad y Nutricion status: NOT_YET_RECRUITING city: Cuernavaca state: Morelos zip: 62250 country: Mexico name: Leobardo Sauque Reyna role: PRINCIPAL_INVESTIGATOR lat: 18.9261 lon: -99.23075 facility: Cardiolink Clin Trials status: NOT_YET_RECRUITING city: Monterrey state: Nuevo León zip: 64060 country: Mexico name: Elías García role: PRINCIPAL_INVESTIGATOR lat: 25.67507 lon: -100.31847 facility: Clínica García Flores SC status: NOT_YET_RECRUITING city: Monterrey state: Nuevo León zip: 64610 country: Mexico name: Pedro Garcia role: PRINCIPAL_INVESTIGATOR lat: 25.67507 lon: -100.31847 facility: Enclifar Ensayos Clínicos Farmacológicos Sc status: NOT_YET_RECRUITING city: Chihuahua zip: 31110 country: Mexico name: Luis Nevarez role: PRINCIPAL_INVESTIGATOR lat: 28.63528 lon: -106.08889 facility: Instituto Veracruzano en Investigación Clínica S.C. status: NOT_YET_RECRUITING city: Veracruz zip: 91851 country: Mexico name: Rosa Luna Ceballos role: PRINCIPAL_INVESTIGATOR lat: 19.18095 lon: -96.1429 facility: Advanced Clinical Research, LLC status: RECRUITING city: Bayamón zip: 00959 country: Puerto Rico name: Angel Comulada-Rivera role: PRINCIPAL_INVESTIGATOR lat: 18.39856 lon: -66.15572 facility: GCM Medical Group, PSC - Hato Rey Site status: RECRUITING city: San Juan zip: 00917 country: Puerto Rico name: Gregorio Cortes-Maisonet role: PRINCIPAL_INVESTIGATOR lat: 18.46633 lon: -66.10572 hasResults: False

 nctId: NCT06260709 id: NN6019-7565 id: 2022-502605-15-00 type: OTHER domain: European Medical Agency (EMA) id: U1111-1284-5820 type: OTHER domain: World Health Organization (WHO) briefTitle: A Research Study to Look at Long-term Treatment With a Medicine Called NNC6019-0001 for People Who Have Heart Failure Due to Transthyretin Amyloidosis overallStatus: RECRUITING date: 2024-02-20 date: 2028-02-29 date: 2028-02-29 date: 2024-02-15 date: 2024-04-26 name: Novo Nordisk A/S class: INDUSTRY briefSummary: This study will test a medicine, NNC6019-0001, for people who have a heart disease due to TTR amyloidosis. It will look at how safe this medicine is in the long term and if it can reduce symptoms of a heart disease due to TTR amyloidosis, such as heart failure. It is an extension to a study called "A research study to look at how a new medicine called NNC6019-0001 works and how safe it is for people who have a heart disease due to TTR amyloidosis". Only participants who have completed that study will be invited for this new study. Participants will get NNC6019-0001, regardless of whether they got placebo or NNC6019-0001 in the first study. The study will last for up to 157 weeks (36 months/3 years). conditions: Transthyretin Amyloid Cardiomyopathy (ATTR CM) studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: NNC6019-0001 measure: Number of Treatment Emergent Adverse Events measure: Change in 6-Minute Walk Test (6MWT) measure: Change in N-terminal-pro brain natriuretic peptide (NT-proBNP) measure: Change in Myocardial Extracellular Volume (ECV) measure: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) measure: Change in Troponin I measure: Change in Global Longitudinal Strain (GLS) on Echocardiography sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic Arizona status: NOT_YET_RECRUITING city: Phoenix state: Arizona zip: 85054 country: United States lat: 33.44838 lon: -112.07404 facility: Cedars-Sinai Medical Center_Los Angeles status: NOT_YET_RECRUITING city: Beverly Hills state: California zip: 90211 country: United States lat: 34.07362 lon: -118.40036 facility: Stanford Hlth Cre-Boswell Clin status: RECRUITING city: Stanford state: California zip: 94305 country: United States lat: 37.42411 lon: -122.16608 facility: Mayo Clinic Jacksonville status: NOT_YET_RECRUITING city: Jacksonville state: Florida zip: 32224 country: United States lat: 30.33218 lon: -81.65565 facility: NW Univ-Bluhm Cardiovasc Inst status: NOT_YET_RECRUITING city: Evanston state: Illinois zip: 60208 country: United States lat: 42.04114 lon: -87.69006 facility: Univ of MD Schl of Med status: RECRUITING city: Baltimore state: Maryland zip: 21201 country: United States lat: 39.29038 lon: -76.61219 facility: Mayo Clinic Rochester status: NOT_YET_RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 facility: University of Calgary_Cardiology status: NOT_YET_RECRUITING city: Calgary state: Alberta zip: T2N 4Z6 country: Canada lat: 51.05011 lon: -114.08529 facility: Ctr for Cardiovascular Innovation status: NOT_YET_RECRUITING city: Vancouver state: British Columbia zip: V5Z 1M9 country: Canada lat: 49.24966 lon: -123.11934 facility: II. interni klinika VFN - Kardiologie a angiologie status: NOT_YET_RECRUITING city: Praha 2 zip: 12808 country: Czechia lat: 50.08804 lon: 14.42076 facility: Ap-Hp-Hopital Henri Mondor status: NOT_YET_RECRUITING city: Créteil zip: 94000 country: France lat: 48.78333 lon: 2.46667 facility: Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1 status: NOT_YET_RECRUITING city: Toulouse Cedex 9 zip: 31059 country: France lat: 43.60426 lon: 1.44367 facility: Universitätsklinik Heidelberg Innere Medizin III Kardiologie, Angiologie, Pneumologie status: NOT_YET_RECRUITING city: Heidelberg zip: 69120 country: Germany lat: 49.40768 lon: 8.69079 facility: LMU Klinikum München Klinik und Poliklinik 1 status: NOT_YET_RECRUITING city: München zip: 81377 country: Germany lat: 48.13743 lon: 11.57549 facility: Uniklinik Münster, Klinik für Kardiologie I status: NOT_YET_RECRUITING city: Münster zip: 48149 country: Germany lat: 51.96236 lon: 7.62571 facility: Universitatsklinikum Wurzburg AöR status: NOT_YET_RECRUITING city: Würzburg zip: 97078 country: Germany lat: 49.79391 lon: 9.95121 facility: Fondazione CNR-Regione Toscana Gabriele Monasterio status: NOT_YET_RECRUITING city: Pisa state: Pi zip: 56124 country: Italy lat: 43.70853 lon: 10.4036 facility: Centro per lo Studio e la Cura delle Amiloidosi Sistemiche Fondazione IRCCS Policlinico San Matteo status: NOT_YET_RECRUITING city: Pavia state: PV zip: 27100 country: Italy lat: 45.19205 lon: 9.15917 facility: UMC Groningen status: NOT_YET_RECRUITING city: Groningen zip: 9713 GZ country: Netherlands lat: 53.21917 lon: 6.56667 facility: Universitair Medisch Centrum Utrecht status: NOT_YET_RECRUITING city: Utrecht zip: 3584 CX country: Netherlands lat: 52.09083 lon: 5.12222 facility: Hospital da Senhora da Oliveira - Guimarães status: NOT_YET_RECRUITING city: Guimarães zip: 4835-044 country: Portugal lat: 41.44443 lon: -8.29619 facility: Centro Hospitalar de Trás-os-Montes e Alto Douro status: NOT_YET_RECRUITING city: Vila Real zip: 5000-508 country: Portugal lat: 41.30062 lon: -7.74413 facility: Hospital Universitario Puerta de Hierro Majadahonda status: NOT_YET_RECRUITING city: Majadahonda state: Madrid zip: 28222 country: Spain lat: 40.47353 lon: -3.87182 hasResults: False

 nctId: NCT06260696 id: DAS-7626 id: U1111-1282-5512 type: OTHER domain: World Health Organization (WHO) briefTitle: Assessing Health-Related Quality of Life and Willingness to Pay for Weight Management in Asia-Pacific by Gender acronym: ASPECT - APAC overallStatus: COMPLETED date: 2023-08-10 date: 2023-10-05 date: 2023-10-05 date: 2024-02-15 date: 2024-02-15 name: Novo Nordisk A/S class: INDUSTRY briefSummary: The purpose of this survey is to collect information for scientific research and to identify the impact of overweight and obesity on health-related quality of life. conditions: Overweight conditions: Obesity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 3000 type: ACTUAL name: No treatment is given measure: Score on IWQOL-Lite validated sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Novo Nordisk Investigational Site city: Dubai country: United Arab Emirates lat: 25.0657 lon: 55.17128 hasResults: False

 nctId: NCT06260683 id: OSU-22240 id: NCI-2023-04102 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: R01DA057327 type: NIH link: https://reporter.nih.gov/quickSearch/R01DA057327 briefTitle: A Comprehensive Evaluation of Tobacco-Flavored vs. Non-Tobacco Flavored E-cigarettes on Smoking Behavior overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2027-04-29 date: 2027-04-29 date: 2024-02-15 date: 2024-04-03 name: Ohio State University Comprehensive Cancer Center class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: This clinical trial compares the use of tobacco flavored electronic cigarettes (ECs) to non-tobacco flavored ECs on smoking behavior in current cigarette smokers to use of nicotine replacement therapy (patches and lozenges). ECs may reduce cigarette craving and withdrawal symptoms, increase motivation and confidence to stop cigarette smoking, and decrease cigarette smoking and dependence. By comparing participants' preferred flavor ECs (PEC) to tobacco flavor ECs (TEC) to NRT, researchers hope to determine the effect of EC flavors on appeal and use, and learn how ECs affect smoking behaviors and health. conditions: Cigarette Smoking-Related Carcinoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 1500 type: ESTIMATED name: Nicotine Replacement name: Questionnaire Administration name: Vaping name: Vaping measure: Biochemically verified 7-day point prevalence abstinence from cigarettes measure: Switching rate measure: Cigarettes smoked per day measure: Change in nicotine dependence measure: Changes in cigarette craving and nicotine withdrawal measure: Number of days used measure: Product appeal measure: Continued purchase and use of ECs sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ohio State University Comprehensive Cancer Center city: Columbus state: Ohio zip: 43210 country: United States name: Theodore L. Wagener, PhD role: CONTACT email: Theodore.Wagener@osumc.edu name: Theodore L. Wagener, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False

 nctId: NCT06260670 id: CP0004 briefTitle: FLOW EVAL-AF: FLOW Mapping Electrogram VALidation in Patients With Persistent Atrial Fibrillation acronym: FLOW EVAL-AF overallStatus: COMPLETED date: 2022-09-01 date: 2022-10-28 date: 2022-10-28 date: 2024-02-15 date: 2024-02-15 name: Ablacon, Inc. class: INDUSTRY briefSummary: FLOW EVAL-AF is a prospective, observational, single center pilot trial. The FLOW EVAL-AF trial is designed to identify driver sources in patients with persistent or longstanding persistent AF using EGF mapping and describe the activation patterns observed from concomitant high density mapping of those regions. conditions: Persistent Atrial Fibrillation conditions: Longstanding Persistent Atrial Fibrillation conditions: Atrial Fibrillation, Persistent conditions: Arrhythmias, Cardiac studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 10 type: ACTUAL name: Electrographic Flow™ Mapping using Ablamap® Software and FIRMap™ Catheter measure: Descriptive correlation of electrogram patterns sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Herz-und Diabeteszentrum NRW (Clinic of Ruhr University of Bochum) city: Bad Oeynhausen state: North Rhine-Westphalia zip: 32545 country: Germany lat: 52.20699 lon: 8.80365 hasResults: False

 nctId: NCT06260657 id: 2021PI124 briefTitle: Search for Olfactory Cells Within the Fetal Ethmoid Epithelium acronym: COEF overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-10 date: 2025-10 date: 2024-02-15 date: 2024-02-15 name: Central Hospital, Nancy, France class: OTHER briefSummary: The recent rhinological functional approach known as "Evo-Devo" leads us to consider the nose not as a single organ, but as the construction of a specifically olfactory organ within which functional respiratory structures have developed over the course of species evolution in the same way they develop during human embryogenesis.

In adult humans, the olfactory structures are limited to two narrow regions situated at the upper part of the nasal passages known as olfactory clefts. Nevertheless, phylogenetic evidence indicates that these olfactory clefts are vestiges of an olfactory organ that once occupied the entire ethmoid bone in the front of the skull base.

The hypothesis of this study posits that, during the embryological development of the ethmoid bone, it would initially be covered with olfactory mucosa, which would gradually diminish as the lateral masses of the ethmoid formed, eventually persisting exclusively within the olfactory clefts of the ethmoid by the conclusion of the first trimester (end of organogenesis). Besides their fundamental interest, the results of this study could help understand the still unknown pathogenesis of nasal polyposis, a chronic anosmic disease with a prevalence of 2 to 4% in the French and European population.

This study requires a series of ethmoidal samples from human fetuses at various ages between 7 and 15 weeks of gestational age. Specific immunohistological labeling techniques under standard optical microscopy will be used to search for and quantify olfactory nerve cells within the fetal ethmoidal mucosa. conditions: Fetal Ethmoidal Mucosa studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Histological analysis on fetal ethmoids measure: Immunohistological positive signal of primary olfactive neurons measure: Concentration of primary olfactory neurons immunohistological signals sex: ALL minimumAge: 7 Weeks maximumAge: 15 Weeks stdAges: CHILD facility: Centre Hospitalier Régional Universitaire - Service ORL city: Nancy country: France name: Roger Jankowski, MD/PhD role: CONTACT email: r.jankowski@chru-nancy.fr lat: 48.68439 lon: 6.18496 hasResults: False

 nctId: NCT06260644 id: Repairing defective composite briefTitle: Evaluation of Using Self-adhering Flowable Resin Composite in Repairing Old Defective Resin Composite Restorations Over 18 Months Follow up. (A Randomized Clinical Trial) overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-01 date: 2025-09 date: 2025-10 date: 2024-02-15 date: 2024-02-15 name: Cairo University class: OTHER briefSummary: This research proposal is evaluating the clinical performance of using self-adhering flowable resin composite in repairing old occlusal defective resin composite versus conventional flowable resin composite restoration over 18 months. conditions: Occlusal Caries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: parallel assignment primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: double ( participants, outcomes assessor) participants and both assessors will be blind to the type of material used whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 34 type: ESTIMATED name: VertiseTM flowable composite (Kerr,USA) measure: Restoration clinical performance using FDI criteria sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Faculty of Dentistry city: Cairo zip: 113311 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06260631 id: P.T.REC/012/004807 briefTitle: Efficacy of High-intensity Laser Acupuncture in Patients With Chronic, Non-specific Low Back Pain overallStatus: RECRUITING date: 2024-02-25 date: 2024-08 date: 2024-08 date: 2024-02-15 date: 2024-04-26 name: Cairo University class: OTHER name: King Khalid University briefSummary: The purpose of this study is to investigate the efficacy of high-intensity laser acupuncture on peak torque, power of trunk extensors and flexors, back pain, range of motion, function, and satisfaction in patients with chronic nonspecific low back pain (CNLBP). conditions: Chronic Nonspecific Low-back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: high-intensity laser acupuncture and exercise therapy program primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: random generator whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: high-intensity laser acupuncture and Exercise therapy program name: Sham laser acupuncture measure: peak torque measure: peak torque measure: Average Power measure: Average Power measure: Pain Intensity measure: Pain Intensity measure: lumbar flexion and extension ROM assessment measure: lumbar flexion and extension ROM assessment measure: Disability measure: Disability measure: patient Satisfaction measure: patient Satisfaction sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Doaa Ayoub Elimy status: RECRUITING city: Giza zip: 11251 country: Egypt name: Doaa A Elimy, lecturer role: CONTACT phone: 00201066474654 email: do3aayoub25@gmail.com lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06260618 id: 2021/HRE00065 briefTitle: Effect of Chitodex Gel in Tympanoplasty Surgery overallStatus: RECRUITING date: 2021-11-20 date: 2024-05-13 date: 2024-05-13 date: 2024-02-15 date: 2024-02-20 name: Central Adelaide Local Health Network Incorporated class: OTHER_GOV name: University of Adelaide briefSummary: The general purpose of this study is to compare Chitosan-dextran (Chitodex) gel versus current standard of care, Gelfoam, as a middle ear (ME) and external auditory canal (EAC) packing agent as part of tympanoplasty procedures to close tympanic membrane perforations (TMP). conditions: Tympanic Membrane Perforation conditions: Tympanic Membrane Inflammation conditions: Surgery conditions: Otitis Media studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Single blinded randomised clinical trial primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Masked: The people receiving the treatment/s, The people analysing the results/data Unmasked: The surgeon administering the treatment. whoMasked: PARTICIPANT count: 44 type: ESTIMATED name: Gelfoam name: Chitodex measure: Number of participants with tympanic membrane closure measure: rate of tympanic membrane closure measure: Number of participants with improved hearing measure: Number of participants with improved eardrum function measure: Ease of use of product compared to active comparator - surgeon feedback measure: Time taken to complete surgery measure: Number of Participants with improved quality of life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Queen Elizabeth Hospital status: RECRUITING city: Adelaide state: South Australia zip: 5011 country: Australia name: Prof Peter John Wormald, MD role: CONTACT phone: +61 8 8222 7158 email: pjwormald@gmail.com name: Emma Barry, BSc (Hons) role: CONTACT phone: +61 8 8222 7158 email: emma.barry@adelaide.edu.au name: Prof Peter John Wormald, MD role: PRINCIPAL_INVESTIGATOR lat: -34.92866 lon: 138.59863 facility: The Memorial Hospital status: RECRUITING city: North Adelaide state: South Australia zip: 5006 country: Australia name: Prof Peter John Wormald, MD role: CONTACT phone: +61 8 8222 7158 email: prwormald@gmail.com lat: -34.90733 lon: 138.59141 hasResults: False

 nctId: NCT06260605 id: Burcu Bayrak 1 id: Burcu type: REGISTRY domain: Bayrak briefTitle: Complications of Diabetes With Puzzles acronym: Diabetes with overallStatus: COMPLETED date: 2023-12-19 date: 2024-02-20 date: 2024-03-04 date: 2024-02-15 date: 2024-03-07 name: Bilecik Seyh Edebali Universitesi class: OTHER briefSummary: In this study, it was aimed to investigate the effect of diabetes complications training on endocrine system diseases and nursing care in the Internal Medicine Nursing course on the knowledge level of nursing students. conditions: Diabetes Complications studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 110 type: ACTUAL name: Education measure: Education sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Bilecik Şeyh Edebali University city: Bilecik state: Merkez country: Turkey lat: 40.14192 lon: 29.97932 hasResults: False

 nctId: NCT06260592 id: Aysun Acun 4 briefTitle: Ethical Attitude and Humanistic Acting Skills of Intensive Care Nurses overallStatus: RECRUITING date: 2024-02-06 date: 2024-03 date: 2024-03 date: 2024-02-15 date: 2024-02-15 name: Bilecik Seyh Edebali Universitesi class: OTHER briefSummary: Today, rapidly developing technology and changing treatment and care conditions increase the tendency towards ethical values both as an intellectual concept and as a moral guide. The nursing profession, which focuses on people in ethical terms, is also performed by people. This situation brings with it many ethical dilemmas in areas where health care services are provided. In ICUs, long and critical treatments of patients, differences of opinion between the medical team and the institution, non-compliance with patient rights, difficulties in terminal patient care, procedures performed without the patient\&#39;s consent, distribution of limited medical resources, unethical attitudes and attitudes of nurse colleagues, Many issues such as long-term exposure to stressors and constant alarm sounds can cause mental distress and negative emotions in intensive care nurses. One of the effective ways to increase the quality of care provided by nurses is humanistic practice ability. The presence of humanistic practice ability provides more realistic, human-centered nursing care, improves the quality of life of patients, and also positively affects health expenditures. conditions: Humanistic Care Skills studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 400 type: ESTIMATED measure: Ethical compliance of nurses in the intensive care unit measure: Humanistic care skills of nurses in the intensive care unit sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bilecik Şeyh Edebali University status: RECRUITING city: Bilecik zip: 11000 country: Turkey name: Aysun Acun, PhD role: CONTACT phone: +905072104506 email: aysun.acun@bilecik.edu.tr name: Aysun Acun, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.14192 lon: 29.97932 hasResults: False

 nctId: NCT06260579 id: S-number 66153 id: S006722N type: OTHER_GRANT domain: Research Foundation Flanders - SBO project briefTitle: Home-based Exercise and Physical Activity Intervention After Kidney Transplantation: Impact of Exercise Intensity acronym: PHOENIX-Kidney overallStatus: RECRUITING date: 2022-11-14 date: 2025-09-30 date: 2029-12 date: 2024-02-15 date: 2024-02-15 name: KU Leuven class: OTHER name: University Ghent briefSummary: This multicentre two-phased RCT aims to evaluate implementation potential, cost-effectiveness, effectiveness, and the role of exercise intensity of a home-based exercise and physical activity intervention to improve de novo kidney transplant recipients' physical fitness, cardiovascular health, gut microbiome characteristics, and health-related quality of life. The first phase of this study comprehends a six-month exercise training intervention. Patients will be randomized into (i) a sham intervention consisting of low-intensity balance and stretching exercises (LIT), (ii) a moderate-intensity aerobic and strength training intervention (MIT), or (iii) a moderate- and high-intensity aerobic and strength training intervention (MHIT). The second phase of this study comprehends a physical activity maintenance intervention provided to MIT and MHIT but not LIT. A total of 147 de novo kidney transplant recipients will be recruited from two independent Belgian transplant centres i.e. UZ Leuven and UZ Ghent. conditions: Physical Activity conditions: Exercise Training conditions: Kidney Transplantation conditions: Physical Fitness conditions: Cardiovascular Health conditions: Gut Microbiome conditions: Health-related Quality of Life conditions: Implementation conditions: Cost-effectiveness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel group randomized controlled trial primaryPurpose: OTHER masking: SINGLE maskingDescription: Outcome assessors are blinded to the group allocation of the patients. Due to the nature of the intervention, blinding of the patients is not possible. However, a sham training intervention is provided to the control group. whoMasked: OUTCOMES_ASSESSOR count: 147 type: ESTIMATED name: Exercise/physical activity measure: Changes in peak oxygen consumption (VO2peak) measure: Health-related physical fitness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UZ Ghent status: RECRUITING city: Ghent zip: 9000 country: Belgium name: Calders Patrick, PhD role: CONTACT lat: 51.05 lon: 3.71667 facility: UZ Leuven status: RECRUITING city: Leuven zip: 3000 country: Belgium name: Amaryllis Van Craenenbroeck, MD, PhD role: CONTACT lat: 50.87959 lon: 4.70093 hasResults: False

 nctId: NCT06260566 id: H-52570 briefTitle: Tolerability of Enteral NAC in Infants overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-02 date: 2027-02 date: 2024-02-15 date: 2024-04-15 name: Sanjiv Harpavat class: OTHER name: Baylor College of Medicine briefSummary: Biliary atresia (BA) is a neonatal liver disease characterized by impaired bile flow and is the most common indication for pediatric liver transplantation. BA can be treated with the Kasai portoenterostomy (KP), a procedure that attempts to restore bile flow and slow disease progression. However, success of the KP procedure is quite variable, and lack of adjuvant medical therapies following KP is a major gap in pediatric hepatology.

This study begins to explore oral N-acetylcysteine (NAC) as a potential medical therapy in BA by determining whether an oral formulation can be given to infants. The primary objective is to determine tolerability of the oral NAC formulation. The primary outcome is tolerating at least 3 out of 4 total doses without emesis. The Bayesian Optimal Interval Design (BOIN) trial design will be used to determine the maximum tolerated dose of oral NAC. Our secondary objective is to assess palatability of the oral NAC formulation by comparing facial expressions when taking oral NAC versus other medications commonly given to cholestatic infants. conditions: Biliary Atresia studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The study consists of two parts:

* Administering applesauce alone (lead-in): In study days 1-2, infants will receive one infant spoon (approximately ½ teaspoon) of plain applesauce by mouth twice a day. If the infant tolerates 3-4 of 4 total doses without emesis, the infant will progress to the final two days of the study.
* Administering applesauce plus NAC (for infants who tolerate applesauce in study days 1-2): In study days 3-4, infants will receive an individualized dose of powdered oral NAC mixed into one infant spoon of applesauce by mouth twice a day for a maximum of four doses of NAC medication. primaryPurpose: OTHER masking: NONE maskingDescription: N/A. No Masking count: 12 type: ESTIMATED name: N-Acetylcysteine measure: No emesis within 30 minutes of administration of at least 3 of 4 total doses of oral NAC measure: Oral NAC palatability compared to clinically indicated medications using the facial expression scale measure: Oral NAC-specific adverse event evaluation sex: ALL minimumAge: 122 Days maximumAge: 273 Days stdAges: CHILD hasResults: False

 nctId: NCT06260553 id: SCOG008 briefTitle: Metronomic Oral Vinorelbine Combination With Tislelizumab in EGFR/ALK-negative Advanced NSCLC overallStatus: ENROLLING_BY_INVITATION date: 2024-02-07 date: 2025-02-07 date: 2025-08-07 date: 2024-02-15 date: 2024-02-15 name: Fujian Cancer Hospital class: OTHER_GOV briefSummary: To evaluate the efficacy of metronomic chemotherapy combination with tislelizumab in EGFR/ALK-negative advanced NSCLC patients intolerant to first-line standard chemotherapy. conditions: EGFR/ ALK-negative Advanced NSCLC studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: tislelizumab and metronomic oral vinorelbine measure: PFS measure: ORR measure: DCR measure: AE sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fujian cancer hospital city: Fuzhou state: Fujian country: China lat: 26.06139 lon: 119.30611 hasResults: False

 nctId: NCT06260540 id: Core Endurance briefTitle: Core Endurance in Healthy Young Adults overallStatus: RECRUITING date: 2024-02-01 date: 2024-02-29 date: 2024-04-29 date: 2024-02-15 date: 2024-03-26 name: Karabuk University class: OTHER briefSummary: This study aimed to examine the effect of core endurance levels on upper extremity function, muscle strength and reaction time in healthy young adults. The "core" region functions as a connection point between the upper and lower extremities and enables the transfer of force from this region to the extremities. This region is a basic structure where the force required for all movements is generated and transmitted from the proximal segments to the distal segments. "Core" stabilization has a significant impact on limb functionality, and stabilization of the proximal segments is necessary to maintain the mobility and function of the distal segments. To establish a stable base during functional activities, the "core" muscles are activated before the upper and lower extremity muscles. This ensures force production and transfer of resulting forces, thus supporting the mobility of the distal segments. Increasing core stabilization increases force production in the extremities, and control of core strength, balance and movement maximizes upper and lower extremity functions. Any impairment in core stabilization reduces the quality of movement and increases the risk of injury to the upper extremity. Therefore, it has been stated that "core" stabilization has a significant effect on athletic performance and upper extremity functions. There are not enough studies in the literature investigating this effect in healthy young adults. Most existing studies focus on the role of core endurance on athlete performance.

The aim of this study is not only to investigate core endurance levels in healthy young adults but also to examine the effect of core endurance levels on upper extremity function, muscle strength and reaction time. conditions: Health Risk Behaviors studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 104 type: ESTIMATED measure: Side bridge test measure: Prone bridge test (plank) test measure: Trunk flexion endurance test measure: Sorensen test measure: Purdue Pegboard test measure: Isometric hand dynamometer for muscle strength measure: Nelson hand reaction test sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Karabuk University status: RECRUITING city: Karabuk zip: 78000 country: Turkey lat: 41.20488 lon: 32.62768 hasResults: False

 nctId: NCT06260527 id: ARTS-011-101 briefTitle: Safety and Pharmacokinetic Study of ARTS-011 in Chinese Healthy Volunteers overallStatus: RECRUITING date: 2023-08-30 date: 2024-05-30 date: 2024-09-30 date: 2024-02-15 date: 2024-02-15 name: Allorion Therapeutics Inc class: INDUSTRY briefSummary: This single- and multiple-ascending dose study is a Phase 1, first in human study of ARTS-011. The goal of the study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of ARTS-011 after single and multiple oral doses of ARTS-011 in Chinese healthy volunteers. conditions: Chinese Healthy Volunteer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Single ascending dose (SAD) following by multiple ascending dose (MAD) and food effect study primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 76 type: ESTIMATED name: ARTS-011 name: Placebo measure: Incidence of Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs measure: Number of Adverse Events (AEs) according to severity measure: Number of participants with change from baseline in vital signs (blood pressure, pulse rate, oral temperature) measure: Number of participants with change from baseline in 12-Lead Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) measure: Number of participants with change from baseline physical examination measure: Incidence and magnitude of treatment emergent clinical laboratory abnormalities measure: Number of participants with change in 24-hour creatine clearance from baseline measure: Maximum Observed Plasma Concentration (Cmax) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) measure: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) measure: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) measure: Plasma Decay Half-Life (t1/2) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) measure: Apparent Volume of Distribution (Vz/F) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) measure: Apparent Clearance (CL/F) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) if data permit measure: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of ARTS-011 in Single Ascending Dose (SAD) measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of ARTS-011 in Multiple Ascending Dose (MAD) measure: Dose Normalized Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf[dn]) of ARTS-011 in Single Ascending Dose (SAD) measure: Dose Normalized Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau[dn]) of ARTS-011 in Multiple Ascending Dose (MAD) measure: Maximum Observed Plasma Concentration (Cmax) of ARTS-011 in Food Effect Cohort measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of ARTS-011 in Food Effect Cohort measure: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of ARTS-011 in Food Effect Cohort measure: Plasma Decay Half-Life (t1/2) of ARTS-011 in Food Effect Cohort measure: Apparent Clearance (CL/F) of ARTS-011 in Food Effect Cohort if data permit measure: Apparent Volume of Distribution (Vz/F) of ARTS-011 in Food Effect Cohort if data permit sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Beijing Friendship Hospital, Capital Medical University status: RECRUITING city: Beijing state: Beijing zip: 100050 country: China name: Ruihua Dong, MD role: CONTACT phone: 010-80839386 email: ruihua_dong_rw@163.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06260514 id: APR-1051-001 briefTitle: Study of APR-1051 in Patients With Advanced Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-06 date: 2028-06 date: 2024-02-15 date: 2024-02-15 name: Aprea Therapeutics class: INDUSTRY briefSummary: The purpose of this study is to assess the safety and effectiveness of APR-1051 through the performance of a Phase 1, open-label, safety, PK, and preliminary efficacy study of oral APR-1051 in patients with advanced solid tumors. conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 79 type: ESTIMATED name: APR-1051 measure: Treatment-related adverse events measure: Recommended dose of APR-1051 measure: Pharmacokinetics: Cmax/Cmin of APR-1051 measure: Pharmacokinetics: Tmax of APR-1051 measure: Pharmacokinetics: AUC of APR-1051 measure: Pharmacokinetics: t1/2 of APR-1051 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06260501 id: ATADEK-2023-13/463 briefTitle: Wetting Solution-ideal Body Weight Ratio in Liposuction Procedures overallStatus: COMPLETED date: 2021-09-01 date: 2023-09-30 date: 2023-10-30 date: 2024-02-15 date: 2024-02-15 name: Acibadem University class: OTHER briefSummary: Although the use of wetting solutions during high-volume liposuction is a standard approach, it is unclear how to optimize wetting solutions and components and their effect on postoperative complications.. Since the super-wet technique (aspiration of 1 cc per 1 cc of infiltrate) was introduced in 1986, it has become one of the most frequently applied techniques worldwide . Adrenaline and lidocaine are often added to WS due to their hemostatic and analgesic effects One of the major advantages of super-wet technique is that blood loss is quite low. However, potential cardiovascular side effects of WS and the amounts of epinephrine and lidocaine they contain, such as volume overload, local anesthetic toxicity, hypertension, arrhythmia, and tachycardia, are still a scoop of investigation. In this study, we examined the WS and the medications it contains from a different perspective to understand the possible cause of these adverse outcomes. Despite the most suitable candidates for liposuction are patients with a BMI\<30 kg/m2 and low comorbidity and age, the patient group undergoing liposuction is often obese, and overweight individuals require that obesity-related pathophysiological changes be taken into consideration. Therefore, we analyzed the patients by dividing them into two groups according to the amount of WS applied according to their IBW (WS/IBW≤90ml/kg: group I and WS/IBW\>90ml/kg: group I). In this study we aimed to evaluate the effect of wetting solutions and components calculated according to ideal body weight (IBW) on postoperative complications conditions: Liposuction conditions: Obesity conditions: Postoperative Complications studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 192 type: ACTUAL name: super-wet technique measure: Mean arterial pressure (MAP) was measured to detect hypertension and hypotension. measure: The Numerical Pain Rating Scale (NRS) was used to assess postoperative pain level sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Acibadem Altunizade Hospital city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06260488 id: 8925 briefTitle: Histological Segmentation of the Superficial Femoral Artery From Microscan to CT Using Artificial Intelligence acronym: CTPred overallStatus: NOT_YET_RECRUITING date: 2024-02-15 date: 2025-06-15 date: 2025-08-15 date: 2024-02-15 date: 2024-02-15 name: University Hospital, Strasbourg, France class: OTHER briefSummary: The femoropopliteal artery segment (FPAS) is one of the longest arteries in the human body, undergoing torsion, compression, flexion and extension due to lower limb movements. Endovascular surgery is considered to be the treatment of choice for the peripheral arterial disease, the results of which depend on the physiological forces on the arterial wall, the anatomy of the vessels and the characteristics of the lesions being treated. The atheromatous disease includes, in a simple way, 3 categories of plaques: calcified, fibrous, and lipidic. The study of these plaques and their differentiation in imaging and histology in the FPAS has already been the subject of research. To treat them, there are angioplasty balloons and stents with different designs and components, with different mechanical properties and different impregnated molecules.

There is no non-invasive method (imaging) to accurately differentiate lesions along the FPAS. The analysis is performed from the preoperative CT scan, but there are high-resolution scanners that allow a quasi-histological analysis of the tissue.

This microscanner can be used ex vivo. In the framework of a project, the learning algorithm was be créated (Convolutional Neural Networks) to automatically segment microscanner slices: after taking FPAS from amputated limbs, we correlated ex-vivo microscanner images of the arteries with their histology. The correlation was then performed manually between the microscanner images, and the histological sections obtained. the algorithm well be trained on these slices and validated its performance. The validation of the CT and microscanner concordance was the subject of scientific publications. conditions: Peripheral Artery Disease conditions: Femoropopliteal Stenosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 20 type: ESTIMATED name: Endovascular surgery measure: Assessing the feasibility of histological segmentation of the superficial femoral artery on preoperative microscanner using artificial intelligence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06260475 id: IUA - 246-18 briefTitle: IUA Committee Research Project on the Management of TASC C and D Aortoiliac Lesions overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-08-31 date: 2024-12-31 date: 2024-02-15 date: 2024-02-15 name: Universidade do Porto class: OTHER name: Clinical Centre of Serbia name: University of Padova name: University of Bari name: University of Trieste name: University of Nis name: Centro Hospitalar de Vila Nova de Gaia/Espinho name: Hospital Centre Hospitalar de Trás-os-Montes e Alto Douro name: Centro Hospitalar do Porto briefSummary: This study aims to evaluate the clinical, imaging results of endovascular revascularization of the aorto-iliac sector in comparison with aortobifemoral bypass and the hybrid approach, in patients with atherosclerotic disease of the iliac sector classified as type C and D by the TransAtlantic Inter-Society Consensus (TASC II conditions: Aortoiliac Atherosclerosis conditions: Aortoiliac Occlusive Disease conditions: Aortoiliac Atherosclerosis With Gangrene conditions: Aortoiliac Atherosclerosis Without Gangrene conditions: Aortoiliac Obstruction conditions: Peripheral Arterial Disease conditions: Peripheral Vascular Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 500 type: ESTIMATED name: Aortobifemoral bypass name: aortoiliac stenting measure: Major Amputation measure: Cardiovascular Death measure: acute myorcardial infartion measure: Major Adverse Limb Events measure: Major adverse cardiovascular events measure: Death measure: Intensive care unit instay measure: acute kidney injury (AKI) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centro Hospitalar Universitário de São João, EPE city: Porto zip: 4200-319 country: Portugal name: Joao Rocha-Neves role: CONTACT phone: +351910486230 email: joaorochaneves@hotmail.com lat: 41.14961 lon: -8.61099 facility: Faculdade de Medicina da Universidade do Porto city: Porto zip: 4200-319 country: Portugal lat: 41.14961 lon: -8.61099 hasResults: False

 nctId: NCT06260462 id: 10 years adrenal insufficiency briefTitle: Effects of Steroid Replacement Therapy on Metabolic, Cardiovascular and Bone Outcomes in Adrenal Insufficiency overallStatus: COMPLETED date: 2012-01-01 date: 2022-09-30 date: 2023-12-30 date: 2024-02-15 date: 2024-02-15 name: University of Palermo class: OTHER briefSummary: The current study is a randomized, open study aimed to compare the effects of conventional glucocorticoid replacement treatment and dual-release hydrocortisone on anthropometric, metabolic, cardiovascular and bone outcomes in treatment-naïve patients with primary adrenal insufficiency and secondary adrenal insufficiency in a 10 year-observation period. conditions: Adrenal Insufficiency studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 88 type: ACTUAL name: dual-release hydrocortisone name: Conventional glucocortidois measure: Change of body weight measure: Change of anthropometric parameters measure: Change of metabolic parameters measure: Change of insulin sensitivity parameters measure: Change of cardiovascular parameters measure: Change of bone metabolic parameters measure: Change of bone density measure: Change of vascular parameters sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06260449 id: Trematode briefTitle: Different Treatment Approaches of Presumed Trematode-Induced Uveitis overallStatus: ACTIVE_NOT_RECRUITING date: 2023-10-21 date: 2024-10-21 date: 2024-12-21 date: 2024-02-15 date: 2024-02-15 name: Assiut University class: OTHER briefSummary: Different Treatment Approaches of Presumed Trematode-Induced Uveitis including periocular injection and medical treatment Nd laser treatment conditions: Uveitis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Single group tested by intervention and medical treatment primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 31 type: ESTIMATED name: Surgical removal measure: Surgical removal sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Assiut city: Assiut country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False

 nctId: NCT06260436 id: Tharwat gamal Mohamed briefTitle: Questionnaire of Lower Urinary Tract Symptoms Among Women Before and After Surgical Correction of Uterine Prolapse overallStatus: RECRUITING date: 2021-05-30 date: 2024-09-30 date: 2024-12-30 date: 2024-02-15 date: 2024-02-21 name: Assiut University class: OTHER briefSummary: . The study will include patients who underwent Pelvic reconstructive surgery for advanced pelvic organ prolapse (POP-Q ≥ 3). Data regarding preoperative evaluation, surgical procedure, and post-operative management will be collected. women will receive a follow up questionnaire. . The baseline questionnaire included data on age, urinary incontinence, daytime frequency, nocturia, postmicturition dribble, straining, urgency, incomplete bladder emptying, and hesitancy. Women were asked about leakage caused by coughing or sneezing, moving, lifting, sleeping, sexual intercourse, urgency, and rest. conditions: Pelvic Organ Prolapse studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 180 type: ESTIMATED measure: effect of surgical correction of pelvic organ prolapse on the lower urinary tract symptoms measure: effect of surgical correction of pelvic organ prolapse on the quality of life sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Assuit University status: RECRUITING city: Assiut state: Assuit zip: 2063045 country: Egypt name: tharwat gl mohamed role: CONTACT phone: 01151166826 email: tharwat.fares3@gmail.com name: tht tg mohamed role: CONTACT phone: 01017941889 email: tharwat.fares3@gmail.com name: abdelghaffar m mohamed, professor role: PRINCIPAL_INVESTIGATOR lat: 27.18096 lon: 31.18368 hasResults: False

 nctId: NCT06260423 id: 18/1/2024 briefTitle: The Effect of Clinical Experience on the Quality of Obturation and Periapical Changes of Teeth Treated With Matched Cones in Combination With Bioceramic Sealer overallStatus: RECRUITING date: 2023-01-01 date: 2025-02-01 date: 2025-04-01 date: 2024-02-15 date: 2024-02-15 name: Al-Azhar University class: OTHER briefSummary: Evaluation of the impact of clinical experience on the quality of obturation and periapical changes of clinical cases using lateral compaction with bioceramic sealers and matched cone obturation with bioceramic sealers both clinically and radiographically. conditions: Obturation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 54 type: ESTIMATED name: Experienced dentist using lateral compaction with bioceramic sealer. name: Unexperienced dentist using lateral compaction with bioceramic sealer. name: Experienced dentist using Single cone with bioceramic sealer. name: Unexperienced dentist using Single cone with bioceramic sealer. measure: Postoperative pain assessment measure: Postoperative pain assessment measure: Postoperative pain assessment measure: Postoperative pain assessment measure: Postoperative pain assessment measure: The quality of obturation and the voids within the root canal filling sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Al-Azhar university status: RECRUITING city: Cairo zip: 11651 country: Egypt name: Mohamed Badr, Master role: CONTACT phone: 0201111777739 email: badrabueida@gmail.com lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06260410 id: 10512 id: NL84672.078.23 type: OTHER domain: CCMO briefTitle: Data Collection in Lutetium Treated Prostate Cancer: Recording of Progression and Tumor Characteristics acronym: LUTRAC overallStatus: RECRUITING date: 2024-02-20 date: 2027-02-01 date: 2027-02-01 date: 2024-02-15 date: 2024-04-22 name: Erasmus Medical Center class: OTHER briefSummary: This prospective study aims to collect data and blood biomarkers from patients undergoing Lu-PSMA therapy at the Erasmus MC. In doing so, it will provide real-world efficacy and safety data on the drug, gather dosimetry data and explore putative biomarkers to identify patients who most benefit from Lu-PSMA treatment. conditions: Prostate Cancer Metastatic studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: Blood draw for ctDNA and circulating tumor cell collection. measure: Overall survival measure: Progression free survival measure: Heterogeneity of PSMA-positivity measure: Effect of CTC PSMA expression on response to treatment. measure: Effect of biomarkers in blood on response to treatment. measure: PSMA-PET scan data and response to treatment. sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erasmus MC status: RECRUITING city: Rotterdam state: Zuid-Holland zip: 3015 CN country: Netherlands name: Stijn Koolen, PhD role: CONTACT phone: +31638740656 email: s.koolen@erasmusmc.nl lat: 51.9225 lon: 4.47917 hasResults: False

 nctId: NCT06260397 id: analgesia for MRM surgeries briefTitle: Serratus Anterior Plane Block and Costotransverse Block for Analgesia Following Modified Radical Mastectomy Surgeries overallStatus: NOT_YET_RECRUITING date: 2024-02-28 date: 2025-02-28 date: 2025-03-30 date: 2024-02-15 date: 2024-02-26 name: Ain Shams University class: OTHER briefSummary: Adequate pain management following modified radical mastectomy (MRM) is crucial for early ambulation and patient satisfaction. Breast cancer is the most common malignancy in females, with an increasing incidence in recent years. Surgery is one of the mainstays of therapy for breast cancer, and modified radical mastectomy (MRM) is the most effective and common type of invasive surgical treatment. Post-mastectomy pain syndrome (PMPS) is a surgical complication of breast surgery characterized by chronic neuropathic pain. The aim of this study is to investigate the efficacy and safety of single injection CTB versus SAPB on post-operative acute pain as a part of a multimodal analgesia plan in patients undergoing MRM. conditions: Regional Anesthesia Morbidity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: serratus anterior plane block name: costotransverse block name: patient controlled analgesia measure: Visual Analogue Scale score at 0,6,12 and 24 hour post-operatively. visual analogue scale is a scale from 0 to 10, 0 represent no pain at all and 10 represent the worst pain measure: The total dose of nalbuphine consumption is used postoperatively per patient rescue analgesia for 24. sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06260384 id: FMASU R 139/2022 briefTitle: Wolf-Parkinson-White Syndrome and Asymptomatic Pre-excitation in Africa (a Multicenter WPW African Registry) overallStatus: RECRUITING date: 2022-05-01 date: 2024-05-31 date: 2024-10-31 date: 2024-02-15 date: 2024-02-26 name: Ain Shams University class: OTHER briefSummary: The purpose of this prospective observational study is to characterize the clinical profile of patients with WPW syndrome and patients with asymptomatic WPW pattern on ECG in different African countries and how these patients are managed across Africa Participants would include many different ethnicities at centers where the number of cardiac patients treated is high. All patients attending outpatient cardiology clinics or referred to Cath Lab for electrophysiological studies who are diagnosed to have a Wolf-Parkinson white pattern on the ECG are either symptomatic or asymptomatic. All patients fulfilling the eligibility criteria will be approached by the research team and asked if they wish to take part in the study.

The exclusion criteria will be any participant who does not consent to the study.

A baseline cardiovascular history (including hypertension, diabetes, heart failure, coronary artery disease, hyperlipidemia, smoking, valve disease, and arrhythmia) will be recorded.

A detailed history will be taken about symptoms, medications and presence of family history of similar cases or sudden cardiac death 12-lead ECG will be recorded to confirm the presence of pre-excitation and determine the localization of the accessory pathway using the modified Aruda algorithm. This will be done by two of the research teams in each center.

Then other data from the electrophysiological study and ablation will be filled in by the research team from the data systems of each center. conditions: Wolf Parkinson White Syndrome conditions: Arrythmias studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: electrocardiogram measure: No recurrence of symptoms measure: Assessment of performance outcome of each center sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Ain shams university status: RECRUITING city: Cairo state: Outside US zip: 11851 country: Egypt name: Nabil M Farag, MD role: CONTACT phone: +201223102180 email: faragnabil@hotmail.com role: CONTACT email: lamallam.eps@gmail.com name: lamyaa E Allam, MD role: PRINCIPAL_INVESTIGATOR lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06260371 id: ORIGAMI briefTitle: National Observatory of Mycoplasma Infections in Children Under 18 Ages in France acronym: ORIGAMI overallStatus: RECRUITING date: 2023-09-01 date: 2030-09-01 date: 2030-09-01 date: 2024-02-15 date: 2024-02-15 name: Association Clinique Thérapeutique Infantile du val de Marne class: OTHER name: GPIP briefSummary: This study was set up because of an unusual increase in the number of cases of mycoplasma infections in France between June and November 2023.

Clinical data from children with mycoplasma infections will be collected to characterise this infection and facilitate hospital management. conditions: Mycoplasma Infections conditions: Hospitalized Children studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 3000 type: ESTIMATED measure: Number of patients hospitalized for mycoplasma infections measure: medical characterisation of mycoplasma infections measure: Identify risk factors of serious infection measure: Identify predictive signs of serious infection measure: Type of complications measure: Patients outcome measure: healthcare used for infected children measure: treatment used during hospitalisation measure: clinical description of infected children measure: Type of mycoplasma involved in infected children measure: performance of complementary diagnostic tests for lung disorders measure: compare medical data collected during hospitalisation sex: ALL minimumAge: 1 Day maximumAge: 17 Years stdAges: CHILD facility: ACTIV status: RECRUITING city: Créteil zip: 94600 country: France name: Corinne Levy, MD role: CONTACT phone: 1 48 85 04 04 phoneExt: +33 email: corinne.levy@activ-france.fr name: Stéphane Béchet, MSc role: CONTACT phone: 1 48 85 04 04 phoneExt: +33 email: stephane.bechet@activ-france.fr lat: 48.78333 lon: 2.46667 hasResults: False

 nctId: NCT06260358 id: 6043 briefTitle: Multidisciplinary Assesssment of Structured Report for Cervical Cancer Staging acronym: STRECC overallStatus: RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2025-03-31 date: 2024-02-15 date: 2024-02-15 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: This study aims to validate a structured report for cervical cancer anchored to the FIGO staging system. A structured report is hypothesized to aid in uniformly applying FIGO staging, reducing staging discrepancies and improving patient care and outcomes.

Furthermore, we believe that the participation of the clinicians will improve the quality of the report to minimize the need for multidisciplinary team discussion conditions: Cervical Cancer studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Survey measure: Efficacy of a contextual structured report measure: Difference between satisfaction rate with narrative and structured report; measure: Comparison Single items response rate (for items 6 to 12 of the questionnaire related to clinical information), on both narrative and structured reports; measure: Differences in the single 6-to-12 items response rate between structured and narrative reports. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Advanced Radiology Center status: RECRUITING city: Rome zip: 00168 country: Italy name: Luca Russo role: CONTACT phone: +390630158637 email: luca.russso@unicatt.it lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06260345 id: CAPRICE briefTitle: CommunautAry Pediatric bacteRial Infection in Intensive CarE Unit acronym: CAPRICE overallStatus: RECRUITING date: 2024-01-01 date: 2030-01-01 date: 2030-01-01 date: 2024-02-15 date: 2024-02-15 name: Association Clinique Thérapeutique Infantile du val de Marne class: OTHER name: GFRUP (Groupe Francophone de Réanimation et d'Urgences Pédiatrique) name: GPIP : Groupe de Pathologies Infectieuses Pédiatriques name: Centre National de Référence des Streptocoques name: Centre National de Référence des Pneumocoques name: Centre National de Référence des Méningocoques et Haemophilus influenzae name: Centre National de Référence des staphylocoques name: Centre National de Référence des E. Coli briefSummary: Severe bacterial infections are a worldwide scourge. However, the epidemiology of this type of infection varies over time. It is therefore essential to monitor them in order to prevent them more effectively. At this time, in France, no monitoring exists for this kind of infections. conditions: Hospitalized Children conditions: Severe Infection conditions: Invasive Bacterial Infection studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 3000 type: ESTIMATED measure: number of pediatrics cases of severe communautary bacterial infections measure: medical characterisation of children hospitalized for severe communautary bacterial infection case measure: Identify risk factors of serious infection measure: Identify predictive signs of severe cases in infected children. measure: healthcare used for infected children measure: Type of complications measure: Patients outcome measure: treatment used during hospitalisation measure: Bacterial strain characterization sex: ALL maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Association Clinique Thérapeutique Infantile du val de Marne status: RECRUITING city: Créteil zip: 94600 country: France name: Corinne Levy, MD role: CONTACT phone: 1 48 85 04 04 phoneExt: +33 email: corinne.levy@activ-france.fr name: Stéphane Béchet, MsC role: CONTACT phone: 1 48 85 04 04 phoneExt: +33 email: stephane.bechet@activ-france.fr lat: 48.78333 lon: 2.46667 hasResults: False

 nctId: NCT06260332 id: INST UNM 2302 id: 23-293 type: OTHER domain: UNM HSC IRB briefTitle: Physical Activity Intervention for the Improvement of Pain in Young, Hispanic Breast Cancer Survivors overallStatus: RECRUITING date: 2023-10-20 date: 2024-08-30 date: 2024-12-31 date: 2024-02-15 date: 2024-02-15 name: New Mexico Cancer Care Alliance class: OTHER name: University of New Mexico briefSummary: This clinical trial tests whether increased activity throughout the day can improve the chronic pain and associated symptoms that breast cancer survivors may experience after surgery. Staying active is a key factor of one's physical, mental, and social health and well-being. Moving more could also reduce pain and associated stress, anxiety, or depression. Using a fitness tracker may help patients to move around more, whether or not they choose to exercise. Information gathered from this study may help researchers learn how the use of a Fitbit tracker with health coaching may improve physical activity and reduce pain in young, Hispanic breast cancer survivors. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 25 type: ESTIMATED name: Supportive Care (Fitbit) measure: Recruitment rate (Feasibility) measure: Retention rate (Feasibility) measure: Adherence rate (Feasibility) measure: Incidence of adverse events measure: Change in chronic post-surgical pain measure: Change in physical activity measure: Change in health-related quality of life (hrQOL) sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: University of New Mexico Comprehensive Cancer Center status: RECRUITING city: Albuquerque state: New Mexico zip: 87106 country: United States name: Ellen R Wojcik, MBA-HCM role: CONTACT email: ewojcik@salud.unm.edu name: Cheryl A Sampson, MBA role: CONTACT email: ChSampson@salud.unm.edu name: Jacklyn M Nemunaitis, MD role: PRINCIPAL_INVESTIGATOR name: Cindy K Blair, Ph.D. role: SUB_INVESTIGATOR lat: 35.08449 lon: -106.65114 hasResults: False

 nctId: NCT06260319 id: C19-64 briefTitle: Decoding Developmental Disorders in Humams acronym: devodecode overallStatus: COMPLETED date: 2019-01-01 date: 2024-01-01 date: 2024-01-01 date: 2024-02-15 date: 2024-02-15 name: Institut National de la Santé Et de la Recherche Médicale, France class: OTHER_GOV name: Imagine Institute name: Commissariat A L'energie Atomique briefSummary: The DEVO-DECODE project aims to align our currently limited knowledge currently limited knowledge of the genetic architecture of developmental with our more advanced knowledge of their "phenome".

To this end, we aim to establish a homogeneous cohort of patients with with developmental disorders to identify new genetic variants genetic variants, and thus study the association between developmental and genetic variants. Secondary objectives are:2

* Carry out WGS studies not only to refine exosomal sequencing data exome sequencing data, but above all to identify and validate non-coding non-coding DNA alterations, in both transcribed and non-transcribed transcribed or non-transcribed genomic domains
* Develop precise preclinical models for functional studies of pathophysiological pathways conditions: Genetic Diseases studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 720 type: ACTUAL name: Whole genome sequencing and Genome-Epigenome-Phenome Associations measure: Primary objectives measure: secondary objectives 1 measure: secondary objectives 2 sex: ALL minimumAge: 1 Year maximumAge: 90 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Institut Imagine city: Paris zip: 75015 country: France lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06260306 id: STUDY00002568 briefTitle: Hip Activation vs. Hip Activation + Core Stabilization overallStatus: COMPLETED date: 2024-01-24 date: 2024-04-12 date: 2024-04-12 date: 2024-02-15 date: 2024-04-26 name: Louisiana State University Health Sciences Center Shreveport class: OTHER briefSummary: The purpose of this investigation is to compare the effects of a combined hip activation and core stabilization training home exercise program (HEP) versus a hip activation training HEP alone on lower extremity (LE) frontal plane mechanics in healthy individuals.

Specific Aim 1: To determine whether between- and/or within-group differences exist on the Forward Step-Down test (FSDT) when comparing a combined hip activation and core stabilization training HEP as compared to a hip activation training HEP.

Specific Aim 2: To determine whether between- and/or within-group differences exist on the peak external knee abduction moment when comparing a combined hip activation and core stabilization training HEP to a hip activation training HEP.

Specific Aim 3: To determine whether between- and/or within-group differences exist on gluteal and core muscle surface electromyography (sEMG) when comparing a combined hip activation and core stabilization training HEP to a hip activation training HEP.

Specific Aim 4: To determine whether a dose-response relationship exists between HEP compliance and change on the FSDT, peak external knee abduction moment, and sEMG. conditions: Movement, Abnormal conditions: Lower Extremity Problem studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The PI who will be performing the data analysis will be blinded to participants' random group allocation. The other investigators who will be collecting the outcome data will know the group allocation. whoMasked: INVESTIGATOR count: 34 type: ACTUAL name: Hip activation home exercise program name: Hip activation plus core stabilization home exercise program measure: Forward Step Down Test (FSDT) measure: Maximal volitional isometric contraction (MVIC) via sensory electromyography (sEMG) of gluteus maximus (GMax) measure: Mean activation of GMax via sEMG measure: Peak activation of GMax via sEMG measure: MVIC via sEMG of gluteus medius (GMed) measure: Mean activation of GMed via sEMG measure: Peak activation of GMed via sEMG measure: MVIC via of transversus abdominis (TA) measure: Mean activation of TA via sEMG measure: Peak activation of TA via sEMG measure: Peak external knee abduction moment during drop landing task measure: Compliance with Home Exercise Program sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: LSU Health Sciences Center at Shreveport city: Shreveport state: Louisiana zip: 71103 country: United States lat: 32.52515 lon: -93.75018 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-12-07 uploadDate: 2024-01-18T21:23 filename: Prot_SAP_000.pdf size: 292995 hasResults: False

 nctId: NCT06260293 id: 4-2022-0208 briefTitle: The Effect of Post-operative Exercise in Gastric Cancer Patients: A Randomized Controlled Trial (RCT) Study overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-03 date: 2024-04-30 date: 2024-04-30 date: 2024-02-15 date: 2024-02-15 name: Yonsei University class: OTHER briefSummary: Medical advancements are enhancing the survival rates of individuals with gastric cancer. The growing population of gastric cancer survivors underscores the importance of managing treatment-related after-effects and side effects. Diminished physical function in cancer patients, particularly following gastric cancer surgery, is linked to increased mortality. The substantial decline in physical activity post-surgery contributes to a notable reduction in cardiorespiratory fitness and lower extremity muscle strength. Early postoperative exercise has demonstrated positive outcomes in colorectal cancer patients, facilitating early hospital discharge and supporting long-term recovery. However, there is a paucity of research on the efficacy of early postoperative exercise in the context of gastric cancer. Therefore, this study aims to evaluate the impact of early postoperative exercise on physical function following gastric cancer surgery. conditions: Gastric Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 52 type: ACTUAL name: exercise measure: Shorts Physical Performance Battery(SPPB) sex: ALL minimumAge: 19 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Surgery, Yonsei University College of Medicine city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06260280 id: 4 briefTitle: Chronic Sleep Deprivation and Changes in Cortical and Hippocampal Volume overallStatus: NOT_YET_RECRUITING date: 2024-02-26 date: 2024-05-26 date: 2024-06-01 date: 2024-02-15 date: 2024-02-15 name: Instituto Mexicano del Seguro Social class: OTHER_GOV briefSummary: Sleep is a physiological state that is essential for human performance, including academic, occupational, interpersonal, and psychological aspects. Sleep disruption or deprivation leads to a loss of psychomotor skills and an increased association with various diseases. Therefore, it is critical to assess how chronic sleep deprivation affects medical residents who work long shifts, including those assigned during their training. conditions: Sleep Deprivation conditions: Hippocampal Atrophy conditions: Cortical Irregularity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 37 type: ESTIMATED name: Cerebral Nuclear Magnetic Resonance measure: Change in Hippocampal volumetry. measure: Change in cortical volumetry sex: ALL minimumAge: 24 Years maximumAge: 30 Years stdAges: ADULT facility: Unidad Medica de Alta Especialidad No. 1, Bajío city: Leon state: Guanajuato zip: 37260, country: Mexico lat: 21.12908 lon: -101.67374 hasResults: False

 nctId: NCT06260267 id: 000417 briefTitle: A Phase 1b Proof-of-concept Trial Exploring the Effects of FE 999322 and FE 999324 in Adults With Mild to Moderate Ulcerative Colitis overallStatus: RECRUITING date: 2024-03-12 date: 2025-09-15 date: 2025-09-15 date: 2024-02-15 date: 2024-04-05 name: Ferring Pharmaceuticals class: INDUSTRY briefSummary: To explore the safety of FE 999322 (microbiota suspension) and FE 999324 (microbiota capsule) versus placebo in subjects with active mild to moderate ulcerative colitis (UC). conditions: Ulcerative Colitis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 90 type: ESTIMATED name: Microbiota suspension name: Microbiota capsule name: Placebo suspension name: Placebo capsule measure: Treatment-emergent adverse events from baseline to week 52 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ferring Investigational Site status: RECRUITING city: North Little Rock state: Arkansas zip: 72117 country: United States name: Global Clinical Compliance role: CONTACT lat: 34.76954 lon: -92.26709 facility: Ferring Investigational Site status: RECRUITING city: Jacksonville state: Florida zip: 32256 country: United States name: Global Clinical Compliance role: CONTACT lat: 30.33218 lon: -81.65565 facility: Ferring Investigational Site status: RECRUITING city: Oklahoma City state: Oklahoma zip: 73102 country: United States name: Global Clinical Compliance role: CONTACT lat: 35.46756 lon: -97.51643 hasResults: False

 nctId: NCT06260254 id: 244826201 briefTitle: Effects of Railway Vibration on Sleep and Disease acronym: BioVib overallStatus: RECRUITING date: 2024-02-05 date: 2024-06-30 date: 2024-12-31 date: 2024-02-15 date: 2024-02-21 name: Göteborg University class: OTHER name: University of Pennsylvania name: University of Manitoba briefSummary: This study will investigate the biological mechanisms linking sleep disruption by vibration and noise, and the development of cardiometabolic disease. In a laboratory sleep study, the investigators will play railway vibration of different levels during the night. The investigators will also measure objective sleep quality and quantity, cognitive performance across multiple domains, self-reported sleep and wellbeing outcomes, and blood samples. Blood samples will be analyzed to identify metabolic changes and indicators of diabetes risk in different nights. Identifying biomarkers that are impacted by sleep fragmentation will establish the currently unclear pathways by which railway vibration exposure at night can lead to the development of diseases in the long term, especially metabolic disorders including diabetes. conditions: Noise Exposure conditions: Sleep Disturbance conditions: Sleep Hygiene conditions: Metabolic Disturbance conditions: Cognitive Change conditions: Glucose Metabolism Disorders (Including Diabetes Mellitus) conditions: Vibration; Exposure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: All participants will be exposed to each of the different vibration conditions. Each study night is treated as a separate arm of the crossover study. The order of the vibration exposure conditions will be be randomly assigned across participants using a Latin square design to avoid first-order carryover effects. Each subject will be exposed to one night of each of the following:

Quiet night: No noise or vibration will be played, serving as a control night to assess individual baseline sleep, metabolic profile, and cognitive performance; Three railway vibration nights to determine consequences of noise-disrupted sleep. The vibration level in these three nights will be 0.5 mm/s, 0.7 mm/s and 0.9 mm/s respectively, so that exposure-response relationships can be derived. primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: Participants will be aware that in any given study night they can be exposed to railway vibration and noise. They will not be informed what exposure condition will occur in any given night, but they can become unblinded to the exposure if they are awake, as they will may hear the noise or feel the vibration.

Study investigators responsible for analysing cognitive performance variables and physiological sleep data will be be blind to which vibration and noise interventions were introduced on which study nights. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Railway noise name: Low level railway vibration name: Intermediate level railway vibration name: High level railway vibration measure: Fasting insulin resistance in the morning immediately after the Control night measure: Fasting insulin resistance in the morning immediately after the low vibration night measure: Fasting insulin resistance in the morning immediately after the intermediate vibration night measure: Fasting insulin resistance in the morning immediately after the high vibration night measure: Total sleep time during the Control night measure: Total sleep time during the low vibration night measure: Total sleep time during the intermediate vibration night measure: Total sleep time during the high vibration night measure: Total amount of N1 sleep during the Control night measure: Total amount of N2 sleep during the Control night measure: Total amount of N3 sleep during the Control night measure: Total amount of rapid eye movement (REM) sleep during the Control night measure: Total amount of N1 sleep during the low vibration night measure: Total amount of N2 sleep during the low vibration night measure: Total amount of N3 sleep during the low vibration night measure: Total amount of rapid eye movement (REM) sleep during the low vibration night measure: Total amount of N1 sleep during the intermediate vibration night measure: Total amount of N2 sleep during the intermediate vibration night measure: Total amount of N3 sleep during the intermediate vibration night measure: Total amount of rapid eye movement (REM) sleep during the intermediate vibration night measure: Total amount of N1 sleep during the high vibration night measure: Total amount of N2 sleep during the high vibration night measure: Total amount of N3 sleep during the high vibration night measure: Total amount of rapid eye movement (REM) sleep during the high vibration night measure: Wakefulness after sleep onset (WASO) during the Control night measure: Wakefulness after sleep onset (WASO) during the low vibration night measure: Wakefulness after sleep onset (WASO) during the intermediate night measure: Wakefulness after sleep onset (WASO) during the high vibration night measure: Number of awakenings during the Control night measure: Number of awakenings during exposure to low vibration measure: Number of awakenings during exposure to intermediate vibration measure: Number of awakenings during exposure to high vibration measure: Sleep onset latency (SOL) during the Control Night measure: Sleep onset latency (SOL) during the low vibration night measure: Sleep onset latency (SOL) during the intermediate vibration night measure: Sleep onset latency (SOL) during the high vibration night measure: Sleep efficiency during the Control night measure: Sleep efficiency during the low vibration night measure: Sleep efficiency during the intermediate vibration night measure: S Sleep efficiency during the high vibration night measure: Sleep depth assessed using the odds ratio product (ORP) during the Control night measure: Sleep depth assessed using the odds ratio product (ORP) during the low vibration night measure: Sleep depth assessed using the odds ratio product (ORP) during the intermediate vibration night measure: Sleep depth assessed using the odds ratio product (ORP) during the high vibration night measure: Maximal change of odds ratio product (ORP) during exposure to railway vibration events measure: Area under the curve of odds ratio product (ORP) during exposure to railway vibration events, calculated using the trapezoid rule measure: N-acetylglucosamine/galactosamine (GlycA) concentration after the Control night measure: N-acetylglucosamine/galactosamine (GlycA) concentration after exposure to low vibration night measure: N-acetylglucosamine/galactosamine (GlycA) concentration after exposure to intermediate vibration measure: N-acetylglucosamine/galactosamine (GlycA) concentration after exposure to high vibration measure: Sialic acid (GlycB) concentration after the Control night measure: Sialic acid (GlycB) concentration after exposure to low vibration measure: Sialic acid (GlycB) concentration after exposure to intermediate vibration measure: Sialic acid (GlycB) concentration after exposure to high vibration measure: Supramolecular phospholipid composite (SPC) concentration after the Control night measure: Supramolecular phospholipid composite (SPC) concentration after exposure to low vibration measure: Supramolecular phospholipid composite (SPC) concentration after exposure to intermediate vibration measure: Supramolecular phospholipid composite (SPC) concentration after exposure to high vibration measure: Ethanol concentration (mmol/L) after the Control night measure: Ethanol concentration (mmol/L) after exposure to low vibration night measure: Ethanol concentration (mmol/L) after exposure to intermediate vibration night measure: Ethanol concentration (mmol/L) after exposure to high vibration night measure: Trimethylamine-N-oxide concentration (mmol/L) after exposure to Control night measure: Trimethylamine-N-oxide concentration (mmol/L) after exposure to low vibration night measure: Trimethylamine-N-oxide concentration (mmol/L) after exposure to intermediate vibration night measure: Trimethylamine-N-oxide concentration (mmol/L) after exposure to high vibration night measure: 2-Aminobutyric acid concentration (mmol/L) after exposure to Control night measure: 2-Aminobutyric acid concentration (mmol/L) after exposure to low vibration night measure: 2-Aminobutyric acid concentration (mmol/L) after exposure to intermediate vibration night measure: 2-Aminobutyric acid concentration (mmol/L) after exposure to high vibration night measure: Alanine concentration (mmol/L) after exposure to Control night measure: Alanine concentration (mmol/L) after exposure to low vibration night measure: Alanine concentration (mmol/L) after exposure to intermediate vibration night measure: Alanine concentration (mmol/L) after exposure to high vibration night measure: Asparagine concentration (mmol/L) after exposure to Control night measure: Asparagine concentration (mmol/L) after exposure to low vibration night measure: Asparagine concentration (mmol/L) after exposure to intermediate vibration night measure: Asparagine concentration (mmol/L) after exposure to high vibration night measure: Creatine concentration (mmol/L) after exposure to Control night measure: Creatine concentration (mmol/L) after exposure to low vibration night measure: Creatine concentration (mmol/L) after exposure to intermediate vibration night measure: Creatine concentration (mmol/L) after exposure to high vibration night measure: Creatinine concentration (mmol/L) after exposure to Control night measure: Creatinine concentration (mmol/L) after exposure to low vibration night measure: Creatinine concentration (mmol/L) after exposure to intermediate vibration night measure: Creatinine concentration (mmol/L) after exposure to high vibration night measure: Glutamic acid concentration (mmol/L) after exposure to Control night measure: Glutamic acid concentration (mmol/L) after exposure to low vibration night measure: Glutamic acid concentration (mmol/L) after exposure to intermediate vibration night measure: Glutamic acid concentration (mmol/L) after exposure to high vibration night measure: Glutamine concentration (mmol/L) after exposure to Control night measure: Glutamine concentration (mmol/L) after exposure to low vibration night measure: Glutamine concentration (mmol/L) after exposure to intermediate vibration night measure: Glutamine concentration (mmol/L) after exposure to high vibration night measure: Glycine concentration (mmol/L) after exposure to Control night measure: Glycine concentration (mmol/L) after exposure to low vibration night measure: Glycine concentration (mmol/L) after exposure to intermediate vibration night measure: Glycine concentration (mmol/L) after exposure to high vibration night measure: Histidine concentration (mmol/L) after exposure to Control night measure: Histidine concentration (mmol/L) after exposure to low vibration night measure: Histidine concentration (mmol/L) after exposure to intermediate vibration night measure: Histidine concentration (mmol/L) after exposure to high vibration night measure: Isoleucine concentration (mmol/L) after exposure to Control night measure: Isoleucine concentration (mmol/L) after exposure to low vibration night measure: Isoleucine concentration (mmol/L) after exposure to intermediate vibration night measure: Isoleucine concentration (mmol/L) after exposure to high vibration night measure: Leucine concentration (mmol/L) after exposure to Control night measure: Leucine concentration (mmol/L) after exposure to low vibration night measure: Leucine concentration (mmol/L) after exposure to intermediate vibration night measure: Leucine concentration (mmol/L) after exposure to high vibration night measure: Lysine concentration (mmol/L) after exposure to Control night measure: Lysine concentration (mmol/L) after exposure to low vibration night measure: Lysine concentration (mmol/L) after exposure to intermediate vibration night measure: Lysine concentration (mmol/L) after exposure to high vibration night measure: Methionine concentration (mmol/L) after exposure to Control night measure: Methionine concentration (mmol/L) after exposure to low vibration night measure: Methionine concentration (mmol/L) after exposure to intermediate vibration night measure: Methionine concentration (mmol/L) after exposure to high vibration night measure: N,N-Dimethylglycine concentration (mmol/L) after Control night measure: N,N-Dimethylglycine concentration (mmol/L) after exposure to low vibration night measure: N,N-Dimethylglycine concentration (mmol/L) after exposure to intermediate vibration night measure: N,N-Dimethylglycine concentration (mmol/L) after exposure to high vibration night measure: Ornithine concentration (mmol/L) after exposure to Control night measure: Ornithine concentration (mmol/L) after exposure to low vibration night measure: Ornithine concentration (mmol/L) after exposure to intermediate vibration night measure: Ornithine concentration (mmol/L) after exposure to high vibration night measure: Phenylalanine concentration (mmol/L) after exposure to Control night measure: Phenylalanine concentration (mmol/L) after exposure to low vibration night measure: Phenylalanine concentration (mmol/L) after exposure to intermediate vibration night measure: Phenylalanine concentration (mmol/L) after exposure to high vibration night measure: Proline concentration (mmol/L) after exposure to Control night measure: Proline concentration (mmol/L) after exposure to low vibration night measure: Proline concentration (mmol/L) after exposure to intermediate vibration night measure: Proline concentration (mmol/L) after exposure to high vibration night measure: Sarcosine concentration (mmol/L) after exposure to Control night measure: Sarcosine concentration (mmol/L) after exposure to low vibration night measure: Sarcosine concentration (mmol/L) after exposure to intermediate vibration night measure: Sarcosine concentration (mmol/L) after exposure to high vibration night measure: Threonine concentration (mmol/L) after exposure to Control night measure: Threonine concentration (mmol/L) after exposure to low vibration night measure: Threonine concentration (mmol/L) after exposure to intermediate vibration night measure: Threonine concentration (mmol/L) after exposure to high vibration night measure: Tyrosine concentration (mmol/L) after exposure toControl night measure: Tyrosine concentration (mmol/L) after exposure to low vibration night measure: Tyrosine concentration (mmol/L) after exposure to intermediate vibration night measure: Tyrosine concentration (mmol/L) after exposure to high vibration night measure: Valine concentration (mmol/L) after Control night measure: Valine concentration (mmol/L) after exposure to low vibration night measure: Valine concentration (mmol/L) after exposure to intermediate vibration night measure: Valine concentration (mmol/L) after exposure to high vibration night measure: 2-Hydroxybutyric acid concentration (mmol/L) after exposure to Control night measure: 2-Hydroxybutyric acid concentration (mmol/L) after exposure to low vibration night measure: 2-Hydroxybutyric acid concentration (mmol/L) after exposure to intermediate vibration night measure: 2-Hydroxybutyric acid concentration (mmol/L) after exposure to high vibration night measure: Acetic acid concentration (mmol/L) after exposure to Control night measure: Acetic acid concentration (mmol/L) after exposure to low vibration night measure: Acetic acid concentration (mmol/L) after exposure to intermediate vibration night measure: Acetic acid concentration (mmol/L) after exposure to high vibration night measure: Citric acid concentration (mmol/L) after Control night measure: Citric acid concentration (mmol/L) after exposure to low vibration night measure: Citric acid concentration (mmol/L) after exposure to intermediate vibration night measure: Citric acid concentration (mmol/L) after exposure to high vibration night measure: Formic acid concentration (mmol/L) after exposure to Control night measure: Formic acid concentration (mmol/L) after exposure to low vibration night measure: Formic acid concentration (mmol/L) after exposure to intermediate vibration night measure: Formic acid concentration (mmol/L) after exposure to high vibration night measure: Lactic acid concentration (mmol/L) after exposure to Control night measure: Lactic acid concentration (mmol/L) after exposure to low vibration night measure: Lactic acid concentration (mmol/L) after exposure to intermediate vibration night measure: Lactic acid concentration (mmol/L) after exposure to high vibration night measure: Succinic acid concentration (mmol/L) after exposure to Control night measure: Succinic acid concentration (mmol/L) after exposure to low vibration night measure: Succinic acid concentration (mmol/L) after exposure to intermediate vibration night measure: Succinic acid concentration (mmol/L) after exposure to high vibration night measure: Choline concentration (mmol/L) after exposure to Control night measure: Choline concentration (mmol/L) after exposure to low vibration night measure: Choline concentration (mmol/L) after exposure to intermediate vibration night measure: Choline concentration (mmol/L) after exposure to high vibration night measure: 2-Oxoglutaric acid concentration (mmol/L) after exposure to Control night measure: 2-Oxoglutaric acid concentration (mmol/L) after exposure to low vibration night measure: 2-Oxoglutaric acid concentration (mmol/L) after exposure to intermediate vibration night measure: 2-Oxoglutaric acid concentration (mmol/L) after exposure to high vibration night measure: 3-Hydroxybutyric acid concentration (mmol/L) after exposure to Control night measure: 3-Hydroxybutyric acid concentration (mmol/L) after exposure to low vibration night measure: 3-Hydroxybutyric acid concentration (mmol/L) after exposure to intermediate vibration night measure: 3-Hydroxybutyric acid concentration (mmol/L) after exposure to high vibration night measure: Acetoacetic acid concentration (mmol/L) after exposure to Control night measure: Acetoacetic acid concentration (mmol/L) after exposure to low vibration night measure: Acetoacetic acid concentration (mmol/L) after exposure to intermediate vibration night measure: Acetoacetic acid concentration (mmol/L) after exposure to high vibration night measure: Acetone concentration (mmol/L) after exposure to Control night measure: Acetone concentration (mmol/L) after exposure to low vibration night measure: Acetone concentration (mmol/L) after exposure to intermediate vibration night measure: Acetone concentration (mmol/L) after exposure to high vibration night measure: Pyruvic acid concentration (mmol/L) after exposure to Control night measure: Pyruvic acid concentration (mmol/L) after exposure to low vibration night measure: Pyruvic acid concentration (mmol/L) after exposure to intermediate vibration night measure: Pyruvic acid concentration (mmol/L) after exposure to high vibration night measure: D-Galactose concentration (mmol/L) after exposure to Control night measure: D-Galactose concentration (mmol/L) after exposure to low vibration night measure: D-Galactose concentration (mmol/L) after exposure to intermediate vibration night measure: D-Galactose concentration (mmol/L) after exposure to high vibration night measure: Glucose concentration (mmol/L) after exposure to Control night measure: Glucose concentration (mmol/L) after exposure to low vibration night measure: Glucose concentration (mmol/L) after exposure to intermediate vibration night measure: Glucose concentration (mmol/L) after exposure to high vibration night measure: Glycerol concentration (mmol/L) after exposure to Control night measure: Glycerol concentration (mmol/L) after exposure to low vibration night measure: Glycerol concentration (mmol/L) after exposure to intermediate vibration night measure: Glycerol concentration (mmol/L) after exposure to high vibration night measure: Dimethylsulfone concentration (mmol/L) after exposure to Control night measure: Dimethylsulfone concentration (mmol/L) after exposure to low vibration night measure: Dimethylsulfone concentration (mmol/L) after exposure to intermediate vibration night measure: Dimethylsulfone concentration (mmol/L) after exposure to high vibration night measure: Response to an oral glucose bolus, calculated as area under curve for glucose, in the morning after the control night measure: Response to an oral glucose bolus, calculated as area under curve for glucose, in the morning after the low vibration night measure: Response to an oral glucose bolus, calculated as area under curve for glucose, in the morning after the intermediate vibration night measure: Response to an oral glucose bolus, calculated as area under curve for glucose, in the morning after the high vibration night measure: Response to an oral glucose load calculated as area under curve for insulin, in the morning after the low vibration night measure: Response to an oral glucose load calculated as area under curve for insulin, in the morning after the intermediate vibration night measure: Response to an oral glucose load calculated as area under curve for insulin, in the morning after the high vibration night measure: Early response to an oral glucose load calculated as area under curve for insulin, in the morning after the control night measure: Early response to an oral glucose load calculated as area under curve for insulin, in the morning after the low vibration night measure: Early response to an oral glucose load calculated as area under curve for insulin, in the morning after the intermediate vibration night measure: Early response to an oral glucose load calculated as area under curve for insulin, in the morning after the high vibration night measure: Glucose tolerance in the morning after exposure to low vibration, assessed as glucose concentration 120 minutes after a glucose bolus measure: Glucose tolerance in the morning after exposure to intermediate vibration, assessed as glucose concentration 120 minutes after a glucose bolus measure: Glucose tolerance in the morning after exposure to high vibration, assessed as glucose concentration 120 minutes after a glucose bolus measure: Glucose tolerance in the morning after Control night, assessed as glucose concentration 120 minutes after a glucose bolus measure: Stumvoll Insulin sensitivity Index in the morning after control measure: Stumvoll Insulin sensitivity Index in the morning after exposure to low vibration measure: Stumvoll Insulin sensitivity Index in the morning after exposure to intermediate vibration measure: Stumvoll Insulin sensitivity Index in the morning after exposure to high vibration measure: Matsuda insulin sensitivity index in the morning after control exposure measure: Matsuda insulin sensitivity index in the morning after exposure to low vibration measure: Matsuda insulin sensitivity index in the morning after exposure to intermediate vibration measure: Matsuda insulin sensitivity index in the morning after exposure to high vibration measure: Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to control measure: Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to low vibration measure: Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to intermediate vibration measure: Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to high vibration measure: Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to control measure: Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to low vibration measure: Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to intermediate vibration measure: Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to high vibration measure: Self-reported sleep disturbance by vibration after control exposure measure: Self-reported sleep disturbance by vibration after exposure to low vibration measure: Self-reported sleep disturbance by vibration after exposure to intermediate vibration measure: Self-reported sleep disturbance by vibration after exposure to high vibration measure: Morning positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after control exposure measure: Morning positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to low vibration measure: Morning positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to intermediate vibration measure: Morning positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to high vibration measure: Morning negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after control exposure measure: Morning negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to low vibration measure: Morning negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to intermediate vibration measure: Morning negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to high vibration measure: Evening negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to control measure: Evening negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to low vibration measure: Evening negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to intermediate vibration measure: Evening negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to high vibration measure: Evening positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to control measure: Evening positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to low vibration measure: Evening positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to intermediate vibration measure: Evening positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to high vibration measure: Event-related cardiovascular activation in response to control measure: Event-related cardiovascular activation in response to low vibration measure: Event-related cardiovascular activation in response to intermediate vibration measure: Event-related cardiovascular activation in response to high vibration measure: Evening neurobehavioural speed measure: Evening neurobehavioural accuracy sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: University of Gothenburg status: RECRUITING city: Gothenburg state: Västra Götaland zip: 42650 country: Sweden name: Michael G Smith, PhD role: CONTACT phone: +46317862843 email: michael.smith@amm.gu.se lat: 57.70716 lon: 11.96679 hasResults: False

 nctId: NCT06260241 id: ShaikhZayedH briefTitle: Gain in Stretched Penile Length After Phalloplasty With & Without Penile Traction in Children. overallStatus: RECRUITING date: 2023-01-01 date: 2025-01-01 date: 2025-01-01 date: 2024-02-15 date: 2024-02-15 name: Shaikh Zayed Hospital, Lahore class: OTHER briefSummary: The goal of this Randomized Controlled Trial is to assess the gain in stretched penile length after phalloplasty with \& without penile traction in children of age group 4 to 13 years presenting in hospital with the complaint of concealed penis.

The main question\[s\] it aims to answer is:

• Gain in stretched penile length after phalloplasty with and without penile traction in children. conditions: Concealed Penis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Control Trial primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 70 type: ESTIMATED name: Traction Dressing name: Without Traction Dressing measure: The gain in stretched penile length (SPL) sex: MALE minimumAge: 4 Years maximumAge: 13 Years stdAges: CHILD facility: Sheikh Zayed Hospital status: RECRUITING city: Lahore state: Punjab country: Pakistan name: ADEEL AHMED, MBBS MS role: CONTACT phone: 00923491467739 email: numberdar12@gmail.com lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06260228 id: STUDY02002270 briefTitle: HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH)-Parkinson's Disease (HOBSCOTCH-Parkinson's) acronym: HOBSCOTCH-PD overallStatus: RECRUITING date: 2024-01-05 date: 2024-08-01 date: 2024-11-30 date: 2024-02-15 date: 2024-02-15 name: Dartmouth-Hitchcock Medical Center class: OTHER briefSummary: The goal of this pilot study is to assess the feasibility of adapting and delivering the existing home-based epilepsy self-management intervention, HOBSCOTCH, for people with Parkinson's Disease (PD)

The main questions it aims to answer are:

1. Can the current HOBSCOTCH program be adapted for people with PD?
2. Will people with PD experience improved quality of life similar to that found in people with epilepsy after participating in the HOBSCOTCH program?

Participants will be asked to:

* attend nine, one-hour virtual (online and/or by telephone) HOBSCOTCH-PD sessions with a one-on-one certified HOBSCOTCH-PD coach
* complete a brief clinical questionnaire about their diagnosis of PD
* complete two questionnaires before and after the HOBSCOTCH-PD sessions about their quality of life and about memory and thinking processes
* keep a short daily diary about their PD symptoms and use of the self-management strategies taught in the HOBSCOTCH-PD program
* complete a brief Satisfaction Survey after the entire HOBSCOTCH-PD program conditions: Parkinson Disease conditions: Cognitive Dysfunction conditions: Memory Disorders studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 5 type: ESTIMATED name: HOme-Based Self-management and COgnitive Training CHanges lives (HOBSCOTCH) measure: Change in quality of life as measured by comparing PDQ-39 (Parkinson's Disease Questionnaire) scores pre- and post-HOBSCOTCH-PD intervention. measure: Change in subjective cognition as measured by comparing Neuro-QOL Item Bank v2.0 Cognitive Function scores pre- and post-HOBSCOTCH-PD intervention. sex: ALL minimumAge: 30 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dartmouth-Hitchcock status: RECRUITING city: Lebanon state: New Hampshire zip: 03756 country: United States name: Sarah J Kaden role: CONTACT phone: 603-540-5824 email: sarah.j.kaden@hitchcock.org lat: 43.64229 lon: -72.25176 hasResults: False

 nctId: NCT06260215 id: FFH briefTitle: Recovery Kinetics Following a Soccer Training in Middle-aged Males overallStatus: RECRUITING date: 2024-02-05 date: 2024-02-26 date: 2024-03-09 date: 2024-02-15 date: 2024-02-21 name: University of Thessaly class: OTHER briefSummary: This study aims at investigating the recovery kinetics of skeletal muscle damage, neuromuscular fatigue and performance following a single soccer trainning session in middle aged males. The participants will perform a soccer training session \[A single training session including 60 minutes of warm up, soccer technical exercises and small-sided game\] and a cotrol trial (No intervention included, only daily measurements) in randomized, repeated measures, crossover design. Assesesments related to skeletal muscle damage, performance and neuromuscular fatigue will be executed before the training session and daily for four consecutive days after training. conditions: Skeletal Muscle Damage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 11 type: ESTIMATED name: ST measure: Change in White blood cell count measure: Change in Granulocyte cell count measure: Change in Platelets cell count measure: Change in Monocyte cell count measure: Change in Lymphocyte cell count measure: Change in percentage of Hematocrit level measure: Change Red blood cells count measure: Change in Hemoglobin level measure: Change in Creatine kinase activity measure: Change in Total antioxidant capacity measure: Change in Glutathione concentration in blood measure: Change in countermovement jump height measure: Change in Peak power during coutermovement jump test measure: Change in isometric peak torque of knee extensors and flexors measure: Change in sprint time of 10 m measure: Change in sprint time of 30 m measure: Change in delayed onset of muscle soreness measure: Dietary intake measure: Peak Maximal oxygen consumption (Peak VO2) measure: Body Mass measure: Body Height measure: Body Fat measure: Lean body mass measure: Bone mass density measure: Bone mass content measure: Field activity during the soccer training measure: Heart rate during the soccer training measure: Systolic Blood Pressure measure: Dystolic Blood Pressure measure: Rest Heart Rate sex: MALE minimumAge: 40 Years maximumAge: 60 Years stdAges: ADULT facility: University o Thessaly, School of Physical Education and Sports Science status: RECRUITING city: Tríkala zip: 42100 country: Greece name: Athanasios Z Jamurtas, Prof role: CONTACT phone: +30 24310 47054 email: ajamurt@pe.uth.gr name: Ioannis G Fatouros, Prof role: CONTACT phone: +30 24310 47047 email: ifatouros@pe.uth.gr name: Athanasios S Poulios, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.55493 lon: 21.76837 hasResults: False

 nctId: NCT06260202 id: 308.273 briefTitle: Nutrition Under Noninvasive Ventilation acronym: NUTRINIV overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-05-31 date: 2024-05-31 date: 2024-02-15 date: 2024-02-16 name: Università degli Studi del Piemonte Orientale "Amedeo Avogadro" class: OTHER briefSummary: Even though nutrition is a fundamental component of Intensive care unit (ICU) therapy, critically ill patients are frequently malnourished, a factor well known for its strong association with a higher risk of complications, prolonged ICU/hospital length of stay, and greater ICU readmission and mortality rates. Noninvasive ventilation (NIV) use has increased considerably over the past twenty years, making this supportive technique a keystone of acute respiratory failure (ARF) treatment. In this setting, respiratory support is provided through an interface, usually a mask or a helmet, that frequently represents an important obstacle to nutrition delivery, making oral intake impossible and posing the necessity to start enteral (EN) or parenteral nutrition (PN). Moreover, while critical care guidelines regarding nutritional management of patients receiving mechanical ventilation (MV) are well established, data and recommendations about the appropriate nutritional support to patients in NIV are still very limited. Due to this limited data, we want to describe characteristics and nutritional management of patients undergoing NIV in ICU, and to evaluate the difference between the mean caloric and protein intake of these patients and the recommended caloric and protein target for critically ill patients. Secondarily, we want to evaluate the difference of the caloric and protein intake among groups of patients undergoing different nutritional modality and to assess potential associations of the nutritional characteristics with patient outcomes. conditions: Noninvasive Ventilation conditions: Nutrition Therapy conditions: Respiratory Insufficiency studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 112 type: ESTIMATED measure: Caloric and protein gap measure: Nutrition modalities outcomes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06260189 id: Soh-Med-24-01-02MD briefTitle: Assessment Of Serum And Tissue Levels Of Cold-Inducible RNA-Binding Protein In Patients With Lichen Planus overallStatus: RECRUITING date: 2024-02 date: 2025-02 date: 2025-10 date: 2024-02-15 date: 2024-02-15 name: Sohag University class: OTHER briefSummary: Lichen planus (LP) is a chronic inflammatory mucocutaneous disease of unknown etiology.

Pathogenesis of LP is not completely understood, but it's considered a T-cell-mediated autoimmune disease. Cold-inducible RNA binding protein (CIRP or CIRBP) is a member of the glycine-rich RNA-binding protein family, Recent studies proved that CIRP acts as a tumor promoter through its actions on different cellular proliferation levels, Recently, the role of the damage associated molecular proteins and cytokines was highlighted in the pathogenesis of many disorders including psoriasis, alopecia areata, vitiligo, rheumatoid arthritis, other autoimmune diseases as well as several types of cancer. The aim of this study is to compare serum and tissue levels of CIRP in patients with LP and healthy controls. conditions: Assessment, Self studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 80 type: ESTIMATED measure: Assessment of cold-inducible RNA binding protein levels in serum and tissue sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Aya Ahmed Elsayed status: RECRUITING city: Sohag zip: 82511 country: Egypt name: Aya A Elsayed, Msc role: CONTACT phone: 00201060094631 phoneExt: Egypt email: aya_shando@yahoo.com lat: 26.55695 lon: 31.69478 hasResults: False

 nctId: NCT06260176 id: 828722 id: R01DK113307 type: NIH link: https://reporter.nih.gov/quickSearch/R01DK113307 id: 15163 type: REGISTRY domain: AsPredicted.org briefTitle: Vending Labeling Sales and Intercepts Study overallStatus: COMPLETED date: 2019-02-01 date: 2020-03-12 date: 2020-03-12 date: 2024-02-15 date: 2024-02-15 name: University of Pennsylvania class: OTHER name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: The aim of this study is to compare the impact of 4 different types of front of package (FOP) food and beverage messages: 1) green labels on healthy foods, 2) red/yellow/green labels on less healthy/moderately healthy/healthy foods, 3) physical activity calorie equivalent labels, and 4) posters reminding consumers of the sweetened beverage tax on consumers' beverage and snack selections. conditions: Food Preferences conditions: Obesity conditions: Weight Gain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Machine locations were randomly assigned to 1 of 4 front-of-package message arms, stratified by baseline machine sales (high/low) and type of machine location (correctional facilities, courts/offices, large offices, police/fire, recreation centers/libraries/other) with equal probability. The investigators first randomized vending locations (e.g., floors) with beverage machines so that all machines on the same floor displayed the same label. They then randomized the remaining "solo" snack locations. Monthly sales data provided by the City's vending contractor indicated consumer choices. Research assistants also asked a subset of consumers (N=1,065) about their purchases. Intercepts were not allowed in the courts/offices location type and were not conducted at correctional facilities with low traffic. The aim was to collect 10 intercepts per machine visited, distributed over the entire study period, however the study was cut short in March 2020 by the Covid pandemic. primaryPurpose: PREVENTION masking: NONE count: 1065 type: ACTUAL name: exposure to healthy labels only name: exposure to healthiness information name: exposure to physical activity equivalents name: exposure to sweetened beverage tax messaging measure: Percentage of beverages sold with calories per month measure: Calories sold from beverages per month, if beverages with calories sold measure: Calories sold from snacks per month measure: Likelihood of selecting a healthy beverage measure: Likelihood of selecting a moderately healthy beverage measure: Likelihood of selecting a less healthy beverage measure: Likelihood of selecting a healthy snack measure: Likelihood of selecting a moderately healthy snack measure: Likelihood of selecting a less healthy snack measure: Total beverage units sold per month per machine. measure: Total snack units sold per month per machine measure: Total revenue per month per beverage machine measure: Total revenue per month per snack machine measure: Total calories sold per customer trip sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Pennsylvania city: Philadelphia state: Pennsylvania zip: 19104 country: United States lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06260163 id: CR109251 id: 2022-001285-35 type: EUDRACT_NUMBER id: CNTO1959PUC3001 type: OTHER domain: Janssen Research & Development, LLC id: 2022-502238-22-00 type: REGISTRY domain: EUCT number briefTitle: A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis acronym: QUASAR Jr overallStatus: RECRUITING date: 2024-01-19 date: 2028-05-22 date: 2028-08-14 date: 2024-02-15 date: 2024-04-24 name: Janssen Research & Development, LLC class: INDUSTRY briefSummary: The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction responders. conditions: Colitis, Ulcerative studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 120 type: ESTIMATED name: Guselkumab Subcutaneous name: Matching Placebo name: Guselkumab Intravenous measure: Percentage of Participants with Clinical Remission at Week 56 measure: Percentage of Participants with Clinical Remission at Week 12 measure: Percentage of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 12 measure: Percentage of Participants with Symptomatic Remission at Week 12 measure: United States: Percentage of Participants with Endoscopic Improvement at Week 12 measure: European Union: Percentage of Participants with Endoscopic Healing at Week 12 measure: Percentage of Participants with Clinical Response at Week 12 measure: Percentage of Participants with Symptomatic Remission at Week 56 measure: United States: Percentage of Participants With Endoscopic Improvement at Week 56 measure: European Union: Percentage of Participants With Endoscopic Healing at Week 56 measure: Percentage of Participants with Corticosteroid-free Clinical Remission at Week 56 measure: Percentage of Participants with Clinical Response at Week 56 measure: Percentage of Participants Histo-endoscopic Mucosal Improvement at Week 56 measure: Percentage of Participants with Symptomatic Remission at Week 56 Among Participants who had Symptomatic Remission at Week 12 measure: Percentage of Participants Who Achieve Endoscopic Normalization at Week 56 measure: Percentage of Participants With PUCAI Remission at Week 56 measure: Serum Concentration of Guselkumab During Induction Phase measure: Serum Concentration of Guselkumab During Maintenance Phase measure: Number of Participants with Incidence of Anti-guselkumab Antibodies measure: Percentage of Participants with Adverse Events (AEs) measure: Percentage of Participants with Serious Adverse Events (SAEs) measure: Percentage of Participants with AEs Leading to Discontinuation of Study Intervention sex: ALL minimumAge: 2 Years maximumAge: 17 Years stdAges: CHILD facility: Riley Hospital for Children status: RECRUITING city: Indianapolis state: Indiana zip: 46202 country: United States lat: 39.76838 lon: -86.15804 facility: UZ Gent status: RECRUITING city: Gent zip: 9000 country: Belgium lat: 51.05 lon: 3.71667 facility: UZ Brussel status: RECRUITING city: Jette zip: 1090 country: Belgium lat: 50.87309 lon: 4.33419 facility: Capital Institute of Pediatrics status: RECRUITING city: Beijing zip: 100020 country: China lat: 39.9075 lon: 116.39723 facility: Peking University Third Hospital status: RECRUITING city: Beijing zip: 100191 country: China lat: 39.9075 lon: 116.39723 facility: Changzhou No 2 Peoples Hospital status: RECRUITING city: Changzhou City zip: 213004 country: China facility: The Childrens Hospital Zhejiang University School Of Medicine status: RECRUITING city: Hangzhou zip: 310005 country: China lat: 30.29365 lon: 120.16142 facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine status: RECRUITING city: Hangzhou zip: 310016 country: China lat: 30.29365 lon: 120.16142 facility: Ruijin Hospital, Shanghai Jiao Tong University status: RECRUITING city: Shanghai zip: 200025 country: China lat: 31.22222 lon: 121.45806 facility: Shengjing Hospital of China Medical University status: RECRUITING city: Shenyang zip: 110004 country: China lat: 41.79222 lon: 123.43278 facility: Hvidovre Hospital status: RECRUITING city: Hvidovre zip: 2650 country: Denmark lat: 55.65719 lon: 12.47364 facility: AOU Policlinico Umberto I status: RECRUITING city: Roma zip: 00161 country: Italy lat: 41.89193 lon: 12.51133 facility: Kanazawa University Hospital status: RECRUITING city: Kanazawa zip: 920-8641 country: Japan lat: 36.6 lon: 136.61667 facility: Kobe University Hospital status: RECRUITING city: Kobe zip: 650-0017 country: Japan lat: 34.6913 lon: 135.183 facility: Japanese Red Cross Kumamoto Hospital status: RECRUITING city: Kumamoto zip: 861-8520 country: Japan lat: 32.80589 lon: 130.69182 facility: Shinshu University Hospital status: RECRUITING city: Matsumoto zip: 390-8621 country: Japan lat: 36.23333 lon: 137.96667 facility: Saga University Hospital status: RECRUITING city: Saga zip: 849-8501 country: Japan lat: 33.23333 lon: 130.3 facility: Tokyo Medical University Hospital status: RECRUITING city: Shinjuku zip: 160-0023 country: Japan lat: 35.2946 lon: 139.57059 facility: Osaka Medical and Pharmaceutical University Hospital status: RECRUITING city: Takatsuki zip: 569-8686 country: Japan lat: 34.84833 lon: 135.61678 facility: Saiseikai Yokohamashi Tobu Hospital status: RECRUITING city: Yokohama zip: 230-8765 country: Japan lat: 35.43333 lon: 139.65 facility: Korczowski Bartosz Gabinet Lekarski status: RECRUITING city: Rzeszow zip: 35-302 country: Poland lat: 50.04132 lon: 21.99901 facility: Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus status: RECRUITING city: Warszawa zip: 04 501 country: Poland lat: 52.22977 lon: 21.01178 facility: Instytut Pomnik Centrum Zdrowia Dziecka status: RECRUITING city: Warszawa zip: 04 730 country: Poland lat: 52.22977 lon: 21.01178 facility: Gazi University Medical Faculty status: RECRUITING city: Ankara zip: 06560 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06260150 id: ZXT briefTitle: Application of IPC During Surgery to Prevent Venous Thrombosis in Gastrointestinal Surgery Patients. overallStatus: ACTIVE_NOT_RECRUITING date: 2023-04-01 date: 2024-04 date: 2024-04 date: 2024-02-15 date: 2024-02-15 name: Feng Tian class: OTHER_GOV briefSummary: The goal of this clinical trial is to evaluate the effectiveness of intraoperative intermittent pneumatic compression (IPC) device usage in preventing lower extremity deep vein thrombosis (DVT) in patients undergoing gastrointestinal surgery.The main question it aims to answer is provide a reference basis for determining the efficacy of IPC application during gastrointestinal surgery for preventing lower extremity DVT in patients.

Participants are patients who require gastrointestinal surgery, specifically for the resection of gastrointestinal tumors. They will be divided into a control group and an experimental group. The experimental group will use an Intermittent Pneumatic Compression (IPC) device during surgery, while the control group will receive standard treatment. The objective is to observe whether the use of IPC during surgery can prevent the formation of Deep Vein Thrombosis (DVT) or lower the Risk of DVT. conditions: Gastrointestinal Neoplasms conditions: Stomach Neoplasms conditions: Intestinal Neoplasms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Intermittent Pneumatic Compression Devices measure: Incidence rate of DVT measure: Length of surgery measure: Intraoperative body temperature measure: Amount of bleeding during surgery sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shandong Provincial Hospital city: Jinan state: Shandong zip: 250021 country: China lat: 36.66833 lon: 116.99722 hasResults: False

 nctId: NCT06260137 id: UludagThorax briefTitle: Comparison of Two Different Methods for Reducing Pain After Lung Surgery overallStatus: ACTIVE_NOT_RECRUITING date: 2023-07-10 date: 2024-07 date: 2024-08 date: 2024-02-15 date: 2024-02-15 name: Uludag University class: OTHER briefSummary: The goal of this clinical study is to compare the effectiveness of the Rhomboid Intercostal Block and Sub-Servitus plan block and the effectiveness of the Rhomboid intercostal block in patients with video-supported thoracoscopic surgery. The main question it aims to answer is:

Which of these two blocks more effectively reduces the patients' pain? conditions: Postoperative Analgesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Rhomboid intercostal block name: Rhomboid intercostal and subserratus plane block measure: Postoperative analgesia sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hastane city: Bursa zip: 16210 country: Turkey lat: 40.19559 lon: 29.06013 hasResults: False

 nctId: NCT06260124 id: Greek Dancing-UTH briefTitle: Acute Physiological Effects of Greek Traditional Dancing overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2024-06-30 date: 2024-10-30 date: 2024-02-15 date: 2024-04-09 name: University of Thessaly class: OTHER briefSummary: In Greece, people of different age groups, including young children to older adults, are involved in traditional dance. To date, the well-know benefits of dancing include entertainment, socialization and increased physical activity. However, the acute effects of Greek traditional dancing on health, physical performance and muscle damage indices remain largely unknown. Therefore, the aim of this project is to evaluate the acute effect of Greek traditional dancing on health-, physical performance-, and muscle damage-related parameters by considering the impact of dancing tempo (slow vs moderate vs fast). In a crossover repeated measures design 10 pre- and 10 post-menopausal women will participate in the three dancing sessions of different tempo in a random order. conditions: Menopause conditions: Cardiovascular Health conditions: Body Composition conditions: Physical Performance conditions: Muscle Damage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: NONE count: 20 type: ESTIMATED name: Slow tempo name: Moderate tempo name: Fast tempo measure: Change in blood pressure measure: Change in perceived exertion measure: Change in blood lactate measure: Change in resting metabolic rate measure: Change in delayed-onset of muscle soreness (DOMS) measure: Change in maximal isometric voluntary contraction measure: Change in joint range of motion measure: Change in functional performance measure: Change in white blood cell count measure: Change in granulocyte count measure: Change in lymphocytes measure: Change in monocytes measure: Change in creatine kinase concentration measure: Change in reduced glutathione measure: Change in oxidized glutathione measure: Change in catalase activity measure: Change in protein carbonyls measure: Change in total antioxidant capacity measure: Change in heart rate measure: Change in oxygen consumption measure: Change in physical activity measure: Change in red blood cell count measure: Change in hematocrit measure: Change in hemoglobin sex: FEMALE minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06260111 id: SA23I0021 briefTitle: Photobiomodulation for Oral Mucositis and Functional Impairments During Hematopoietic Stem Cell Transplantation acronym: POMFITT overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2025-10-30 date: 2025-10-30 date: 2024-02-15 date: 2024-02-15 name: Universidad del Desarrollo class: OTHER name: Agencia Nacional de Investigación y Desarrollo name: Clínica Dávila briefSummary: The goal of this clinical trial is to test the efficacy of laser photobiomodulation in adult hematologic cancer patients undergoing hematopoietic stem cell transplantation (HSCT). The main questions it aims to answer are: • Is photobiomodulation with laser in the oral cavity, compared to standard care, effective in preventing oral mucositis and functional impairments in adult patients receiving HSCT? • What is the level of patient´s acceptability of photobiomodulation with laser in the oral cavity during HSCT? Participants once a day will receive photobiomodulation (diode laser device) in their oral cavity from the first day of transplantation conditioning until third day post-transplant. Researchers will compare with usual care to see if photobiomodulation helps preventing oral mucositis and functional impairment. conditions: Hematologic Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The design of the study consists of a randomized, controlled trial with parallel groups (photobiomodulation + usual care versus a control group with only usual care), allocation ratio of 1:1. primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Assessor will be blinded only for the secondary outcomes. The person responsible for statistical analyses will also be blinded. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Photobiomodulation name: Usual care measure: Oral Mucositis measure: Level of Pain measure: Handgrip strength measure: Exercise tolerance measure: Physical fitness measure: Health related quality of life measure: Length of hospital stay measure: Use of opioids measure: Body mass index measure: Nutritional status measure: Daily calorie intake measure: Arm circumference measure: Triceps skinfold sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinica Dávila city: Santiago state: Metropolitana zip: 8431657 country: Chile name: Tomás A López-Espinoza, MSc.C. role: CONTACT phone: +56962056755 email: tlopeze@udd.cl name: Hernán López, MD role: CONTACT phone: +56966795985 email: hernan.lopez@davila.cl name: Monica Peña, Nurse role: SUB_INVESTIGATOR lat: -33.45694 lon: -70.64827 hasResults: False

 nctId: NCT06260098 id: H23-0617 briefTitle: StressLess Yoga Study overallStatus: RECRUITING date: 2024-04-03 date: 2024-05-30 date: 2024-05-30 date: 2024-02-15 date: 2024-04-05 name: University of Connecticut class: OTHER briefSummary: The purpose of this study is to assess the feasibility and acceptability of using an asynchronous online yoga program to reduce stress. The study will use an 8 week asynchronous yoga intervention of two different types of yoga (high in breath work and meditation; low in vigorous movement/postures vs. low breath work and meditation; high movement/postures). In addition to self-report stress, measures include sleep, heart rate variability, mindfulness, Essential Properties of Yoga, and acceptability questions. conditions: Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: Yoga with High Breath work & meditation; Low movement/postures name: Yoga with Low Breath work & meditation; High movement/postures measure: The number (percentage)of people completing the whole protocol (6/8 yoga classes & 2 in-person visits) measure: The combined score (out of 35) on the 5-item Treatment Acceptability Questionnaire (TAQ) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bousfield Psychology Building, 406 Babbidge Road status: RECRUITING city: Storrs state: Connecticut zip: 06269 country: United States name: Crystal Park, PhD role: CONTACT phone: 860-486-3520 email: crystal.park@uconn.edu name: Crystal Park, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.80843 lon: -72.24952 hasResults: False

 nctId: NCT06260085 id: 686 briefTitle: Effect of Listening to Relatives' Voice Recordings on Chest Pain, Anxiety, and Depression in Coronary ICU Patients overallStatus: COMPLETED date: 2022-06-04 date: 2023-07-04 date: 2023-09-04 date: 2024-02-15 date: 2024-02-15 name: T.C. ORDU ÜNİVERSİTESİ class: OTHER briefSummary: The aim of the study was to evaluate the effect of listening to the voice recordings of relatives of patients with acute myocardial infarction (AMI) who were treated in the coronary intensive care unit on chest pain, anxiety and depression parameters of the patients.

Methods In the study, which was conducted as a randomised, controlled, experimental study, voice recordings of the family members of the patients were created and played to the patients through a music pillow. The study was carried out with 60 patients, 30 experimental and 30 control groups. Three tests were applied to the patients 15 minutes before, 15 and 30 minutes after the application. The data of the study were collected using the "Patient Introduction Form", "Hospital Anxiety Depression Scale", "Visual Analogue Scale" and "Patient Follow-up Form". conditions: Acute Myocardial Infarction conditions: Intensive Care Unit Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The clinical nurse collected the data whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: Relatives vioce record measure: Chest Pain measure: Anxiety, and Depression sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yasemin Kalkan Uğurlu city: Ordu zip: 52200 country: Turkey lat: 40.97782 lon: 37.89047 hasResults: False

 nctId: NCT06260072 id: IRB-HSR 21920 briefTitle: Magnesium and Riboflavin Treatment for Post-Concussion Headache overallStatus: RECRUITING date: 2020-02-10 date: 2024-12-31 date: 2024-12-31 date: 2024-02-15 date: 2024-02-16 name: University of Virginia class: OTHER briefSummary: This clinical trial will try to determine if the supplements magnesium and riboflavin will reduce the pain and duration of headaches in persons diagnosed with a concussion. The participant will be randomized to either active magnesium and riboflavin capsules or placebo (inert) capsules. The capsules will be taken once a day for 14 days. The participant will also complete a short diary form for the 14 days and will have 3 follow up visits either by telephone or in person. conditions: Concussion, Intermediate studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 108 type: ESTIMATED name: magnesium and riboflavin supplement measure: Headache Intensity and Duration sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: University of Virginia Student Health and Wellness Center status: RECRUITING city: Charlottesville state: Virginia zip: 22903 country: United States name: Karen Ahern, BSN MBA role: CONTACT phone: 434-924-1549 email: kaa7p@virginia.edu lat: 38.02931 lon: -78.47668 hasResults: False

 nctId: NCT06260059 id: STUDY23070148 id: Pitt2024 type: OTHER_GRANT domain: Pittsburgh Foundation briefTitle: Efficacy Of Sodium Glucose Transporter Inhibitor (SGLT2I) In Adult Patients With Congenital Heart Disease acronym: EmpaCHD overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2026-12-31 date: 2027-06-01 date: 2024-02-15 date: 2024-02-15 name: Anita Saraf class: OTHER name: The Pittsburgh Foundation briefSummary: The goal of the study is to investigate the feasibility and benefit of novel guideline-directed heart failure therapy drug Empagliflozin (Jardiance) for adult patients with congenital heart disease (ACHD). conditions: Adult Congenital Heart Disease conditions: Heart Failure studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Group 1: Empagliflozin 10 MG daily Group 2: Placebo primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Empagliflozin 10 MG name: Placebo measure: Change in Ejection fraction (EF) measure: Change in Myocardial characteristics (T1 mapping of cMRI) measure: Change in Myocardial characteristics (Global strain on MRI) measure: Change in Myocardial characteristics (Global strain on echocardiogram) measure: Change in functional exercise capacity of participants. measure: Number of Participants Hospitalized for Cardiac Reasons or heart transplantation measure: Number of Deaths measure: Change in inflammatory serum biomarkers measure: Change in functional Neuropsychological Testing measure: Change in New York Heart Association (NYHA) Class measure: Change Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Change in Kansas City Cardiomyopathy (KCCQ) measure: Change in Neuro-QOL sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Magee Women's Hospital city: Pittsburgh state: Pennsylvania zip: 15213 country: United States lat: 40.44062 lon: -79.99589 facility: Presbyterian Hospital city: Pittsburgh state: Pennsylvania zip: 15213 country: United States lat: 40.44062 lon: -79.99589 facility: Children's Hospital of Pittsburgh city: Pittsburgh state: Pennsylvania zip: 15224 country: United States lat: 40.44062 lon: -79.99589 hasResults: False

 nctId: NCT06260046 id: Robot Nx-SFTN briefTitle: Effect of Sufentanil on the Postoperative Pain overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-01-15 date: 2027-01-15 date: 2024-02-15 date: 2024-02-15 name: Seoul National University Hospital class: OTHER briefSummary: This study is a randomized, controlled trial. A total of 48 patients will be randomized to receive sufentanil or remifentanil during robot-assisted nephrectomy surgery. conditions: Postoperative Pain, Acute studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: Sufentanil name: Remifentanil measure: opioid consumption measure: Richmond Agitation-Sedation scale measure: Incidence of postoperative nausea and vomiting measure: Number of patients who administered antiemetics measure: Pain score sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul National University Bundang Hospital city: Seongnam country: Korea, Republic of name: Chang-Hoon Koo role: CONTACT email: vollock9@gmail.com lat: 37.43861 lon: 127.13778 hasResults: False